Lechien Jérôme R, Huet Kathy, Finck Camille, Khalife Mohamad, Fourneau Anne-Françoise, Delvaux Véronique, Piccaluga Myriam, Harmegnies Bernard, Saussez Sven
Laboratory of Anatomy and Cell Biology, Faculty of Medicine, UMONS Research Institute for Health Sciences and Technology, University of Mons (UMONS), Mons, Belgium; Laboratory of Phonetics, Faculty of Psychology, Research Institute for Language Sciences and Technology, University of Mons (UMONS), Mons, Belgium; Department of Otorhinolaryngology and Head and Neck Surgery, RHMS Baudour, EpiCURA Hospital, Baudour, Belgium.
Laboratory of Phonetics, Faculty of Psychology, Research Institute for Language Sciences and Technology, University of Mons (UMONS), Mons, Belgium.
J Voice. 2017 Jul;31(4):512.e1-512.e7. doi: 10.1016/j.jvoice.2016.11.020. Epub 2017 Jan 6.
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.
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 (r = 0.78) and in healthy subjects (r = 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.
开发反流症状指数法语版(Fr-RSI),并评估其内部一致性、可靠性和临床有效性。
对照前瞻性试验。
纳入44例反流发现评分>7且Fr-RSI>13的患者,给予每日2次20毫克泮托拉唑治疗并改变饮食3个月。研究还纳入了90名无症状受试者。为评估可靠性,在7天内让受试者完成两次Fr-RSI评估。通过比较44例患者中24例在基线和治疗后3个月时Fr-RSI评分与嗓音障碍指数(VHI)评分来评估有效性。
喉咽反流(LPR)患者基线时和7天后Fr-RSI的平均值分别为20.17±5.76和19.75±7.08,对照组分别为4.02±3.49和3.71±3.82。LPR患者和健康受试者的重测信度较高(LPR患者r = 0.78,健康受试者r = 0.80)。Cronbach's α为0.85,表明内部一致性较高。治疗3个月后,Fr-RSI平均评分从基线的20.17±5.76显著改善至5.58±3.65(P = 0.001),初始VHI总分从20.29±19.62显著改善至12.87±12.04(P = 0.029),表明结果有效。然而,在VHI的子类别中,只有平均生理评分从基线的11.19±9.22改善至治疗后的7.35±5.96(P = 0.016)。
本研究开发的Fr-RSI具有可靠性和有效性。它可轻松用于协助诊断和监测说法语患者的LPR。