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Michele Fusaroli, Francesco Salvo, Bernard Bégaud, Thamir M. Alshammari, Andrew Bate, Vera Battini, Andreas Brueckner, Gianmario Candore, Carla Carnovale, Salvatore Crisafulli and 24 more
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.
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Fusaroli, M., Salvo, F., Bégaud, B., Alshammari, T. M., Bate, A., Battini, V., Brueckner, A., Candore, G., Carnovale, C., Crisafulli, S., Cutroneo, P. M., Dolladille, C., Drici, M., Faillie, J., Goldman, A., Hauben, M., Herdeiro, M. T., Mahaux, O., Manlik, K., … 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
Fusaroli, Michele, et al. "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, vol. 47, no. 6, 2024, pp. 585–599, https://doi.org/10.1007/s40264-024-01423-7.
Fusaroli, Michele, Francesco Salvo, Bernard Bégaud, Thamir M. Alshammari, Andrew Bate, Vera Battini, Andreas Brueckner, et al. "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, no. 6 (2024): 585–599. https://doi.org/10.1007/s40264-024-01423-7.
Fusaroli M., Salvo F., Bégaud B. [и др.] 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. — 2024. — Vol. 47, № 6. — P. 585–599. — URL: https://doi.org/10.1007/s40264-024-01423-7
@article{fusaroli2024reporting,
title = {{The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration}},
author = {Michele Fusaroli and Francesco Salvo and Bernard Bégaud and Thamir M. Alshammari and Andrew Bate and Vera Battini and Andreas Brueckner and Gianmario Candore and Carla Carnovale and Salvatore Crisafulli and Paola Maria Cutroneo and Charles Dolladille and Milou‐Daniel Drici and Jean‐Luc Faillie and Adam Goldman and Manfred Hauben and María Teresa Herdeiro and Olivia Mahaux and Katrin Manlik and François Montastruc and Yoshihiro Noguchi and G. Niklas Norén and Roberta Noseda and Igho Onakpoya and Antoine Pariente and Elisabetta Poluzzi and Myriam Salem and Daniele Sartori and Nhung TH Trinh and Marco Tuccori and Florence P. A. M. van Hunsel and Eugène van Puijenbroek and Emanuel Raschi and Charles Khouri},
journal = {Drug Safety},
year = {2024},
volume = {47},
number = {6},
pages = {585--599},
doi = {10.1007/s40264-024-01423-7},
url = {https://doi.org/10.1007/s40264-024-01423-7}
}TY - JOUR AU - Fusaroli, Michele AU - Salvo, Francesco AU - Bégaud, Bernard AU - Alshammari, Thamir M. AU - Bate, Andrew AU - Battini, Vera AU - Brueckner, Andreas AU - Candore, Gianmario AU - Carnovale, Carla AU - Crisafulli, Salvatore AU - Cutroneo, Paola Maria AU - Dolladille, Charles AU - Drici, Milou‐Daniel AU - Faillie, Jean‐Luc AU - Goldman, Adam AU - Hauben, Manfred AU - Herdeiro, María Teresa AU - Mahaux, Olivia AU - Manlik, Katrin AU - Montastruc, François AU - Noguchi, Yoshihiro AU - Norén, G. Niklas AU - Noseda, Roberta AU - Onakpoya, Igho AU - Pariente, Antoine AU - Poluzzi, Elisabetta AU - Salem, Myriam AU - Sartori, Daniele AU - Trinh, Nhung TH AU - Tuccori, Marco AU - Hunsel, Florence P. A. M. van AU - Puijenbroek, Eugène van AU - Raschi, Emanuel AU - Khouri, Charles TI - The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration JO - Drug Safety VL - 47 IS - 6 SP - 585 EP - 599 PY - 2024 DA - 2024/05/07 DO - 10.1007/s40264-024-01423-7 UR - https://doi.org/10.1007/s40264-024-01423-7 ER -
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