Inter-session reliability of electrical impedance myography in children in a clinical trial setting.

Inter-session reliability of electrical impedance myography in children in a clinical trial setting.
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DOI:
10.1016/j.clinph.2014.11.017
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发表时间:
2015-09
期刊:
Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology
影响因子:
--
通讯作者:
Darras BT
Darras BT
中科院分区:
其他
文献类型:
--
作者:
Geisbush TR;Visyak N;Madabusi L;Rutkove SB;Darras BT

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高可靠性是任何测试在临床试验中用作生物标志物的先决条件。在这里,我们评估了电阻抗肌电图(EIM)在儿童中的再现性,通过比较不同的评价者在不同的日子获得的数据。2-14岁的健康男孩和患有杜氏肌营养不良症(DMD)的男孩在间隔3-7天的两次访视中由两名评估者进行多块肌肉的EIM。单频和多频数据进行了分析。通过计算相对标准偏差百分比(% RSD)、Bland-Altman分析和组内相关系数(ICC)评估可靠性。对于单个肌肉数据和跨肌肉的平均数据,评价者内测量显示50 kHz相位和50/200 kHz相位比值具有高重复性,ICC通常高于0.90,% RSD低于10%。评价者间结果显示ICC和% RSD值与同一评价者获得的结果非常相似。50 kHz相位和50/200 kHz相位比都是跨时间和评估者以及健康和疾病的可靠测量。这些结果支持的概念,EIM可以作为一个可靠的措施,在儿科人群的临床治疗试验。
High reliability is a prerequisite for any test to be useful as a biomarker in a clinical trial. Here we assessed the reproducibility of electrical impedance myography (EIM) in children by comparing data obtained by different evaluators on separate days. Healthy boys and boys with Duchenne muscular dystrophy (DMD) aged 2-14 years underwent EIM of multiple muscles performed by two evaluators on two visits separated by 3-7 days. Single and multifrequency data were analyzed. Reliability was assessed via calculation of the percent relative standard deviation (% RSD), Bland-Altman analysis, and the intraclass correlation coefficient (ICC). For both individual muscle data and data averaged across muscles, intra-evaluator measurements showed high repeatability for both 50 kHz phase and 50/200 kHz phase ratio values, with ICCs generally above 0.90 and % RSD below 10%. Inter-evaluator results showed very similar ICC and % RSD values as those obtained by the same evaluator. Both the 50 kHz phase and 50/200kHz phase ratio are reliable measures both across time and evaluators and in both health and disease. These results support the concept that EIM can serve as a reliable measure in clinical therapeutic trials in a pediatric population.
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发表时间: 2014-06
期刊: Muscle & nerve
影响因子: 3.4
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影响因子: 3.2
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