Adcock Kim G, Hogan Shirley M, Elci Okan U, Mills Keri L
Department of Pharmacy Practice, University of Mississippi, Jackson, Mississippi ; Department of Pediatrics, University of Mississippi Medical Center, Jackson, Mississippi.
J Pediatr Pharmacol Ther. 2012 Jul;17(3):228-35. doi: 10.5863/1551-6776-17.3.228.
The purpose of this study was to assess children's comprehension of a new assent booklet, (K(id)S(ent)), which uses pictures and written information.
A randomized, crossover study evaluated the comprehension of assent documents by children, 7 to 11 years of age at a local elementary school. The two types of documents tested were the standard assent form and the K(id)S(ent) Assent Booklet. Participants were randomized as to which test document they received first by using a cluster randomization design. Participants read the document and then took a short quiz. The process was repeated for the other document on a separate day. Study participants were assigned a percentage score and a binary perfect score for each quiz. Mixed effects logistic and linear regression models with random intercepts were applied to the continuous percent quiz scores and binary perfect quiz scores, respectively.
A total of 190 participants completed the standard quiz, and 195 students completed the booklet quiz. A statistically significant difference in perfect quiz scores (p=0.004) and percent quiz scores (p≤0.001) between booklet and standard form was noted.
The quiz scores may indicate that the style of document is not the only factor influencing participant understanding.
本研究旨在评估儿童对一本新的同意书（K(id)S(ent)）的理解情况，该同意书使用了图片和书面信息。
一项随机交叉研究评估了当地一所小学7至11岁儿童对同意文件的理解。测试的两种文件类型为标准同意书和K(id)S(ent)同意手册。通过整群随机设计将参与者随机分配，决定他们首先收到哪种测试文件。参与者阅读文件后进行简短测验。在另一天对另一份文件重复该过程。为研究参与者的每次测验分配一个百分比分数和一个二元满分分数。分别对连续的百分比测验分数和二元满分测验分数应用具有随机截距的混合效应逻辑回归模型和线性回归模型。
共有190名参与者完成了标准测验，195名学生完成了手册测验。手册和标准表格在满分测验分数（p = 0.004）和百分比测验分数（p≤0.001）上存在统计学显著差异。
测验分数可能表明文件的形式并非影响参与者理解的唯一因素。
