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Core outcome set for perinatal interventions for congenital diaphragmatic hernia
S Vergote1, F R De Bie1, J M N Duffy2
1Department of Development and Regeneration, Cluster Woman and Child, Biomedical Sciences, KU Leuven, Leuven, Belgium.
Insights
A consensus-based core outcome set for congenital diaphragmatic hernia interventions was developed. This standardized set will improve clinical trial comparisons and guide future research in perinatal care.
Area of Science:
- Perinatal medicine
- Neonatology
- Pediatric surgery
Background:
- Congenital diaphragmatic hernia (CDH) requires complex perinatal interventions.
- Standardized outcome measures are lacking for clinical studies evaluating CDH interventions.
- This hinders the comparison and synthesis of research findings.
Purpose of the Study:
- To establish a core set of prenatal and neonatal outcomes for CDH clinical trials.
- To utilize a validated consensus-building methodology for outcome selection.
- To enhance the comparability and utility of research on CDH interventions.
Main Methods:
- An international steering group guided the process.
- Systematic literature review identified potential outcomes.
- A two-round online Delphi survey involved 221 stakeholders.
- Consensus meetings refined and finalized the core outcome set.
Main Results:
- Eight core outcomes were agreed upon by 93 stakeholders.
- Included maternal morbidity, gestational age at delivery, intrauterine demise, interval to delivery, lung size change, neonatal mortality, pulmonary hypertension, and extracorporeal membrane oxygenation use.
- Three aspirational outcomes were also identified: ventilation duration, oxygen supplementation, and pulmonary vasodilator use at discharge.
Conclusions:
- A stakeholder-developed core outcome set for CDH perinatal interventions has been established.
- Implementation will standardize outcome reporting in clinical studies.
- This facilitates trial result comparison and advances clinical practice guidance.
Objective:
To develop a core set of prenatal and neonatal outcomes for clinical studies evaluating perinatal interventions for congenital diaphragmatic hernia, using a validated consensus-building method.
Methods:
An international steering group comprising 13 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 of the literature and entered into a two-round online Delphi survey. A call was made for stakeholders with experience of congenital diaphragmatic hernia to review the list and score outcomes based on their perceived relevance. Outcomes that fulfilled the consensus criteria defined a priori were discussed subsequently 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 by a selection of 45 stakeholders.
Results:
Overall, 221 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, which constituted the core outcome set. Maternal and obstetric outcomes included maternal morbidity related to the intervention and gestational age at delivery. Fetal outcomes included intrauterine 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. Definitions and measurement methods were formulated by 45 stakeholders, who also added three aspirational outcomes: duration of invasive ventilation, duration of oxygen supplementation and use of pulmonary vasodilators at discharge.
Conclusions:
We developed with relevant stakeholders a core outcome set for studies evaluating perinatal interventions in congenital diaphragmatic hernia. Its implementation should facilitate the comparison and combination of trial results, enabling future research to better guide clinical practice. © 2023 International Society of Ultrasound in Obstetrics and Gynecology.
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