How to Ask A Good Question PICO

How to Ask A Good QuestionPICO

What is EBM?

How to make a clinical decision?

EBM

• "the conscientious, explicit and judicious use of current best evidence in making decisions about the care of the individual patient. It means integrating individual clinical expertise with the best available external clinical evidence from systematic research." (Sackett D, 1996)

• EBM is the integration of clinical expertise, patient values, and the best evidence into the decision making process for patient care.

The Steps in the EBM Process

6. Evaluate your performance with this patientSelf-evaluation

5. Return to the patient -- integrate that evidence with clinical expertise, patient preferences and apply it to practice

The patient

4. Appraise that evidence for its validity (closeness to the truth) and applicability (usefulness in clinical practice)

The evaluation

3. Select the appropriate resource(s) and conduct a search

The resource

2. Construct a well built clinical question derived from the case

The question

1. Start with the patient -- a clinical problem or question arises out of the care of the patient

The patient

Lifelong learning model

• A process of lifelong, self-directed, problem-based learning in which caring for one's own patients creates the need for clinically important information about diagnosis, prognosis, therapy and other clinical and health care issues.

• Target your reading to issues related to specific patient problems. Developing clinical questions and then searching current databases may be a more productive way of keeping current with the literature.

Why is EBM important?

• Physicians reported that their practice generated about 2 questions for every 3 patients

• Investigators found that physicians had about 5 questions for each patient. 52% of these question could be answered by the medical record or hospital information system. 25% could have been answered by published information resources such as textbooks or MEDLINE

• Studies have also shown that when clinicians have access to information, it changes their patient care management decisions

What is the best way to deliver 2-agonist therapy for the acute asthma patient in the ED?MDI with a holding chamber or Nebulizer ?

Physical Methods for Cooling

• Tepid sponging• Bathing• Fanning• Cooling blankets • Rubbing alcohol on the skin • Cool enemas• Ice packs

Is the Evidence Available?

• 145 cases and clinical decisions analyzed: – 31 could be supported by a randomized

controlled trial– 65 were supported by a head-to-head trial

(not a placebo-controlled trial)– 23 were supported by case-control or cohort

studies– 4 were supported by case series reports– 22 could not be supported with a study from

the literature

The EBM Process Pauline is a new patient who recently moved to the area to be closer to her son and his family. She is 67 years old and has a history of congestive heart failure brought on by several myocardial infarctions. She has been hospitalized twice within the last 6 months for worsening of heart failure. At the present time she remains in normal sinus rhythm. She is extremely diligent about taking her medications (enalapril, aspirin and simvastatin) and wants desperately to stay out of the hospital. She lives alone with several cats.You think she should also be taking digoxin but you are not certain if this will help keep her out of the hospital. You decide to research this question before her next visit.

Pauline

Can you construct a well built clinical question ?

Anatomy of a good clinical question

• Patient or problem – How would you describe a group of patients similar to yours? What are the

most important characteristics of the patient?

• Intervention, prognostic factor, or exposure – Which main intervention, prognostic factor, or exposure are you

considering? What do you want to do for the patient? Prescribe adrug? Order a test? Order surgery? What factor may influence theprognosis of the patient? Age? Co-existing problems? What was the patient exposed to? Asbestos? Cigarette smoke?

• Comparison – What is the main alternative to compare with the intervention?

• Outcomes – What can you hope to accomplish, measure, improve or affect?

Clinical Experience

Medical Students

Expert Practitioners

Background knowledge

Foreground knowledge

The structure of the question might look like this:

primary: reduce need for hospitalization; secondary: reduce mortality

Outcomenone, placeboComparison, if anydigoxinIntervention

congestive heart failure, elderly

Patient / Problem

For our patient, the clinical question might be:

In elderly patients with congestive heart failure, is digoxin effective in reducing the need for rehospitalization?

Oral, rectal or tympanic temperature?

Type of question

how to identify causes for disease (including iatrogenic forms)

Harm/ Etiology

how to estimate the patient's likely clinical course over time and anticipate likely complications of

disease

Prognosis

how to select treatments to offer patients that do more good than harm and that are worth the efforts and costs of using them

Therapy

how to select and interpret diagnostic tests Diagnosis

Type of Study Meta-Analysis

Systematic Review

Randomized Controlled Trial

Cohort studies

Case Control studies

Case Series/Case Reports

Animal research/Laboratory studies

The type of question is important and can help lead you to the best study design

economic analysisCost

prospective, blind comparison to gold standardClinical Exam

RCT>cohort study > case control > case seriesPrevention

cohort study > case control > case seriesPrognosis

RCT > cohort > case control > case seriesHarm/Etiology

prospective, blind comparison to a gold standardDiagnosis

RCT>cohort > case control > case seriesTherapy

Suggested best type of StudyType of Question

For our patient, the clinical question is:

In elderly patients with congestive heart failure, is digoxin effective in reducing the need for rehospitalization

It is a therapy question and the best evidence would be a randomized controlled trial (RCT). If we found numerous RCTs, then we might want to look for a systematic review.

Limit to randomized controlled trial as publication type

RCTType of study

therapyType of question

hospitalization rate of hospitalization

Outcome

none or placebo Comparison (if any)

digoxindigoxinIntervention

heart failure, congestive Limit to Aged

congestive heart failure, elderly

Patient Population

Clinical question

Clinical Scenario

MEDLINE strategy

Select a resource

• Colleagues • Summaries of the primary evidence

ACP Journal Club | Clinical Evidence | eMedicine | FPIN Clinical Inquiries | InfoPOEMs| UpToDate

• DatabasesMEDLINE | Cochrane Library

• Electronic textbooks and librariesACP Medicine | Harrisons | MD Consult | Stat!Ref

• Meta-Search EnginesSUMSearch | TRIP Plus: Turning Research into Practice

• ACP Online: http://www.acpjc.org/• Clinical Evidence:

http://www.clinicalevidence.com/• eMedicine: http://www.emedicine.com• FPIN: http://www.fpin.org• InfoPOEMS: http://www.infopoems.com/• UpToDate: http://www.uptodate.com• MEDLINE Access PubMed at:

http://www.pubmed.gov

Clinical Questions

Appraise evidence and make decision

Fore-ground

Background

Foreground or background question?

Map to question type

Map to study designs

Design and execute search

Map to resource

Choose database within resource

Textbook or other source

Clinical query

Henry is an active 5 year old boy. His mother brought him in for a check-up because Henry has had a fever and a sore throat for several days. You suspect Strep and take a throat culture. The standard treatment for Streptococcal Pharyngitisis oral Penicillin three times a day. However, for Henry and his mother, you are concerned about compliance and the expense of this medication.You recall that a drug representative recently told you that a daily dose of amoxicillin is just as good as penicillin, but costs less. You want to review the literature before you decide on amoxicillin for Henry and possibly changing your standard practice.

Based on this scenario, choose the best, well-built clinical question:

A. In children with strep throat, is amoxicillin as effective as penicillin for relief of symptoms?

B. What is the best treatment for relieving the symptoms of a sore throat?

C. Is amoxicillin better than penicillin for young children?

Experience on The Application of EMB

Evidence-Based Case Conference

Modified PBL

History

• A 68 year-old female is brought to the ED by her husband who is concerned that she is “not acting right”.

• The patient has been not eating well for several days, and has been increasingly confused.

• Intermittent “stomach pains” intermittently and vomiting

Vital signs

• Blood Pressure - 78/60 mmHg• Heart Rate - 120 beats/minute• Respiratory Rate - 24 breaths/minute• Temperature 38.50 C• Oxygen Saturation (SaO2): 100% on 2

liters via nasal cannula

Physical Exam

• General: patient responds verbally, but is weak appearing and somewhat confused

• HEENT: possible scleral jaundice• Neck: Soft, no JVD, no meningismus• Heart: Increased rate, no murmurs or rubs. • Respiratory: Mild basilar rhonchi in both lung

fields, no retractions• Abdomen: Soft, non-distended, RUQ tenderness

with deep palpation, no rebound or guarding• Extremities: no appreciable edema, rash, or

erythema

Labs

• WBC: 22,000/mm3• HCT: 30%• HCO3: 17 mEq/L• BUN: 60 mg/dL• Cr: 2.1 mg/dL• Total Bilirubin: 4.6 mg/dl• Alkaline Phosphatase: 223 U/L• Coagulation values: normal• Urinalysis: (+) urobilinogen• Blood, Urine, Sputum Cultures pending

Imaging

• ECG: sinus tachycardia with an old LBBB• Head CT: no acute changes• Chest x-ray: normal

Clinical Course • Within the first 3hs: 2 liters NS, Ceftriaxone

1g IV, and 500mg metronidazole 500 mg IVRepeat BP: 88/30 mmHg norepinephrineat 3 mcg/kg/min, BP increased to 105/60 with HR115, and she appeared somewhat improvedAdmitted to the ICU and arrived about 3 hours later when a bed became availableShe died shortly after arriving to the ICU

Mortality Conference

Patient Profile 16:27

• Age: 76 years old• Sex: male• Arrival: walk by himself• Vital signs: BT 37.6 PR 118 RR16

BP 132/78• Triage III

History

• A 76 y/o male suffered from progressive abdominal pain since yesterday afternoon after “painless” colonoscopy in a medical center

• Nausea(+), vomiting(+), no stool passage for 1 day

• Denied fever, tarry stool• PH: irritable bowel disease, constipation, GU,

appendicitis s/p op, denied hypertension and DM

PE

• Consciousness: clear E4M6V5• HEENT: no icteric, no anemic• Chest and heart: no specific findings• Abdomen: Soft, distended, mild diffuse

tenderness, no rebound pain, hypoactive bowel sound

• Extremities: no edema, warm, no rash

Management

• IV fluid with NS• Morphine 5mg IV st• CBC+DC/PL, BCS• KUB, CXR (Standing)

Lab 17:57

• WBC 24070 with Seg 87%, Band 2%• Hb: 16.3 Platelet: 175k

Management 18:20

• Primperan 10mg IV st• Fleet enema 1 BT st: Fail• Fleet enema 1 BT st again

Lab 18:43

• Na 132 K 4.5 Sugar 171 GOT 50• BUN 27 Cr 2.5• CRP 23.7

Progression (19:15)

• Abdominal pain exacerbation after the 2nd enema

• Vital signs: PR 116 RR 14 BP 104/56• On Monitor, 12-lead ECG, Cardiac

enzyme and D-dimer• Plain abdomen (Left decubitous view) and

Abdomen CT

Progression (20:00)

• Vital signs: PR 120, RR 36 BP 98/62• Intubation (RSI)• Fluid resuscitation and Inotropic agents• Antibiotics• Consult surgeon• No ICU bed available

Lab (20:10)

• ABG 7.301/35.7/205.1/17.8 (O2 mask 6L/min)

• TnT: neg, D-dimer 708

Progression 21:00

• Vital signs: PR 118 RR 22 BP 85/57• Admitted to ICU• Operation was performed until 00:50 due

to– Unstable hemodynamics– No key family member could make decision

OP Findings

• A huge perforation hole about 6x4cm was found on the anterior wall of the rectosigmoid area at the distance 18~20cm from the anal verge

• A marked gangrene change with impending perforation was seen on a segment about 50cm of small bowel, 80cm away from the ileocecalvalve

• There were multiple spots to patches of ischemic changes spreading on the whole colon and small bowel.

• The whole colon was congested, edematous. thick-walled and erythematous changes

What was happened?

• General surgeon: Colon perforation complicated with intestinal necrosis ( ischemic bowel disease)

• Operator of colonoscopy: colon perforation by enema, not related to colonoscopy

• EP????? ! !

Clinical Guidline

When to Perform Head CT in The Patients with Mild Head Injury

Yi-Kung Lee MDDepartment of Emergency Medicine

Buddish Tzu Chi Dalin General Hospital

Guidelines

• Clinical Policy: Neuroimaging and Decisionmaking in Adult Mild Traumatic Brain Injury in the Acute Setting (ACEP)

• Pratice Management Guidelines For The Management Of Mild Traumatic Brain Injury (Eastern Association for the Surgery of Trauma)

• New Orleans and Canadian Criteria• NICE Head Injury Guideline• NCWFNS Proposal• Results of The WHO Collaborating Center Task

Force on Mild Traumatic Brain

Clinical Policy: Neuroimaging andDecisionmaking in Adult Mild Traumatic Brain Injury in the

Acute Setting

Ann Emerg Med. August 2002;40:231-249

Inclusion Criteria

• Blunt trauma to the head within 24 hours of presentation to the ED

• Any period of posttraumatic LOC or of posttraumatic amnesia

• A GCS score of 15 on initial evaluation in the ED

• Age older than 15 years

Exclusion Criteria

• Presence of a bleeding disorder• Penetrating trauma• Patients with multisystem trauma• Focal neurologic findings

Core Questions

• Is there a role for plain film radiographs in the assessment of acute MTBI in the ED?

• Which patients with acute MTBI should have a noncontrast head CT scan in the ED?

• Can a patient with MTBI be safely discharged from the ED if a noncontrasthead CT scan shows no evidence of acute injury?

Outcome

• Presence of an acute intracranial abnormality on noncontrast head CT scan

• Is there a role for plain film radiographs in the assessment of acute MTBI in the ED?

• Recommendation B: – Skull film radiographs are not recommended

in the evaluation of MTBI. – Although the presence of a skull fracture

increases the likelihood of an intracranial lesion, its sensitivity is not sufficient to be a useful screening test. Indeed, negative findings on skull films may mislead the clinician.

• Which patients with acute MTBI should have a noncontrast head CT scan in the ED?

• Recommendation A: (New Orleans low risk criteria)– A head CT scan is not indicated in those patients with

MTBI who do not have • headache,• vomiting, • age greater than 60 years, • drug or alcohol intoxication, • deficits in short-term memory, • Physical evidence of trauma above the clavicle, or • seizure.

• Can a patient with MTBI be safely discharged from the ED if a noncontrast head CT scan shows no evidence of acute injury?

• Recommendation C: – Patients with MTBI who present 6 hours after

sustaining the injury, have a normal clinical examination, and who have a head CT scan that does not demonstrate acute injury can be safely discharged from the ED.

– Patients can be discharged after a shorter period of observation if they are under the care of a responsible third party.

Pratice Management Guidelines for The Management of Mild

Traumatic Brain Injury

The EAST Practice Management Guidelines Work Group

Copyright 2001 Eastern Association for the Surgery of Trauma

Mild Traumatic Brain Injury

• An injury caused by blunt acceleration/deceleration forces which produce a period of unconsciousness for 20 minutes or less and/or brief retrograde amnesia, a Glasgow Coma Scale score of 13 to 15, no focal neurological deficit, no intracranial complications (e.g. seizure activity), and normal computed tomography (CT) findings.

Recommendation

• CT of the brain is the gold standard diagnostic study for MTBI patients and should be performed on all patients sustaining a transient neurologic deficit secondary to trauma. A patients with a normal hCT has a 0 to 3% probability for neurologic deterioration, usually in patients with a GCS 13 and 14.

(N Engl J Med 2000;343:100-5.)

Low Risk Criteria Study

• Objective: To develop and validate a set of clinical criteria that could be used to identify patients with minor head injury who do not needto undergo CT

• Prospective cohort study (Dec 1997 ~ Jun 1999)• Two Phases study• Minor head injury, >3 y/o, <24 hours after the

injury

Definition of Minor Head Injury

• Loss of consciousness – witness or– the patient reported loss of consciousness– the patient could not remember the traumatic event

• Normal findings on a brief neurologicexamination– normal cranial nerves and normal strength and

sensation in the arms and legs

• A score of 15 on the Glasgow Coma Scale

Phase I

6.9%

X

Definition of Items• Headache: any head pain, whether diffuse or local.• Vomiting: any emesis after the traumatic event.• Drug or alcohol intoxication :on the basis of the history

obtained from the patient or a witness and suggestive findings on physical examination, such as slurred speech or the odor of alcohol on the breath. Measurements of blood alcohol and toxicologic tests were ordered at the discretion of the physician.

• A deficit in short-term memory : persistent anterograde amnesia in a patient with an otherwise normal score on the GCS

• Physical evidence of trauma above the clavicles: any external evidence of injury, including contusions, abrasions, lacerations, deformities, and signs of facial or skull fracture.

• Seizure : a suspected or witnessed seizure after the traumatic event.

• Coagulopathy : a history of bleeding or a clotting disorder or current treatment with warfarin.

Phase II

Sensitivity 100%! (95-100%)

Positive CT Findings

Conclusion

JAMA. 2005;294:1511-1518

Lancet 2001; 357: 1391–96

Clinical Decision Rule

• To develop a highly sensitive clinical decision rule for use of CT in patients with minor head injuries

• Prospective cohort study• Adults who presented with a GCS score of

13–15 after head injury• From 1996 to 1999

Inclusion Criteria

• Blunt trauma to the head resulting in witnessed loss of consciousness, definite amnesia, or witnessed disorientation; and

• Initial emergency department GCS score of 13 or greater as determined by the treating physician; and

• Injury within the past 24 h• 3121 patients

Exclusion criteria• < 16 years old• Minimal head injury (ie, no loss of consciousness,

amnesia, or disorientation)• No clear history of trauma as the primary event (eg,

primary seizure or syncope)• Obvious penetrating skull injury or obvious depressed

fracture• Acute focal neurological deficit • Unstable vital signs associated with major trauma • A seizure before assessment in the emergency

department • Bleeding disorder or used oral anticoagulants (ie,

coumadin) • Returned for reassessment of the same head injury • Pregnancy

Outcome Measure

• The primary outcome was need for neurological intervention (3121/3121)– either death within 7 days secondary to head injury or

the need for any of the following procedures within 7 days:

• craniotomy, elevation of skull fracture, intracranial pressure monitoring, or intubation for head injury (shown on CT).

• The secondary outcome was clinically importantbrain injury, on CT. (2078/3121, 67%)– Any acute brain finding revealed on CT and which

would normally require admission to hospital and neurological follow-up

Lancet 2001; 357: 1391–96

Lancet 2001; 357: 1391–96

Variables

Lancet 2001; 357: 1391–96

Lancet 2001; 357: 1391–96

Lancet 2001; 357: 1391–96

External Validity

• External Validation of the Canadian CT Head Rule and the New Orleans Criteria for CT Scanning in Patients With Minor Head Injury

• Dutch prospective study

• >16 y/o

JAMA. 2005;294:1519-1525

CT Findings

JAMA. 2005;294:1519-1525

Validation

JAMA. 2005;294:1519-1525

Comparison of the CCHR and NOC

• Canadian prospective study• (1) blunt trauma to the head resulting in

witnessed loss of consciousness, definite amnesia, or witnessed disorientation; (2) initial ED GCS score of 13 or greater as determined by the treating physician, and (3) injury within the previous 24 hours

JAMA. 2005;294:1511-1518

Clinical Outcome

JAMA. 2005;294:1511-1518

JAMA. 2005;294:1511-1518

Sensitivity and Specificity

JAMA. 2005;294:1511-1518

Sensitivity and Specificity

JAMA. 2005;294:1511-1518

Realities

Emerg. Med. J. 2004;21;420-425

Before application of CCHR

Realities

Emerg. Med. J. 2004;21;420-425

After application of CCHR

Compliance

Emerg. Med. J. 2004;21;420-425

Compliance

Emerg. Med. J. 2004;21;420-425

Impaction

Emerg. Med. J. 2004;21;426-428

NICE (National Institute forClinical Excellence) Head

Injury GuidelineHead injury

Triage, assessment, investigation and earlymanagement of head injury in infants,

children and adultsJune 2003

Developed by the NationalCollaborating Centre for Acute Care

Definitions

• Infants<1 y/o, children 1–15 y/o and adults >16 y/o, the ‘infants and young children’ < 5y/o

• ‘Head injury’: any trauma to the head, other than superficial injuries to the face.

• The primary patient outcome of concern throughout the guideline is “clinically important brain injury’.

Selection of patients for CT imaging of the head

• Patients who have sustained a head injury and present with any one of the following risk factors should have CT scanning of the head immediately requested.– GCS < 13 at any point since the injury.– GCS = 13 or 14 at 2 hours after the injury.– Suspected open or depressed skull fracture.– Any sign of basal skull fracture (haemotympanum, ‘panda’ eyes,

cerebrospinal fluid otorrhoea, Battle’s sign).– Post-traumatic seizure.– Focal neurological deficit.– More than one episode of vomiting (clinical judgement should be used

regarding the cause of vomiting in those aged <12 y, and whetherimaging is necessary).

– Amnesia for greater than 30 minutes of events before impact. Theassessment of amnesia will not be possible in pre-verbal children and is unlikely to be possible in any child aged under 5 years.

Selection of patients for CT imaging of the head

• CT should also be immediately requested in patients with any of the following risk factors, provided they have experienced some loss of consciousness or amnesia since the injury:– Age 65 years.– Coagulopathy (history of bleeding, clotting disorder,

current treatment with warfarin).– Dangerous mechanism of injury (a pedestrian struck

by a motor vehicle, an occupant ejected from a motor vehicle or a fall from a height of greater than 1 metreor five stairs). A lower threshold for height of falls should be used when dealing with infants and young children (that is, aged under 5 years).

Evaluate the impact of the NICEhead injury guidelines

• Before/ after study• month A, six months

before the implementation of NICE (Nov 2002 at NTGH and May 2003 at Hope), and month B, one month after the implementation of NICE (May 2003 at NTGH and Jan 2004 at Hope).

Emerg. Med. J. 2005;22;845-849

Emerg. Med. J. 2005;22;845-849

Conclusion

• cost effectiveness should not be a barrier for the implementation of the NICE head injury guidelines in UK EDs

Clinical Performance of NICE Recommendations versus

NCWFNS Proposal in Patients with Mild Head Injury

JOURNAL OF NEUROTRAUMAVolume 22, Number 12, 2005

• Over a 5-year period, the clinical data of 7,955 adolescent and adult patients with mild head injury were prospectively collected

Results

• Three hundred fifty-four patients (6.8%)had intracranial lesions on computed tomography (CT) scan;

• Neurosurgical intervention was needed in 108 patients (1.3%), and

• An unfavorable outcome occurred in 54 patients (0.7%) at 6-month follow-up.

Favor!

Favor!

Meta-Analysis (for Risk Factor Analysis)

• Cohort or nested cohort studies• MEDLINE and EMBASE were searched from

01/1990 to 06/2002• Grey literature• The reference lists of guidelines developed by

the American Academy of Pediatrics, The Eastern Association for the Surgery of Trauma, The Scottish Intercollegiate Guidelines Network, and The Royal College of Surgeons of England

JOURNAL OF NEUROTRAUMA,21(7),877-885 2004

• 83,636 patients from 35 papers• Present relative risk ratios for 23 clinical

variables that may predict the presence of significant intracranial injury in adults sustaining minor head injury

Clinical History

JOURNAL OF NEUROTRAUMA,21(7),877-885 2004

Mode of Injury

JOURNAL OF NEUROTRAUMA,21(7),877-885 2004

Clinical Exam&Imaging

JOURNAL OF NEUROTRAUMA,21(7),877-885 2004

JOURNAL OF NEUROTRAUMA,21(7),877-885 2004

DIAGNOSTIC PROCEDURES IN MILD TRAUMATIC BRAIN INJURY: RESULTS OF THE WHO

COLLABORATING CENTRE TASK FORCE ON MILDTRAUMATIC BRAIN INJURY

J Rehabil Med 2004; Suppl. 43: 61–75