对时间到事件终点的传统和新效应措施的评估:对已公布的瘤学试验的超流行病学研究
Qiao Huang1, Rong Peng2, Rui-Qing Cai3
1Center for Evidence-Based and Translational Medicine, Zhongnan Hospital of Wuhan University, Wuhan, China; Department of Evidence-Based Medicine and Clinical Epidemiology, Second School of Clinical Medicine, Wuhan University, Wuhan, China.
Journal of clinical epidemiology
|July 12, 2025
概括
新的平均危险 (AH) 测量比传统的危险比率更好地了解瘤学试验结果. 评估多重效应措施可以提高癌症研究中的临床解释和基于证据的决策.
科学领域:
- 临床试验 临床试验
- 在瘤学瘤学.
- 生物统计学 生物统计学
背景情况:
- 时间到事件的终点对于评估癌症治疗疗效至关重要.
- 危险比率是一种常见的指标,只提供相对的影响,在各种临床环境中可能不足.
- 现有的措施,如发病率,受限制的平均存活时间和新型平均危险 (AH) 措施,提供了相对和绝对的观点,但缺乏在瘤学中的系统评估.
研究的目的:
- 系统地评估和比较在瘤学试验中使用的七种不同的效果测量方法.
- 评估基于比率和基于差异的措施的一致性和临床实用性,包括危险比率,发病率措施,受限平均存活时间措施和AH措施.
主要方法:
- 一项超流行病学研究分析了来自52个卡普兰-梅尔曲线的重建的个体患者数据,这些数据来自46个随机对照瘤学试验.
- 从已发表的曲线中使用经过验证的算法重建患者级数据.
- 用可视化,中位数差异,斯皮尔曼等级相关性和类内相关系数来评估七个效果措施的对对一致性.
主要成果:
- 在七项措施中,在临床方向和统计学意义上观察到高度一致.
- 基于比率的措施 (危险比率,发病率比率,AH比率) 显示出强烈的一致性 (相关性>0.96).
- 受限制的平均存活时间比率显示出显著的不一致性,其基于差异的对应物表现出相当大的变化,中位数比率超过300.
结论:
- 基于平均危险 (AH) 的措施是危险比率的有希望的替代方案,提供相对和绝对的见解.
- 限制的平均存活时间测量提供了临床相关的数据,但由于大小差异,应独立解释.
- 在瘤学试验中报告多重效应措施可以改善临床解释并支持细微的决策.
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