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).

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

Bibliographical note

Funding Information:
This work is supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD071915). The Pediatric Emergency Care Applied Research Network is supported by the Health Resources and Services Administration, Maternal and Child Health Bureau, Emergency Medical Services for Children Program through the following cooperative agreements: U03MC00001, U03MC00003, U03MC00006, U03MC00007, U03MC00008, U03MC22684, and U03MC22685. S.B.F. is supported by the Alberta Children’s Hospital Foundation Professorship in Child Health and Wellness. P.I.T. is supported by the Washington University Digestive Diseases Research Core Center (P30DK052574).

Publisher Copyright:
Copyright © 2020.

Keywords

  • Acute gastrointestinal infections
  • Compliance
  • Study participants

PubMed: MeSH publication types

  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial

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