小弟不才第一次读到non-inferiority 的trials
我看的这篇是有符合intention-to-treat
不劣性的区间 (margin)设订这个地方就让我有点头大 因为以前的生统
是用辗过去的，考完都忘了
这篇是比较primary chemotherapy 和 primary surgery intervention
the expected 3 year survival rate was 50% with primary
surgery. We defined the non-inferiority boundary, selected
after consideration of the size of diff erences noted
in similar trials and clinical consensus, to exclude a
detriment of more than 6% with primary chemotherapy,
with a 10% (one-sided) level of signifi cance. Therefore, to
show non-inferiority, the upper bound of the one-sided
90% CI for the hazard ratio (HR) had to be less than 1·18
想问几个问题，exclude a detriment of more than 6% with primary chemotherapy
查了一下，这边我是应该解释成根据以前的文献，所以我们用primary chemotherapy做的
non-inferiority 最多可以接受比primary surgery 多6%的伤害多还在可以接受的范围
吗?
2. 他说文章中另有提到不提供p-value是因为 non-inferiority trials
但为什么他没说
不知道有没有好心的板友可以稍微提点我一下或是跟我说有什么相关的书籍比较能够找
到答案 感谢:)