Methodologic considerations in randomized clinical trials in reproductive medicine

被引：5
作者：
Venetis, Christos [1 ,2 ,3 ]
d'Hooghe, Thomas [4 ,5 ,6 ]
Barnhart, Kurt T. [7 ]
Bossuyt, Patrick M. M. [8 ]
Mol, Ben Willem J. [9 ]
机构：
[1] Univ New South Wales Med, Ctr Big Data Res Hlth, Sydney, NSW, Australia
[2] Univ New South Wales Med, Sch Womens & Childrens Hlth, Sydney, NSW, Australia
[3] IVF Australia, Sydney, NSW, Australia
[4] Merck Healthcare KGaA, Res & Dev, Global Med Affairs Fertil, Darmstadt, Germany
[5] KU Leuven Univ Leuven, Reprod Med Res Grp, Dept Dev & Regenerat, Organ Syst,Grp Biomed Sci, Leuven, Belgium
[6] Yale Sch Med, Dept Obstet Gynecol & Reprod Sci, New Haven, CT USA
[7] Univ Penn, Dept Obstet & Gynecol, Perelman Sch Med, Philadelphia, PA 19104 USA
[8] Univ Amsterdam, Med Ctr, Dept Clin Epidemiol Biostat & Bioinformat, Amsterdam, Netherlands
[9] Monash Univ, Dept Obstet & Gynaecol, Clayton, Vic, Australia
来源：
FERTILITY AND STERILITY | 2020年 / 113卷 / 06期
关键词：
Randomized clinical trial; methodology; personalized medicine; big data; frequentist approach; bayesian analysis; BAYESIAN METHODS; BIG DATA; PROGESTERONE; TECHNOLOGY; PREDICTION; DESIGN; WOMEN; MODEL;
D O I：
10.1016/j.fertnstert.2020.04.038
中图分类号：
R71 [妇产科学];
学科分类号：
100211 ;
摘要：
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. (C) 2020 by American Society for Reproductive Medicine.
引用
收藏
页码：1107 / 1112
页数：6
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