TY - JOUR
T1 - Factors associated with nonadherence in an emergency department-based multicenter randomized clinical trial of a probiotic in children with acute gastroenteritis
AU - Pediatric Emergency Care Applied Research Network (PECARN)
AU - Schnadower, David
AU - Roskind, Cindy G.
AU - Vanburen, John M.
AU - Powell, Elizabeth C.
AU - Norris, Jesse G.
AU - Tarr, Phillip I.
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.
N1 - 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.
PY - 2021/1
Y1 - 2021/1
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).
AB - 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).
KW - Acute gastrointestinal infections
KW - Compliance
KW - Study participants
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U2 - 10.1097/MPG.0000000000002904
DO - 10.1097/MPG.0000000000002904
M3 - Article
C2 - 32804911
AN - SCOPUS:85098674745
SN - 0277-2116
VL - 72
SP - 24
EP - 28
JO - Journal of Pediatric Gastroenterology and Nutrition
JF - Journal of Pediatric Gastroenterology and Nutrition
IS - 1
ER -