Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina.
Escola Paulista de Medicina-Universidade Federal de São Paulo, Brazil.
Am J Perinatol. 2019 Jun;36(7):759-764. doi: 10.1055/s-0038-1675157. Epub 2018 Oct 31.
The main purpose of this article is to determine parental consent rates in neonatal drug trials and describe trial characteristics associated with higher rates.
We included neonatal drug trials published between 2009 and 2014 and compared parental consent rates among the following characteristics: phase type, gestational age, randomization type, drug administration route, drug dosing frequency, blood sampling, control type, length of study, funding source, and length of treatment. We compared characteristics using chi-square, Fisher's exact, one-way analysis of variance or Kruskal-Wallis tests.
We identified 52 trials: 38 trials (73%) reported data of parental consent. Median percentage (interquartile range) of parental consent was 79% (62, 89). Higher rates were observed in studies that used active comparators (87%) and shorter study lengths (81% for studies <24 hours).
Parental consent rates for neonatal drug trials varied by study characteristics. Information on proportion of parents consented is valuable to assess generalizability of trial results and for preparing trial protocols.
本文的主要目的是确定新生儿药物试验中的家长同意率，并描述与较高同意率相关的试验特征。
我们纳入了 2009 年至 2014 年期间发表的新生儿药物试验，并比较了以下特征中的家长同意率：试验阶段、胎龄、随机分组类型、药物给药途径、药物给药频率、采血、对照类型、研究长度、资金来源和治疗时间。我们使用卡方检验、Fisher 确切检验、单因素方差分析或 Kruskal-Wallis 检验比较特征。
我们共确定了 52 项试验：38 项试验（73%）报告了家长同意的数据。家长同意的中位数百分比（四分位间距）为 79%（62，89）。使用活性对照物（87%）和较短研究时间（<24 小时的研究为 81%）的研究中，家长同意率较高。
新生儿药物试验的家长同意率因研究特征而异。家长同意比例的信息对于评估试验结果的可推广性和制定试验方案非常有价值。
