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如何对随机对照试验进行批判性分析。

How to perform a critical analysis of a randomised controlled trial.

作者信息

Estellat Candice, Torgerson David J, Ravaud Philippe

机构信息

INSERM U738, Department d'Epidémiologie, de Biostatistique et de Recherche Clinique, Groupe Hospitalier Bichat - Claude Bernard, Paris, France.

出版信息

Best Pract Res Clin Rheumatol. 2009 Apr;23(2):291-303. doi: 10.1016/j.berh.2009.03.003.

Abstract

Given the large amount of medical literature of varying methodological quality, care must be taken when translating the results of randomised controlled trials into clinical practice. To assist in this translation process, we provide a method that involves answering three main questions: 'Can I trust the results?' 'How do I understand the results?' and 'To whom do the results apply?' To answer the first question, we describe important items that help in judging the reliability of the findings. For the second question, we address the clinical and statistical significance of results by looking at the size and precision of the effect. Finally, we raise the issue of external validity and of reporting adverse effects to determine which patients may best benefit from the new intervention.

摘要

鉴于存在大量方法学质量参差不齐的医学文献,在将随机对照试验的结果转化为临床实践时必须谨慎。为协助这一转化过程,我们提供一种方法,该方法涉及回答三个主要问题:“我能相信这些结果吗?”“我如何理解这些结果?”以及“这些结果适用于哪些人?”为回答第一个问题,我们描述有助于判断研究结果可靠性的重要项目。对于第二个问题,我们通过观察效应的大小和精确性来探讨结果的临床和统计学意义。最后,我们提出外部有效性和报告不良反应的问题,以确定哪些患者可能从新干预措施中获益最大。

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