Novel Approach to Parental Permission and Child Assent for Research: Improving Comprehension
Novel Approach to Parental Permission and Child Assent for Research: Improving Comprehension
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DOI：
10.1542/peds.2010-3283
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发表时间：
2011-05-01
期刊：
影响因子：
8
通讯作者：
Forster-Harwood, Jeri E.
中科院分区：
文献类型：
--
作者：
O'Lonergan, Theresa A.;Forster-Harwood, Jeri E.
目的：本研究的目的是测试多媒体许可/同意（P/A）过程。总体假设是，儿童和他们的父母接触到一个多媒体P/A的过程中会有更好的理解相比，那些接触到一个基于文本的process.METHODS：传统和多媒体P/A的过程中创建了一个创新的学习目标的方法。共有194个亲子配对（11-14岁的儿童）参加了研究：24个配对在预研究中测试P/A组件的偏好和对理解的影响，170个配对在多媒体或纸张P/A过程的随机试验中进行假设性研究。参与者主要是白色，来自一个由三级护理儿科医院和门诊设施服务的大都市地区。对P/A过程的8个基本要素的理解进行了评估。结果：大多数研究前的受试者更喜欢双能X线片吸收测量描述的视频版本，而不是动画和纸质版本相结合（41/48 [85%]; P < .0001），腹部超声描述的结果相似（38/47 [81%]; P < .0001）。与纸质P/A过程相比，接触新过程的儿童表现出明显更好的整体理解（P = .0009），并且在理解研究程序（P = .0002）和风险（P < .0001）方面存在非常显著的差异。家长多媒体组有显着更好的整体理解（P = .03）。结论：多媒体的研究P/A过程的方法，可以提高整体的理解，研究参与儿童和家长。提高对研究特定研究组成部分（而不是研究权利）的理解可能会提高整体理解。儿科2011; 127：917-924
OBJECTIVE: The aim of this research was to test a multimedia permission/assent (P/A) process. The overall hypothesis was that children and their parents exposed to a multimedia P/A process would have better comprehension compared with those exposed to a text-based process.METHODS: Traditional and multimedia P/A processes were created by using an innovative learning-objective approach. A total of 194 parent-child dyads (children aged 11-14 years) were enrolled: 24 dyads in a prestudy testing P/A components for preference and effect on comprehension and 170 dyads in a randomized trial of a multimedia or paper P/A process for a hypothetical study. Participants were predominantly white and were from a metropolitan area served by a tertiary care pediatric hospital and outpatient facility. Comprehension of 8 essential elements of the P/A process was assessed.RESULTS: The majority of prestudy subjects preferred the video version of the dual-energy radiograph absorptiometry description over the animated and paper versions combined (41 of 48 [85%]; P < .0001), and there were similar results for the abdominal ultrasound description (38 of 47 [81%]; P < .0001). Children exposed to the novel process showed significantly better overall comprehension compared with the paper P/A process (P = .0009), and there were highly significant differences in understanding of study procedures (P = .0002) and risks (P < .0001). The parental multimedia group had significantly better overall comprehension (P = .03).CONCLUSIONS: Multimedia approaches to the research P/A process may improve overall understanding of research participation for children and parents. Improved understanding of study-specific research components (rather than research rights) may improve overall comprehension. Pediatrics 2011; 127: 917-924