Use of health-related quality of life in prescribing research. Part 2: methodological considerations for the assessment of health-related quality of life in clinical trials

Use of health-related quality of life in prescribing research. Part 2: methodological considerations for the assessment of health-related quality of life in clinical trials
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DOI:
10.1046/j.0269-4727.2003.00520.x
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发表时间:
2004-02-01
影响因子:
2
通讯作者:
Freemantle, N
Freemantle, N
中科院分区:
医学4区
文献类型:
--
作者:
Calvert, MJ;Freemantle, N

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本文旨在解决在临床试验中评估健康相关生活质量(HRQoL)时应考虑的关键方法学问题。这些包括选择HRQoL作为主要或次要结局的理由,以及选择符合基本心理测量学特性的适当工具来评估HRQoL。此外,我们考虑通过优化依从性和评估时间来最大限度地减少试验中偏倚的方法。
This article aims to address key methodological issues that should be considered when assessing health-related quality of life (HRQoL) in a clinical trial. These include justification for the selection of HRQoL as a primary or secondary outcome and choice of an appropriate instrument to assess HRQoL, which meets basic psychometric properties. In addition we consider ways to minimize bias within the trial through optimization of compliance and timing of assessments.