Department of Biology, Faculty of Science, University of Ottawa, Ottawa, ON, Canada.
Research Institute, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.
Pediatr Crit Care Med. 2020 Jun;21(6):526-534. doi: 10.1097/PCC.0000000000002234.
To describe legal guardians' understanding of key concepts in a research consent form presented within 24 hours of their child's admission to the PICU and to explore legal guardians' opinions of the format (language, length) of the consent form and the overall consent process.
Single-center, exploratory pilot study.
PICU at a tertiary-care hospital in Canada.
Forty-one English- and French-speaking legal guardians of children less than 18 years old, who had been admitted to the PICU within the past 24 hours and were expected to stay at least 48 hours, between October 2018 and February 2019.
The consent form from a previous PICU trial was given and explained to legal guardians within 24 hours of their child's admission to the PICU.
Legal guardians' understanding of key concepts in the consent form was evaluated using a questionnaire the day after the form was explained, and opinions were collected verbally and using an additional survey. The median number of questions answered incorrectly was three of seven (interquartile range = 2-4). Participants best understood the topic of the study (5% incorrect), but 80% of participants were unable to recall a single risk. The median rating of the language in the form was five of five (very easy to understand; interquartile range = 4-5), and 88% of participants said it was a reasonable length.
Despite positive opinions of the consent form, most legal guardians did not understand all key components of the consent information provided to them orally and in writing within 24 hours of their child's PICU admission. Future studies are required to determine barriers to understanding and explore alternative approaches to obtaining consent in this setting.
描述患儿被收入 PICU 后 24 小时内其法定监护人对研究知情同意书中关键概念的理解，并探讨法定监护人对知情同意书格式（语言、篇幅）和整个知情同意过程的看法。
单中心、探索性试点研究。
加拿大一家三级医院的 PICU。
2018 年 10 月至 2019 年 2 月期间，41 名母语为英语或法语、年龄在 18 岁以下、入院 24 小时内且预计至少住院 48 小时的患儿的法定监护人。
患儿被收入 PICU 后 24 小时内，将之前的 PICU 试验知情同意书交给法定监护人并进行解释。
在解释知情同意书的次日，通过问卷评估法定监护人对知情同意书中关键概念的理解程度，并通过口头和额外的调查收集意见。7 个问题中答错 3 个的人数为中位数（四分位间距=2-4）。参与者对研究主题（答错 5%）的理解最好，但 80%的参与者无法回忆出单个风险。对书面知情同意书中语言的评分中位数为 5 分（非常易懂；四分位间距=4-5），88%的参与者表示篇幅合理。
尽管对知情同意书的评价积极，但大多数法定监护人在患儿被收入 PICU 后 24 小时内，通过口头和书面形式获得的知情同意信息中，并未理解所有关键内容。需要进一步研究以确定理解障碍，并探讨在这种情况下获得同意的替代方法。
