大型协作临床数据集的内部验证协议:对CONGRESS数据库的评估
K Cole1, J A Gossage2, P Bhandari1
1Portsmouth Hospitals University NHS Trust, UK.
Annals of the Royal College of Surgeons of England
|January 20, 2026
概括
对CONGRESS数据库的内部数据验证显示,大多数变量都具有很高的一致性,确保可靠的研究结果. 该框架为多中心临床数据质量提供了一个标准.
科学领域:
- 临床研究方法论临床研究方法论
- 数据质量保证数据质量保证
- 胃食管癌研究 胃食管癌研究
背景情况:
- 多中心协作生成大量数据集,但由于实习生参与,数据质量面临挑战.
- 这些研究中的验证实践不一致,可能导致偏见.
- 本研究通过评估CONGRESS数据库内的内部数据验证来解决这些问题.
研究的目的:
- 概述多中心临床数据库内部数据验证的方法,可行性和结果.
- 为验证大型协作临床数据集建立可重复的框架和基准.
- 从多中心数据库中确保可靠,高质量的研究成果.
主要方法:
- 从早期食道胃癌的多中心CONGRESS数据集中随机选择了20%的患者样本进行验证.
- 从医疗记录中重新抽象了患者,疾病和结果数据,并与原始数据库进行了比较.
- 科恩的卡帕系数 (κ) 和皮尔森相关性 (r) 用于评估分类和连续变量的一致性.
主要成果:
- 302名患者 (18.1%) 被纳入验证组,与3320个数据点进行了比较.
- 对变量确切一致的百分比在82.5%至98.7%之间 (中位数为92.3%).
- 九个变量显示出"几乎完美的"一致性 (κ或r>0.8),五个显示出实质性的一致性 (κ>0.6),没有观察到弱或不良的一致性.
结论:
- 使用CONGRESS数据库进行内部数据验证被证明是可行的和有效的.
- 为验证大型协作临床数据集提出了一个可重复的框架和基准.
- 这种方法为确保跨多中心数据库的高质量研究成果提供了标准.
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