临床研究与方法学：次要终点如何使用及采用何种层级顺序？
Clinical research and methodology What usage and what hierarchical order for secondary endpoints?
AI总结：
本文探讨了随机临床试验中次要终点分析导致I类错误风险膨胀的问题，并对比了共同主要终点风险分配法与层级检验程序两种控制错误结论风险的方法。
摘要：
在随机临床试验中，当主要终点的结果显示出显著获益时，次要终点会被仔细审查以识别治疗的额外效应。然而，这种方法存在得出某个次要终点有获益而实际并不存在的风险（I类错误风险膨胀）。目前主要有两种方法用于控制次要终点得出错误结论的风险。第一种方法是将风险分配到多个共同主要终点上，以维持5%的总体风险。第二种是层级检验程序，即首先确立终点的层级，然后在该层级下依次评估每个终点，只要终点持续显示统计学显著性就继续检验。这种简单的方法能够展示治疗的额外优势，并识别区分它们的因素。
英文摘要：
In a randomised clinical trial, when the result of the primary endpoint shows a significant benefit, the secondary endpoints are scrutinised to identify additional effects of the treatment. However, this approach entails a risk of concluding that there is a benefit for one of these endpoints when such benefit does not exist (inflation of type I error risk). There are mainly two methods used to control the risk of drawing erroneous conclusions for secondary endpoints. The first method consists of distributing the risk over several co-primary endpoints, so as to maintain an overall risk of 5%. The second is the hierarchical test procedure, which consists of first establishing a hierarchy of the endpoints, then evaluating each endpoint in succession according to this hierarchy while the endpoints continue to show statistical significance. This simple method makes it possible to show the additional advantages of treatments and to identify the factors that differentiate them.
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。
