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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
BACKGROUND AND AIM: Disproportionality analyses using reports of suspected adverse drug reactions are the most commonly used quantitative methods for detecting safety signals in pharmacovigilance. However, their methods and results are generally poorly reported in published articles and existing guidelines do not capture the specific features of disproportionality analyses. We here describe the development of a guideline (REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance [READUS-PV]) for reporting the results of disproportionality analyses in articles and abstracts. METHODS: We established a group of 34 international experts from universities, the pharmaceutical industry, and regulatory agencies, with expertise in pharmacovigilance, disproportionality analyses, and assessment of safety signals. We followed a three-step process to develop the checklist: (1) an open-text survey to generate a first list of items; (2) an online Delphi method to select and rephrase the most important items; (3) a final online consensus meeting. RESULTS: Among the panel members, 33 experts responded to round 1 and 30 to round 2 of the Delphi and 25 participated to the consensus meeting. Overall, 60 recommendations for the main body of the manuscript and 13 recommendations for the abstracts were retained by participants after the Delphi method. After merging of some items together and the online consensus meeting, the READUS-PV guidelines comprise a checklist of 32 recommendations, in 14 items, for the reporting of disproportionality analyses in the main body text and four items, comprising 12 recommendations, for abstracts. CONCLUSIONS: The READUS-PV guidelines will support authors, editors, peer-reviewers, and users of disproportionality analyses using individual case safety report databases. Adopting these guidelines will lead to more transparent, comprehensive, and accurate reporting and interpretation of disproportionality analyses, facilitating the integration with other sources of evidence.
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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): Development and Statement. Drug Safety, 47(6), 575–584. https://doi.org/10.1007/s40264-024-01421-9
Fusaroli, Michele, et al. "The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement." Drug Safety, vol. 47, no. 6, 2024, pp. 575–584, https://doi.org/10.1007/s40264-024-01421-9.
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): Development and Statement." Drug Safety 47, no. 6 (2024): 575–584. https://doi.org/10.1007/s40264-024-01421-9.
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): Development and Statement // Drug Safety. — 2024. — Vol. 47, № 6. — P. 575–584. — URL: https://doi.org/10.1007/s40264-024-01421-9
@article{fusaroli2024reporting,
title = {{The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement}},
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 = {575--584},
doi = {10.1007/s40264-024-01421-9},
url = {https://doi.org/10.1007/s40264-024-01421-9}
}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): Development and Statement JO - Drug Safety VL - 47 IS - 6 SP - 575 EP - 584 PY - 2024 DA - 2024/05/07 DO - 10.1007/s40264-024-01421-9 UR - https://doi.org/10.1007/s40264-024-01421-9 ER -
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