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Reusing data from HL7 CDA-based shared EHR systems for clinical trial conduct: a method for analyzing feasibility.

Georg Duftschmid¹, Florian Katsch^2,3, Gabriela Ciortuz⁴

¹Center for Medical Data Science (CEDAS), Medical University of Vienna, Spitalgasse 23, Vienna, 1090, Austria. georg.duftschmid@muv.ac.at.

BMC Medical Informatics and Decision Making

|April 1, 2025

Summary

Shared electronic health record (EHR) systems can support clinical trials. A new method shows these systems cover most required data elements, with 77% structured, for trial reuse.

Keywords:

Clinical trials Data collection Data models Electronic medical records

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Last Updated: May 16, 2025

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

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Published on: December 11, 2016

TBase - an Integrated Electronic Health Record and Research Database for Kidney Transplant Recipients

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Published on: April 13, 2021

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts

Published on: September 20, 2018

Area of Science:

Health Informatics
Clinical Trial Management
Data Standards

Background:

Electronic health record (EHR) systems are valuable for clinical trial data reuse.
Shared EHR systems, though prevalent, have been underutilized for trials.
The data coverage of shared EHR systems for clinical trial requirements is unclear.

Purpose of the Study:

To present a method for analyzing shared EHR systems for clinical trial data element coverage.
To assess the suitability of shared EHR systems for clinical trial conduct.

Main Methods:

Focused on HL7 CDA-standardized shared EHR systems.
Utilized the EHR4CR reference list for common clinical trial data elements.
Employed ART-DECOR for semi-automatic mapping and an additional open-source tool for analysis.

Main Results:

Developed a stepwise approach to analyze HL7 CDA-based shared EHR systems.
Made all tools and mappings publicly accessible for reusability and reproducibility.
Applied the method to Austria's ELGA system, finding 88% EHR4CR data element coverage (77% structured).

Conclusions:

The method enables easy analysis of shared EHR systems for clinical trial data reuse potential.
Results for ELGA demonstrate substantial potential for clinical trial data integration.