Spencer Sandra P, Stoner Michael J, Kelleher Kelly, Cohen Daniel M
From the *Section of Emergency Medicine, and †Center for Innovative Pediatric Practice, The Research Institute, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH.
Pediatr Emerg Care. 2015 Aug;31(8):572-6. doi: 10.1097/PEC.0000000000000513.
Informed consent is an ethical process for ensuring patient autonomy. Multimedia presentations (MMPs) often aid the informed consent process for research studies. Thus, it follows that MMPs would improve informed consent in clinical settings.
The aim of this study was to determine if an MMP for the informed consent process for ketamine sedation improves parental satisfaction and comprehension as compared with standard practice.
This 2-phase study compared 2 methods of informed consent for ketamine sedation of pediatric patients. Phase 1 was a randomized, prospective study that compared the standard verbal consent to an MMP. Phase 2 implemented the MMP into daily work flow to validate the previous year's results. Parents completed a survey evaluating their satisfaction of the informed consent process and assessing their knowledge of ketamine sedation. Primary outcome measures were parental overall satisfaction with the informed consent process and knowledge of ketamine sedation.
One hundred eighty-four families from a free-standing, urban, tertiary pediatric emergency department with over 85,000 annual visits were enrolled. Different demographics were not associated with a preference for the MMP or improved scores on the content quiz. Intervention families were more likely "to feel involved in the decision to use ketamine" and to understand that "they had the right to refuse the ketamine" as compared with control families. The intervention group scored significantly higher overall on the content section than the control group. Implementation and intervention families responded similarly to all survey sections.
Multimedia presentation improves parental understanding of ketamine sedation, whereas parental satisfaction with the informed consent process remains unchanged. Use of MMP in the emergency department for informed consent shows potential for both patients and providers.
知情同意是确保患者自主性的伦理过程。多媒体演示(MMPs)通常有助于研究的知情同意过程。因此,可以推断MMPs会改善临床环境中的知情同意情况。
本研究的目的是确定与标准做法相比,用于氯胺酮镇静知情同意过程的MMP是否能提高家长的满意度和理解度。
这项两阶段研究比较了小儿患者氯胺酮镇静知情同意的两种方法。第一阶段是一项随机前瞻性研究,比较了标准口头同意与MMP。第二阶段将MMP纳入日常工作流程以验证前一年的结果。家长完成了一项调查,评估他们对知情同意过程的满意度并评估他们对氯胺酮镇静的了解。主要结局指标是家长对知情同意过程的总体满意度和对氯胺酮镇静的了解。
来自一家独立的城市三级儿科急诊科的184个家庭参与了研究,该科室每年就诊人数超过85000人。不同的人口统计学特征与对MMP的偏好或内容测验得分的提高无关。与对照组家庭相比,干预组家庭更有可能“感到参与了使用氯胺酮的决定”,并理解“他们有权拒绝使用氯胺酮”。干预组在内容部分的总体得分显著高于对照组。实施组和干预组家庭对所有调查部分的回答相似。
多媒体演示提高了家长对氯胺酮镇静的理解,而家长对知情同意过程的满意度保持不变。在急诊科使用MMP进行知情同意对患者和提供者都显示出潜力。