Department of Surgery, Faculty of Medicine, University Malaya, Kuala Lumpur, Malaysia.
Department of Surgery, Faculty of Medicine, University Malaya, Kuala Lumpur, Malaysia; Department of General Surgery, Serdang Hospital, Kajang, Selangor, Malaysia.
Surgeon. 2022 Jun;20(3):169-176. doi: 10.1016/j.surge.2021.04.002. Epub 2021 May 8.
Consent is an important component of surgical care. Poorly attempted consent bears significant ethical and legal implications. We assessed the effectiveness of handouts in improving postoperative consent understanding and recall compared to standard verbal consent during laparoscopic cholecystectomy as a tool that may improve information retention and leads to better treatment satisfaction.
This is a prospective block randomized, non-blinded study conducted at a single tertiary hospital. Patients undergoing elective laparoscopic cholecystectomy between August 2017 and October 2018 were recruited and randomized into Handout Assisted Consent (HC) and Verbal Consent (VC) group. The HC group was given an adjunct handout on laparoscopic cholecystectomy during consent process in addition to the standard verbal consent. A validated open-ended verbal understanding and recall questionnaire was administered to all patients in both groups at Day 1, 30 and 90 after surgery. Patient satisfaction of the consent process was evaluated with Likert scale.
A total of 79 patients were enrolled, 41 patients and 38 patients in VC and HC groups respectively. Level of understanding among patients were equal and consistent across time in both groups (P > 0.05). There was significant decline (P < 0.0001) for both groups in ability to recall information between Day 1 to Day 30 and Day 30 to Day 90. A slightly higher satisfaction rate was found among patients that received HC (P > 0.05).
There is good consistent understanding of the surgery in both groups. However, recall of specific surgical consent items decreased significantly over time in both groups. Handouts may have increased satisfaction among patients but did not improve recall in this preliminary study.
MREC No.:201783-5468.
同意是外科护理的重要组成部分。尝试不佳的同意会带来重大的伦理和法律影响。我们评估了在腹腔镜胆囊切除术期间，与标准口头同意相比，使用手册作为一种可能提高信息保留并导致更好治疗满意度的工具，对手册辅助同意对改善术后同意理解和回忆的效果。
这是一项在一家三级医院进行的前瞻性、随机、非盲研究。2017 年 8 月至 2018 年 10 月期间招募了接受择期腹腔镜胆囊切除术的患者，并将其随机分为手册辅助同意（HC）和口头同意（VC）组。HC 组在同意过程中除了标准口头同意外，还提供腹腔镜胆囊切除术的附加手册。在手术后第 1、30 和 90 天，对两组患者均进行了一项经验证的开放式口头理解和回忆问卷。使用李克特量表评估患者对同意过程的满意度。
共纳入 79 例患者，VC 组和 HC 组分别有 41 例和 38 例患者。两组患者在各个时间点的理解水平均相等且一致（P>0.05）。两组患者在第 1 天到第 30 天和第 30 天到第 90 天之间的信息回忆能力均显著下降（P<0.0001）。接受 HC 的患者满意度略高（P>0.05）。
两组患者对手术的理解都很好且一致。然而，两组患者的特定手术同意项目的回忆在时间上都显著下降。手册可能提高了患者的满意度，但在这项初步研究中，并未提高回忆能力。
MREC 编号：201783-5468。
