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

Objective: 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).

Study design: Prospective, multicenter study.

Setting: University hospital.

Methods: 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.

Results: 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.

Conclusion: 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.