Responsiveness and sensitivity to change of SLE disease activity measures

Responsiveness and sensitivity to change of SLE disease activity measures
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DOI:
10.1191/096120399680411416
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发表时间:
1999-01-01
期刊:
影响因子:
2.6
通讯作者:
Stucki, G
Stucki, G
中科院分区:
医学4区
文献类型:
--
作者:
Corzillius, M;Fortin, P;Stucki, G

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结果测量检测随时间变化的能力对其在临床试验中的有用性至关重要。在评估评价工具时采用了两个概念:我们赞同区分敏感性和反应性的建议。对变化的敏感性是指仪器在统计上测量变化的能力。敏感性统计将观察到的变化的幅度与某种变异性的度量联系起来,本质上是信噪比。反应性涉及临床相关变化的检测。该方法仍在不断发展,但一种常见的方法是将观察到的分数变化与外界认为表明临床相关性的标准(例如,基于医生或患者的过渡量表)联系起来。对变化的敏感性和SLE活动指数的反应性已经在少数研究中得到解决。这些表明,最广泛使用的系统(SLEDAI。SLAM, BILAG)对变化敏感,尽管现有证据不允许对一种仪器优于其他仪器。对这些措施的反应性进行的研究很少。本文回顾了测量临床变化的方法学概念,并总结了狼疮活动评分的敏感性和反应性的报告。
The ability of outcome measures to detect change over time is critical fbr their usefulness in clinical trials. Two concepts are applied in the assessment of evaluative instruments: We endorse the recommendation that a distinction be made between sensitivity and responsiveness. Sensitivity to change refers to the capacity of instruments to measure change statistically. Sensitivity statistics relate the magnitude of observed change to some measure of variablity and are essentially signal-to-noise ratios. Responsiveness addresses the detection of clinically relevant change. The methodology is still evolving but a common approach has been to correlate the observed change in scores with external standards that are believed to indicate clinical relevance (e.g., physician- or patient-based transition scales).Sensitivity to change and responsiveness of SLE activity indices have been addressed in a small number of studies. These indicate that the most widely used systems (SLEDAI. SLAM, BILAG) are sensitive to change although the available evidence does not allow preference for one instrument over the others. Little research has been done on the responsiveness of these measures.This article reviews the methodological concepts in measuring clinical change and summarizes reports on sensitivity and responsiveness of lupus activity scores.