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

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 guid...

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Bibliographic Details
Published in:Drug safety 2024-06, Vol.47 (6), p.575-584
Main Authors: Fusaroli, Michele, Salvo, Francesco, Begaud, Bernard, AlShammari, Thamir M., Bate, Andrew, Battini, Vera, Brueckner, Andreas, Candore, Gianmario, Carnovale, Carla, Crisafulli, Salvatore, Cutroneo, Paola Maria, Dolladille, Charles, Drici, Milou-Daniel, Faillie, Jean-Luc, Goldman, Adam, Hauben, Manfred, Herdeiro, Maria Teresa, Mahaux, Olivia, Manlik, Katrin, Montastruc, François, Noguchi, Yoshihiro, Norén, G. Niklas, Noseda, Roberta, Onakpoya, Igho J., Pariente, Antoine, Poluzzi, Elisabetta, Salem, Myriam, Sartori, Daniele, Trinh, Nhung T. H., Tuccori, Marco, van Hunsel, Florence, van Puijenbroek, Eugène, Raschi, Emanuel, Khouri, Charles
Format: Article
Language:English
Subjects:
Bibliometrics
Check lists
Delphi method
Drug Safety and Pharmacovigilance
Guidelines
Medicine
Medicine & Public Health
Methods
Observational studies
Original Research Article
Pharmaceutical industry
Pharmacology/Toxicology
Pharmacovigilance
Product safety
Regulatory agencies
Safety
Side effects
Signal detection
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Summary: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.
ISSN:0114-5916
1179-1942
DOI:10.1007/s40264-024-01421-9