Pp306 Patient Research Partners at the Bristol Academic Rheumatology Unit.ppt JLA/AMRC 17 September 2007

Patient Research Partners at the Bristol Academic Rheumatology Unit

Who are we? Bristol Academic Rheumatology Unit Pam Richards Patient Research Partner PRP Coordinator John Kirwan Professor of Rheumatic Diseases University of Bristol

Whats missing?

What we will cover Rheumatology Research Partners in Bristol OMERACT & the story of fatigue FIRST

What we hope you will learn It is practical to include patients as full partners in the research process This takes time and effort… …but there are some simple principles to follow

Working with patients as Research Partners

Collaboration between patients and professionals in research Using personal experience as a resource

Patient Involvement in Research Patients can be actively involved: Prioritizing research Member of grant funding board Review grant applications Relevance of the research question Significance for patients - will it be beneficial? Is it a good use of resources?

Patient Involvement in Research Patients can be actively involved: Help manage research Member of research steering committee Has something obvious been missed from the protocol? One-off advisory role e.g. scientific studies Help to implement the findings - service delivery Advocate for best practice; evidence based treatment

How are Bristol Rheumatology patients involved? Research Participants Patients Advisory Group Patient Teaching Partners Patient Project Partners Patient Research Partners

Patient Research & Project Partners Karen Robert Pam Enid Marie Margaret Bev Jackie John Val Shelagh Sylvia Sean Greg

Bristol projects involving Patient Research Partners AHP Education in Rheumatology Anti-TNF Injector Project ARC Project on aids and appliances DA PsA/AS Roll out Definition of wellbeing Direct Access Roll Out Effective Healthcare Consumers Fatigue qualitative study Fatigue self-management module Knee OA and Physio Measuring Fatigue Multicentre DA Trial New Patient Nurse Clinics NICE/RCP Nurses perceptions of Rheumatology OMERACT Patient Group Overnight IL-6 & Prednisone Overnight SF IL-6 Patient outcomes study PI HAQ Study 1 PI HAQ Study 2 - Sensitivity Prompts for change RASE and patient education Sleep study in RA Steps pilot project

Patient Research Partner Activities Advice and support 8 Grant co-applicant 9 Contributions to protocol23 Analysed results 9 Interpretation of results13 Co-Author papers 5 Presentation of results 5 OMERACT Patient Panel 3

OMERACT and the story of fatigue

OMERACT Outcome Measures in Rheumatology Clinical Trials Working conference of clinicians and methodologists Formed 14 years ago Meets 2-yearly Seeks to identify outcomes, instruments and methods of assessing benefit in rheumatology

OMERACT 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

OMERACT Core set for rheumatoid arthritis Pain Physical Function Swollen Joint Count Tender Joint Count Patient Global Assessment Physician Global Assessment Acute Phase Reactants (CRP, PV, ESR) Imaging (in trials of 1 yr or more) Tugwell P, Boers M. Developing concesus on preliminary core efficacy endpoints for rheumatoid arthritis clinical trials. J Rheumatol 1993; 20:

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

Voting at OMERACT 5 Research to include the patient perspective should be carried forward We will increase patient involvement in research Patient participation should be an integral part of OMERACT activities

Patients at OMERACT 6 May patients with rheumatoid arthritis - Patient Perspective Workshop

Patients became involved in and contributed to all sessions It became clear that some outcomes of importance to patients had not been considered by researchers Patients at OMERACT 6

Voting at OMERACT 6 Research to include patient perspective in outcome assessment should be carried forward

Patients at OMERACT 7 May patients with rheumatoid arthritis Australia, Canada, France, Holland, Norway, Sweden, UK, USA International patient panel formed

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

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

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

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

Voting at OMERACT 7 Fatigue is an important symptom in rheumatoid arthritis

Patients at OMERACT 8 May Patients with rheumatoid arthritis or psoriatic arthritis Australia, Canada, Denmark, France, Germany, Holland, Norway, Sweden, UK, USA Inclusion of patient views in all future international agreements

Voting at OMERACT 8 Fatigue should be measured in clinical trials and clinical studies of rheumatoid arthritis whenever possible

Patients at OMERACT Professionals and Patient Research Partners bring different skills, values and experiences Patients experience-based knowledge is a resource to be utilised, not wasted

Challenges for patients and researchers

Summary: Role of Patient Research Partner Help target resources towards issues of importance to patients Point out what appears to have been missed Bridge the gap between learned knowledge and experiential knowledge

Challenges for patients: Overcoming the first hurdles Doubts about ability to contribute Doubts about value of contribution Personal knowledge of long-term condition complements learned knowledge of professionals Concern over lack of technical knowledge Concern over lack of clarity of role Not wanting to appear foolish Hearing difficult facts about condition Learning curve - Challenging

Researchers: Challenges of involving patients Adjusting to altered roles Avoiding tokenism Facilitating contribution

Altered roles Establish Boundaries to avoid conflict of roles Patient and Clinician, or Colleagues? Establish boundary between patient v partner role Solution Compartmentalize different roles: Clinic: patient and clinician Meeting etc: partner and colleague This is difficult for both patient and clinician Important to discuss all issues openly

Altered roles Establish Boundaries to avoid conflict of roles Patient and Clinician, or Colleagues? Establish boundary between patient v partner role Solution Compartmentalize different roles: Clinic: patient and clinician Meeting etc: partner and colleague This is difficult for both patient and clinician Important to discuss all issues openly

Altered roles Establish Boundaries to avoid conflict of roles Patient and Clinician, or Colleagues? Establish boundary between patient v partner role Solution Compartmentalize different roles: Clinic: patient and clinician Meeting etc: partner and colleague This is difficult for both patient and clinician Important to discuss all issues openly

Avoid tokenism Simply there to satisfy funding body Assumptions: Knowledge, Ability, Impairment Not giving equal consideration of views Patients should not be expected to endorse a project at the end if they have not had input throughout Dont use patients out of a sense of political correctness

Avoid tokenism Simply there to satisfy funding body Assumptions: Knowledge, Ability, Impairment Not giving equal consideration of views Patients should not be expected to endorse a project at the end if they have not had input throughout Dont use patients out of a sense of political correctness

Facilitating Contribution How researchers can help patients to be research partners

Practicalities of involving patients - FIRST steps Facilitate - early inclusion, enable contribution Identify - projects, patients, roles Respect - views, abilities, confidentiality Support - communication, working Train - e.g. research methods, ethics, evidence FIRSTFIRST Patients & Professionals as research partners: Benefits, challenges, practicalities. S Hewlett, M De Witt, P Richards, E Quest, R Hughes, T Heiberg, J Kirwan. Arthritis & Rheumatism (Arthritis Care & Research) 2006; 55:

Facilitate: Contribution, inclusion Involve before protocol finalized Meetings – access; timing; comfort Expenses – travel; postage; cartridges Ask their opinions; encourage; explain; Consider equally for tasks - as any other Apply criteria - co-applicant; co-author Principal Investigator has key responsibility to facilitate

Identify: Projects, patients, Projects:Clinical / outcome / service delivery Patients:Experience of disease / issue Able to review / discuss information / unbiased Questioning, confident, interested, have time to commit, can step out of patient role Selected for personal experience (From your clinical practice)? Own views, new perspective Selected to represent a society (Advocates) ? Official views - official agenda? May be crucial for policy decisions

Identify: Roles Review draft protocols Member of Steering Group Review outcome selection, questionnaires Study design, patient selection Analyse and interpret data Attend conferences Present results Co-author

Respect : Contribution, Views Respect Contribution and Views Each team member brings their expertise Patients have unwittingly gained expertise of their condition Consequently patients bring a perspective which is not available to most researchers Treat as any other member of the team: Use other experiences (e.g teacher) Develop abilities (attend courses?) Value contribution - by paying?

Respect: Confidentiality Information shared by the patient of their own experience should remain confidential Patients also need to respect and keep confidential anything they may hear Trust Confidentiality Agreement should be considered

Support: Communication, working Protocol, glossary. ( One-to-one meeting initially with PI Researcher contact point Web access: , info, papers (Athens) Hon Contract = legitimacy, value, access Partner desk with computer/stationery? Partner Network with facilitator?

I Training I : Novices Why do researchers need Research Partners? The value of the patients perspective How and when can patients be involved? Can we believe what we think we know? Evidence Different projects need different methods Research methods: Randomized Control trial, Observation What do you want to measure and how? Measuring Outcomes, Statistics – chance, association What does getting informed consent mean? Public protection: Ethics, Research Governance Keeping up standards, being accountable

Training II : Experienced Role of Patient Research Partners Using the net to find information (practical) Designing a research project Quantitative, Qualitative research Proof of Principle studies Implementing a research project Analysing and Interpreting the results Feedback: experiences and concerns Groups better than individual Modular training easier for Research Partners

What have we learned?

Benefits of patient research collaboration Research related to priorities & clinical need Appropriate outcomes, relevant to patients Projects include patient perspective and interpretation Better recruitment and dissemination Better use of resources (relevant issues) The patients experience is a valuable resource which should be utilised

Summary Patient Research Partners can contribute in a variety of ways Take the FIRST step – make specific provision for patient inclusion Support you patient research partners as a group and as individuals

Patient Research Partners at the Bristol Academic Rheumatology Unit