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临床数据仓库实施的良好实践:法国的一个案例研究。

Good practices for clinical data warehouse implementation: A case study in France.

作者信息

Doutreligne Matthieu, Degremont Adeline, Jachiet Pierre-Alain, Lamer Antoine, Tannier Xavier

机构信息

Mission Data, Haute Autorité de Santé, Saint-Denis, France.

Inria, Soda team, Palaiseau, France.

出版信息

PLOS Digit Health. 2023 Jul 6;2(7):e0000298. doi: 10.1371/journal.pdig.0000298. eCollection 2023 Jul.

DOI:10.1371/journal.pdig.0000298
PMID:37410797
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10325086/
Abstract

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 multilevel governance. The transparency of the studies and the tools of transformation of the data must improve to allow successful multicentric data reuses as well as innovations in routine care.

摘要

真实世界数据(RWD)有望极大地改善医疗质量。然而,需要特定的基础设施和方法来获取可靠的知识并为患者带来创新。借鉴法国32家地区和大学医院治理的国家案例研究,我们强调了现代临床数据仓库(CDW)的关键方面:治理、透明度、数据类型、数据重用、技术工具、文档以及数据质量控制流程。2022年3月至11月,我们以半结构化方式进行了半结构化访谈,并对法国CDW的相关研究报告进行了综述。在法国的32家地区和大学医院中,14家拥有正在运行的CDW,5家正在进行试验,5家有前瞻性CDW项目,8家在撰写本文时没有任何CDW项目。法国CDW的实施始于2011年,并在2020年末加速。从这个案例研究中,我们得出了一些关于CDW的一般指导方针。CDW实际向研究的导向需要在治理稳定、数据模式标准化以及数据质量和数据文档方面进行努力。必须特别关注仓库团队的可持续性和多级治理。研究的透明度以及数据转换工具必须得到改善,以实现成功的多中心数据重用以及常规护理中的创新。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d055/10325086/b6f8cb6fa209/pdig.0000298.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d055/10325086/295d561a3ea7/pdig.0000298.g001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d055/10325086/b6f8cb6fa209/pdig.0000298.g004.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d055/10325086/1a1d7bd18c55/pdig.0000298.g002.jpg
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