Acceptance and Understanding of the Informed Consent Procedure Prior to Gastrointestinal Endoscopy by Patients: A Single-Center Experience in Korea

ABSTRACT

BACKGROUND/AIMS: Only a few reports have examined informed consent for gastrointestinal endoscopy in Korea. The aim of this study was to evaluate the appropriateness of the informed consent procedure in Korea. METHODS: A total of 209 patients who underwent endoscopy were asked to answer a self-administered structured questionnaire on the informed consent procedure for gastrointestinal endoscopy. RESULTS: One hundred thirteen patients completed questionnaires and were enrolled. In the survey, 91.2% answered that they understood the procedure, and the degree of understanding decreased with age; 85.8% were informed of the risks of the procedure, and the proportion was higher for inpatients and for those receiving therapeutic endoscopy or endoscopic retrograde cholangiopancreatography; 60.2% were informed of alternative methods, and the proportion was higher in older patients; 76.1% had the opportunity to ask questions during the informed consent procedure, and the proportion was higher in inpatients. The understanding of the risks of the endoscopic procedure was better in the younger and more highly educated groups. About 80% had sedation before endoscopy, and only 56% were informed of the risks of sedation during endoscopy. CONCLUSIONS: The current informed consent process may be reasonably acceptable and understandable to the patients. However, the understanding of the risks of endoscopy was insufficient especially in the cases of older, poorly educated patients and outpatients. The information about alternatives, the opportunity to ask for additional information, and the information about the risks of sedation during endoscopy were also insufficient in the current consent process.