The place of the crossover design in infertility trials: a maximum likelihood approach.
The place of the crossover design in infertility trials: a maximum likelihood approach.
复制标题
交叉设计在不孕症试验中的地位：最大似然法。
DOI：
10.1093/humrep/deh475
复制
发表时间：
2004
影响因子：
6.1
通讯作者：
J. Vermeiden
中科院分区：
文献类型：
--
作者：
J. McDonnell;A. Goverde;J. Vermeiden
背景
多年来，关于交叉试验在辅助生殖技术（ART）中的地位一直存在争议。我们的目的是研究交叉和平行设计是否会导致治疗效果的不同估计。
方法
我们在平行和交叉设计下，在涉及删失和遗留效应的情况下，对接受子宫内授精（IUI）或IVF的患者队列进行了计算机模拟。使用最大似然法对模拟结果进行了分析。
结果
两种设计之间未发现相关差异。交叉设计的妊娠率略高于平行设计。残留效应可能会略微扭曲治疗效应的估计值。交叉和平行设计将产生基本相同的治疗效果和妊娠百分比的统计估计值。如果数据分析正确，交叉设计在不孕症研究中是可以接受的设计。
BACKGROUND
For some years, there has been a debate as to the place of the crossover trial in assisted reproduction technology (ART). We aimed to investigate whether crossover and parallel designs result in different estimates of treatment effects.
METHODS
We carried out computer simulation of cohorts of patients undergoing either intra-uterine insemination (IUI) or IVF under both parallel and crossover designs, under scenarios involving censoring and carryover effects. Results of the simulation were analysed using a maximum likelihood approach.
RESULTS
No relevant difference was found between the designs. The crossover design resulted in slightly more pregnancies than the parallel design. Carryover effects may slightly distort the estimates of treatment effects. Crossover and parallel designs will produce essentially the same statistical estimates of treatment effect and percentage of pregnancies. The crossover design is an acceptable design in infertility research provided the data are analysed correctly.