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)在提升医疗质量方面具有巨大潜力。然而,需要特定的基础设施和方法论才能从中提炼出稳健的知识并为患者带来创新。基于法国32家区域及大学医院治理体系的国家级案例研究,我们着重阐述了现代临床数据仓库(CDW)的关键要素:治理架构、透明度、数据类型、数据复用、技术工具、文档规范及数据质量控制流程。研究采用半结构化访谈与已发表的法国CDW相关研究报告回顾相结合的方式,于2022年3月至11月间进行。在法国32家区域及大学医院中,14家已部署CDW并投入生产,5家处于试验阶段,5家拥有前瞻性CDW项目,8家在本研究撰写时尚未启动CDW项目。法国CDW的实施始于2011年,并于2020年代末开始加速推进。基于该案例研究,我们提炼出CDW建设的通用指导原则。当前CDW的研究导向要求加强治理稳定性建设、数据模式标准化以及数据质量与文档体系的完善。尤其需要关注仓库团队的可持续性与多层级治理机制。研究透明度与数据转换工具必须得到改进,以支持多中心数据复用及常规医疗中的创新应用。