Ebrahim Valojerdi Ameneh, Tanha Kiarash, Janani Leila
Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
Med J Islam Repub Iran. 2017 Dec 25;31:127. doi: 10.14196/mjiri.31.127. eCollection 2017.
The calculation of the sample size is one of the most important steps in designing a randomized controlled trial. The purpose of this study is drawing the attention of researchers to the importance of calculating and reporting the sample size in randomized controlled trials. We reviewed related literature and guidelines and discussed some important issues in sample size calculation and reporting in randomized controlled trials. The calculation of the sample size is one of the most important steps in designing a randomized controlled trial. According to the CONSORT (Consolidated Standards of Reporting Trials) guideline and other standard guidelines for designing and reporting of RCTs, sample size calculations should be reported and justified in all published RCTs. Because sample size calculations are prone to bias and because of the high ethical and financial costs related to conducting an RCT, we recommend involving a biostatistician at the designing stage of the study and to ask for statistical advice for sample size calculations.
样本量的计算是设计随机对照试验最重要的步骤之一。本研究的目的是引起研究人员对随机对照试验中样本量计算和报告重要性的关注。我们回顾了相关文献和指南，并讨论了随机对照试验中样本量计算和报告的一些重要问题。样本量的计算是设计随机对照试验最重要的步骤之一。根据CONSORT（试验报告统一标准）指南以及其他关于随机对照试验设计和报告的标准指南，所有已发表的随机对照试验都应报告并说明样本量的计算。由于样本量计算容易出现偏差，并且进行随机对照试验涉及高昂的伦理和财务成本，我们建议在研究设计阶段让生物统计学家参与，并就样本量计算寻求统计建议。
