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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

Author

Listed:
  • Michele Fusaroli

    (University of Bologna)

  • Francesco Salvo

    (Université de Bordeaux, INSERM, BPH, Team AHeaD, U1219
    CHU de Bordeaux, INSERM, U1219)

  • Bernard Begaud

    (Université de Bordeaux, INSERM, BPH, Team AHeaD, U1219)

  • Thamir M. AlShammari

    (Almaarefa University)

  • Andrew Bate

    (Global Safety, GSK
    London School of Hygiene and Tropical Medicine)

  • 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
    CHU de Caen Normandie)

  • 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
    Sackler School of Medicine, Tel Aviv University)

  • Manfred Hauben

    (Pfizer Inc
    New York Medical College)

  • 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)
    Toulouse University Hospital)

  • 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
    CHU de Bordeaux, INSERM, U1219)

  • Elisabetta Poluzzi

    (University of Bologna)

  • Myriam Salem

    (Health Canada)

  • Daniele Sartori

    (Uppsala Monitoring Centre
    University of Oxford)

  • Nhung T. H. Trinh

    (University of Oslo)

  • Marco Tuccori

    (University Hospital of Pisa)

  • Florence Hunsel

    (Netherlands Pharmacovigilance Centre Lareb
    University of Groningen, Groningen Research Institute of Pharmacy)

  • Eugène Puijenbroek

    (Netherlands Pharmacovigilance Centre Lareb
    University of Groningen, Groningen Research Institute of Pharmacy)

  • Emanuel Raschi

    (University of Bologna)

  • Charles Khouri

    (Université Grenoble Alpes, Grenoble Alpes University Hospital
    Université Grenoble Alpes, INSERM, Grenoble Alpes University)

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.

Suggested Citation

  • Michele Fusaroli & Francesco Salvo & Bernard Begaud & Thamir M. AlShammari & Andrew Bate & Vera Battini & Andreas Brueckner & Gianmario Candore & Carla Carnovale & Salvatore Crisafulli & Paola Maria C, 2024. "The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration," Drug Safety, Springer, vol. 47(6), pages 585-599, June.
    • Handle: RePEc:spr:drugsa:v:47:y:2024:i:6:d:10.1007_s40264-024-01423-7
    DOI: 10.1007/s40264-024-01423-7
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    References listed on IDEAS

    as
    1. Valentina Giunchi & Michele Fusaroli & Manfred Hauben & Emanuel Raschi & Elisabetta Poluzzi, 2023. "Challenges and Opportunities in Accessing and Analysing FAERS Data: A Call Towards a Collaborative Approach," Drug Safety, Springer, vol. 46(10), pages 921-926, October.
    2. Oskar Gauffin & Judith S. Brand & Sara Hedfors Vidlin & Daniele Sartori & Suvi Asikainen & Martí Català & Etir Chalabi & Daniel Dedman & Ana Danilovic & Talita Duarte-Salles & Maria Teresa García Mora, 2023. "Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study," Drug Safety, Springer, vol. 46(12), pages 1335-1352, December.
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    Cited by:

    1. Yoon K. Loke, 2024. "Not Just Another Reporting Guideline? Here’s Why READUS-PV is a Major Step Forward," Drug Safety, Springer, vol. 47(6), pages 571-573, June.
    2. Almut G. Winterstein & Celeste L. Y. Ewig & Yanning Wang & Nicole E. Smolinski & Gita A. Toyserkani & Cynthia LaCivita & Leila Lackey & Sara Eggers & Esther H. Zhou & Vakaramoko Diaby & Amir Sarayani , 2025. "Teratogenic Risk Impact and Mitigation (TRIM): Study Protocol for the Development of a Decision Support Tool to Prioritize Medications for Risk Mitigation," Drug Safety, Springer, vol. 48(2), pages 107-117, February.

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