Federated electronic data capture (fEDC): Architecture and prototype
Federated electronic data capture (fEDC): Architecture and prototype
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DOI：
10.1016/j.jbi.2023.104280
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发表时间：
2023-01-30
影响因子：
4.5
通讯作者：
Dugas, Martin
中科院分区：
文献类型：
--
作者：
Ganzinger, Matthias;Blumenstock, Max;Dugas, Martin
在临床研究和患者护理中，结构化的结果文档是一项重要任务。在许多情况下，这是通过使用相应信息技术系统的电子病例报告表（eCRF）来实现的。为了避免重复数据输入，eCRF系统可以与电子健康记录（EHR）集成。然而，当来自不同机构的研究人员合作收集数据时，他们通常使用互联网上的单个联合eCRF系统。在这种情况下，集成EHR系统是不可能的，在大多数情况下，由于信息安全和数据保护的限制。为了克服这一缺点，我们提出了一种新的架构，联邦电子数据采集系统（fEDC）。确定了fEDC的四个关键要求：表格的定义必须以可靠和受控的方式提供，必须能够与电子健康记录系统集成，患者数据应完全处于本地控制之下，直到它们被明确转移用于联合分析，并且系统必须支持科学界接受的数据共享原则，用于数据模型和数据捕获。参与联合研究的研究中心可以运行符合当地标准的fEDC系统实例（例如在网络防火墙后面），同时还能够通过在整个合作过程中共享由临床数据交换标准联盟（CDISC）发布的操作数据模型（ODM）格式的元数据来受益于使用相同的表单定义。在德国的五所大学医院中，真实性得到了开源原型的验证。fEDC架构提供了一种新的方法，有可能显着改善协作数据采集：减少了数据输入的工作，同时，由于与本地电子健康记录系统集成的障碍降低，数据质量得到了提高。此外，元数据被共享，并且在高水平上确保患者隐私。
In clinical research as well as patient care, structured documentation of findings is an important task. In many cases, this is achieved by means of electronic case report forms (eCRF) using corresponding information tech-nology systems. To avoid double data entry, eCRF systems can be integrated with electronic health records (EHR). However, when researchers from different institutions collaborate in collecting data, they often use a single joint eCRF system on the Internet. In this case, integration with EHR systems is not possible in most cases due to information security and data protection restrictions.To overcome this shortcoming, we propose a novel architecture for a federated electronic data capture system (fEDC). Four key requirements were identified for fEDC: Definitions of forms have to be available in a reliable and controlled fashion, integration with electronic health record systems must be possible, patient data should be under full local control until they are explicitly transferred for joint analysis, and the system must support data sharing principles accepted by the scientific community for both data model and data captured.With our approach, sites participating in a joint study can run their own instance of an fEDC system that complies with local standards (such as being behind a network firewall) while also being able to benefit from using identical form definitions by sharing metadata in the Operational Data Model (ODM) format published by the Clinical Data Interchange Standards Consortium (CDISC) throughout the collaboration.The fEDC architec-ture was validated with a working open-source prototype at five German university hospitals. The fEDC architecture provides a novel approach with the potential to significantly improve collaborative data capture: Efforts for data entry are reduced and at the same time, data quality is increased since barriers for integrating with local electronic health record systems are lowered. Further, metadata are shared and patient privacy is ensured at a high level.