Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, The Netherlands.
Department of Epidemiology, RTI Health Solutions, Barcelona, Spain.
Pharmacoepidemiol Drug Saf. 2024 Aug;33(8):e5871. doi: 10.1002/pds.5871.
Metadata for data dIscoverability aNd study rEplicability in obseRVAtional studies (MINERVA), a European Medicines Agency-funded project (EUPAS39322), defined a set of metadata to describe real-world data sources (RWDSs) and piloted metadata collection in a prototype catalogue to assist investigators from data source discoverability through study conduct.
A list of metadata was created from a review of existing metadata catalogues and recommendations, structured interviews, a stakeholder survey, and a technical workshop. The prototype was designed to comply with the FAIR principles (findable, accessible, interoperable, reusable), using MOLGENIS software. Metadata collection was piloted by 15 data access partners (DAPs) from across Europe.
A total of 442 metadata variables were defined in six domains: institutions (organizations connected to a data source); data banks (data collections sustained by an organization); data sources (collections of linkable data banks covering a common underlying population); studies; networks (of institutions); and common data models (CDMs). A total of 26 institutions were recorded in the prototype. Each DAP populated the metadata of one data source and its selected data banks. The number of data banks varied by data source; the most common data banks were hospital administrative records and pharmacy dispensation records (10 data sources each). Quantitative metadata were successfully extracted from three data sources conforming to different CDMs and entered into the prototype.
A metadata list was finalized, a prototype was successfully populated, and a good practice guide was developed. Setting up and maintaining a metadata catalogue on RWDSs will require substantial effort to support discoverability of data sources and reproducibility of studies in Europe.
数据发现和观察性研究可重复性元数据（MINERVA），这是一个欧洲药品管理局资助的项目（EUPAS39322），定义了一组元数据来描述真实世界数据源（RWDS），并在原型目录中进行元数据收集试点，以协助研究人员从数据源发现到研究实施。
从现有元数据目录和建议的审查、结构化访谈、利益相关者调查和技术研讨会中创建了一份元数据清单。原型旨在符合 FAIR 原则（可发现、可访问、可互操作、可重用），使用 MOLGENIS 软件。元数据收集由来自欧洲各地的 15 个数据访问合作伙伴（DAP）进行试点。
在六个领域中定义了 442 个元数据变量：机构（与数据源相关联的组织）；数据库（由组织支持的数据集合）；数据源（涵盖共同基础人群的可链接数据库集合）；研究；网络（机构）；和通用数据模型（CDM）。原型中记录了 26 个机构。每个 DAP 都填充了一个数据源及其选定数据库的元数据。数据库的数量因数据源而异；最常见的数据库是医院行政记录和药房配药记录（每个数据来源 10 个）。根据不同的 CDM 从三个数据源成功提取了定量元数据并输入到原型中。
最终确定了元数据清单，成功填充了原型，并制定了良好实践指南。在 RWDS 上建立和维护元数据目录将需要大量努力，以支持数据源的可发现性和欧洲研究的可重复性。
