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Comparing the Accuracy of Traditional vs. FHIR®-Based Extraction of Electronic Health Record Data for Two Clinical Trials
Maryam Y. Garza, Christina Spencer, Muayad Hamidi, Michael Liss, Manju Bikkanuri, Mahanazuddin Syed, Sunita Yadav, Gurtejpal Bhardwaj, Amar P.S. Chahal, Keith Goodman, Byeong Yeob Choi, Eric L. Eisenstein, Meredith Zozus
While pilots and production use of software based on the Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) standard are increasing in clinical research, we lack consistent evaluative data on important outcomes, such as data accuracy. We compared the accuracy of EHR collected, FHIR® extracted data (called EHR-to-eCRF data collection) to traditional clinical trial data collection. The accuracy rate for EHR-collected data was significantly higher than for the same data collected through traditional methods. It is possible that EHR-collected (FHIR® extracted) data can substantially improve data quality in clinical studies while decreasing the burden on study sites.
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