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量化并记录临床试验中的先验信念。

Quantifying and documenting prior beliefs in clinical trials.

作者信息

Chaloner K, Rhame F S

机构信息

School of Statistics, University of Minnesota, 313 Ford Hall, 224 Church Street S.E., Minneapolis, MN 55455, USA.

出版信息

Stat Med. 2001 Feb 28;20(4):581-600. doi: 10.1002/sim.694.

Abstract

Collecting and documenting subjective prior beliefs from knowledgeable clinicians about the potential results of a clinical trial has many advantages. Two large trials of prophylactic treatments in an HIV-positive population are used as examples. The trials recruited patients of primary care physicians and compared treatments which were in use in clinical practice. Opinions about these trials were elicited from 58 practising HIV clinicians. It is shown how the documented opinions can be used to augment the monitoring process; the prior opinions are updated with interim data using approximate Bayesian methods to give posterior opinions incorporating interim results. These posterior opinions can be used by the monitoring board to anticipate the clinicians' reaction to the results. Eliciting prior beliefs is also ethically important for documenting the nature of the uncertainty or equipoise. Important information is provided for the informed consent process and Institutional Review Board (IRB).

摘要

收集并记录知识渊博的临床医生对临床试验潜在结果的主观先验信念有诸多益处。以两项针对HIV阳性人群的预防性治疗大型试验为例。这些试验招募了初级保健医生的患者,并比较了临床实践中正在使用的治疗方法。从58名执业HIV临床医生那里征集了对这些试验的意见。展示了记录的意见如何用于加强监测过程;使用近似贝叶斯方法根据中期数据更新先验意见,以给出纳入中期结果的后验意见。监测委员会可使用这些后验意见来预测临床医生对结果的反应。引出先验信念对于记录不确定性或均衡性的性质在伦理上也很重要。为知情同意过程和机构审查委员会(IRB)提供了重要信息。

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