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PROSPECTIVE RANDOMISED CONTROLLED TRIAL ON THE ROLE OF PATIENT INFORMATION LEAFLETS IN OBTAINING INFORMED CONSENT



Abstract

Objective: To determine whether patient information leaflets improve patient recall during the process of informed consent.

Design: Prospective randomised controlled trial which compared a group of patients who were posted a patient information leaflet with those given verbal consent only.

Setting: Orthopaedic Unit of a District General Hospital

Patients: 110 patients were selected, of which 57 were randomly allocated to receive patient information leaflets through the post and 53 were given verbal consent only.

Outcome Measure: The recall of information given to the patient. This was tested using a questionnaire on admission. Each patient was allocated a score out of ten.

Results: There was a significant difference between the group who received patient information leaflets compared to those who did not (P< 0.0001, CI 2.0 to 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.

Correspondence should be addressed to The Secretary, BHS, c/o BOA, The Royal College of Surgeons, 35–43 Lincoln’s Inn Fields, London WC2A 3PE.