1 Department of Statistics, George Mason University, Fairfax, VA, USA.
2 Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Clin Trials. 2019 Aug;16(4):363-374. doi: 10.1177/1740774519852708. Epub 2019 Jun 5.
Various non-proportional hazard models have been developed in the literature for competing risks data. The regression coefficients under these models, however, typically cannot be compared directly. We propose new methods to quantify the average of the time-varying cause-specific hazard ratios and subdistribution hazard ratios through two general classes of transformations and weight functions that are chosen to reflect the relative importance of the hazard ratios in different time periods. We further propose an -norm type of test statistic that incorporates the test statistics for all possible pairs of the transformation function and weight function under consideration. Extensive simulations are conducted under various settings of the hazards and demonstrate that the proposed test performs well under all settings. An application to a clinical trial in follicular lymphoma is examined in detail.
在竞争风险数据的文献中,已经开发了各种非比例风险模型。然而,这些模型下的回归系数通常不能直接比较。我们通过两种一般类别的变换和权重函数提出了新的方法来量化时变的特定原因风险比和子分布风险比的平均值,这些变换和权重函数是为了反映在不同时间段内风险比的相对重要性而选择的。我们进一步提出了一种 -范数类型的检验统计量,它结合了考虑的变换函数和权重函数的所有可能对的检验统计量。在各种风险设置下进行了广泛的模拟,结果表明,所提出的检验在所有设置下都表现良好。对滤泡性淋巴瘤临床试验的应用进行了详细检查。