医学研究人员对从病例报告表格共享元数据的看法
Alexandra Meidt1, Carolin Walter1, Christoph U Lehmann2
1Institute of Medical Informatics University of Münster Münster Germany.
Learning health systems
|January 17, 2025
概括
医学研究人员表现出强烈的愿意分享病例报告表 (CRF) 和其元数据,支持学习健康系统. 然而,赞助商的批准和公共注册表的可信度是广泛共享CRF数据的关键障碍.
科学领域:
- 健康研究方法的方法论.
- 医疗信息学医学信息学
- 临床试验的管理管理.
背景情况:
- 从病例报告表 (CRF) 中发布医疗元数据对于开发学习健康系统 (LHS) 至关重要.
- 在健康研究中,元数据的重用和标准化通过CRF的出版物得到了促进.
- 学习健康系统 (LHS) 依赖于通过数据和证据不断改进医疗保健的循环.
研究的目的:
- 调查医学研究人员 (MR) 愿意分享CRF的情况.
- 确定影响CRF共享决策的因素.
- 确定在公共注册表中公布CRF元数据的条件.
主要方法:
- 对在德国临床试验注册 (DRKS) (2020-2021) 中注册的1842项干预试验的CRF数据共享承诺的分析.
- 基于网络的调查分发给DRKS上列出的1360个联系人 (2022年5月至6月).
- 检查301名医学研究人员关于CRF共享态度和障碍的调查答复.
主要成果:
- 对CRF共享的认识较低:只有0.3%的试验计划共享空白CRF.
- 对共享的高度支持:超过70%的受访者愿意共享CRF,83.7%的人对重复使用感兴趣.
- 分享的主要驱动因素:改善数据可比性 (81.0%).
- 主要障碍:缺乏赞助人的批准 (53.2%).
- 与非商业研究人员相比,商业试验研究人员不太可能共享/重复使用CRF.
- 对于公开注册的可靠性至关重要 (81.1%) 的元数据公布.
结论:
- 尽管研究人员对共享和重复使用CRF有强烈的支持,但仍存在重大障碍.
- 较低的CRF共享承诺表明愿意与实践之间存在差距.
- 解决赞助商批准问题和确保注册表可信度对于推进CRF元数据发布和LHS开发至关重要.
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