Division of Orthodontics, College of Dentistry, Ohio State University, Columbus, OH 43218-2357, USA.
Am J Orthod Dentofacial Orthop. 2012 Feb;141(2):174-86. doi: 10.1016/j.ajodo.2011.06.043.
Comprehension of informed consent information has been problematic. The purposes of this study were to evaluate the effectiveness of a shortened explanation of an established consent method and whether customized slide shows improve the understanding of the risks and limitations of orthodontic treatment.
Slide shows for each of the 80 subject-parent pairs included the most common core elements, up to 4 patient-specific custom elements, and other general elements. Group A heard a presentation of the treatment plan and the informed consent. Group B did not hear the presentation of the informed consent. All subjects read the consent form, viewed the customized slide show, and completed an interview with structured questions, 2 literacy tests, and a questionnaire. The interviews were scored for the percentages of correct recall and comprehension responses. Three informed consent domains were examined: treatment, risk, and responsibility. These groups were compared with a previous study group, group C, which received the modified consent and the standard slide show.
No significant differences existed between groups A, B, and C for any sociodemographic variables. Children in group A scored significantly higher than did those in group B on risk recall and in group C on overall comprehension, risk recall and comprehension, and general risks and limitations questions. Children in group B scored significantly higher than did those in group C on overall comprehension, treatment recall, and risk recall. Elements presented first in the slide show scored better than those presented later.
This study suggested little advantage of a verbal review of the consent (except for patients for risk) when other means of review such as the customized slide show were included. Regression analysis suggested that patients understood best the elements presented first in the informed consent slide show. Consequently, the most important information should be presented first to patients, and any information provided beyond the first 7 points should be given as supplemental take-home material.
对知情同意信息的理解一直存在问题。本研究的目的是评估简化已确立的同意方法的解释以及定制幻灯片是否能提高对正畸治疗风险和局限性的理解。
为每对 80 名患者-家长制作的幻灯片包括最常见的核心要素，最多 4 个患者特定的定制要素以及其他一般要素。A 组听取了治疗计划和知情同意的介绍。B 组没有听取知情同意的介绍。所有受试者阅读同意书，观看定制幻灯片，并完成了带有结构化问题的访谈、2 项读写能力测试和一份问卷。访谈的分数为正确回忆和理解的百分比。检查了三个知情同意领域：治疗、风险和责任。将这些组与之前接受改良同意书和标准幻灯片的 C 组进行比较。
A、B 和 C 组在任何社会人口统计学变量方面均无显著差异。A 组的儿童在风险回忆方面的得分明显高于 B 组，在总体理解、风险回忆和理解以及一般风险和限制问题方面的得分明显高于 C 组。B 组的儿童在总体理解、治疗回忆和风险回忆方面的得分明显高于 C 组。幻灯片中首先呈现的要素的得分优于后来呈现的要素。
本研究表明，当包括其他审查方式（如定制幻灯片）时，口头审查同意书（除风险外）几乎没有优势。回归分析表明，患者对知情同意幻灯片中首先呈现的要素理解得最好。因此，应首先向患者呈现最重要的信息，任何超出前 7 点的信息都应作为补充的家庭作业材料提供。
