Factors associated with nonadherence in an emergency department-based multicenter randomized clinical trial of a probiotic in children with acute gastroenteritis

Pediatric Emergency Care Applied Research Network (PECARN)

Research output: Contribution to journalArticlepeer-review

Abstract

Nonadherence in clinical trials affects safety and efficacy determinations. Predictors of nonadherence in pediatric acute illness trials are unknown. We sought to examine predictors of nonadherence in a multicenter randomized trial of 971 children with acute gastroenteritis receiving a 5-day oral course of Lactobacillus rhamnosus GG or placebo. Adherence, defined as consuming all doses of the product, was reported by the parents and recorded during daily follow-up contacts. Of 943 patients with follow-up data, 766 (81.2%) were adherent. On multivariate analysis, older age (OR 1.19; 95% CI: 1.00-1.43), increased vomiting duration (OR 1.23; 95% CI: 1.05-1.45), higher dehydration score (OR 1.23, 95% CI: 1.07-1.42), and hospitalization following ED discharge (OR 4.16, 95% CI: 1.21-14.30) were factors associated with nonadherence; however, those with highest severity scores were more likely to adhere (OR 0.87, 95% CI: 0.80-0.95). These data may inform strategies and specific targets to maximize adherence in future pediatric trials

Original languageEnglish (US)
Pages (from-to)24-28
Number of pages5
JournalJournal of pediatric gastroenterology and nutrition
Volume72
Issue number1
DOIs
StatePublished - Jan 2021

Keywords

  • Acute gastrointestinal infections
  • Compliance
  • Study participants

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Gastroenterology

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