Article Dans Une Revue Drug Safety Année : 2024

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

1 UNIBO - Alma Mater Studiorum Università di Bologna = University of Bologna [Bologne]
2 BPH - Bordeaux population health
3 CHU de Bordeaux Pellegrin [Bordeaux]
4 Almaarefa College
5 LSHTM - London School of Hygiene and Tropical Medicine
6 GSK - GlaxoSmithKline [Headquarters, London, UK]
7 UNIMI - Università degli Studi di Milano = University of Milan
8 Novartis Pharma AG
9 Bayer AG [Germany]
10 UNIVR - Università degli studi di Verona = University of Verona
11 UniMe - Università degli Studi di Messina = University of Messina
12 SEILIRM - Signalisation, électrophysiologie et imagerie des lésions d’ischémie-reperfusion myocardique
13 Département de Pharmacologie [CHU Caen]
14 CHU Nice - Centre Hospitalier Universitaire de Nice
15 IDESP - Institut Desbrest d'Epidémiologie et de Santé Publique
16 Département de Pharmacologie Médicale et de Toxicologie [CHRU Montpellier]
17 Chaim Sheba Medical Center
18 TAU - Tel Aviv University
19 NYMC - New York Medical College
20 Pfizer
21 Universidade de Aveiro = University of Aveiro
22 CIC 1436 - Centre d'investigation clinique de Toulouse
23 CRPV - Centre Régional de PharmacoVigilance [CHU Toulouse]
24 Gifu University
25 Uppsala Monitoring Centre
26 Lugano Regional Hospital [Lugano]
27 University of Oxford
28 Health Canada - Santé Canada
29 Nuffield Department of Primary Care Health Sciences, University of Oxford
30 UiO - University of Oslo
31 Azienda Ospedaliera Universitaria Pisana
32 University of Groningen [Groningen]
33 Netherlands Pharmacovigilance Centre Lareb
34 CRPV-Grenoble - Centre Régional de PharmacoVigilance
35 HP2 - Hypoxie et PhysioPathologie
Bernard Bégaud
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Roberta Noseda
Marco Tuccori
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Résumé

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.ResultsAmong 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.

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Dates et versions

hal-05019734 , version 1 (04-04-2025)

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Michele Fusaroli, Francesco Salvo, Bernard Bégaud, Thamir Alshammari, Andrew Bate, et al.. The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement. Drug Safety, 2024, 47 (6), pp.575-584. ⟨10.1007/s40264-024-01421-9⟩. ⟨hal-05019734⟩
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