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Multi-country study Publications

Multi-country study Publications

  • Systemic antibiotic prescribing to paediatric outpatients in 5 European countries: a population-based cohort study.Abstract

    BACKGROUND: To describe the utilisation of antibiotics in children and adolescents across 5 European countries based on the same drug utilisation measures and age groups. Special attention was given to age-group-specific distributions of antibioticsubgroups, since comparison in this regard between countries is lacking so far

    Holstiege J, Schink T, Molokhia M, Mazzaglia G, Innocenti F, Oteri A, Bezemer I, Poluzzi E, Puccini A, Ulrichsen SP, Sturkenboom MC, Trifiro G, Garbe E. BMC Pediatr. 2014 14 174.
  • Replication of the OMOP Experiment in Europe: Evaluating Methods for Risk Identification in Electronic Health Record Databases.Abstract

    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

    Schuemie MJ, Gini R, Coloma PM, Straatman H, Herings RM, Peder sen L, Innocenti F, Mazzaglia G, Picelli G, van der Lei J, Sturkenboom MC. Drug Saf. 2013 Oct; 36 Suppl 1 159-69.
  • Risk of fracture with thiazolidinediones: an individual patient data meta-analysis.Abstract

    Background: The use of thiazolidinediones (TZDs) has been associated with increased fracture risks. Our aim was to estimate the risk of fracture with TZDs in three different healthcare registries, using exactly the same study design, and to performan individual patient data meta-analysis of these three studies

    Bazelier MT, de Vries F, Vestergaard P, Herings RM, Gallagher AM, Leufkens HG, van Staa TP. Front Endocrinol (Lausanne). 2013 4 11.
  • 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?.Abstract

    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

    Valkhoff VE, Schade R, tJong GW, Romio S, Schuemie MJ, Arfe A, Garbe E, Herings R, Lucchi S, Picelli G, Schink T, Straatman H, Villa M, Kuipers EJ, Sturkenboom MC, investigatorsofTheSafetyofNon-steroidalAnti-inflammatoryDrugs project. BMC Pediatr. 2013 13 192.
  • Harmonization process for the identification of medical events in eight European healthcare databases: the experience from the EU-ADR project.Abstract

    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)

    Avillach P, Coloma PM, Gini R, Schuemie M, Mougin F, Dufour JC, Mazzaglia G, Giaquinto C, Fornari C, Herings R, Molokhia M, Peder sen L, Fourrier-Reglat A, Fieschi M, Sturkenboom M, van der Lei J, Pariente A, Trifiro G. J Am Med Inform Assoc. 2013 Jan 1; 20 (1): 184-192.
  • Drug-induced acute myocardial infarction: identifying ‘prime suspects’ from electronic healthcare records-based surveillance system.Abstract

    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

    Coloma PM, Schuemie MJ, Trifiro G, Furlong L, van Mulligen E, Bauer-Mehren A, Avillach P, Kors J, Sanz F, Mestres J, Oliveira JL, Boyer S, Helgee EA, Molokhia M, Matthews J, Prieto-Merino D, Gini R, Herings R, Mazzaglia G, Picelli G, Scotti L, Peder sen L, van der Lei J, Sturkenboom M, consortium Eu-Adr. PLoS One. 2013 8 (8): e72148.
  • Using Electronic Health Care Records for Drug Safety Signal Detection: A Comparative Evaluation of Statistical Methods.Abstract

    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

    Schuemie MJ, Coloma PM, Straatman H, Herings RM, Trifiro G, Matthews JN, Prieto-Merino D, Molokhia M, Peder sen L, Gini R, Innocenti F, Mazzaglia G, Picelli G, Scotti L, van der Lei J, Sturkenboom MC. Med Care. 2012 Oct; 50 (10): 890-897.
  • Electronic healthcare databases for active drug safety surveillance: is there enough leverage?.Abstract

    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)

    Coloma PM, Trifiro G, Schuemie MJ, Gini R, Herings R, Hippisley-Cox J, Mazzaglia G, Picelli G, Corrao G, Peder sen L, van der Lei J, Sturkenboom M. Pharmacoepidemiol Drug Saf. 2012 Jun; 21 (6): 611-21.
  • Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project.Abstract

    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))

    Coloma PM, Schuemie MJ, Trifiro G, Gini R, Herings R, Hippisley-Cox J, Mazzaglia G, Giaquinto C, Corrao G, Peder sen L, van der Lei J, Sturkenboom M. Pharmacoepidemiol Drug Saf. 2011 Jan; 20 (1): 1-11.
  • EU-ADR healthcare database network vs. spontaneous reporting system database: preliminary comparison of signal detection.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 netwok and two spontaneous reporting databases, the Food and Drug Administration and World Health Organization databases

    Trifiro G, Patadia V, Schuemie MJ, Coloma PM, Gini R, Herings R, Hippisley-Cox J, Mazzaglia G, Giaquinto C, Scotti L, Peder sen L, Avillach P, Sturkenboom MC, van der Lei J, Eu-Adr Group. Stud Health Technol Inform. 2011 166 25-30.