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. (Korean J Intern Med 2010;25:36-43)

Patients' recollection and understanding of informed consent: a literature review

“…Thirteen studies met the inclusion criteria for this literature review. Two studies were conducted in the USA; four in Australia; two in the UK, and New Zealand, Korea, Italy, Canada and Turkey . There was agreement in the studies that the process of obtaining informed consent involved ‘the traditional verbal interaction between the patient and the doctor’.…”

Effects of written plus oral information vs. oral information alone on precolonoscopy anxiety

“…Medical staff has a legal responsibility to tell patients about the procedure in the form of an informed consent. Usually, the information provided before a medical procedure has one main goal: to let patients fully understand the factors relevant to their future medical treatment (Song et al. 2010).…”

“…It has been shown to be effective in reducing situational pain, discomfort and anxiety, reducing recovery time and improving postoperative recovery (Jlala et al. 2010, Song et al. 2010).…”

Portable video media for presenting informed consent and wound care instructions for skin biopsies: a randomized controlled trial

“…The current consent process prior to a procedure involves a physician and/or medical staff member verbally explaining a procedure, its risks and its benefits to a patient. This process is inadequate, 1–5 inconsistent among physicians obtaining informed consent, 6,7 and variably comprehensible among patients with different educational levels 8 . Incomplete informed consent can result in poor legal outcomes for physicians 4 and cause anxiety and confusion among patients.…”