Ultrasound Obstet Gynecol
. 2023 Apr 26.
doi: 10.1002/uog.26235. Online ahead of print. https://pubmed.ncbi.nlm.nih.gov/37099763/
Core outcome set for perinatal interventions for congenital diaphragmatic hernia
S Vergote 1, F R De Bie 1, J M N Duffy 2, J Bosteels 1, A Benachi 3 4, B Power 5, F Meijer 6, H L Hedrick 7, C J Fernandes 8, I K M Reiss 9, P De Coppi 1 10 11, K P Lally 12, J A Deprest 1 2
- PMID: 37099763
- DOI: 10.1002/uog.26235
Objective: To develop a core set of prenatal and neonatal outcomes for clinical studies on perinatal interventions for congenital diaphragmatic hernia, using a validated consensus-building method.
Methods: An international steering group (n=13) comprised of leading maternal-fetal medicine specialists, neonatologists, pediatric surgeons, patient representatives, researchers and methodologists guided the development of this core outcome set. Potential outcomes were collected through a systematic review and entered into a two-round online Delphi survey. A call was made for stakeholders with experience with the condition, to review the list and score outcomes based on their perceived relevance. Outcomes that fulfilled the a priori defined consensus criteria were subsequently discussed in online breakout meetings. Results were reviewed in a consensus meeting during which the core outcome set was defined. Finally, the definitions, measurement methods and aspirational outcomes were defined in online and in person definition meetings with a selection from the stakeholders (n=45).
Results: Two hundred and twenty stakeholders participated in the Delphi-survey and 198 completed both rounds. Fifty outcomes met the consensus criteria and were discussed and rescored by 78 stakeholders in the breakout meetings. During the consensus meeting, 93 stakeholders agreed eventually on eight outcomes constituting the core outcome set. Maternal and obstetric outcomes included maternal morbidity related to the intervention and gestational age at delivery. Fetal outcomes included intra-uterine demise, interval between intervention and delivery and change in lung size in utero around the time of the intervention. Neonatal outcomes included neonatal mortality, pulmonary hypertension and use of extracorporeal membrane oxygenation. Additionally, definitions, measurement methods and three aspirational outcomes were added by 45 stakeholders: duration of invasive ventilation, duration of oxygen supplementation and pulmonary vasodilators at discharge.
Conclusions: We developed with relevant stakeholders a core outcome set for studies on perinatal interventions in CDH. Its implementation will facilitate comparison, contrasting and combination of trial results, enabling research to guide clinical practice. This article is protected by copyright. All rights reserved.
Keywords: Core outcome set; Delphi survey; congenital diaphragmatic hernia; perinatal interventions; pregnancy.
This article is protected by copyright. All rights reserved