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使用R进行临床试验中的样本量计算。

Sample size calculation in clinical trial using R.

作者信息

Park Suyeon, Kim Yeong-Haw, Bang Hae In, Park Youngho

机构信息

Department of Biostatistics, Academic Research Office, Soonchunhyang University Seoul Hospital, Seoul, Korea.

International Development and Cooperation, Graduate School of Multidisciplinary Studies Toward Future, Soonchunhyang University, Asan, Korea.

出版信息

J Minim Invasive Surg. 2023 Mar 15;26(1):9-18. doi: 10.7602/jmis.2023.26.1.9.

Abstract

Since the era of evidence-based medicine, it has become a matter of course to use statistics to create objective evidence in clinical research. As an extension of this, it has become essential in clinical research to calculate the correct sample size to demonstrate a clinically significant difference before starting the study. Also, because sample size calculation methods vary from study design to study design, there is no formula for sample size calculation that applies to all designs. It is very important for us to understand this. In this review, each sample size calculation method suitable for various study designs was introduced using the R program (R Foundation for Statistical Computing). In order for clinical researchers to directly utilize it according to future research, we presented practice codes, output results, and interpretation of results for each situation.

摘要

自循证医学时代以来,在临床研究中运用统计学来创建客观证据已成为理所当然的事情。在此基础上,在临床研究开始前计算出正确的样本量以证明具有临床显著差异变得至关重要。此外,由于样本量计算方法因研究设计而异,不存在适用于所有设计的样本量计算公式。我们理解这一点非常重要。在本综述中,使用R程序(R统计计算基金会)介绍了适用于各种研究设计的每种样本量计算方法。为了让临床研究人员能够根据未来的研究直接使用它,我们针对每种情况给出了实践代码、输出结果和结果解释。

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