Assessment of the American-English Version of the French FLARE in Rheumatoid Arthritis

Nashla Barroso¹, Thasia G Woodworth², Francis Guillemin³, Daniel E. Furst⁴, Jenny Brook⁵, Suzanne Kafaja⁶, David Elashoff⁵, Bruno Fautrel⁷ and Veena Ranganath⁸, ¹Rheumatology, UCLA David Geffen School of Medicine, Los Angeles, CA, ²Leading Edge Clinical Research, Stuart, FL, ³CHRU Nancy, Clinical Epidemiology and Evaluation, Université de Lorraine, Paris Descartes University, APEMAC, EA 4360, Nancy, France, ⁴David Geffen School of Medicine at UCLA, Los Angeles, CA, ⁵Medicine, David Geffen School of Medicine, Los Angeles, CA, ⁶Medicine/Rheumatology, University of California Los Angeles, David Geffen School of Medicine, Los Angeles, CA, ⁷Rheumatology, Pitié Salpêtrière Hospital, Paris, France, ⁸Cumberland Valley Rheumatology, P.C., Chambersburg, PA

Meeting: ACR/ARHP Annual Meeting 2016

Date of first publication: September 28, 2016

Keywords: Disease Activity, outcomes and rheumatoid arthritis (RA)

Session Information

Date: Tuesday, November 15, 2016

Title: Rheumatoid Arthritis – Clinical Aspects - Poster III: Treatment – Monitoring, Outcomes, Adverse Events

Session Type: ACR Poster Session C

Session Time: 9:00AM-11:00AM

Background/Purpose: Due to the lack of consensus of the definition of a rheumatoid arthritis (RA) flare, the French “FLARE” (FLare Assessment in RA) instrument was developed and validated to assess worsening of disease activity between visits for the purposes of clinical trials. Prior work by our group ensured a robust validation process of translation and back-translation from French to American English (1). The objective of this study was to assess the performance of the American-English version of the FLARE questionnaire and to assure its validity in an American Native English-speaking RA cohort.

Methods: Fifty consecutive RA patients were recruited from the UCLA multi-physician rheumatology clinics who met the 1987 American College of Rheumatology (ACR) RA criteria. Patients completed a questionnaire with the following information: demographics, Routine Assessment of Patient Index Data 3 (RAPID3), patient global visual analogue scale (VAS), self-reported flare (Y/N), and American-English FLARE. The FLARE questionnaire was subcategorized into: physical component and emotional component. Other items obtained included: MD global VAS, MD reported flare, seropositivity, disease duration, swollen joint count (SJC), and tender joint count (TJC). The clinical disease activity index was calculated (CDAI). Analyses included Wilcoxon rank sum test and Spearman correlations.

Results: Subjects were separated in to two groups based on their report of RA flare (Y/N). RAPID3, CDAI, and FLARE totals were all significantly different between the groups (Table, p<0.05). In addition, there was a strong correlation between FLARE total and RAPID3 (corr=0.66, p<0.05) and a correlation between FLARE total and CDAI (corr=0.52, p<0.05). In addition, the correlation between CDAI and RAPID3 was 0.76 (p<0.5).

Conclusion: The French/Danish and the American-English translation of the FLARE questionnaire correlate similarly with CDAI and RAPID3 (2, 3), and validates the suitable translation of the FLARE to American-English. There may be merit in using this instrument to assess flare in RA patients. However, further validation of the American-English FLARE questionnaire will be required to evaluate it prospectively in a randomized controlled trial. References:1) Woodworth et al EULAR14-4820; 2) Berthelot et al ACR2013-2871 3) Maribo et al. Patient-self assessment of flare in rheumatoid arthritis: translation and reliability of the Flare instrument. Clin Rheumatol.2016 Apr;35(4):1053-8.

Patient Assessment of Flare
	No Flare Mean (SD)/ N (%) n=30	Flare Mean (SD)/ N (%) n=20	*p-value
Age	53.57 (16.35)	48.55 (15.92)	0.34
Female	27(90%)	18(90%)
Race Asian Black Pac Island White Other	8(27) 2(7) 1(3) 18(60%) 1(3%)	2(10) 2(10) 1(5) 15(75%) 0(0)	0.06
Seropositivity	22(73%)	13(65%)	0.53
Disease duration	11.60(10.77)	13.45(10.78)	0.54
RAPID3	8.64 (6.37)	15.33 (5.66)	0.001
CDAI	13.10 (9.28)	26.75 (13.60)	0.001
TJC	4.23 (4.97)	11.05 (7.76)	0.001
SJC	2.87 (2.71)	5.60 (4.27)	0.02
Patient Global	3.23 (2.27)	5.75 (2.29)	0.001
Physician Global	2.77 (1.70)	4.35 (2.46)	0.02
FLARE Total	4.64 (2.68)	6.73 (2.13)	0.03
FLARE Physical	5.08 (3.07)	7.31 (2.04)	0.02
FLARE Emotional	4.19 (2.77)	6.14 (2.78)	0.04
CDAI = Clinical Disease Activity Index; RAPID3 = Routine Assessment of Patient Index Data; TJC = Tender Joint Count; SJC = Swollen Joint Count; Seropositivity = either CCP+ or RF+; *Wilcoxon rank sum test

Disclosure: N. Barroso, None; T. G. Woodworth, F Hoffmann-La Roche, 9; F. Guillemin, None; D. E. Furst, None; J. Brook, None; S. Kafaja, None; D. Elashoff, None; B. Fautrel, None; V. Ranganath, Genentech, Pfizer, 8,BMS, 9.

To cite this abstract in AMA style:

Barroso N, Woodworth TG, Guillemin F, Furst DE, Brook J, Kafaja S, Elashoff D, Fautrel B, Ranganath V. Assessment of the American-English Version of the French FLARE in Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/assessment-of-the-american-english-version-of-the-french-flare-in-rheumatoid-arthritis/. Accessed .

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