Feasibility and Domain Validation of Rheumatoid Arthritis (RA) Flare Core Domain Set: Report of the OMERACT 2014 RA Flare Group Plenary

Susan J Bartlett; Vivian P Bykerk; Roxanne Cooksey; Ernest H Choy; Rieke Alten; Robin Christensen; Daniel E Furst; Francis Guillemin; Serena Halls; Sarah Hewlett; Amye L Leong; Anne Lyddiatt; Lyn March; Pamela Montie; Ana Maria Orbai; Christoph Pohl; Marieke Scholte Voshaar; Thasia G Woodworth; Clifton O Bingham 3rd

doi:10.3899/jrheum.141169

Feasibility and Domain Validation of Rheumatoid Arthritis (RA) Flare Core Domain Set: Report of the OMERACT 2014 RA Flare Group Plenary

J Rheumatol. 2015 Nov;42(11):2185-9. doi: 10.3899/jrheum.141169. Epub 2015 Feb 15.

Authors

Susan J Bartlett¹, Vivian P Bykerk², Roxanne Cooksey², Ernest H Choy², Rieke Alten², Robin Christensen², Daniel E Furst², Francis Guillemin², Serena Halls², Sarah Hewlett², Amye L Leong², Anne Lyddiatt², Lyn March², Pamela Montie², Ana Maria Orbai², Christoph Pohl², Marieke Scholte Voshaar², Thasia G Woodworth², Clifton O Bingham 3rd²

Affiliations

¹ From McGill University, Montreal, Quebec, Canada; Johns Hopkins University, Baltimore, Maryland; Hospital for Special Surgery, New York, New York, USA; Swansea University, Swansea; Cardiff University, Cardiff, UK; Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany; The Parker Institute, Copenhagen University Hospital at Frederiksberg, Copenhagen, Denmark; University of California, Los Angeles, California, USA; University of Lorraine, Nancy, France; University of the West of England, Bristol, UK; Healthy Motivation, Santa Barbara, California, USA; University of Sydney, Sydney, Australia; and University of Twente, Enschede, The Netherlands.S.J. Bartlett, PhD, McGill University; and Johns Hopkins University; V.P. Bykerk, MD, Hospital for Special Surgery; R. Cooksey, MSc, Swansea University; E.H. Choy, MD, Cardiff University; R. Alten, Schlosspark-Klinik, University Medicine Berlin; R. Christensen, PhD, Parker Institute, Copenhagen University Hospital at Frederiksberg; D.E. Furst, MD, University of California, Los Angeles; F. Guillemin, MD, PhD, University of Lorraine; S. Halls, MSc; S. Hewlett, PhD, RN, University of the West of England; A.L. Leong, Healthy Motivation; A. Lyddiatt; University of Sydney; L. March, MD, PhD; P. Montie; A.M. Orbai, MD, MHS, Johns Hopkins University; C. Pohl, MD, Schlosspark-Klinik, University Medicine; M. Scholte Voshaar, University of Twente; T.G. Woodworth, MD, University of California, Los Angeles; and C.O. Bingham 3rd, MD, Johns Hopkins University. Susan.bartlett@mcgill.ca.
² From McGill University, Montreal, Quebec, Canada; Johns Hopkins University, Baltimore, Maryland; Hospital for Special Surgery, New York, New York, USA; Swansea University, Swansea; Cardiff University, Cardiff, UK; Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany; The Parker Institute, Copenhagen University Hospital at Frederiksberg, Copenhagen, Denmark; University of California, Los Angeles, California, USA; University of Lorraine, Nancy, France; University of the West of England, Bristol, UK; Healthy Motivation, Santa Barbara, California, USA; University of Sydney, Sydney, Australia; and University of Twente, Enschede, The Netherlands.S.J. Bartlett, PhD, McGill University; and Johns Hopkins University; V.P. Bykerk, MD, Hospital for Special Surgery; R. Cooksey, MSc, Swansea University; E.H. Choy, MD, Cardiff University; R. Alten, Schlosspark-Klinik, University Medicine Berlin; R. Christensen, PhD, Parker Institute, Copenhagen University Hospital at Frederiksberg; D.E. Furst, MD, University of California, Los Angeles; F. Guillemin, MD, PhD, University of Lorraine; S. Halls, MSc; S. Hewlett, PhD, RN, University of the West of England; A.L. Leong, Healthy Motivation; A. Lyddiatt; University of Sydney; L. March, MD, PhD; P. Montie; A.M. Orbai, MD, MHS, Johns Hopkins University; C. Pohl, MD, Schlosspark-Klinik, University Medicine; M. Scholte Voshaar, University of Twente; T.G. Woodworth, MD, University of California, Los Angeles; and C.O. Bingham 3rd, MD, Johns Hopkins University.

Abstract

Objective: The Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis (RA) Flare Group was established to develop an approach to identify and measure RA flares. An overview of our OMERACT 2014 plenary is provided.

Methods: Feasibility and validity of flare domains endorsed at OMERACT 11 (2012) were described based on initial data from 3 international studies collected using a common set of questions specific to RA flare. Mean flare frequency, severity, and duration data were presented, and domain scores were compared by flare status to examine known-groups validity. Breakout groups provided input for stiffness, self-management, contextual factors, and measurement considerations.

Results: Flare data from 501 patients in an observational study indicated 39% were in flare, with mean (SD) severity of 6.0 (2.6) and 55% lasting > 14 days. Pain, physical function, fatigue, participation, and stiffness scores averaged ≥ 2 times higher (2 of 11 points) in flaring individuals. Correlations between flare domains and corresponding legacy instruments were obtained: r = 0.46 to 0.93. A combined definition (patient report of flare and 28-joint Disease Activity Score increase) was evaluated in 2 other trials, with similar results. Breakout groups debated specific measurement issues.

Conclusion: These data contribute initial evidence of feasibility and content validation of the OMERACT RA Flare Core Domain Set. Our research agenda for OMERACT 2016 includes establishing duration/intensity criteria and developing criteria to identify RA flares using existing disease activity measures. Ongoing work will also address discordance between patient and physician ratings, facilitate application of flare criteria to clinical care, elucidate the role of self-management, and finalize recommendations for RA flare measurement.

Keywords: DISEASE EXACERBATION; FLARE; OMERACT; RHEUMATOID ARTHRITIS.

Publication types

Research Support, Non-U.S. Gov't
Review
Validation Study

MeSH terms

Arthritis, Rheumatoid / physiopathology*
Consensus Development Conferences as Topic*
Disease Progression*
Feasibility Studies
Female
Humans
Male
Observational Studies as Topic
Outcome Assessment, Health Care*
Pain Measurement*
Quebec
Randomized Controlled Trials as Topic

Abstract

Publication types

MeSH terms

Grants and funding