title: Completion of hand-written surgical consent forms is frequently suboptimal and could be improved by using electronically generated, procedure-specific forms.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Academic Surgical Unit, Division of Surgery and Cancer, Imperial College London, St Mary's Hospital, Paddington, London, UK. Electronic address: edward.stjohn@imperial.ac.uk.
authors.forename: E R
authors.initials: ER
authors.lastname: St John
authors.affiliation: Academic Surgical Unit, Division of Surgery and Cancer, Imperial College London, St Mary's Hospital, Paddington, London, UK; Division of Surgery, Imperial College Healthcare NHS Trust, St Mary's Hospital, Paddington, London, UK.
authors.forename: A J
authors.initials: AJ
authors.lastname: Scott
authors.affiliation: Department of Breast Surgery, Royal Surrey County Hospital, Guildford, UK.
authors.forename: T E
authors.initials: TE
authors.lastname: Irvine
authors.affiliation: Department of Breast Surgery, Royal Surrey County Hospital, Guildford, UK.
authors.forename: F
authors.initials: F
authors.lastname: Pakzad
authors.affiliation: Academic Surgical Unit, Division of Surgery and Cancer, Imperial College London, St Mary's Hospital, Paddington, London, UK; Division of Surgery, Imperial College Healthcare NHS Trust, St Mary's Hospital, Paddington, London, UK.
authors.forename: D R
authors.initials: DR
authors.lastname: Leff
authors.affiliation: Department of Breast Surgery, Royal Surrey County Hospital, Guildford, UK; Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, UK.
authors.forename: G T
authors.initials: GT
authors.lastname: Layer
mesh_terms: D032962:Consent Forms / Q000592:standards* / Q000706:statistics & numerical data; D006801:Humans; D007258:Informed Consent / Q000592:standards* / Q000706:statistics & numerical data; D020407:Internet; D008485:Medical Audit; D008490:Medical Informatics; D011446:Prospective Studies; D011785:Quality Assurance, Health Care; D058996:Quality Improvement; D013222:State Medicine; D013514:Surgical Procedures, Operative; D006113:United Kingdom
keywords: Consent; Consent forms; Medical informatics; Surgery