Lin Yen-Ko, Chen Chao-Wen, Lee Wei-Che, Cheng Yuan-Chia, Lin Tsung-Ying, Lin Chia-Ju, Shi Leiyu, Tien Yin-Chun, Kuo Liang-Chi
Division of Trauma and Surgical Critical Care, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Department of Medical Humanities and Education, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.
BMC Med Ethics. 2018 Mar 9;19(1):23. doi: 10.1186/s12910-018-0264-7.
We investigated whether, in the emergency department (ED), educational video-assisted informed consent is superior to the conventional consent process, to inform trauma patients undergoing surgery about the procedure, benefits, risks, alternatives, and postoperative care.
We conducted a prospective randomized controlled trial, with superiority study design. All trauma patients scheduled to receive trauma-related debridement surgery in the ED of Kaohsiung Medical University Hospital were included. Patients were assigned to one of two education protocols. Participants in the intervention group watched an educational video illustrating informed consent information, whereas those in the control group read an informed consent document. The primary outcome was knowledge scores and the secondary outcome was assessment of patient satisfaction. A multivariable regression model, with predefined covariates, was used to analyze differences in knowledge scores and patient satisfaction levels between the groups.
A total of 142 patients were enrolled, with 70 and 72 assigned to the intervention and control groups, respectively. Mean knowledge scores were higher in the intervention (72.57 ± 16.21 (SD)) than in the control (61.67 ± 18.39) group. By multivariate analysis, the intervention group had significantly greater differences in knowledge scores (coefficient: 7.646, 95% CI: 3.381-11.911). Age, injury severity score, and baseline knowledge score significantly affected the differences in knowledge scores. Significant improvements were observed in patients' perception of statements addressing comprehension of the information provided, helpfulness of the supplied information for decision making, and satisfaction with the informed consent process. Multivariate analysis showed significant correlations between video education and patient satisfaction.
Both the educational approach and severity of injury may have an impact on patient understanding during the informed consent process in an emergency environment. Video-assisted informed consent may improve the understanding of surgery and satisfaction with the informed consent process for trauma patients in the ED. Institutions should develop structured methods and other strategies to better inform trauma patients, facilitate treatment decisions, and improve patient satisfaction.
The ClinicalTrials.gov Identifier is NCT01338480 . The date of registration was April 18, 2011 (retrospectively registered).
我们研究了在急诊科（ED），教育视频辅助的知情同意是否优于传统的同意过程，以告知接受手术的创伤患者有关手术程序、益处、风险、替代方案和术后护理的信息。
我们进行了一项前瞻性随机对照试验，采用优效性研究设计。纳入所有计划在高雄医学大学医院急诊科接受与创伤相关清创手术的创伤患者。患者被分配到两种教育方案之一。干预组的参与者观看了一段说明知情同意信息的教育视频，而对照组的参与者阅读了一份知情同意文件。主要结局是知识得分，次要结局是患者满意度评估。使用具有预定义协变量的多变量回归模型来分析两组之间知识得分和患者满意度水平的差异。
总共招募了142名患者，分别有70名和72名被分配到干预组和对照组。干预组的平均知识得分（72.57±16.21（标准差））高于对照组（61.67±18.39）。通过多变量分析，干预组在知识得分上有显著更大的差异（系数：7.646，95%置信区间：3.381 - 11.911）。年龄、损伤严重程度评分和基线知识得分显著影响知识得分的差异。在患者对所提供信息的理解、所提供信息对决策的帮助以及对知情同意过程的满意度的陈述感知方面观察到显著改善。多变量分析显示视频教育与患者满意度之间存在显著相关性。
在紧急环境下的知情同意过程中，教育方式和损伤严重程度可能都会对患者的理解产生影响。视频辅助的知情同意可能会提高急诊科创伤患者对手术的理解以及对知情同意过程的满意度。机构应制定结构化方法和其他策略，以便更好地告知创伤患者，促进治疗决策，并提高患者满意度。
ClinicalTrials.gov标识符为NCT01338480。注册日期为2011年4月18日（追溯注册）。
