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.