The effectiveness of handout assisted versus verbal consent on post-operative recall and understanding-A randomized control study

Background: 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. Methods: 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. Results: 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). Conclusion: 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. Trial registration: MREC No.:201783-5468. (c) 2021 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

Automated summary

This study aimed to assess the effectiveness of handouts in improving postoperative consent understanding and recall compared to standard verbal consent. The results showed no significant difference in understanding between the two groups, but there was a significant decline in recall of specific consent items over time in both groups. Handouts may have increased patient satisfaction, but did not improve recall.