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Development of a Core Outcome Set for Children Aged 1-18 Years with Gastroesophageal Reflux Disease
Robyn Rexwinkel1, Vera W A van Berge Henegouwen2, Maartje M J Singendonk1
1Department of Pediatric Gastroenterology, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.
Insights
A core outcome set for pediatric gastroesophageal reflux disease (GERD) was developed. This set includes 9 key outcomes to standardize clinical study assessments and improve GERD treatment in children.
Area of Science:
- Pediatric Gastroenterology
- Clinical Trial Methodology
- Outcome Measurement
Background:
- Gastroesophageal reflux disease (GERD) significantly impacts children's quality of life.
- Standardized outcome measures are lacking in pediatric GERD clinical studies.
- Consistent assessment is crucial for evaluating treatment efficacy and safety.
Purpose of the Study:
- To establish a consensus-based core outcome set for pediatric GERD clinical trials.
- To define essential outcomes for assessing GERD in children aged 1-18 years.
- To enhance comparability and reliability of research findings in pediatric GERD.
Main Methods:
- A 2-round Delphi technique involving healthcare professionals, parents, and children (aged 1-18 years).
- Adherence to Outcome Measures in Rheumatology (OMERACT) recommendations for outcome set development.
- Final consensus achieved through an expert panel meeting.
Main Results:
- Nine core outcomes were identified for pediatric GERD: adequate relief, evidence of esophagitis, feeding difficulties, heartburn, hematemesis, regurgitation, sleeping difficulties, vomiting, and adverse events.
- High participation rates (93-100%) across all participant groups in the Delphi rounds.
- The outcomes cover both symptom-based and objective measures relevant to pediatric GERD.
Conclusions:
- A comprehensive core outcome set of 9 outcomes has been established for pediatric GERD.
- This set provides a foundation for minimally required measurements in clinical studies.
- Implementation will facilitate study comparison and inform future GERD treatment guidelines for children.
Objective:
To develop a core outcome set for clinical studies assessing gastroesophageal reflux disease (GERD) in children.
Study Design:
This core outcome set was developed using a 2-round Delphi technique and adhering to the Outcome Measures in Rheumatology Initiative (OMERACT 2.0) recommendations. Healthcare professionals (HCPs) and (parents of) children (age 1-18 years) with a GERD diagnosis (ie, the presence of bothersome symptoms), listed up to 5 harmful and/or beneficial outcomes that they considered important in the treatment of GERD. Outcomes mentioned by more than 10% of participants were put forward and rated and prioritized by HCPs, parents, and children in a second round. Outcomes with the highest rank formed the draft core outcome set. The final core outcome set was created during an online consensus meeting between an expert panel.
Results:
The first round was completed by 118 of 125 HCPs (94%), 146 of 146 parents (100%), and 69 of 70 children (99%). A total of 80 of 118 HCPs (68%), 130 of 140 parents (93%), and 77 children (100%) completed round 2. "Adequate relief," "evidence of esophagitis," "feeding difficulties," "heartburn (≥4 years)," "hematemesis," "regurgitation," "sleeping difficulties," "vomiting," and "adverse events" were included in the final core outcome set for GERD in children aged 1-18 years.
Conclusions:
We identified a total set of 9 core outcomes and suggest these outcomes to be minimally measured in clinical studies assessing GERD in children. Implementation of this core outcome set is likely to increase comparison between studies and may thus provide future recommendations to improve treatment of GERD in children.
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