(260) Evaluation of Digital Data collection Methods in a Prospective Pregnancy Registry for a Migraine Product with Both Acute and Preventive Indications

Background: For some newly marketed products, the FDA requires two pregnancy safety studies – one using a prospective registry design and another using an alternative design (e.g., retrospective database study). Prospective registries are able to collect detailed disease and exposure data (e.g., disease patterns, treatments) throughout pregnancy. This is especially important for products used on an as-needed basis for acute indications. Secondary data sources, repurposed for retrospective studies, generally do not have this level of detail.

Objectives: To evaluate the effectiveness of weekly and monthly digital logs to capture disease and exposure data in an existing pregnancy registry.

Methods: This prospective pregnancy registry utilizes weekly (to capture migraine headaches and acute therapies) and monthly (to capture chronic medication use for the prevention of migraine) logs to collect data throughout pregnancy. Logs are completed via an app in real-time by participants and submitted on a weekly or monthly basis. Patients are paid $50 each month for submitted logs. Analyses were conducted to produce metrics related to the completeness/missingness of log data.

Results: As of 01Feb2024, 202 participants were included in the analysis population for the registry. Among these, 79.2% completed ≥80% of weekly logs, 77.2% completed ≥80% of monthly logs, and 76.2% completed ≥80% of both logs. More than half completed all weekly (60.4%), all monthly (66.8%), or all weekly and monthly logs (57.4%) through data cut-off or pregnancy outcome. More than three-quarters completed all weekly logs (76.7%), all monthly logs (81.7%), or all weekly and monthly logs (75.3%) in the 1st trimester of pregnancy. Nearly all participants who completed at least one weekly log (99.5%), completed weekly logs continuously (without gaps of ≥7 days), and all participants who completed at least 1 monthly log continuously completed monthly logs (without gaps of ≥28 days).

Conclusions: For products with acute indications, it is important to weigh reporter burden and recall bias when determining data collection frequency. Weekly and monthly logs are effective at capturing detailed information related to migraine headaches and medication use during pregnancy. This frequency of data collection does not appear to overburden participants, and recall bias is minimized with weekly touchpoints.