电子健康记录更新与变更对嵌入式实用临床试验中干预措施的实施与监测的影响
Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials.
作者信息
Marsolo Keith A, Cheville Andrea, Melnick Edward R, Jarvik Jeffrey G, Simon Gregory E, Sluka Kathleen A, Crofford Leslie J, Staman Karen L, Richesson Rachel L, Schlaeger Judith M, Curtis Lesley H
机构信息
Duke University School of Medicine, Department of Population Health Sciences, Durham, NC, United States of America.
Mayo Clinic Comprehensive Cancer Center, Rochester, MN, United States of America.
出版信息
Contemp Clin Trials. 2025 Jan;148:107744. doi: 10.1016/j.cct.2024.107744. Epub 2024 Nov 17.
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.
美国国立卫生研究院（NIH）实用试验协作实验室支持32项嵌入式实用临床试验的设计与实施，其中许多试验依靠电子健康记录（EHR）数据来监测结果和/或利用EHR平台提供的功能来实施干预措施。鉴于EHR系统的复杂性和动态性，研究团队在将EHR用于这些目的时遇到了挑战，包括与试验干预措施的本地实施、技术快速发展、EHR更新以及EHR系统转换相关的挑战。在本文中，我们分享了案例和经验教训，并建议团队需要意识到——或许还应主动调查——EHR系统和数据可能发生的变化，这些变化会影响干预措施的实施以及实用临床试验的完整性和安全性。
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