[問題] non-inferiority trial判讀

作者: aifor3 (ai)   2016-04-12 13:40:34
小弟不才第一次讀到non-inferiority 的trials
我看的這篇是有符合intention-to-treat
不劣性的區間 (margin)設訂這個地方就讓我有點頭大 因為以前的生統
是用輾過去的,考完都忘了
這篇是比較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
想問幾個問題,exclude a detriment of more than 6% with primary chemotherapy
查了一下,這邊我是應該解釋成根據以前的文獻,所以我們用primary chemotherapy做的
non-inferiority 最多可以接受比primary surgery 多6%的傷害多還在可以接受的範圍
嗎?
2. 他說文章中另有提到不提供p-value是因為 non-inferiority trials
但為什麼他沒說
不知道有沒有好心的板友可以稍微提點我一下或是跟我說有甚麼相關的書籍比較能夠找
到答案 感謝:)

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