Löbe Matthias, Bartow Martin, Bialke Martin, Gatrio Margaux, Gulden Christian, Sass Julian, Stäubert Sebastian, Zautke Alexander
Institute for Medical Informatics (IMISE), University of Leipzig, Germany.
TMF - Technologie- und Methodenplattform für die vernetzte medizinische Forschung e.V., Berlin, Germany.
Stud Health Technol Inform. 2025 Aug 7;329:43-47. doi: 10.3233/SHTI250798.
The broad registration of research studies in international registries would give the research community a good oversight of ongoing projects, but would also serve the information needs of study participants. However, there is currently a lack of widely accepted transparency registers as well as harmonized interfaces for populating and managing them. The German Medical Informatics Initiative (MII) makes healthcare data from German university hospitals available for a variety of research purposes. As a complement to the MII core dataset, an extension module for representing research studies was specified and implemented in HL7 FHIR. This allows both local research projects at the sites and cross-site projects to be represented. One focus was on modeling the criteria for the inclusion or exclusion of subjects and the connection of patients to study participants. This initial version will be supplemented with additional functionalities in the future to enable a semi-automatic synchronization with transparency registers such as the German Portal for Medical Research Data (FDPG).
在国际注册机构广泛登记研究项目，将使研究界能够很好地监督正在进行的项目，但也能满足研究参与者的信息需求。然而，目前缺乏广泛接受的透明度登记机构以及用于填充和管理这些机构的统一接口。德国医学信息学倡议（MII）使德国大学医院的医疗保健数据可用于各种研究目的。作为MII核心数据集的补充，在HL7 FHIR中指定并实现了一个用于表示研究项目的扩展模块。这使得站点的本地研究项目和跨站点项目都能够得到呈现。一个重点是对纳入或排除受试者的标准以及患者与研究参与者的关联进行建模。这个初始版本未来将补充更多功能，以实现与德国医学研究数据门户（FDPG）等透明度登记机构的半自动同步。
