Document Detail


Methods for the analysis of bleeding outcomes in randomized trials of PLT transfusion triggers.
MedLine Citation:
PMID:  15265116     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: A number of methodologic challenges arise in the analysis of bleeding data from clinical trials of PLT transfusion triggers. It is important to understand the assumptions and role of the various methods of analysis to interpret published trials and to design future studies appropriately. STUDY DESIGN AND METHODS: The methods of analysis used for testing the effectiveness and safety of transfusion strategies are reviewed from several recent PLT transfusion trigger trials. The underlying assumptions of these methods are discussed, as well as the clinical interpretations of the resulting summary statistics. Four methods of analysis were applied to data from a large PLT transfusion trigger study to illustrate the differences in the interpretations that can arise from various approaches. RESULTS: PLT transfusion trigger trials of patients with leukemia have based their primary analyses on 1) simple dichotomous classifications of whether or not at least 1 day of clinically important bleeding was experienced; 2) the time to the first day of clinically important bleeding; and 3) the proportion of days at risk with clinically important bleeding. Recurrent event methods provide a robust alternative approach to the analysis of this kind of data and should be considered if interest is in capturing the overall burden of bleeding over time. These four methods differ in the extent to which they utilize information on the number of days with bleeding and the temporal variation in bleeding patterns. Inferences drawn regarding the relative safety and efficacy of different transfusion triggers can vary depending on the method of analysis. CONCLUSION: To rigorously design and analyze future PLT transfusion studies based on bleeding outcomes, it is important to have a clear understanding of the interpretation of the different ways of analyzing bleeding outcomes. The analysis strategy should be selected based on the clinical question being addressed.
Authors:
R J Cook; N M Heddle; P Rebulla; C S Sigouin; K E Webert;
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Transfusion     Volume:  44     ISSN:  0041-1132     ISO Abbreviation:  Transfusion     Publication Date:  2004 Aug 
Date Detail:
Created Date:  2004-07-21     Completed Date:  2004-08-19     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0417360     Medline TA:  Transfusion     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1135-42     Citation Subset:  IM    
Affiliation:
Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, Ontario, Canada.
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MeSH Terms
Descriptor/Qualifier:
Hemorrhage / etiology*
Humans
Platelet Transfusion / adverse effects*
Randomized Controlled Trials as Topic*
Recurrence
Research Design
Treatment Outcome

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


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