Braakhekke M, Mol F, Mastenbroek S, Mol B Willem J, van der Veen F
Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Room Q3-119, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands
Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Room Q3-119, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.
Hum Reprod. 2017 Feb;32(2):257-260. doi: 10.1093/humrep/dew286. Epub 2016 Nov 14.
Clinical decisions in reproductive medicine are often made in uncertainty. To reduce uncertainty and to improve clinical decision-making, RCTs are increasingly called upon. A key concept underpinning the ethics of RCTs is equipoise. Here, we aimed to dissect the basic reasoning behind the concept of equipoise and we proposed a line of thinking delineating under which conditions it is ethical to design and execute an RCT. This might prevent a priori negative trials, reduce research waste and aid in the design of meaningful ones. It is these trials that will provide insight on how to safely and effectively assist subfertile couples.
生殖医学中的临床决策往往是在不确定的情况下做出的。为了减少不确定性并改善临床决策，随机对照试验（RCT）的应用越来越广泛。支撑随机对照试验伦理的一个关键概念是 equipoise（平衡原则）。在此，我们旨在剖析平衡原则背后的基本推理，并提出一种思路，以界定在哪些条件下设计和实施随机对照试验是符合伦理的。这可能会避免先验性的阴性试验，减少研究浪费，并有助于设计有意义的试验。正是这些试验将为如何安全有效地帮助不孕夫妇提供见解。
