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

Autor: Fusaroli M; Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy. michele.fusaroli2@unibo.it., Salvo F; Université de Bordeaux, INSERM, BPH, Team AHeaD, U1219, 33000, Bordeaux, France. francesco.salvo@u-bordeaux.fr.; Service de Pharmacologie Médicale, CHU de Bordeaux, INSERM, U1219, 33000, Bordeaux, France. francesco.salvo@u-bordeaux.fr., Begaud B; Université de Bordeaux, INSERM, BPH, Team AHeaD, U1219, 33000, Bordeaux, France., AlShammari TM; College of Pharmacy, Almaarefa University, Riyadh, Saudi Arabia., Bate A; Global Safety, GSK, Brentford, UK.; Department of Non-Communicable Epidemiology, London School of Hygiene and Tropical Medicine, London, UK., Battini V; Pharmacovigilance and Clinical Research, International Centre for Pesticides and Health Risk Prevention, Department of Biomedical and Clinical Sciences (DIBIC), ASST Fatebenefratelli-Sacco University Hospital, Università degli Studi di Milano, Milan, Italy., Brueckner A; Novartis Pharma AG, Basel, Switzerland., Candore G; Medical Affairs and Pharmacovigilance, Bayer AG, Berlin, Germany., Carnovale C; Pharmacovigilance and Clinical Research, International Centre for Pesticides and Health Risk Prevention, Department of Biomedical and Clinical Sciences (DIBIC), ASST Fatebenefratelli-Sacco University Hospital, Università degli Studi di Milano, Milan, Italy., Crisafulli S; Department of Medicine, University of Verona, Verona, Italy., Cutroneo PM; Unit of Clinical Pharmacology, Sicily Pharmacovigilance Regional Centre, University Hospital of Messina, Messina, Italy., Dolladille C; UNICAEN, EA4650 SEILIRM, CHU de Caen Normandie, Normandie University, Caen, France.; Department of Pharmacology, CHU de Caen Normandie, Caen, France., Drici MD; Department of Clinical Pharmacology, Université Côte d'Azur Medical Center, Nice, France., Faillie JL; Desbrest Institute of Epidemiology and Public Health, Department of Medical Pharmacology and Toxicology, INSERM, Univ Montpellier, Regional Pharmacovigilance Centre, CHU Montpellier, Montpellier, France., Goldman A; Department of Internal Medicine, Sheba Medical Center, Ramat-Gan, Israel.; Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel., Hauben M; Pfizer Inc, New York, NY, USA.; Department of Family and Community Medicine, New York Medical College, Valhalla, New York, USA., Herdeiro MT; Department of Medical Sciences, IBIMED-Institute of Biomedicine, University of Aveiro, 3810-193, Aveiro, Portugal., Mahaux O; Global Safety, GSK, Brentford, UK., Manlik K; Medical Affairs and Pharmacovigilance, Bayer AG, Berlin, Germany., Montastruc F; Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Faculty of Medicine, Toulouse University Hospital (CHU), Toulouse, France.; CIC 1436, Team PEPSS (Pharmacologie En Population cohorteS et biobanqueS), Toulouse University Hospital, Toulouse, France., Noguchi Y; Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University, Gifu, Japan., Norén GN; Uppsala Monitoring Centre, Uppsala, Sweden., Noseda R; Institute of Pharmacological Sciences of Southern Switzerland, Division of Clinical Pharmacology and Toxicology, Ente Ospedaliero Cantonale, Lugano, Switzerland., Onakpoya IJ; Department for Continuing Education, University of Oxford, Oxford, UK., Pariente A; Université de Bordeaux, INSERM, BPH, Team AHeaD, U1219, 33000, Bordeaux, France.; Service de Pharmacologie Médicale, CHU de Bordeaux, INSERM, U1219, 33000, Bordeaux, France., Poluzzi E; Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy., Salem M; Health Canada, Ottawa, ON, Canada., Sartori D; Uppsala Monitoring Centre, Uppsala, Sweden.; Centre for Evidence-Based Medicine, Nuffield, Department of Primary Care Health Sciences, University of Oxford, Oxford, UK., Trinh NTH; PharmacoEpidemiology and Drug Safety Research Group, Department of Pharmacy, University of Oslo, Oslo, Norway., Tuccori M; Tuscany Regional Centre, Unit of Adverse Drug Reaction Monitoring, University Hospital of Pisa, Pisa, Italy., van Hunsel F; Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.; PharmacoTherapy, Epidemiology and Economics, University of Groningen, Groningen Research Institute of Pharmacy, Groningen, The Netherlands., van Puijenbroek E; Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.; PharmacoTherapy, Epidemiology and Economics, University of Groningen, Groningen Research Institute of Pharmacy, Groningen, The Netherlands., Raschi E; Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy., Khouri C; Pharmacovigilance Department, Université Grenoble Alpes, Grenoble Alpes University Hospital, Grenoble, France.; UMR 1300-HP2 Laboratory, Université Grenoble Alpes, INSERM, Grenoble Alpes University, Grenoble, France.
Jazyk: angličtina
Zdroj: Drug safety [Drug Saf] 2024 Jun; Vol. 47 (6), pp. 585-599. Date of Electronic Publication: 2024 May 07.
DOI: 10.1007/s40264-024-01423-7
Abstrakt: 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
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