非虚假设综合卡方检验

A Summary Chi Square Test of the Non-Null Hypothesis

  • 摘要: 目的:本文提出一种非虚假设综合卡方检验.它包括两种统计量.方法:以非虚假设取代虚假设分别由经典Cochran检验和Mantel-Haenszel检验推导出这两种统计量及其功效函数,并以Monte Carlo方法展示其行为.结果:所得两种统计量与其功效函数一一匹配.其观测功效与预定功效吻合.当最小临床承认差量取零时还原为经典检验.当只有一层时还原为Dunnett-Gent检验.当最小临床承认差量取零且只有一层时还原为两比例(率)检验.结论:对于以建立治疗-对照差临床意义或临床等效性为目的的分层两组临床试验,可用该检验进行分析.附有工作实例说明计算过程.

     

    Abstract: Objective: A summary chi square test of the non-null hypothesis is proposed including two statistics. Meth-ods: The two statistics and their power functions are respectively derived from the classical Cochran test and the Mantel-Haenszel test using the non-null hypothesis in place of the null hypothesis. Their performance is exhibited by Monte Carlo method. Results: The two statistics are matched with their power functions respec-tively. The observed power of the statistics coincides with the prescribed power. They reduce to their classical counterparts when the minimal clinically relevant difference equals zero, to the Dunnett-Gent test when there is only one stratum, and to the common test on two binomial proportions (rates) when both the minimal clinically relevant difference equals zero and there is only one stratum. Conclusion: The test can be applied to analyzing the data from the clinical trials for establishing the clinical significance of treatment-control difference or clinical equivalence. A worked example illustrates the methodology.

     

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