Validity and Reliability of the Reflux Sign Assessment-10 (RSA-10)

Jérôme R Lechien; Lisa G De Marrez; Camille Finck; Sven Saussez

doi:10.1002/lary.31420

Validity and Reliability of the Reflux Sign Assessment-10 (RSA-10)

Laryngoscope. 2024 Mar 29. doi: 10.1002/lary.31420. Online ahead of print.

Authors

Jérôme R Lechien^{1

2

3

4}, Lisa G De Marrez⁴, Camille Finck^{1

5}, Sven Saussez^{2

3}

Affiliations

¹ Research Committee of the Young-Otolaryngologists of the International Federations of Oto-rhino-laryngological Societies (YO-IFOS), Paris, France.
² Division of Laryngology and broncho-esophagology, Department of Otolaryngology-Head and Neck Surgery, Faculty of Medicine, UMONS Research Institute for Health Sciences and Technology, University of Mons (UMons), Mons, Belgium.
³ Department of Otorhinolaryngology and Head and Neck Surgery, CHU Saint-Pierre, Brussels, Belgium.
⁴ Department of Otolaryngology-Head & Neck Surgery, Foch Hospital, Paris Saclay University, Paris, France.
⁵ Department of Otorhinolaryngology and Head and Neck Surgery, CHU de Liège (Sart Tilman), Liège, Belgium.

PMID: 38551328
DOI: 10.1002/lary.31420

Abstract

Objective: To develop and validate the Reflux Sign Assessment-10 (RSA-10) for documenting the physical findings of laryngopharyngeal reflux disease (LPRD).

Methods: Patients with LPRD at the hypopharyngeal-esophageal multichannel intraluminal impedance-pH monitoring and asymptomatic individuals were consecutively recruited from two European hospitals. Three experienced otolaryngologists rated RSA-10 in patients and controls for assessing internal validity. RSA-10 was rated within a 7-day period to assess test-retest reliability. Internal consistency was measured using Cronbach's α in patients and controls. Convergent validity was evaluated through a correlation analysis between RSA-10 and Reflux Finding Score (RFS). Interrater reliability was evaluated by comparing the RSA-10 evaluations of the three otolaryngologists through Fleiss kappa. Pre- to posttreatment change of RSA-10 was evaluated to assess responsiveness to change. The RSA-10 thresholds were examined by receiver operating characteristic analysis.

Results: Fifty-five patients completed the pre- to posttreatment evaluations from January 2020 to December 2023. A total of 115 asymptomatic individuals completed the study. RSA-10 reported high internal consistency reliability (α = 0.822) and test-retest reliability (r_s = 0.725). The RSA-10 scores of patients were significantly higher than those of controls (p = 0.001), suggesting high internal validity. RSA-10 was significantly correlated with the RFS (r_s = 0.771). The interrater reliability was adequate for sub- and total RSA-10 scores (k = 0.708). RSA-10 significantly improved from baseline to 3-month posttreatment (p = 0.001). An RSA-10 > 13 may be suggestive of LPRD. Both RSA-10 > 13 and Reflux Symptom Score-12 > 11 were associated with a sensitivity of 92.7% and a specificity of 97.3%.

Conclusion: The RSA-10 is a reliable and valid clinical instrument for documenting the most prevalent laryngeal and extra-laryngeal findings associated with LPRD.

Level of evidence: 3 Laryngoscope, 2024.

Keywords: finding; laryngitis; laryngology; laryngopharyngeal; otolaryngology; reflux; score; sign.

Grants and funding

2020JL/Roi Baudouin Foundation