Multi-country study

Replication of the OMOP Experiment in Europe: Evaluating Methods for Risk Identification in Electronic Health Record Databases

BACKGROUND: The Observational Medical Outcomes Partnership (OMOP) has just completed a large scale empirical evaluation of statistical methods and analysis choices for risks identification in longitudinal observational healthcare data. This experimnt drew data from four large US health insurance claims databases and one US electronic health record (EHR) database, but it is unclear to what extend the findings of this study apply to other data sources

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Harmonization process for the identification of medical events in eight European healthcare databases: the experience from the EU-ADR project

OBJECTIVE: Data from electronic healthcare records (EHR) can be used to monitor drug safety, but in order to compare and pool data from different EHR databases, the extraction of potential adverse events must be harmonized. In this paper, we descrie the procedure used for harmonizing the extraction from eight European EHR databases of five events of interest deemed to be important in pharmacovigilance: acute myocardial infarction (AMI); acute renal failure (ARF); anaphylactic shock (AS); bullous eruption (BE); and rhabdomyolysis (RHABD)

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Population-based analysis of non-steroidal anti-inflammatory drug use among children in four European countries in the SOS project: what size of data platforms and which study designs do we need to assess safety issues?

BACKGROUND: Data on utilization patterns and safety of non-steroidal anti-inflammatory drugs (NSAIDs) in children are scarce. The purpose of this study was to investigate the utilization of NSAIDs among children in four European countries as part othe Safety Of non-Steroidal anti-inflammatory drugs (SOS) project

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Drug-induced acute myocardial infarction: identifying ‘prime suspects’ from electronic healthcare records-based surveillance system

BACKGROUND: Drug-related adverse events remain an important cause of morbidity and mortality and impose huge burden on healthcare costs. Routinely collected electronic healthcare data give a good snapshot of how drugs are being used in ‘real-world’settings. OBJECTIVE: To describe a strategy that identifies potentially drug-induced acute myocardial infarction (AMI) from a large international healthcare data network

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Using Electronic Health Care Records for Drug Safety Signal Detection: A Comparative Evaluation of Statistical Methods

BACKGROUND:: Drug safety monitoring relies primarily on spontaneous reporting, but electronic health care record databases offer a possible alternative for the detection of adverse drug reactions (ADRs). OBJECTIVES:: To evaluate the relative perforance of different statistical methods for detecting drug-adverse event associations in electronic health care record data representing potential ADRs

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Electronic healthcare databases for active drug safety surveillance: is there enough leverage?

PURPOSE: To provide estimates of the number and types of drugs that can be monitored for safety surveillance using electronic healthcare databases. METHODS: Using data from eight European databases (administrative claims, medical records) and in thcontext of a cohort study, we determined the amount of drug exposure required for signal detection across varying magnitudes of relative risk (RR)

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Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project

PURPOSE: In this proof-of-concept paper we describe the framework, process, and preliminary results of combining data from European electronic healthcare record (EHR) databases for large-scale monitoring of drug safety. METHODS: Aggregated demograpic, clinical, and prescription data from eight databases in four countries (Denmark, Italy, Netherlands, the UK) were pooled using a distributed network approach by generation of common input data followed by local aggregation through custom-built software, Jerboa((c))

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EU-ADR healthcare database network vs. spontaneous reporting system database: preliminary comparison of signal detection

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 netwok and two spontaneous reporting databases, the Food and Drug Administration and World Health Organization databases

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