TY - JOUR T1 - Establishing a Core Domain Set to Measure Rheumatoid Arthritis Flares: Report of the OMERACT 11 RA Flare Workshop JF - The Journal of Rheumatology JO - J Rheumatol SP - 799 LP - 809 DO - 10.3899/jrheum.131252 VL - 41 IS - 4 AU - Vivian P. Bykerk AU - Elisabeth Lie AU - Susan J. Bartlett AU - Rieke Alten AU - Annelies Boonen AU - Robin Christensen AU - Daniel E. Furst AU - Sarah Hewlett AU - Amye L. Leong AU - Anne Lyddiatt AU - Lyn March AU - James E. May AU - Pam Montie AU - Ana-Maria Orbai AU - Christoph Pohl AU - Marieke Scholte Voshaar AU - Thasia Woodworth AU - Clifton O. Bingham III AU - Ernest H. Choy Y1 - 2014/04/01 UR - http://www.jrheum.org/content/41/4/799.abstract N2 - Objective. The OMERACT Rheumatoid Arthritis (RA) Flare Group (FG) is developing a data-driven, patient-inclusive, consensus-based RA flare definition for use in clinical trials, longterm observational studies, and clinical practice. At OMERACT 11, we sought endorsement of a proposed core domain set to measure RA flare. Methods. Patient and healthcare professional (HCP) qualitative studies, focus groups, and literature review, followed by patient and HCP Delphi exercises including combined Delphi consensus at Outcome Measures in Rheumatology 10 (OMERACT 10), identified potential domains to measure flare. At OMERACT 11, breakout groups discussed key domains and instruments to measure them, and proposed a research agenda. Patients were active research partners in all focus groups and domain identification activities. Processes for domain selection and patient partner involvement were case studies for OMERACT Filter 2.0 methodology. Results. A pre-meeting combined Delphi exercise for defining flare identified 9 domains as important (> 70% consensus from patients or HCP). Four new patient-reported domains beyond those included in the RA disease activity core set were proposed for inclusion (fatigue, participation, stiffness, and self-management). The RA FG developed preliminary flare questions (PFQ) to measure domains. In combined plenary voting sessions, OMERACT 11 attendees endorsed the proposed RA core set to measure flare with ≥ 78% consensus and the addition of 3 additional domains to the research agenda for OMERACT 12. Conclusion. At OMERACT 11, a core domain set to measure RA flare was ratified and endorsed by attendees. Domain validation aligning with Filter 2.0 is ongoing in new randomized controlled clinical trials and longitudinal observational studies using existing and new instruments including a set of PFQ. ER -