A prospective randomised study comparing the current surgical informed consent form with a modified, pre-printed consent form

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 nursing team and the patient.