On confidence intervals for the hazard ratio in randomized clinical trials.
On confidence intervals for the hazard ratio in randomized clinical trials.
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DOI：
10.1111/biom.12528
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发表时间：
2016-12
期刊：
影响因子：
1.9
通讯作者：
Sailer MO
中科院分区：
文献类型：
--
作者：
Lin DY;Dai L;Cheng G;Sailer MO
对数秩检验被广泛用于比较随机临床试验中的两种生存分布，而偏似然是在比例风险模型下推断风险比的首选方法。当对数秩检验的p值小于0.05时，风险比的Wald 95%置信区间可能包括空值1。提供了基于对数秩统计量的风险比估计值;当且仅当对数秩检验的p值小于0.05时，相应的95%置信区间排除空值1。然而，Peto的估计是不一致的，相应的置信区间没有正确的覆盖概率。在本文中，我们通过反转（可能分层）考克斯模型下的评分检验来构建置信区间，并修改方差估计量，使得无治疗差异的零假设的所得评分检验与可能存在关系的对数秩检验相同。与Peto的方法类似，当且仅当对数秩检验显著时，建议的置信区间不包括空值。然而，与Peto的方法不同，该区间具有正确的覆盖概率。建议的置信区间的一个额外好处是，它往往比Wald置信区间更准确和更窄。我们通过广泛的模拟研究和结肠癌研究证明了所提出的方法的优点。
The log-rank test is widely used to compare two survival distributions in a randomized clinical trial, while partial likelihood is the method of choice for making inference about the hazard ratio under the proportional hazards model. The Wald 95% confidence interval of the hazard ratio may include the null value of 1 when the p-value of the log-rank test is less than 0.05. provided an estimator for the hazard ratio based on the log-rank statistic; the corresponding 95% confidence interval excludes the null value of 1 if and only if the p-value of the log-rank test is less than 0.05. However, Peto’s estimator is not consistent, and the corresponding confidence interval does not have correct coverage probability. In this paper, we construct the confidence interval by inverting the score test under the (possibly stratified) Cox model, and we modify the variance estimator such that the resulting score test for the null hypothesis of no treatment difference is identical to the log-rank test in the possible presence of ties. Like Peto’s method, the proposed confidence interval excludes the null value if and only if the log-rank test is significant. Unlike Peto’s method, however, this interval has correct coverage probability. An added benefit of the proposed confidence interval is that it tends to be more accurate and narrower than the Wald confidence interval. We demonstrate the advantages of the proposed method through extensive simulation studies and a colon cancer study.
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影响因子：
2
作者：
BERRY, G;KITCHIN, RM;MOCK, PA
通讯作者：
MOCK, PA
影响因子：
8.8
作者：
Peto R;Pike MC;Armitage P;Breslow NE;Cox DR;Howard SV;Mantel N;McPherson K;Peto J;Smith PG
通讯作者：
Smith PG
影响因子：
2.7
作者：
COX, DR
通讯作者：
COX, DR
影响因子：
158.5
作者：
MOERTEL, CG;FLEMING, TR;MAILLIARD, JA
通讯作者：
MAILLIARD, JA
影响因子：
4.5
作者：
ANDERSEN, PK;GILL, RD
通讯作者：
GILL, RD