统计学、伦理学和益生菌
Statistics, ethics, and probiotica
摘要：
在以下情况下，一项将实验性新疗法与标准疗法进行比较的随机临床试验应该基于伦理理由尽早停止：（1）新疗法明显优于标准疗法;（2）试验不会显示新疗法优于标准疗法。试验在第三种情况下继续进行：（3）新的治疗方法最终有可能比标准治疗方法更好，但我们还不确定。然而，“PROPATRIA”试验中的（盲法）数据监测委员会允许试验在中期分析时继续进行，因为仍然有很大的机会证明益生菌治疗对其患者非常有害。委员会不知道治疗A是益生菌治疗还是安慰剂。这本身不应该造成问题，因为它可以很容易地在两种情况下作出适当的决定。如果两种情况下的决策不同，则必须对数据进行揭盲，以确定适当的决策。委员会误读了SPSS的输出，它报告了两个单侧p值中较小的一个，而没有告诉用户它在做什么。看起来，大约有5条生命被牺牲，以获得一个显著的结果，即益生菌治疗对试验中的患者不利。
英文摘要：
A randomized clinical trial comparing an experimental new treatment to a standard therapy for a life-threatening medical condition should be stopped early on ethical grounds, in either of the following scenarios: (1) it has become overwhelmingly clear that the new treatment is better than the standard; (2) it has become overwhelmingly clear that the trial is not going to show that the new treatment is any better than the standard. The trial is continued in the third scenario: (3) there is a reasonable chance that the new treatment will finally turn out to be better than the standard, but we aren't sure yet. However, the (blinded) data monitoring committee in the "PROPATRIA" trial of an experimental probiotica treatment for patients with acute pancreatitis allowed the trial to continue at the half way interim analysis, in effect because there was still a good chance of proving that the probiotica treatment was very harmful to their patients. The committee did not know whether treatment A was the probiotica treatment or the placebo. In itself this should not have caused a problem, since it could easily have determined the appropriate decision under both scenarios. Were the decisions in the two scenarios different, then the data would have to be de-blinded, in order to determine the appropriate decision. The committee mis-read the output of SPSS, which reports the smaller of two one-sided p-values, without informing the user what it is doing. It seems that about 5 lives were sacrificed to the chance of getting a significant result that the probiotica treatment was bad for the patients in the trial.
机构、总结、中文摘要均由AI分析而来，可能存在错误，请以论文正文为准。
