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Equivalence and noninferiority testing in anesthesiology research.

机译:麻醉学研究中的等效性和非劣效性检测。

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摘要

CLINICAL studies frequently test whether one treatment or intervention is superior to another. When a test for superiority is statistically significant, we happily conclude that one method is better than the other, especially if it is in the expected direction! But what can it mean if the test is not significant? Can we conclude that the treatments are "similar" or "equivalent"? Actually, no, because although it could be that no clinically meaningful population difference exists, it is also possible that one does exist-but either the study was underpowered to detect it (sample size was too small) or we just got unlucky (false negative result). So from a nonsignificant test for superiority, we can really conclude only that no population difference was detected, and not equivalence, even if the observed means are very similar!
机译:临床研究经常测试一种治疗或干预是否优于另一种。当优越性检验在统计学上很显着时,我们很高兴地得出结论,一种方法比另一种方法更好,尤其是在预期的方向上!但是,如果测试不重要,那意味着什么呢?我们是否可以得出结论,治疗是“相似的”或“等效的”?实际上,没有,因为尽管可能没有临床意义上的人口差异,但也有可能存在人口差异,但要么研究不足以检测到它(样本量太小),要么我们倒霉(假阴性)结果)。因此,从对优势的非显着性检验中,我们可以得出的结论是,即使观察到的均值非常相似,也只能得出未检测到总体差异的结论,而不能得出等同的结论!

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