Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center and Department of Pediatrics University of Cincinnati College of Medicine, Cincinnati OH.
Department of Emergency Medicine, Columbia University College of Physicians & Surgeons, New York, NY.
J Pediatr Gastroenterol Nutr. 2021 Jan 1;72(1):24-28. doi: 10.1097/MPG.0000000000002904.
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.
临床试验中的不依从会影响安全性和疗效的确定。儿科急性疾病试验中不依从的预测因素尚不清楚。我们旨在研究一项多中心随机试验中的 971 例急性肠胃炎患儿的不依从预测因素，这些患儿接受为期 5 天的口服鼠李糖乳杆菌 GG 或安慰剂治疗。依从性由父母报告，并在每日随访接触时记录。在有随访数据的 943 名患者中，766 名（81.2%）是依从的。多变量分析显示，年龄较大（比值比 1.19；95%可信区间：1.00-1.43）、呕吐持续时间增加（比值比 1.23；95%可信区间：1.05-1.45）、脱水评分较高（比值比 1.23，95%可信区间：1.07-1.42）和 ED 出院后住院（比值比 4.16，95%可信区间：1.21-14.30）是与不依从相关的因素；然而，那些病情最严重的患者更有可能依从（比值比 0.87，95%可信区间：0.80-0.95）。这些数据可能为未来儿科试验中的依从性最大化提供策略和具体目标。
