2024 | Michele Fusaroli, Francesco Salvo, Bernard Begaud, Thamir M. AlShammari, Andrew Bate, Vera Battini, Andreas Brueckner, Gianmaro Candore, Carla Carnovale, Salvatore Crisafulli, Paola Maria Cutroneo, Charles Dolladille, Milou-Daniel Drici, Jean-Luc Faillie, Adam Goldman, Manfred Hauben, Maria Teresa Herdeiro, Olivia Mahaux, Katrin Manlik, François Montastruc, Yoshihiro Noguchi, G. Niklas Norén, Roberta Nosed, Igho J. Onakpoya, Antoine Pariante, Elisabetta Poluzzi, Myriam Salem, Daniele Sartori, Nhung T. H. Trinh, Marco Tuccori, Florence van Hunsel, Eugène van Puijenbroek, Emanuel Raschi, Charles Khouri
The article introduces the REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance (READUS-PV) guidelines, which aim to improve the reporting and interpretation of disproportionality analyses in pharmacovigilance. These guidelines are developed by a panel of 34 international experts and follow a three-step process: an open-text survey, a modified Delphi method, and an online consensus meeting. The final guidelines consist of a checklist with 32 recommendations for the main body of the manuscript and 12 recommendations for abstracts. The READUS-PV guidelines are designed to enhance transparency, comprehensiveness, and accuracy in reporting disproportionality analyses, facilitating the integration of evidence from these analyses with other data sources. The guidelines are intended to support authors, editors, peer-reviewers, and users of disproportionality analyses, and they are expected to improve the quality and reproducibility of research in this field.The article introduces the REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance (READUS-PV) guidelines, which aim to improve the reporting and interpretation of disproportionality analyses in pharmacovigilance. These guidelines are developed by a panel of 34 international experts and follow a three-step process: an open-text survey, a modified Delphi method, and an online consensus meeting. The final guidelines consist of a checklist with 32 recommendations for the main body of the manuscript and 12 recommendations for abstracts. The READUS-PV guidelines are designed to enhance transparency, comprehensiveness, and accuracy in reporting disproportionality analyses, facilitating the integration of evidence from these analyses with other data sources. The guidelines are intended to support authors, editors, peer-reviewers, and users of disproportionality analyses, and they are expected to improve the quality and reproducibility of research in this field.