title: Establishing a core domain set to measure rheumatoid arthritis flares: report of the OMERACT 11 RA flare Workshop.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: From the Department of Rheumatology, Hospital for Special Surgery, New York, New York, USA; Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway; Johns Hopkins University, Baltimore, Maryland, USA; McGill University, Montreal, Quebec, Canada; Schlosspark Klinik, Charité University Medicine, Berlin, Germany; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht, The Netherlands; Musculoskeletal Statistics Unit, The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark; David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, California, USA; University of the West of England, Bristol, UK; Healthy Motivation, Bone and Joint Decade, Santa Barbara, California, USA; Musculoskeletal Group, Cochrane Collaboration; University of Sydney Department of Rheumatology, Royal North Shore Hospital, St. Leonards, Australia; National Fathers' Network, Seattle, Washington, USA; Arthritis Research Center, Vancouver, British Columbia, Canada; Tools2use.eu, Bussum, The Netherlands; and the Department of Rheumatology, Cardiff University, Cardiff, UK.
authors.forename: Vivian P
authors.initials: VP
authors.lastname: Bykerk
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Lie
authors.forename: Susan J
authors.initials: SJ
authors.lastname: Bartlett
authors.forename: Rieke
authors.initials: R
authors.lastname: Alten
authors.forename: Annelies
authors.initials: A
authors.lastname: Boonen
authors.forename: Robin
authors.initials: R
authors.lastname: Christensen
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Furst
authors.forename: Sarah
authors.initials: S
authors.lastname: Hewlett
authors.forename: Amye L
authors.initials: AL
authors.lastname: Leong
authors.forename: Anne
authors.initials: A
authors.lastname: Lyddiatt
authors.forename: Lyn
authors.initials: L
authors.lastname: March
authors.forename: James E
authors.initials: JE
authors.lastname: May
authors.forename: Pam
authors.initials: P
authors.lastname: Montie
authors.forename: Ana-Maria
authors.initials: AM
authors.lastname: Orbai
authors.forename: Christoph
authors.initials: C
authors.lastname: Pohl
authors.forename: Marieke
authors.initials: M
authors.lastname: Scholte Voshaar
authors.forename: Thasia
authors.initials: T
authors.lastname: Woodworth
authors.forename: Clifton O
authors.initials: CO
authors.lastname: Bingham
authors.forename: Ernest H
authors.initials: EH
authors.lastname: Choy
mesh_terms: D001172:Arthritis, Rheumatoid / Q000175:diagnosis* / Q000628:therapy*; D003245:Consensus Statements as Topic; D003697:Delphi Technique; D018450:Disease Progression; D005260:Female; D017144:Focus Groups; D006305:Health Status Indicators; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D018434:Sickness Impact Profile; D016896:Treatment Outcome
keywords: CLINICAL TRIALS; DISEASE ACTIVITY; FLARE; OMERACT FILTER; OUTCOME AND PROCESS ASSESSMENT; RHEUMATOID ARTHRITIS