Background and Aim: 

Informed consent for endoscopy is variable across institutions and remains understudied in gastrointestinal endoscopy. This study aims to standardize informed consent for screening and diagnostic colonoscopies with a supplemental video tool that includes the key components of informed consent.

Methods: 

A video tool was developed that incorporated the key components of informed consent for colonoscopy. In addition, a 7-question survey was developed to query patients on core aspects of informed consent and satisfaction with the informed consent process. Patients undergoing elective outpatient colonoscopy with conscious sedation were randomized to traditional consent or consent with the addition of a video tool. A pilot study determined the sample size. Traditional consent was standard of practice before the procedure. Patients in the video tool group watched the video tool in the preprocedure area followed by traditional consent. Both groups had the opportunity to address questions with the attending physician before the procedure. All patients were contacted 1 to 2 days following the colonoscopy to answer the question survey.

Results: 

A total of 110 patients were eligible for participation, and 91 were included in the final data analysis. Subjects in the video tool group demonstrated significantly higher recall of key aspects of informed consent and higher satisfaction with the informed consent process versus the traditional consent group. The history of prior colonoscopy was similar between both groups. Mean endoscopy operation metrics were not negatively impacted by the inclusion of the video tool.

Conclusion: 

Patients undergoing screening and diagnostic colonoscopies who received informed consent supplemented by a video tool had a higher recall of core aspects of informed consent and higher satisfaction with the process, with no impact on procedural times.

中文翻译：

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结肠镜检查视频同意可提高知识保留率和患者满意度：一项随机对照研究

背景和目标： 

内窥镜检查的知情同意因机构而异，并且胃肠道内窥镜检查的研究仍然不足。本研究旨在通过包含知情同意的关键组成部分的补充视频工具来标准化筛查和诊断结肠镜检查的知情同意。

方法： 

开发了一种视频工具，其中包含结肠镜检查知情同意的关键组成部分。此外，还制定了一项包含 7 个问题的调查，以询问患者知情同意的核心方面以及对知情同意流程的满意度。接受清醒镇静的选择性门诊结肠镜检查的患者被随机分为传统同意或添加视频工具的同意。一项试点研究确定了样本量。传统的同意是手术前的实践标准。视频工具组的患者在术前区域观看视频工具，然后获得传统同意。两组都有机会在手术前向主治医生提出问题。结肠镜检查后 1 至 2 天联系所有患者回答问题调查。

结果： 

共有 110 名患者符合参与资格，91 名患者进入最终数据分析。与传统同意组相比，视频工具组的受试者对知情同意的关键方面的回忆明显更高，并且对知情同意过程的满意度更高。两组之前的结肠镜检查史相似。平均内窥镜操作指标并未因视频工具的加入而受到负面影响。

结论： 

接受筛查和诊断性结肠镜检查并获得辅以视频工具的知情同意的患者对知情同意的核心方面有更高的回忆，对过程的满意度也更高，且对手术时间没有影响。