D'Angio C T, Wang H, Hunn J E, Pryhuber G S, Chess P R, Lakshminrusimha S
Department of Pediatrics, University of Rochester Medical Center, Golisano Children's Hospital, Rochester, NY, USA.
Department of Biostatistics, University of Rochester, Rochester, NY, USA.
J Perinatol. 2017 Jun;37(6):735-739. doi: 10.1038/jp.2017.26. Epub 2017 Mar 30.
We hypothesized that, among parents of potential neonatal research subjects, an accompanying cover sheet added to the permission form (intervention) would increase understanding of the research, when compared to a standard form (control).
This pilot study enrolled parents approached for one of two index studies: one randomized trial and one observational study. A one-page cover sheet described critical study information. Families were randomized 1:1 to receive the cover sheet or not. Objective and subjective understanding and satisfaction were measured.
Thirty-two parents completed all measures (17 control, 15 intervention). There were no differences in comprehension score (16.8±5.7 vs 16.3±3.5), subjective understanding (median 6 vs 6.5), or overall satisfaction with consent (median 7 vs 6.5) between control and intervention groups (all P>0.50).
A simplified permission form cover sheet had no effect on parents' understanding of studies for which their newborns were being recruited.
我们假设，在潜在新生儿研究对象的父母中，与标准表格（对照）相比，添加到许可表格中的附带封面页（干预措施）会增强对研究的理解。
这项试点研究纳入了因两项索引研究之一而被接触的父母：一项随机试验和一项观察性研究。一页的封面页描述了关键的研究信息。家庭被1:1随机分配以接收或不接收封面页。测量了客观和主观理解及满意度。
32名父母完成了所有测量（17名对照，15名干预）。对照组和干预组之间在理解分数（16.8±5.7对16.3±3.5）、主观理解（中位数6对6.5）或对同意的总体满意度（中位数7对6.5）方面没有差异（所有P>0.50）。
简化的许可表格封面页对父母对其新生儿所参与研究的理解没有影响。
