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.

Influence of Percutaneous Endoscopic Gastrostomy on Gastroesophageal Reflux Disease in Children.

OBJECTIVE: To determine if gastroesophageal reflux disease (GERD) is present at long-term follow-up after percutaneous endoscopic gastrostomy (PEG), and to identify factors associated with the occurrence or aggravation of GERD after PEG placement. STUDY DESIGN: This prospective, observational study was conducted in our single tertiary center over a 13-year period (gastrostomy performed from 1990 to 2003 and follow-up to 2015). Every child who underwent PEG in our center (N = 368) from 1990 to 2003 was eligible. GERD was defined by clinical manifestations requiring antisecretory or prokinetic treatment, occurrence of a GERD-related complication, or the need for antireflux surgery. Outcomes among patients without antireflux surgery were also assessed. Multivariate analysis was used to identify factors aggravating GERD after PEG placement. RESULTS: A total 326 patients (89%; 56% with a neurologic impairment) were studied with a median follow-up after 3.5 years (range, 2.0-13.5 years). After PEG placement, GERD appeared in 11% of patients and was aggravated in 25% of patients with preexisting GERD. Factors associated with GERD worsening after PEG placement were neurologic impairment and preexisting GERD. Only 53 patients (16%) required antireflux surgery, among whom 22 required surgery in the year after PEG. Neurologic impairment was the only factor significantly associated with the need for antireflux surgery. CONCLUSIONS: GERD predominantly remains clinically controlled after PEG placement. Routine antireflux surgery at the time of PEG placement is not justified.

Long-term outcome of children receiving percutaneous endoscopic gastrostomy feeding.

OBJECTIVES: The aim of the present study was to analyze the long-term follow-up of children receiving percutaneous endoscopic gastrostomy (PEG) in terms of survival, nutritional outcome, and weaning from enteral nutrition. The secondary objectives were to evaluate the complications related to PEG and the outcome of patients with neurological disability. METHODS: The present study was a single-center retrospective study including all of the 368 patients who underwent PEG from 1990 to 2003 in our tertiary hospital. RESULTS: A total of 368 patients received PEG during the study period. After a median follow-up of 2.4 years (interquartile range 1.4-4.2 years), PEG was in place in 36% and was removed in 27%; 26% of patients were deceased. Two deaths could be directly related to PEG. A statistically significant weight and height catch-up was observed in patients with PEG in place in whom weight/age z score increased from -2.6 to -1.7 (P < 0.01) and height/age z score also increased from -2.1 to -1.6 (P < 0.01). In patients who had their PEG removed weight/age z score increased from -2.5 to -1.6 (P < 0.01) and height/age z score from -2.8 to -1.4 (P = 0.01) at the time of weaning. Early complications occurred in 152 patients, whereas late complications occurred in 191 patients. Most complications were minor (85%). After multivariate analyses, the factors associated with late complications were digestive and ear, nose, and throat (ENT) diseases, age <1 year at the time of PEG placement, and use of PEG longer than 2 years. Early complications were less frequent in patients with respiratory diseases. CONCLUSIONS: PEG allows nutritional and growth catch-up and is safe in the long term.