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.