(237) Application of a direct-to-participant EMR data collection platform for pregnancy registries

Background: Pregnancy registries collect information on the possible effects of medicine or vaccine exposure on the health of pregnant women and their developing fetus. The information collected can help healthcare providers and researchers learn more about the safety of medical products during pregnancy, at birth and thereafter. Traditional, prospective pregnancy registries, however, face several challenges, including the need for data from multiple treating physicians, lack of motivation and engagement from physicians to provide these data, and limitations in linkage of mother-child pairs in secondary data sources.

Objectives: This study uses IQVIA’s Health Research Space (HRS), a direct-to-participant data collection and engagement platform, which allows participants to provision access to their electronic medical records (EMR). The study aimed to assess participant acceptability of this novel data collection method and evaluate the availability and quality of essential data elements required for a regulatory-grade pregnancy registry.

Methods: Participants from an existing US pregnancy cohort, who have had a singleton, live birth after October 2017, were invited to participate in the study. Eligible participants received a link via email that directed them to the study-configured HRS platform. In the platform, participants electronically signed an informed consent form and provided access to their and their child’s EMR from relevant healthcare providers. Key metrics for assessment included: the proportion of participants who registered and consented for the study; data availability and quality; and the percentage of healthcare providers that were interoperable, i.e., allow automatic sharing of EMR via the platform following a standardized set of health data classes and elements for interoperable health data exchange - the United States Core Data for Interoperability (USCDI).

Results: A total of 322 participants enrolled in the study and 145 (45%) completed the process for sharing their and their child’s EMR records. On average, participants shared EMR from 1.55 healthcare providers, of which 47% were interoperable. An interim analysis showed that 41% of mothers had a record of child delivery. The prevalence of hypertension and gestational diabetes was aligned with values reported in the literature. Child birthweight was recorded for 77% of children, though APGAR score was not available as it is currently not included in the mandated USCDI version. Feedback from participants indicated that 66% of participants preferred connecting their health records via a study platform, compared to traditional questionnaires, and found it easy to share their EMR data via this process. Over 74% of participants found the platform easy to use and would feel disappointed if they were no longer be able to use the platform for the study.

Conclusions: Metrics indicated that the participant-mediated EMR data collection methodology provides acceptable data availability and quality and is well accepted by study participants. We encourage healthcare providers and other stakeholders to support increased rollout of EMR interoperability which would further improve viability of this approach for future pregnancy registries.