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Development of a gastroschisis core outcome set
Benjamin Saul Raywood Allin1, Nigel J Hall2, Andrew R Ross3
1National Perinatal Epidemiology Unit, University of Oxford, Oxford, UK.
Archives of Disease in Childhood. Fetal and Neonatal Edition
|March 16, 2018
Summary
A new core outcome set (COS) for gastroschisis was developed to standardize research. This set includes eight critical outcomes, aiming to help identify the best treatments for infants with gastroschisis.
Area of Science:
- Pediatric Surgery
- Neonatology
- Clinical Trial Methodology
Background:
- Gastroschisis treatment research is hindered by inconsistent outcome reporting.
- Core Outcome Sets (COSs) standardize outcome measurement in clinical studies.
- A gastroschisis-specific COS is needed to improve research relevance and comparability.
Purpose of the Study:
- To develop a consensus-based Core Outcome Set (COS) for gastroschisis.
- To establish a standardized set of outcomes for research in gastroschisis.
Main Methods:
- Systematic reviews and stakeholder nomination identified candidate outcomes.
- A three-phase online Delphi process with 71 participants prioritized outcomes.
- A consensus meeting finalized the COS using a 9-point Likert scale.
Main Results:
- Eighty-seven outcomes were assessed during the Delphi process.
- Eight outcomes met the consensus criteria for inclusion in the COS.
- Included outcomes: mortality, sepsis, growth, operations, GI complications, parenteral nutrition duration, liver disease, and quality of life.
Conclusions:
- A gastroschisis COS comprising eight key outcomes was successfully developed.
- Implementing this COS will enhance the ability to identify optimal treatments for gastroschisis.
- Standardized reporting will improve research quality and patient-centered care in gastroschisis management.
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