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

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.

PMID: 25684764
PMCID: PMC4747421
DOI: 10.3899/jrheum.141169

Review

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

Susan J Bartlett et al. J Rheumatol. 2015 Nov.

. 2015 Nov;42(11):2185-9.

doi: 10.3899/jrheum.141169. Epub 2015 Feb 15.

Authors

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.

PMID: 25684764
PMCID: PMC4747421
DOI: 10.3899/jrheum.141169

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.

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Figures

**Figure 1**
RA flare represented as a reflective or formative model.

See this image and copyright information in PMC

References

1. Alten R, Pohl C, Choy EH, Christensen R, Furst DE, Hewlett SE, et al. Developing a construct to evaluate flares in rheumatoid arthritis: a conceptual report of the OMERACT RA Flare Definition Working Group. J Rheumatol. 2011;38:1745–1750. - PubMed
1. Bingham CO, 3rd, Alten R, Bartlett SJ, Bykerk VP, Brooks PM, Choy E, et al. Identifying preliminary domains to detect and measure rheumatoid arthritis flares: report of the OMERACT 10 RA Flare Workshop. J Rheumatol. 2011;38:1751–1758. - PubMed
1. Bingham CO, III, Pohl C, Alten R, Christensen R, Choy EH, Hewlett SE, et al. Flare and disease worsening in rheumatoid arthritis: time for a definition. Int J Adv Rheumatol. 2009;7:85–91.
1. Bykerk VP, Lie E, Bartlett SJ, Alten R, Boonen A, Christensen R, et al. Establishing a core domain set to measure rheumatoid arthritis flares: report of the OMERACT 11 RA flare Workshop. J Rheumatol. 2014;41:799–809. - PMC - PubMed
1. Bingham CO, 3rd, Pohl C, Woodworth TG, Hewlett SE, May JE, Rahman MU, et al. Developing a standardized definition for disease "flare" in rheumatoid arthritis (OMERACT 9 Special Interest Group) J Rheumatol. 2009;36:2335–2341. - PubMed

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

Affiliations

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

Authors

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Abstract

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References

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Medical