Generalizability of the Necrotizing Enterocolitis Surgery Trial to the Target Population of Eligible Infants.

OBJECTIVE: The objective of this study was to evaluate whether infants randomized in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network Necrotizing Enterocolitis Surgery Trial differed from eligible infants and whether differences affected the generalizability of trial results. STUDY DESIGN: Secondary analysis of infants enrolled in Necrotizing Enterocolitis Surgery Trial (born 2010-2017, with follow-up through 2019) at 20 US academic medical centers and an observational data set of eligible infants through 2013. Infants born ≤1000 g and diagnosed with necrotizing enterocolitis or spontaneous intestinal perforation requiring surgical intervention at ≤8 weeks were eligible. The target population included trial-eligible infants (randomized and nonrandomized) born during the first half of the study with available detailed preoperative data. Using model-based weighting methods, we estimated the effect of initial laparotomy vs peritoneal drain had the target population been randomized. RESULTS: The trial included 308 randomized infants. The target population included 382 (156 randomized and 226 eligible, non-randomized) infants. Compared with the target population, fewer randomized infants had necrotizing enterocolitis (31% vs 47%) or died before discharge (27% vs 41%). However, incidence of the primary composite outcome, death or neurodevelopmental impairment, was similar (69% vs 72%). Effect estimates for initial laparotomy vs drain weighted to the target population were largely unchanged from the original trial after accounting for preoperative diagnosis of necrotizing enterocolitis (adjusted relative risk [95% CI]: 0.85 [0.71-1.03] in target population vs 0.81 [0.64-1.04] in trial) or spontaneous intestinal perforation (1.02 [0.79-1.30] vs 1.11 [0.95-1.31]). CONCLUSION: Despite differences between randomized and eligible infants, estimated treatment effects in the trial and target population were similar, supporting the generalizability of trial results. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT01029353.

Emergency Department Visits and Readmissions among Children after Gastrostomy Tube Placement.

OBJECTIVES: To define the incidence of 30-day postdischarge emergency department (ED) visits and hospital readmissions following pediatric gastrostomy tube (GT) placement across all procedural services (Surgery, Interventional-Radiology, Gastroenterology) in 38 freestanding Children's Hospitals. STUDY DESIGN: This retrospective cohort study evaluated patients <18 years of age discharged between 2010 and 2012 after GT placement. Factors significantly associated with ED revisits and hospital readmissions within 30 days of hospital discharge were identified using multivariable logistic regression. A subgroup analysis was performed comparing patients having the GT placed on the date of admission or later in the hospital course. RESULTS: Of 15 642 identified patients, 8.6% had an ED visit within 30 days of hospital discharge, and 3.9% were readmitted through the ED with a GT-related issue. GT-related events associated with these visits included infection (27%), mechanical complication (22%), and replacement (19%). In multivariable analysis, Hispanic ethnicity, non-Hispanic black race, and the presence of ≥3 chronic conditions were independently associated with ED revisits; gastroesophageal reflux and not having a concomitant fundoplication at time of GT placement were independently associated with hospital readmission. Timing of GT placement (scheduled vs late) was not associated with either ED revisits or hospital readmission. CONCLUSIONS: GT placement is associated with high rates of ED revisits and hospital readmissions in the first 30 days after hospital discharge. The association of nonmodifiable risk factors such as race/ethnicity and medical complexity is an initial step toward understanding this population so that interventions can be developed to decrease these potentially preventable occurrences given their importance among accountable care organizations.