Assessing meaningful change in quality of life over time: A users' guide for clinicians
Assessing meaningful change in quality of life over time: A users' guide for clinicians
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DOI：
10.4065/77.6.561
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发表时间：
2002-06-01
影响因子：
8.9
通讯作者：
Revicki, DA
中科院分区：
文献类型：
--
作者：
Sprangers, MAG;Moinpour, CM;Revicki, DA
这篇文章的目的是帮助临床医生解释随着时间的推移，基于试验的生活质量（QOL）的变化。我们解决了一系列问题，并提供了评估和解释变化的基本指导方针。解决的问题如下：（1）什么是人口的特点，生活质量的变化报告？(2)QOL问卷是否可靠、有效、对变化有反应？(3)评估的时间和频率是否适当？(4)研究是否具有充分的把握度？(5)在分析中如何处理多个QOL结局？(6)如何处理多个时间点？(7)其他解释能否解释观察到的变化或未观察到的变化（例如，缺失数据的处理、生存差异和患者QOL观点随时间的变化）？（8）统计学意义如何转化为有意义的变化？这些指南将支持临床医生审查临床试验文献，这反过来又可以帮助他们在治疗决策过程中使用数据。
The objective of this article is to help clinicians interpret trial-based quality of life (QOL) changes over time. We address a series of questions and provide guidelines that are fundamental to assessing and interpreting change. The issues addressed are as follows: (1) What are the characteristics of the population for whom changes in QOL are reported? (2) Is the QOL questionnaire reliable, valid, and responsive to change? (3) Are the timing and frequency of assessments adequate? (4) Is the study adequately powered? (5) How are multiple QOL outcomes addressed in analyses? (6) How are multiple time points handled? (7) Can alternative explanations account for the observed change or lack of observed change (eg, handling of missing data, survival differences, and changes in patient's QOL perspective over time)? and (8) How is statistical significance translated into meaningful change? These guidelines will support clinicians in reviewing the clinical trial literature, which in turn can help them use the data in the treatment decision process.