Digital approach to informed consent in bariatric surgery: a randomized controlled trial

Abstract

Background

Informed consent is of paramount importance in surgery. Digital media can be used to enhance patient’s comprehension of the proposed operation. The objective of this study was to examine the effects of adding a digital educational platform (DEP) to a standard verbal consent (SVC) for a laparoscopic Roux-en-Y gastric bypass (LRYGB) on patient’s knowledge of the procedure, satisfaction with the clinical encounter and duration of the consent appointment.

Methods

This prospective non-blinded randomized controlled trial allocated 51 patients, who were candidates for a LRYGB, into DEP+SVC (intervention, n = 26) or SVC (control, n = 25) groups. Data were collected at one Bariatric Centre of Excellence (Ontario, Canada) between December 2018 and December 2019. DEP consisted of a 29-slide video-supplemented module detailing the risks, benefits, expectations and outcomes for the LRYGB. Primary outcome was knowledge about the LRYGB operation following the consent discussion. Secondary outcomes were knowledge retention, patient satisfaction, and duration of time required to obtain an informed consent.

Results

Baseline demographic data were equivalent between groups except for a greater proportion of male patients in the DEP+SVC group (7/19 vs 0/25; p < 0.01). Baseline procedure-specific knowledge was equivalent between the groups (72.3 ± 11.3% vs 74.7 ± 9.6%; p = 0.41). Post-consent knowledge was significantly higher in the DEP + SVC vs SVC group (85.0 ± 8.8% vs 78.7 ± 8.7%; p = 0.01; ES = 0.72). The duration of time to obtain informed consent was significantly shorter for the DEP + SVC vs SVC group (358 ± 198 sec vs 751 ± 212 sec; p < 0.01; ES = 1.92). There was no difference in knowledge retention at 4–6 weeks (84.4 ± 10.2% vs 82.9 ± 6.8%; p = 0.55) and in patient satisfaction (31.5 ± 1.1 vs 31 ± 2.7; p = 0.10).

Conclusion

The addition of a DEP online module to a standard verbal consent for LRYGB resulted in improved patient’s understanding of the procedure-specific risks and benefits, high patient satisfaction, and over 50% time savings for the bariatric surgeon conducting the consent discussion.

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Acknowledgements

The authors would like to thank patients from Kingston Bariatric Centre of Excellence for participating in this study. They would also like to thank Jennifer Bunn for help in data collection and patients recruitment.

Funding

Department of Surgery Research Fund, Queen’s University.

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Affiliations

Authors

Contributions

MA, UM, BZ: Study conception and design. BZ: Acquisition of data. MA, UM, DIR, BZ: Analysis and interpretation of data. MA, UM, BZ: Drafting of manuscript. MA, UM, DIR, BZ: Critical revision.

Corresponding author

Correspondence to Boris Zevin.

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Disclosures

Boris Zevin received an educational grant from Ethicon and research funding from Medtronic. Mancini, Almakky and Robertson do not have conflicts of interest to declare.

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Zevin, B., Almakky, M., Mancini, U. et al. Digital approach to informed consent in bariatric surgery: a randomized controlled trial. Surg Endosc (2021). https://doi.org/10.1007/s00464-020-08277-x

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Keywords

  • Informed consent
  • Digital education platform
  • Roux-en-Y gastric bypass
  • Technology