Definition and construct validation of clinically relevant cutoffs on the Flare Assessment in Rheumatoid Arthritis (FLARE-RA) questionnaire.

The Flare Assessment in Rheumatoid Arthritis (FLARE-RA) questionnaire was devised for the detection of flares in patients with RA. We aimed to define construct validity and cut-off(s) for the FLARE-RA questionnaire. This cross-sectional study included adult patients with prevalent RA (2010 ACR/EULAR criteria) attending outpatient rheumatology clinics in France (n = 138), Denmark (n = 253), USA (n = 75), and Argentina (n = 105). Flare occurrence over the past 3 months was assessed with the FLARE-RA questionnaire scoring from 0 (no flare) to 10 (maximum flare). The cut-offs for the FLARE-RA score were defined using the following anchor items obtained at the same encounter: (1) Patient report of flare; (2) DAS28-CRP > 3.2; (3) Change of anti-rheumatic treatment, based on the area under the receiver operating characteristic curve (AUC) and distance to (0,1). Four hundred seventy four patients with RA duration ≥2 years (mean age 58.6 years, 74.9% female) were included in the main analysis. The discrimination for the FLARE-RA cut-offs was acceptable-to-excellent: AUC for the global FLARE-RA score ranged from 0.71 to 0.92. The cut-offs for the FLARE-RA score were lower using "patient report of flare" than DAS28-CRP and "change of anti-rheumatic treatment". Proposed FLARE-RA cut-offs for clinical detection and change of anti-rheumatic treatment are 2 and 5, respectively, for patients with RA duration 2-5 years, and 2 and 3.5, respectively, for patients with RA duration >5 years. Proposed FLARE-RA cut-offs have acceptable discriminative capacity across the tested anchor items and are expected to aid in early recognition and timely management of RA flares.

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Declaration of competing interest Dr. Myasoedova reports a grant from Pfizer Grant ID 15322005, during the conduct of the study. Dr. De Thurah reports grants from Central Region Denmark Health Research Foundation, the Danish Rheumatism Foundation (grant A2920), grants from the Novo Nordisk Research Foundation (grant NNF14OC0013029), grants from the Hede Nielsen Family Foundation, during the conduct of the study. Dr. Erpelding reports a grant from AbbVie (ACA-FRAN-11-02), during the conduct of the study. Dr. Schneeberger has nothing to disclose. Dr. Maribo reports grants from Central Region Denmark Health Research Foundation, the Danish Rheumatism Foundation (grant A2920), grants from the Novo Nordisk Research Foundation (grant NNF14OC0013029), grants from the Hede Nielsen Family Foundation, during the conduct of the study. Dr. Citera has nothing to disclose. Dr. Davis, III reports a grant from Pfizer Grant ID 15322005, during the conduct of the study. Dr. Matteson reports a grant from Pfizer Grant ID 15322005, during the conduct of the study. Dr. Crowson reports a grant from Pfizer Grant ID 15322005, during the conduct of the study. D. Fautrel reports a grant from AbbVie (ACA-FRAN-11-02), during the conduct of the study. Dr. Guillemin reports a grant from AbbVie (ACA-FRAN-11-02), during the conduct of the study.