NYMC Faculty Publications
The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration
Author Type(s)
Faculty
DOI
10.1007/s40264-024-01423-7
Journal Title
Drug Safety
First Page
585
Last Page
599
Document Type
Article
Publication Date
6-2024
Department
Family and Community Medicine
Keywords
Pharmacovigilance, Humans, Adverse Drug Reaction Reporting Systems, Drug-Related Side Effects and Adverse Reactions, Guidelines as Topic
Disciplines
Medicine and Health Sciences
Abstract
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.
Recommended Citation
Fusaroli, M., Hauben, M., & Khouri, C. (2024). The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration. Drug Safety, 47 (6), 585-599. https://doi.org/10.1007/s40264-024-01423-7
Comments
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