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Empirical assessment of case-based methods for identification of drugs associated with upper gastrointestinal bleeding in the French National Healthcare System database (SNDS)

dc.rights.licenseopenen_US
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorTHURIN, Nicolas
dc.contributor.authorLASSALLE, R.
dc.contributor.authorSCHUEMIE, M.
dc.contributor.authorPENICHON, M.
dc.contributor.authorGAGNE, J. J.
dc.contributor.authorRASSEN, J. A.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBENICHOU, Jacques
dc.contributor.authorWEILL, A.
dc.contributor.authorBLIN, Patrick
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorMOORE, Nicholas
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorDROZ-PERROTEAU, Cécile
dc.date.accessioned2021-02-18T15:42:41Z
dc.date.available2021-02-18T15:42:41Z
dc.date.issued2020
dc.identifier.issn1099-1557 (Electronic) 1053-8569 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/26293
dc.description.abstractEnPurpose Upper gastrointestinal bleeding (UGIB) is a severe and frequent drug‐related event. In order to enable efficient drug safety alert generation in the French National Healthcare System database (SNDS), we assessed and calibrated empirically case‐based designs to identify drug associated with UGIB risk. Methods All cases of UGIB were extracted from SNDS (2009‐2014) using two definitions. Positive and negative drug controls were used to compare 196 self‐controlled case series (SCCS), case‐control (CC) and case‐population (CP) design variants. Each variant was evaluated in a 1/10th population sample using area under the receiver operating curve (AUC) and mean square error (MSE). Parameters that had major impacts on results were identified through logistic regression. Optimal designs were replicated in the unsampled population. Results Using a specific UGIB definition, AUCs ranged from 0.64 to 0.80, 0.44 to 0.61 and 0.50 to 0.67, for SCCS, CC and CP, respectively. MSE ranged from 0.07 to 0.39, 0.83 to 1.33 and 1.96 to 4.6, respectively. Univariate regressions showed that high AUCs were achieved with SCCS with multiple drug adjustment and a 30‐day risk window starting at exposure. The top‐performing SCCS variant in the unsampled population yielded an AUC = 0.84 and MSE = 0.14, with 10/36 negative controls presenting significant estimates. Conclusions SCCS adjusting for multiple drugs and using a 30‐day risk window has the potential to generate UGIB‐related alerts in the SNDS and hypotheses on its potential population impact. Negative control implementation highlighted that low systematic error was generated but that protopathic bias and confounding by indication remained unaddressed issues.
dc.language.isoENen_US
dc.subjectPharmacoEpi-Drugs
dc.title.enEmpirical assessment of case-based methods for identification of drugs associated with upper gastrointestinal bleeding in the French National Healthcare System database (SNDS)
dc.title.alternativePharmacoepidemiol Drug Safen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1002/pds.5038en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed32524701en_US
bordeaux.journalPharmacoepidemiology and Drug Safetyen_US
bordeaux.page890-903en_US
bordeaux.volume29en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - U1219en_US
bordeaux.issue8en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamPharmacoEpi-Drugsen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03145899
hal.version1
hal.date.transferred2021-02-18T15:42:46Z
hal.exporttrue
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