To develop a French version of the Reflux Symptom Index (Fr-RSI) and to assess its internal consistency, reliability, and clinical validity.
Controlled, prospective trial.
Materials and Methods
Forty-four patients with a reflux finding score > 7 and an Fr-RSI > 13 were enrolled and treated with 20 mg of pantoprazole twice daily and diet changes for 3 months. Ninety asymptomatic subjects were also included in the study. To assess reliability, Fr-RSI was completed twice within a 7-day period. Validity was assessed by comparing Fr-RSI scores with scores from the Voice Handicap Index (VHI) in 24 of 44 patients, at baseline and at 3 months posttherapy.
The mean values of Fr-RSI at baseline and after 7 days were 20.17 ± 5.76 and 19.75 ± 7.08, respectively, for patients with laryngopharyngeal reflux (LPR) and 4.02 ± 3.49 and 3.71 ± 3.82, respectively, for controls. The test-retest reliability was high in patients with LPR (rBP = 0.78) and in healthy subjects (rBP = 0.80). Cronbach's alpha was 0.85, indicating high internal consistency. The mean Fr-RSI score significantly improved from a baseline of 20.17 ± 5.76 to 5.58 ± 3.65 after 3 months of treatment (P = 0.001), and the initial mean VHI total score significantly improved from 20.29 ± 19.62 to 12.87 ± 12.04 after treatment (P = 0.029), indicating validity of the results. However, of the subcategories of the VHI, only the mean physical score improved from a baseline of 11.19 ± 9.22 to 7.35 ± 5.96 after treatment (P = 0.016).
The Fr-RSI developed in this study demonstrated both reliability and validity. It can be easily administered to assist in diagnosing and monitoring of LPR in French-speaking patients.
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Published online: January 06, 2017
Accepted: November 28, 2016
Funding: This research has been subsidized by the ARC N°AUWB-2012-12/17-UMONS convention from Communauté Française de Belgique.
© 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.