Calvert M J, Freemantle N
Department of Primary Care and General Practice, University of Birmingham, Birmingham, UK.
J Clin Pharm Ther. 2004 Feb;29(1):85-94. doi: 10.1046/j.0269-4727.2003.00520.x.
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.
本文旨在探讨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。这些问题包括选择HRQoL作为主要或次要结局的理由，以及选择一种符合基本心理测量特性的合适工具来评估HRQoL。此外，我们还考虑了通过优化评估的依从性和时间安排来尽量减少试验中的偏倚的方法。
