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Review
. 2014 Apr;41(4):799-809.
doi: 10.3899/jrheum.131252. Epub 2014 Mar 1.

Establishing a core domain set to measure rheumatoid arthritis flares: report of the OMERACT 11 RA flare Workshop

Vivian P Bykerk  1 , Elisabeth Lie, Susan J Bartlett, Rieke Alten, Annelies Boonen, Robin Christensen, Daniel E Furst, Sarah Hewlett, Amye L Leong, Anne Lyddiatt, Lyn March, James E May, Pam Montie, Ana-Maria Orbai, Christoph Pohl, Marieke Scholte Voshaar, Thasia Woodworth, Clifton O Bingham 3rd, Ernest H Choy
Affiliations
Review

Establishing a core domain set to measure rheumatoid arthritis flares: report of the OMERACT 11 RA flare Workshop

Vivian P Bykerk et al. J Rheumatol. 2014 Apr.

Abstract

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.

Keywords: CLINICAL TRIALS; DISEASE ACTIVITY; FLARE; OMERACT FILTER; OUTCOME AND PROCESS ASSESSMENT; RHEUMATOID ARTHRITIS.

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Figures

Figure 1
Figure 1
A. Work plan of OMERACT RA Flare Working Group. HCP: healthcare professional; RCT: randomized controlled trials; LOS: longitudinal observational studies. B. Core domain set to measure RA flare aligns with OMERACT Filter 2.0 (from Boers M, et al. J Clin Epidemiol 2014; in press; adapted with permission).
Figure 2
Figure 2
Consensus agreement for inclusion of domains used to define rheumatoid arthritis (RA) flare among patients and their healthcare professionals (HCP). Bubble size reflects the relative precision of each estimate. Domains reflecting the 1993 American College of Rheumatology preliminary core set for disease activity measures for RA clinical trials are shaded. From Bartlett, et al. Ann Rheum Dis 2012;71:1855-60; used with permission.
Figure 3
Figure 3
Core domain set to identify and measure rheumatoid arthritis flare.
See this image and copyright information in PMC

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