Department of Medical Informatics, University Medical Center Göttingen, Germany.
Department of General Practice, University Medical Center Göttingen, Germany.
Stud Health Technol Inform. 2023 Sep 12;307:12-21. doi: 10.3233/SHTI230688.
There is increasing interest on re-use of outpatient healthcare data for research, as most medical diagnosis and treatment is provided in the ambulatory sector. One of the early projects to bring primary data from German ambulatory care into clinical research technically, organizationally and in compliance with legal demands has been the RADAR project, that is based on a broad consent and has used the then available practice information system's interfaces to extract and transfer data to a research repository. In course of the digital transformation of the German healthcare system, former standards are abandoned and new interoperability standards, interfaces and regulations on secondary use of patient data are defined, however with slow adoption by Health-IT systems. Therefore, it is of importance for all initiatives that aim at using ambulatory healthcare data for research, how to access this data in an efficient and effective way.
Currently defined healthcare standards are compared regarding coverage of data relevant for research as defined by the RADAR project. We compare four architectural options to access ambulatory health data through different components of healthcare and health research data infrastructures along the technical, organizational and regulatory conditions, the timetable of dissemination and the researcher's perspective.
A high-level comparison showed a high degree of semantic overlap in the information models used. Electronic patient records and practice information systems are alternative data sources for ambulatory health data - but differ strongly in data richness and accessibility.
Considering the compared dimensions of architectural routes to access health data for secondary research use we conclude that data extraction from practice information systems is currently the most promising way due to data availability on a mid-term perspective. Integration of routine data into the national research data infrastructures might be enforced by convergence of to date different information models.
由于大多数医疗诊断和治疗都是在门诊部门进行的，因此人们对重新使用门诊医疗保健数据进行研究的兴趣日益增加。将德国门诊护理的原始数据纳入临床研究的早期项目之一是 RADAR 项目，该项目在技术上、组织上和法律要求方面都基于广泛的同意，并利用当时可用的实践信息系统接口来提取和传输数据到研究存储库。在德国医疗保健系统数字化转型的过程中，以前的标准被放弃，新的互操作性标准、接口和关于患者数据二次使用的法规被定义，但卫生信息技术系统的采用速度缓慢。因此，对于所有旨在使用门诊医疗保健数据进行研究的倡议而言，如何以高效和有效的方式访问这些数据至关重要。
目前定义的医疗保健标准与 RADAR 项目定义的研究相关数据的覆盖范围进行了比较。我们比较了四种通过医疗保健和健康研究数据基础设施的不同组件访问门诊健康数据的架构选项，比较了技术、组织和监管条件、传播时间表以及研究人员视角。
高级别比较显示，所使用的信息模型在语义上有很高的重叠度。电子病历和实践信息系统是门诊健康数据的替代数据源-但在数据丰富度和可访问性方面差异很大。
考虑到访问二级研究使用的健康数据的架构路线的比较维度，我们得出结论，由于实践信息系统中的数据在中期视角上具有可用性，因此从实践信息系统中提取数据是目前最有前途的方法。通过将迄今为止不同的信息模型融合，可以加强常规数据纳入国家研究数据基础设施。
