期刊
PEDIATRICS
卷 127, 期 5, 页码 917-924出版社
AMER ACAD PEDIATRICS
DOI: 10.1542/peds.2010-3283
关键词
multimedia consent; multimedia assent; consent comprehension; assent comprehension; study-specific research information; regulatory research information; learning objectives
类别
资金
- National Institutes of Health (NIH)
- Children's Hospital Research Institute
- NIH/NCRR Colorado [UL1RR025780]
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
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据