Comparing shared decision making using a paper and digital consent process. A multi-site, single centre study in a trauma and orthopaedic department

Elsevier

Available online 11 June 2022

The SurgeonHighlights•

The paper consent process is associated with errors and omissions of core risks.

A digital consent process improved error rate and omission rate of core risks.

Patients reported a higher level of shared decision making with a digital process.

Documentation of consent can be reliably standardised with an electronic record.

AbstractIntroduction

The importance of shared decision making (SDM) for informed consent has been emphasised in the updated regulatory guidelines. Errors of completion, legibility and omission have been associated with paper-based consent forms. We introduced a digital consent process and compared it against a paper-based process for quality and patient reported involvement in shared decision making.

Methods

223 patients were included in this multi-site, single centre study. Patient consent documentation was by either a paper consent form or the Concentric digital consent platform. Consent forms were assessed for errors of legibility, completion and accuracy of content. Core risks for 20 orthopaedic operations were pre-defined by a Delphi round of experts and forms analysed for omission of these risks. SDM was determined via the ‘collaboRATE Top Score’, a validated measure for gold-standard SDM.

Results

72% (n = 78/109) of paper consent forms contained ≥1 error compared to 0% (n = 0/114) of digital forms (P < 0.0001). Core risks were unintentionally omitted in 63% (n = 68/109) of paper-forms compared to less than 2% (n = 2/114) of digital consent forms (P < 0.0001). 72% (n = 82/114) of patients giving consent digitally reported gold-standard SDM compared to 28% (n = 31/109) with paper consent (P < 0.001).

Conclusion

Implementation of a digital consent process has been shown to reduce both error rate and the omission of core risks on consent forms whilst increasing the quality of SDM. This novel finding suggests that using digital consent can improve both the quality of informed consent and the patient experience of SDM.

Keywords

Consent

Digital consent

eConsent

Surgery

Montgomery

Digital healthcare

Trauma and orthopaedic surgery

Shared decision making

Electronic healthcare records

Crown Copyright © 2022 Published by Elsevier Ltd on behalf of Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland.

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