Reliability and Validity of the Reflux Sign Assessment (RSA) in the Diagnosis of Laryngopharyngeal Reflux among...

Diagnosing laryngopharyngeal reflux disease (LPRD) remains challenging. The reflux sign assessment (RSA) is a novel tool designed to quantify LPRD-related signs. The study aimed to evaluate the validity and reliability of the RSA in a Chinese patient population.

In this prospective validation study, the RSA was translated into Chinese through a standardized forward-backward process. A total of 170 patients with suspected LPRD completed baseline assessments, including the Chinese RSA, reflux symptom index, reflux finding score, and 24-hour laryngopharyngeal pH monitoring (Dx-pH monitoring). After 8 weeks of anti-reflux therapy, the RSA was repeated. Reliability (internal consistency, test-retest, inter-rater), criterion validity against Dx-pH monitoring, and responsiveness to treatment were evaluated.

The Chinese RSA demonstrated strong psychometric performance. Internal consistency was acceptable (Cronbach's α = 0.662), with excellent test-retest reliability (Spearman's r = 0.661-0.899, P < 0.01) and high inter-rater agreement (χ² = 0.267, P = 0.875). RSA scores correlated significantly with Dx-pH monitoring, confirming criterion validity. Antacid treatment was given to patients diagnosed with laryngopharyngeal reflux based on pharyngeal reflux detection. Complete pre and post-treatment data were available for 52 patients (22 females, 30 males, aged 18-76 years). Post-treatment RSA scores significantly decreased, indicating strong responsiveness.

The Chinese RSA is a reliable, valid, and responsive instrument for evaluating LPRD signs. Its comprehensive scope and strong psychometric properties support its use in clinical practice and research to enhance diagnosis, assess disease burden, and monitor therapeutic efficacy in Chinese-speaking populations.