Duftschmid Georg, Katsch Florian, Ciortuz Gabriela, Kalra Dipak, Rinner Christoph
Center for Medical Data Science (CEDAS), Medical University of Vienna, Spitalgasse 23, Vienna, 1090, Austria.
Ludwig Boltzmann Institute for Digital Health and Prevention, Salzburg, Austria.
BMC Med Inform Decis Mak. 2025 Apr 1;25(1):155. doi: 10.1186/s12911-025-02980-2.
Electronic health record (EHR) systems have been shown to represent a valuable source of data reuse in the design and conduct of clinical trials. Earlier work has mostly focused on institutional EHR systems. Shared EHR systems have been neglected so far, even though they are highly prevalent today and their characteristics (integrated data across a patient's care providers, standardized information model) make them attractive for the task. However, as they typically focus on a limited data set for the most common care situations, it remains unclear, whether shared EHR systems actually cover the data elements required for clinical trial conduct. In this paper we present a method, which allows shared EHR systems to be analyzed in this regard.
We focus on shared EHR systems using HL7 CDA as this is currently the most-widely used content standard. For the data elements that are commonly used in clinical trials we refer to the EHR4CR reference list. The latter is semiautomatically mapped to the EHR system's information model using the open source tool ART-DECOR. For the final automatic analysis of the mappings, another open source tool is provided.
A stepwise approach was developed to analyze HL7 CDA-based shared EHR systems for their coverage of data elements that are relevant for clinical trials. All tools used in this work as well as all mappings are publicly accessible to make the method reusable and the results reproducible. We applied our approach to the Austrian nation-wide EHR system ELGA and showed that the latter allows the recording of 88% of all EHR4CR data elements, 77% in structured format.
Our method allows HL7 CDA-based shared EHR systems to be easily analyzed to what extent their content could be reused in the context of clinical trials. The results for ELGA indicate that it has a substantial corresponding potential.
Not applicable.
电子健康记录（EHR）系统已被证明是临床试验设计和实施中数据复用的宝贵来源。早期工作主要集中在机构EHR系统。共享EHR系统至今一直被忽视，尽管它们如今非常普遍，且其特点（跨患者护理提供者整合数据、标准化信息模型）使其在这项任务中颇具吸引力。然而，由于它们通常专注于最常见护理情况的有限数据集，共享EHR系统是否实际涵盖临床试验实施所需的数据元素仍不明确。在本文中，我们提出一种方法，可在这方面对共享EHR系统进行分析。
我们聚焦于使用HL7 CDA的共享EHR系统，因为这是目前使用最广泛的内容标准。对于临床试验中常用的数据元素，我们参考EHR4CR参考列表。使用开源工具ART-DECOR将后者半自动映射到EHR系统的信息模型。为进行映射的最终自动分析，还提供了另一个开源工具。
开发了一种逐步方法，用于分析基于HL7 CDA的共享EHR系统对与临床试验相关的数据元素的覆盖情况。这项工作中使用的所有工具以及所有映射均可公开获取，以使该方法可重复使用且结果可重现。我们将我们的方法应用于奥地利全国范围的EHR系统ELGA，结果表明后者能够记录所有EHR4CR数据元素的88%，其中77%为结构化格式。
我们的方法能够轻松分析基于HL7 CDA的共享EHR系统，以确定其内容在临床试验背景下可被复用的程度。ELGA的结果表明它具有相当大的相应潜力。
不适用。
