The Reflux Symptom Score-12: Cross-cultural Adaptation and Validation for European Portuguese Speakers With Laryngopharyngeal Reflux

Isabel Guimarães; Ana P Batista; Aldora Quintal; Rita Bom; Cláudia Romeiro; Madalena Saraiva; Maura Cunha; Daniela B Ferreira; Paula Correia; Lina Almeida; Gabriela Torrejano

doi:10.1016/j.jvoice.2023.06.016

The Reflux Symptom Score-12: Cross-cultural Adaptation and Validation for European Portuguese Speakers With Laryngopharyngeal Reflux

J Voice. 2023 Jul 29:S0892-1997(23)00190-X. doi: 10.1016/j.jvoice.2023.06.016. Online ahead of print.

Authors

Affiliations

¹ Speech and Language Pathologist (SLP), Speech Therapy Department, Alcoitão Health School of Sciences; Clinical and Therapeutics Pharmacological Unit, Faculty of Medicine, Instituto de Medicina Molecular, University of Lisbon, Portugal.
² PMR Department, Centro Hospitalar e Universitário do Algarve, Portimão, Portugal. Electronic address: ana.batista@chalgarve.min-saude.pt.
³ ENT Department, Hospital Garcia de Orta, Almada, Portugal.
⁴ ENT Department, Hospital do Espírito Santo de Évora, EPE, Évora, Portugal.
⁵ ENT Department, Hospital do Divino Espírito Santo, Ponta Delgada, EPE, Portugal.
⁶ PMR Department, Centro Hospitalar e Universitário do Algarve, Faro, Portugal.
⁷ ENT Department Centro Hospitalar de Entre Douro e Vouga, Santa Maria da Feira, Portugal.
⁸ ENT Department, Hospital dos Lusíadas, Lisboa, Portugal.
⁹ ENT Department, Centro Hospitalar Universitário Lisboa Norte, EPE, Lisboa, Portugal.

PMID: 37524579
DOI: 10.1016/j.jvoice.2023.06.016

Abstract

Objectives: To translate and cross-culturally adapt the 12-item reflux symptom score (RSS-12) to European Portuguese (EP) and determine its clinimetric properties for symptomatic individuals with laryngopharyngeal reflux (LPR).

Study design: Multinational cross-sectional cohort study.

Methods: The English RSS-12 was cross-culturally adapted according to the recommendations of the international guidelines. The validation study included the completion of the RSS-12, reflux symptom index, and voice handicap index by symptomatic and asymptomatic subjects with LPR. The RSS-12 was completed a second time by symptomatic subjects. Nine clinimetric properties were analyzed according to the international guidelines for validation of patient-reported outcome measures.

Results: The EP RSS-12 is equivalent to the English version (content, depth, and scoring). A total of 155 adults (84 with LPR symptoms) aged 21-78 years participated in the validation study. Statistical analyses revealed high internal consistency (Cronbach alpha >0.90), high test-retest reliability (intraclass correlation coefficient > 0.70, P < 0.001), low measurement error (Standard measure error of 5.21 for RSS and 1.59 for quality of life), good content validity (omission data <1% and item-total correlations > 0.652), good construct validity (61.9% of the total item variance with moderate item loadings), strong concurrent validity with reflux symptom index (r_p = 0.772, P < 0.001) and moderate validity with voice handicap index (r_p = 0.531, P < 0.001), and significantly known-groups validity (P < 0.001). The EP RSS-12 showed cross-cultural validity with French and Persian versions and high predictive validity with a cut-off value >8 for a sensitivity of 91.7% and a specificity of 91.5%.

Conclusions: The EP RSS-12 retained the features of the English version and is a reliable and valid patient-reported outcome measure for EP individuals with LPR in the study.

Keywords: Dysphonia; Laryngopharyngeal reflux; Outcome; Reflux symptom score-12.