Author:
Orbai Ana-Maria,de Wit Maarten,Mease Philip J.,Callis Duffin Kristina,Elmamoun Musaab,Tillett William,Campbell Willemina,FitzGerald Oliver,Gladman Dafna D.,Goel Niti,Gossec Laure,Hoejgaard Pil,Leung Ying Ying,Lindsay Chris,Strand Vibeke,van der Heijde Désirée M.,Shea Bev,Christensen Robin,Coates Laura,Eder Lihi,McHugh Neil,Kalyoncu Umut,Steinkoenig Ingrid,Ogdie Alexis
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.
Publisher
The Journal of Rheumatology
Subject
Immunology,Immunology and Allergy,Rheumatology
Cited by
99 articles.
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