Development of a Core Outcome Set for Children Aged 1-18 Years with Gastroesophageal Reflux Disease

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