Electronic health records based phenotyping in next-generation clinical trials: a perspective from the NIH Health Care Systems Collaboratory
Electronic health records based phenotyping in next-generation clinical trials: a perspective from the NIH Health Care Systems Collaboratory
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DOI：
10.1136/amiajnl-2013-001926
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发表时间：
2013-12-01
影响因子：
6.4
通讯作者：
Califf, Robert M.
中科院分区：
文献类型：
--
作者：
Richesson, Rachel L.;Hammond, W. Ed;Califf, Robert M.
广泛共享来自电子健康记录和患者报告结果的数据可以加强国家进行具有成本效益的临床试验的能力，并允许将研究纳入常规护理提供。虽然实用的临床试验(PCT)已经进行了几十年，但它们现在可以利用不断反馈的丰富的临床和操作数据来源，为研究和实践提供信息。由美国国立卫生研究院共同基金于2012年发起的医疗保健系统合作实验室计划，让医疗保健系统作为合作伙伴参与讨论和促进支持积极参与PCTS的活动、工具和战略。NIH合作实验室由七个示范项目和七个针对特定问题的工作组“核心”组成，旨在利用在不同的“现实世界”环境中捕获的数据进行研究，从而提高试验的效率、相关性和普适性。在这里，我们介绍合作实验室，重点介绍其表型、数据标准和数据质量核心，并展示研究人员在大型医疗保健系统中实施PCT的早期观察结果。我们还确定了知识差距，并提出了信息学研究议程，其中包括确定在不同医疗保健环境中定义和适当应用表型的方法，以及验证基于电子健康记录的表型的定义和执行的方法。
Widespread sharing of data from electronic health records and patient-reported outcomes can strengthen the national capacity for conducting cost-effective clinical trials and allow research to be embedded within routine care delivery. While pragmatic clinical trials (PCTs) have been performed for decades, they now can draw on rich sources of clinical and operational data that are continuously fed back to inform research and practice. The Health Care Systems Collaboratory program, initiated by the NIH Common Fund in 2012, engages healthcare systems as partners in discussing and promoting activities, tools, and strategies for supporting active participation in PCTs. The NIH Collaboratory consists of seven demonstration projects, and seven problem-specific working group 'Cores', aimed at leveraging the data captured in heterogeneous 'real-world' environments for research, thereby improving the efficiency, relevance, and generalizability of trials. Here, we introduce the Collaboratory, focusing on its Phenotype, Data Standards, and Data Quality Core, and present early observations from researchers implementing PCTs within large healthcare systems. We also identify gaps in knowledge and present an informatics research agenda that includes identifying methods for the definition and appropriate application of phenotypes in diverse healthcare settings, and methods for validating both the definition and execution of electronic health records based phenotypes.