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用于确定两组临床试验效能的图表辅助工具。

Graphical aid for determining power of clinical trials involving two groups.

作者信息

Miller D K, Homan S M

机构信息

Department of Medicine, Saint Louis University School of Medicine, Missouri 63104.

出版信息

BMJ. 1988 Sep 10;297(6649):672-6. doi: 10.1136/bmj.297.6649.672.

Abstract

Physicians need to evaluate clinical research critically, and determining the power of a study is an essential component of research evaluation. This report presents a graphical aid that permits rapid power determination for clinical trials with two groups. Power curves were developed for dichotomous outcomes by setting two tail alpha at 0.05 and varying the sample size, the control group response rate, and the clinically important difference between control and experimental groups as defined by the user. Use of the graphical aid was demonstrated to a group of 18 medical students, residents, fellows, and faculty in a 15 minute session. Evaluation of the trainees' application of the aid showed a small average bias of -0.0003 and an average variance of 0.006. Ninety percent of power estimates were within 0.05 of the true value determined by formula. This graphical aid is recommended as a rapid and accurate method for determining power in the critical appraisal of clinical research.

摘要

医生需要审慎地评估临床研究,而确定一项研究的检验效能是研究评估的重要组成部分。本报告介绍了一种图形辅助工具,可用于快速确定两组临床试验的检验效能。通过将双侧α设定为0.05,并改变样本量、对照组反应率以及用户定义的对照组与试验组之间的临床重要差异,得出了二分结局的检验效能曲线。在一次15分钟的课程中,向18名医学学生、住院医师、研究员和教员展示了该图形辅助工具的使用方法。对学员使用该辅助工具情况的评估显示,平均偏差较小,为-0.0003,平均方差为0.006。90%的检验效能估计值与通过公式确定的真实值相差在0.05以内。推荐使用这种图形辅助工具作为在临床研究的批判性评价中确定检验效能的一种快速且准确的方法。

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