Video or verbal? A randomised trial of the informed consent process prior to endoscopy.

Aim: Informed consent (IC) prior to endoscopy is often inconsistently and poorly performed. We compared use of video-assisted consent to standard verbal consent for enhancing patients' recollection of procedural risks, understanding and fulfilment of expectation.

Method: Two hundred patients attending for gastroscopy or colonoscopy were randomised to either video-assisted consent (n=100) or verbal consent (n=100). The primary outcomes measured via a questionnaire were the recollection of procedural risks (sum of all correct answers for risk recall items) and patient experience compared to information provided in the consent process. Secondary outcomes included reported patient understanding and staff satisfaction between groups.

Results: There was no difference between video or verbal groups in terms of risk recall scores (p=0.46), with less than half the patients able to recall more than two risks. There was a signal towards improved recall of bleeding as a potential risk in the video as compared to the verbal arm but it did not reach statistical significance (p=0.059). Patients' perceived understanding and fulfilment of expectation was high (>96%) in both groups. Seventy-one percent of the staff preferred using the video over the verbal IC.

Conclusion: Video-assisted consent made no significant difference to the IC process in terms of patient recollection or experience compared to usual verbal IC. Despite very poor recollection of procedural risks, patients in both the video and verbal groups reported understanding of the procedure and satisfaction with the IC process. Reasons for this mismatch are unclear. Further action to prioritise information delivery during IC is required. Future studies in this field should include patient-centred outcomes as a measure of success.