Westfall P H, Krishen A, Young S S
Department of Information Systems and Quantitative Sciences, Texas Tech University, Lubbock 79409, USA.
Stat Med. 1998 Sep 30;17(18):2107-19. doi: 10.1002/(sici)1097-0258(19980930)17:18<2107::aid-sim910>3.0.co;2-w.
We maximize power in a replicated clinical trial involving multiple endpoints by adjusting the individual significance levels for each hypothesis, using preliminary data to obtain the optimal adjustments. The levels are constrained to control the familywise error rate. Power is defined as the expected number of significances, where expectations are taken with respect to the posterior distributions of the non-centrality parameters under non-informative priors. Sample size requirements for the replicate study are given. Intuitive principles such as downweighting insignificant variables from a preliminary study and giving primary endpoints more emphasis are justifiable within the conceptual framework.
在涉及多个终点的重复临床试验中,我们通过调整每个假设的个体显著性水平来最大化检验效能,利用初步数据获得最优调整。这些水平受到约束以控制族系错误率。检验效能定义为显著结果的期望数量,其中期望是针对非信息先验下非中心参数的后验分布而言的。给出了重复研究的样本量要求。在这个概念框架内,诸如对初步研究中不显著的变量进行降权以及更强调主要终点等直观原则是合理的。