Storer Barry E, Gooley Ted A, Jones Michael P
Fred Hutchinson Cancer Research Center, Seattle, USA.
Lifetime Data Anal. 2008 Dec;14(4):484-95. doi: 10.1007/s10985-008-9098-9. Epub 2008 Sep 15.
In the analysis of retrospective data or when interpreting results from a single-arm phase II clinical trial relative to historical data, it is often of interest to show plots summarizing time-to-event outcomes comparing treatment groups. If the groups being compared are imbalanced with respect to factors known to influence outcome, these plots can be misleading and seemingly incompatible with results obtained from a regression model that accounts for these imbalances. We consider ways in which covariate information can be used to obtain adjusted curves for time-to-event outcomes. We first review a common model-based method and then suggest another model-based approach that is not as reliant on model assumptions. Finally, an approach that is partially model free is suggested. Each method is applied to an example from hematopoietic cell transplantation.
在回顾性数据分析中，或者在解释单臂II期临床试验相对于历史数据的结果时，展示总结治疗组事件发生时间结局的图表通常很有意义。如果所比较的组在已知会影响结局的因素方面不均衡，这些图表可能会产生误导，并且看似与考虑了这些不均衡因素的回归模型所得到的结果不一致。我们考虑了利用协变量信息来获得事件发生时间结局的调整曲线的方法。我们首先回顾一种常见的基于模型的方法，然后提出另一种基于模型的方法，该方法对模型假设的依赖程度较低。最后，提出了一种部分无模型的方法。每种方法都应用于造血细胞移植的一个实例。
