Diagnostic Accuracy of Patient-Reported Outcome Measures and Finding Instruments in Laryngopharyngeal Reflux Disease.

Abstract

To investigate the diagnostic accuracy of various combinations of patient-reported outcome measures (PROMs) and upper aerodigestive tract finding instruments dedicated to the clinical diagnosis of laryngopharyngeal reflux disease (LPRD). Prospective, multicenter study. University hospital. Patients with LPRD at the 24-hour hypopharyngeal-esophageal multichannel intraluminal impedance-pH monitoring were recruited from three European hospitals. Asymptomatic individuals served as the control group. Participants completed the Reflux Symptom Index (RSI), Reflux Symptom Score (RSS), and Reflux Symptom Score-12 (RSS-12) at baseline and 3-month posttreatment. Clinical signs were evaluated with the Reflux Finding Score (RFS), Reflux Sign Assessment (RSA), and Reflux Sign Assessment-10 (RSA-10). Sensitivity (SE), specificity (SP), positive predictive value (PPV), and negative predictive value (NPV) were calculated for each instrument and their combinations. A total of 542 LPRD patients and 204 healthy controls were included. The RSS was the PROM with the highest SE (95.4%), whereas RSS-12 reported the highest SP (94.7%). RSA had the highest SE (94.0%), and RSA-10 reported the highest SP (76.3%). The highest SE and SP of combination tools were found for RSS+RSA (90.4%) and RSS+RSA-10 (99.4%), respectively. RSS+RSA-10 achieved the highest PPV value (99.7%) and RSS+RSA had the highest NPV (79.3%). Overall, the RSS demonstrated the greatest diagnostic accuracy with an area under the curve (AUC) of 0.985. The combination RSS+RSA reported an AUC of 0.934. The combination of RSS and RSA provided the most accurate diagnostic performance, maximizing SE, SP, PPV, and NPV. This combination offers enhanced utility for the preliminary diagnosis of LPRD.