Principle of sample size calculation in gastroenterology research: a practical guide for clinicians.

IF 3.8 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Expert Review of Gastroenterology & Hepatology Pub Date : 2024-10-01 Epub Date: 2024-10-16 DOI:10.1080/17474124.2024.2416239

Antonio Facciorusso, Viktor Domislovic, Lorenzo Fuccio, Ivo Boskoski, Cristiano Spada, Gabriele Capurso, Marianna Arvanitakis, Marcello Maida

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引用次数: 0

Abstract

Introduction: A proper sample size calculation enables to conduct adequately powered randomized controlled trials (RCTs) and to provide a valid assessment of a specific clinical question.

Areas covered: In the current manuscript, we tried to provide the reader with an easy guide on the principles of sample size calculation in RCTs, tailored specifically to the context of gastroenterology and hepatology. The basics of sample size calculation were commented with a description of some of the main methods, including the calculation of the non-inferiority margin for non-inferiority RCTs and the calculation of the minimum clinically important difference (MCID). Some examples from the gastroenterology literature were also provided.

Expert opinion: Collaborating with a biostatistician can provide valuable insights into the nuances of sample size calculation and study design. However, it is crucial that the clinicians understand the basics of calculating sample size, so they could provide valuable input in designing the study from a clinical point of view.

查看原文本刊更多论文

胃肠病学研究样本量计算原则：临床医师实用指南》。

简介：正确的样本量计算有助于开展有充分支持的随机对照试验（RCT），并对特定临床问题进行有效评估：在本手稿中，我们试图为读者提供一份关于 RCT 样本量计算原则的简易指南，该指南专门针对胃肠病学和肝病学。我们对样本量计算的基本原理进行了评论，并介绍了一些主要方法，包括非劣效性 RCT 的非劣效边际计算和最小临床重要差异 (MCID) 计算。此外，还提供了胃肠病学文献中的一些实例：专家意见：与生物统计学家合作可为样本量计算和研究设计的细微差别提供有价值的见解。不过，临床医生必须了解样本量计算的基础知识，这样他们才能从临床角度为研究设计提供宝贵意见。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Review of Gastroenterology & Hepatology GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

6.80

自引率

2.60%

发文量

审稿时长

6-12 weeks

期刊介绍： The enormous health and economic burden of gastrointestinal disease worldwide warrants a sharp focus on the etiology, epidemiology, prevention, diagnosis, treatment and development of new therapies. By the end of the last century we had seen enormous advances, both in technologies to visualize disease and in curative therapies in areas such as gastric ulcer, with the advent first of the H2-antagonists and then the proton pump inhibitors - clear examples of how advances in medicine can massively benefit the patient. Nevertheless, specialists face ongoing challenges from a wide array of diseases of diverse etiology.