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)

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

Background The manner in which informed consent is obtained varies. The aim of this study is to evaluate the level of knowledge about colonoscopy and comparing 2 methods of obtaining informed consent. Materials and methods A comparative, cross-sectional, observational study was conducted on patients that underwent colonoscopy in a public hospital (Group A) and in a private hospital (Group B). Group A received information verbally from a physician, as well as in the form of printed material, and Group B only received printed material. A telephone survey was carried out one or 2 weeks later. Results The study included a total of 176 subjects (group A [n = 55] and group B [n = 121]). As regards education level, 69.88% (n = 123) of the patients had completed university education, 23.29% (n = 41) secondary level, 5.68% (n = 10) primary level, and the remaining subjects (n = 2) had not completed any level of education. All (100%) of the subjects knew the characteristics of the procedure, and 99.43% were aware of its benefits. A total of 97.7% received information about complications, 93.7% named some of them, and 25% (n = 44) remembered major complications. All the subjects received, read, and signed the informed consent statement before the study. There were no differences between the groups with respect to knowledge of the characteristics and benefits of the procedure, or the receipt and reading of the consent form. Group B responded better in relation to complications (P = .0027) and group A had a better recollection of the major complications (P  Conclusions The combination of verbal and written information provides the patient with a more comprehensive level of knowledge about the procedure.

Informed consent in colonoscopy: A comparative analysis of 2 modes

Resumen Antecedentes La forma de obtener el consentimiento informado es variable, por lo que el objetivo de este trabajo fue evaluar el nivel de conocimientos sobre la colonoscopia comparando 2 modalidades de consentimiento. Materiales y metodos Estudio observacional, transversal y comparativo realizado en pacientes sometidos a colonoscopia en un hospital publico (grupo A) y en un hospital privado (grupo B). El grupo A recibio informacion verbal por un medico e impresa y el grupo B solo impresa. Una o 2 semanas despues se realizo una encuesta telefonica. Resultados Se incluyo a 176 sujetos (grupo A n = 55 y grupo B n = 121). El 69.88% (n = 123) de los pacientes tenian nivel educativo universitario, el 23.29% (n = 41) nivel educativo secundario, el 5.68% (n = 10) nivel educativo primario completo y los restantes (n = 2) no habian completado estudios. El 100% conocia las caracteristicas y el 99.43% los beneficios del procedimiento. El 97.7% recibio informacion sobre complicaciones, el 93.7% nombro alguna y el 25% (n = 44) recordo complicaciones mayores. Todos respondieron, recibieron y leyeron el consentimiento informado antes del estudio. No hubo diferencias entre los grupos en el conocimiento de las caracteristicas, los beneficios, la recepcion y la lectura del consentimiento. El grupo B respondio mejor sobre las complicaciones (p = 0.0027) y el grupo A recordaba mas las complicaciones mayores (p  Conclusiones La combinacion de informacion verbal y escrita logra mejor nivel de conocimientos por el paciente.

Consentimiento informado en colonoscopia: un estudio comparativo de 2 modalidades

OBJECTIVE We conducted a randomized trial aiming at improving patients' informed consent for undergoing endoscopic retrograde cholangiopancreatography (ERCP) in clinical care by comparing the efficacy of an additional educational video to written informed consent with that of written informed consent alone. METHODS This was a single-center, randomized controlled trial. Consecutive patients undergoing ERCP were randomized to a video education or a control group. An educational video detailing ERCP procedure plus standard written informed consent was administered to the video education group, while the control group reviewed standard written informed consent only. The primary outcome was the patients' perception of the risk or possibility of ERCP complications. Their perception of the benefits of ERCP, alternative treatments and overall satisfaction with the process of informed consent were also compared. RESULTS In total 205 patients were included in the study (104 in the control group and 101 in the video education group). Patients' comprehension of ERCP-related complications in the video education group was significantly increased (P < 0.001), and these patients were more likely to correctly identify the incidence of such complications. Significantly more patients in the video education group were very satisfied with informed consent process (87.1% vs 76.0%, P = 0.040) and fewer patients needed additional explanations (31.7% vs 47.1%, P = 0.024). CONCLUSIONS A supplementary educational video could greatly improve patient's understanding of ERCP procedure, in particular, its potential risks and complications, as well as their overall satisfaction with the process of informed consent (ClinicalTrials.gov no. NCT02810379).

Video education can improve awareness of risks for patients undergoing endoscopic retrograde cholangiopancreatography: A randomized trial

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.

Background/Aim: Data on informed consent procedures in endoscopy centers in China are lacking. The aim of this study was to record the current status of informed consent procedures

A multicenter prospective survey on informed consent for gastrointestinal endoscopy in China.

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A multicenter prospective survey on informed consent for gastrointestinal endoscopy in China.