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Research: The TOTAL trial dilemma: a survey among professionals on equipoise regarding fetal therapy for severe congenital diaphragmatic hernia

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Research: The TOTAL trial dilemma: a survey among professionals on equipoise regarding fetal therapy for severe congenital diaphragmatic hernia

Prenat Diagn

. 2020 Oct 19. doi: 10.1002/pd.5849. Online ahead of print. https://pubmed.ncbi.nlm.nih.gov/33074552/

The TOTAL trial dilemma: a survey among professionals on equipoise regarding fetal therapy for severe congenital diaphragmatic hernia

Simen Vergote #Daniel Pizzolato #Francesca RussoKris DierickxJan DeprestNeeltje Crombag

Abstract

Objective: Running randomized clinical trials(RCT) in fetal therapy is challenging. This is no different for fetoscopic endoluminal tracheal occlusion(FETO) for severe left-sided Congenital Diaphragmatic Hernia(CDH). We assessed the knowledge, attitude and practice(KAP) of maternal-fetal medicine specialists towards the antenatal management of CDH, and the randomized controlled clinical (RCT) “Tracheal Occlusion To Accelerate Lung growth-trial”.

Methods: A cross-sectional KAP-survey was conducted among 311 registrants of the 18th World Congress in Fetal Medicine.

Results: The overall knowledge of CDH and FETO was high. Remarkably only 45% considers prenatal prediction of neonatal outcome reliable. Despite, in their clinical practice they perform severity assessment (80%) and refer families for FETO either within the context of an RCT (43%) or on patient request (32%). Seventy percent perceives not offering FETO on patient demand seems as if no treatment is provided to a fetus with predicted poor outcome. Only 20% of respondents considers denying access to FETO on patient demand not as a psychological burden.

Conclusion: Often the views of individual respondents contradicted with their clinical practice. It seems that, for severe CDH, clinicians face personal and practical dilemmas that undermine equipoise. To us, this indicates the tension between the clinical and scientific obligations physicians experience. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.

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