Real World Data (RWD) bears great promises to improve the quality of care. However, specific infrastructures and methodologies are required to derive robust knowledge and brings innovations to the patient. Drawing upon the national case study of the 32 French regional and university hospitals governance, we highlight key aspects of modern Clinical Data Warehouses (CDWs): governance, transparency, types of data, data reuse, technical tools, documentation and data quality control processes. Semi-structured interviews as well as a review of reported studies on French CDWs were conducted in a semi-structured manner from March to November 2022. Out of 32 regional and university hospitals in France, 14 have a CDW in production, 5 are experimenting, 5 have a prospective CDW project, 8 did not have any CDW project at the time of writing. The implementation of CDW in France dates from 2011 and accelerated in the late 2020. From this case study, we draw some general guidelines for CDWs. The actual orientation of CDWs towards research requires efforts in governance stabilization, standardization of data schema and development in data quality and data documentation. Particular attention must be paid to the sustainability of the warehouse teams and to the multi-level governance. The transparency of the studies and the tools of transformation of the data must improve to allow successful multi-centric data reuses as well as innovations in routine care.
翻译:真实世界数据(RWD)有望显著提升医疗质量,但需要特定基础设施和方法论来获取可靠知识并为患者带来创新。基于法国32所地区大学医院治理体系的国家案例研究,我们重点阐述了现代临床数据仓库(CDW)的关键维度:治理架构、透明度、数据类型、数据再利用、技术工具、文档规范及数据质量控制流程。我们于2022年3月至11月采用半结构化访谈法,并结合对法国CDW相关研究报告的审查,发现法国32所地区大学医院中,14所已部署生产级CDW,5所处于试验阶段,5所已规划CDW项目,另有8所在研究期间尚未启动CDW项目。法国CDW的部署始于2011年,在2020年末进入加速期。基于此案例研究,我们提炼出CDW建设的通用准则:当前CDW以研究为导向的定位需在治理体系稳定化、数据模式标准化、数据质量与文档完善等方面持续投入;尤其需关注数据仓库团队的可持续性与多层级治理机制;须提升研究透明度及数据转换工具的可靠性,以促进多中心数据复用及常规诊疗创新。