在随机对照试验中处理时间到事件分析中缺失的结果:一个范围审查,重点关注多重归因
Saravanaraj Karuppasamy1, Prasanna Samuel Premkumar2, Venkata Raghava Mohan3
1Department of Biostatistics, Christian Medical College, Vellore, India.
BMC medical research methodology
|September 30, 2025
概括
在时间到事件分析中处理缺失的数据对于可靠的随机对照试验 (RCT) 至关重要. 这次审查发现,在生存分析中缺失的结果的多重归算 (MI) 等方法的不足利用和报告不足.
科学领域:
- 生物统计学 生物统计学
- 临床试验方法论 临床试验方法论
- 生存分析的分析.
背景情况:
- 随机对照试验 (RCT) 对于治疗评估至关重要,但缺失的结果可能会损害有效性.
- 在时间到事件分析中缺少数据,特别是被审查的事件时间,带来了独特的挑战.
- 正确地解决缺失事件时间对于公正可靠的RCT结论至关重要.
研究的目的:
- 在高影响力医学期刊的时间到事件研究中,对缺失结果的处理进行范围审查.
- 评估RCT中多重归算 (MI) 技术的实施和报告.
- 探索用于归咎审查事件时间的理论方法.
主要方法:
- 在NEJM,The Lancet和JAMA发表的2019-2024年RCT的范围审查.
- 确定缺少时间到事件结果的研究以及用于解决这些问题的方法.
- 详细检查MI的实施和报告,并探索对被审查数据的归算方法.
主要成果:
- 审查了383个RCT;29个 (7.6%) 使用统计方法解决了缺少的数据.
- 在12项研究中应用了多重推算 (MI),在10项研究中应用了完整的病例分析,在6项研究中应用了敏感性分析,在1项研究中应用了倾向性评分.
- MI方法显示出差异性,一些研究缺乏详细的报告;非行政审查信息往往有限.
结论:
- 对于具有生存结果的RCT,有效处理缺失事件时间至关重要.
- 对于失踪的时间到事件结果的统计方法的使用和文档仍然低于最佳.
- 对MI技术和审查信息的报告不足突出了关键差距,影响了生存分析的可靠性和可重复性.
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