Evaluation of electronic health record to HL7® FHIR® mappings in pediatric research studies

Background: eSource technologies that exchange patient data from electronic health records (EHR) to clinical study electronic data capture (EDC) systems can reduce data quality errors and decrease data collection time. However, the availability of site-specific EHR data to support pediatric studies has not been evaluated. Methods: We used a previously developed data element mapping procedure to evaluate the HL7® FHIR® standard's coverage in multi-center pediatric clinical studies. Four study sites independently mapped three pediatric studies’ case report forms (CRFs) to their site's EHR and FHIR® server data elements. Results: Site investigators mapped 4152 total and 2070 distinct data elements. Only 33.8 % of total CRF data elements (n = 1402) and 27.4 % of distinct data elements (n = 568) were able to be mapped in FHIR® at the four sites. However, the percent of total data elements mapped varied by pediatric study (55.3 %, 30.8 %, and 26.2 %) and study site (46.4 %, 32.3 %, 27.8 %, and 26.6 %). The percent of total CRF data elements mapped was higher in domains containing standard of care data (e.g., Concomitant Medications, Demographics, Diagnosis/Procedures, Medical History, and Vital Signs) and lower in domains containing protocol-specific data (e.g., Adverse Events, Concomitant Medications, Enrollment/Eligibility/Consent, and study treatment-related Labs, and Vital Signs). Conclusions: There is substantial between-study and between-site variability in the percentage of pediatric study data elements available in FHIR® at study sites. These results suggest that mapping solutions for pediatric studies utilizing eSource technologies will need to be site-specific.