JMIR Publications

ABSTRACT

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<.001) and 20.8% (P<.001), and overall symptom by 16.5% (P<.001) and 18.5% (P<.001) in the Second and Third Stage. The frequency of GERD symptoms was positively associated with higher adherence, with an increase of 0.7% (P<.001) for overall symptoms, and 0.9% (P<.001) for both daytime and nighttime symptoms per additional symptom occurrence. The adherence was gradually decreased along the study period. (first vs. eighth week for nighttime, daytime, and overall symptom: 80.1% vs. 61.5%, 85.1% vs. 66.8%, and 95.1% vs. 78%, P<.001).

Conclusions:

The adherence of the GERD e-diary can be optimized by using SMS text messaging reminders. Higher frequency of GERD symptoms was associated with increased adherence. A decreasing trend in adherence of the e-diary in GERD symptoms recording was noted during the study period. This PRO-based e-diary may serve as a useful tool to evaluate GERD symptoms in clinical management and research.