Educational Informed Consent Video Equivalent to Standard Verbal Consent for Rhinologic Surgery: A Randomized Controlled Trial

Abstract

Background Informed consent is an integral part of pre-operative counseling. However, information discussed can be variable. Recent studies have explored the use of multimedia in providing informed consent for rhinologic surgery. Objective To measure impact of an educational video (Video) compared to verbal informed consent (Verbal) on knowledge gained, alleviation of concerns, and efficiency. Methods Patients undergoing endoscopic sinus surgery (ESS), septoplasty, or ESS+septoplasty were prospectively enrolled and randomized to receive Video or Verbal consent. The Video group watched an educational video; the Verbal group received standard verbal consent from an Otolaryngology resident per institutional protocol. Both groups had the opportunity to discuss questions or concerns with their attending surgeon. Prior to, and after, consent was signed, both groups completed surveys regarding knowledge of purpose, risks, and benefits of surgery as well as surgical concerns. Decision regret and patient satisfaction were also assessed post-operatively. Results 77 patients were enrolled (39 Video, 38 Verbal). Demographics were not significantly different between groups. Overall knowledge significantly improved (p < 0.005) and concerns significantly decreased (p < 0.001) following consent in both groups. Improvements in these metrics were equivalent between groups (p < 0.02). Furthermore, resident time to complete consent, patient satisfaction, and decision regret were not significantly different between groups. Conclusion Use of an educational video was equivalent to standard verbal informed consent for patients undergoing rhinologic surgery. Otolaryngologists can consider developing procedure-specific videos to allow allocation of time to other tasks, standardized education of patients, and streamlining of the informed consent process.

Digital technology in informed consent for surgery: systematic review

“…A total of 3842 patients were included in studies. Comprehension was assessed in 38 studies 11 , 15 , 28–63 , satisfaction in 24 28 , 31 , 33–39 , 43–45 , 47 , 49 , 50 , 52 , 54–56 , 58 , 59 , 63–65 , anxiety in 16 studies 29 , 31–33 , 35 , 44 , 46 , 47 , 49 , 50 , 52 , 53 , 56 , 58–60 , 65 , and time taken face to face with the treating clinician in seven studies 34–36 , 52 , 57 , 60 . Thirty-nine studies specified that the trial setting was for elective surgery and only one study was carried out for an emergency procedure 37 .…”

“…Twenty-five studies reported results on digital consent with PPP ( Table S2 ). Video-only interventions were reported in 15 of 25 (60 per cent) studies 29 , 36 , 37 , 39 , 41 , 44 , 45 , 50 , 51 , 53 , 57 , 60 , 61 , 63 , 65 , non-interactive PowerPoint presentations with audio-visual content in 3 of 25 (12 per cent) studies 11 , 43 , 46 , and via a website in 2 of 25 (8 per cent) studies 47 , 49 . Five studies (20 per cent) had multicomponent interventions 30–32 , 35 , 54 and all five used video and written pamphlets in the intervention group ( Fig.…”

“…One study only reported ‘self-reported knowledge’ measured as good/average/poor 58 . Three studies did not report the format of the comprehension assessment 29 , 43 , 49 .…”

To Think Outside the Box Requires Stepping Outside of Your Comfort Zone

“…The results of the randomized, controlled study by Penn and co-workers is very interesting in showing that an educational informed consent video can be equivalent to a standard verbal consent. 23 However, such an application clearly would require careful thought about the content and delivery.…”

“…The results of the randomized, controlled study by Penn and co-workers is very interesting in showing that an educational informed consent video can be equivalent to a standard verbal consent. 23 However, such an application clearly would require careful thought about the content and delivery. If key details are omitted, the video consent method could end up being added to the list of common medical malpractice allegations such as those presented in the study by Coppess et al 24…”