EBMRC Dr SOLTANI RDC

Evidence-Based Journal Club An

Overview

Akbar Soltani MDTehran University of Medical Sciences (TUMS)

Endocrine and Metabolism Research Center (EMRC)Evidence-Based Medicine Research Center (EBMRC)

Shariati Hospitalwwwsoltaniebmcom

wwwebmir

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

The ProblemsThe Problems

bull We need information to make decisions We need information to make decisions

bull How oftenHow often

From From 55 times for every times for every in-patientin-patient

To 2 times for every 3 out-patientsTo 2 times for every 3 out-patients

bull We get less than a third of itWe get less than a third of it

bull To keep up to date it is estimatedTo keep up to date it is estimated

I need to read 17 articles a day 365 days a I need to read 17 articles a day 365 days a yearyear

Covell DG Uman GC Manning PR Information needs in office practice Are they being met Ann Intern Med 1985103596-9

EBMRC Dr SOLTANI RDC

Sample scenario

bull In ICU patients do you suggest tight blood glucose control

bull Wrong format

EBMRC Dr SOLTANI RDC

Traditional approach

bull Pathophysiologic approach

bull Recency bias (in a paper that i read last night or a case that i had hellip

bull Rarity bias (complicationshellip)

bull Personal habit bias

bull Territory bias

bull In my experience (selection bias information biashellip)

EBMRC Dr SOLTANI RDC

bull Journal clubs are dying or dead in many clinical centers especially when they rely on a rotating schedule by which members are asked to summarize the latest issues of pre-assigned journals

Traditional journal clubTraditional journal club

bull UsefulnessUsefulnessbull Postman

EBMRC Dr SOLTANI RDC

Information Sources for Use at the Point of Care

Usefulness = Usefulness = Relevance x ValidityRelevance x Validity

WorkWork

POEM

EBM

EBMRC Dr SOLTANI RDC

1Translate these needs into answerable 1Translate these needs into answerable questionsquestions2 2 TrackTrack downdown the best evidence to answer them the best evidence to answer them3 3 AppraiseAppraise that evidence for its validity that evidence for its validity (closeness to the truth) and applicability (closeness to the truth) and applicability (usefulness in our clinical practices)(usefulness in our clinical practices)4Integrate that evidence with our clinical 4Integrate that evidence with our clinical expertise and expertise and applyapply it in practice (MDM) it in practice (MDM)5 5 EvaluateEvaluate our performance our performance

Evidence Based Medicine Evidence Based Medicine

EBMRC Dr SOLTANI RDC

bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage

bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution

part 1Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Pt Name Mr XY

Patient Elderly Stroke HTNhellip

Exposure Intervention Carotid Stenosis

(+- comparison)

Outcome Risk of (dying from) recurrent Stroke

Date and Place to be filled

Learner Resident

Discuss Search strategy

Search results

Validity

Importance of the valid results

Can you apply this to your pt

EBMRC Dr SOLTANI RDC

P P Among patients who are Among patients who are in ICU

I I does the use of intensive insulin therapy to maintain tight blood glucose control

C C standard therapy

OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying

Right formatRight format

PICOPICO

EBMRC Dr SOLTANI RDC

The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence

part 2Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession

part 3Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

Evidence Based Journal Club Evidence Based Journal Club part 3

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Definition

bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

The ProblemsThe Problems

bull We need information to make decisions We need information to make decisions

bull How oftenHow often

From From 55 times for every times for every in-patientin-patient

To 2 times for every 3 out-patientsTo 2 times for every 3 out-patients

bull We get less than a third of itWe get less than a third of it

bull To keep up to date it is estimatedTo keep up to date it is estimated

I need to read 17 articles a day 365 days a I need to read 17 articles a day 365 days a yearyear

Covell DG Uman GC Manning PR Information needs in office practice Are they being met Ann Intern Med 1985103596-9

EBMRC Dr SOLTANI RDC

Sample scenario

bull In ICU patients do you suggest tight blood glucose control

bull Wrong format

EBMRC Dr SOLTANI RDC

Traditional approach

bull Pathophysiologic approach

bull Recency bias (in a paper that i read last night or a case that i had hellip

bull Rarity bias (complicationshellip)

bull Personal habit bias

bull Territory bias

bull In my experience (selection bias information biashellip)

EBMRC Dr SOLTANI RDC

bull Journal clubs are dying or dead in many clinical centers especially when they rely on a rotating schedule by which members are asked to summarize the latest issues of pre-assigned journals

Traditional journal clubTraditional journal club

bull UsefulnessUsefulnessbull Postman

EBMRC Dr SOLTANI RDC

Information Sources for Use at the Point of Care

Usefulness = Usefulness = Relevance x ValidityRelevance x Validity

WorkWork

POEM

EBM

EBMRC Dr SOLTANI RDC

1Translate these needs into answerable 1Translate these needs into answerable questionsquestions2 2 TrackTrack downdown the best evidence to answer them the best evidence to answer them3 3 AppraiseAppraise that evidence for its validity that evidence for its validity (closeness to the truth) and applicability (closeness to the truth) and applicability (usefulness in our clinical practices)(usefulness in our clinical practices)4Integrate that evidence with our clinical 4Integrate that evidence with our clinical expertise and expertise and applyapply it in practice (MDM) it in practice (MDM)5 5 EvaluateEvaluate our performance our performance

Evidence Based Medicine Evidence Based Medicine

EBMRC Dr SOLTANI RDC

bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage

bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution

part 1Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Pt Name Mr XY

Patient Elderly Stroke HTNhellip

Exposure Intervention Carotid Stenosis

(+- comparison)

Outcome Risk of (dying from) recurrent Stroke

Date and Place to be filled

Learner Resident

Discuss Search strategy

Search results

Validity

Importance of the valid results

Can you apply this to your pt

EBMRC Dr SOLTANI RDC

P P Among patients who are Among patients who are in ICU

I I does the use of intensive insulin therapy to maintain tight blood glucose control

C C standard therapy

OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying

Right formatRight format

PICOPICO

EBMRC Dr SOLTANI RDC

The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence

part 2Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession

part 3Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

Evidence Based Journal Club Evidence Based Journal Club part 3

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Definition

bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Sample scenario

bull In ICU patients do you suggest tight blood glucose control

bull Wrong format

EBMRC Dr SOLTANI RDC

Traditional approach

bull Pathophysiologic approach

bull Recency bias (in a paper that i read last night or a case that i had hellip

bull Rarity bias (complicationshellip)

bull Personal habit bias

bull Territory bias

bull In my experience (selection bias information biashellip)

EBMRC Dr SOLTANI RDC

bull Journal clubs are dying or dead in many clinical centers especially when they rely on a rotating schedule by which members are asked to summarize the latest issues of pre-assigned journals

Traditional journal clubTraditional journal club

bull UsefulnessUsefulnessbull Postman

EBMRC Dr SOLTANI RDC

Information Sources for Use at the Point of Care

Usefulness = Usefulness = Relevance x ValidityRelevance x Validity

WorkWork

POEM

EBM

EBMRC Dr SOLTANI RDC

1Translate these needs into answerable 1Translate these needs into answerable questionsquestions2 2 TrackTrack downdown the best evidence to answer them the best evidence to answer them3 3 AppraiseAppraise that evidence for its validity that evidence for its validity (closeness to the truth) and applicability (closeness to the truth) and applicability (usefulness in our clinical practices)(usefulness in our clinical practices)4Integrate that evidence with our clinical 4Integrate that evidence with our clinical expertise and expertise and applyapply it in practice (MDM) it in practice (MDM)5 5 EvaluateEvaluate our performance our performance

Evidence Based Medicine Evidence Based Medicine

EBMRC Dr SOLTANI RDC

bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage

bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution

part 1Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Pt Name Mr XY

Patient Elderly Stroke HTNhellip

Exposure Intervention Carotid Stenosis

(+- comparison)

Outcome Risk of (dying from) recurrent Stroke

Date and Place to be filled

Learner Resident

Discuss Search strategy

Search results

Validity

Importance of the valid results

Can you apply this to your pt

EBMRC Dr SOLTANI RDC

P P Among patients who are Among patients who are in ICU

I I does the use of intensive insulin therapy to maintain tight blood glucose control

C C standard therapy

OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying

Right formatRight format

PICOPICO

EBMRC Dr SOLTANI RDC

The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence

part 2Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession

part 3Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

Evidence Based Journal Club Evidence Based Journal Club part 3

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Definition

bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Traditional approach

bull Pathophysiologic approach

bull Recency bias (in a paper that i read last night or a case that i had hellip

bull Rarity bias (complicationshellip)

bull Personal habit bias

bull Territory bias

bull In my experience (selection bias information biashellip)

EBMRC Dr SOLTANI RDC

bull Journal clubs are dying or dead in many clinical centers especially when they rely on a rotating schedule by which members are asked to summarize the latest issues of pre-assigned journals

Traditional journal clubTraditional journal club

bull UsefulnessUsefulnessbull Postman

EBMRC Dr SOLTANI RDC

Information Sources for Use at the Point of Care

Usefulness = Usefulness = Relevance x ValidityRelevance x Validity

WorkWork

POEM

EBM

EBMRC Dr SOLTANI RDC

1Translate these needs into answerable 1Translate these needs into answerable questionsquestions2 2 TrackTrack downdown the best evidence to answer them the best evidence to answer them3 3 AppraiseAppraise that evidence for its validity that evidence for its validity (closeness to the truth) and applicability (closeness to the truth) and applicability (usefulness in our clinical practices)(usefulness in our clinical practices)4Integrate that evidence with our clinical 4Integrate that evidence with our clinical expertise and expertise and applyapply it in practice (MDM) it in practice (MDM)5 5 EvaluateEvaluate our performance our performance

Evidence Based Medicine Evidence Based Medicine

EBMRC Dr SOLTANI RDC

bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage

bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution

part 1Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Pt Name Mr XY

Patient Elderly Stroke HTNhellip

Exposure Intervention Carotid Stenosis

(+- comparison)

Outcome Risk of (dying from) recurrent Stroke

Date and Place to be filled

Learner Resident

Discuss Search strategy

Search results

Validity

Importance of the valid results

Can you apply this to your pt

EBMRC Dr SOLTANI RDC

P P Among patients who are Among patients who are in ICU

I I does the use of intensive insulin therapy to maintain tight blood glucose control

C C standard therapy

OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying

Right formatRight format

PICOPICO

EBMRC Dr SOLTANI RDC

The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence

part 2Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession

part 3Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

Evidence Based Journal Club Evidence Based Journal Club part 3

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Definition

bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

bull Journal clubs are dying or dead in many clinical centers especially when they rely on a rotating schedule by which members are asked to summarize the latest issues of pre-assigned journals

Traditional journal clubTraditional journal club

bull UsefulnessUsefulnessbull Postman

EBMRC Dr SOLTANI RDC

Information Sources for Use at the Point of Care

Usefulness = Usefulness = Relevance x ValidityRelevance x Validity

WorkWork

POEM

EBM

EBMRC Dr SOLTANI RDC

1Translate these needs into answerable 1Translate these needs into answerable questionsquestions2 2 TrackTrack downdown the best evidence to answer them the best evidence to answer them3 3 AppraiseAppraise that evidence for its validity that evidence for its validity (closeness to the truth) and applicability (closeness to the truth) and applicability (usefulness in our clinical practices)(usefulness in our clinical practices)4Integrate that evidence with our clinical 4Integrate that evidence with our clinical expertise and expertise and applyapply it in practice (MDM) it in practice (MDM)5 5 EvaluateEvaluate our performance our performance

Evidence Based Medicine Evidence Based Medicine

EBMRC Dr SOLTANI RDC

bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage

bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution

part 1Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Pt Name Mr XY

Patient Elderly Stroke HTNhellip

Exposure Intervention Carotid Stenosis

(+- comparison)

Outcome Risk of (dying from) recurrent Stroke

Date and Place to be filled

Learner Resident

Discuss Search strategy

Search results

Validity

Importance of the valid results

Can you apply this to your pt

EBMRC Dr SOLTANI RDC

P P Among patients who are Among patients who are in ICU

I I does the use of intensive insulin therapy to maintain tight blood glucose control

C C standard therapy

OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying

Right formatRight format

PICOPICO

EBMRC Dr SOLTANI RDC

The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence

part 2Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession

part 3Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

Evidence Based Journal Club Evidence Based Journal Club part 3

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Definition

bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Information Sources for Use at the Point of Care

Usefulness = Usefulness = Relevance x ValidityRelevance x Validity

WorkWork

POEM

EBM

EBMRC Dr SOLTANI RDC

1Translate these needs into answerable 1Translate these needs into answerable questionsquestions2 2 TrackTrack downdown the best evidence to answer them the best evidence to answer them3 3 AppraiseAppraise that evidence for its validity that evidence for its validity (closeness to the truth) and applicability (closeness to the truth) and applicability (usefulness in our clinical practices)(usefulness in our clinical practices)4Integrate that evidence with our clinical 4Integrate that evidence with our clinical expertise and expertise and applyapply it in practice (MDM) it in practice (MDM)5 5 EvaluateEvaluate our performance our performance

Evidence Based Medicine Evidence Based Medicine

EBMRC Dr SOLTANI RDC

bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage

bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution

part 1Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Pt Name Mr XY

Patient Elderly Stroke HTNhellip

Exposure Intervention Carotid Stenosis

(+- comparison)

Outcome Risk of (dying from) recurrent Stroke

Date and Place to be filled

Learner Resident

Discuss Search strategy

Search results

Validity

Importance of the valid results

Can you apply this to your pt

EBMRC Dr SOLTANI RDC

P P Among patients who are Among patients who are in ICU

I I does the use of intensive insulin therapy to maintain tight blood glucose control

C C standard therapy

OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying

Right formatRight format

PICOPICO

EBMRC Dr SOLTANI RDC

The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence

part 2Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession

part 3Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

Evidence Based Journal Club Evidence Based Journal Club part 3

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Definition

bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

1Translate these needs into answerable 1Translate these needs into answerable questionsquestions2 2 TrackTrack downdown the best evidence to answer them the best evidence to answer them3 3 AppraiseAppraise that evidence for its validity that evidence for its validity (closeness to the truth) and applicability (closeness to the truth) and applicability (usefulness in our clinical practices)(usefulness in our clinical practices)4Integrate that evidence with our clinical 4Integrate that evidence with our clinical expertise and expertise and applyapply it in practice (MDM) it in practice (MDM)5 5 EvaluateEvaluate our performance our performance

Evidence Based Medicine Evidence Based Medicine

EBMRC Dr SOLTANI RDC

bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage

bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution

part 1Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Pt Name Mr XY

Patient Elderly Stroke HTNhellip

Exposure Intervention Carotid Stenosis

(+- comparison)

Outcome Risk of (dying from) recurrent Stroke

Date and Place to be filled

Learner Resident

Discuss Search strategy

Search results

Validity

Importance of the valid results

Can you apply this to your pt

EBMRC Dr SOLTANI RDC

P P Among patients who are Among patients who are in ICU

I I does the use of intensive insulin therapy to maintain tight blood glucose control

C C standard therapy

OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying

Right formatRight format

PICOPICO

EBMRC Dr SOLTANI RDC

The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence

part 2Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession

part 3Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

Evidence Based Journal Club Evidence Based Journal Club part 3

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Definition

bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

bull Journal club members describe patients who exemplify clinical situations which they are uncertain how best to diagnose or manage

bull This discussion continues until there is consensus that a particular clinical problem is worth the time and effort necessary to find its solution

part 1Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Pt Name Mr XY

Patient Elderly Stroke HTNhellip

Exposure Intervention Carotid Stenosis

(+- comparison)

Outcome Risk of (dying from) recurrent Stroke

Date and Place to be filled

Learner Resident

Discuss Search strategy

Search results

Validity

Importance of the valid results

Can you apply this to your pt

EBMRC Dr SOLTANI RDC

P P Among patients who are Among patients who are in ICU

I I does the use of intensive insulin therapy to maintain tight blood glucose control

C C standard therapy

OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying

Right formatRight format

PICOPICO

EBMRC Dr SOLTANI RDC

The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence

part 2Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession

part 3Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

Evidence Based Journal Club Evidence Based Journal Club part 3

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Definition

bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Pt Name Mr XY

Patient Elderly Stroke HTNhellip

Exposure Intervention Carotid Stenosis

(+- comparison)

Outcome Risk of (dying from) recurrent Stroke

Date and Place to be filled

Learner Resident

Discuss Search strategy

Search results

Validity

Importance of the valid results

Can you apply this to your pt

EBMRC Dr SOLTANI RDC

P P Among patients who are Among patients who are in ICU

I I does the use of intensive insulin therapy to maintain tight blood glucose control

C C standard therapy

OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying

Right formatRight format

PICOPICO

EBMRC Dr SOLTANI RDC

The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence

part 2Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession

part 3Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

Evidence Based Journal Club Evidence Based Journal Club part 3

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Definition

bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Pt Name Mr XY

Patient Elderly Stroke HTNhellip

Exposure Intervention Carotid Stenosis

(+- comparison)

Outcome Risk of (dying from) recurrent Stroke

Date and Place to be filled

Learner Resident

Discuss Search strategy

Search results

Validity

Importance of the valid results

Can you apply this to your pt

EBMRC Dr SOLTANI RDC

P P Among patients who are Among patients who are in ICU

I I does the use of intensive insulin therapy to maintain tight blood glucose control

C C standard therapy

OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying

Right formatRight format

PICOPICO

EBMRC Dr SOLTANI RDC

The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence

part 2Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession

part 3Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

Evidence Based Journal Club Evidence Based Journal Club part 3

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Definition

bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

P P Among patients who are Among patients who are in ICU

I I does the use of intensive insulin therapy to maintain tight blood glucose control

C C standard therapy

OO lead to improvements in ICU outcomereduce their risk of dying reduce their risk of dying

Right formatRight format

PICOPICO

EBMRC Dr SOLTANI RDC

The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence

part 2Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession

part 3Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

Evidence Based Journal Club Evidence Based Journal Club part 3

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Definition

bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

The results of the The results of the evidence searchevidence search on on the previous sessionrsquos problem are the previous sessionrsquos problem are shared in the form of photocopies of the shared in the form of photocopies of the abstractsabstracts of four to six systematic of four to six systematic reviews original articles or other reviews original articles or other evidenceevidence

part 2Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession

part 3Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

Evidence Based Journal Club Evidence Based Journal Club part 3

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Definition

bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

The The main partmain part of the journal club of the journal club session is spent in a session is spent in a critical critical appraisalappraisal of the evidence found in of the evidence found in response to a clinical question response to a clinical question posed two sessions ago and posed two sessions ago and selected for detailed study last selected for detailed study last sessionsession

part 3Evidence based journal clubEvidence based journal club

EBMRC Dr SOLTANI RDC

Evidence Based Journal Club Evidence Based Journal Club part 3

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Definition

bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Evidence Based Journal Club Evidence Based Journal Club part 3

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Definition

bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Definition

bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Definition

bull A Critically Appraised Topic (CAT) is ldquoa one- or two page lsquosummary of a search and critical appraisal of the literature related to a focused clinical question which should be kept in an easily accessible place so that it can be used to help make clinical decisionsrsquordquo

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Six Necessary Elements of CATs

bull 1 Date of completion (of the CAT)

bull 2 Question

ndash The person or problem being addressed

ndash The intervention or exposure being considered

ndash The comparison of the intervention or exposure when relevant

ndash The outcomes of interest

bull 3 Clinical Bottom Line (CAT summary should include applicability of results to your client)

bull 4 Evidence (CAT summary should include a summary of evidence)

bull 5 Gold Standard (For Diagnosis or Screening - compare to best test out there for Risk and Harm - compare to existing treatments

bull 6 Notes (important issues your reflections)

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Bottom line read in seconds

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Declarative title

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Get bottom line quickly (seconds)

Tight blood glucose control improves ICU survival

For every 29 patients given intensive insulin therapy to keep glucose 44-61 mmoll-1 compared to standard therapy one less patient dies in ICU (95 CI 17 to 101)

Increased risk of biochemical but not symptomatic hypoglycaemia

Level 1+ evidence

Summary of treatment effect and level of evidence

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Citation details and search strategy read in hours

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Read the study (for hours)

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Hyperlink to journal web site

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Citations Intensive Insulin Therapy in Critically Ill Patients NEJM 2001 345 1359 - 67Three-part Clinical Question In ICU patients does the use of intensive insulin therapy to maintain tight blood glucose control compared to standard therapy lead to improvements in ICU outcomeSearch Terms 1 exp sepsis or severe sep$tw or sept$tw or sepsi$tw (50301) 2 exp critical care or critical ca$tw or intensive ca$tw (22553) 3 exp insulin or insuli$tw (50202) 4 1 and 2 and 3 (25) 5 therapy filter (652119) 6 4 and 5 (17)

Search terms used for reference and to repeat in future

Read the study (for hours)

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Trial details read in minutes

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Key design validity features

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

The Study Single-blinded randomised controlled trial with intention-to-treat

The Study Patients All patients admitted to a surgical ICU in Belgium (62 had cardiac surgery) Median APACHE 9 (IQ range 7-13) Median TISS 43 13 had diabetes Randomised at ICU admission All patients given iv glucose on admission next day parenteral enteral nutrition or enteral nutrition alone Matched for blood glucose at admission Control group group (N = 783 783 analysed) Insulin infusion (1 Uml -1) started if glucose gt 12 mmoll-1 and titrated to range 100 - 111 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care Experimental group (N = 765 765 analysed) Insulin infusion (1 unitml) started if glucose gt 61 mmoll-1 and titrated to keep glucose in range 44 - 61 mmoll-1 Blood glucose checked 1 - 4 hourly algorithm used and discussion with study clinician not involved in patient care

Intervention (s)

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Outcome (s) of interest

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Control group event rate Experimental group event rate

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Relative risk reduction Absolute risk reduction

Negative risk reduction = an increase

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Read trial details (minutes)

Outcome Time to outcome

CER EER RRR ARR NNT

Mortality ICU 63783

008

35765

0046

43 0034 29

95 Confidence Intervals 001 to 0058

17 to 101

Hypoglycaemia

(biochemical)

ICU 6783

0008

39765

0059

-61 -0043 -23

95 Confidence Intervals -006 to

-0026-38 to

-17

Number needed to treat to benefit

Number needed to treat to harm

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Particularised for your own practice integrate with your expertise

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Remember to particularise for your patient1 Predominantly cardiac surgery patients (59 had CABG) could

this group be more like the DIAGMI group of patients 2 No main effect was reduction in deaths due to multiple organ

failure due a proven septic focus 3 No details provided of algorithm in article ndash aimed for

normoglycaemia Now available via NEJM website4 Reduction in sepsis and critical illness neuropathy but are EMG

recordings are a surrogate end-point5 Insulin is an inexpensive drug especially compared to activated

protein C and may be more widely applicable6 Only single episodes of hypoglycaemia reported with no physical

complications7 We have a higher MR death (and death due to sepsis) is more

common per 100 patients we need to treat fewer patients to save a life = NNT f = 29 3 = 10 Note this is a rough estimate

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Antioxidant vitamins did not reduce death vascular events or cancer in

high risk patients

presenter endocrine fellowsEMRC

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Q

bull Inpatients with a high risk of death does antioxidant supplementation reduce deathvascular eventsand cancer

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Design

bull RCT

bull Blinded

bull FU 5 y

bull Setting 69 UK hospitals

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Patients

bull 20536 patients who were 40-80y(28were gt70y 75men)

bull Total cholestrol gt35mmoll

bull 5y risk of death because history of CHD oclusive disease of noncoronary arteiesDMor treated HTN

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Exclusion Criteria

bull Indication of statin therapy

bull Abnormal LFT or RFT

bull Severe heart failure

bull COPD

bull Cancer

bull Indication Of high dose vitamin E

fu 997

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Intervention

bull Patients Synthetic vitamin E 600 mgd plus vitamin C 250 mgd B-caroten 20mgd

(n=10269)

bull Placebo(10267)

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Outcome

bull All causevascular or non vascular mortality

bull Secondary outcomecoronary(non fatal MI or death from CHD)

stroke

revascularisation

cancer

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Main results

bull Antioxidants did not differ from placebo for any outcome

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRI

(95CI)NNH

All cause mortality

141 1354

(-3_12)Not significant

Vascular

Mortality 86 82

5

(-5_15)Not significant

Non vas

Mortality 55 53

4

(-8_17)Not significant

Major coronary event

104 1022

(-6_11)Not significant

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Outcome Vitamins PlaceboRRR

(95CI)NNT

Stroke 5 51

(-12_13)

Not significant

Revascularisation

103 1062

(-6_10)

Not significant

Cancer 78 8

2

(-8_11)

Not significant

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Conclusion

Antioxidants did not reduce mortality

coronary events

stroke

revascularization or

cancer

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

In the name of godJournal club

Dr hasani ranjbarsh21 Jan 2006

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in

Women with Postmenopausal Osteoporosis

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

The New England Journalof Medicine

3505wwwnejmorg january

29 2004

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Q In postmenopausal women with osteoporosis is strontium ranelate

more effective than placebo for reducing the risk of vertebral fractures

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Designrandomized controlled trial Follow up3 Y

Blinded (patients and healthcare providers)

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Patient1649 women who were gt50 y of age and had been menopausal forgt 5y had gt1fracture confirmed by radiography and BMD (spine)lt0840gcm2

Exclusion criteria1)severe diseases that interfere with bone metabolism2)use of antiosteoporosis treatment

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

InterventionThroughout the study subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium depending on their dietary calcium intake) to maintain a daily calcium intake above 1500 mg and vitamin D (400 to 800 IU depending on the base-line serum concentration of 25-hydroxyvitamin D) After a run-in period of 2 to 24 weeks depending on the severity of the deficiency of calcium and vitamin D the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years

(casen=828)and(controln=821)

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Outcomebull New vertebral fracture the semiquantitative

grading scale was as follows grade 0 normal grade 1 a decrease in the height of any vertebra of 20 to 25 percent grade 2 a decrease of 25 to 40 percent and grade 3 a decrease of 40 percent or more

bull Non vertebral fracture andbull BMD (spine and proximal femur)

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Main Resultsfewer patients had height loss of at least 1 cm in the strontium ranelate group (301 percent) than

in the placebo group (375 percent P=0003) Over the entire three-year study period the strontium ranelate group had a 41 percent lower risk of a new vertebral fracture than the placebo group (209 percent vs 328 percent relative risk 059 95 percent confidence interval048 to 073 Plt0001)

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

In strontium group BMD had increased from base line by 127 percent at the lumbar spine 72 percent at the femoral neck and 86 percent at the total hip (Plt0001 for all three comparisons with base-line values) corresponding to differences between the placebo and the treatment groups at three years of

144 percent 83 percent and 98 percent

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Outcome Strontium PlaceboRRR

(95CI)

NNT

(CI)

New V Fx 21 3336

(24-47)

9

(7-14)

Vertebral Height Lossgt1cm

30 37520

(7-31)

14

(9-40)

Non Vertebral

Fx16 17

8

(-17-27)

Not

significant

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

ConclusionStrontium ranelate ingested daily reduced the

risk of new vertebral fractures by 49 percent at one year and by 41 percent over a three-year period among postmenopausal women with osteoporosis

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Commentarybull 2 trials (PREVOS and SOTI)showed that strontium

increased corrected BMD(lumbar) over 2 ybull Meunier showed strontium reduced morphometric

vertebral fracture by 47(NNT17)at 1y and 36 (NNT 9)by 3y

bull the reduction in the risk of vertebral fracture seems similar to the reduction reported with alendronate (47 percent)

5 mg of risedronate (49 percent) 60 mg of raloxifene(30 percent) and parathyroid hormone (65 percent after 21

months of treatment

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

CAT Ferritin can diagnose iron deficiency in the elderly

Clinical bottom line Serum ferritin can be very useful in diagnosing iron deficiency anemia in the elderly

Clinical scenario 75 yo retired schoolteacher (in for a check-up) found to have a Hb of 10 with an MCV of

80 a negative history and physical and no meds likely to suppress her marrow or cause a bleed I think her

probability of iron deficiency is 1 out of 2 or 50

Three-part question In an elderly symptomless woman with mild anemia would a serum ferritin help determine whether her bone marrow iron stores were depleted

Example Diagnosis

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Search terms In Best Evidence I searched on ldquoferritinrdquo and got six hits (plus normal value ) including a

great single study and an overview

Appraised by Sackett in the CEBM Oxford Friday July 09 1999

The study

Independent hellip Yes

Blind hellip Yes

Standard applied regardless of test result hellip Yes

Appropriate spectrum hellip Canrsquot tell

Target disorder and gold standard Bone marrow stained for iron

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Patients Consecutive anemic patients in several in-patient and out-patient settings Transfused patients excluded

Diagnostic test Serum ferritin by radioimmunoassay

The evidence

Present Absent

Test result No Prop No Prop LR

lt 15 474 059 20 001 5185

15ndash34 175 022 79 004 485

35ndash64 82 010 171 011 105

65ndash94 30 004 168 009 039

95 48 006 1332 075 008

Comments

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Critically Appraised Topic (CAT)Critically Appraised Topic (CAT)

A one page summaryA one page summary

bull Declarative titleDeclarative title

bull Bottom lineBottom linebull QuestionQuestionbull Name of paperName of paperbull Search termsSearch termsbull DesignDesignbull SettingSetting

bull PatientsPatients

bull InterventionInterventionbull Outcome MeasuresOutcome Measuresbull ResultsResultsbull TableTablebull Commentary and Commentary and

ConclusionConclusion

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

11The clinical question How it was The clinical question How it was formed formed (5 min)(5 min) 22HOW you found what you found HOW you found what you found (2 min)(2 min) 33WHAT you found WHAT you found (3 min) (3 min) 44The VALIDITY amp APPLICABILITY of The VALIDITY amp APPLICABILITY of what you found what you found (7 min) (7 min) 55How what you found will ALTER your How what you found will ALTER your MANAGEMENT of the patient MANAGEMENT of the patient (8 min)(8 min)

Making Your PresentationMaking Your Presentation

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

bull Be able to develop a well-built Be able to develop a well-built (PICO)(PICO) question from question from a clinical scenario a clinical scenario

bull Understand Understand key search termskey search terms and use them to identify and use them to identify relevant literature relevant literature

bull Critically appraiseCritically appraise an article in the style outlined by an article in the style outlined by Sackett et al Sackett et al

bull ApplyApply the results of the EBM process to the care of a the results of the EBM process to the care of a patient (clinical reasoning) patient (clinical reasoning)

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

bull Present journal club in an educational fashion Present journal club in an educational fashion giving equal emphasis to both the giving equal emphasis to both the clinical clinical contentcontent and the and the EBM processEBM process

bull Highlight one aspect of Highlight one aspect of study design or study design or statisticsstatistics during the journal club making it during the journal club making it relevant and useful to those in attendance relevant and useful to those in attendance

bull Contribute a well-done Critically-Appraised Topic Contribute a well-done Critically-Appraised Topic ((CATCAT) to the files ) to the files

Goals for Journal Club Goals for Journal Club

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Agenda

bull Introduction and problems

bull Conventional Vs Evidence-Based Journal club

bull What is CAT

bull Examples

bull Goals for journal club

bull Limitations of CATs

bull Summary

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Limitations bull 1048698First is the limited applicability of individual CAT

ndashCreated in busy practice

ndashIt is a single piece of evidence summarized

ndashIncomplete non-representative of the entire body of evidence

bull 1048698Individual CATs can be wrongndashFirst appear as drafts without peer review

ndashMay contain inferior evidence or errors of fact calculation or interpretation

bull 1048698They have a short ldquohalf liferdquo ndashbe obsolete as new evidence becomes available

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Bottom LineBottom Line

1 The new challenge in medicine is 1 The new challenge in medicine is information mastery (Vs content expert)information mastery (Vs content expert)

2 In order to survive in the information age 2 In order to survive in the information age every clinician needs tools based on the every clinician needs tools based on the information mastery equation information mastery equation

Usefulness = (Relevance x Validity) WorkUsefulness = (Relevance x Validity) Work

3 CATs have evolved to be highly useful 3 CATs have evolved to be highly useful

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

EBMRC Dr SOLTANI RDC

Thank you

EBMRC Dr SOLTANI RDC

Thank you