| Graphic reanalysis of the two NINDS-tPA trials confirms substantial treatment benefit. | |
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MedLine Citation:
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PMID: 20829518 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND AND PURPOSE: Multiple statistical analyses of the 2 NINDS-tPA trials have confirmed study findings of benefit of fibrinolytic therapy. A recent graphic analysis departed from best practices in the visual display of quantitative information by failing to take into account the skewed functional importance of NIH Stroke Scale raw scores and by scaling change axes at up to 20 times the range achievable by individual patients. METHODS: Using the publicly available datasets of the 2 NINDS-tPA trials, we generated a variety of figures appropriate to the characteristics of acute stroke trial data. RESULTS: A diverse array of figures all visually delineated substantial benefits of fibrinolytic therapy, including: bar charts of normalized gain and loss; stacked bar, bar, and matrix plots of clinically relevant ordinal ranks; a time series stacked line plot of continuous scale disability weights; and line plot, bubble chart, and person icon array graphs of joint outcome table analysis. The achievable change figure showed substantially greater improvement among tPA than placebo patients, median 66.7% (interquartile range, 0 to 92.0) versus 50.0% (interquartile range, -7.1 to 80.0), P=0.003. CONCLUSIONS: On average, under 3 hour patients treated with tPA recovered two-thirds while placebo patients improved only half of the way toward fully normal. Graphical analyses of the 2 NINDS-tPA trials, when performed according to best practices, is a useful means of conveying details about patient response to therapy not fully delineated by summary statistics, and confirms a valuable treatment benefit of under 3 hour fibrinolytic therapy in acute stroke. |
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Authors:
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Jeffrey L Saver; Jeffrey Gornbein; Sidney Starkman |
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Publication Detail:
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Type: Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't Date: 2010-09-09 |
Journal Detail:
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Title: Stroke; a journal of cerebral circulation Volume: 41 ISSN: 1524-4628 ISO Abbreviation: Stroke Publication Date: 2010 Oct |
Date Detail:
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Created Date: 2010-09-29 Completed Date: 2010-10-19 Revised Date: 2012-04-27 |
Medline Journal Info:
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Nlm Unique ID: 0235266 Medline TA: Stroke Country: United States |
Other Details:
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Languages: eng Pagination: 2381-90 Citation Subset: IM |
Affiliation:
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Stroke Center and Department of Neurology, David Geffen School of Medicine, University of California Los Angeles, Calif 90095, USA. jsaver@ucla.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Brain Ischemia
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drug therapy* Clinical Trials as Topic Fibrinolytic Agents / therapeutic use Humans National Institute of Neurological Disorders and Stroke Stroke / drug therapy* Tissue Plasminogen Activator / therapeutic use* Treatment Outcome United States |
| Grant Support | |
ID/Acronym/Agency:
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P50 NS044378/NS/NINDS NIH HHS; U01 NS 44364/NS/NINDS NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Fibrinolytic Agents; EC 3.4.21.68/Tissue Plasminogen Activator |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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