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

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          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.

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          Most cited references21

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          Informed consent for GI endoscopy.

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            Informed consent: not just for procedures anymore.

            The ethical and legal requirement to obtain informed consent prior to performing a procedure or administering a treatment derives from the concept of personal (patient) autonomy. The competent patient, after receiving appropriate disclosure of the material risks of the procedure or treatment, understanding those risks, the benefits, and the alternative approaches, makes a voluntary and uncoerced informed decision to proceed. This article will present a general overview of the modern concept of informed consent as a process (mutual communication) rather than an event (document signing). The historical evolution of this concept and the legal rulings that have shaped the requirements of informed consent will be cited. The benefits of informed decision making as a communication and risk management tool are presented. This review is intended as general information, and not as legal advice, which should be sought from a health-care attorney.
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              A randomized trial using videotape to present consent information for colonoscopy.

              A randomized controlled trial was conducted to determine if a videotaped presentation by a physician conveys information more effectively than an in-person discussion by the same physician using the identical script. Two hundred one patients undergoing colonoscopy were enrolled in the study. Patients were randomly assigned to one of three groups: video plus discussion, video alone, and discussion alone. A validated, 13-item knowledge test and the State-Trait Anxiety Inventory were administered to all patients. Mean number of correct test answers for video plus discussion was 11.04; for video alone, 10.70; and for discussion alone, 9.61. ANOVA with planned orthogonal comparisons showed that the patients in the two video groups had significantly better scores (p < 0.001) than those in the discussion-only group. No difference was noted between the two video groups (p = 0.32). Anxiety did not increase with increased understanding of the risks and benefits of colonoscopy. This approach may work as well for other invasive medical procedures and could save physician time while laying a foundation for a more personalized discussion.
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                Author and article information

                Journal
                Korean J Intern Med
                KJIM
                The Korean Journal of Internal Medicine
                The Korean Association of Internal Medicine
                1226-3303
                2005-6648
                March 2010
                26 February 2010
                : 25
                : 1
                : 36-43
                Affiliations
                Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
                Author notes
                Correspondence to Jae J. Kim, M.D. Department of Internal Medicine, Sungkyunkwan University School of Medicine, 50 Irwon-dong, Gangnam-gu, Seoul 135-710, Korea. Tel: 82-2-3410-3409, Fax: 82-2-3410-6983, jjkim@ 123456skku.edu
                Article
                10.3904/kjim.2010.25.1.36
                2829414
                20195401
                ead13cbd-58ba-4c02-92c7-834adaaf1376
                Copyright © 2010 The Korean Association of Internal Medicine
                History
                : 24 February 2009
                : 03 June 2009
                Categories
                Original Article

                Internal medicine
                endoscopy,consent forms,informed consent
                Internal medicine
                endoscopy, consent forms, informed consent

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