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教育性知情同意视频等同于鼻科学手术的标准口头同意:一项随机对照试验。

Educational Informed Consent Video Equivalent to Standard Verbal Consent for Rhinologic Surgery: A Randomized Controlled Trial.

机构信息

Department of Otolaryngology-Head and Neck Surgery, University of Kansas, Medical Center, Kansas City, Kansas.

School of Medicine, University of Kansas, Kansas City, Kansas.

出版信息

Am J Rhinol Allergy. 2021 Nov;35(6):739-745. doi: 10.1177/1945892421992659. Epub 2021 Feb 2.

Abstract

BACKGROUND

Informed consent is an integral part of pre-operative counseling. However, information discussed can be variable. Recent studies have explored the use of multimedia in providing informed consent for rhinologic surgery.

OBJECTIVE

To measure impact of an educational video (Video) compared to verbal informed consent (Verbal) on knowledge gained, alleviation of concerns, and efficiency.

METHODS

Patients undergoing endoscopic sinus surgery (ESS), septoplasty, or ESS+septoplasty were prospectively enrolled and randomized to receive Video or Verbal consent. The Video group watched an educational video; the Verbal group received standard verbal consent from an Otolaryngology resident per institutional protocol. Both groups had the opportunity to discuss questions or concerns with their attending surgeon. Prior to, and after, consent was signed, both groups completed surveys regarding knowledge of purpose, risks, and benefits of surgery as well as surgical concerns. Decision regret and patient satisfaction were also assessed post-operatively.

RESULTS

77 patients were enrolled (39 Video, 38 Verbal). Demographics were not significantly different between groups. Overall knowledge significantly improved (p < 0.005) and concerns significantly decreased (p < 0.001) following consent in both groups. Improvements in these metrics were equivalent between groups (p < 0.02). Furthermore, resident time to complete consent, patient satisfaction, and decision regret were not significantly different between groups.

CONCLUSION

Use of an educational video was equivalent to standard verbal informed consent for patients undergoing rhinologic surgery. Otolaryngologists can consider developing procedure-specific videos to allow allocation of time to other tasks, standardized education of patients, and streamlining of the informed consent process.

摘要

背景

知情同意是术前咨询的一个组成部分。然而,讨论的信息可能会有所不同。最近的研究探讨了多媒体在提供鼻科学手术知情同意方面的应用。

目的

测量教育视频(Video)与口头知情同意(Verbal)相比对获得的知识、减轻的担忧和效率的影响。

方法

前瞻性招募接受内镜鼻窦手术(ESS)、鼻中隔成形术或 ESS+鼻中隔成形术的患者,并随机分配至接受 Video 或 Verbal 同意。Video 组观看教育视频;Verbal 组按照机构协议由耳鼻喉科住院医师提供标准口头同意。两组均有机会与主治外科医生讨论问题或担忧。在签署同意书之前和之后,两组都完成了关于手术目的、风险和收益以及手术关注点的知识、决策后悔和患者满意度的调查。

结果

共纳入 77 例患者(39 例 Video,38 例 Verbal)。两组患者的人口统计学特征无显著差异。两组患者在签署同意书后,总体知识显著提高(p<0.005),担忧显著减轻(p<0.001)。这些指标的改善在两组之间是等效的(p<0.02)。此外,住院医师完成同意的时间、患者满意度和决策后悔在两组之间无显著差异。

结论

在接受鼻科学手术的患者中,使用教育视频与标准口头知情同意等效。耳鼻喉科医生可以考虑制作特定手术的视频,以便将时间分配到其他任务、标准化患者教育和简化知情同意过程。

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