DATASET - landlaeknir.is

Report on a Recommended Minimum Dataset for Collection

in People with Diabetes

ScottishIntercollegiate

GuidelinesNetwork

S I G N 25SIGN PublicationNumber

June 1998

DEVELOPMENT GROUPProfessor Roland Jung Diabetes Physician, Ninewells Hospital and Medical School, Dundee(Chairman)Dr Lawrence Bidwell General Practitioner, DumbartonMr Douglas Boyle Computer Analyst, MEMO, Ninewells Hospital and Medical School, DundeeDr Jo Butt General Practitioner, Livingston, West LothianDr Ian Davey General Practitioner, EdinburghDr Rod Harvey Diabetes Physician, Dr Grays�s Hospital, ElginDr Ian Jones Director, Scottish Centre for Infections and Environmental Health, GlasgowDr Andrew Morris Diabetes Senior Lecturer, Ninewells Hospital and Medical School, DundeeDr Donald Pearson Diabetes Physician, Aberdeen Royal InfirmaryDr Sheila Reith Diabetes Physician, Stirling Royal InfirmaryProfessor Lewis Ritchie Professor of General Practice, University of AberdeenDr Tanya Siann Clinical Audit Coordinator, Kirklands Hospital, BothwellDr Peter Smail Diabetes Paediatrician, Aberdeen Royal InfirmaryMrs Audrey Stacey Information and Statistics Division, Scottish Office Department of HealthMrs Barbara Stewart Diabetes Nurse, Crosshouse Hospital, KilmarnockDr James Walker Diabetes Physician, Royal Infirmary of Edinburgh

SPECIALIST REVIEWERSMr Iain Bourne Compliance Manager - Health Sector, Data Protection RegistrarDr Clare Campbell General Practitioner, Broxburn, West LothianDr Kenneth Harden General Practitioner and Medical Secretary, Glasgow Local Medical CommitteeDr Angus MacCuish Consultant Physician, Glasgow Royal InfirmaryMr Bill McKechnie Audit Training Centre, Lanarkshire Health BoardDr David Matthews Chairman, Scottish Committee, British Diabetic AssociationDr Dorothy Moir Director of Public Health, Lanarkshire Health BoardDr Ken Paterson Consultant Physician, Glasgow Royal InfirmaryDr Norman Waugh Director, Scottish Health Purchasing Information Centre

Comments were also received from:Dr Alastair Bishop Clinical Computing SpecialistDr Jim Chalmers Information & Statistics Division, Scottish Office Department of HealthDr Bill Dodd Chairman, Diabetes Registers and IT Systems Steering Group, Scottish OfficeDr Tim Dyke Consultant in Public Health (Primary Care Services), Fife Health BoardDr Hamish McBride General Practitioner, Grampian Healthcare NHS TrustMs Mel Miller On behalf of the National Nursing, Midwifery and Health Visiting Advisory

Committee and the National Paramedical Advisory CommitteeDr R M Milne General Practitioner, AberdeenDr Sheena Parker Consultant in Public Health Medicine, Lothian Health BoardDr Michael Taylor Senior Lecturer, University of Aberdeen Department of General Practice and

Primary Care; and Chairman, GPASS Planning Group

STEERING COMMITTEE FOR IMPLEMENTATION OF THE ST VINCENT DECLARATION IN SCOTLANDProfessor Ian Campbell Scottish Representative, UK Department of Health/British Diabetic Association

Task ForceDr Aileen Keel Senior Medical Officer, Scottish Office Department of HealthDr Angus MacCuish Royal College of Physicians & Surgeons of Glasgow and Scottish Study Group

for the Care of Young DiabeticsProfessor James Petrie Royal College of Physicians of Edinburgh and member of the Clinical Resource

and Audit Group (CRAG)SIGN EDITORIAL BOARDDr Doreen Campbell CRAG Secretariat, Scottish OfficeDr Patricia Donald Royal College of General PractitionersDr Jeremy Grimshaw Health Services Research Unit, University of AberdeenMr Douglas Harper Royal College of Surgeons of EdinburghDr Grahame Howard Royal College of RadiologistsDr Peter Semple Royal College of Physicians & Surgeons of Glasgow

S I G N

Report on a Recommended Minimum Dataset for Collection

in People with Diabetes

Scottish Intercollegiate Guidelines Network

June 1998

SIGN SecretariatRoyal College of Physicians9 Queen StreetEdinburgh EH2 1JQ

http://show.cee.hw.ac.uk/sign/home.htm

Scottish Intercollegiate Guidelines Network

ISBN 1 899893 21 0

First published 1996 (as Annex to SIGN publication no. 4)Second edition 1998

SIGN consents to the photocopying of this publication forthe purpose of implementation in the NHS in Scotland

Contents

1 Introduction 1

2 Demographic information 4

3 Monitoring data 6

4 Outcomes data 10

5 Pregnancy data and births outcome 12

6 Additional data on the care of the young person with diabetes 14

7 Implementation of the minimum dataset7.1 Data collection 15

7.2 Data quality and standards 15

7.3 Confidentiality 15

AnnexExample annual update data collection form 18

References 20

1 Introduction

1.1 The implementation of the general goals and five year targets embodied in the St VincentDeclaration requires systematic monitoring of the key quality indicators of diabetes care.1 Toachieve this on a national basis for each and every diabetic patient requires the use of informationtechnology and a dataset which will ensure quality and complete retrieval of data.

1.2 The pilot SIGN dataset recommended for collection in diabetic patients was published in March1996.2 The present document updates these recommendations in light of experience gained inregister development,3-6 the implementation of new computer facilities, and the publication offurther SIGN guidelines on the different aspects of diabetes management. These guidelines are:

Prevention of visual impairment in diabetes 2

Management of diabetes in pregnancy 7

Report on good practice in the care of children and young people with diabetes 8

Management of diabetic renal disease 9

Management of diabetic foot disease 10

Management of diabetic cardiovascular disease.11

1.3 To achieve completeness of monitoring, it is essential to set up a computer register:

§ of all diabetic patients aggregated at a regional (Board) level which can then form part of anational collation

§ which encompasses all known diabetic patients whether followed up or otherwise in thecommunity or a hospital based setting

§ which uses the NHS number as the unique patient identifier

§ which is based on the Board of residence of the individual patient

§ which is updated continuously and audited on an annual basis.

1.4 A reasonably complete and accurate register of all diabetic patients can be achieved by thecollation of databases and local listings which are presently available. In Scotland, generalpractice lists of known diabetic patients have been found to be 91% complete for the diagnosisof diabetes, compared with a completeness of 96% for sophisticated electronic linkage ofdatasets.6 A register of known diabetic patients which is reasonably complete can be constructedif existing information is collated and verified.

1.5 To achieve complete and quality retrieval of information, it is essential that a register is based onthe minimum data necessary for this purpose. There are two major objectives:

1 To collect data to measure the outcome (end-point) indicators set out in the St VincentDeclaration (i.e. blindness, end stage renal failure, amputation, heart disease, and pregnancyoutcome).

2 To collect data of sensitive medical processing indicators which have been proven to influencelong term outcomes, and have been recommended in the SIGN guidelines on diabetesmanagement.2, 7-11 These indicators include:

§ microalbuminuria, proteinuria and serum creatinine, indicators of progressive renal disease,which is accelerated by elevated blood pressure 9

§ absence of foot pulses, an indicator of peripheral vascular disease, which is a risk factor foramputation 10

1 INTRODUCTION

1

MINIMUM DATASET FOR COLLECTION IN PEOPLE WITH DIABETES

§ reduced foot sensation, an indicator of peripheral neuropathy, which is a risk factor for skinulceration, itself a risk factor for amputation 10

§ retinal laser therapy, an indicator of sight-threatening eye disease which if left untreatedresults in blindness 2

§ serum cholesterol and smoking, both involved in the development of cardiovasculardisease 11

§ glycated haemoglobin, an indicator of glycaemic control, which is related to the risk ofdeveloping diabetic complications 2, 7-11

§ body mass index as a measure of obesity is associated with glycemic control, blood pressureand hyperlipidaemia, with the consequent risk of cardiovascular disease.11

These indicators would provide some evaluation of the quality of diabetes care and act asindicators of the effectiveness of changes necessary to achieve an improved outcome in order todeliver the targets set out in the St Vincent Declaration, i.e. that good care will result in a betteroutcome.

1.6 The minimum dataset comprises the following elements:

§ Demographic information

§ Process measures

§ Outcome indicators

§ Pregnancy data

§ Births outcome

§ Additional data on the care of the young person with diabetes.

1.7 To support the interchange of data between systems, the following standard filenames should beused while exporting or importing data:

1. Default Demographic information one record per patient

2. Monitor Recurring process measures one record per event date(monitoring file)

3. Outcomes Non recurring outcome indicators one record per patient(outcome file)

4. Pregnant Pregnancy data one record per pregnancy

5. Births Births outcome one record per birth/abortion

6. Young Additional data on the care of the one record per change in history/statusyoung person with diabetes

It is important that any adjustments of the file content and definitions of the minimum dataset foruse across all Boards in Scotland should be debated and agreed after wide consultation, and notadjusted by local decision independent of other areas.

1.8 The decision to use event based files (i.e. one record for each date on which an event occurred ora clinical sign was recorded) in the recurring process measures (�monitor� file), is based on the factthat certain variables such as the measurement of laboratory tests, eye screening, laser therapy andrecurrent episodes of myocardial infarction may occur on dates which do not necessarily coincidewith the date of the annual clinical screening review for the diabetic patient, and indeed may takeplace several times in any year. The dataset therefore requires to record multiple dates. If dates arerecorded within the file structure then one would only be able to record single events beforerequiring a separate record. To ensure data uniformity there must be one record per event date.

2

If data are collected continuously by computer and transferred electronically, it is advantageousto have every event date recorded and event based files should not cause any problem. If the dataare collected and returned by paper, event based files may cause difficulty and in this situation itmight be advisable to record the most recent data since the last return, although each and everyepisode (with dates) of myocardial infarction, laser therapy and amputation require capture (anexample data collection form is included in the Annex). The recommended minimum dataset isdesigned for future electronic usage throughout, but is compatible with paper usage until fullautomation is available.

1.9 The computer systems should support data transfer via �quote comma delimited� format andfollow open data standards (ODBC/JDBC) where possible, using the data structure defined insection 2. In �quote comma delimited� format:

§ Each field is separated by a comma

§ Text fields are surrounded by quotation marks

§ Date values must use a full four digits when representing year

§ Date separator is �/�

§ Leading zeros on date fields are not necessary.

Example �default� file record:

“1703750789”,,,”HART”,”JAMES”,”ANDREW”,,17/3/1975,”46 Andrews Terrace, Dundee”

,,,,”DD2 4DY”,1,”T1012”,,27/4/1997,,,

1.10 Outcomes data should be standardised to the European Standard Population based, whereappropriate, on five-year age bands. Outcomes will require analysis as for prevalence and incidence.

1.11 It is recommended that any adjustment of the file content and definitions of the minimum datasetfor use across Scotland should be decided nationally after debate and wide consultation and notadjusted by independent local decision.

1 INTRODUCTION

3


2 Demographic information

FILE �DEFAULT� (ONE RECORD PER PATIENT)

4

NHS number (CHI)

Principal treatinghospital patient number

Principal treating hospitalidentifierGeneral practice identifier

Present surname

1st forename

2nd forename

Previous surname

Date of birth

Postcode

Sex

Current practice registrationstatus

Date of diagnosis

Fasting glucose at diagnosis

2-hour OGTT at diagnosis

Random glucose at diagnosis

Field name

PT_NHS

PAT_ID

HOSP_ID

Field description

PRACID

SURNAME

FNAME1

FNAME2

OLDNAME

DOB

ADDR1

ADDR2

ADDR3

ADDR4

PCODE

SEX

STATUS

DTDIAG

FASTING

2HRGLU

RANDGLU

Parameters / Ranges / Constraints

Constraints as apply to CHI numberfor Scotland (10 digits)

14 characters

6 characters

6-digit practice code

20 characters

20 characters

20 characters

20 characters

dd/mm/yyyy (where ASCII)

35 characters

35 characters

35 characters

35 characters

8 characters

1 = Male, 2 = Female

1 = On practice list,2 = Not on practice list

dd/mm/yyyy (days & months optional)

(nn.n) mmol/l

(nn.n) mmol/l

(nn.n) mmol/l

Notes

1

2

2

3

4

5

6

7

8

9

ETHN_GP Ethnic grouping 0 = White, 1 = Black Carribean,2 = Black African, 3 = Indian,4 = Pakistani, 5 = Bangladeshi,6 = Chinese, 30 = Other

TYPE_DM Type of diabetes 1 = Type 1, 2 = Type 2,3 = Impaired fasting glucose,4 = Gestational, 5 = Other

9

9

10

NOTES

1 Demographic information must comply with the national standards according to the �Definitionsand codes for the NHS in Scotland� (NHS number, Hospital Patient Identifier, and Hospital Identifier).12

The recommended UK patient identifier is the NHS number which is a 10 digit number starting witha first digit of 0-3 in Scotland, allowing the current Community Health Number (CHI) to be compatiblewith the proposed NHS number. The current CHI number uses the first six digits to represent the dateof birth. As this may well be scrambled for data protection reasons in the future, no system shouldrely on the CHI number for the date of birth. The first 9 digits of the number are the unique patientidentifier and the 10th digit is a check digit used to confirm the validity of the number.

2 Systems must provide support for two other identifiers where the Community Health Number isnot available�a Hospital Patient Number and a Hospital Identifier. In certain sites, four additionalcharacters are used by COMPAS, requiring 14 characters for the Hospital Patient Number, i.e. fourcharacters for COMPAS and 10 characters for the Patient Identifier. Use of the NHS number, or theHospital Patient Number and the Hospital Identifier is mandatory. It should be noted that properlinkage of patient data at the regional level requires the use of the NHS number. Use of the NHSnumber throughout Scotland is a national priority.13

3 The practice code identifier is required to validate information if there is no hospital contact and aproblem arises (e.g. transcription error) with the NHS number.

4 Present surname, first forename and date of birth are also mandatory.

5 Phenotypic at birth.

6 The standard OPCS (Office of Population and Census Surveys) classification should be used.

7 This is required to record accurate prevalence data.

8 Where day and/or month are unknown, the format ??/??/1997 is recommended.

9 To ensure that a patient entered on the database has the appropriate diagnosis of diabetes mellitus,some measurement of blood glucose at diagnosis is required. This should be interpreted accordingto the prevailing agreed UK classification of diabetes. In some cases, a random or fasting bloodglucose will be sufficient; in others, the OGTT (glucose value two hours post 75g oral glucose)will be required.

10 Classification has been stated in line with American Diabetes Association recommendations, butthis has yet to be implemented in the UK and therefore the field is presently not mandatory.14

When updating this section, which has only one record per patient, an item (such as �address�) shouldonly be updated if new data presents itself (i.e. ignore null values).

2 DEMOGRAPHIC INFORMATION

5


3 Monitoring data

FILE �MONITOR� (ONE RECORD PER EVENT DATE)

Field name

PT_NHS

PAT_ID

HOSP_ID

DATE

PRACID

ANNUAL

DRUGS

HOSPCARE

CLINIC

WEIGHT

HEIGHT

BMI

SBP

DBP

CREAT

CHOL

ALBUSTIX

MAMETHOD

MAVALUE

MATEXT

MASTAGE

Field description

NHS number (CHI)

Principal treating hospitalpatient number

Principal treating hospitalidentifier

General practice identifier

Date of event

Annual review on this date

Hypoglycaemic drug therapy

Attends / does not attend ahospital diabetes clinic

Principal treating hospitaldiabetes clinic ID

Patient weight in kilograms- measured without shoes inindoor clothing

Patient height in metres- measured without shoes

Patient body mass index

Systolic blood pressure- mm Hg taken sitting

Diastolic blood pressure- mm Hg taken sitting

Serum creatinine

Serum total cholesterol(either fasted or unfasted)

Albustix positive (≥1+)

Defines method of urinaryalbumin measurement

Numeric result of urinaryalbumin relating to method

Where MA is not an exactmatch, use a '<' or '>' symbol

Albumin excretion (stages 1-4)



14 characters

6 characters


dd/mm/yyy

1 Yes, 2 = No

1 = Insulin only, 2 = Tablet only,3 = Insulin + tablets, 4 = None

1 = Attends, 2 = Does not attend

6 characters

>0 - 300 kg (nnn.n)

>0 - 2.50 m (n.nn)

(nn.n) kg/m2

(nnn) mm Hg

(nnn) mm Hg

(nnnn) µmol/l

(nn.n) mmol/l

1 = Yes, 2 = No

1 = albumin concentration mg/l,2 = albumin creatinine ratio (ACR) mg/mmol, 3 = timed overnight albuminexcretion rate µg/min, 4 = 24 hr albuminexcretion rate mg/24hrs

nnnn.n

'>' or '<'

1 = Stage 1 (Normoalbuminuria2 = Stage 2 (Microalbuminuria)3 = Stage 3 & 4 (Macroalbuminuria)

Notes

1

1

1

1

2

3

4

5

6

7

Monitoring file continues on page 8

6

NOTES

1 These four fields are repeated in each of the data files and are related to the original demographicfields in the �DEFAULT� file.

2 The recurrent process measures, which should be monitored at least annually, must each be dated.With event based files, each visit is recorded on the database. This field is used to record the date onwhich the annual review was completed and all data fields checked for completion.

3 BMI is calculated automatically from the above fields as weight/height 2 (kg/m2).

4 Local areas may wish to expand the lipid profile but for cross comparison and as an indicator ofsecondary prevention of ischaemic heart disease most evidence relies on total cholesterol and this istherefore the most appropriate monitoring indicator at present.

5 Local clinical biochemistry departments should be consulted concerning the specificity of proprietarydipsticks. Presence of dipstick proteinuria as defined above negates the need for microalbuminuriascreening.9

6 The urine specimen to check for microalbuminuria may be collected in several ways depending onlocal preference:

§ albumin concentration mg/l measured in first voided morning specimen

§ albumin creatinine ratio (ACR) mg/mmol measured on first voided morning specimen

§ timed collection under 24 hours, often overnight, of albumin excretion rate µg/min

§ 24 hour albumin excretion rate mg/24 hrs.

7 For cross comparison the value of albumin excretion by whatever method should be graded intothree stages as recommended in SIGN guideline on Management of Diabetic Renal Disease: 9

Stage 1 Normoalbuminuria

Stage 2 Microalbuminuria

Stage 3 & 4 Macroalbuminuria.

The staging definitions according to chosen method are as follows:

3 MONITORING DATA

7

The computer program should automatically grade the stage according to the method chosen.

First voidedalbumin

concentration mg/l

<20

20-200

>200

Albumin Excretion

Stage 1Normoalbuminuria

Stage 2Microalbuminuria

Stages 3 & 4Macroalbuminuria

Albumincreatinine ratio(ACR) mg/mmol

<3.5 women<2.5 men

≥3.5 women≥ 2.5 men

n/a

Timedcollection under24 hours µg/min

<20

20-200

>200

24 hour timedcollectionmg/24 hr

<30

30-300

>300


FILE �MONITOR� (ONE RECORD PER EVENT DATE)

Continued from page 6

GHB

SMOKER

MI

AMPUT_L

AMPUT_R

PULSES_L

PULSES_R

FTSENS_L

FTSENS_R

VA_L

VA_R

RETIN_L

RETIN_R

LASER_L

LASER_R

Glycated haemoglobin(HbA1c not HbA1)

Is patient a smoker?

Myocardial Infarct on this date

Amputation, left lower limb

Amputation, right lower limb

Any foot pulse - left

Any foot pulse - right

Foot sensation - left

Foot sensation - right

Visual Acuity - left (corrected)

Visual Acuity - right (corrected)

Diabetic Retinopathy - left

Diabetic Retinopathy - right

Commencement of lasertherapy (left eye) on this date

Commencement of lasertherapy (right eye) on this date

0.0 - 30.0% (nn.n)

1 = Current smoker, 2 = Ex smoker,3 = Never smoked

1 = Yes, 2 = No

1 = Transfemoral, 2 = Transtibial,3 = Forefoot

1 = Transfemoral, 2 = Transtibial,3 = Forefoot

1 = Present, 2 = Absent

1 = Present, 2 = Absent

1 = Normal, 2 = Impaired

1 = Normal, 2 = Impaired

4 characters : 6/4, 6/5, 6/6, 6/9, 6/12, 6/18, 6/24, 6/36, 6/60, 3/60, CF, HM, PL

4 characters : 6/4, 6/5, 6/6, 6/9, 6/12, 6/18, 6/24, 6/36, 6/60, 3/60, CF, HM, PL

1 = Present, 2 = Absent,3 = Not visualised

1 = Present, 2 = Absent,3 = Not visualised

1 = Yes, 2 = No

1 = Yes, 2 = No

8

Notes

9

10

11

12

13

14

15

8

NOTES

8 Glycated haemoglobin should be measured and recorded as HbA1c not HbA1.

NB: Direct electronic transfer of biochemical values from laboratory computers improves accuracyand capture, and is the preferred method of capture for the purpose of the register.

9 Record of recurrent myocardial infarction is used as an indicator of the success or otherwise ofsecondary prevention. In most situations a myocardial infarction will have occurred on a differentdate to the diabetic assessment. This will be accommodated by the use of event based files with aseparate record, with appropriate date, for each episode of myocardial infarction.

10 Amputation is defined as recommended in the SIGN guideline on Management of Diabetic FootDisease as removal of forefoot or part of the lower limb.10 This excludes loss of toes or singlemetatarsals. The record is one of amputation events with the appropriate date for every amputationepisode.

11 Foot pulses should be recorded as present if either one or both of the two major arteries (dorsalispedis and posterior tibial) of the foot are felt to pulsate upon physical palpation. The presence ofpulses by Doppler ankle pressure should be interpreted with cautionnormal readings may berecorded in the presence of medial arterial calcification and could be misleadinghence the emphasison physical palpation.

12 The measurement of foot sensation should be carried out as recommended in the SIGN Guideline onManagement of Diabetic Foot Disease.10 This consists of one or more tests and should be consideredimpaired if:

§ monofilament of 10 gram weight is not detected on the dorsum of the foot; and/or

§ vibration of a 128 Hz tuning fork over the medial malleolus for 5 seconds or more failure is notperceived; and/or

§ ankle jerk is absent (less reliable in the elderly).

13 Visual acuity should be recorded in the corrected state as either 6/4, 6/5, 6/6, 6/9, 6/12, 6/18, 6/24,6/36, 6/60, 3/60, CF (counting fingers), HM (hand movements), or PL (perception of light).

14 Where retinal examination is performed outwith the attending diabetic clinic, such as by eye van,ophthalmologist or optometrist, it is essential that this data capture is recorded.

15 In many situations laser therapy will have been applied on a different date to the diabetic assessment.This will be accommodated by a separate record of the recurring event date(s) on the �monitor� file.Often laser therapy is given as a course of treatment: the record refers to the commencement date ofa course of therapy. This record is an indicator of progressive sight-threatening eye disease.

3 MONITORING DATA

9


4 Outcomes data

FILE �OUTCOMES� (ONE RECORD PER PATIENT)

Field name

PT_NHS

PAT_ID

HOSP_ID

PRACID

YRLASER

BLIND

YRBLIND

YRCABG

YRANGINA

YRMI

YRSTROKE

YRULCER

YR1STAMP

YRRENAL

YRESRF

DOD

DEATHGRO

Field description

NHS number (CHI)




Year of commencement of firstdiabetes related laser therapy

Permanent blindness as defined

Year of onset of permanentblindness

Year of CABG / coronaryrevascularisation

Year of onset of angina / CHD

Year of first MI

Year of onset of neurologicaldeficit >24 hrs as defined

Year foot ulcer first observedYear of first lower limbamputationYear commenced renalreplacement therapy (dialysis,transplant)Year of end-stage renal failure

Date of death

Cause of death



14 characters

6 characters


yyyy

1 = Diabetic cause, 2 = Non-diabetic cause, 3 = Not known

yyyy

yyyy

yyyy

yyyy

yyyy

yyyy

yyyy

yyyy

yyyy

dd/mm/yyyy

ICD 9/10 code

Notes

1

2

9

10

8

7

6

5

4

3

10

NOTES

1 Year of commencement of first course of laser therapy to either eye for diabetic retinopathy / maculardisease.

2 Permanent blindness is defined as a permanent visual acuity corrected (i.e wearing corrective lenses)of <3/60 (i.e. CF, HM or PL) in the better eye.

3 Year of first cardiac revascularisation; angioplasty and/or coronary artery bypass graft.

4 Year of onset or clinical diagnosis of angina or objective evidence of coronary heart disease.

5 Year of onset of first myocardial infarction proven by ECG, cardiac enzymes or heart perfusion scanor other reliable methodology, but not on clinical features alone.

6 Year of first cerebrovascular accident (stroke), defined as rapidly developing signs of focal (and/orglobal) disturbance of cerebral function lasting more than 24 hours or leading to death with noapparent cause other than vascular origin.

7 Year of first foot ulcer on either foot, defined as any break in the epithelium greater than a crackbelow the level of the malleoli. (This outcome is required as an indicator of possible risk for futureamputation.)

8 Year of first amputation of forefoot or part of the lower limb. Excludes loss of toes or single metatarsals.

9 Year that either serum creatinine was chronically greater than 500 µmol/l (i.e. >500 µmol/l on twooccasions three months apart) or the patient was placed on permanent dialysis or received a renaltransplant. This field may be automatically collated by computer.

10 This field would be appropriately completed with ICD9/10 code by data linkage. From this, deathdue to coronary heart disease (a St Vincent target) could be ascertained.

4 OUTCOMES DATA

11


5 Pregnancy data and births outcome

FILE �PREGNANT� (ONE RECORD PER PREGNANCY)

0 = Normal, spontaneous vertexvaginal delivery, occipito-anterior,1 = Cephalic vaginal delivery withabnormal presentation of the head atdelivery, without instruments, with orwithout manipulation, 2 = Forceps,low application, without manipulation,forceps NOS, 3 = Other forcepsdelivery, forceps with manipulation,high forceps, mid-cavity forceps,4 = Vacuum extraction. Ventouse,5 = Breech delivery, spontaneous,assisted or unspecified partial breechextraction, 6 = Breech extraction, NOS.Version with breech extraction,7 = Elective (planned) caesariansection, 8 = Emergency andunspecified caesarean section,9 = Other and unspecified method ofdelivery, 10 = Aborted by any method

Field name

PT_NHS

PAT_ID

HOSP_ID

PRACID

PREG_NO

PDATE

DMODE

PNUMBER

MATMORT

Field description

NHS number (CHI)




Pregnancy episode number

Date of completion of episodee.g. date of delivery / abortion

Mode of delivery of fetus

Number of births / abortedfetuses in this pregnancy

Notes

Maternal mortality



14 characters

6 characters


nn

dd/mm/yyy

1 = Yes (died), 2 = No (did not die)

1 = Single birth, 2 = Twin birth,3 - 6 = 3 - 6 births

1

12

NOTES

Files �PREGNANT� and �BIRTHS� are designed to correspond with the COPPISH SMR database wherefeasible.

1 In chronological order (e.g. in 2nd pregnancy, PREG_NO = 2).

2 Abortion for the purpose of categories 10 and 11 is defined as loss of fetus before 24 weeks gestation.This field may subsequently be updated if the outcome alters, in particular as regards categories 3-5.If the situation is not validated, record 0.

3 Major malformation detected at birth or during the first year of life (i.e. one which results in death,requires major surgery, or has a major effect on the quality of life of the child).

Field name

PT_NHS

PAT_ID

HOSP_ID

PRACID

PREG_NO

FOUTCOME

GESTAGE

MALFORM

Field description

NHS number (CHI)




Pregnancy episode number

Fetal outcome

Gestational age for each fetusdelivered / abortedMajor malformation at birth orin first year of life



14 characters

6 characters


nn

0 = Live birth (requires validation)1 = Live birth (surviving >1yr),2 = Stillbirth (i.e. >24 weeks), 3 = Livebirth dying within the first 6 days (earlyneonatal death), 4 = Live birth dying onor after the 7th completed day butbefore the 28th day (late neonataldeath), 5 = Live birth dying on or afterthe 28th completed day, but before theend of the first year of life (postneonataldeath), 8 = Abortion of a dead fetus of amultiple pregnancy ending before 24weeks gestation in which the otherbabies are live born, 10 = Abortioninduced for congenital malformation,11 = Abortion for any other reason

nn (weeks)

Notes

1 = Yes, 2 = No

1

2

3

FILE �BIRTHS� (ONE RECORD PER BIRTH/ABORTION)

5 PREGNANCY DATA AND BIRTHS OUTCOME

13


Field name

PT_NHS

PAT_ID

HOSP_ID

PRACID

DATE

FHIST

PUBSTAT

Field description

NHS number (CHI)

Principal treating hospitalpatient numberPrincipal treating hospitalidentifier


Date of record

Family history of diabetes(IDDM) in 1st degree relative

Pubertal status



14 characters

6 characters


dd/mm/yyyy

1 = Yes, 2 = No

1= Pre, 2 = Pubertal, 3 = Adult

Notes

1

2

3

14

6 Additional data on the care of young peoplewith diabetes

FILE �YOUNG� (ONE RECORD PER CHANGE IN HISTORY/STATUS)

NOTES

1 A young diabetic is defined as a person diagnosed <15 years of age.

2 Family history of insulin dependent diabetes mellitus: IDDM is defined for this purpose as a personrequiring insulin <35 years of age.

3 Pubertal status is necessary as puberty alters glycaemic control and may influence comparisoncharacteristics.

7 Implementation of the minimum dataset

The development group considered separately the issues involved in implementation of theminimum dataset. A report on implementation has been been submitted to the Diabetes Registersand IT Systems Steering Group of the Scottish Office Department of Health Clinical Resource andAudit Group (CRAG) and will be published as an Annex to the report of that steering group.15

7.1 DATA COLLECTIONThe mechanism of collection and subsequent analysis must be robust if the data is to be a reliablerecord. The development group considered this issue in detail, and have made a number ofconsensus-based recommendations regarding responsibility for the diabetes register, the role ofthe facilitator, methods of data collection, the requirements of computer systems in primary careand hospital clinics, the relationship with the central register, and IT support requirements. Forfurther details, see the CRAG Diabetes Registers and IT Systems Steering Group report.15

7.2 DATA QUALITY AND STANDARDSThe St Vincent Declaration envisages that the development of outcomes should be an ongoingprocess of refinement which will necessitate review of the dataset at regular intervals. To achievethe desired goals, it is essential that the dataset not only records outcomes but also monitors themanagement of diabetes care. Local audit requirements may also require specific datasets inaddition to this minimum dataset. Nevertheless, it is crucial that the quantity of items collectedshould not dilute the quality or compromise the completeness of collection of the required dataset.

In order to assess the health care of the diabetic population, standards will be required to definethe desired completeness of data collection and quality of care. Such standards should reflectthose components critical to achieve if the desired health gains are to be monitored and confirmed.Such standards require wide acceptance before implementation and further discussion is requiredbetween the Royal Colleges, Scottish Office, British Diabetic Association, British MedicalAssociation, Boards, Trusts, Primary Care Purchasing Authorities and the professions involved.There is a need to consider the setting of standards as a two stage process, the first to ensure thata register is set-up and then delivers accurate and complete data, the second to ensure appropriateclinical standards of care are met.

For further details, see the CRAG Diabetes Registers and IT Systems Steering Group report.15

7.3 CONFIDENTIALITYConfidentiality will require careful consideration but should not hinder the development of aregister or its maintenance if the following are considered:

7.3.1 PATIENT CONSENTMedical confidentiality requires that informed individual patient consent is obtained prior toentry onto a register (as confirmed by the Data Protection Registrar). A clear information leaflet(see example at figure 1) would assist in the consultation regarding consent. Written opt-out orimplied consent are not acceptable. Entry of personal details is acceptable as the register is usedfor screening. Note that it is considered good practice to offer screening repeatedly unless thepatient makes it absolutely clear that they never wish to be contacted in this regard again.

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7 IMPLEMENTATION OF THE MINIMUM DATASET


Figure 1

EXAMPLE PATIENT LEAFLET

16

Diabetes Register

You have been diagnosed as having diabetes. There are many different types of thiscondition, and your doctor can give you further information. Whatever type of diabetes youhave it is important that you are seen regularly for check-ups. These check-ups will bearranged for you, any may be with your own General Practitioner, the practice nurse, or ahospital specialist.

Details of your health will be placed on your local diabetes register. This will be done forthe following reasons:

1. To make sure that you are given appointments for regular check-ups.

2. To share any information about you with other health professionals who may beinvolved with your care.

3. So that information about all patients with diabetes can be put together to planservices and to help our understanding of the condition.

The information about you is confidential, and will be stored securely. Only National HealthService staff will be able to see it, and only if they have a particular need to use theinformation. The staff who might see your information are:

§ Your General Practitioner, and his/her colleagues such as nursing staff andclerical staff who help to complete the form.

§ Hospital specialists to whom you have been referred, and their staff.

§ Health service statistics staff who analyse the information on the register.

Information which can identify you will not be given to anybody else without your writtenpermission.

You are welcome to see what information is held on the register, and you can ask for helpin understanding what it says. You are free to have your name and details removed fromthe register at any time, although this will make it more difficult for us to give you the besttreatment, and it will mean that we cannot use information about you to help others. If youare under sixteen, you should discuss any decision about removing your details with aparent or guardian.

If you would like any further information about this register, please ask your doctor or otherhealth service staff, or write to your Health Board.

7.3.2 INFORMATION TRANSFER TO THE CENTRAL REGISTERTransfer of information to the central register should not compromise confidentiality if there isboth informed individual patient consent and practice consent, and the information on one practice�spatients is kept strictly confidential from another. This would allow information for each practiceto be returned to that practice showing a comparison with the entire data received over a Board�sarea of jurisdiction. Data should be encrypted during transfer to maintain both security andconfidentiality.

7.3.3 AGGREGATION OF INFORMATION FOR AUDIT AND RESEARCHThe need to use the register for aggregated information for health service planning is acceptableas long as the relevant information is anonymised. This is based on the concept that in societyeveryone has a responsibility to the common good and therefore the use of the register for thebenefit of the population is acceptable. This would allow data on individuals to be linked toinformation on the same individual from other sources (e.g. SMR1). Although personal identifiersmay be used in the actual linkage, these must be removed subsequently and no identifiableindividual data should be issued or observed.

It is important to differentiate, in this context, health care requirements from research.16 If theregister is used as a framework for further research outside health care needs as defined above thenindividual patient consent will be required as each patient is protected by the common law dutyof confidentiality. At no time should a third party make direct contact with the patient for anysuch purpose: it is necessary to make initial contact with the patient�s general practitioner, whosepermission must be sought and who should be involved in seeking the consent of the patient toparticipate in the research.

7.3.4 CHILDRENAs this relates to children, it is acceptable for the patient to be on the register after consent.Separate permission should be obtained for all research studies. For young children, such consentshould come from the parents. For older children, the individual child�s consent should be soughtif that child is capable of understanding the implications. There is no set age when this occurs.

7.3.5 CUSTODIANSHIPCustodianship of any clinical data must be with a Data Ownership Group which should representall interested parties in the locality, including patient representation from the Local Health Councilor Local Diabetes Services Advisory Group. This group should oversee issues of confidentiality,ethical considerations, security and consent as well as ensuring the appropriate use of the data.The Group should also ensure compliance with NHSiS guidance and UK legislation.17 Researchand other uses involving the register should be registered with and approved by the Group. In eachData Ownership Group there should be one named person who would have overall responsibilityfor security and confidentiality issues. Likewise, there is need for a Scottish National CustodialGroup for the purpose of national collation and other uses. This group should have representationfrom the local Data Ownership Groups, Privacy Advisory Group, and the Data Protection Office.

7.3.6 IT SUPPORT AND TRAININGSystem security and storage should be professionally managed with local IT support and writtensecurity policies developed and observed.

Adequate training should be available for authorised users to ensure the maintenance ofconfidentiality, as most of the more serious violations of confidentiality and security arise fromwithin organisations due to ignorance.

17

7 IMPLEMENTATION OF THE MINIMUM DATASET


Annex

EXAMPLE ANNUAL UPDATE DATA COLLECTION FORM

This sample annual update form from the DARTS project is compatible with the recommended datasetand is designed to be optically scanned onto computer.6 The form has been pilot-tested in generalpractice in Dundee.

18

Example instructions for completion of patient annual update form

Please use BLOCK CAPITALS when completing this form.

Any colour pen can be used provided it contrasts well with the white background.

1 Please complete this form annually if possible for each diabetic patient for whom you are responsiblefor the annual patient review.

2 If demographic details such as Surname or Type of Care have changed, please make the relevantamendments on a Registration/Status form.

3 Please complete a Registration/Status form as well as this form the first time you see a new patient.DARTS will provide a list of all patients in your practice who are already registered.

4 This form provides an overview of the status of a diabetic patient in the year preceding the lastconsultation for diabetes. Please do not record data older than this except in the cases of amputationor dates of MI - these items are still relevant.

5 Where sections are not relevant e.g. not recorded in the last year, please leave blank.

6 Do not worry about making mistakes on the form. If you make a mistake, score it out and write in thecorrection next to the appropriate box.

PATIENTCommunity Health Index Number: All patients in Scotland have a CHI number consisting of the date ofbirth followed by 4 additional identifying digits. This must be entered.

Annual Review Date: Date of main annual review of patients diabetic condition. This must be recorded.

GENERAL/LAB This section must be completed.

Smoking: If a patient is a non-smoker, then cross the Non-Current box.

Height: May not have been measured in the last year but may still be accurate - record it in this case.

Biochemistry: Do not worry about returning biochemistry results if the lab you use is linked to theregional diabetes register. Ninewells, Stracathro and PRI labs are linked in Tayside.

MA Recording Method:1 = albumin concentration (mg/l)2 = albumin creatinine ratio (ARC, mg/ml)3 = timed overnight albumin excretion rate (µg/min)4 = 24 hr albumin excretion rate (mg/24 hrs)

EYESVisual Acuity: HM = Hand Movements, CF = Counting Fingers, PL = Perception of Light. A patientmay receive more than one course of laser therapy per eye in one year. This is recognised, but pleaserecord only the date of commencement of the most recent course of therapy in each eye.

Permanent Blindness: Corrected visual acuity < 3/60 or worse (CF, HM or PL) in the better eye.

FEETFoot sensation impaired if:§ Monofilament of 10 gram weight is not detected on the dorsum of the foot.§ Failure to perceive a vibration of a 128 Hz tuning fork over the medial malleolus for seconds or more.§ Absence of ankle jerk (less reliable in the elderly).Pulses: Absent if no pulse found in either major artery (dorsal pedis or posterior tibial) upon physicalpalpitation, otherwise Present.Amputation: Defined as removal of forefoot or part of the lower limb; excludes loss of toes or singlemetatarsals.

OTHER

MI: Record the latest two MI events regardless of whether they occur in the last year.Angina: Year of onset of clinical diagnosis of angina or objective evidence of coronary heart disease.Stroke: Focal neurological deficit with acute onset which lasts for more than 24 hours.

19

ANNEX

DIABETES MINIMUM DATASET

References

1 World Health Organisation (Europe) and International Diabetes Federation (Europe). Diabetes care andresearch in Europe: the St Vincent Declaration. Diabet Med 1990; 7: 360-370.

2 Scottish Intercollegiate Guidelines Network (SIGN). The Care of Diabetic Patients in Scotland. Preventionof Visual Impairment - Incorporating a report on a recommended minimum dataset for collection indiabetic patients. Edinburgh: SIGN, 1996 (SIGN Publication No. 4).

3 Greene SA, Robertson KJ on behalf of the Scottish Study Group for the Care of the Young Diabetic (SSG).(DIABAUD), Audit of the clinical management of insulin dependent diabetes in Scottish children andteenagers. Clinical Resource and Audit Group Report , March 1995.

4 Vaughan NJA, Home PD for RCP and BDA. The UK Diabetes Dataset: a standard for information exchangeDiabet Med 1995; 12: 717-722.

5 Piwernetz K, Home PD, Snorgaard O, Antsiferov M, Staehr-Johansen K, Krans M. Monitoring the targets ofthe St Vincent Declaration and the implementation of quality management in diabetes care. The DiabCareInitiative. Diabet Med 1993; 10:371-377.

6 Morris AD, Boyle DI, MacAlpine R, Emslie-Smith A, Jung RT, Newton RW, MacDonald. The diabetes auditand research in Tayside Scotland (DARTS) study: electronic record linkage to create a diabetes register.DARTS/MEMO Collaboration. BMJ 1997; 315: 524-528.

7 Scottish Intercollegiate Guidelines Network (SIGN). Management of Diabetes in Pregnancy. Edinburgh:SIGN, 1996 (SIGN Publication No. 9).

8 Scottish Intercollegiate Guidelines Network (SIGN). Report on Good Practice in the Care of Children andYoung People with Diabetes. Edinburgh: SIGN, 1996 (SIGN Publication No. 10).

9 Scottish Intercollegiate Guidelines Network (SIGN). Management of Diabetic Renal disease. Edinburgh:SIGN, 1997 (SIGN Publication No. 11).

10 Scottish Intercollegiate Guidelines Network (SIGN). Management of Diabetic Foot Disease. Edinburgh:SIGN, 1997 (SIGN Publication No. 12).

11 Scottish Intercollegiate Guidelines Network (SIGN). Management of Diabetic Cardiovascular Disease.,Edinburgh: SIGN, 1997 (SIGN Publication No. 19).

12 SMR & Standards Unit, ISD. Definitions and codes for the NHS in Scotland (5th Update, February 1997).

13 Scottish Office Department of Health. Designed to Care. Renewing the National Health Service in Scotland.1997.

14 Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care1998; 21 (Suppl 1): S5-S19.

15 Clinical Resource and Audit Group (CRAG) Diabetes Registers and IT Systems Steering Group. Overviewof Diabetic Registers and Diabetic IT Systems in Scotland. Edinburgh, CRAG. 1998 (in production).

16 Confidentiality, Implied Consent and the Common Law. Protec 1997; 4: 6-7.

17 Caldicott Committee. Report on the review of patient identifiable information. Department of Health.December 1997.

20

OTHER SIGN PUBLICATIONS

1 Clinical guidelines: Criteria for appraisal for national use (out of print - under review in 1998)

2 Prophylaxis of venous thromboembolism (out of print - under review in 1998)

3 Palliative radiotherapy for non-small-cell lung carcinoma (superceded by lung cancer guideline - no. 23)

4 Prevention of visual impairment in diabetes (March 1996)

5 Interface between the hospital and the community: The immediate discharge document (June 1996)

6 Hospital inpatient management of acute asthma attacks (August 1996)

7 Helicobacter Pylori: Eradication therapy in dyspeptic disease (August 1996)

8 Obesity in Scotland: Integrating prevention with weight management (out of print - under reviewin 1998/99)

9 Managment of diabetes in pregnancy (December 1996)

10 Report on good practice in the care of children and young people with diabetes (December 1996)

11 Management of diabetic renal disease (March 1997)

12 Management of diabetic foot disease (March 1997)

13 Management of patients with stroke, part I: Assessment, investigation, immediate management andsecondary prevention (May 1997)

14 Management of patients with stroke, part II: Management of carotid stenosis and carotid endarterectomy(May 1997)

15 Management of elderly people with fractured hip (July 1997)

16 Colorectal cancer (June 1997)

17 Investigation of asymptomatic microscopic haematuria in adults (August 1997)

18 Investigation of asymptomatic proteinuria in adults (August 1997)

19 Management of diabetic cardiovascular disease (August 1997)

20 Management of patients with stroke, part III: Identification and management of dysphagia (November1997)

21 Diagnosis and management of epilepsy in adults (November 1997)

22 Interventions in the management of behavioural and psychological aspects of dementia (February 1998)

23 Management of lung cancer (February 1998)

24 Management of patients with stroke, part IV: Rehabilitation, prevention and management of complications,and discharge planning (April 1998)

SIGN guidelines and reports are available free of charge within the NHS in Scotland. Elsewhere, a charge of £5.00per copy for publications no. 1-24 and £7.50 per copy for publications no. 25 onwards applies.

An additional charge is made for postage: 1-2 copies £1.00; 3-5 copies £3.00; 6-10 copies £5.00; 11-20 copies£6.00; 21-25 copies £7.00.

To order publications please contact the SIGN secretariat, Royal College of Physicians, 9 Queen Street, EdinburghEH2 1JQ. (Tel 0131 225 7324).

Please make cheques payable to �Royal College of Physicians of Edinburgh�.

SIGN guidelines and reports can also be downloaded free of charge from the SIGN website:


SIGN SecretariatRoyal College of Physicians9 Queen StreetEdinburgh EH2 1JQ


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