Document Detail

Comparison of data mining methodologies using Japanese spontaneous reports.
MedLine Citation:
PMID:  15170768     Owner:  NLM     Status:  MEDLINE    
PURPOSE: Five data mining methodologies for detecting a possible signal from spontaneous reports on adverse drug reactions (ADRs) were compared. METHODS: The five methodologies, the Bayesian method using the Gamma Poissson Shrinker (GPS), the method employed in the UK Medicines Control Agency (MCA), the Bayesian Confidence Propagation Neural Network (BCPNN), the method using the 95% confidence interval (CI) for the reporting odds ratio (RORCI) and that using the 95% CI of the proportional reporting ratio (PRRCI) were compared using Japanese data obtained between 1998 and 2000. RESULTS: There were all in all 38,731 drug-ADR combinations. The count of drug-ADR pairs was equal to 1 or 2 for 31,230 combinations and none of them were identified as a possible signal with the MCA or BCPNN. Similarly, the GPS detected a possible signal in none of the combinations where the count was equal to 1 but in 7.5% of the combinations where the count was equal to 2. The RORCI and PRRCI detected a possible signal in more than half of the combinations where the count was equal to 1 or 2. When the pairwise agreement on whether or not a drug-ADR combination satisfied the criteria for a possible signal was assessed for the 38,731 combinations, the concordance measure kappa was greater than 0.9 between the MCA and BCPNN and between the RORCI and PRRCI. Kappa was around 0.6 between the GPS and MCA and between the GPS and BCPNN. Otherwise, kappa was smaller than 0.2. CONCLUSIONS: The drug-ADR combinations detected as a possible signal vary between different methodologies.
Kiyoshi Kubota; Daisuke Koide; Toshiki Hirai
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Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Pharmacoepidemiology and drug safety     Volume:  13     ISSN:  1053-8569     ISO Abbreviation:  Pharmacoepidemiol Drug Saf     Publication Date:  2004 Jun 
Date Detail:
Created Date:  2004-06-01     Completed Date:  2004-10-07     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9208369     Medline TA:  Pharmacoepidemiol Drug Saf     Country:  England    
Other Details:
Languages:  eng     Pagination:  387-94     Citation Subset:  IM    
Copyright Information:
Copyright 2004 John Wiley & Sons, Ltd.
Department of Pharmacoepidemiology, Faculty of Medicine, University of Tokyo, Bunkyo-ku, Tokyo, Japan.
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MeSH Terms
Adverse Drug Reaction Reporting Systems*
Bayes Theorem
Confidence Intervals
Information Storage and Retrieval*
Neural Networks (Computer)
Odds Ratio
Pharmacoepidemiology / methods*
Poisson Distribution
Sensitivity and Specificity

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