Literature DB >> 26791394

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

E R St John1, A J Scott2, T E Irvine3, F Pakzad3, D R Leff2, G T Layer4.   

Abstract

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.
Copyright © 2015 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

Entities:  

Keywords:  Consent; Consent forms; Medical informatics; Surgery

Mesh:

Year:  2016        PMID: 26791394     DOI: 10.1016/j.surge.2015.11.004

Source DB:  PubMed          Journal:  Surgeon        ISSN: 1479-666X            Impact factor:   2.392


  7 in total

1.  [Analysis of documented informed consent forms for computed tomography : Completeness and data quality in four clinics].

Authors:  D Vogele; O Schöffski; K Efinger; S A Schmidt; M Beer; D Kildal
Journal:  Radiologe       Date:  2020-02       Impact factor: 0.635

Review 2.  Key components and IT assistance of participant management in clinical research: a scoping review.

Authors:  Johannes Pung; Otto Rienhoff
Journal:  JAMIA Open       Date:  2020-10-14

3.  A survey of doctors at a UK teaching hospital to assess understanding of recent changes to consent law.

Authors:  J W O'Brien; M Natarajan; I Shaikh
Journal:  Ann Med Surg (Lond)       Date:  2017-04-21

4.  Improving consent form documentation and introduction of procedure-specific labels in a district general hospital.

Authors:  Stefan Bajada; Samuel Dwamena; Zabihullah Abdul; Rhodri Williams; Owain Ennis
Journal:  BMJ Qual Improv Rep       Date:  2017-02-08

5.  The Use of Electronic Consent for COVID-19 Clinical Trials: Lessons for Emergency Care Research During a Pandemic and Beyond.

Authors:  Eric Jaton; Jamie Stang; Michelle Biros; Abbey Staugaitis; Julie Scherber; Florian Merkle; Nicholas M Mohr; Christopher Streib; Lauren Klein; Michael A Puskarich
Journal:  Acad Emerg Med       Date:  2020-11-03       Impact factor: 5.221

6.  Chronic groin pain following open inguinal hernia repair: has consenting practice improved?

Authors:  V Sivarajah; Bjm Farquharson; S Mahdi; P Cathcart; S Jeyarajah
Journal:  Ann R Coll Surg Engl       Date:  2020-09-28       Impact factor: 1.891

7.  Improving the surgical consenting process for patients with acute hip fractures: a pilot quality improvement project.

Authors:  Kirit Singh; Ali Assaf; Morgan Bayley; Gordon Gillespie
Journal:  Patient Saf Surg       Date:  2020-06-13
  7 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.