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

Abstract

ObjectiveTo develop and validate the Reflux Sign Assessment‐10 (RSA‐10) for documenting the physical findings of laryngopharyngeal reflux disease (LPRD).MethodsPatients 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.ResultsFifty‐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 (rs = 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 (rs = 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%.ConclusionThe RSA‐10 is a reliable and valid clinical instrument for documenting the most prevalent laryngeal and extra‐laryngeal findings associated with LPRD.Level of Evidence3 Laryngoscope, 134:3981–3988, 2024