The American English version of the validated French Flare Assessment in RA Questionnaire (FLARE-RA)
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To evaluate use of a British English version of the validated French FLARE-RA questionnaire among American English speaking patients. In addition, to create a culturally adapted American English (AmE) FLARE-RA questionnaire and to examine its attributes of patient-reported RA flare status.
Using standardized cultural adaptation guidelines, we cognitively debriefed 25 American English speaking rheumatoid arthritis (RA) outpatients and created AmE-FLARE-RA with their input. One hundred three additional RA patients were recruited. Patients completed the Routine Assessment of Patient Index Data 3 (RAPID3), patient global visual analogue scale (VAS), AmE-FLARE-RA, and self-reports of flare. Physician global VAS, physician-assessed flare, swollen and tender joint count (TJC), and clinical disease activity index (CDAI) were documented. AmE-FLARE-RA and disease activity measures were compared between patient-reported and physician-reported flare categories.
Patients were female (89%), with mean (SD) age 51.1 (± 15.3) years and mean disease duration (SD) 11.9 (± 10.1) years, with 26% in remission/low disease activity. Total AmE-FLARE-RA scores, RAPID3, CDAI, and patient global VAS were significantly higher for both patient-reported flares and physician-reported flares compared with non-flaring patients by self- or physician report (p < 0.05). Total AmE-FLARE-RA scores correlated significantly with RAPID3 (corr = 0.50, p < 0.0001) and with CDAI (corr = 0.45, p < 0.0001). Across “no flares,” “one flare,” and “several flare” groups, there was a non-significant increase in AmE-FLARE-RA scores (p = 0.07).
• The American English FLARE-RA (AmE-FLARE-RA) questionnaire is the result of cognitive debriefing with American RA patients using the British English version of the validated French FLARE-RA and incorporates patient-recommended language modifications..
• Patients self-reporting flares had significantly higher AmE-FLARE-RA scores, compared with those without flares at the time of visit. AmE-FLARE-RA scores correlate with RAPID3 and CDAI.
• There was a non-statistically significant trend using the AmE-FLARE-RA scores when examining patients with no flare, one flare, or several flares.
• AmE-FLARE-RA total scores are uniformly elevated (~ 6.0 on a 0–10 scale), regardless of discordance between patient and MD assessment of flare at time of visit (~ 30%)
KeywordsOutcome measures Patient-reported outcome measure (PROM) Rheumatoid arthritis
The authors thank Dr. Sarah Thomas, who facilitated cognitive debriefing interviews and managed patient recruitment. Dr. Fabrice Kwiatkowski (FK) conducted the back translation and FG and BF evaluated for cross-cultural adaptation.
Compliance with ethical standards
This study is in compliance with and approved by the University of California, Los Angeles (UCLA) Office of the Human Research Protection Program. Patients voluntarily signed the UCLA internal review board (IRB)-approved (#12-001784) consent.
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