急性心肌梗死研究中患者知情同意时的感受:基于DANAMI-2研究中患者知情同意过程的问卷调查

• 作 者: Gammelgaard A. Mortensen O.S. 姜馨
• 机 构: Dept. Med. Philos. and Clin. Theor., Institute of Public Health, University of Copenhagen, Blegdamsv
• 出 处: 世界核心医学期刊文摘(心脏病学分册)
• 发表日期: 2005年02期
• 关键词: 知情同意 急性心肌梗死 问卷调查 伦理委员会 试验者 急性期患者 调查表 临床试验 口头信息 当时

Objective: To analyse how patients in the acute phase of a myocardial infarct experience the informed consent procedure of a clinical trial. Design: A questio nnaire based follow up survey including patients who gave informed consent as we ll as patients who did not consent to the trial. Patients: 103 patients who gave informed consent and 78 who did not consent to the second Danish acute myocardi al infarction trial(DANAMI 2). Results: 76%of the trial participants and 63%o f the nonparticipants agreed or mostly agreed that they felt able to make a deci sion about whether or not to participate in the trial; 50%of the trial particip ants and 34%of the non participants found it acceptable that patients in their situation have to make such a decision. Only 28%of the trial participants and 7%of the non participants read the information sheet before they made the deci sion. Conclusions: Informed consent should be sought in acute myocardial infarct ion trials despite the emergency situation and the medical condition of the pati ents. Patientsself assessed ability to make a decision should be explicitly ad dressed during the informed consent process and patients should not be pressuris ed into decision making. Physicians and research ethics committees should focus specifically on improving the oral information.

Objective: To analyze the how patients in the acute phase of a myocardial infarct experience the informed consent procedure of a clinical trial. Design: A questio nnaire based follow up survey including patients who gave Informal consent as we ll as patients who did not consent to the Patients: 103 patients who gave informed consent and 78 who did not consent to the second Danish acute myocardial infarction trial (DANAMI 2). Results: 76% of the trial participants and 63% of the nonparticipator agreed or mostly agreed that they felt able to make a deci sion about whether or not to participate in the trial; 50% of the trial participants and 34% of the non participants found it acceptable that patients in their situation have to make such a decision. Only 28% of the trial participants and 7% of the non participants read the information sheet before they made the deci- sion. Conclusions: Informed consent should be sought in acute myocardial infarction trials despite the emergency situation and the medical condition of the pati ents. patients who self ability ability to make a decision should be explicitly ad dressed during the informed consent process and patients should not be pressuris ed into decision making. Physicians and research ethics committees should focus specifically on improving the oral information.