incorporating patients in research what have we done and how did we do it maarten de wit-04112014
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Incorporating the patient perspective in outcome research. A best practice case from the field of rheumatology
Oslo November 4, 2014
Maarten de Wit
Researchers can easily overlook the complexity and capriciousness of living with a chronic disease, reducing the meaning of life experiences to abstract themes and models.
Schipper, K. (2011). Patient participation & knowledge [thesis]. VU University, Amsterdam (p.232)
Introducing EULAR’s recommendations for patient involvement
Developing a PROM for Psoriatic Arthritis
Multiple levels of patient involvement
Added value of patient involvement
Take home messages
Overview
Introducing EULAR’s recommendations for patient involvement
Developing a PROM for Psoriatic Arthritis
Multiple levels of patient involvement
Added value of patient involvement
Take home messages
Overview
The European League Against Rheumatism (EULAR) is the organisation which represents the patient, health professional and
scientific societies of rheumatology of all the European nations. EULAR endeavours to stimulate, promote, and support the research, prevention, treatment and rehabilitation of rheumatic diseases. In line with UEMS, EULAR defines rheumatology as including rheumatic diseases of the connective tissue, locomotor and musculoskeletal systems.
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EULAR
EULAR initiative: Patients as research partners
Introducing EULAR’s recommendations for patient involvement
Developing a PROM for Psoriatic Arthritis
Multiple levels of patient involvement
Added value of patient involvement
Take home messages
Overview
June 2014, Volume 73, Issue 6
A EULAR case study
The development and validation of the EULAR PsAID
(Psoriatic Arthritis Impact of Disease score)
Development and validation of the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire.
A 13-country EULAR initiative
New, short questionnaire to better assess all patient-perceived impact of PsA
Both for clinical practice as well as for clinical trials
Developed with patient-partners
PsA Impact of Disease – participants
Participation of patient research partners is strongly recommended for clinical research projects and for the development of recommendations and guidelines, and should be considered for all other research projects. WHEN
1
Participation of patient research partners should be considered in all phases of the project to provide experiential knowledge, with the aim of improving the relevance, quality and validity of the research process. WHEN
2
Methods and phases in the research project
Elaboration of domains
into questions
Formulations of items
Translation of items
Cognitive debriefing
on translation
Identification and selection of
domains of health
Initial
identification
of domains
Domains
prioritised for
importance
Ranking order
Priority (yes/no)
VA
LID
AT
ION
Filling in
qu
estion
naires
Steering Committee
A minimum of two patient research partners should be involved in each project. NUMBER
Identification of potential patient research partners should be supported by a clear description of expected contributions. RECRUITMENT
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Tasks and numbers
Identification /
elaboration of
questions
Physician and
Patient-partner
opinion on wording
65 patients pre-testing
translated items
Identification / selection of
domains of health
Initial
identification
11 patient-
partners
Domains
prioritised for
importance
139 patients
Ranking order
Priority (yes/no)
VA
LID
AT
ION
49
9 re
spo
nd
en
ts
Steering Committee: 2 patient experts
The selection process of patient research partners should take into account communication skills, motivation and constructive assertiveness in a team setting. SELECTION
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Introducing EULAR’s recommendations for patient involvement
Developing a PROM for Psoriatic Arthritis
Multiple levels of patient involvement
Added value of patient involvement
Take home messages
Overview
Levels of participation
© Teunissen 2009
Consultation
Advise
Collaboration
Control
4) Study participants to prioritize important domains (n=139) and to fill in questionnaires (n=499)
3) Patient respondents in cognitive debriefing (n=65)
2) National patient research partners (n=11)
1) Patient steering Group members (n=2)
Levels of participation
The principal investigator must facilitate and encourage the contribution of patient research partners, and consider their specific needs. SUPPORT
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Pre-meeting material for patient-research-partners
Zurich, November 2012
Table of Contents Introduction 1 Logistic information 2 Reminder on the PsAID project: objectives 3 Reminder on the PsAID project: previous steps 4 First steps: elaboration of the questionnaire 4 Second step: finalization and validation of the
questionnaire 6 What does validation mean? 6 The meeting in Zurich: what will happen there? 7 PsAID glossary: some terms you may be hearing at the
meeting 8
Introducing EULAR’s recommendations for patient involvement
Developing a PROM for Psoriatic Arthritis
Multiple levels of patient involvement
Added value of patient involvement
Take home messages
Overview
Added value of patients´ involvement
Identification /
elaboration of
questions
Physician and
Patient-partner
opinion on wording
65 patients pre-testing
translated items
Identification / selection of
domains of health
Initial
identification
11 patient-
partners
Domains
prioritised for
importance
139 patients
Ranking order
Priority (yes/no)
VA
LID
AT
ION
49
9 re
spo
nd
en
ts
Steering Committee: 2 patient experts
16 domains
of health
12 domains
of health
9 domains
of health
Ranking
Mean rank Priority Priority
order
In top 8
ranks
Lowest
4 ranks
1 Pain 2.56 84% 1 95% 0
2 Skin problems 6.2 53% 2 65% 13%
3 Fatigue 6.43 43% 5 74% 6%
4 Ability to work / leisure 6.67 50% 3 67% 9
5 Disability 7.23 46% 4 64% 12%
6 Feeling of discomfort 7.58 26% 10 64% 7%
7 Sleep disturbance 7.96 36% 6 56% 25%
8 Anxiety, fear and uncertainty 8.42 33% 8 50% 19%
9 Coping 8.45 35% 7 53% 17%
10 Embarrassment and/or shame 9.74 24% 11 40% 35%
11 Social participation 10.01 23% 13 33% 30%
12 Depression 10.06 24% 12 39% 32%
13 Relationship with family 10.51 30% 9 34% 44%
14 Concentration difficulties 10.61 19% 14 32% 37%
15 Rejection and discrimination 11.60 12% 16 22% 53%
16 Sexual life 11.61 15% 15 25% 52%
Ranking
Mean rank Priority Priority
order
In top 8
ranks
Lowest
4 ranks
1 Pain 2.56 84% 1 95% 0
2 Skin problems 6.2 53% 2 65% 13%
3 Fatigue 6.43 43% 5 74% 6%
4 Ability to work / leisure 6.67 50% 3 67% 9
5 Disability 7.23 46% 4 64% 12%
6 Feeling of discomfort 7.58 26% 10 64% 7%
7 Sleep disturbance 7.96 36% 6 56% 25%
8 Anxiety, fear and uncertainty 8.42 33% 8 50% 19%
9 Coping 8.45 35% 7 53% 17%
10 Embarrassment and/or shame 9.74 24% 11 40% 35%
11 Social participation 10.01 23% 13 33% 30%
12 Depression 10.06 24% 12 39% 32%
13 Relationship with family 10.51 30% 9 34% 44%
14 Concentration difficulties 10.61 19% 14 32% 37%
15 Rejection and discrimination 11.60 12% 16 22% 53%
16 Sexual life 11.61 15% 15 25% 52%
Results: Patients’ contributions
Identification /
elaboration of
questions
Physician and
Patient-partner
opinion on wording
65 patients pre-testing
translated items
Identification / selection of
domains of health
Initial
identification
11 patient-
partners
Domains
prioritised for
importance
139 patients
Ranking order
Priority (yes/no)
VA
LID
AT
ION
49
9 re
spo
nd
en
ts
Steering Committee: 2 patient experts
16 domains
of health
12 questions
9 questions
2 validated
questionnaires
12 domains
of health
9 domains
of health
The principal investigator must ensure that patient research partners receive information and training appropriate to their roles. EDUCATION
The contribution of patient research partners to projects should be appropriately recognised, including co-authorship when eligible. ACKNOWLEDGEMENT
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Introducing EULAR’s recommendations for patient involvement
Developing a PROM for Psoriatic Arthritis
Multiple levels of patient involvement
Added value of patient involvement
Take home messages
Overview
Take home messages
Patient involvement should be considered in every phase of the research process
Patient involvement should be considered on multiple levels
The role of the principal investigator is key in enabling patients to contribute to the research
