dr. maarten amsterdam november 10 2016 wit patie… · collaborators m. de wit a. ogdie w. campbell...
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Feasibility and added value of patient involvement in thedevelopment of core outcome set development
A case study from the field of rheumatology
AmsterdamNovember 102016
Dr. Maartende Wit
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Collaborators
M. de Wit
A. Ogdie
W. Campbell
P. Mease, P.
N. Goel
L. Gossec,
Y.Y. Leung
C. Lindsay
P. Palominos
I. Steinkoenig
S. Grieb
A-M Orbai
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Core domain set development according to the OMERACT filter 2.0
Patient involvement througoutthe process of updating thePsoriatic Arthritis core domain set
Challenges of patientinvolvement in core set development
Conclusions
Overview
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ImpactofHealthCondi ons
PathophysiologicalManifesta ons
CoreAreas Death LifeImpact
ExamplesofspecificDomainswithinAreas
• ICFdomains:ac vityandpar cipa on
• qualityoflife• pa entpercep onof
health• lossofabilitytowork• psychosocialimpact• 2aryimpactonfamily,
caregivers• u lity
• ICF:bodyfunc onandstructure
• organfunc on(eglungfunc on)
• reversiblemanifesta ons
• irreversiblemanifesta ons
• biomarkers• surrogateoutcomes
PathophysiologicalManifesta ons
Concepts
• societal• individual• healthcare• direct/indirect
(produc vity)• intangible
costs
AdverseEventsaremeasuredwithinthecoreareas,butarelabeledseparatelytoallowassessmentofbenefitandharm.
ResourceUse/EconomicalImpact
• disease• interven on
Domains
OMERACT disease specific core domain sets
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OMERACT Filter 2.0: Developing a Core Domain Set
Death Life Impact
Core Areas
Resource UsePathophysiological
Manifestations
Draft Core Domain Set
All important stakeholders are included from the start: patients and their proxies,
caregivers, researchers, etc.
Match Domains to Core Areas
Literature reviewList of Domains & Instruments
Setting/Contextual factors
Stakeholder input
Adverse events
consensusupdate cycle
agreement on what to measureat least one Domain from each Core Area
Core Domain Set
Source: OMERACT Handbook http://www.omeract.org/pdf/OMERACT_Handbook.pdfBoers M, et al. J Clin Epidemiol. 2014; 67(7):745-53
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Template of an OMERACT core domain set
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Acute phase reactants
Ultrasound
Gladman D, et al. J Rheum 2006
2006
Peripheral
joint activity
Skin activity
Patient global
Pain
Physical Function
HRQoL
OMERACT-GRAPPAPsoriatic Arthritis
core set
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Peripheral
joint activity
Skin activity
Patient global
Pain
Physical Function
HRQoL
Acute phase reactants
Ultrasound
Tillett W, Adebajo A, Brooke M, et al. Patient involvement in outcome measures for psoriatic arthritis. Curr Rheumatol Rep 2014;16(5):418.
2006
2012
2013
Why updating the PsA COS?
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Peripheral
joint activity
Skin activity
Patient global
Pain
Physical Function
HRQoL
Acute phase reactants
Ultrasound
Tillett W, Adebajo A, Brooke M, et al. Patient involvement in outcome measures for psoriatic arthritis. Curr Rheumatol Rep 2014;16(5):418.
2006
2012
2013
Core set discussed with patients
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Peripheral
joint activity
Skin activity
Patient global
Pain
Physical Function
HRQoL
Dactylitis
Acute phase reactants
Ultrasound
Fatigue
Tillett W, Eder L. Enhanced patient involvement and the need to revise the core set- report from the PsA workshop at OMERACT 2014. Jrn of Rheum, 2015
2006
2012
2013
2014
OMERACT conference
2014
Need to update the
PsA core set with active
patient involvement
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Core domain set development according to the OMERACT filter 2.0
Patient involvement througoutthe process of updating thePsoriatic Arthritis core domain set
Challenges of patientinvolvement in core set development
Conclusions
Overview
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Methods of involvementPatient participation – following OMERACT recommendations*
The patient voice was sought through
1. Active partnership of five patient research partners (PRPs) in
the working group and one PRP in the Steering Group
2. International focus group study representing five continents
and including seven countries
3. Delphi study
4. Consensus meeting
• Cheung PP ea Recommendations for the Involvement of Patient Research Partners (PRP) in OMERACT Working Groups. The Journal of rheumatology 2016;43(1):187-93)
• De Wit M ea, Successful Stepwise Development of Patient Research Partnership: 14 Years’ Experience of Actions and Consequences in OMERACT, The Patient 2016,
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Work streams Update core outcome set for Psoriatic Arthritis
Trying to ensure representativeness
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Steering
group
Working
group
Study
design
SLR FG protocol FG
moderation
analysis
Delphi
Design
NGT
meeting
PRP 1 X X X X X X XPRP 2 X X X X XPRP 3 X X X X X XPRP 4 X X X X X X X XPRP 5 XPRP 6 XPRP 7 X X X XPRP 8
PRP 9
PRP 10
PRP 11 X X X XPRP 12
PRP 13 XPRP 14 X
TOTAL 1 5 5 4 9 4 5 5
What about PRPs Tasks?
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Steering
group
Working
group
Study
design
SLR 1 FG protocol FG
moderation
analysis
Delphi
Design
NGT
meeting
PRP 1 X X X X X X XPRP 2 X X X X XPRP 3 X X X X X XPRP 4 X X X X X X X XPRP 5 XPRP 6 XPRP 7 X X X XPRP 8
PRP 9
PRP 10
PRP 11 X X X XPRP 12
PRP 13 XPRP 14 X
TOTAL 1 5 5 4 9 4 5 5
What about PRPs’ recognition?Co-authorship
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Steering
group
Working
group
Study
design
SLR 1 FG protocol FG
moderation
analysis
Delphi NGT
meeting
PRP 1 X X X X X X XPRP 2 X X X X XPRP 3 X X X X X XPRP 4 X X X X X X X XPRP 5 X X XPRP 6 X X XPRP 7 X X X XPRP 8 X XPRP 9 X XPRP 10 X XPRP 11 X X X X X XPRP 12 X XPRP 13 XPRP 14 X X
TOTAL 1 5 5 4 4 4 13 12
Extended PRP involvement
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Peripheral
joint activity
Skin activity
Patient global
Pain
Physical Function
HRQoL
Dactylitis
Fatigue
Acute phase reactants
Ultrasound
Orbai, A. et al. Annals of Rheum
Diseases 2016
2006
2012
2013
2014
2015
New domains identified through SLR and the
qualitative studies
Systemic inflammation
IndependenceStiffness
SleepTreatment burden
Emotional wellbeing
Economic costs
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Peripheral
joint activity
Skin activity
Patient global
Pain
Physical Function
HRQoL
Dactylitis
Fatigue
Acute phase reactants
Ultrasound
Orbai, A. et al. Annals of Rheum
Diseases 2016
2006
2012
2013
2014
2015
New domains identified through SLR and the
qualitative studies
Systemic inflammation
IndependenceStiffness
SleepTreatment burden
Emotional wellbeing
Economic costs
2016
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Core domain set development according to the OMERACT filter 2.0
Patient involvement througoutthe process of updating thePsoriatic Arthritis core domain set
Challenges of patientinvolvement in core set development
Conclusions
Overview
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What were challenges of involving patients in the COS update process?
1. Unanticipated Work Load for PRPs and researchers
2. Communication and equal collaboration
How to enhance new approaches and attitudes
3. Ensuring broad representativeness of patients’ perspectives
In demography, geography, disease severity and in numbers
4. Keeping PRPs and researchers motivated to collaborate
5. Preserving the patient perspective throughout the research process
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Preserving the patients’ perspectives
• Core domain sets should be short and feasible to measure, and based on stakeholder input and consensus.
• But how can we guarantee that consensus is obtained without losing important domains for patients and hence content validity of the core set?
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PRP participation as integral part of the consensus building
12 HPs
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Orbai AM ea, International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials. Annals of the rheumatic diseases 2016.
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• Full day consensus meeting• Equal representation• Independent facilitator• Open dialogue
Preliminary consensus on the updated PsA core
domain set
12 HPs
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12 HPs
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What has been the impact of patient and PRP involvement?
• PRP involvement in coding focus group transcripts ensured domains important to patients were captured.
• PRP involvement in developing the domain Delphi list ensured that domain descriptions were phrased in a manner understandable to patients.
• Integration of the patient perspective in a meaningful and representative manner provided face validity to the COS
• PRP involvement in the consensus process resulted in new domains on the research agenda and in the middle core. No patient relevant domains were added to the inner core.
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How can this be explained?
Potential factors to look at….
• Risk of patient representatives aligning with physicians views and priorities?
• Influence of existing power imbalances?
• Influence of clinical relationships?
• Lack of proportional representation in numbers?
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Conclusion
• PRP involvement is needed to ensure face validity of a core domain set.
• Attributes for an effective consensus meeting are:
– Equal numbers of patients and other stakeholders
– An independent facilitator
– Open dialogue
– Inclusion of opinions of all participants via consensus techniques (Nominal Group Technique).
• More research is needed to explore strategies to preserve the patients’ perspectives in the consensus building process and final core domain set.
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MSK activity
Skin activity
Patient global
Pain
Physical Function
HRQoL
Systemic inflammation
Fatigue
2006
2012
2013
2014
2015
2016
Orbai, A. et al. Annals of Rheum
Diseases 2016
Treatment burden
Stiffness OMERACT meeting 2016
Participation
Economic costs