Completion of hand-written surgical consent forms is frequently suboptimal and could be improved by using electronically generated, procedure-specific forms

Surgeon. 2017 Aug;15(4):190-195. doi: 10.1016/j.surge.2015.11.004. Epub 2016 Jan 11.


Introduction: Completion of hand-written consent forms for surgical procedures may suffer from missing or inaccurate information, poor legibility and high variability. We audited the completion of hand-written consent forms and trialled a web-based application to generate modifiable, procedure-specific consent forms.

Methods: The investigation comprised two phases at separate UK hospitals. In phase one, the completion of individual responses in hand-written consent forms for a variety of procedures were prospectively audited. Responses were categorised into three domains (patient details, procedure details and patient sign-off) that were considered "failed" if a contained element was not correct and legible. Phase two was confined to a breast surgical unit where hand-written consent forms were assessed as for phase one and interrogated for missing complications by two independent experts. An electronic consent platform was introduced and electronically-produced consent forms assessed.

Results: In phase one, 99 hand-written consent forms were assessed and the domain failure rates were: patient details 10%; procedure details 30%; and patient sign-off 27%. Laparoscopic cholecystectomy was the most common procedure (7/99) but there was significant variability in the documentation of complications: 12 in total, a median of 6 and a range of 2-9. In phase two, 44% (27/61) of hand-written forms were missing essential complications. There were no domain failures amongst 29 electronically-produced consent forms and no variability in the documentation of potential complications.

Conclusion: Completion of hand-written consent forms suffers from wide variation and is frequently suboptimal. Electronically-produced, procedure-specific consent forms can improve the quality and consistency of consent documentation.

Keywords: Consent; Consent forms; Medical informatics; Surgery.

MeSH terms

  • Consent Forms / standards*
  • Consent Forms / statistics & numerical data
  • Humans
  • Informed Consent / standards*
  • Informed Consent / statistics & numerical data
  • Internet
  • Medical Audit
  • Medical Informatics
  • Prospective Studies
  • Quality Assurance, Health Care
  • Quality Improvement*
  • State Medicine
  • Surgical Procedures, Operative*
  • United Kingdom