Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Preliminary Rheumatoid Arthritis (RA) Flare Assessment for Randomized Clinical Trials (RCTs): An Outcome Measures in Rheumatology (OMERACT) Data-Driven, Patient-Centered, and Consensus-Based Initiative.
Bingham3, Clifton O., Choy4, Ernest, Alten6, Rieke, Boers11, Maarten, Brooks9, Peter, Bykerk1, Vivian, Christensen5, Robin
Brigham and Women's
University of the West of England
Vu University Medical Center
Johns Hopkins University, Baltimore, MD
Parker Institute: Musculoskeletal Statistics Unit Copenhagen University Hospital
Schlosspark Klinik University Charite
University of Queensland
There is no established definition of flare in RA, a potentially disabling disease feature that can impair function, confidence, and productivity. Patients (pts) use "flare" to describe episodes of disease worsening, but the magnitude, quality and duration of symptoms leading to a change of therapy have not been studied. Our objective was to establish a framework for the assessment of RA flare in RCTs which could serve to develop new efficacy parameters and/or facilitate tapering strategies and tight disease control.
An international multidisciplinary group of health care providers (HCPs), outcomes researchers, and pts established that RA flare would be anchored by worsening or return of disease activity of sufficient duration and intensity to result in (re)initiation or/and change of therapy. Qualitative research in RA pts utilizing detailed thematic analysis identified potential relevant domains. Additional candidate domains were obtained from literature search, face-to-face meetings, teleconferences, and stakeholder survey. Parallel HCP and pt research partner Delphi exercises identified and ranked potential domains as essential, important, or not important. To evaluate measurement properties of these items, standardized response means (SRMs) were derived from LOS and RCT databases. At the OMERACT 10 conference approximately 120 HCPs and pt experts participated in data review, in depth discussions, and consensus voting regarding domains to detect and measure flare. In consensus voting analysis, "don't know" responses were imputed conservatively as "no", and descriptive statistics used for reporting.
HCPs and researchers (>100) and 78 pts identified >20 potential domains and participated in online Delphi exercises prior to OMERACT10 with strong agreement regarding importance of pain, function, patient global assessment (PtGA), swollen joints (SJC) and tender joints (TJC) (core domains). Analyses of LOS and RCT showed that instruments assessing most potential domains are available and moderately sensitive to change. There was >90% agreement that the above core domains and investigator global assessment (MDGA) should be included in a preliminary flare core set. Respondents also identified fatigue (80%), stiffness (70%), and laboratory features (eg ESR/CRP, 66%) as domains of potential importance. 75% affirmed the importance of symptom persistence, and 74% that pt self report of flare should be measured. Other important areas included systemic features (60%), participation (57%), and self-management (58%).
Developing a common set of items to prospectively capture RA flare in RCTs is needed. Qualitative research and stakeholder consensus identified the existing RA core set of SJC, TJC, pain, function, PtGA, MDGA, and acute phase response to define RA flare. In addition, fatigue and stiffness were identified as requisite domains and systemic features, participation, and self-management as desirable to include. A preliminary flare assessment tool will be incorporated in upcoming RCTs and LOS for refinement and validation. Ongoing data analysis and a third Delphi will inform a final consensus based definition.
To cite this abstract, please use the following information:
Bingham, Clifton O., Choy, Ernest, Alten, Rieke, Boers, Maarten, Brooks, Peter, Bykerk, Vivian, et al; Preliminary Rheumatoid Arthritis (RA) Flare Assessment for Randomized Clinical Trials (RCTs): An Outcome Measures in Rheumatology (OMERACT) Data-Driven, Patient-Centered, and Consensus-Based Initiative. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1766