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滑动二分法是否能为中风和创伤性脑损伤研究带来更高效能的临床试验?

Does the sliding dichotomy result in higher powered clinical trials for stroke and traumatic brain injury research?

作者信息

Price Megan, Hertzberg Vicki, Wright David W

机构信息

aThe Benetech Human Rights Program, Palo Alto, CA, USA.

出版信息

Clin Trials. 2013;10(6):924-34. doi: 10.1177/1740774512458601. Epub 2012 Oct 1.

Abstract

BACKGROUND

Recent research has proposed a new method for defining a favorable outcome in traumatic brain injury and stroke research.

PURPOSE

This new method is called the sliding dichotomy, and it is suggested as a potential solution to the problem of underpowered clinical trials.

METHODS

We present a brief simulation study and graphical comparison of the power of each method to detect varying treatment effect sizes.

RESULTS

Simulations of a patient population similar to the National Acute Brain Injury Study: Hypothermia (NABISH) study indicate that the sliding dichotomy method does not result in higher power than traditional methods.

CONCLUSIONS

Although the sliding dichotomy may present gains in power in some cases, several aspects of the patient population need to be considered in choosing between sliding dichotomy and traditional definitions of favorable outcomes.

摘要

背景

最近的研究提出了一种在创伤性脑损伤和中风研究中定义良好预后的新方法。

目的

这种新方法称为滑动二分法,被认为是解决临床试验效能不足问题的一种潜在方案。

方法

我们进行了一项简短的模拟研究,并对每种方法检测不同治疗效应大小的效能进行了图形比较。

结果

对类似于国家急性脑损伤研究:低温治疗(NABISH)研究的患者群体进行的模拟表明,滑动二分法的效能并不高于传统方法。

结论

尽管滑动二分法在某些情况下可能会提高效能,但在选择滑动二分法和传统的良好预后定义之间,需要考虑患者群体的几个方面。

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