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

Vivian P. Bykerk, 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, Ernest H. Choy

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)799-809
Number of pages11
JournalJournal of Rheumatology
Volume41
Issue number4
DOIs
StatePublished - Apr 2014

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Keywords

  • Clinical trials
  • Disease activity
  • Flare
  • Omeract filter
  • Outcome and process assessment
  • Rheumatoid arthritis

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

Cite this

Bykerk, V. P., Lie, E., Bartlett, S. J., Alten, R., Boonen, A., Christensen, R., Furst, D. E., Hewlett, S., Leong, A. L., Lyddiatt, A., March, L., May, J. E., Montie, P., Orbai, A. M., Pohl, C., Voshaar, M. S., Woodworth, T., Bingham, C. O., & 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