Wang Rui, Chen Zi-Jiang, Vuong Lan N, Legro Richard S, Mol Ben W, Wilkinson Jack
Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia.
Center for Reproductive Medicine, Shandong University, Jinan, Shandong; National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Shandong University, Jinan, Shandong; Shandong Provincial Clinical Medicine Research Center for Reproductive Health, Shandong University, Jinan, Shandong, People's Republic of China.
Fertil Steril. 2020 Jun;113(6):1093-1099. doi: 10.1016/j.fertnstert.2020.04.037.
As the first paper in this series of Views and Reviews on randomized controlled trials (RCTs), we aim to provide the basics of RCTs in infertility research. In this paper, we discuss the need and ethical considerations of large trials in infertility research and important aspects to guarantee the quality of a trial, including protocols, registrations and monitoring, issues of study design and analysis, and reporting standards. Because most of the treatment effects we would like to study represent relatively small signal-to-noise ratios, large RCTs are required to provide sufficient power to answer these questions. Trial protocols, registrations, and monitoring facilitate the transparency of conduct, analysis, and reporting of the trial. Issues of trial design and analysis, such as nonblinding and misuse of the denominators, are common in published trials in this area and could be further improved. Finally, following the current reporting standard facilitates complete and transparent reporting, critical appraisal, and interpretation.
作为关于随机对照试验（RCT）的“观点与综述”系列的第一篇文章，我们旨在介绍不孕症研究中随机对照试验的基础知识。在本文中，我们讨论了不孕症研究中大型试验的必要性和伦理考量，以及保证试验质量的重要方面，包括试验方案、注册和监测、研究设计与分析问题以及报告标准。由于我们想要研究的大多数治疗效果的信噪比相对较小，因此需要大型随机对照试验来提供足够的效力以回答这些问题。试验方案、注册和监测有助于提高试验实施、分析和报告的透明度。试验设计与分析问题，如非盲法和分母的不当使用，在该领域已发表的试验中很常见，并且可以进一步改进。最后，遵循当前的报告标准有助于进行完整、透明的报告、批判性评价和解读。
