Establishment and Optimization of a Patient-Reported Outcome–Based Electronic-Diary for Symptoms Evaluation in Patients With Gastroesophageal Reflux Disorder: Prospective Cohort Study
7 January 2026 at 05:30
Background: Gastroesophageal reflux disease (GERD) symptoms significantly affect patients’ quality of life. Patient-reported outcome (PRO) instruments for symptoms measurement in GERD patients is advocated by regulatory authority. Current tools for GERD symptoms evaluation are limited and the results can be biased by the recall bias. To better characterize the GERD symptoms, an e-diary was developed for daily GERD symptom monitoring. Objective: To build up and optimize a PRO-based e-diary, and to investigate the effect of symptom frequency on adherence. Methods: The GERD e-diary evaluated 8 daytime (acid regurgitation, cough, heartburn, sour taste in the mouth, hiccups, hoarseness, dysphagia, and chest pain) and 2 nighttime symptoms (acid regurgitation and cough) for consecutive 8 weeks. The adherence of e-diary, defined as daily completing rate of e-diary, was evaluated and optimized from First Stage to Third Stage with no reminder implemented in First Stage, sending reminding SMS (Short Message Service) text messaging upon detecting missing data in Second Stage (no reminder during the first 3 to 5 days after enrollment), and immediate installation of reminding system at enrollment in Third Stage. GERD symptom frequency was obtained by summation of the symptomatic days in each week. A multiple regression analysis was performed to examine the effects of system optimization and GERD symptom frequency on patient adherence, while controlling for potential confounding variables. Results: 138 GERD patients (M/F=70/68; age: mean 52.9, SD 12.3 years) were recruited. At First Stage, the adherence was 47.2%, 40% and 57.6% for nighttime, daytime and overall symptom. System optimization significantly improved adherence with increased adherence of nighttime symptoms by 12.5% (P=.005) and 10.9% (P=.01), daytime symptom by 21.7% (P