Facilitating Research within the Current Governance Framework ?

1. Facilitating Research within the Current Governance Framework? Dr Davida De La Harpe Assistant National Director of Population Health

2. Outline • The HSE, Health Intelligence and Population Health in the HSE and health service transformation • Research and clinical audit • Work so far • Current Challenges • Future

3. Selling health intelligence ? • In its widest sense – Developing and using knowledge to improve health outcomes for the population • (Instead of following deeply held yet unexamined ideologies)

4. Health Services Executive • Transition to unified health delivery system represents biggest change management project in history of the state • Advantages – uniform interpretation of policy • Much stronger leverage to drive change, put into practice international evidence of best practice, recommendations from local studies, audits, transfer learning and models of good practice • Opportunity to apply resources strategically in line with best intelligence • HSE has adopted a population health approach

5. Board / Sec C / PAD Quality & Risk Consumer RHO Comms. Executive Structure Board Audit CEO Office of the CEO SPRI Steering Group & Unit Expert Advisory Groups * Children * PCCC NHO Corp. Plng. & Ctrl. Processes Corporate Services HR Population Health Finance Ageing * ICT Shared Srvs. Disability * Cancer * Estates Procure Surgery * Health Services A & E * Support Services Medicine * Mental Health * Reform & Innovation * Examples

6. Population Health Approach promotes and protects the health of the whole population or sub – groups, with particular emphasis on reducing Health Inequalities

7. Population Health National Directorate • Director of Population Health – medical‡ • 3 Assistant National Directors – medical‡ • 3 Assistant National Directors –non medical + 1 transition non-medical) • ‡ Public health doctors - subject to same professional standards as other specialities including confidentiality • ‡ HI. SHP.HP

8. Public health practice • Protecting the health of the public • Epidemiology, surveillence, programmatic evaluations provision of clinical services (health protection, infectious diseases,evidence based care pathway development) • Collection and analysis of identifiable health data for purpose of protecting health of group or community- not research • But may also engage in research in these and other areas

9. health intelligence commitment • Gather the facts and information necessary to make more informed and intelligent decisions • Keep pace with new evidence • Use the new facts to support updating practices

10. Health Intelligence components

11. Research • The systematic investigation into, and study of materials, sources etc in order to establish facts and reach new conclusions.www.wit.ie/library/olas/glossary.htm • Today's health research is tomorrow's health care

12. Our main research settings • Population based research • Clinical settings- hospital,primary care and other clinical settings and the interfaces • Laboratory

13. Research continuum • Biomedical and clinical research has made great progress in identifying ways to prevent and treat common and uncommon conditions and manage chronic illness. • Health services research complements and builds on the findings of clinical and biomedical research.

14. The gains for our population • Health services research, unlike biomedical research, can provide insight into which care settings, including home or community-based care, are best and which risk factors are associated with entering these settings-patient centred-complex settings • Quality issues and outcomes

15. Issues for research • Prospective research- patient consent • Retrospective - extract information – anonymise • Follow-up- permission and consent • Clarity and explanation about how data and information will be used • Safeguards on data storage etc • Usually clearly signalled by ethics committees if not already part of proposals

16. Current HSE work in research area • Support for research • Draft research strategy • METR • Ethics processes • Commissioning • Partnerships

17. Clinical Audit • Clinical Audit was introduced to the NHS in 1993.  -an essential element of professional practice in the Health Service. Now integral to HSE work • a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change • Governance of our services

18. Clinical audit vs research • Clinical Audit and Research are closely related but distinct disciplines • Research is about creating new knowledgee.g about whether treatments work or whether one treatment works better than another • Clinical Audit is about making sure that this knowledge is being used to best effect so that outcomes for patients are as good as they should be

19. Context • patients/clients of healthcare services have specific rights in relation to their personal health information. • Right to non-disclosure • Right to make a complaint to the Data protection Commissioner if they are unhappy how their personal information is used.

20. Current Process • Patients/client give personal health details to healthcare professionals as part of their care process. • The extent to which they are informed of the purposes to which their information will be used is variable (Fair obtaining and processing - consent) • Not specifically told their data may be used for clinical governance purposes

21. Current Process • No written informed consent obtained for the future potential use of their data for clinical governance/audit purposes • For prospective clinical audit work, informed written consent is usually obtained • Healthcare professional and clinical audit staff anonymise the data (No disclosure-unless compatible). Are Clinical Audit staff part of the healthcare team? ( Regulations 1989)HSE vs HIQA?

22. Requirements under the Act and future implementation of the EU Standards • Patients have the right to be informed of the purposes to which their personal health information will be used • They have the right to give written consent for the use of the information for the purposes of clinical governance/audit • They have the right to withdraw consent at any time

23. Requirements under the Act and future implementation of the EU Standards • EU Standards on Confidentiality and Privacy in Healthcare • http://www.eurosocap.org/eurosocap-standards.htm

24. Requirements under the Act and future implementation of the EU Standards • Recommendation 6: • Provider Institutions must ensure that the express consent of the patient is obtained for processes of clinical audit by staff not involved in the care of that patient. • Ethical requirements and legal obligations to protect patient confidentiality

25. Patients vs staff? • Service providers: sensitivities and rights - • E.g death rates by hospital and by e.g. surgeon…. Needs to be carefully handled • Public right to know • Informed choice • Quality

26. Impact of technologyexample • Health Atlas Ireland • Uses a number of databases already available • Cannot link individuals – eg RTA victim cannot be tracked into the hospital admission and further • governance arrangements? • Conceivable that where small numbers of a condition reported together with geographic data that individuals might somehow be identifiable –rules for numbers in small areas

30. Existing databases? • HSE and other institutions – databases with individual information about for instance , disability, specific disease registers etc etc • Variable IT systems • Variable quality • Ownership • Access • Probably variable compliance with best practice • unlinked

31. Why link? • To allow individual to be tracked through the system • linking databases so the combinations of issues for people can be seen and understood • Identifying on a small area basis where people are coming from • Tracking services and patterns of health and disease • Audit, quality, service gaps, poor outcomes

32. Recommendations • National Patient Information Leaflets • Evidence Based Guideline for all healthcare professionals and clinical governance staff • Training and induction • Monitor and Review effectiveness of these approaches • Develop Key Performance Indicators - e.g number of complaints received under the Act.

33. Issues for all our work • Unique identifier • Linking of databases • Information governance • Postcoding • Balance between individual confidentiality and need to be able to track and analyse services, patterns of health and illness. • What does public want us to know? • What do they think /expect us to know? • Ethics/research – biomed vs HSR- research supports for all

34. Future? • Proposal for an identity management and privacy protection framework • Linking datasets- data protection and governance- ?HIQA • Surveys vs inclusion of data items routinely?- working together for best value- CSO, ESRI, IPH etc • Cohort studies? • Genetics- will add a whole new dimension • Horizon scanning- new and emerging technologies and interventions- may be put in place with limited research base

35. Consent? ( example) • To help educate our staff and students and to teach them how to treat illnesses more effectively they may view your medical record. Your medical record may also be used for our quality controls and audits to help us to improve our services. • To improve our understanding of illnesses we also sometimes carry out research using your medical record. Any research carried out by the hospital is governed by the policies of the Ethics Committee. We also may provide data to other health agencies such as the National Cancer Registry in order to plan for the health needs of patients nationally. • How feasible is this in the hospital environment? • What about primary care setting?

36. Other issues • Ethics and Protocols: There needs to be clear ‘rules of engagement’ and there will need to be guidelines on issues such as permissions to take and use information. There should be explicit Confidentiality Agreements in place for all staff • Training and expert advice • Right to Access: There should be a right to access to some information and there may be a need for legally underpinned accessibility. Equally, access to other types of information may have to be restricted.

37. Start of public debate? • Public Perceptions of Biomedical Research - A survey of the general population in Ireland, was conducted by a team led by Professor Hannah McGee 2005 • public is generally aware of and committed to making a contribution to research and related activities in the healthcare system for their benefit and for the benefit of future patients. • ongoing dialogue to foster research as a core activity of, and for the greater good of, the Irish and wider general public.

38. Summary • HSE in process of transformation • Legacy issues from former organisational structures • Opportunity for excellence in health care • Collaborative approach to issues • Thanks for support from various agencies including DPC over last year • Thanks to all with whom I work & their contributions