Duke University School of Medicine, Durham, NC, United States of America.
New York University Grossman School of Medicine, Ronald O. Perelman Department of Emergency Medicine, New York, NY, United States of America.
Contemp Clin Trials. 2024 Feb;137:107426. doi: 10.1016/j.cct.2023.107426. Epub 2023 Dec 30.
The NIH Pragmatic Trials Collaboratory supports the design and conduct of 27 embedded pragmatic clinical trials, and many of the studies collect patient reported outcome measures as primary or secondary outcomes. Study teams have encountered challenges in the collection of these measures, including challenges related to competing health care system priorities, clinician's buy-in for adoption of patient-reported outcome measures, low adoption and reach of technology in low resource settings, and lack of consensus and standardization of patient-reported outcome measure selection and administration in the electronic health record. In this article, we share case examples and lessons learned, and suggest that, when using patient-reported outcome measures for embedded pragmatic clinical trials, investigators must make important decisions about whether to use data collected from the participating health system's electronic health record, integrate externally collected patient-reported outcome data into the electronic health record, or collect these data in separate systems for their studies.
NIH 实用临床试验协作中心支持 27 项嵌入式实用临床试验的设计和实施，其中许多研究将患者报告的结果测量作为主要或次要结果进行收集。研究团队在这些措施的收集过程中遇到了挑战，包括与竞争的医疗保健系统优先级相关的挑战、临床医生对患者报告的结果测量的采用的认同、在资源匮乏的环境中技术的低采用率和覆盖率，以及电子健康记录中患者报告的结果测量选择和管理缺乏共识和标准化。在本文中，我们分享案例和经验教训，并建议在为嵌入式实用临床试验使用患者报告的结果测量时，研究人员必须做出重要决策，即是否使用来自参与的医疗系统的电子健康记录中收集的数据，将外部收集的患者报告的结果数据整合到电子健康记录中，还是为其研究在单独的系统中收集这些数据。
