A prospective randomised study comparing the current surgical informed consent form with a modified, preprinted consent form

Research output: Contribution to journalArticle

  • Authors:
  • Bhuvaneswari Krishnamoorthy (Lead)
  • Kok-Hooi Yap
  • William Critchley
  • J Nair
  • Nehru Devan
  • And 3 others
  • External authors:
  • J Barnard
  • Ann-Louise Caress
  • PD Waterworth


Background: Patient understanding is a fundamental requirement for the consent process, yet current UK Department of Health consent forms rely on handwritten explanations on admission prior to cardiac surgery. A pre-printed consent form containing pertinent information about the planned procedure and its associated benefits/risks may benefit in patient retention of information. Trial design: Randomised study using a pre-test/post-test design in which participants completed a questionnaire prior to providing consent and following surgery. Methods: 100 patients scheduled for coronary artery bypass surgery were recruited and randomised by computer into two groups receiving either the current standard handwritten consent form (group 1) or a modified pre-printed consent form (group 2). Objective: To assess whether a standardised, pre-printed consent form improves patient information retention and experience of the consent process. Results: No significant differences in demographics or pre-consent questionnaire data were observed between groups. A greater proportion of patients could identify (62.0% vs. 30.0%, p=0.011) and understand their surgical procedure (66.0% vs. 20.0%, p=0.001) in group 2 compared to group 1. Group 2 exhibited greater understanding of the benefits (72.0% vs. 8.0%, p<0.001) and risks (82.0% vs. 10.0%, p<0.001) of the surgery and indicated greater satisfaction with the consent process post-operatively (94.29% vs. 85.22%, p<0.001) compared to group 1. Conclusion: This study highlights the importance of a written explanation on the consent form, which encourages greater patient understanding and aids in shared decision making between the surgical team and the patient.

Bibliographical metadata

Original languageEnglish
Pages (from-to)17-21
Number of pages5
JournalHealth Education and Care
Issue number1
Publication statusPublished - 22 Aug 2016