Keith A Marsolo, Andrea Cheville, Edward R Melnick, Jeffrey G Jarvik, Gregory E Simon, Kathleen A Sluka, Leslie J Crofford, Karen L Staman, Rachel L Richesson, Judith M Schlaeger, Lesley H Curtis
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引用次数: 0
摘要
美国国立卫生研究院（NIH）实用临床试验协作组支持 32 项嵌入式实用临床试验的设计和实施，其中许多试验依赖电子病历（EHR）中的数据来监测结果和/或使用 EHR 平台提供的功能来实施干预。鉴于电子病历系统的复杂性和动态性，研究团队在将电子病历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、快速技术演进、电子病历更新和电子病历系统过渡有关的挑战。在这篇文章中，我们分享了案例和经验教训，并建议研究小组需要意识到--或许可以主动调查--电子病历系统和数据可能发生的变化，这些变化将影响干预措施的实施以及务实临床试验的完整性和安全性。
Impact of electronic health record updates and changes on the delivery and monitoring of interventions in embedded pragmatic clinical trials.
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.
期刊介绍：
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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