Lehmann E H, Sandvik H
Senter for klinisk osteoporoseforskning, Haugesund.
Tidsskr Nor Laegeforen. 1997 Jan 10;117(1):47-9.
Group sequential experiments are terminated when an interim statistical test turns out to be "significant", or when maximum study size is attained. To ensure a stipulated total level of significance the interim tests have to be performed at a stricter level of significance determined by the maximum number of interim tests. As for fixed size studies, it is possible to determine a study size leading to a stipulated power. This study size depends on expected effect of intervention, number of interim tests and level of significance. Tables and computer simulation programs have been developed to facilitate the design of such plans. If the intervention turns out to be about as effective as expected, a saving in study size of about 30% can be expected in the long run, relative to studies of fixed size. If the intervention is much more effective than expected, larger savings can be achieved.
序贯试验在期中统计检验结果为“显著”时,或达到最大样本量时终止。为确保规定的总体显著性水平,期中检验必须在由期中检验的最大次数所确定的更严格显著性水平上进行。与固定样本量研究一样,可以确定一个能达到规定检验效能的样本量。这个样本量取决于干预的预期效果、期中检验次数和显著性水平。已经开发了表格和计算机模拟程序来辅助此类方案的设计。从长远来看,如果干预效果与预期大致相同,相对于固定样本量的研究,预计样本量可节省约30%。如果干预效果比预期好得多,则可以节省更多。