Susan J Bartlett1,2, Skye P Barbic3,4, Vivian P Bykerk3,4, Ernest H Choy3,4, Rieke Alten3,4, Robin Christensen3,4, Alfons den Broeder3,4, Bruno Fautrel3,4, Daniel E Furst3,4, Francis Guillemin3,4, Sarah Hewlett3,4, Amye L Leong3,4, Anne Lyddiatt3,4, Lyn March3,4, Pamela Montie3,4, Christoph Pohl3,4, Marieke Scholte Voshaar3,4, Thasia G Woodworth3,4, Clifton O Bingham3,4. 1. From McGill University, Montreal, Quebec; University of British Columbia, Vancouver, British Columbia, Canada; Johns Hopkins University, Baltimore, Maryland; Hospital for Special Surgery, New York, New York; University of California, Los Angeles; Healthy Motivation, Santa Barbara, California, USA; Cardiff University, Cardiff; University of the West of England, Bristol, UK; Schlosspark-Klinik University Medicine, Berlin, Germany; Parker Institute, Copenhagen University, Copenhagen, Denmark; Sint Maartenskliniek, Nijmege; Vrije Universiteit (VU), Amsterdam, the Netherlands; Pierre et Marie Curie University, Paris; University of Lorraine, Lorraine, France; University of Sydney, Sydney, Australia. susan.bartlett@mcgill.ca. 2. S.J. Bartlett, PhD, McGill University, and Johns Hopkins University; S.P. Barbic, PhD, University of British Columbia; V.P. Bykerk, MD, Hospital for Special Surgery; E.H. Choy, MD, Cardiff University; R. Alten, MD, Schlosspark-Klinik University Medicine; R. Christensen, PhD, Parker Institute, Copenhagen University; A. den Broeder, MD, PhD, Sint Maartenskliniek; B. Fautrel, MD, PhD, Pierre et Marie Curie University; D.E. Furst, MD, University of California; F. Guillemin, MD, PhD, University of Lorraine; S. Hewlett, PhD, RN, University of the West of England; A.L. Leong, MBA, Healthy Motivation; A. Lyddiatt, Patient Research Partner; L. March, MD, PhD, University of Sydney; P. Montie, Patient Research Partner; C. Pohl, MD, Schlosspark-Klinik University Medicine; M. Scholte Voshaar, MSc, VU; T.G. Woodworth, MD, University of California; C.O. Bingham III, MD, Johns Hopkins University. susan.bartlett@mcgill.ca. 3. From McGill University, Montreal, Quebec; University of British Columbia, Vancouver, British Columbia, Canada; Johns Hopkins University, Baltimore, Maryland; Hospital for Special Surgery, New York, New York; University of California, Los Angeles; Healthy Motivation, Santa Barbara, California, USA; Cardiff University, Cardiff; University of the West of England, Bristol, UK; Schlosspark-Klinik University Medicine, Berlin, Germany; Parker Institute, Copenhagen University, Copenhagen, Denmark; Sint Maartenskliniek, Nijmege; Vrije Universiteit (VU), Amsterdam, the Netherlands; Pierre et Marie Curie University, Paris; University of Lorraine, Lorraine, France; University of Sydney, Sydney, Australia. 4. S.J. Bartlett, PhD, McGill University, and Johns Hopkins University; S.P. Barbic, PhD, University of British Columbia; V.P. Bykerk, MD, Hospital for Special Surgery; E.H. Choy, MD, Cardiff University; R. Alten, MD, Schlosspark-Klinik University Medicine; R. Christensen, PhD, Parker Institute, Copenhagen University; A. den Broeder, MD, PhD, Sint Maartenskliniek; B. Fautrel, MD, PhD, Pierre et Marie Curie University; D.E. Furst, MD, University of California; F. Guillemin, MD, PhD, University of Lorraine; S. Hewlett, PhD, RN, University of the West of England; A.L. Leong, MBA, Healthy Motivation; A. Lyddiatt, Patient Research Partner; L. March, MD, PhD, University of Sydney; P. Montie, Patient Research Partner; C. Pohl, MD, Schlosspark-Klinik University Medicine; M. Scholte Voshaar, MSc, VU; T.G. Woodworth, MD, University of California; C.O. Bingham III, MD, Johns Hopkins University.
Abstract
OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis (RA) Flare Group was established to develop a reliable way to identify and measure RA flares in randomized controlled trials (RCT). Here, we summarized the development and field testing of the RA Flare Questionnaire (RA-FQ), and the voting results at OMERACT 2016. METHODS: Classic and modern psychometric methods were used to assess reliability, validity, sensitivity, factor structure, scoring, and thresholds. Interviews with patients and clinicians also assessed content validity, utility, and meaningfulness of RA-FQ scores. RESULTS: People with RA in observational trials in Canada (n = 896) and France (n = 138), and an RCT in the Netherlands (n = 178) completed 5 items (11-point numerical rating scale) representing RA Flare core domains. There was moderate to high evidence of reliability, content and construct validity, and responsiveness. Factor analysis supported unidimensionality. Rasch analysis showed acceptable fit to the Rasch model, with items and people covering a broad measurement continuum and evidence of appropriate targeting of items to people, ordered thresholds, minimal differential item functioning by language, sex, or age. A summative score across items is defensible, yielding an interval score (0-50) where higher scores reflect worsening flare. The RA-FQ received endorsement from 88% of attendees that it passed the OMERACT Filter 2.0 "Eyeball Test" for instrument selection. CONCLUSION: The RA-FQ has been developed to identify and measure RA flares. Its review through OMERACT Filter 2.0 shows evidence of reliability, content and construct validity, and responsiveness. These properties merit its further validation as an outcome for clinical trials.
OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis (RA) Flare Group was established to develop a reliable way to identify and measure RA flares in randomized controlled trials (RCT). Here, we summarized the development and field testing of the RA Flare Questionnaire (RA-FQ), and the voting results at OMERACT 2016. METHODS: Classic and modern psychometric methods were used to assess reliability, validity, sensitivity, factor structure, scoring, and thresholds. Interviews with patients and clinicians also assessed content validity, utility, and meaningfulness of RA-FQ scores. RESULTS:People with RA in observational trials in Canada (n = 896) and France (n = 138), and an RCT in the Netherlands (n = 178) completed 5 items (11-point numerical rating scale) representing RA Flare core domains. There was moderate to high evidence of reliability, content and construct validity, and responsiveness. Factor analysis supported unidimensionality. Rasch analysis showed acceptable fit to the Rasch model, with items and people covering a broad measurement continuum and evidence of appropriate targeting of items to people, ordered thresholds, minimal differential item functioning by language, sex, or age. A summative score across items is defensible, yielding an interval score (0-50) where higher scores reflect worsening flare. The RA-FQ received endorsement from 88% of attendees that it passed the OMERACT Filter 2.0 "Eyeball Test" for instrument selection. CONCLUSION: The RA-FQ has been developed to identify and measure RA flares. Its review through OMERACT Filter 2.0 shows evidence of reliability, content and construct validity, and responsiveness. These properties merit its further validation as an outcome for clinical trials.
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