Validity and reliability of the reflux symptom score

Jérôme R Lechien; Francois Bobin; Vinciane Muls; Marie-Paule Thill; Mihaela Horoi; Katharina Ostermann; Kathy Huet; Bernard Harmegnies; Didier Dequanter; Giovanni Dapri; Marie-Therese Maréchal; Camille Finck; Alexandra Rodriguez Ruiz; Sven Saussez

doi:10.1002/lary.28017

Validity and reliability of the reflux symptom score

Laryngoscope. 2020 Mar;130(3):E98-E107. doi: 10.1002/lary.28017. Epub 2019 Apr 14.

Authors

Jérôme R Lechien^{1

2

3

4}, Francois Bobin^{1

5}, Vinciane Muls⁶, Marie-Paule Thill⁴, Mihaela Horoi⁴, Katharina Ostermann⁴, Kathy Huet^{1

3}, Bernard Harmegnies^{1

3}, Didier Dequanter^{1

4}, Giovanni Dapri⁷, Marie-Therese Maréchal⁷, Camille Finck^{1

8}, Alexandra Rodriguez Ruiz^{1

4}, Sven Saussez^{1

2

4}

Affiliations

¹ Research Committee of the Young Otolaryngologists of the International Federation of Oto-Rhino-Laryngological Societies (YO-IFOS), Marseille, France.
² Laboratory of Anatomy and Cell Biology, Faculty of Medicine, Research Institute for Health Sciences and Technology, University of Mons (UMons), Mons, Belgium.
³ Laboratory of Phonetics, Faculty of Psychology, Research Institute for Language Science and Technology, University of Mons (UMons), Mons, Belgium.
⁴ Department of Otorhinolaryngology and Head and Neck Surgery, CHU Saint-Pierre, Brussels, Belgium.
⁵ Department of Otorhinolaryngology and Head and Neck Surgery, Polyclinique de Poitiers, Poitiers, France.
⁶ Department of Gastroenterology and Endoscopy, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.
⁷ Department of Surgery, CHU Saint-Pierre, Université Libre de Bruxelles, Brussels, Belgium.
⁸ Department of Otorhinolaryngology and Head and Neck Surgery, CHU de Liège (Sart Tilman), Liège, Belgium.

PMID: 30983002
DOI: 10.1002/lary.28017

Abstract

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 (r_s = 0.921) and internal consistency reliability (α = 0.969) were high. RSS exhibited high external validity indicated by a significant correlation with the RSI (r_s = 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.

Keywords: Laryngopharyngeal; laryngitis; outcome; reflux; symptom; tool.

Publication types

Research Support, Non-U.S. Gov't
Validation Study

MeSH terms

Adult
Aged
Aged, 80 and over
Female
Humans
Laryngopharyngeal Reflux / diagnosis*
Male
Middle Aged
Patient Reported Outcome Measures
Prospective Studies
ROC Curve
Reproducibility of Results
Severity of Illness Index*
Surveys and Questionnaires / standards*
Symptom Assessment / standards*
Translations
Young Adult