重新利用基于HL7CDA的共享EHR系统的数据进行临床试验:分析可行性的一种方法
Georg Duftschmid1, Florian Katsch2,3, Gabriela Ciortuz4
1Center for Medical Data Science (CEDAS), Medical University of Vienna, Spitalgasse 23, Vienna, 1090, Austria. georg.duftschmid@muv.ac.at.
BMC medical informatics and decision making
|April 1, 2025
概括
共享电子健康记录 (EHR) 系统可以支持临床试验. 一种新的方法表明,这些系统涵盖了大多数所需的数据元素,其中77%是结构化的,用于试验重复使用.
科学领域:
- 医疗信息学 医疗信息学
- 临床试验管理 临床试验管理
- 数据标准 数据标准
背景情况:
- 电子健康记录 (EHR) 系统对于临床试验数据的再利用非常有价值.
- 虽然共享的EHR系统普遍存在,但在试验中未得到充分利用.
- 对于临床试验要求的共享EHR系统的数据覆盖范围尚不清楚.
研究的目的:
- 介绍一种分析临床试验数据元素覆盖范围的共享电子健康记录系统的方法.
- 评估共享EHR系统对临床试验进行的适用性.
主要方法:
- 专注于HL7 CDA标准化的共享EHR系统.
- 使用EHR4CR参考列表来获得常见的临床试验数据元素.
- 使用ART-DECOR进行半自动映射和额外的开源分析工具.
主要成果:
- 开发了一种逐步方法来分析HL7基于CDA的共享EHR系统.
- 让所有工具和映射公开可用,以便可重复使用和重复复制.
- 将该方法应用于奥地利的ELGA系统,发现88%的EHR4CR数据元素覆盖率 (77%结构化).
结论:
- 该方法可以轻松分析共享EHR系统的临床试验数据重复使用潜力.
- 针对ELGA的结果显示了临床试验数据整合的巨大潜力.
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