Presentation MRCG October 2012

1. Presentation MRCG October 2012 Fionnuala Donohue

2. Presentation Outline • Requirements • Description Research Components • Research Findings • Recommendations

3. Requirements • Thorough assessment of patient registries in Ireland • Agreed definition of registry • Identification of registries that currently exist • Detailed inventory of registries in Ireland via questionnaire • Literature review & expert opinion on critical issues • Research to provide recommendations for future development of registries

4. Definition “an organized system that uses observational study methods to collect uniform data (clinical and other) ….. for a population defined by a particular disease, condition or exposure, and that serves one or more predetermined scientific, clinical or policy purposes.” Association for Healthcare Quality and Research in America (AHRQ 2007)

5. Research Components • International Guidelines for registries • Identification of Registers in Ireland • Survey with Registers • Stakeholder Interviews • Focus Groups with Patients

6. Guidelines

9. Identification of Registries

10. Identification of Registries • Previous work by Newton & Garner in UK 2002 (postal survey) and National Health and Medical Research Council in Australia 2007 (peer consultation & search strategy) • The establishment of an information board at the 2008 Healthcare Informatics Society of Ireland annual meeting • The examination of the website of the Office of the Data Protection Commissioner. • A search in PubMed and a web based search • A canvas of 250 stakeholders from healthcare services, academic bodies and clinical societies.

11. Outcome of identification process • Canvas response rate 70% (175/250) • 102 provided information on registries • Smaller number of additional registries identified through search strategy • Process validation & de-duplication • End outcome 47 registries currently active

12. Survey Results

13. Survey Results General • Response rate 70.2% (33/47) • 75.8% National/Regional • 42% ≤ 100 new cases/year • 58% held on server, 1 on paper & 71% paper element in data transfer • 21% had web enabled data access

15. Year data collection started

16. Survey Results Uses

17. Survey results standards • 39% registries 100% coverage, 30% < 50% • 60% assessed coverage within 12 mths • 58% used a case definition • 51% used a data dictionary • 54% carried out regular data validation • 70% carried out data de-duplication (70% software) • 77% followed up missing data (58% contact with original clinical source

18. Survey Results Standards

19. Survey Results Consent • 73% used some form of consent • 46% used written consent • 75% had an “opt out” system • Of the 27% with no consent 55% also did not have an opt out system

20. Consent

21. Governance structures & processes

22. Survey Results Resources • 21% of registers had no staff directly employed • For those with staff (79%) • 69% two or less staff members • 27% between three and ten staff • 88% of registers (including 71% of those with no staff) had a named administrator. • Availability of expertise • 30% no statistical support • 3% no clinical support • 6% no IT support

23. Survey Results Resources Initial Funding • 68% state funds • 12% commercial funding • 20% funding through a charity Ongoing Funding • 72% state funding • 12% funding through a charity • 4% commercial funding • 12% no funding • 3 registers had dual funding

24. Comparative Analysis

27. Lessons Learnt • 63% good quality consistent data that is used • 37% stakeholder involvementimproves data quality & utility • 26% resources esp for staff training to ensure quality data • 19% importance of giving enough resources to planning and implementation phase

28. Way Forward • 26% continuity in resource allocation • 22% improved IT • 22% introduction of national standards • 19% legislation

29. Focus Groups

30. Methodology Focus groups with patients with experience of chronic illness Participants identified through patient support organisations Two groups held in neutral venue with facilitator and note taker present Tapes transcribed by commercial company Thematic content analysis supported by Weft QDA software package

31. Focus Groups Main Themes

32. Semi structured interviews

33. Semi structured interviews • 13 interviews over 6 months • Interviews by phone or in person • Male:Female 10:3 Dublin:Outside Dublin 7:6 • Variety of backgrounds • Interviews recorded, transcribed and analysed using thematic content analysis • Weft QDA software used to support analysis

34. Themes

36. Recommendations

37. Role of patient registries • A planned approach to the establishment of new registries. • Existing work (IPH (2007) and HIQA (2010a)) should be used to establish areas where a registry is the appropriate solution to information deficits. • Existing registries should be examined to identify possible opportunities for merger, rationalisation or economies of scale. • Registries that are found not to be fit for purpose should be re-vamped or closed.

38. Consent • Legislation to clearly outline the circumstances in which registries can operate without consent & to address areas where there is ambiguity regarding an individual’s ability to consent • Registries that are permitted to operate without consent must undergo an approval and on-going evaluation process. • Law Reform Commission proposals relating to those aged 16 & 17 yrs of age & those > 18 yrs deemed to lack capacity to consent and the Health Information Bill in relation to those aged 16 & 17 years of age should be implemented. • Where a person < 18 years is currently enrolled in a registry their assent should be sought & documented with their parent’s consent. • Registries should have procedures in place to ensure consent is obtained as soon as practicable after an individual reaches the age of 18 years.

39. Data Linkage • Introduction of legislation proposed in the Health Information Bill to govern circumstances & rules under which data linkage/data matching can occur. • Enactment of the Health Information Bill (part five) to allow for the introduction of a unique health identifier in accordance with the recommendations of the HIQA report • Continued introduction of information standards across the healthcare system to allow meaningful sharing & comparability of data

40. National policy for patient registries A national policy should be developed to address; • Priority areas for registry development having regard to: • National Health Information Strategy. • Current available information systems. • Impact of the health issue concerned on the population. • Potential for registry to drive change in the health system. • Description & designation of a central oversight function for registries. • Description of priority areas for inclusion in national guidelines for registries & designation of the role of guideline development & implementation • Determination of sustainable & transparent funding process that is linked to approval & evaluation

41. National guidelines • National guidelines for patient registries in Ireland informed by the international guidelines and cognisant of Irish legal & ethical obligations • The guidelines should be compatible with • Department of Health and Health Service Executive policy and • Current & emerging legislation (particularly the Health Information Bill) • Work by HIQA in the area of health information technical standards and health information governance. • The guidelines should cover areas including: • Consent • Ethics • Security • Data standards • Governance (structures and processes) • Evaluation • Dissemination of registry outputs.

42. Central oversight A national function for the oversight of patient registries should be established encompassing the following; • Development of national guidelines for patient registries. • Approval of new registries and evaluation of pre-existing registries. • Approval of registry funding based on evaluation outcomes • Identification of appropriate registry data standards with HIQA to facilitate sharing of data & comparability between registries. • Dissemination and promotion of best practice guidelines to registries. • Maintenance of a directory of approved registries, a “registry of registries”. • Facilitation of access to specialised expertise (e.g. biostatistics, epidemiology)

43. Confidentiality & security • Registries should undergo regular security audits to identify & address potential threats to data security. • All registries should carry out regular access audits to ensure that inappropriate access to data does not occur. • The legal position around court ordered disclosure should be clarified and if necessary legislation enacted to protect against this. • Exploration of the feasibility of limiting the scope of compelled authorisation of access to personal health information. • Implementation of the statutory prohibition on the advertisement for sale or the sale of personal health information and on the disclosure of personal health information for direct or indirect financial benefit in the proposed Health Information Bill. This proposal should be supported.

44. Registry Funding • Development of a centralised funding mechanism linked to the outcome of registry approval & evaluation processes. • Uniform and transparent application procedures with set deadlines for submission of applications. • Security of funding to registries that meet priority target areas identified in the national policy for patient registries subject to successful evaluation outcomes.

45. Approval & Evaluation Approval for new registries & ongoing evaluation for pre-existing registries. • Approval process for new registries should include • Evaluation of the relevance of the registries stated purpose • Consideration of existing data sources • Review of the function, duration and scope of the registry • Assessment of the practical feasibility of the registry • Probability of the availability of sufficient start up and maintenance funding • Evaluation of the cost effectiveness of the registry. • The evaluation of existing registries should include; • Continued relevance of the stated purpose of the registry • Data quality • Governance • Dissemination of findings. • Outcome of evaluation/approval linked to funding & available to the public.

46. Thanks! • Research participants; registers, interviewees and the patients who so freely gave of their time/knowledge • MRCG Working Group on Patient Registers • Dr Howard Johnson/Dr Máire O’Connor

47. Contact Details • fionnuala.donohue2@hse.ie • Health Intelligence Unit, Dr Steevens Hospital