On tests of equivalence via non-unity relative risk for matched-pair design
On tests of equivalence via non-unity relative risk for matched-pair design
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DOI：
10.1002/sim.1213
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发表时间：
2003-04-30
影响因子：
2
通讯作者：
Chan, ISF
中科院分区：
文献类型：
--
作者：
Tang, NS;Tang, ML;Chan, ISF
临床试验中经常采用配对设计，以提高治疗比较的效率。我们考虑了二元结果配对研究中具有相对风险终点的等效性检验问题，并开发了几种用于检验非统一相对风险假设的得分和Wald型统计量。从艾滋病病毒筛查试验和交叉临床试验的软接触镜的评估的例子来说明所提出的方法。通过模拟，我们比较这些测试的经验表现与Lachenbruch和Lynch提出的测试。我们发现，一个得分测试的基础上重新参数化的多项模型的探戈执行最好的意义上说，测试令人满意地控制I型错误率和经验的I型错误率一般更接近预先指定的名义显著性水平比其他测试。版权所有（C）2003约翰威利父子有限公司。
Matched-pair design is often used in clinical trials to increase the efficiency of treatment comparison. We consider the problem of equivalence test with a relative risk endpoint in matched-pair studies with binary outcomes, and develop several score and Wald-type statistics for testing a hypothesis of non-unity relative risk. Examples from an assessment of HIV screening test and a cross-over clinical trial of soft contact lenses are used to illustrate the proposed methods. Through simulations we compare the empirical performance of these tests with the test proposed by Lachenbruch and Lynch. We show that a score test based on a reparameterized multinomial model by Tango performs best in the sense that the test satisfactorily controls the type I error rate and its empirical type I error rates are generally much closer to the prespecified nominal significance level than those of the other tests. Copyright (C) 2003 John Wiley Sons, Ltd.