当代CDK4/6抑制剂研究中的不朽时间偏差:从目标试验仿真证据
G Hari Prakash1, Sunil Kumar2, Kiran Pk3
1Department of Allied Health Sciences, Division of Public Health, MS Ramaiah University of Applied Sciences, Bengaluru, India.
概括
针对转移性乳腺癌的CDK4/6抑制剂的现代研究显示,时间偏差是最小的. 在这些观察性研究中,迅速启动治疗和高事件率减少了对历史偏见的担忧.
科学领域:
- 在瘤学瘤学.
- 流行病学 流行病学
- 生物统计学 生物统计学
背景情况:
- 观察性研究对于转移性乳腺癌中CDK4/6抑制剂治疗决策至关重要.
- 不朽的时间偏差,在治疗开始时开始随访,可以膨胀治疗效益.
- 历史偏差估计对当代研究与快速治疗启动的概括性是未知的.
研究的目的:
- 为了评估CDK4/6抑制剂的当代观察性研究中的不朽时间偏差.
- 为了比较天真的观察分析与合成队列中的目标试验仿真.
主要方法:
- 基于模拟的研究,比较天真分析 (治疗时间为零) 与目标试验仿真 (诊断时间为零).
- 从已发表的CDK4/6抑制剂研究中利用了三个合成队列:丹麦注册 (N=1196),Flatiron数据库 (N=9146) 和BRCA亚组 (N=4050).
- 量化偏差大小,并检查了与治疗延迟和患者特征的关联.
主要成果:
- 观察到最小的不朽时间偏差 (平均绝对偏差0.55个月;0.5-2.1%偏差).
- 纯粹的分析低估了影响,普遍的用户偏见 (不包括过早死亡) 主导.
- 治疗延迟只解释了25%的偏差变化,这表明其他取决于背景的因素有影响.
结论:
- 当代CDK4/6抑制剂观察性研究显示,由于迅速启动治疗和高事件率,最小的不朽时间偏差.
- 不朽的时间偏差在当前环境中可能比历史文献表明的不那么普遍.
- 明确的零时规范仍然是一个关键的方法论最佳实践.
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