Andrea Nacci, Nicola de Bortoli, Silvia Capobianco, Federica Simoni, Tamanai Giusti, Pierfrancesco Visaggi, Maria Rosaria Barillari, Edoardo Vincenzo Savarino, Marzio Frazzoni, Stefano Berrettini, Bruno Fattori, Luca Bastiani
{"title":"The Revised Reflux Symptom Index (R-RSI): Development, Internal and External Validation Study.","authors":"Andrea Nacci, Nicola de Bortoli, Silvia Capobianco, Federica Simoni, Tamanai Giusti, Pierfrancesco Visaggi, Maria Rosaria Barillari, Edoardo Vincenzo Savarino, Marzio Frazzoni, Stefano Berrettini, Bruno Fattori, Luca Bastiani","doi":"10.1159/000540233","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>This study proposes a revised version of the Reflux Symptom Index (R-RSI), a seventeen-item questionnaire that was revised to increase the suspicion of laryngopharyngeal reflux disease (LPRD).</p><p><strong>Methods: </strong>Internal validation involved 213 participants, comprising 160 subjects without a previous LPRD diagnosis and 53 subjects with a self-reported previous diagnosis of LPRD with or without gastroesophageal reflux disease (GERD). Test-retest reliability and internal consistency were calculated. For the external validation, 56 patients (independent from the previous cohort) were enrolled to explore the R-RSI screening properties and determine a cutoff using 24-h MII-pH as the gold standard.</p><p><strong>Results: </strong>R-RSI test-retest reliability was high, both for the total score (ICC: 0.970) and for each item (ranging from 0.876 to 0.980). Cronbach's alpha was 0.910, indicating excellent internal consistency of the questionnaire. Participants with a previous self-reported diagnosis scored significantly higher (mean 24.94 ± 7.4; median 26, IQR 20-29) than those without a previous diagnosis (mean 4.66 ± 5.3; median 4, IQR 1-6) (p value <0.0001). Participants with both previous LPRD and GERD diagnoses had higher scores (27.20 ± 7.8) compared to those with only LPRD (21.77 ± 5.5) (p value = 0.003). Using 24-h MII-pH diagnosis as a gold standard, the optimal R-RSI cutoff point was determined to be 18, with a sensitivity of 84.5% and a specificity of 81.8%, positive predictive value of 95%, and negative predictive value of 60%.</p><p><strong>Conclusions: </strong>Our results suggest that the R-RSI may be useful to suspect LPRD, with or without GERD. The R-RSI is a self-administered patient-reported outcome questionnaire that demonstrates excellent reliability and high screening properties. Employing a cutoff of ≥18 in the R-RSI can assist in diagnosing and monitoring LPRD.</p>","PeriodicalId":12114,"journal":{"name":"Folia Phoniatrica et Logopaedica","volume":null,"pages":null},"PeriodicalIF":1.1000,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Folia Phoniatrica et Logopaedica","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1159/000540233","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"AUDIOLOGY & SPEECH-LANGUAGE PATHOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: This study proposes a revised version of the Reflux Symptom Index (R-RSI), a seventeen-item questionnaire that was revised to increase the suspicion of laryngopharyngeal reflux disease (LPRD).
Methods: Internal validation involved 213 participants, comprising 160 subjects without a previous LPRD diagnosis and 53 subjects with a self-reported previous diagnosis of LPRD with or without gastroesophageal reflux disease (GERD). Test-retest reliability and internal consistency were calculated. For the external validation, 56 patients (independent from the previous cohort) were enrolled to explore the R-RSI screening properties and determine a cutoff using 24-h MII-pH as the gold standard.
Results: R-RSI test-retest reliability was high, both for the total score (ICC: 0.970) and for each item (ranging from 0.876 to 0.980). Cronbach's alpha was 0.910, indicating excellent internal consistency of the questionnaire. Participants with a previous self-reported diagnosis scored significantly higher (mean 24.94 ± 7.4; median 26, IQR 20-29) than those without a previous diagnosis (mean 4.66 ± 5.3; median 4, IQR 1-6) (p value <0.0001). Participants with both previous LPRD and GERD diagnoses had higher scores (27.20 ± 7.8) compared to those with only LPRD (21.77 ± 5.5) (p value = 0.003). Using 24-h MII-pH diagnosis as a gold standard, the optimal R-RSI cutoff point was determined to be 18, with a sensitivity of 84.5% and a specificity of 81.8%, positive predictive value of 95%, and negative predictive value of 60%.
Conclusions: Our results suggest that the R-RSI may be useful to suspect LPRD, with or without GERD. The R-RSI is a self-administered patient-reported outcome questionnaire that demonstrates excellent reliability and high screening properties. Employing a cutoff of ≥18 in the R-RSI can assist in diagnosing and monitoring LPRD.
期刊介绍:
Published since 1947, ''Folia Phoniatrica et Logopaedica'' provides a forum for international research on the anatomy, physiology, and pathology of structures of the speech, language, and hearing mechanisms. Original papers published in this journal report new findings on basic function, assessment, management, and test development in communication sciences and disorders, as well as experiments designed to test specific theories of speech, language, and hearing function. Review papers of high quality are also welcomed.