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

Electronic health record (EHR) systems have been shown to represent a valuable source of data reuse in the design and conduct of clinical trials. Earlier work has mostly focused on institutional EHR systems. Shared EHR systems have been neglected so far, even though they are highly prevalent today and their characteristics (integrated data across a patient's care providers, standardized information model) make them attractive for the task. However, as they typically focus on a limited data set for the most common care situations, it remains unclear, whether shared EHR systems actually cover the data elements required for clinical trial conduct. In this paper we present a method, which allows shared EHR systems to be analyzed in this regard.

We focus on shared EHR systems using HL7 CDA as this is currently the most-widely used content standard. For the data elements that are commonly used in clinical trials we refer to the EHR4CR reference list. The latter is semiautomatically mapped to the EHR system's information model using the open source tool ART-DECOR. For the final automatic analysis of the mappings, another open source tool is provided.

A stepwise approach was developed to analyze HL7 CDA-based shared EHR systems for their coverage of data elements that are relevant for clinical trials. All tools used in this work as well as all mappings are publicly accessible to make the method reusable and the results reproducible. We applied our approach to the Austrian nation-wide EHR system ELGA and showed that the latter allows the recording of 88% of all EHR4CR data elements, 77% in structured format.

Our method allows HL7 CDA-based shared EHR systems to be easily analyzed to what extent their content could be reused in the context of clinical trials. The results for ELGA indicate that it has a substantial corresponding potential.

Not applicable.