PT  - JOURNAL ARTICLE
AU  - Susan J. Bartlett
AU  - Skye P. Barbic
AU  - Vivian P. Bykerk
AU  - Ernest H. Choy
AU  - Rieke Alten
AU  - Robin Christensen
AU  - Alfons den Broeder
AU  - Bruno Fautrel
AU  - Daniel E. Furst
AU  - Francis Guillemin
AU  - Sarah Hewlett
AU  - Amye L. Leong
AU  - Anne Lyddiatt
AU  - Lyn March
AU  - Pamela Montie
AU  - Christoph Pohl
AU  - Marieke Scholte Voshaar
AU  - Thasia G. Woodworth
AU  - Clifton O. Bingham III
TI  - Content and Construct Validity, Reliability, and Responsiveness of the Rheumatoid Arthritis Flare Questionnaire: OMERACT 2016 Workshop Report
AID  - 10.3899/jrheum.161145
DP  - 2017 Oct 01
TA  - The Journal of Rheumatology
PG  - 1536--1543
VI  - 44
IP  - 10
4099  - http://www.jrheum.org/content/44/10/1536.short
4100  - http://www.jrheum.org/content/44/10/1536.full
SO  - J Rheumatol2017 Oct 01; 44
AB  - 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.