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Study protocol: a core outcome set for perinatal interventions for congenital diaphragmatic hernia
Simen Vergote1, Felix De Bie1,2, Jan Bosteels1
1Department of Development and Regeneration cluster Woman and Child, Biomedical Sciences, KU Leuven, Herestraat 49 - Box 805, B-3000, Leuven, Belgium.
Trials
|February 24, 2021
Summary
This study outlines a plan to develop a core outcome set (COS) for congenital diaphragmatic hernia (CDH) research. Standardizing outcomes will improve the quality of perinatal interventions and patient care for CDH.
Area of Science:
- Neonatal Research
- Pediatric Surgery
- Medical Interventions
Background:
- Congenital diaphragmatic hernia (CDH) is a severe birth defect with high mortality and morbidity.
- Prenatal ultrasound can detect CDH, enabling specialized care planning.
- Improving outcomes necessitates standardized measurement of perinatal interventions.
Purpose of the Study:
- To develop a core outcome set (COS) for congenital diaphragmatic hernia (CDH).
- To standardize outcome measures for perinatal interventions in CDH.
- To enhance research quality, clinical practice, and patient care for CDH.
Main Methods:
- Systematic literature review to identify potential outcomes.
- Delphi method for stakeholder consensus on core outcomes.
- Modified Nominal Group Technique for final COS selection.
Main Results:
- A methodology for developing a CDH COS is described.
- The process involves international collaboration and consensus-building.
- The study is registered with PROSPERO and COMET.
Conclusions:
- A procedure to develop a COS for CDH research has been initiated.
- The COS aims to improve research quality and guide clinical practice.
- Standardized outcomes will benefit future clinical trials and guidelines.
