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The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration

dc.rights.licenseopenen_US
dc.contributor.authorFUSAROLI, Michele
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorSALVO, Francesco
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBEGAUD, Bernard
dc.contributor.authorALSHAMMARI, Thamir M
dc.contributor.authorBATE, Andrew
dc.contributor.authorBATTINI, Vera
dc.contributor.authorBRUECKNER, Andreas
dc.contributor.authorCANDORE, Gianmario
dc.contributor.authorCARNOVALE, Carla
dc.contributor.authorCRISAFULLI, Salvatore
dc.contributor.authorCUTRONEO, Paola Maria
dc.contributor.authorDOLLADILLE, Charles
dc.contributor.authorDRICI, Milou-Daniel
dc.contributor.authorFAILLIE, Jean-Luc
dc.contributor.authorGOLDMAN, Adam
dc.contributor.authorHAUBEN, Manfred
dc.contributor.authorHERDEIRO, Maria Teresa
dc.contributor.authorMAHAUX, Olivia
dc.contributor.authorMANLIK, Katrin
dc.contributor.authorMONTASTRUC, Francois
dc.contributor.authorNOGUCHI, Yoshihiro
dc.contributor.authorNOREN, G Niklas
dc.contributor.authorNOSEDA, Roberta
dc.contributor.authorONAKPOYA, Igho J
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorPARIENTE, Antoine
dc.contributor.authorPOLUZZI, Elisabetta
dc.contributor.authorSALEM, Myriam
dc.contributor.authorSARTORI, Daniele
dc.contributor.authorTRINH, Nhung T H
dc.contributor.authorTUCCORI, Marco
dc.contributor.authorVAN HUNSEL, Florence
dc.contributor.authorVAN PUIJENBROEK, Eugene
dc.contributor.authorRASCHI, Emanuel
dc.contributor.authorKHOURI, Charles
dc.date.accessioned2024-08-22T09:45:52Z
dc.date.available2024-08-22T09:45:52Z
dc.date.issued2024-06-01
dc.identifier.issn1179-1942en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/201248
dc.description.abstractEnIn pharmacovigilance, disproportionality analyses based on individual case safety reports are widely used to detect safety signals. Unfortunately, publishing disproportionality analyses lacks specific guidelines, often leading to incomplete and ambiguous reporting, and carries the risk of incorrect conclusions when data are not placed in the correct context. The REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance (READUS-PV) statement was developed to address this issue by promoting transparent and comprehensive reporting of disproportionality studies. While the statement paper explains in greater detail the procedure followed to develop these guidelines, with this explanation paper we present the 14 items retained for READUS-PV guidelines, together with an in-depth explanation of their rationale and bullet points to illustrate their practical implementation. Our primary objective is to foster the adoption of the READUS-PV guidelines among authors, editors, peer reviewers, and readers of disproportionality analyses. Enhancing transparency, completeness, and accuracy of reporting, as well as proper interpretation of their results, READUS-PV guidelines will ultimately facilitate evidence-based decision making in pharmacovigilance.
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc/3.0/us/*
dc.title.enThe REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration
dc.title.alternativeDrug Safen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1007/s40264-024-01423-7en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed38713347en_US
bordeaux.journalDrug Safetyen_US
bordeaux.page585-599en_US
bordeaux.volume47en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue6en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamAHEAD_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-04675261
hal.version1
hal.date.transferred2024-08-22T09:45:58Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Drug%20Safety&rft.date=2024-06-01&rft.volume=47&rft.issue=6&rft.spage=585-599&rft.epage=585-599&rft.eissn=1179-1942&rft.issn=1179-1942&rft.au=FUSAROLI,%20Michele&SALVO,%20Francesco&BEGAUD,%20Bernard&ALSHAMMARI,%20Thamir%20M&BATE,%20Andrew&rft.genre=article


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