Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Jun;47(6):575-584.
doi: 10.1007/s40264-024-01421-9. Epub 2024 May 7.

The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement

Michele Fusaroli  1 , Francesco Salvo  2   3 , Bernard Begaud  2 , Thamir M AlShammari  4 , Andrew Bate  5   6 , Vera Battini  7 , Andreas Brueckner  8 , Gianmario Candore  9 , Carla Carnovale  7 , Salvatore Crisafulli  10 , Paola Maria Cutroneo  11 , Charles Dolladille  12   13 , Milou-Daniel Drici  14 , Jean-Luc Faillie  15 , Adam Goldman  16   17 , Manfred Hauben  18   19 , Maria Teresa Herdeiro  20 , Olivia Mahaux  5 , Katrin Manlik  9 , François Montastruc  21   22 , Yoshihiro Noguchi  23 , G Niklas Norén  24 , Roberta Noseda  25 , Igho J Onakpoya  26 , Antoine Pariente  2   3 , Elisabetta Poluzzi  1 , Myriam Salem  27 , Daniele Sartori  24   28 , Nhung T H Trinh  29 , Marco Tuccori  30 , Florence van Hunsel  31   32 , Eugène van Puijenbroek  31   32 , Emanuel Raschi  33 , Charles Khouri  34   35
Affiliations

The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement

Michele Fusaroli et al. Drug Saf. 2024 Jun.

Abstract

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.

PubMed Disclaimer

Conflict of interest statement

Gianmario Candore and Katrin Manlik are full-time employees at Bayer AG. Olivia Mahaux and Andrew Bate are full-time employees at GSK and own GSK restricted shares. Manfred Hauben was a full-time employee at Pfizer when the Delphi was conducted and owns stock/stock options in pharmaceutical companies that may manufacture/market drugs mentioned in this paper. The remaining authors declare no conflict of interest specific for this research.

Comment in

References

    1. CIOMS-Cumulative-PV-Glossary-v1.0.pdf [Internet]. [cited 2023 Jul 11]. Available from https://cioms.ch/wp-content/uploads/2021/03/CIOMS-Cumulative-PV-Glossary.... Accessed 6 Mar 2024.
    1. Croteau D, Pinnow E, Wu E, Muñoz M, Bulatao I, Dal Pan G. Sources of evidence triggering and supporting safety-related labeling changes: a 10-year longitudinal assessment of 22 new molecular entities approved in 2008 by the US Food and Drug Administration. Drug Saf. 2022;45:169–180. doi: 10.1007/s40264-021-01142-3. - DOI - PubMed
    1. Insani WN, Pacurariu AC, Mantel-Teeuwisse AK, Gross-Martirosyan L. Characteristics of drugs safety signals that predict safety related product information update. Pharmacoepidemiol Drug Saf. 2018;27:789–796. doi: 10.1002/pds.4446. - DOI - PMC - PubMed
    1. Tau N, Shochat T, Gafter-Gvili A, Tibau A, Amir E, Shepshelovich D. Association between data sources and US Food and Drug Administration drug safety communications. JAMA Intern Med. 2019;179:1590–1592. doi: 10.1001/jamainternmed.2019.3066. - DOI - PMC - PubMed
    1. Onakpoya IJ, Heneghan CJ, Aronson JK. Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature. BMC Med. 2016;14:1–11. - PMC - PubMed

MeSH terms