The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies.
The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies.
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DOI：
10.1186/1745-6215-15-139
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发表时间：
2014-04-23
期刊：
影响因子：
2.5
通讯作者：
Morris TP
中科院分区：
文献类型：
--
作者：
Kahan BC;Jairath V;Doré CJ;Morris TP
对预后协变量的调整可以增加随机试验分析的能力。然而，调整后的分析在实践中并不经常进行。我们使用模拟来检查协变量调整对来自一系列治疗领域的8项研究的12项结果的影响。我们评估了(1)在实践中可以预期的功率增长幅度；以及(2)对不能预测的协变量进行调整的影响。对已知的预后协变量进行调整后，大多数结果的威力都会大幅增加。根据一项未经调整的分析，当功率设置为80%时，协变量调整导致12个结果的功率中位数增加到92.6%(范围为80.6-99.4%)。12个结果中有8个结果的功率增加到85%以上，12个结果中有5个结果的功率增加到95%以上。相反，对不能预测预后的协变量进行调整后，功率的最大降幅从80%降至78.5%。对已知的预后协变量进行调整可以导致能量的显著增加，应该常规地纳入随机试验的分析中。在中等或大样本量的试验中，调整少量可能影响预后的协变量的潜在好处远远超过这样做的风险，因此也应该考虑到这一点。
Adjustment for prognostic covariates can lead to increased power in the analysis of randomized trials. However, adjusted analyses are not often performed in practice. We used simulation to examine the impact of covariate adjustment on 12 outcomes from 8 studies across a range of therapeutic areas. We assessed (1) how large an increase in power can be expected in practice; and (2) the impact of adjustment for covariates that are not prognostic. Adjustment for known prognostic covariates led to large increases in power for most outcomes. When power was set to 80% based on an unadjusted analysis, covariate adjustment led to a median increase in power to 92.6% across the 12 outcomes (range 80.6 to 99.4%). Power was increased to over 85% for 8 of 12 outcomes, and to over 95% for 5 of 12 outcomes. Conversely, the largest decrease in power from adjustment for covariates that were not prognostic was from 80% to 78.5%. Adjustment for known prognostic covariates can lead to substantial increases in power, and should be routinely incorporated into the analysis of randomized trials. The potential benefits of adjusting for a small number of possibly prognostic covariates in trials with moderate or large sample sizes far outweigh the risks of doing so, and so should also be considered.
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