RT Journal Article
SR Electronic
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
FD The Journal of Rheumatology
SP 799
OP 809
DO 10.3899/jrheum.131252
VO 41
IS 4
A1 Vivian P. Bykerk
A1 Elisabeth Lie
A1 Susan J. Bartlett
A1 Rieke Alten
A1 Annelies Boonen
A1 Robin Christensen
A1 Daniel E. Furst
A1 Sarah Hewlett
A1 Amye L. Leong
A1 Anne Lyddiatt
A1 Lyn March
A1 James E. May
A1 Pam Montie
A1 Ana-Maria Orbai
A1 Christoph Pohl
A1 Marieke Scholte Voshaar
A1 Thasia Woodworth
A1 Clifton O. Bingham III
A1 Ernest H. Choy
YR 2014
UL http://www.jrheum.org/content/41/4/799.abstract
AB 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.