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

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

Authors

Ana Maria Orbai

Vivian P. Bykerk

Elisabeth Lie

Susan J. Bartlett

Rieke Alten

Annelies Boonen

Robin Christensen

Daniel E. Furst

Amye L. Leong

Anne Lyddiatt

Lyn March

James E. May

Pam Montie

M. Scholte Voshaar

Christoph Pohl

Thasia Woodworth

Clifton O. Bingham

Ernest H. Choy



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. Copyright © 2014. All rights reserved.

Journal Article Type Article
Publication Date Jan 1, 2014
Journal Journal of Rheumatology
Print ISSN 0315-162X
Electronic ISSN 1499-2752
Publisher Journal of Rheumatology
Peer Reviewed Peer Reviewed
Volume 41
Issue 4
Pages 799-809
APA6 Citation Voshaar, M. S., Orbai, A. M., Bykerk, V. P., Lie, E., Bartlett, S. J., Alten, R., …Choy, E. H. (2014). Establishing a core domain set to measure rheumatoid arthritis flares: Report of the OMERACT 11 RA flare workshop. Journal of Rheumatology, 41(4), 799-809. https://doi.org/10.3899/jrheum.131252
DOI https://doi.org/10.3899/jrheum.131252
Keywords outcome and process assessment, flare, disease activity, omeract filter, clinical trials, rheumatoid arthritis
Publisher URL http://dx.doi.org/10.3899/jrheum.131252
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