The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement

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
Gianmario Candore: Bayer AG, Medical Affairs and Pharmacovigilance
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, Medical Affairs and Pharmacovigilance
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: Univ. Grenoble Alpes, Grenoble Alpes University Hospital

Drug Safety, 2024, vol. 47, issue 6, No 8, 575-584

Abstract: Abstract Background and aim Disproportionality analyses using reports of suspected adverse drug reactions are the most commonly used quantitative methods for detecting safety signals in pharmacovigilance. However, their methods and results are generally poorly reported in published articles and existing guidelines do not capture the specific features of disproportionality analyses. We here describe the development of a guideline (REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance [READUS-PV]) for reporting the results of disproportionality analyses in articles and abstracts. Methods We established a group of 34 international experts from universities, the pharmaceutical industry, and regulatory agencies, with expertise in pharmacovigilance, disproportionality analyses, and assessment of safety signals. We followed a three-step process to develop the checklist: (1) an open-text survey to generate a first list of items; (2) an online Delphi method to select and rephrase the most important items; (3) a final online consensus meeting. Results Among the panel members, 33 experts responded to round 1 and 30 to round 2 of the Delphi and 25 participated to the consensus meeting. Overall, 60 recommendations for the main body of the manuscript and 13 recommendations for the abstracts were retained by participants after the Delphi method. After merging of some items together and the online consensus meeting, the READUS-PV guidelines comprise a checklist of 32 recommendations, in 14 items, for the reporting of disproportionality analyses in the main body text and four items, comprising 12 recommendations, for abstracts. Conclusions The READUS-PV guidelines will support authors, editors, peer-reviewers, and users of disproportionality analyses using individual case safety report databases. Adopting these guidelines will lead to more transparent, comprehensive, and accurate reporting and interpretation of disproportionality analyses, facilitating the integration with other sources of evidence.

Date: 2024
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DOI: 10.1007/s40264-024-01421-9

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