Department of Obstetrics and Gynecology, University Medical Centre Groningen, Groningen, The Netherlands.
Prenat Diagn. 2011 Jun;31(6):589-94. doi: 10.1002/pd.2756. Epub 2011 Apr 11.
In this article, we reflect on whether randomized controlled trials (RCTs) are adequate for the clinical evaluation of maternal-fetal surgery for congenital diaphragmatic hernia (CDH), focusing on the role of patients' preferences in the setting up of research protocols, on the requirement of equipoise and on the concept of therapeutic misconception (TM).
We describe the conception and setting up of the tracheal occlusion (TO) to accelerate lung growth trial and analyze the ethical dilemmas faced by the research team during that time.
Depending on the view adopted regarding the scope of equipoise, there are two ways of dealing with patient's preferences concerning fetoscopic endoluminal TO and expectant management during pregnancy for CDH.
The solution adopted for fetoscopic endoluminal tracheal occlusion (FETO) is justified by the extended period of time it has been available to patients before the start of the RCT. Strong patient and referring physician preferences do not entail a right to have FETO, since it is a procedure of yet unproven efficacy and safety. In the future, to avoid the dilemmas posed by the TM and in name of the right of future generations of patients to have access to treatment of proven safety and efficacy, researchers must be able to plan RCT in due time.
本文反思了随机对照试验（RCT）是否足以评估胎儿手术治疗先天性膈疝（CDH）的临床效果，重点关注患者偏好在研究方案制定中的作用、均衡状态的要求以及治疗误解（TM）的概念。
我们描述了气管阻塞（TO）加速肺生长试验的构思和设立，并分析了研究团队在此期间面临的伦理困境。
根据对均衡状态范围的看法，有两种方法可以处理患者对胎儿镜腔内 TO 和 CDH 妊娠期间期待性管理的偏好。
在 RCT 开始之前，患者有足够的时间了解胎儿镜腔内气管阻塞（FETO），因此采用 FETO 作为解决方案是合理的。强烈的患者和转诊医生的偏好并不意味着有权进行 FETO，因为它是一种尚未证明疗效和安全性的程序。将来，为了避免 TM 带来的困境，并为了后代患者有权获得经过验证的安全有效的治疗，研究人员必须能够及时计划 RCT。
