Prospective Randomised Controlled Trial on the Role of Patient Information Leaflets in Obtaining Informed Consent

Background: The aim of this study was to determine whether patient information leaflets help to improve patient recall during the process of informed consent.

Methods: A prospective randomized controlled trial that compared a group of patients who were posted a patient information leaflet with those given verbal consent only was carried out. The study was conducted at the orthopaedic unit of a district general hospital. A total of 110 patients were selected, of whom 57 were randomly allocated to receive patient information leaflets by post and 53 were given verbal consent only. The outcome measure was the recall of information given to the patient. This was tested on admission by using a questionnaire. Each patient was allocated a score out of 10.

Results: There was a significant difference between the patients in the group that received patient information leaflets and those in the group that did not (P < 0.0001; confidence interval, 2.0-3.1).

Conclusion: Patient information leaflets are a useful tool for the surgeon to improve the recall of the information given to the patient, in order to facilitate informed consent.