Noncompliance in clinical trials has an impact on safety and effectiveness assessments. Nonadherence predictors in paediatric acute illness studies are unclear. In a multicenter randomised study of 971 children with acute gastroenteritis receiving a 5-day oral course of Lactobacillus rhamnosus GG or placebo, researchers wanted to investigate factors of nonadherence. Adherence, defined as taking all of the product’s dosages, was reported by the parents and documented during daily follow-up visits. 766 (81.2 percent) of the 943 patients with follow-up data were adherent.
In a multivariate analysis, older age, longer vomiting duration, a higher dehydration score, and hospitalisation after ED release were all linked with nonadherence; however, individuals with the highest severity levels were more likely to adhere. These findings may help to shape methods and particular objectives for maximising adherence in future paediatric studies.