Centre for Biostatistics, University of Manchester, Manchester, UK.
Biomedical Evidence Synthesis and Translation to Practice (BEST) Research Unit, School of Medicine, University of Central Lancashire, National Institute of Health Research, Preston, UK.
United European Gastroenterol J. 2021 Feb;9(1):47-53. doi: 10.1177/2050640620967899. Epub 2021 Feb 18.
Sample-size estimation is an important factor in designing a clinical trial. A recent study found that 65% of Cochrane systematic reviews had imprecise results.
This study set out to review the whole body of inflammatory bowel disease (IBD) randomised controlled trials systematically in order to identify the reporting of sample-size estimation.
We conducted a comprehensive hand search of the Cochrane Library and Cochrane IBD Specialized Trials Register. We extracted information on relevant features and the results of the included studies. We produced descriptive statistics for our results.
A total of 242 randomised controlled trials were included from 44 Cochrane systematic reviews. About 25% of the studies failed to report on sample-size estimation. Of those that did report on sample-size estimation, 33% failed to recruit their target sample size.
Around half of the randomised controlled trials in IBD either do not report sample-size estimation or reach their recruitment target with the level of detail in reporting being limited.
样本量估计是临床试验设计的一个重要因素。最近的一项研究发现，65%的 Cochrane 系统评价结果不精确。
本研究旨在对炎症性肠病（IBD）的所有随机对照试验进行系统综述，以确定样本量估计的报告情况。
我们对 Cochrane 图书馆和 Cochrane IBD 专门试验登记处进行了全面的手工检索。我们提取了相关特征和纳入研究结果的信息。我们对结果进行了描述性统计。
共纳入了 44 项 Cochrane 系统评价中的 242 项随机对照试验。约 25%的研究未报告样本量估计。在报告样本量估计的研究中，有 33%未能招募到目标样本量。
约一半的 IBD 随机对照试验要么没有报告样本量估计，要么报告的详细程度有限，未能达到招募目标。
