现实世界证据中的暗数据:挑战,含义和医学研究数据素养的必要性
Hun-Sung Kim1,2
1Department of Medical Informatics, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Journal of Korean medical science
|March 12, 2024
概括
现实世界证据 (RWE) 研究,结合外部因素和"黑暗数据",补充随机对照试验 (RCT). 了解这些复杂的数据对于在大数据时代导航的医疗专业人员至关重要.
科学领域:
- 临床研究方法论临床研究方法论
- 现实世界的证据 (RWE) 分析分析.
- 健康数据科学健康数据科学
背景情况:
- 随机对照试验 (RCT) 和现实世界的证据 (RWE) 在临床证据生成方面是互补的,但却是不同的.
- 实验室试验提供了受控环境,而RWE包含了现实世界的外部因素,这些因素可以挑战实验室试验结果.
- 在RWE的外部因素可能导致与RCT不同结果,需要先进的分析方法.
研究的目的:
- 探索外部因素对现实世界证据 (RWE) 结果的影响.
- 调查RWE中"暗数据" (收集但未使用的数据) 的作用和潜力.
- 突出医学数据素养在解释复杂的RWE方面的重要性.
主要方法:
- 对"暗数据"类型的分析:"已知-未知"和"未知-未知".
- 检查外部因素如何影响RWE结果,超出统计纠正范围.
- 在临床研究中理解和利用未使用或被排除的数据的概念框架.
主要成果:
- 暗数据,包括被排除在外的受试者和未使用的数据,包含了对临床背景的潜在见解.
- 外在因素显著影响RWE,导致与RCT结果的差异.
- 将未知的数据转化为可用的知识依赖于数据素养和医学专业知识.
结论:
- 了解暗数据对于准确反映RWE临床环境的复杂性至关重要.
- 桥梁RCT和RWE需要提高临床医生的医疗数据素养.
- 准备好的医疗保健专业人员对于利用大数据和人工智能来推动医学的发展至关重要.
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