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Repeated-measures analysis of the National Institute of Neurological Disorders and Stroke rt-PA stroke trial.

Author(s): Feng W, Vasquez G, Suri MF, Lakshminarayan K, Qureshi AI

Affiliation(s): Department of Neurosciences, Medical University of South Carolina, 96 Jonathan Lucas Street, Charleston, SC 29425, USA. feng@musc.edu

Publication date & source: 2011-05, J Stroke Cerebrovasc Dis., 20(3):241-6. Epub 2010 Jul 10.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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 NINDS 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. Copyright (c) 2011 National Stroke Association. All rights reserved.

Page last updated: 2011-12-09

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