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主要结局呈阳性——足以说明疗效好吗
The Primary Outcome Is Positive — Is That Good Enough?


Stuart J. Pocock ... 心脑血管疾病 其他 • 2016.09.08

研究者往往会将临床试验结果简单描述为一分为二的结论:“阳性结局,还是阴性结局?”为在一定程度上客观地回答此问题,人们通常关注是否达到了对主要结局预设的成功指标,也就是说,在不同治疗方案下,两者差异的P值是否小于0.05。事实上,如需更合理地对结论进行解读,常常需要彻底考察所有的证据,包括次要终点、安全性问题、临床试验的样本量及质量等。如同我们在既往文章中评价“阴性”试验一样1,本文的意图是通过评估结果呈阳性的临床试验,促进更精益求精、更均衡地解读临床试验证据。本文中的这些试验虽然都属于我们所专注的心血管领域,但原理同样适用于其他的领域。





作者信息

Stuart J. Pocock, Ph.D., and Gregg W. Stone, M.D.
From the Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London (S.J.P.); and Columbia University Medical Center, New York Presbyterian Hospital, and the Cardiovascular Research Foundation — all in New York (G.W.S.). Address reprint requests to Dr. Pocock at the Department of Medical Statistics, London School of Hygiene and Tropical Medicine, Keppel St., London WC1E 7HT, United Kingdom; or at stuart.pocock@lshtm.ac.uk.

 

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