Luus H G, Muller F O, Meyer B H
Department of Pharmacology, University of the Orange Free State, Bloemfontein.
S Afr Med J. 1989 Nov 18;76(10):568-70.
When comparing two treatment groups, hypothesis testing is widely used. However, clinical trialists should be more interested in statistical methods which elicit the magnitude of the differences between treatment groups, rather than a simple indication of whether or not the differences are statistically significant. Statistical significance does not necessarily imply clinical relevance. If the true difference between two treatment groups is so small that it is clinically irrelevant, a sample size can be found for which this difference is statistically significant. On the other hand, if the difference between treatment groups is statistically non-significant, it may still be clinically important. The limitations of conventional hypothesis testing of equal true means as such are highlighted. The need to control the power of the test--which takes into account the difference in treatment means which is considered important (clinically relevant) by the researcher--is discussed.
在比较两个治疗组时，假设检验被广泛使用。然而，临床试验人员应该对能够揭示治疗组之间差异大小的统计方法更感兴趣，而不是仅仅关注差异是否具有统计学显著性。统计学显著性并不一定意味着具有临床相关性。如果两个治疗组之间的真实差异非常小以至于在临床上无关紧要，那么可以找到一个样本量，使得这种差异具有统计学显著性。另一方面，如果治疗组之间的差异在统计学上不显著，它仍然可能具有临床重要性。文中强调了传统的等真实均值假设检验存在的局限性。还讨论了控制检验效能的必要性，检验效能考虑了研究人员认为重要（具有临床相关性）的治疗均值差异。
