Validity and reliability of the reflux symptom score

• Published in: The Laryngoscope 2020-03, Vol.130 (3), p.E98-E107
• Main 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
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Female; Humans; laryngitis; Laryngopharyngeal; Laryngopharyngeal Reflux - diagnosis; Male; Middle Aged; outcome; Patient Reported Outcome Measures; Prospective Studies; reflux; Reproducibility of Results; ROC Curve; Severity of Illness Index; Surveys and Questionnaires - standards; symptom; Symptom Assessment - standards; Translations; Young Adult
• ISSN: 0023-852X; 1531-4995
• DOI: 10.1002/lary.28017

Objectives/Hypothesis To develop and validate the Reflux Symptom Score (RSS), a self‐administered patient‐reported outcome questionnaire for patients with laryngopharyngeal reflux (LPR). Study Design Prospective controlled study. Methods 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. Results 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. Conclusions 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. Level of Evidence 3b Laryngoscope, 130:E98–E107, 2020