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)

doi:10.1097/MPG.0000000000002904

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)

Pediatrics

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

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 language	English (US)
Pages (from-to)	24-28
Number of pages	5
Journal	Journal of pediatric gastroenterology and nutrition
Volume	72
Issue number	1
DOIs	https://doi.org/10.1097/MPG.0000000000002904
State	Published - 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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10.1097/MPG.0000000000002904

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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).
In: Journal of pediatric gastroenterology and nutrition, Vol. 72, No. 1, 01.2021, p. 24-28.

Research output: Contribution to journal › Article › peer-review

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

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).",

keywords = "Acute gastrointestinal infections, Compliance, Study participants",

author = "{Pediatric Emergency Care Applied Research Network (PECARN)} and David Schnadower and Roskind, {Cindy G.} and Vanburen, {John M.} and Powell, {Elizabeth C.} and Norris, {Jesse G.} and Tarr, {Phillip I.} and Sapien, {Robert E.} and O'Connell, {Karen J.} and Chun, {Thomas H.} and Rogers, {Alexander J.} and Bhatt, {Seema R.} and Prashant Mahajan and Gorelick, {Marc H.} and Cheryl Vance and Dean, {J. Michael} and Freedman, {Stephen B.}",

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{\textquoteright}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 {\textcopyright} 2020.",

year = "2021",

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AU - Sapien, Robert E.

AU - O'Connell, Karen J.

AU - Chun, Thomas H.

AU - Rogers, Alexander J.

AU - Bhatt, Seema R.

AU - Mahajan, Prashant

AU - Gorelick, Marc H.

AU - Vance, Cheryl

AU - Dean, J. Michael

AU - Freedman, Stephen B.

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N2 - 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).

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KW - Study participants

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

Abstract

Bibliographical note

Keywords

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