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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.
Insights
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.
Objective:
Outcome reporting heterogeneity impedes identification of gold standard treatments for children born with gastroschisis. Use of core outcome sets (COSs) in research reduces outcome reporting heterogeneity and ensures that studies are relevant to patients. The aim of this study was to develop a gastroschisis COS.
Design And Setting:
Systematic reviews and stakeholder nomination were used to identify candidate outcomes that were subsequently prioritised by key stakeholders in a three-phase online Delphi process and face-to-face consensus meeting using a 9-point Likert scale. In phases two and three of the Delphi process, participants were shown graphical and numerical representations of their own, and all panels scores for each outcome respectively and asked to review their previous score in light of this information. Outcomes were carried forward to the consensus meeting if prioritised by two or three stakeholder panels in the third phase of the Delphi process. The COS was formed from outcomes where ≥70% of consensus meeting participants scored the outcome 7-9 and <15% of participants scored it 1-3.
Results:
71 participants (84%) completed all phases of the Delphi process, during which 87 outcomes were assessed. Eight outcomes, mortality, sepsis, growth, number of operations, severe gastrointestinal complication, time on parenteral nutrition, liver disease and quality of life for the child, met criteria for inclusion in the COS.
Conclusions:
Eight outcomes have been included in the gastroschisis COS as a result of their importance to key stakeholders. Implementing use of the COS will increase the potential for identification of gold standard treatments for the management of children born with gastroschisis.
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