实施临床数据仓库的良好实践:法国的一个案例研究
Matthieu Doutreligne1,2, Adeline Degremont1, Pierre-Alain Jachiet1
1Mission Data, Haute Autorité de Santé, Saint-Denis, France.
PLOS digital health
|July 6, 2023
概括
现实世界数据 (RWD) 需要强大的临床数据仓库 (CDWs) 来改善医疗保健. 法国医院在CDW实施方面取得了进展,突出了治理,数据质量和透明度的需求,以促进研究和创新.
科学领域:
- 医疗信息学 医疗信息学
- 数据管理数据管理
- 临床研究基础设施 临床研究基础设施
背景情况:
- 现实世界数据 (RWD) 为提高患者护理质量提供了巨大的潜力.
- 有效利用RWD需要专门的基础设施和知识衍生和创新的方法.
- 临床数据仓库 (CDW) 对于管理和利用RWD至关重要.
研究的目的:
- 分析法国地区和大学医院现代CDW的关键方面.
- 确定强有力的CDW实施的基本组成部分,包括治理,透明度,数据类型,重复使用,工具,文档和质量控制.
- 为研究和临床创新优化CDW功能得出一般指南.
主要方法:
- 一项涉及32家法国地区和大学医院的国家案例研究.
- 2022年3月至11月期间进行的半结构面试.
- 对法国CDW报告的研究进行了综述.
主要成果:
- 在32家医院中,有14家医院在生产中拥有CDW,其中5家正在试验,5家有前性项目.
- 在法国,CDW的实施始于2011年,并于2020年底加速实施.
- 需要改进的关键领域包括治理稳定,数据模式标准化,数据质量和文档.
结论:
- CDWs需要加强治理,标准化数据,并提高研究方向的质量/文档.
- CDW团队的可持续性和多层管理是关键的成功因素.
- 研究和数据转换工具的透明度提高对于多中心数据再利用和日常护理创新至关重要.
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