Document Detail

Comparison of the global statistical test and composite outcome for secondary analyses of multiple coronary heart disease outcomes.
MedLine Citation:
PMID:  22226004     Owner:  NLM     Status:  MEDLINE    
Multiple outcomes (or multiple endpoints), such as mortality and recurrent myocardial infarction, are increasingly common in clinical trials and are often of interest in secondary analyses. Traditionally, a clinical trial protocol is built around a single event as its primary outcome, with several secondary outcomes specified, the analyses for which lack the same level of power. To accommodate all the relevant outcomes and to increase the power of the comparison in trials evaluating the efficacy of treatments for coronary heart disease, investigators often chose to construct a composite outcome. The more conventional composite outcome fails to account for the relative importance and the relationship (correlation) among its components. The purpose of this work is to demonstrate the usefulness of the Global Statistical Test, which considers the correlation between multiple outcomes, as an alternative strategy for these situations and to demonstrate its effect on hypothesis testing and power analysis issues in comparison with the traditional composite outcome analysis. Data from the cardiovascular clinical trial Systolic Hypertension in the Elderly Population are used as an example.
Sarah Baraniuk; Roann Seay; Arup K Sinha; Linda B Piller
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Publication Detail:
Type:  Comparative Study; Journal Article    
Journal Detail:
Title:  Progress in cardiovascular diseases     Volume:  54     ISSN:  1873-1740     ISO Abbreviation:  Prog Cardiovasc Dis     Publication Date:    2012 Jan-Feb
Date Detail:
Created Date:  2012-01-09     Completed Date:  2012-02-23     Revised Date:  2014-06-26    
Medline Journal Info:
Nlm Unique ID:  0376442     Medline TA:  Prog Cardiovasc Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  357-61     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012 Elsevier Inc. All rights reserved.
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MeSH Terms
Coronary Disease / complications,  mortality,  therapy*
Data Interpretation, Statistical*
Logistic Models
Models, Statistical
Outcome Assessment (Health Care)*
Randomized Controlled Trials as Topic / statistics & numerical data*
Statistics as Topic
Treatment Outcome
Grant Support

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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