Journal Article

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

Tuccori, Marco, Salvo, Francesco, van Puijenbroek, Eugène, Mahaux, Olivia, Noguchi, Yoshihiro, Brueckner, Andreas, Manlik, Katrin, Dolladille, Charles, Drici, Milou-Daniel, Bate, Andrew, Onakpoya, Igho J., Pariente, Antoine, Cutroneo, Paola Maria, Khouri, Charles, Battini, Vera, Norén, G. Niklas, Carnovale, Carla, Hauben, Manfred, Raschi, Emanuel, Poluzzi, Elisabetta, Noseda, Roberta, Goldman, Adam, van Hunsel, Florence, Salem, Myriam, Candore, Gianmario, AlShammari, Thamir M., Begaud, Bernard, Crisafulli, Salvatore, Montastruc, François, Trinh, Nhung T. H., Fusaroli, Michele, Herdeiro, Maria Teresa, Sartori, Daniele, Faillie, Jean-Luc

2024

Overview

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.

• Publisher: Springer Science and Business Media LLC,Springer International Publishing,Springer Nature B.V,Springer Verlag
• Subject: [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie / Adverse Drug Reaction Reporting Systems/statistics & numerical data / Clinical trials / Decision making / Drug Safety and Pharmacovigilance / Drug-Related Side Effects and Adverse Reactions/epidemiology / Guidelines / Guidelines as Topic / Humans / Hypotheses / Industrial safety / Life Sciences / Medicine / Medicine & Public Health / Original Research Article / Pharmacology/Toxicology / Pharmacovigilance / Pharmacovigilance, disproportionality analysis, spontaneous reporting systems / Product safety / Safety / Santé publique et épidémiologie / Signal detection / Systematic review