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. 2025 Jan:148:107744.
doi: 10.1016/j.cct.2024.107744. Epub 2024 Nov 17.

Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials

Keith A Marsolo  1 , Andrea Cheville  2 , Edward R Melnick  3 , Jeffrey G Jarvik  4 , Gregory E Simon  5 , Kathleen A Sluka  6 , Leslie J Crofford  7 , Karen L Staman  8 , Rachel L Richesson  9 , Judith M Schlaeger  10 , Lesley H Curtis  11
Affiliations

Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials

Keith A Marsolo et al. Contemp Clin Trials. 2025 Jan.

Abstract

The NIH Pragmatic Trials Collaboratory supports the design and conduct of 32 embedded pragmatic clinical trials, and many of these trials rely on data from the electronic health record (EHR) to monitor outcomes and/or use functionality provided by the EHR platform to deliver the intervention. Given the complexity and dynamic nature of EHR systems, study teams have encountered challenges in use of the EHR for these purposes, including challenges related to local implementation of trial interventions, rapid technology evolution, EHR updates, and transitions in EHR systems. In this article, we share case examples and lessons learned, and suggest that teams need to be aware of-and perhaps proactively investigate- possible changes to EHR systems and data that will affect the delivery of interventions and the integrity and safety of pragmatic clinical trials.

Keywords: Electronic health record; Health systems research; Monitoring; Pragmatic trials.

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Conflict of interest statement

Declaration of competing interest KM has no disclosures relevant to the manuscript and reports that he is a Co-inventor of Hive Networks, Inc. and his salary is funded in part through research contracts from Bayer, BMS, BI, Amgen, Novartis, Seqirus, and Genentech. JGJ: Dr. Jarvik was supported by the University of Washington Clinical Learning, Evidence, And Research (CLEAR) Center for Musculoskeletal Disorders, Administrative, Methodologic Cores and NIAMS/NIH grant P30AR072572. Dr. Jarvik r has no disclosures relevant to the manuscript but reports royalties as a book co-editor from Springer Publishing and travel reimbursement for Faculty Board of Review from GE-Association of University Radiologists Radiology Research Academic Fellowship (GERRAF) and royalties as a chapter author from Wolters Kluwer/UpToDate.

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