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

• DOI: 10.1007/s40264-024-01423-7
• Publication Date: 2024-05-07T10:02:32Z
• Authors: 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 Herd...; 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 van Hunsel; Eugène van Puijen...; Emanuel Raschi; Charles Khouri
• Keywords: Pharmacovigilance; Pharmacovigilance, disproportionality analysis, spontaneous reporting systems; 610; Humans; [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie; Guidelines as Topic; Original Research Article; disproportionality analysis; reporting guidelines; Adverse Drug Reaction Reporting Systems/statistics & numerical data; Drug-Related Side Effects and Adverse Reactions/epidemiology

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.