Establishment and Optimization of a Patient-Reported Outcome–Based Electronic-Diary for Symptoms Evaluation in Patients With Gastroesophageal Reflux Disorder: Prospective Cohort Study

Abstract BackgroundGastroesophageal reflux disease (GERD) symptoms substantially impair patients’ quality of life. The use of patient-reported outcome (PRO) instruments for symptom measurement has been advocated by regulatory authorities. However, current tools for GERD symptom evaluation are limited by recall bias. To improve the real-time characterization of GERD symptoms, we developed an electronic diary (e-diary) for daily symptom monitoring. ObjectiveThis study aimed to develop and optimize a PRO-based e-diary for GERD symptom evaluation and to examine the effect of symptom frequency on adherence. MethodsThe 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 8 consecutive weeks. Adherence, defined as the daily completion rate of e-diary, was analyzed and optimized across three stages: (1) no reminder, (2) sending reminder SMS text messaging upon the detection of missing data (no reminders during the first 3-5 days after enrollment), and (3) immediate installation of reminder system at enrollment. Weekly symptom frequency was calculated as the sum of symptomatic days per week. Multiple regression analyses were performed to examine the effects of system optimization and symptom frequency on adherence after controlling for confounders. ResultsA total of 138 patients with GERD (70 men, 68 women; mean [SD] age 52.9 [12.3] years) were recruited. At the first stage, the adherence was 47.2%, 40%, and 57.6% for nighttime, daytime, and overall symptoms. System optimization significantly improved the adherence of nighttime symptoms by 12.5% (95% CI 3.7-21.3) and 10.9% (95% CI 2.6-19.2), daytime symptoms by 21.7% (95% CI 14.2-29.2) and 20.8% (95% CI 13.7-27.9), and overall symptoms by 16.5% (95% CI 9.8-23.2) and 18.5% (95% CI 12.2-4.8) in the second and third stages, respectively. Symptom frequency was positively associated with adherence, increasing by 0.7% (95% CI 0.6-0.8) for overall symptoms and 0.9% (95% CI 0.7-1) for both daytime and nighttime symptoms per additional symptom frequency. Adherence gradually decreased along the study period. (first vs eighth week: nighttime 80.1% vs 61.5%, βββ ConclusionsThe adherence of the GERD e-diary can be optimized by using SMS text messaging reminders. Higher symptom frequency was associated with increased adherence, although engagement declined over time. This innovative PRO-based e-diary with prolonged recording provides a real-time, prospective tool that overcomes the recall and ecological biases inherent in traditional short-term retrospective GERD symptom assessments. This advancement empowers patients through improved self-awareness and provides physicians with precise, long-term data, facilitating tailored therapeutic interventions and supporting personalized GERD management.