Responsiveness, effect size, and smallest detectable difference of Magnetic Resonance Imaging in knee osteoarthritis

Responsiveness, effect size, and smallest detectable difference of Magnetic Resonance Imaging in knee osteoarthritis
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DOI:
10.1016/j.joca.2006.02.027
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发表时间:
2006-01-01
影响因子:
7
通讯作者:
Genant, H. K.
Genant, H. K.
中科院分区:
医学2区
文献类型:
--
作者:
Hunter, D. J.;Conaghan, P. G.;Genant, H. K.

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目的:本研究的目的是确定两种磁共振成像(MRI)测量膝关节骨关节炎(OA)的反应性、效应量(ES)和最小可检测差异(SDD):全器官半定量评估和软骨体积。设计:这项分析是在一项随机、双盲试验的数据集上进行的(Roche NI-15713)于1998年在轻度-中度膝关节OA受试者中进行了一项新疗法的研究,基线和6个月随访时进行了MRI检查。试验测量包括(1)使用专有软件方法测量的软骨体积;和(2)使用全器官MRI评分(蠕虫)对OA膝关节病理学的“全器官”评价重要的其他参数进行半定量评分。分析首先检查了蠕虫项目的分布特征,如软骨形态。标准化反应平均值(SRM),ES,和SDD之间的基线和6个月的后续计算在整个组和安慰剂组单独。结果:在一般情况下,差异很小,这是反映在小ES和SRM。也有一个建议的治疗效果与减少基线和后续的治疗group.Conclusion之间的差异:MRI半定量措施,软骨形态,滑膜炎和骨赘似乎是响应的变化和重点重复措施应突出这些关节功能。一般来说,ES和SRM都很小。(C)2006年国际骨关节炎研究学会。由爱思唯尔有限公司出版。保留所有权利。
Objective: The aim of this study was to determine the responsiveness, effect size (ES) and smallest detectable difference (SDD) of two Magnetic Resonance Imaging (MRI) measures for osteoarthritis (OA) of the knee: a whole-organ semiquantitative evaluation and cartilage volume.Design: This analysis was performed on a dataset from a randomized, double-blind trial (Roche NI-15713) conducted in 1998 of a novel therapy in subjects with mild-moderate knee OA, with MRI at baseline and 6-month follow-up. The trial measurements included (1) cartilage volume measured using a proprietary software method; and (2) semiquantitative scoring of other parameters important for "whole organ" evaluation of OA knee joint pathology, using the Whole-Organ MRI Score (WORMS). The analysis initially examined the distributional characteristics of WORMS items, such as cartilage morphology. Standardized response mean (SRM), ES, and SDD between baseline and 6-month follow-up were then calculated in the whole group and the placebo group alone.Results: In general, the differences were small and this was reflected in the small ESs and SRMs. There was also a suggestion of a treatment effect with reduction in differences between baseline and follow-up in the treatment group.Conclusion: Of the MRI semi quantitative measures, cartilage morphology, synovitis and osteophytes appeared to be responsive to change and the focus of repeat measures should highlight these articular features. In general, the ESs and SRMs were small. (C) 2006 OsteoArthritis Research Society International. Published by Elsevier Ltd. All rights reserved.