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阐明并应对临床研究中的不确定性。

Articulating and responding to uncertainties in clinical research.

作者信息

Djulbegovic Benjamin

机构信息

Department of Interdisciplinary Oncology, University of South Florida, Tampa, Florida 33612, USA.

出版信息

J Med Philos. 2007 Mar-Apr;32(2):79-98. doi: 10.1080/03605310701255719.

DOI:10.1080/03605310701255719
PMID:17454416
Abstract

This paper introduces taxonomy of clinical uncertaintes and argues that the choice of scientific method should match the underlying level of uncertainty. Clinical trial is one of these methods aiming to resolve clinical uncertainties. Whenever possible these uncertainties should be quantified. The paper further shows that the still ongoing debate about the usage of "equipoise" vs. "uncertainty principle" vs. "indifference" as an entry criterion to clinical trials actually refers to the question "whose uncertainty counts". This question is intimately linked to the control of research agenda, which is not quantifiable and hence is not solvable to equal acceptability to all interested parties. The author finally shows that there is a predictable relation between [acknowledgement of] uncertainty (the moral principle) on which trials are based and the ultimate outcomes of clinical trials. That is, [acknowledgement of] uncertainty determines a pattern of success in medicine and drives clinical discoveries.

摘要

本文介绍了临床不确定性的分类,并认为科学方法的选择应与潜在的不确定性水平相匹配。临床试验是旨在解决临床不确定性的方法之一。只要有可能,这些不确定性都应进行量化。本文进一步表明,关于将“ equipoise”(平衡)、“不确定性原则”还是“无差异”用作临床试验入组标准的持续争论,实际上涉及“谁的不确定性算数”这一问题。这个问题与研究议程的控制密切相关,而研究议程是不可量化的,因此无法让所有相关方都同等接受地解决。作者最后表明,试验所基于的(对)不确定性(这一道德原则)的认知与临床试验的最终结果之间存在可预测的关系。也就是说,(对)不确定性的认知决定了医学上的成功模式并推动临床发现。

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Articulating and responding to uncertainties in clinical research.阐明并应对临床研究中的不确定性。
J Med Philos. 2007 Mar-Apr;32(2):79-98. doi: 10.1080/03605310701255719.
2
Destabilizing the 'equipoise' framework in clinical trials: prioritizing non-exploitation as an ethical framework in clinical research.破坏临床试验中的“均衡”框架:将非剥削作为临床研究中的伦理框架的优先级。
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Clinical equipoise and the incoherence of research ethics.临床 equipoise 与研究伦理的不一致性。 (注:equipoise 这个词在医学伦理语境中有特定含义,一般译为“ equipoise 是指在医学研究中,对于两种或多种治疗方法的相对有效性存在真正的不确定性,使得研究者在伦理上可以合理地招募受试者参与比较这些治疗方法的试验” ,这里按照要求不添加解释,直接给出字面翻译。)
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