Document Detail


An evaluation of central laboratories in three VA cooperative studies.
MedLine Citation:
PMID:  2189186     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
We compared central laboratory with local determinations of key clinical measurements in three VA Cooperative Studies. Electrocardiographic evidence of new myocardial infarction was assessed in the study of Aspirin Therapy and Unstable Angina, ejection fraction measurement in the Coronary Artery Bypass Surgery Trial and lesion size in the Angioplasty Compared with Medicine (ACME) Trial. The findings in the Aspirin Trial indicated that central coding of all serial electrocardiograms in 1266 patients to detect new acute myocardial infarction by computer algorithm was not cost-effective when compared with the local investigator's diagnosis on the basis of a central Electrocardiographic Committee as the reference standard. In the other two trials, the contribution of the central laboratories was important because the assessments of the local investigators generally underestimated the degree of abnormality in the Bypass Trial and overestimated it in the ACME Trial. The VA results have clearly demonstrated two cases in which the decision for central evaluation was prudent, but one case in which it was not cost-effective. These equivocal findings indicate the need to evaluate the contribution of central laboratories when used as an adjunct to local determinations. Such evaluations may provide guidelines for decision-making in the design of future trials.
Authors:
P Peduzzi; P Hartigan; G Johnson
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Publication Detail:
Type:  Journal Article; Research Support, U.S. Gov't, Non-P.H.S.    
Journal Detail:
Title:  Statistics in medicine     Volume:  9     ISSN:  0277-6715     ISO Abbreviation:  Stat Med     Publication Date:    1990 Jan-Feb
Date Detail:
Created Date:  1990-06-29     Completed Date:  1990-06-29     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  125-34; discussion 135-6     Citation Subset:  IM    
Affiliation:
Cooperative Studies Program Coordinating Center, VA Medical Center, West Haven, CT 06516.
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MeSH Terms
Descriptor/Qualifier:
Angioplasty, Transluminal, Percutaneous Coronary
Aspirin / therapeutic use
Coronary Artery Bypass
Coronary Disease / complications,  therapy
Costs and Cost Analysis
Electrocardiography
Humans
Laboratories* / economics,  organization & administration
Male
Multicenter Studies as Topic*
Myocardial Infarction / diagnosis,  etiology,  prevention & control
Research Design
Stroke Volume
United States
United States Department of Veterans Affairs
Chemical
Reg. No./Substance:
50-78-2/Aspirin

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


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