数字化知情同意在减重手术中的应用：一项随机对照试验。

Digital approach to informed consent in bariatric surgery: a randomized controlled trial.

机构信息

Department of Surgery, Queen's University, Kingston, Canada.

Division of General Surgery, Kingston Health Sciences Centre, 76 Stuart Street, Burr 2, Kingston, ON, K7L 2V7, Canada.

出版信息

Surg Endosc. 2022 Jan;36(1):809-816. doi: 10.1007/s00464-020-08277-x. Epub 2021 Jan 27.

DOI:10.1007/s00464-020-08277-x

PMID:33502615

Abstract

BACKGROUND

Informed consent is of paramount importance in surgery. Digital media can be used to enhance patient's comprehension of the proposed operation. The objective of this study was to examine the effects of adding a digital educational platform (DEP) to a standard verbal consent (SVC) for a laparoscopic Roux-en-Y gastric bypass (LRYGB) on patient's knowledge of the procedure, satisfaction with the clinical encounter and duration of the consent appointment.

METHODS

This prospective non-blinded randomized controlled trial allocated 51 patients, who were candidates for a LRYGB, into DEP+SVC (intervention, n = 26) or SVC (control, n = 25) groups. Data were collected at one Bariatric Centre of Excellence (Ontario, Canada) between December 2018 and December 2019. DEP consisted of a 29-slide video-supplemented module detailing the risks, benefits, expectations and outcomes for the LRYGB. Primary outcome was knowledge about the LRYGB operation following the consent discussion. Secondary outcomes were knowledge retention, patient satisfaction, and duration of time required to obtain an informed consent.

RESULTS

Baseline demographic data were equivalent between groups except for a greater proportion of male patients in the DEP+SVC group (7/19 vs 0/25; p < 0.01). Baseline procedure-specific knowledge was equivalent between the groups (72.3 ± 11.3% vs 74.7 ± 9.6%; p = 0.41). Post-consent knowledge was significantly higher in the DEP + SVC vs SVC group (85.0 ± 8.8% vs 78.7 ± 8.7%; p = 0.01; ES = 0.72). The duration of time to obtain informed consent was significantly shorter for the DEP + SVC vs SVC group (358 ± 198 sec vs 751 ± 212 sec; p < 0.01; ES = 1.92). There was no difference in knowledge retention at 4-6 weeks (84.4 ± 10.2% vs 82.9 ± 6.8%; p = 0.55) and in patient satisfaction (31.5 ± 1.1 vs 31 ± 2.7; p = 0.10).

CONCLUSION

The addition of a DEP online module to a standard verbal consent for LRYGB resulted in improved patient's understanding of the procedure-specific risks and benefits, high patient satisfaction, and over 50% time savings for the bariatric surgeon conducting the consent discussion.

摘要

背景

知情同意在外科手术中至关重要。数字媒体可用于增强患者对拟议手术的理解。本研究的目的是检查在腹腔镜 Roux-en-Y 胃旁路术（LRYGB）中，在标准口头同意（SVC）基础上增加数字教育平台（DEP）对患者对手术程序的了解、对临床就诊的满意度以及同意预约时间的影响。

方法

这项前瞻性非盲随机对照试验将 51 名候选 LRYGB 的患者分为 DEP+SVC（干预组，n=26）或 SVC（对照组，n=25）组。数据于 2018 年 12 月至 2019 年 12 月在加拿大安大略省的一个减重卓越中心收集。DEP 包括一个 29 页幻灯片的视频补充模块，详细介绍了 LRYGB 的风险、益处、期望和结果。主要结局是知情同意讨论后对 LRYGB 手术的了解。次要结局是知识保留、患者满意度和获得知情同意所需的时间。

结果

两组的基线人口统计学数据相当，除了干预组中男性患者的比例更高（7/19 比 0/25；p<0.01）。两组的基线特定手术知识相当（72.3±11.3%比 74.7±9.6%；p=0.41）。知情同意后，干预组的知识明显高于对照组（85.0±8.8%比 78.7±8.7%；p=0.01；ES=0.72）。干预组获得知情同意的时间明显短于对照组（358±198 秒比 751±212 秒；p<0.01；ES=1.92）。4-6 周时的知识保留率无差异（84.4±10.2%比 82.9±6.8%；p=0.55），患者满意度也无差异（31.5±1.1 比 31±2.7；p=0.10）。