1. Disease Registers Dr John Newton
Consultant Epidemiologist,
Unit of Health-care Epidemiology
University of Oxford

2. Quality in the NHS depends on competence
Knowledge
Competence
Structures

3. High Quality Health Care
Education,
Training,
CPD, Information,
Libraries, R&D
High Quality Health Care
Clinical Governance,
Controls Assurance,
Learning Organisation,
IT, Clinical Audit,
User involvement,
Learning Hospital, etc…...

4. Source: BMJ 2003;326:

5. Ophthalmology Waiting List:
Analysis using survival analysis
waiting time
800
600
400
200
-200
Cum Survival
1.2
1.0 .8 .6 .4 .2
0.0
-.2
procedure group
other procedures
DCR
trabeculectomy
squint surgery
vitrectomy
lens surgery

6. “We will strengthen the information base on
chronic diseases in the population by establishing
a series of disease registers in different
parts of the country.”
Saving Lives: our healthier nation July 1999

7. maintain registers of those at greatest risk
“primary care trusts will identify and
maintain registers of those at greatest risk
from serious illness - concentrating particularly on areas where ill health is most prevalent – so that people can be offered preventive treatment”
(NHS Plan, paragraph 1.6).

8. Registers identified 234 registers
Contacted 117 of which 70 provided complete data

9. Types of register identified
Specific diseases 31
Cancer 29
Diabetes 27
CHD
Congenital anomalies 22
Cerebral palsy 8
HIV 6
Cystic fibrosis 5
Interventions 5
Mental health 5

10. Some specific disease registers
Ankylosing Spondylitis Register
Brittle Bone Disease Register
Central Register of Systemic Sclerosis Patients
Childhood Fatigue Register
Conn's Syndrome Register (primary hyperaldosteronism)
Cystinosis Register
Duchenne Muscular Dystrophy
European Neuronal Ceroid Lipofusinosis (Battens disease)

11. Generic registers
Biobank Target population

12. Uses of registers 1 Patient care regular review and recall
structured care programmes
monitoring high risk groups
managing demand / regulating access
communication
risk stratification

13. Uses of registers 2 Public Health surveillance
planning the provision of health care
monitoring the burden of ill health
monitoring the impact of prevention

15. Uses of registers 3 Technology assessment Research descriptive studies
improving the performance of clinical trials
studies of process
hypothesis testing when trials are not available

17. National audit of thalassaemia screening using UK registers
Ethnic Group No. of cases (%) offered screening
Cypriot (92)
Indian 46 (63)
Pakistani 76 (51)
Bangladeshi 7 (35)
Modell B, BMJ 2000

18. Service and research registers compared
Service use
Accuracy and timeliness are important
Value determined by number of cases
Internal consistency is important
Patients can opt out if they wish
Subjects need access to their own information on demand
Research use
Accuracy and completeness are important
Value from a representative group and adequate power
Internal and external consistency important
Non-consent is a problem for the whole register
costs of analysis and reporting should be considered

19. Issues raised in the study
Definitions
Need for evaluation
Standards of good practice
Costs and funding sources
Privacy and confidentiality
Service or research or both?
Appropriate population levels

20. The “IEA definition”
Register: In epidemiology the term register is applied to the file of data concerning all cases of a particular disease or other health-relevant condition in a defined population such that the cases can be related to a population base.
Last, 1995

21. Features of registers People not events
People registered having something in common
Information held is systematically updated
Register is based on a defined population
Donaldson, 1992

24. Characteristics of a good register
appropriate multidisciplinary team
stable funding
focused aims
data collection systems and design that relate well to function
relevant leadership
Pryor, 1985

26. Evaluation of a register should include
public health importance
systems and objectives
uses and outputs
evaluation against eight attributes
resources used
system meeting its objectives

27. Assessing validity Completeness Validity death certificate method
independent case ascertainment
historic comparisons
Validity
diagnostic criteria
re-abstracted data
internal consistency

28. I want to set up a register
Expert Group & Steering Group
Notify the Information Commissioner
Ethics approval
Arrange access to data
Data security
Accountability
Publicity

29. “The temptation to collect information is hard to resist.”
Weddell, 1973

30. Fundamental considerations
Case definition
Case ascertainment
Identification of duplicates
Follow up
Consent

31. Number of Tayside residents with known diabetes who were identified independently by each data source used in electronic record linkage
Type of treatment
Source of data Insulin Oral Diet
Encashed prescriptions
Hospital diabetes clinics
Young adult/paed. clinics
Mobile eye unit
Biochemistry database
Hospital discharge diag
Total

32. Satisfying the DPA 98
General awareness of uses of personal health data
Cogent reasons for not obtaining consent
Necessary for a legitimate “medical” purpose
Data controller should be a medical practitioner or owe an equivalent duty of confidence to the data subject

33. Satisfying the common law duty of confidentiality
Personal data should only be disclosed
with consent
where the law requires it
if it is in the public interest to do so

34. Consent
“any freely given specific and informed indication of his wishes by which the data subject signifies his agreement to personal data relating to him being processed.”
EC Directive 95/46/EC

35. Human beings have a right to privacy in a humane society but this right is not absolute in either an ethical or a legal sense.
Adapted from Higgs, 1996

36. Why not get consent? Disproportionate effort bias against ill disabled
disadvantaged
busy

37. Registers need identifiable data
To avoid double-counting
To link cases over time - follow up
For validation
To link to other databases

38. PERIC results 3921 adults in GB
Asked to assess a selection of vignettes (n=10)
How happy to allow access to their records?
2.1% of respondents were unhappy with all vignettes
11.6% of all responses were “unhappy”

39. “The only correct method of handling persons lost to follow-up is not to have any.”
Dorn, 1950

40. How much do registers cost?
from
CJD - £1.2 million pa
Cardiac intervention database - £500,000 pa to
Osteogenesis Imperfecta - research fellow half a day per week

41. Which registers to fund?
adequate quality
important problem
avoid duplication
exploit economies of scale
generic registers - “just in case”
funding according to function
long term funding

42. Recommendations National strategy
recognition of different purposes
establish agreed standards
system for appraisal
rational resource allocation
Public Health Observatories to collate and evaluate registers

43. Recommendations National co-ordinating centres to: develop methodology
provide advice to local registers
develop data standards for common diseases
practical support (questionnaire design etc.)
quality assurance
collate information at national level

44. Recommendations
The NHS should establish a research infrastructure funding programme, together with other sponsors, that could fund appropriate research registers.
How much is needed?
£200k pa x 10
£50k pa x 60
i.e. about £5 m pa in total

45. Conclusions Useful but obscure literature
Registers have a lot to contribute
Over 250 “registers” in England
Terminolgy confused, quality variable
Fragmentation of policy & strategy
Need for expert resource
No rational funding system
Uncertainty over data protection law