Document Detail

The role of the critical event committee in a major cardiovascular outcome study.
MedLine Citation:
PMID:  12523676     Owner:  NLM     Status:  MEDLINE    
Outcome studies in cardiovascular diseases such as hypertension are often based in a number of countries recruiting from multiple centres. This can lead to difficulties in end-point evaluation and classification. The INSIGHT study provided the unique opportunity to examine the role and usefulness of a Critical Event Committee (CEC) established to examine all events occurring in a cohort of 6321 patients and classifying them according to pre-determined criteria. More than 28% of investigator-coded primary events and more than 41% of secondary events were re-classified by the CEC. Particularly difficult diagnoses included myocardial infarction, angina and heart failure, and the database finally analysed was substantially altered after CEC Committee evaluation. Post hoc analysis of the INSIGHT database demonstrated that the primary events compared would have been reduced from 6.3% vs 5.8% of those randomized on nifedipine vs co-amilozide to 5.1% vs 4.7%--an overall reduction of 72 events of 382, a fall of 18.8%. We conclude that a CEC should be a crucial component of any large outcome study and that if all events are subjected to scrutiny, the quality of the database is greatly enhanced.
Anthony Heagerty; Anne Deverly; Christopher Palmer; Elieser Kaplinsky; Antonio Salvetti; Nils-Gunnar Wahlgren; Christian Funck-Brentano
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Blood pressure     Volume:  11     ISSN:  0803-7051     ISO Abbreviation:  Blood Press.     Publication Date:  2002  
Date Detail:
Created Date:  2003-01-13     Completed Date:  2003-06-23     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9301454     Medline TA:  Blood Press     Country:  Norway    
Other Details:
Languages:  eng     Pagination:  339-44     Citation Subset:  IM    
Department of Medicine, University of Manchester, UK.
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MeSH Terms
Calcium Channel Blockers / therapeutic use
Cardiovascular Diseases / complications,  mortality,  therapy*
Clinical Trials as Topic*
Hypertension / drug therapy
Nifedipine / therapeutic use
Research Design
Sentinel Surveillance*
Treatment Outcome
Reg. No./Substance:
0/Calcium Channel Blockers; 21829-25-4/Nifedipine

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

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