Patient recall and appropriate timing for obtaining informed consent for endoscopic procedures.
OBJECTIVES: Although informed consent is an issue in many medical malpractice claims, there is no standardized time or method to obtain informed consent for endoscopic procedures. The objectives of this study were to determine whether sedation for endoscopic procedures interfered with pre-endoscopic informed consent and to determine the appropriate time to obtain informed consent. METHODS: Patients undergoing a sedated esophagogastroduodenoscopy had informed consent obtained either 48-72 h before the procedure (group 1A, n = 50) or 10-60 min before the procedure (group 1B, n = 50). Patients undergoing an unsedated flexible sigmoidoscopy had informed consent obtained either 48-72 h before (group 2A, n = 47) or 10-60 min before the procedure (group 2B, n = 49). Methods of informed consent consisted of an oral and a written explanation about the procedure. Patients were sedated with midazolam and meperidine. A Trieger test evaluated recovery from sedation. Recall was assessed by asking six questions about the procedure before discharge and again 2-3 days later. RESULTS: Standard t tests and Mann-Whitney U nonparametric rank tests were used to compare the 1) 1-h recall scores, 2) 2-3-day recall scores, and 3) recall difference scores for groups 1A and 1B, 1A and 2A, 2A and 2B, and 1B and 2B. There were no differences in recall for the different groups. CONCLUSIONS: This study shows that sedation for endoscopic procedures does not interfere with pre-endoscopic informed consent. Informed consent for endoscopic procedures can be obtained at any time before sedation with similar recall.