Determining clinically important differences in health status measures - A general approach with illustration to the Health Utilities Index Mark II
Determining clinically important differences in health status measures - A general approach with illustration to the Health Utilities Index Mark II
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DOI：
10.2165/00019053-199915020-00003
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发表时间：
1999-02-01
影响因子：
4.4
通讯作者：
Matchar, D
中科院分区：
文献类型：
--
作者：
Samsa, G;Edelman, D;Matchar, D
本文的目的是描述和说明一种评估与健康相关的生活质量（HR-QOL）的临床重要差异（CIDs）的综合方法。进行了文献综述和初步研究，以确定基于效应大小的基准是否与从其他方法获得的CIDs一致。cid的估计主要基于效应量，辅以更传统的基于锚点的基准方法（即直接、横断面或纵向方法）。一篇讨论CIDs的文献综述提供了各种慢性疾病效应量的比较数据。然后进行了一项试点研究，以估计健康效用指数（HUI） Mark II的最小CID，并比较在最近的急性卒中干预随机试验中观察到的组间差异。使用标准化效应大小基准具有许多优点，例如，效应大小是有效的，在HR-QOL之外被广泛接受，并且具有基于外部锚点的公认基准。此外，我们的文献综述和试点研究表明，基于效应大小的CID基准与使用更传统的方法获得的基准相似。对于大多数HR-QOL仪器，我们不知道构成不同程度CIDs的评分变化。这使得解释临床试验的HR-QOL结果变得困难，并且拥有一个相对简单的基准过程是非常可取的。
The objective of this article was to describe and illustrate a comprehensive approach for estimating clinically important differences (CIDs) in health-related quality-of-life (HR-QOL). A literature review and pilot study were conducted to determine whether effect size-based benchmarks are consistent with CIDs obtained from other approaches.CIDs may be estimated based primarily upon effect sizes, supplemented by more traditional anchor-based methods of benchmarking (i.e. direct, cross-sectional or longitudinal approaches). A literature review of articles discussing CIDs provided comparative data on effect sizes for various chronic conditions. A pilot study was then conducted to estimate the minimum CID of the Health Utilities Index (HUI) Mark II, and to compare the observed between-group differences observed in a recent randomised trial of an acute stroke intervention with this benchmark.The use of standardised effect size benchmarks has a number of advantages for example, effect sizes are efficient, widely accepted outside HR-QOL, and have well accepted benchmarks based upon external anchors. In addition, our literature review and pilot study suggest that effect size-based CID benchmarks are similar to those which would be obtained using more traditional methods.For most HR-QOL instruments, we do not know the changes in score which constitute CIDs of various magnitudes. This makes interpretation of HR-QOL results from clinical trials difficult, and having a benchmarking process which is relatively straightforward would be highly desirable.