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相似文献

1
At what level of collective equipoise does a clinical trial become ethical?临床试验在何种集体均衡水平下才具有伦理合理性?
J Med Ethics. 1991 Mar;17(1):30-4. doi: 10.1136/jme.17.1.30.
2
At what level of collective equipoise does a randomized clinical trial become ethical for the members of institutional review board/ethical committees?对于机构审查委员会/伦理委员会的成员而言,随机临床试验在何种集体均衡水平上才符合伦理道德?
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3
Equipoise as a means of managing uncertainty: personal, communal and proxy.作为管理不确定性手段的 equipoise:个人层面、群体层面及替代层面。 (注:equipoise 常见释义为“平衡”“均衡”等,这里可能是医学领域的特定术语,保留英文以便准确理解其在专业语境中的含义)
J Med Ethics. 1996 Jun;22(3):135-9. doi: 10.1136/jme.22.3.135.
4
Equipoise and the ethics of clinical research.equipoise与临床研究伦理
N Engl J Med. 1987 Jul 16;317(3):141-5. doi: 10.1056/NEJM198707163170304.
5
Community equipoise and the architecture of clinical research.社区均衡与临床研究架构
Camb Q Healthc Ethics. 1997 Fall;6(4):385-96. doi: 10.1017/s0963180100008136.
6
Equipoise: a case study of the views of clinicians involved in two neonatal trials.equipoise:一项关于参与两项新生儿试验的临床医生观点的案例研究。
Clin Trials. 2004;1(2):170-8. doi: 10.1191/1740774504cn020xx.
7
Patient-centred equipoise and the ethics of randomised controlled trials.以患者为中心的 equipoise 与随机对照试验的伦理学
Monash Bioeth Rev. 2002 Apr;21(2):S55-67. doi: 10.1007/BF03351269.
8
Equipoise, knowledge and ethics in clinical research and practice.临床研究与实践中的 equipoise(平衡)、知识与伦理。 (注:equipoise 这个词在医学领域有特定含义,常指在临床研究中对于不同治疗方案的利弊处于一种不确定的平衡状态,但按照要求不做额外解释)
Bioethics. 1999 Jul;13(3-4):314-26. doi: 10.1111/1467-8519.00160.
9
An argument that all prerandomized clinical trials are unethical.一种认为所有预随机临床试验都不道德的观点。
J Med Philos. 1986 Nov;11(4):367-83. doi: 10.1093/jmp/11.4.367.
10
A closer look at the bad deal trial: beyond clinical equipoise.深入审视不良交易试验:超越临床 equipoise
Hastings Cent Rep. 2005 Sep-Oct;35(5):29-36.

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2
Clinicians' experiences of obtaining informed consent for research and treatment: a nested qualitative study from Pakistan.临床医生在研究和治疗中获取知情同意的经验:来自巴基斯坦的嵌套定性研究。
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Using Equipoise to Determine the Radiographic Characteristics Leading to Agreement on Best Treatment for Thoracolumbar Burst Fractures Without Neurologic Deficits.运用 equipoise 确定导致无神经功能缺损的胸腰椎爆裂骨折最佳治疗方案达成共识的影像学特征。
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Is it time to study routine car seat tolerance screening in a randomized controlled trial? An international survey of current practice and clinician equipoise.
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Is there a social cost of randomization?随机分组存在社会成本吗?
Soc Choice Welfare. 2019 Apr;52(4):709-739. doi: 10.1007/s00355-018-1168-7. Epub 2019 Jan 24.
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Colorectal surgeon consensus with diverticulitis clinical practice guidelines.结直肠外科医生对憩室炎临床实践指南的共识。
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本文引用的文献

1
Evaluating new treatments and diagnostic technologies in obstetrics. Practical problems, ethics, and solutions.评估产科领域的新治疗方法和诊断技术。实际问题、伦理及解决方案。
Int J Technol Assess Health Care. 1989;5(3):459-72. doi: 10.1017/s0266462300007510.
2
The framing of decisions and the psychology of choice.决策的框架与选择的心理学。
Science. 1981 Jan 30;211(4481):453-8. doi: 10.1126/science.7455683.
3
Ethics and clinical research.伦理与临床研究
N Engl J Med. 1966 Jun 16;274(24):1354-60. doi: 10.1056/NEJM196606162742405.
4
Ethics and human experimentation. Henry Beecher revisited.伦理与人体实验。再访亨利·比彻。
N Engl J Med. 1987 Nov 5;317(19):1195-9. doi: 10.1056/NEJM198711053171906.
5
The alpha and beta errors in randomized trials.随机试验中的Ⅰ类错误和Ⅱ类错误。
N Engl J Med. 1990 Mar 15;322(11):780-1. doi: 10.1056/NEJM199003153221119.

临床试验在何种集体均衡水平下才具有伦理合理性?

At what level of collective equipoise does a clinical trial become ethical?

作者信息

Johnson N, Lilford R J, Brazier W

机构信息

Department of Obstetrics and Gynaecology, St James's University Hospital.

出版信息

J Med Ethics. 1991 Mar;17(1):30-4. doi: 10.1136/jme.17.1.30.

DOI:10.1136/jme.17.1.30
PMID:2033628
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1375968/
Abstract

It has often been argued that if a clinician cannot decide which of two treatments to offer, a trial may be ethical, but it is unethical if she/he has a preference. Since individual clinicians usually have a preference, most trials could be judged unethical according to this line of argument. A recent important article in the New England Journal of Medicine argued that individual preferences are not as important as the collective uncertainty of informed clinicians. If clinicians are equally divided, there is a state of collective equipoise and a trial is ethical. However, clinicians will seldom be exactly equally divided. We conducted an ethometric study to find out how much collective equipoise can be disturbed before the potential subjects in a trial think that it is unethical. Half of our subjects perceived a trial as unethical when equipoise was disturbed beyond 70:30. In other words, when 70 per cent of experts favour one treatment, 50 per cent of subjects would prefer that treatment to be administered rather than subjected to critical assessment. When equipoise is disturbed beyond 80:20, less than 3 per cent of subjects would consider human trials morally justifiable.

摘要

人们常常认为,如果临床医生无法决定提供两种治疗方法中的哪一种,进行试验可能是符合伦理的,但如果她/他有偏好,那就是不符合伦理的。由于个体临床医生通常有偏好,按照这种论点,大多数试验可能会被判定为不符合伦理。《新英格兰医学杂志》最近的一篇重要文章认为,个体偏好不如知情临床医生的集体不确定性重要。如果临床医生意见平分秋色,就存在一种集体平衡状态,试验就是符合伦理的。然而,临床医生很少会完全平分秋色。我们进行了一项伦理测量研究,以了解在试验中的潜在受试者认为试验不符合伦理之前,集体平衡会受到多大程度的干扰。当平衡被打破超过70:30时,我们一半的受试者认为试验不符合伦理。换句话说,当70%的专家支持一种治疗方法时,50%的受试者会希望采用那种治疗方法而不是进行严格评估。当平衡被打破超过80:20时,不到3%的受试者会认为人体试验在道德上是合理的。