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A meta-epidemiological study found lack of transparency and poor reporting of disproportionality analyses for signal detection in pharmacovigilance databases

dc.rights.licenseopenen_US
dc.contributor.authorKHOURI, Charles
dc.contributor.authorREVOL, Bruno
dc.contributor.authorLEPELLEY, Marion
dc.contributor.authorMOUFFAK, Amelle
dc.contributor.authorBERNARDEAU, Claire
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorSALVO, Francesco
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorPARIENTE, Antoine
IDREF: 13395711X
dc.contributor.authorROUSTIT, Matthieu
dc.contributor.authorCRACOWSKI, Jean-Luc
dc.date.accessioned2021-10-04T08:56:22Z
dc.date.available2021-10-04T08:56:22Z
dc.date.issued2021-07-27
dc.identifier.issn0895-4356en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/112536
dc.description.abstractEnOBJECTIVE: To review and appraise methods and reporting characteristics of pharmacovigilance disproportionality analyses. STUDY DESIGN AND SETTING: We randomly selected 100 disproportionality analyses indexed in Medline found during a systematic literature search. We then extracted and synthetized methodological and reporting characteristics using 7 key items: 1) title transparency; 2) protocol pre-registration; 3) date of data extraction and analysis; 4) outcome, population, exposure and comparator definitions; 5) adjustment and stratification of results; 6) method and threshold for signal detection; 7) secondary and sensitivity analyses. RESULTS: We found that methods used to generate disproportionality signals were extremely heterogeneous; there were nearly as many unique analyses as studies. The authors used various populations, methods, signal detection thresholds, adjustment or stratification variables, generally without justification for their choice or pre-specification in protocols. Moreover, 78% of studies failed to report methods for case, adverse drug reactions or comparator selection and 32 studies did not define the threshold for signal generation. CONCLUSION: Our survey raises major concerns regarding all aspects of disproportionality analyses that could lead to misleading results and generate unjustified alarms. We advocate for a strong and transparent rationale for variable selection, choice of population and comparators pre-specified in a protocol and assessed by sensitivity analyses.
dc.language.isoENen_US
dc.subject.enPharmacovigilance
dc.subject.enDisproportionality analyses
dc.subject.enSignal detection
dc.subject.enTransparency
dc.subject.enReporting
dc.title.enA meta-epidemiological study found lack of transparency and poor reporting of disproportionality analyses for signal detection in pharmacovigilance databases
dc.typeArticle de revue
dc.identifier.doi10.1016/j.jclinepi.2021.07.014en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed34329725en_US
bordeaux.journalJournal of Clinical Epidemiologyen_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamPharmacoEpi-Drugsen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03363722
hal.version1
hal.date.transferred2021-10-04T08:56:27Z
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
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