The DOI matches its Crossref record; 36 of the 36 references it cites were found in a registry or an index.
The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement
Open accessAbstract
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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The PRISMA 2020 statement: An updated guideline for reporting systematic reviews
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The PRISMA 2020 statement: an updated guideline for reporting systematic reviews
Page, M. J., McKenzie, J., Bossuyt, P., Boutron, I., Hoffmann, T., mulrow, C., Shamseer, L., Tetzlaff, J., Akl, E., Brennan, S. E., et al. (2020) · doi:10.31222/osf.io/v7gm2 · Cited by 5,177
CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials
Schulz, K. F., Altman, D. G., Moher, D., & for the CONSORT Group* (2010) · Annals of Internal Medicine · doi:10.7326/0003-4819-152-11-201006010-00232 · Cited by 3,824 · cited 1×
“Reporting guidelines, representing a minimum standard of items that should be reported in published articles, have therefore been developed for a range of study designs [23–26].”
BackgroundAvoidable waste in the production and reporting of research evidence
Chalmers, I., & Glasziou, P. (2009) · The Lancet · doi:10.1016/s0140-6736(09)60329-9 · Cited by 2,208
Guidance for Developers of Health Research Reporting Guidelines
Moher, D., Schulz, K. F., Simera, I., & Altman, D. G. (2010) · PLoS Medicine · doi:10.1371/journal.pmed.1000217 · Cited by 1,437
Reducing waste from incomplete or unusable reports of biomedical research
Glasziou, P., Altman, D. G., Bossuyt, P., Boutron, I., Clarke, M., Julious, S., Michie, S., Moher, D., & Wager, E. (2014) · The Lancet · doi:10.1016/s0140-6736(13)62228-x · Cited by 1,319
Quantitative signal detection using spontaneous ADR reporting
Bate, A., & Evans, S. J. W. (2009) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.1742 · Cited by 912
Self-citationPlint, A. C., Moher, D., Morrison, A., Schulz, K., Altman, D. G., Hill, C., & Gaboury, I. (2006) · Medical Journal of Australia · doi:10.5694/j.1326-5377.2006.tb00557.x · Cited by 872
Cited by
Schoretsanitis, G., Weiler, S., Barbui, C., Raschi, E., & Gastaldon, C. (2024) · JAMA Network Open · doi:10.1001/jamanetworkopen.2024.23385 · Cited by 107
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Metadata
- Authors
- Fusaroli, M., Salvo, F., Begaud, B., AlShammari, T. M., Bate, A., Battini, V., Brueckner, A., Candore, G., Carnovale, C., Crisafulli, S., Cutroneo, P. M., Dolladille, C., Drici, M.-D., Faillie, J.-L., Goldman, A., Hauben, M., Herdeiro, M. T., Mahaux, O., Manlik, K., Montastruc, F., Noguchi, Y., Norén, G. N., Noseda, R., Onakpoya, I. J., Pariente, A., Poluzzi, E., Salem, M., Sartori, D., Trinh, N. T. H., Tuccori, M., van Hunsel, F., van Puijenbroek, E., Raschi, E., & Khouri, C.
- Venue
- Drug Safety
- Published
- 2024-05-07
- Volume
- 47
- Issue
- 6
- Pages
- 575-584
- ISSN
- 0114-5916 (ISSN-L)
- 1179-1942
- OpenAlex
- W4396696202
- Cited by
- 270
- References
- 36
- FWCI
- 206.30
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- Fusaroli, M., Salvo, F., Begaud, B., AlShammari, T. M., Bate, A., Battini, V., Brueckner, A., Candore, G., Carnovale, C., Crisafulli, S., Cutroneo, P. M., Dolladille, C., Drici, M.-D., Faillie, J.-L., 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. https://doi.org/10.1007/s40264-024-01421-9
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
