FREMONT, Calif., Sept. 12, 2024 -- The 34th Medical Informatics Europe Conference was held in Athens, Greece August 25-29, 2024. The conference theme was "Digital Health and Informatics Innovations for Sustainable Health Care Systems."
At the conference, Maryam Y. Garza, PhD, MPH, MMCi, presented her peer-reviewed article "Comparing the Accuracy of Traditional vs. FHIR®-Based Extraction of Electronic Health Record Data for Two Clinical Trials." Dr. Garza is an Associate Professor in the Department of Population Health Sciences at University of Texas Health Science Center at San Antonio and a senior academic researcher in a team, led by Meredith Zozus, PhD, regarded globally as leading experts in secondary uses of Electronic Health Record (EHR) data.
The article was published online with Open Access by IOS Press here: https://ebooks.iospress.nl/volumearticle/68949. The article is a report on a study led by Dr. Garza comparing the accuracy of FHIR-based EHR-to-eCRF data collection using nCartes to manual clinical trial data collection on two clinical studies conducted by the SWOG Cancer Research Network (https://www.swog.org), a National Cancer Institute (NCI)-supported National Clinical Trials Network (NCTN) group.
In the study, as part of pre-production testing, three participant cases for each of two studies were selected, and data for each was extracted from the EHR using nCartes and compared to the previously collected study data in the study EDC system. Between the two studies, a total of 1,067 populated fields were compared using the nCartes-assisted method and manual entry. There were no data errors in the nCartes-assisted approach versus 13 errors, or an error rate of 1.22% with a 95% confidence interval (0.65, 2.07), with manual data collection and entry followed by a local quality control check. Those errors were then corrected in the SWOG study database.
The zero error rate obtained in the nCartes-assisted approach was primarily the result of nCartes ability to map the data elements for each study to the FHIR® resources generated by the facility's EHR. In addition to producing an error free result in this assessment, the effort produced "elation of site staff proclaiming up to 50% time savings in MRA (Medical Record Abstraction), data entry, and QC (Quality Control)" once nCartes went live.
"Extracting data from medical records for use in clinical studies has been a dream since the first uses of computers in medicine," says Meredith Zozus, MD, CCDM, Professor and Division Chief, Director Clinical Research Informatics at UT Health San Antonio. "Today, that dream is possible and necessary for improving population health and to pursue tomorrow's cures. The Ancillary Studies to Evaluate Real-World Data Quality (ACE-RWD) program, partially supported through the Burroughs Wellcome Fund, is working with industry, academia, and technology providers to advance regulatory compliant and confident use of EHR data in research."
"Drs. Garza and Zozus, their team, and our colleagues at SWOG are a delight to collaborate with," says John S. McIlwain, CEO of nCartes, Inc. "The project shows the significant data quality improvements and staff time savings nCartes can produce."
About nCartes:
nCartes (https://ncartes.ncoup.com) is a transformational cloud software platform provider. The nCartes platform enables clinical research sponsors and research sites to harness electronic health systems (EHRs) to automate data capture for clinical trials, patient registries, cell manufacturing and more.
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