Electronic health records to facilitate clinical research.
Electronic health records to facilitate clinical research.
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DOI：
10.1007/s00392-016-1025-6
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发表时间：
2017-01
期刊：
影响因子：
--
通讯作者：
Zalewski A
中科院分区：
文献类型：
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作者：
Cowie MR;Blomster JI;Curtis LH;Duclaux S;Ford I;Fritz F;Goldman S;Janmohamed S;Kreuzer J;Leenay M;Michel A;Ong S;Pell JP;Southworth MR;Stough WG;Thoenes M;Zannad F;Zalewski A
电子健康记录(EHR)提供了加强患者护理、将绩效评估嵌入临床实践和促进临床研究的机会。有人对审判中越来越多的征聘挑战、繁琐和引人注目的数据收集以及结果的不确定普遍性表示关切。利用电子健康记录来平衡这些趋势是一个非常感兴趣的领域。电子健康记录作为主要数据来源的初步应用设想用于观察性研究、嵌入式实用或上市后基于登记册的随机研究或比较有效性研究。将这一方法推进到随机临床试验中，电子健康记录可能被用于评估研究的可行性，促进患者招募，并简化基线和后续的数据收集。确保数据安全和隐私，克服与连接不同系统相关的挑战，维护重复使用高质量数据的基础设施，是在临床研究中使用电子健康记录所面临的一些挑战。学术界、产业界、监管机构、政策制定者、患者和电子健康记录供应商之间的合作对于在临床研究中更多地使用电子健康记录至关重要。这份手稿确定了推进电子健康记录在心血管临床研究中的作用所需的关键步骤。
Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research.