Core Outcome Measures in Effectiveness Trials

Updating the Psoriatic Arthritis (PsA) Core Domain Set: A Report from the PsA Workshop at OMERACT 2016

General Information

Abstract:
OBJECTIVE: To include the patient perspective in accordance with the Outcome Measures in Rheumatology (OMERACT) Filter 2.0 in the updated Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials (RCT) and longitudinal observational studies (LOS). METHODS: At OMERACT 2016, research conducted to update the PsA Core Domain Set was presented and discussed in breakout groups. The updated PsA Core Domain Set was voted on and endorsed by OMERACT participants. RESULTS: We conducted a systematic literature review of domains measured in PsA RCT and LOS, and identified 24 domains. We conducted 24 focus groups with 130 patients from 7 countries representing 5 continents to identify patient domains. We achieved consensus through 2 rounds of separate surveys with 50 patients and 75 physicians, and a nominal group technique meeting with 12 patients and 12 physicians. We conducted a workshop and breakout groups at OMERACT 2016 in which findings were presented and discussed. The updated PsA Core Domain Set endorsed with 90% agreement by OMERACT 2016 participants included musculoskeletal disease activity, skin disease activity, fatigue, pain, patient's global assessment, physical function, health-related quality of life, and systemic inflammation, which were recommended for all RCT and LOS. These were important, but not required in all RCT and LOS: economic cost, emotional well-being, participation, and structural damage. Independence, sleep, stiffness, and treatment burden were on the research agenda. CONCLUSION: The updated PsA Core Domain Set was endorsed at OMERACT 2016. Next steps for the PsA working group include evaluation of PsA outcome measures and development of a PsA Core Outcome Measurement Set.

Authors:
Orbai, A. M. de Wit, M. Mease, P. J. Callis Duffin, K. Elmamoun, M. Tillett, W. Campbell, W. FitzGerald, O. Gladman, D. D. Goel, N. Gossec, L. Hoejgaard, P. Leung, Y. Y. Lindsay, C. Strand, V. van der Heijde, D. M. Shea, B. Christensen, R. Coates, L. Eder, L. McHugh, N. Kalyoncu, U. Steinkoenig, I. Ogdie, A.

Publication

Journal:
J Rheumatol
Volume:
44
Issue:
10
Pages:
1522 - 1528
Year:
2017
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Rheumatology

Disease Name
Psoriatic arthritis

Target Population

Age Range
-

Sex
Unknown


Nature / type of Intervention
Unknown

Method(s)

Nominal group technique (NGT)

We conducted research to develop the updated PsA Core Domain Set. At OMERACT 2016 this work was presented, discussed in breakout groups and the updated PsA core domain set was voted on and endorsed by OMERACT participants.


Stakeholders Involved

Clinical experts
Consumers (patients)

Study Type

COS for clinical trials or clinical research

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