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:真正的世界数据(RWD)具有改善护理质量的巨大承诺,然而,需要具体的基础设施和方法来获得扎实的知识并向病人带来创新。根据法国32所区域和大学医院治理的国家案例研究,我们强调现代临床数据仓库的关键方面:治理、透明度、数据类型、数据再利用、技术工具、文件和数据质量控制流程。半结构性访谈以及对法国CDW报告的研究的审查,从2022年3月至11月以半结构方式进行了。在法国32所区域和大学医院中,14所正在生产CDW,5所正在试验中,5所有未来的CDW项目,8所在撰写时没有任何CDW项目。在法国实施CDW的日期是2011年,2020年底加快了。我们从案例研究中为CDW制定了一些一般性准则。CDW的实际研究方向要求努力在治理稳定、数据规划和数据质量和数据文件发展方面实现标准化。必须特别注意仓库中数据质量和数据质量和文件开发的可持续性,必须注意仓库改革的常规性改革以及数据管理工具的稳定性。