Enid Quest John Kirwan Academic Rheumatology Unit Bristol Royal Infirmary Bristol BS2 8HW

1. The James Lind AllianceTackling treatment uncertainties together University of BristolAcademic Rheumatology Unit Taking patients’ and clinicians’ questions about the effects of treatment seriously.Rheumatoid arthritis – What have we found and what are we trying to do about it? Enid Quest John Kirwan Academic Rheumatology Unit Bristol Royal Infirmary Bristol BS2 8HW United Kingdom

2. Enid Quest Patient Research Partner Researchers and patients can be friends! Academic Rheumatology Unit Bristol Royal Infirmary, Bristol BS2 8HW, UK

3. Enid Quest Patient Research Partner John Kirwan Professor of Rheumatic Diseases Researchers and patients can be friends! Academic Rheumatology Unit Bristol Royal Infirmary, Bristol BS2 8HW, UK

4. Agenda for our presentation • Rheumatoid arthritis (John & Enid) • How international standardised outcomes were devised (John) • How patients got into the act (Enid) • Differences between patients and professionals (John) • What we are trying to do about it in Bristol (Enid & John)

5. What is rheumatoid arthritis?

12. Symptoms of rheumatoid arthritis • Pain • Stiffness and ‘gelling’ after inactivity • Unpredictable ‘flares’ of inflammation • Fatigue • Disability • Psychological effects • anxiety • depression • helplessness

13. Swollen finger joints in early RA Joint damage inRA of the hands 2003 2004 2005 Signs of rheumatoid arthritis in the joints • Swelling • effusions • soft tissue swelling • Warmth • Joint deformity • Reduced range of movement • Bony destruction • Crepitus

14. Who gets RA? Which joints are affected? • Men  • Women  • Children () • Young  • Prime of life  • Elderly 

15. So… • Rheumatoid arthritis (RA) involves • Inflammation inside joints • Destruction of joints • It can also affect other parts of the body in some people • About 1 person in 100 will get RA • RA costs the country £1,200,000,000 per year • Severe RA shortens life

16. Rheumatoid arthritismy experience • Onset • Early symptoms • Diagnosis • Relief only rheumatoid arthritis • Soon replaced with the realisation that it was more serious

17. Rheumatoid arthritismy experience Living with rheumatoid arthritis Anxiety Loss of independence soon replaced the pain and stiffness Finding the right medication Coping with fatigue

18. The operation was a success… What did we used to do? ... but the pain remained.

19. Different investigators rated different outcomes as important What did we used to do? • Trials used a variety of outomes which were considered by a particular investigator to be important • Doctors do not make ‘standard’ decisions about treatment response

20. Questioning the paradigm that doctors make ‘standard’ decisions in rheumatoid arthritis…. ….Helped in founding OMERACT (Outcome Measures in Rheumatology Clinical trials)

21. OMERACT • Working conference of clinicians and methodologists • Formed 14 years ago, meets 2-yearly • Seeks to identify outcomes, instruments and methods of asessing benefit in rheumatology • Standardised a ‘core set’ of outcome measures for rheumatoid arthritis clinical trials • The core set has be adopted by the regulatory agencies in USA and Europe

22. OMERACT 5, May 2000 • Tried to define ‘minimum clinically important difference’ for changes in outcomes • Realised this depends on who defines ‘important’! • Resolved to include patients directly as participants in future work on defining the outcomes of arthritis

23. OMERACT 6 Patients at OMERACT 6 • The OMERACT meeting of 2002 • included 9 patients as full delegates to the meeting and • had a Patient Perspective Workshop as a major part of the programme….

24. OMERACT 6 Patients at OMERACT 6 • During the this conference it became evident that there was a miss-match between the views of the researchers and the patients • Patients soon became involved in a series of discussions and were able to attend and contribute in all sessions

25. OMERACT 6 Patients at OMERACT 6 • One stumbling block was the use of technical and medical terminology • A glossary has been produced by patients to enable them to be confident in their participation

26. OMERACT 6 Patients at OMERACT 6 • The openness and encouragement of the professionals at this first conference has led the way for involvement at other international conferences • Many patients now feel able to make presentations and contribute on many different topics.

27. OMERACT 6 OMERACT 6 – April 2002Patient Perspective Workshop Research Agenda Three areas for exploration and development • Novel outcomes and approaches to assessment • Terminology and current knowledge • The role of the patient

28. OMERACT 6 OMERACT 6 – April 2002Patient Perspective Workshop • An international patient panel has now been formed • Around 20 patients from Europe, America, Canada and Australia. • The panel attended the 7th conference in California in 2004, and are preparing for the OMERACT 8 in Malta in 2006.

29. OMERACT 7 May 2004 • Patient participation increased to 20 • Funding underwritten to ensure patient participation • Patient input into three topic areas • Patient orientation built into programme • Clinical support available if needed

30. OMERACT 7 May 2004 • Patients have been involved in a number of research projects and discussion groups on a variety of subjects • Fatigue • Low disease activity state • Being an effective consumer • Drug safety workshops • The question of well-being

31. OMERACT 7 May 2004 • Training sessions have been held in order to help patients develop skills and the necessary confidence to participate with professionals on a level playing field.

32. Patient Perspective Workshop Objectives • Review the recent progress in the area • Identify requirements for further development of valid instruments • Delineate a research agenda which can attain these requirements • Enthuse participants to undertake the appropriate research

33. Research Agenda Main Topics • Fatigue • Well being • Real time assessment of symptoms • Incorporating patient priorities • Outcomes in early and late disease

34. Patients and professionals view things differently…

35. Reviews of the available evidence made it clear that: • Patients and professionals view the outcome of rheumatoid arthritis differently. • Many of the consequences of arthritis which patients find important to them are not measured at all, or are not included in the ‘core set’.

36. Patients and professionals view the outcome of rheumatoid arthritis differently

37. Patients and professionals view things differently… …this makes a difference to our work!

38. Patients and professionals view the outcome of rheumatoid arthritis differently Importance of outcomes reported by women with established rheumatoid arthritisPatricia Minnock, Barry Bresnihan (in preparation)

39. Patient Involvement in Bristol • Patient Advisory Group. • Meets every three months • Advised on the refurbishment of the Rheumatology Centre • Produced a booklet for new patients, and a yearly newsletter • Corresponds with other agencies regarding issues that affect patients.

40. Patient Involvement in Bristol • Volunteers in clinic. • Meeting other patients in clinic gives the opportunity to discuss issues and offer support and encouragement. • Involvement in Research. • Patients help to make grant applications, suggest topics for research and are often the subject of research.

41. Patient Involvement in Bristol • Patient Teaching Partners • Patients speak to groups of students to help them understand the consequences of being diagnosed with Rheumatoid Arthritis and answer questions about the affect on daily living • International Involvement • Several patients serve on an international patient panel and have made presentations at conferences around the world

42. Patient Involvement in Bristol Our involvement as patients and our dialogue with staff has brought about benefits for the patients, the service and the staff.

43. Patients and Professionals as Research Partners: Challenges, Practicalities and Benefits Pamela Richards1, Maarten de Wit2, John Kirwan3, Enid Quest1, Rod Hughes4, Turid Heiberg5, Sarah Hewlett3 1Bristol University Academic Rheumatology, UK, 2Dutch Arthritis Patients League, The Netherlands, 3University of Bristol Academic Rheumatology, UK, 4St Peter’s Hospital, Chertsey, UK, 5Centre Education & Skill Training, Ulleval University Hospital, Norway Background Most researchers do not have personal experience of arthritis Patients’ experiences can complement researchers’ analytical skills Effective patient involvement requires new ways of working

44. Patients and Professionals as Research Partners: Challenges, Practicalities and Benefits Methods: The authors have been collaborating in research Some are patient research partners or are on research steering committees Patient Research Partners have taken an active role in OMERACT and EULAR We reviewed our collective experience of partnership in practice

45. Results - Challenges and barriers encountered: Challenges: Enabling and empowering partner participation Barriers: Terminology, training, expense Establishing boundaries Patient and clinician or colleagues? Avoiding tokenism Understanding patients’ barriers No real contribution encouraged Anxiety about ability to contribute

46. Results - Challenges and barriers encountered: Challenges: Enabling and empowering partner participation Barriers: Terminology, training, expense Establishing boundaries Patient and clinician or colleagues? Avoiding tokenism Understanding patients’ barriers No real contribution encouraged Anxiety about ability to contribute

47. Results - Practicalities: We have developed a philosophy of patient partner involvement based on FIRST principles

48. Results - Practicalities: We have developed a philosophy of patient partner involvement based on FIRST principles

49. Results - Practicalities: We have developed a philosophy of patient partner involvement based on FIRST principles

50. Results - Practicalities: We have developed a philosophy of patient partner involvement based on FIRST principles