Informed consent for upper gastrointestinal endoscopy

Informed consent for upper gastrointestinal endoscopy requires that the patient understands the nature of, and reason for, the proposed procedure, and that he or she is given adequate time to deliberate and ask questions. In a prospective study, 200 outpatients completed questionnaires immediately before, and one day after, endoscopy, which assessed satisfaction with information provided by: (a) the referring doctor, (b) a standard information sheet sent out two to four weeks before endoscopy, and (c) the endoscopist. The first 100 patients were asked to read and sign a standard consent form immediately before the endoscopy. In the second 100 patients, a new endoscopy consent form that was simpler and easier to read than the standard form was sent out with the information sheet. Patients were directed to sign the new consent form before arriving at the unit only if they had no further questions. Overall, the indication for the endoscopy, and how it would be done, were explained clearly by the referring doctor in 79% and 68% of cases, respectively. Of the first 100 patients, only 54% had read the standard consent form in the endoscopy unit before signing it. In contrast, of the second 100 patients, the new form sent with the information sheet was read by 95%, and signed by 88% before coming to the unit. Furthermore, 84% found the new form easier to read and understand than the standard form. In our unit, roughly one quarter of patients referred for endoscopy are not adequately informed about the procedure. In contrast with the standard consent form, a simple endoscopy consent form sent out with the information sheet is preferred by most patients, and safeguards against patients undergoing endoscopy without informed consent.