On the variability of covariate adjustment: experience with Koch's method for evaluating the absolute difference in proportions in randomized clinical trials
On the variability of covariate adjustment: experience with Koch's method for evaluating the absolute difference in proportions in randomized clinical trials
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DOI：
10.1016/s0197-2456(01)00201-x
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发表时间：
2002-04-01
期刊：
影响因子：
--
通讯作者：
Bluhmki, E
中科院分区：
文献类型：
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作者：
Lesaffre, E;Bogaerts, K;Bluhmki, E
最近，Koch等人提出了一种有趣的方法，用于随机临床试验中的协变量调整。在这里，我们报告了我们在Assent II中的经验，这是一项比较两种溶栓治疗30天死亡率的大型随机试验。还将使用来自Gusto-I研究和最近的Assent 11研究的数据。此外，我们平衡协变量调整（科赫方法）的优势，以额外的努力和必要的资源。在这种情况下，我们强调的事实是，有一个潜在的风险，使用协变量调整的分析作为主要分析，并表明，协变量调整时，它是最需要的效果最小。分析结果将量化这种风险和模拟研究说明了我们的研究结果。(C)2002年爱思唯尔科学公司All rights reserved.
Recently Koch et al. suggested an interesting approach for covariate adjustment in randomized clinical trials. Here we report our experience with the approach in Assent II, a large randomized trial comparing 30-day mortality rates of two thrombolytic treatments. Data from the Gusto-I study and a recent successor to the Assent 11 study will also be used. Further, we balance the advantage of covariate adjustment (with Koch's method) to the extra efforts and resources necessary. In this context we highlight the fact that there is a potential risk of using a covariate-adjusted analysis as primary analysis and show that covariate adjustment has the least effect when it is needed most. Analytic results will be given to quantify this risk and a simulation study illustrates our findings. (C) 2002 Elsevier Science Inc. All rights reserved.