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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.

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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