PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions
PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions
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DOI：
10.1016/j.jclinepi.2015.08.038
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发表时间：
2016-05-01
影响因子：
7.2
通讯作者：
Cella, David
中科院分区：
文献类型：
--
作者：
Cook, Karon F.;Jensen, Sally E.;Cella, David
目的：为了提出一个概述的一系列研究中，美国国立卫生研究院的患者报告的结果测量信息系统（NIH; PROMIS）的措施的临床有效性进行了评估，由域，在六个clinical population.Study设计和设置：约1,500人在基线和1,300在后续完成PROMIS措施。本期报告的分析是事后进行的，汇总了6项先前研究的数据，并适应了6项条件内母研究的不同设计。在每项研究中计算T评分、标准化反应均值和效应量的变化。当母研究设计允许时，使用线性混合模型计算已知组的有效性。结果：结果为9个PROMIS措施在一系列慢性疾病中的临床有效性提供了实质性支持。分析的交叉条件焦点提供了一个独特的和多方面的视角，PROMIS措施如何在“现实世界”中发挥作用。临床设置，并提供外部锚点，可以支持比较有效性研究。目前的9个PROMIS措施的临床有效性证据表明，NIH PROMIS在开发一系列慢性疾病有效的措施方面取得了成功。(C)2016 Elsevier Inc. All rights reserved.
Objective: To present an overview of a series of studies in which the clinical validity of the National Institutes of Health's Patient Reported Outcome Measurement Information System (NIH; PROMIS) measures was evaluated, by domain, across six clinical populations.Study Design and Setting: Approximately 1,500 individuals at baseline and 1,300 at follow-up completed PROMIS measures. The analyses reported in this issue were conducted post hoc, pooling data across six previous studies, and accommodating the different designs of the six, within-condition, parent studies. Changes in T-scores, standardized response means, and effect sizes were calculated in each study. When a parent study design allowed, known groups validity was calculated using a linear mixed model.Results: The results provide substantial support for the clinical validity of nine PROMIS measures in a range of chronic conditions.Conclusion: The cross-condition focus of the analyses provided a unique and multifaceted perspective on how PROMIS measures function in "real-world" clinical settings and provides external anchors that can support comparative effectiveness research. The current body of clinical validity evidence for the nine PROMIS measures indicates the success of NIH PROMIS in developing measures that are effective across a range of chronic conditions. (C) 2016 Elsevier Inc. All rights reserved.