Incorporating patients in research what have we done and how did we do it? Maarten de Wit, patient researcher, University Medical Centre Amsterdam. Foredrag, Brukermedvirkning i helseforskning, fra ord til handling, Diakonhjemmet Sykehus 4. november 2014

1. Incorporating the patient perspective in outcome research.
A best practice case from the field of rheumatology
Oslo November 4, 2014
Maarten
de Wit

2. 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)

3. 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

4. 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

5. 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.
5
EULAR

6. EULAR initiative: Patients as research partners

7. 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

8. June 2014, Volume 73, Issue 6

9. A EULAR case study
The development and validation of the EULAR PsAID
(Psoriatic Arthritis Impact of Disease score)

10. 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

11. PsA Impact of Disease – participants

12. 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

13. 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)
VALIDATION
Filling in questionnaires
Steering Committee

14. 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
3
4

15. 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)
VALIDATION
499 respondents
Steering Committee: 2 patient experts

16. The selection process of patient research partners should take into account communication skills, motivation and constructive assertiveness in a team setting.
SELECTION
5

17. 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

18. Levels of participation
© Teunissen 2009
Consultation
Advise
Collaboration
Control

19. 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

20. The principal investigator must facilitate and encourage the contribution of patient research partners, and consider their specific needs.
SUPPORT
6

21. 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

22. 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

23. 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)
VALIDATION
499 respondents
Steering Committee: 2 patient experts
16 domains of health
12 domains of health
9 domains of health

24. Ranking
Mean rank
Priority
Priorityorder
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%

25. Ranking
Mean rank
Priority
Priorityorder
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%

26. 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)
VALIDATION
499 respondents
Steering Committee: 2 patient experts
16 domains of health
12 questions
9 questions
2 validated questionnaires
12 domains of health
9 domains of health

27. 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
7
8

28. 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

29. 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

30. Thanks for listening
martinusdewit@hotmail.com
Oslo
November, 4
2014
M. de Wit
L. Gossec
T. Kvien