Venetis Christos, d'Hooghe Thomas, Barnhart Kurt T, Bossuyt Patrick M M, Mol Ben Willem J
Centre for Big Data Research in Health, University of New South Wales Medicine, New South Wales, Australia; School of Women's and Children's Health, University of New South Wales Medicine, New South Wales, Australia; IVF Australia, Sydney, New South Wales, Australia.
Global Medical Affairs Fertility, Research and Development, Merck Healthcare KGaA, Darmstadt, Germany; Reproductive Medicine Research Group, Department of Development and Regeneration, Organ Systems, Group Biomedical Sciences, KU Leuven (University of Leuven), Leuven, Belgium; Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut.
Fertil Steril. 2020 Jun;113(6):1107-1112. doi: 10.1016/j.fertnstert.2020.04.038.
Randomized controlled trials (RCTs) are the cornerstone of evidence-based medicine. In this series in Fertility and Sterility, several aspects of RCTs are discussed, with contributions on multicenter RCTs, different international settings, and integrity of RCTs. The present contribution deals with methodologic issues. We discuss different types of RCTs based on null hypothesis (superiority vs. noninferiority vs. equivalence) as well as frequentist versus Bayesian interpretation. We also discuss the use of RCTs in the era of personalized medicine and RCTs to address diagnostic and prognostic questions. Finally, we address the use of big data compared with the use of RCTs.
随机对照试验（RCTs）是循证医学的基石。在《生育与不育》的这个系列中，讨论了RCTs的几个方面，包括多中心RCTs、不同国际背景以及RCTs的完整性。本文稿探讨方法学问题。我们基于零假设（优效性与非劣效性与等效性）以及频率学派与贝叶斯学派的解释来讨论不同类型的RCTs。我们还讨论了RCTs在个性化医疗时代的应用以及用于解决诊断和预后问题的RCTs。最后，我们探讨了大数据的应用与RCTs应用的比较。
