Evaluation of electronic health record to HL7® FHIR® mappings in pediatric research studies.
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2026-04
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Abstract
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.Type
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Garza, Maryam Y, Zhan Wang, Bhargav Adagarla, Michael W Rutherford, Umit Topaloglu, Daniel K Benjamin, Kanecia O Zimmerman, Eric L Eisenstein, et al. (2026). Evaluation of electronic health record to HL7® FHIR® mappings in pediatric research studies. International journal of medical informatics, 209. p. 106265. 10.1016/j.ijmedinf.2026.106265 Retrieved from https://hdl.handle.net/10161/35560.
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Bhargav Srinivas Adagarla
Daniel Kelly Benjamin
Dr. Danny Benjamin is the Principal Investigator and Chair of the National Institute of Child Health and Human Development’s Pediatric Trials Network. The Network is responsible for designing and leading clinical trials of off-patent medicines in children of all ages across all therapeutic areas. The team has established, or is actively studying, the correct dosing and safety of more than 100 of the most commonly used medicines in children. These trials are conducted under an Investigational New Drug (IND) application with guidance from the Food and Drug Administration for labeling.
The Pediatric Trials Network has directly impacted the healthcare of over 90% of American children.
Signature programs of the Network include clinical trials in premature, term infants, breast feeding mothers, and obese children. Over the past 10 years, Danny’s group has enrolled more premature infants, at more sites, in more clinical trials of off-patent anti-infectives under an IND than all other academic medical centers, pharmaceutical companies, and government agencies in the world, combined.
Danny is recognized by the National Institutes of Health as a premiere mentor and educator. His research program serves as a platform to train students and early career investigators. Danny’s group has a clinical research summer program for high school, college graduate school, and medical students that recruits and mentors ~30 students each academic year. He has been the primary or secondary mentor for 10 faculty who have received career development awards and who have then gone on to establish their own independent research programs; six of whom are now Distinguished Professors.
Danny's service to the community is expressed through his passion for coaching baseball. He has coached over 1,000 recreation league, travel league, and scholastic baseball games. He is the head coach for Smith Middle School Baseball, perennially southern conference champions. Danny and his wife own a charitable non-profit that provides athletic and fitness opportunities for disadvantaged and special-needs school-aged boys and girls.
Kanecia Obie Zimmerman
Eric Leo Eisenstein
Research Interests:
Dr. Eisenstein is a member of the Duke Clinical Research Institute’s Outcomes Research and Assessment Group, with a special interest in understanding the relationships between complex interventions in health care systems and the long-term clinical and economic outcomes of patients. He has served as Principal Investigator for phase II, III, and IV economic and quality of life studies conducted alongside randomized clinical trials in cardiovascular, emergency, pulmonary, and vascular medicine and surgery. He also has conducted health technology evaluations making use of innovative research methods designed to better understand key relationships in observation (non-randomized) patient data. This work has included evaluations of the long-term clinical outcomes of coronary artery disease patients receiving drug-eluting vs. bare metal intracoronary stents, and how the use of clopidogrel changes those relationships. He also has conducted several studies assessing factors contributing to the costs of and evaluating different design considerations for multi-center randomized clinical trials.
In addition to his working in traditional health technology evaluation, Dr. Eisenstein has an interest in evaluating information technologies as interventions in health care systems. In this regard, he has collaborated in the design and conduct of large-scale, randomized clinical trials to evaluate clinical decision support systems. The research objective in these studies has been to develop methods for evaluating health information technologies in practice-based settings using a “tool kit” of inexpensive, yet highly scalable methods that make use of data sets created as a byproduct of normal clinical and administrative operations. The use of these evaluation methods has been demonstrated in four clinical trials that include care process, clinical, economic, and quality of life measurements.
Karan Ravindra Kumar
I am an Assistant Professor of Pediatrics and a Pediatric Critical Care Physician at Duke University School of Medicine, and I am also affiliated with the Duke Clinical Research Institute (DCRI). My research focuses on advancing pediatric healthcare through the integration of biostatistics, clinical research informatics, and data science. I have significant experience managing large datasets, including the Pediatrix Medical Group Clinical Data Warehouse and the NICHD-funded Pediatric Trials Network, which have provided vital insights into disease patterns and pediatric drug labeling. I contribute analytical support to various pediatric research initiatives. My efforts extend to exploring automation of data integration in clinical trials, enhancing research infrastructure, and leading critical trials and registries to improve pediatric health outcomes. I am enthusiastic about applying my expertise in biostatistics, database management, and predictive analytics to future projects.
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