Dette H, Munk A
Fakultät und Institut für Mathematik, Bochum, Germany.
Biometrics. 1997 Sep;53(3):1143-50.
As an extension of Welch's test to equivalence trials in a matched pair design, we determine the sample sizes n1 and n2 that maximize the power at given alternatives for a given total sample size n = n1 + n2. Although the optimal allocation is obtained asymptotically when the ratio of the standard deviations in both treatment groups equals the ratio of the sample sizes, numerical investigations show that this result does not hold for sample sizes where n < or = 25. For convenience, we provide tables containing the optimal combinations for the bioequivalence problem as well as for the problem of testing a clinically relevant difference. Results indicate that for small sample sizes, the optimum allocations of the treatments differ significantly in both testing problems, although they are asymptotically identical. In addition, we provide simple approximate equations that can be used for the determination of the required sample sizes to control a preassigned probability of type II error.
作为韦尔奇检验在配对设计等效性试验中的扩展,我们确定在给定总样本量(n = n1 + n2)的情况下,能使给定备择假设下检验功效最大化的样本量(n1)和(n2)。尽管当两个治疗组标准差的比值等于样本量的比值时,最优分配是渐近获得的,但数值研究表明,对于(n\leq25)的样本量,该结果不成立。为方便起见,我们提供了包含生物等效性问题以及检验临床相关差异问题的最优组合的表格。结果表明,对于小样本量,在这两个检验问题中,治疗的最优分配有显著差异,尽管它们在渐近情况下是相同的。此外,我们提供了简单的近似方程,可用于确定所需的样本量,以控制预先指定的II类错误概率。