eSource for Standardized Health Information Exchange in Clinical Research: A Systematic Review of Progress in the Last Year

Abstract

To identify studies conductedusing the direct, electronic extraction of electronic health record (EHR) datato electronic data capture (EDC) systems, also known as eSource, and toidentify any gaps or limitations present for promoting standardized healthinformation exchange in clinical research.Materials and Methods:Articleswere included only if the solution described (1) utilized eSource to directlyexchange data electronically from EHR-to-EDC and (2) was relevant to aprospective clinical study use case.Results:Intotal, 20 relevant articles were identified, describing a total of 15 uniqueeSource interventions. Of the 15interventions, 12 were single-site, single-EHR (SS-SE) implementations and 3were multi-site, multi-EHR (MS-ME) implementations. All 15 implementationsmentioned the use of standards, but nearly all referenced older data exchangestandards. Discussion:Following the trajectory of work towardsdirect EHR-to-EDC, eSource data collection, we appear to have arrived at thepoint where information systems leveraging data standards can offer efficiencyand increased quality in clinical research. However, these methods need to betested for effectiveness and acceptance in the context of real multicenterclinical trials. Several early studies using a single source of data forresearch and patient care appeared over a decade ago. Since that time,implementations and evaluations have been scarce and almost always confined tosingle-EHR, single-EDC, single-institution implementations.Conclusion:These results only further emphasize the observation thatthe clinical trial use case continues to be the most difficult and leastdemonstrated eSource-related initiative. Thus, additional work is criticallyneeded in this area to address the gaps identified from the literature.