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EU-ADR healthcare database network vs. spontaneous reporting system database: preliminary comparison of signal detection.
https://arctichealth.org/en/permalink/ahliterature101665
Source
Stud Health Technol Inform. 2011;166:25-30
Publication Type
Article
Date
2011
More detail
Author
Gianluca Trifirò
Vaishali Patadia
Martijn J Schuemie
Preciosa M Coloma
Rosa Gini
Ron Herings
Julia Hippisley-Cox
Giampiero Mazzaglia
Carlo Giaquinto
Lorenza Scotti
Lars Pedersen
Paul Avillach
Miriam C J M Sturkenboom
Johan van der Lei
Eu-Adr Group
Author Affiliation
Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands. g.trifiro@erasmusmc.nl
Source
Stud Health Technol Inform. 2011;166:25-30
Date
2011
Language
English
Publication Type
Article
Keywords
Adverse Drug Reaction Reporting Systems - organization & administration
Data Mining - methods
Databases, Factual - statistics & numerical data
Drug Toxicity - epidemiology
Europe
Humans
Medical Records Systems, Computerized - statistics & numerical data
United States
United States Food and Drug Administration
World Health Organization
Abstract
The EU-ADR project aims to exploit different European electronic healthcare records (EHR) databases for drug safety signal detection. In this paper we report the preliminary results concerning the comparison of signal detection between EU-ADR network and two spontaneous reporting databases, the Food and Drug Administration and World Health Organization databases. EU-ADR data sources consist of eight databases in four countries (Denmark, Italy, Netherlands, and United Kingdom) that are virtually linked through distributed data network. A custom-built software (Jerboa©) elaborates harmonized input data that are produced locally and generates aggregated data which are then stored in a central repository. Those data are subsequently analyzed through different statistics (i.e. Longitudinal Gamma Poisson Shrinker). As potential signals, all the drugs that are associated to six events of interest (bullous eruptions - BE, acute renal failure - ARF, acute myocardial infarction - AMI, anaphylactic shock - AS, rhabdomyolysis - RHABD, and upper gastrointestinal bleeding - UGIB) have been detected via different data mining techniques in the two systems. Subsequently a comparison concerning the number of drugs that could be investigated and the potential signals detected for each event in the spontaneous reporting systems (SRSs) and EU-ADR network was made. SRSs could explore, as potential signals, a larger number of drugs for the six events, in comparison to EU-ADR (range: 630-3,393 vs. 87-856), particularly for those events commonly thought to be potentially drug-induced (i.e. BE: 3,393 vs. 228). The highest proportion of signals detected in SRSs was found for BE, ARF and AS, while for ARF, and UGIB in EU-ADR. In conclusion, it seems that EU-ADR longitudinal database network may complement traditional spontaneous reporting system for signal detection, especially for those adverse events that are frequent in general population and are not commonly thought to be drug-induced. The methodology for signal detection in EU-ADR is still under development and testing phase.
PubMed ID
21685607
View in PubMed
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