Abstracts

Rationale: Clinical trials in epilepsy historically depended on paper diaries for reporting seizures and adverse events. Since written diary entries can be made at any time between study visits, paper diaries cannot assess the time interval between clinical event occurrence and the diary documentation, or if there is evidence of data entry fatigue. Electronic diaries may facilitate reporting by subjects and enable monitoring of the interval from occurrence of event to entry time as a marker of validity and accuracy. Electronic reporting also allows for constant monitoring of adherence, which can be particularly important in long-term clinical trials. The WEPOD (Women with Epilepsy: Pregnancy Outcomes and Deliveries) study is a 3-site prospective, observational study evaluating fertility in women with epilepsy (WWE) and healthy controls (HC) as they transition from preconception planning through pregnancy and delivery. This interim analysis assessed subjects' use of an electronic diary and whether data entry fatigue occurred over the course of subject participation in the fertility phase, which could be up to one year. Methods: Women with epilepsy and healthy controls, ages 18-40 years, seeking pregnancy were enrolled within 6 months of discontinuing contraception. We developed a customized mobile Application (the WEPOD App™) for daily data tracking. The WEPOD App™ is connected to a web-based program that allows for data entry and provides central data monitoring. Subjects were given a 4th generation iPod Touch, which they could also use with the web-based program, or choose to use a paper diary. Subjects recorded menstrual bleeding and sexual activity daily (fertility diary). WWE also tracked AED compliance and seizure occurrence. The WEPOD App™ includes a "pop-up" reminder asking the subject to make their daily diary entry. Subjects track fertility data daily until conception or until 12 months elapses, creating a potentially long duration for study participation. Results: At the time of this analysis, 119 participants (49 WWE and 70 controls) were enrolled and provided diary data for 17,191 days. Demographics are listed in Table 1. All subjects used the WEPOD app and/or web portal; none chose paper diaries. Average days of fertility data entry were 145.6 ±111.9 (range 0-365). The average completion of the fertility diary was 90% +0.21 (minimum 0%). Average number of days per week in the study that subjects made a data entry was 6.30, without a substantial decline over time in the study (Figure 1). A slight reduction in mean number of days diary data was recorded appeared after 44 weeks, but less than 20 subjects were still in the fertility phase of the WEPOD study at that time. Conclusions: Subjects preferred an electronic diary for monitoring of fertility-related data in the WEPOD study. Adherence with diary use was high and stable over time without showing signs of appreciable diary entry fatigue. This data capture tool has the potential to be used across different disease populations and clinical trials.