The electronic health record as a clinical trials tool: Opportunities and challenges
The electronic health record as a clinical trials tool: Opportunities and challenges
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DOI：
10.1177/1740774520913819
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发表时间：
2020-04-08
期刊：
影响因子：
2.7
通讯作者：
Piantadosi, Steven
中科院分区：
文献类型：
--
作者：
Bertagnolli, Monica M.;Anderson, Brian;Piantadosi, Steven
临床试验为医疗保健的进步提供了必不可少的证据，随着医疗保健复杂性的增加，对此类数据的需求急剧扩大。开展临床试验也变得更加复杂，不断发展，以应对提供临床护理和满足监管要求方面日益增加的挑战。尽管如此，数据收集的一般方法保持不变，要求研究人员根据研究治疗方案提交临床数据，使用研究特定病例报告表中提供的精确定义的数据结构。目前，研究数据管理没有整合到患者的临床护理记录中，这给临床工作人员带来了额外的负担，并可能出现错误。在过去的十年中，电子健康记录已成为美国医疗保健系统的标准，并越来越多地用于收集和分析临床护理提供的数据报告质量指标。最近，电子健康记录数据也被用来解决临床研究问题，然而，这种方法有显着的缺点，由于当前的电子健康记录数据的非结构化和不完整的性质。本报告描述了使用电子健康记录作为进行高质量临床研究的工具所需的步骤。
Clinical trials provide evidence essential for progress in health care, and as the complexity of medical care has increased, the demand for such data has dramatically expanded. Conducting clinical trials has also become more complicated, evolving to meet increasing challenges in delivering clinical care and meeting regulatory requirements. Despite this, the general approach to data collection remains the same, requiring that researchers submit clinical data in response to study treatment protocols, using precisely defined data structures made available in study-specific case report forms. Currently, research data management is not integrated within the patient's clinical care record, creating added burden for clinical staff and opportunities for error. During the past decade, the electronic health record has become standard across the US healthcare system and is increasingly used to collect and analyze data reporting quality metrics for clinical care delivery. Recently, electronic health record data have also been used to address clinical research questions; however, this approach has significant drawbacks due to the unstructured and incomplete nature of current electronic health record data. This report describes steps necessary to use the electronic health record as a tool for conducting high-quality clinical research.