2. The James Lind Alliance Tackling treatment uncertainties together Lester Firkins, John Scadding and Mark Fenton INVOLVE Conference 2006

3. James Lind Alliance WHO?……Are they WHAT?…..Do they do HOW?…….Do they do it WHEN?…..Will they do it WHY?…….BOTHER

4. WHO? Convened in 2004 by: –James Lind Library –INVOLVE –Royal Society of Medicine Secretariat funded by DH and MRC ( 6 part-time do’ers; an excellent overview committee and 100+ Affiliates)

5. WHAT? To increase the focus of the therapeutic research agenda on questions and priorities shared by patients and clinicians. To promote working partnerships and collaborations between patients and clinicians to identify and promote their shared priorities for therapeutic research. To increase general awareness and understanding of the need to refocus the therapeutic research agenda.

6. WHY….. BOTHER? What influences Research at the moment? Over to you……. Let us know what you think currently influences priorities in research

7. HOW? Address the questions of uncertainties, in any given area, by assembling the unanswered questions from a variety of sources. Work with and support “Working Partnerships” of patient groups and clinician groups to identify to prioritize these unanswered questions about the effects of treatments

8. ADVANTAGES of WORKING PARTNERSHIPS Address issues of importance & relevance to patients: recognise mismatches in therapeutic research. Patients & clinicians set priorities for research, not industry. Working together minimises biases of individuals. Involvement of patients in setting research agenda: better recruitment to trials and understanding of trial methods (RCT). Identification of under-researched but important treatments.

9. ADVANTAGES of WORKING PARTNERSHIPS Identification of systematic reviews needed. Potentially, easier passage of research proposals through ethics committees. Prospect of attraction of non-commercial funding. Ensure the most relevant trials are conducted: new vs best existing treatment. Ensure trials of existing treatments for “indication switches”. Greater involvement of NHS clinicians in therapeutic research. More research done as part of routine NHS healthcare.

10. HOW? WPs: patients ( and/or advocates) and clinicians. Organisations representing patients and clinicians: advantages:representative, potentially better balance. authoritative, higher external profile. disadvantages:difficulty establishing agreed views within large organisations. lack of clearly defined responsibility. repeated referral back to organisation for approval. Success of non-organisation based methods, eg RA.

11. CHALLENGES Ability to work together; skills needed to reach consensus decisions. Ensure clinicians and patients in WPs are representative of the condition. Set aside personal (and institutional) agendas. Clinicians must accept need to work to patient defined outcomes and preferred interventions to be investigated. Work must be done within NHS framework: research becomes a part of routine care, with need to engage HNS managers and funders. Obtaining funding for trials prioritised by WPs.

12. Identifying patients’ and clinicians’ questions about the effects of treatments Mark Fenton Database of Uncertainties about the Effects of Treatments (DUETs) and Secretariat, James Lind Initiative

13. Address the questions of uncertainties, in any given area, by assembling the unanswered questions from a variety of sources. HOW?

14. Challenges Identifying outcomes that matter to patients Harvesting patients’ and clinicians’ unanswered questions about the effects of treatments

15. Identifying outcomes that matter to patients Everything works! If you use outcomes that a patient or clinician wouldn’t recognise What do you want treatments to do? what should researchers measure how should they decide on the question to answer?

16. Do automated/mechanical chest compression devices improve survival in adult out-of-hospital cardiac arrest? –Outcome – Mortality – No difference –Outcome – Survival – a non statistically significant increase of 40% in the "risk" of surviving Identifying outcomes that matter to patients

17. Alexander J, Tharyan P, Adams C, John T, Mol C, Philip J. British Journal of Psychiatry. 2004 Jul;185:63-9 Rapid tranquillisation of violent or agitated patients in a psychiatric emergency setting. Pragmatic randomised trial of intramuscular lorazepam v. haloperidol plus promethazine.

18. ‘.. carers said they wanted to see their relatives quiet and not causing a problem in 10-15 minutes. They were for the use of injections, if needed ( people respect injections, sometimes inappropriately, in these parts). Most were not for the use of restraints, unless absolutely necessary. The patients themselves were grateful that they were given treatments that got them better but their opinions were more mixed than the carers.’ Identifying outcomes that matter to patients

19. DUETs’ working definition of uncertainty about the effects of treatments No up-to-date systematic reviews exist OR Up-to-date systematic reviews show that uncertainty exists

20. Harvesting questions for DUETs Sources of uncertainties about the effects of treatments Patients and carers Patient information/advice services (e.g. Asthma UK, NHS Direct, interviews) Clinicians Clinical question answering services (e.g. NLH's Primary Care Question Answering Service) Other sources (e.g. BMJ Clinical Evidence) Systematic reviews, clinical guidelines, policy makers Registers of ongoing research

23. To visit DUETs go to: www.duets.nhs.uk

24. Long Term Goals Better quality and relevant research Informal Network of Working Partnerships who support each other Funding is attracted to those propositions that carry a Consumer / Clinician badge It becomes “the way we do things round here”

25. W.I.F.M. The JLA is just one vehicle where real people with personal experiences can add value, by working with clinician groups. It may seem more hard work to involve “the public” but the JLA is convinced that it is the preferable way And for you … –Confidence that you are spending time on the right things to change peoples’ lives –Ability to put faces to conditions - it’s always personal –Huge support and encouragement –Easier route through governance –Funding

26. Over to you … James Lind Alliance –www.lindalliance.orgwww.lindalliance.org 01865 517635 Summertown Pavillion Middle Way, Oxford OX2 7LG