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2. Choosing outcomes and measures - for doing and using research James Lind Alliance Outcomes in clinical research – whose responsibility? 20 November 2008 Sandy Oliver Professor of Public Policy www.ioe.ac.uk/ssru Sub-brand to go here

3. 3 Outline Using outcomes in decisions Choosing outcomes for decision What are the challenges? Who to involve, and why? What expertise is required? What roles may we adopt? What are our responsibilities?

4. Using outcomes in decisions? Personal decisions About own care, or patient’s care About participating in research (providing data, recruiting participants) Collective decisions Developing policy Planning services Doing research 4

5. 5 Choosing outcomes for decisions IF USING RESEARCH… Choosing from a set of outcomes available from completed research for personal decisions for collective decisions IF DOING RESEACH… Thinking of plausible outcomes of treatment, good and bad Choosing those which are important and measurable

6. 6 Plausible, important and measurable PLAUSIBLE AND IMPORTANT To whom? –Patients, carers, clinicians, researchers? For what? –Choosing personal care, Planning services, Developing interventions? MEASURABLE Technically? Within staffing resources? Without exhausting participants good will? For how long?

7. 7 Challenges when choosing outcomes Thinking about… Complex issues Complex health conditions Undesired effects as well as desired effects Deciding priorities Choosing between all possible outcomes Limited personal perspective Sharing ideas and coming to agreement

8. Thinking about outcomes It’s difficult thinking about personal recovery goals… for coping strategies. (CEO charity) undesired effects… But they are just as important [as desired effects]. (Health services Researcher) a complex outcome study. Useful though. (Health services researcher) In contrast Quite easy as there are research questions I am exploring currently in a multi-centre trial. (Health service researcher) 8

9. Deciding priorities Hard to disentangle the effects and therefore hard to prioritise (anon.) Quite easy to list the symptoms and the desired effects, it was harder to decide which was the most important and why. (Research funder) I’m afraid that it is not possible to rank the desired effects in this way. [This condition] is multi-faceted; the facets vary in intensity in any one individual, over time and between individuals. What matters is to ensure that all the effects of the disease are included in the outcome measures. (Service user/ Support group representative) 9

10. Limited personal perspective I found it hard to move between my personal experience and objective notions of measurement and ranking…In thinking about a condition which I don’t have myself but have professional responsibility for, I found it easier to answer the questions. But I’m not convinced that my answers are generally accurate. (Service user/ Support group representative) [What was hard?] Not knowing how physiological benefits are measured (Patient involvement lead) I am not a sufferer myself. I don’t represent patients for any single disease area, and so am not knowledgeable about any one disease to give a sensible set of examples. (Patient Involvement specialist) 10

11. Sharing ideas I found it difficult to summarise in a few words the major issues (Health services user-researcher) 11

12. Who to involve, and why? Ethical, rights, citizenship arguments justify involvement in choosing areas of life deserving research prioritising problems ensuring accountability of researchers Pragmatic arguments for better research, use of research findings and, ultimately, health justify involvement in: deciding how the research should be done finding solutions 12

13. What expertise do we need? To prioritise problems deserving research… Understanding about living with the condition Understanding about treating people with the condition Understanding the purpose of research Skills for communicating with and for the different groups 13

14. What expertise do we need? To improve research and research use… Understanding about living with the condition Understanding about treating people with the condition Understanding the nature, potential, limitations and options for research Skills for communicating with and for the different groups 14

15. What roles? As individual patients or clinicians – to make individual decisions about particular treatments or research projects As a voice for patients or clinicians – to be well informed and able to speak about a range of views As a researcher – to take into account the views of patients and clinicians when planning, conducting and reporting research As a ‘link’ person – to help different people understand each others’ issues and work together 15

16. Spokespeople for collective decisions Networked/ well informed patients and carers Networked/ well informed health professionals Who… Understand the purpose of research Understand the nature, potential and limitations of research Are up-to-date with their peers Listen, share ideas, learn 16

17. Spokespersons: the current cast Networked/ well informed patients and carers Networked/ well informed health professionals Individual patients and carers Individual health professionals Patient and Public Involvement (PPI) leads 17

18. The current cast: roles for choosing outcomes and measures Researchers Networked patients, carers & health professionals Individual patients Individual health professionals PPI leads Designing measures Spokespersons Piloting measures Link persons 18

19. Our responsibilities Be clear about the types of decisions (personal/collective) Learn about the topic Be clear about own expertise and roles (as an individual, spokesperson, link person) Be clear about other people’s expertise and roles Listen to other people Share our own ideas Keep our expertise up-to-date Learn from our experiences of sharing decisions 19

20. Ideas about roles and responsibilities… World Health Organisation International Conference on Primary Health Care, Alma-Ata, USSR, 1978. Philosophy of communication Habermas’ ideology about fair play in speech and mutual understanding History of public involvement in science Collins and Evans (2002) The Third Wave of Science Studies: Studies of Expertise and Experience. Social Studies of Science, Vol. 32, No. 2, 235-296. Study of expertise Stewart (2007) The communication of expertise in the context of multi-disciplined, participatory, problem-based training in evidence-based decision-making. PhD thesis. Studies of getting research findings into decisions Greenhalgh et al (2004) Diffusion of innovations in service organizations: systematic review and recommendations. The Milbank Quarterly 82 (4): 581 – 629. Your pre-seminar contributions to today’s discussion 20

21. 21 Thank you