论文标题
使用协变量调整后的伪回归限制了平均生存时间估计值以提高精度
Restricted mean survival time estimate using covariate adjusted pseudovalue regression to improve precision
论文作者
论文摘要
从业者和随机临床试验的调节剂都需要协变量调整，因为它提高了估计治疗效果的精度。但是，协变量调整在事实分析中提出了一个特殊的挑战。我们建议将协变量调整后的假产回回归应用于限制的平均生存时间（RMST）的处理间差异。我们提出的方法结合了预后协变量，以提高治疗效果估计的精度，从而在不引入偏差的情况下保持严格的I型误差控制。另外，可以在研究设计阶段的样本量计算中量化精度的增加量。因此，我们提出的方法提供了设计较小的随机研究的能力，该研究无需支付统计能力。
Covariate adjustment is desired by both practitioners and regulators of randomized clinical trials because it improves precision for estimating treatment effects. However, covariate adjustment presents a particular challenge in time-to-event analysis. We propose to apply covariate adjusted pseudovalue regression to estimate between-treatment difference in restricted mean survival times (RMST). Our proposed method incorporates a prognostic covariate to increase precision of treatment effect estimate, maintaining strict type I error control without introducing bias. In addition, the amount of increase in precision can be quantified and taken into account in sample size calculation at the study design stage. Consequently, our proposed method provides the ability to design smaller randomized studies at no expense to statistical power.
