Presentation (CTI)

OBJECTIVES: Electronic diaries (eDiaries) have become an important tool for collecting patient-reported data in clinical trials. eDiaries are often used to collect episodic events that contribute to important clinical trial endpoints such as migraines, seizures, and cataplexy events. The benefits of eDiaries include the ability to track the date/time of entries and events, which could be entered as they happen (event-driven or episodically), or through a once daily evening diary that prompts the patient to complete through notifications. Within a clinical trial setting, patient preference/habits for event-driven vs. prompted evening diary entry remain unclear. Therefore, the objective of this research was to examine patient habits in reporting events in eDiaries to determine how often the entries are event-driven vs. reported through prompted evening diary to help inform good diary design.
METHODS: eCOA data from neuroscience clinical trials that included both event-driven eDiaries (EDeD) and evening eDiaries were identified and analyzed. Compliance was calculated based on number of evening diaries submitted vs. expected.
RESULTS: A total of 3037 patients across 6 studies in narcolepsy, epilepsy, and migraine prevention that included evening (n=599,431) and event-driven diaries (n=379,517) were identified. A total of 2021 cataplexy events (narcolepsy), 174 seizures (epilepsy), and 269,369 migraines were reported. In narcolepsy, cataplexy events were reported in 39.0% of evening diaries suggesting potential missed reporting within the event-driven diary at the time of event. Similarly, in epilepsy, seizures were reported in 11.1% of evening diaries and in migraine prevention therapy, migraines were reported in 17.2% of evening diaries. Average compliance for eDiaries was 86.3%.
CONCLUSIONS: Prompted evening diaries are often used to report additional events showing the importance of their inclusion. However, a larger proportion of events were entered episodically, suggesting that including both an evening diary and event-driven diary better matches patient’s habits and allows greater flexibility.