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临床试验与临床决策科学的结合。

The marriage of clinical trials and clinical decision science.

作者信息

Hilden J, Habbema J D

机构信息

Institute of Medical Genetics (Biostatistics), University of Copenhagen, Denmark.

出版信息

Stat Med. 1990 Nov;9(11):1243-57. doi: 10.1002/sim.4780091105.

DOI:10.1002/sim.4780091105
PMID:2277876
Abstract

Clinical decision science is concerned with rational clinical decisions. All branches of medical research contribute here, but controlled clinical trials of the pragmatic variety carry a particular responsibility. Usually, however, they are not conducted and reported so that they can be used directly as input to a decision analysis. We suggest that the forces of the two methodologies should be united, and point out some areas where this 'marriage' will have a non-trivial impact: choice of end points, style of outcome recording, adaptive designs, and style of result presentation. Special attention is given to the decision-analytic setting of research priorities, the role of utility calculus in quantifying the ethical dilemmas that surround clinical trials, and the use of patient attitude towards outcomes of treatment as a covariate in its own right.

摘要

临床决策科学关注的是合理的临床决策。医学研究的各个分支都在此发挥作用,但实用型的对照临床试验承担着特殊的责任。然而,通常情况下,这些试验的开展和报告方式并不能使其直接作为决策分析的输入。我们建议将这两种方法的力量结合起来,并指出这种“结合”将产生重大影响的一些领域:终点的选择、结果记录方式、适应性设计以及结果呈现方式。特别关注研究优先级的决策分析设定、效用计算在量化围绕临床试验的伦理困境中的作用,以及将患者对治疗结果的态度本身作为一个协变量的使用。

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1
The marriage of clinical trials and clinical decision science.临床试验与临床决策科学的结合。
Stat Med. 1990 Nov;9(11):1243-57. doi: 10.1002/sim.4780091105.
2
Ethics and statistical methodology in clinical trials.临床试验中的伦理与统计方法
J Med Ethics. 1993 Dec;19(4):219-22. doi: 10.1136/jme.19.4.219.
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[Adaptive clinical study methodologies in drug development].[药物研发中的适应性临床研究方法]
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Stakeholder views regarding ethical issues in the design and conduct of pragmatic trials: study protocol.利益相关者对实用试验设计与实施中伦理问题的看法:研究方案
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Sample-size calculations for trials that inform individual treatment decisions: a 'true-choice' approach.为指导个体治疗决策的试验进行样本量计算:一种“真实选择”方法。
Clin Trials. 2007;4(1):15-24. doi: 10.1177/1740774506075872.
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Science, ethics, and the making of clinical decisions. Implications for risk factor intervention.科学、伦理与临床决策的制定。对风险因素干预的启示。
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Exploring the ethical and regulatory issues in pragmatic clinical trials.探讨实用临床试验中的伦理和监管问题。
Clin Trials. 2015 Oct;12(5):436-41. doi: 10.1177/1740774515598334. Epub 2015 Sep 15.
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Does a decision aid improve informed choice in mammography screening? Study protocol for a randomized controlled trial.决策辅助工具能否改善乳房X光检查筛查中的知情选择?一项随机对照试验的研究方案。
BMC Womens Health. 2015 Jul 22;15:53. doi: 10.1186/s12905-015-0210-5.
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Logistics and management of clinical trials.临床试验的后勤保障与管理
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Ethically optimised designs.符合伦理道德的优化设计。
Br J Clin Pharmacol. 1982 Apr;13(4):469-80. doi: 10.1111/j.1365-2125.1982.tb01407.x.

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Bayesian communication: a clinically significant paradigm for electronic publication.贝叶斯通信:电子出版的一种具有临床意义的范式。
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