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

Michele Fusaroli (), Francesco Salvo (), Bernard Begaud, Thamir M. AlShammari, Andrew Bate, Vera Battini, Andreas Brueckner, Gianmario Candore, Carla Carnovale, Salvatore Crisafulli, Paola Maria Cutroneo, Charles Dolladille, Milou-Daniel Drici, Jean-Luc Faillie, Adam Goldman, Manfred Hauben, Maria Teresa Herdeiro, Olivia Mahaux, Katrin Manlik, François Montastruc, Yoshihiro Noguchi, G. Niklas Norén, Roberta Noseda, Igho J. Onakpoya, Antoine Pariente, Elisabetta Poluzzi, Myriam Salem, Daniele Sartori, Nhung T. H. Trinh, Marco Tuccori, Florence Hunsel, Eugène Puijenbroek, Emanuel Raschi () and Charles Khouri
Additional contact information
Michele Fusaroli: University of Bologna
Francesco Salvo: Université de Bordeaux, INSERM, BPH, Team AHeaD, U1219
Bernard Begaud: Université de Bordeaux, INSERM, BPH, Team AHeaD, U1219
Thamir M. AlShammari: Almaarefa University
Andrew Bate: Global Safety, GSK
Vera Battini: ASST Fatebenefratelli-Sacco University Hospital, Università degli Studi di Milano
Andreas Brueckner: Novartis Pharma AG
Gianmario Candore: Bayer AG
Carla Carnovale: ASST Fatebenefratelli-Sacco University Hospital, Università degli Studi di Milano
Salvatore Crisafulli: University of Verona
Paola Maria Cutroneo: Sicily Pharmacovigilance Regional Centre, University Hospital of Messina
Charles Dolladille: UNICAEN, EA4650 SEILIRM, CHU de Caen Normandie, Normandie University
Milou-Daniel Drici: Université Côte d’Azur Medical Center
Jean-Luc Faillie: INSERM, Univ Montpellier, Regional Pharmacovigilance Centre, CHU Montpellier
Adam Goldman: Sheba Medical Center
Manfred Hauben: Pfizer Inc
Maria Teresa Herdeiro: IBIMED-Institute of Biomedicine, University of Aveiro
Olivia Mahaux: Global Safety, GSK
Katrin Manlik: Bayer AG
François Montastruc: Toulouse University Hospital (CHU)
Yoshihiro Noguchi: Gifu Pharmaceutical University
G. Niklas Norén: Uppsala Monitoring Centre
Roberta Noseda: Ente Ospedaliero Cantonale
Igho J. Onakpoya: University of Oxford
Antoine Pariente: Université de Bordeaux, INSERM, BPH, Team AHeaD, U1219
Elisabetta Poluzzi: University of Bologna
Myriam Salem: Health Canada
Daniele Sartori: Uppsala Monitoring Centre
Nhung T. H. Trinh: University of Oslo
Marco Tuccori: University Hospital of Pisa
Florence Hunsel: Netherlands Pharmacovigilance Centre Lareb
Eugène Puijenbroek: Netherlands Pharmacovigilance Centre Lareb
Emanuel Raschi: University of Bologna
Charles Khouri: Université Grenoble Alpes, Grenoble Alpes University Hospital

Drug Safety, 2024, vol. 47, issue 6, No 9, 585-599

Abstract: Abstract In 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.

Date: 2024
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DOI: 10.1007/s40264-024-01423-7

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