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Primer: measuring the effects of treatment in clinical trials.

机译:底漆:在临床试验中测量治疗效果。

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摘要

The results of clinical trials are often used as the basis for changes in clinical practice. Proper execution and interpretation of the results of trials are, therefore, of paramount importance to the welfare of patients. The results of a clinical trial are based on four key elements: the choice of the primary study end point, the method used to compare end points between groups, the clinically meaningful difference in the primary end point selected a priori by the investigators, and the power of the study to detect as statistically significant a difference between groups that is as large as the preselected clinically meaningful difference. These key elements directly follow from the primary hypothesis tested by the trial. This article reviews the basic features of these four elements, and the influence they have on the interpretation of clinical trials.
机译:临床试验的结果通常被用作改变临床实践的基础。因此,正确执行和解释试验结果对患者的福利至为重要。临床试验的结果基于四个关键要素:选择主要研究终点,用于比较各组之间终点的方法,研究者事先选定的主要终点的临床意义差异以及这项研究能够发现两组之间的差异具有统计学意义,该差异与预先选择的具有临床意义的差异一样大。这些关键要素直接来自试验检验的主要假设。本文回顾了这四个要素的基本特征,以及它们对临床试验解释的影响。

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