Department of Surgery, Queen's University, Kingston, Canada.
Division of General Surgery, Department of Surgery, Queen's University, Burr 2, 76 Stuart Street, Kingston, ON, K7L 2V7, Canada.
Surg Endosc. 2024 May;38(5):2593-2601. doi: 10.1007/s00464-024-10775-1. Epub 2024 Mar 18.
Informed consent is essential for any surgery. The use of digital education platforms (DEPs) can enhance patient understanding of the consent discussion and is a method to standardize the consent process in elective, ambulatory settings. The use of DEP as an adjunct to standard verbal consent (SVC) has not been studied in an acute care setting.
We conducted a prospective randomized control trial with patients presenting to the emergency department of a tertiary care hospital with acute biliary pathology requiring a laparoscopic cholecystectomy (LC) between August 2021 and April 2023. Participants were randomized 1:1 to receive either a DEP module with SVC or SVC alone. Baseline procedure-specific knowledge and self-reported understanding of risks and benefits of LC were collected using a questionnaire. Primary outcome was immediate post-intervention knowledge assessed using a 21-question multiple choice questionnaire. Secondary outcomes were delayed procedure-specific knowledge and participants' satisfaction with the consent discussion.
We recruited 79 participants and randomized them 1:1 into the intervention group (DEP + SVC, n = 40) and the control group (SVC, n = 39). Baseline demographics and baseline procedure-specific knowledge were similar between groups. The immediate post-intervention knowledge was significantly higher for participants in the intervention versus the control group with a Cohen's d effect size of 0.68 (85.2(10.6)% vs. 78.2(9.9)%; p = 0.004). Similarly, self-reported understanding of risks and benefits of LC was significantly greater for participants in the intervention versus the control group with a Cohen's effect size of 0.76 (68.5(16.4)% vs. 55.1(18.8)%; p = 0.001). For participants who completed the delayed post-intervention assessment (n = 29), there continued to be significantly higher retention of acquired knowledge in the intervention group with a Cohen's effect size of 0.61 (86.5(8.5)% vs. 79.8 (13.1)%; p = 0.024). There was no difference in participants' self-reported satisfaction with the consent discussion between groups (69.5(6.7)% vs. 67.2(7.7)%; p = 0.149).
The addition of digital education platform to standard verbal consent significantly improves patient's early and delayed understanding of risks and benefits of LC in an acute care setting.
知情同意是任何手术的必要条件。数字教育平台（DEP）的使用可以增强患者对同意讨论的理解，是规范择期门诊环境下同意过程的一种方法。在急症护理环境中，尚未研究将 DEP 作为标准口头同意（SVC）的辅助手段。
我们进行了一项前瞻性随机对照试验，纳入 2021 年 8 月至 2023 年 4 月期间因急性胆道疾病需行腹腔镜胆囊切除术（LC）而就诊于三级医院急诊科的患者。参与者按照 1:1 随机分配至接受 DEP 模块加 SVC 组或仅接受 SVC 组。使用问卷收集基线时特定于手术的知识以及对 LC 的风险和益处的自我报告理解。主要结局为使用 21 个多项选择题的即时干预后知识评估。次要结局为延迟的特定于手术的知识和参与者对同意讨论的满意度。
我们招募了 79 名参与者，并将他们按照 1:1 随机分配至干预组（DEP+SVC，n=40）和对照组（SVC，n=39）。两组的基线人口统计学和基线特定于手术的知识相似。干预组参与者的即时干预后知识明显高于对照组，Cohen's d 效应量为 0.68（85.2(10.6)% vs. 78.2(9.9)%; p=0.004）。同样，干预组参与者对 LC 的风险和益处的自我报告理解也明显大于对照组，Cohen's 效应量为 0.76（68.5(16.4)% vs. 55.1(18.8)%; p=0.001）。对于完成延迟干预后评估的参与者（n=29），干预组保留的获得知识仍然明显更高，Cohen's 效应量为 0.61（86.5(8.5)% vs. 79.8 (13.1)%; p=0.024）。两组参与者对同意讨论的自我报告满意度无差异（69.5(6.7)% vs. 67.2(7.7)%; p=0.149）。
在急症护理环境中，标准口头同意加数字教育平台可显著提高患者对 LC 风险和益处的早期和延迟理解。
