Patients' experiences of intervention trials on the treatment of myocardial infarction:: is it time to adjust the informed consent procedure to the patient's capacity?
Patients' experiences of intervention trials on the treatment of myocardial infarction:: is it time to adjust the informed consent procedure to the patient's capacity?
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DOI：
10.1136/heart.86.6.632
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发表时间：
2001-12-01
期刊：
影响因子：
5.7
通讯作者：
Herlitz, J
中科院分区：
文献类型：
--
作者：
Ågard, Å;Hermerén, G;Herlitz, J
目的-调查急性心肌梗死早期治疗试验患者对同意程序的体验。设计-定性和定量相结合的访谈，内容包括患者对试验的了解、被要求参加试验的感受以及对同意程序的态度。设置-第三转诊中心。患者-31名已书面知情同意参与急性心肌梗死随机干预试验的患者。结果-受访患者对他们所参与的试验只有零星的了解。大多数人认为阅读和签署同意书是不受欢迎或不必要的程序。相反，他们更愿意得到关于这项研究的简明口头信息。大多数人愿意让医生在他们病情太重而无法被问及参与的情况下为他们做出决定。结论--在急性心肌梗死早期被要求参与干预试验的患者似乎缺乏足够的知识来达成自主选择。在这种特殊情况下，获取书面知情同意的过程存在问题和不利因素，特别是在疾病急性期需要患者签署同意书的情况下。
Objective-To investigate how patients included in trials on treatment in the early phase of acute myocardial infarction experience the consent procedure.Design-A combined qualitative and quantitative interview concerning the patients' knowledge of the trial, their feelings about being asked to participate, and their attitudes towards the consent procedure.Setting-Tertiary referral centre.Patients-31 patients who had given written informed consent for their participation in randomised intervention trials of acute myocardial infarction.Results-The patients interviewed had only fragmentary knowledge about the trial they were involved in. Most considered that reading and signing a consent form was an unwanted or unnecessary procedure. Instead, they would have preferred to have been given concise verbal information about the study. Most were willing to allow a physician to decide for them in the event of their being too ill to be asked about their participation.Conclusions-Patients who are asked to participate in intervention trials in the early phase of acute myocardial infarction often appear to lack sufficient knowledge to reach an autonomous choice. There were problems and disadvantages associated with the process of obtaining written informed consent in this particular situation, especially regarding the need for the patient to sign a consent form during the acute phase of the disease.