Repeated-Measures Analysis of the National Institute of Neurological Disorders and Stroke rt-PA Stroke Trial
Repeated-Measures Analysis of the National Institute of Neurological Disorders and Stroke rt-PA Stroke Trial
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DOI：
10.1016/j.jstrokecerebrovasdis.2010.01.003
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发表时间：
2011-05-01
影响因子：
2.5
通讯作者：
Qureshi, Adnan I.
中科院分区：
文献类型：
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作者：
Feng, Wuwei;Vasquez, Gabriela;Qureshi, Adnan I.
先前的分析，包括国家神经疾病和卒中研究所（NINDS） rt-PA Stoke试验，仅在单个研究点评估了临床治疗疗效，但没有使用多个时间点收集的结果评估疗效并纳入患者内部相关性。来自MINDS rt-PA卒中试验的数据采用广义估计方程（GEE）方法进行重复测量分析，采用二分类结果（修正Rankin量表[mRS]、美国国立卫生研究院卒中量表[NIHSS]、Barthel指数[BI]和格拉斯哥结局量表[GOS]）。结果与先前的分析数据进行了比较。不同时间点各结局变量均有显著相关。rt-PA总体上优于安慰剂，个别特定时间点优于安慰剂。接受rt-PA治疗的患者患轻度或无残疾（mRS评分0或1）的总几率高于接受安慰剂治疗的患者（优势比[or]， 2.1； 95%可信区间[CI]， 1.5-3.0）。3个月时的or是2.3 （95% CI, 1.5-3.4）倍，6个月时的or是1.9 （95% CI, 1.3-2.8）倍，12个月时的or是2.0 （95% CI, 1.3-2.9）倍。NIHSS、BI和GOS也观察到类似的治疗效果。与以往的分析相比，观察到更大的or值和更小的P值的增强治疗效果。正如NINDS rt-PA卒中试验数据分析所证明的那样，重复测量分析为评估治疗效果提供了另一种方法。该方法可用于在多个时间点收集感兴趣的结果的未来卒中试验。
Previous analyses, including the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA Stoke Trial, have assessed the clinical treatment efficacy only at single study point, but did not assess efficacy using outcomes collected at multiple time points and incorporate within-patient correlation. The data from the MINDS rt-PA Stroke Trial was analyzed with repeated-measures analysis with generalized estimating equations (GEE) approach using dichotomized outcomes (modified Rankin Scale [mRS], National Institutes of Health Stroke Scale [NIHSS], Barthel Index [BI], and Glasgow Outcome Scale [GOS]). The results were compared with data from previous analyses. All of the outcome variables at different time points were significantly correlated. rt-PA was superior to placebo overall and at specific time points individually. The overall odds of having minimal or no disability (mRS score 0 or 1) for patients treated with rt-PA was higher than those treated with placebo (odds ratio [OR], 2.1; 95% confidence interval [CI], 1.5-3.0). The ORs were 2.3 (95% CI, 1.5-3.4) times higher at 3 months, 1.9 (95% CI, 1.3-2.8) times higher at 6 months, and 2.0 (95% CI, 1.3-2.9) times higher at 12 months. A similar treatment effect also was observed with the NIHSS, BI, and GOS. Compared with previous analyses, an augmented treatment effect with larger ORs and smaller P values were observed. Repeated-measures analysis provides an alternative method for assessing treatment effect, as demonstrated in the analysis of data from the NINDS rt-PA Stroke Trial. This method could be used in future stroke trials in which outcomes of interest are collected at multiple time points.