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- Title
Validity and reliability of the reflux symptom score.
- Authors
Lechien, Jérôme R.; Bobin, Francois; Muls, Vinciane; Thill, Marie‐Paule; Horoi, Mihaela; Ostermann, Katharina; Huet, Kathy; Harmegnies, Bernard; Dequanter, Didier; Dapri, Giovanni; Maréchal, Marie‐Therese; Finck, Camille; Rodriguez Ruiz, Alexandra; Saussez, Sven; Thill, Marie-Paule; Maréchal, Marie-Therese
- Abstract
<bold>Objectives/hypothesis: </bold>To develop and validate the Reflux Symptom Score (RSS), a self-administered patient-reported outcome questionnaire for patients with laryngopharyngeal reflux (LPR).<bold>Study Design: </bold>Prospective controlled study.<bold>Methods: </bold>A total of 113 patients with LPR were enrolled and treated with diet and 3 months of pantoprazole, alginate, and/or magaldrate depending on the LPR characteristics (acid, nonacid, or mixed). Eighty asymptomatic individuals completed the study. Patients and controls completed the RSS twice within a 7-day period to assess test-retest reliability. Internal consistency was measured using Cronbach's α for the RSS items in patients and controls. Validity was assessed by comparing the baseline RSS with the Reflux Symptom Index (RSI) and Voice Handicap Index (VHI). Seventy-seven patients completed the RSS at baseline and after 6 and 12 weeks of treatment to assess responsiveness to change. The RSS cutoff for determining the presence and absence of LPR was examined by receiver operating characteristic analysis.<bold>Results: </bold>Test-retest reliability (rs = 0.921) and internal consistency reliability (α = 0.969) were high. RSS exhibited high external validity indicated by a significant correlation with the RSI (rs = 0.831). Internal validity was excellent based on the higher RSS in patients compared with controls (P = .001). RSS, RSI, and VHI scores significantly improved from pre- to posttreatment, indicating a high responsiveness to change. RSS >13 can be considered suggestive of LPR-related symptoms. RSS was not influenced by the occurrence of gastroesophageal reflux disease, LPR subtypes, or patient characteristics.<bold>Conclusions: </bold>RSS is a self-administered patient-reported outcome questionnaire that demonstrates high reliability and excellent criterion-based validity. RSS can be used in diagnosing and monitoring LPR disease.<bold>Level Of Evidence: </bold>3b Laryngoscope, 130:E98-E107, 2020.
- Subjects
RECEIVER operating characteristic curves; STATISTICAL reliability; TEST reliability; GASTROESOPHAGEAL reflux diagnosis; RESEARCH; RESEARCH evaluation; RESEARCH methodology; EVALUATION research; MEDICAL cooperation; SEVERITY of illness index; COMPARATIVE studies; SYMPTOMS; RESEARCH funding; LONGITUDINAL method; TRANSLATIONS
- Publication
Laryngoscope, 2020, Vol 130, Issue 3, pE98
- ISSN
0023-852X
- Publication type
journal article
- DOI
10.1002/lary.28017