ArticleDrug safety2024
The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement.
Article in Drug safety, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 180 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
180 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Safety of immune checkpoint inhibitors: A systematic review of disproportionality analysis studies.European journal of clinical pharmacology · 2026Pooled it
- The quantity, reliability, transparency, reporting, and interpretation of pharmacovigilance signal detection studies in pregnancy: a meta-epidemiological study.European journal of clinical pharmacology · 2025Pooled it
- Linezolid-related Optic Nerve Disorders: Insight From a Pharmacovigilance Analysis of the US FDA Adverse Event Reporting System.Open forum infectious diseases · 2025Trial
- Bone and growth safety profiles of biologic and conventional DMARDs in juvenile idiopathic arthritis: a 21-year FAERS disproportionality analysis.Inflammopharmacology · 2026Article
- Pharmacovigilance signals for congenital heart disease related to drug exposure: A disproportionality analysis based on the FAERS database.American heart journal plus : cardiology research and practice · 2026Article
- Differential signal strength of male sexual dysfunction associated with antidepressants: a disproportionality analysis of FAERS database.Sexual medicine · 2026Article
- Sex-stratified disproportionality signals of adverse events with allopurinol and febuxostat: a retrospective pharmacovigilance analysis of FAERS and EudraVigilance.Clinical rheumatology · 2026Article
- Cardiotoxicity of macrolide antibiotics: a pharmacovigilance study integrating FAERS and JADER databases.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Signal Detection of Adverse Events Associated with PCSK9 Inhibitors: A Nationwide Sequence Symmetry and Combined Worldwide Disproportionality Analysis.Drug safety · 2026Article
- Interpreting Positive and Inverse Disproportionality Signals in Spontaneous Reporting Systems: A Claim-Strength Framework with Direction-Aware Evaluation.Drug safety · 2026Review
- Thrombotic and ischemic event reporting with anticoagulant reversal agents: a multi-agent FAERS pharmacovigilance study.Journal of thrombosis and thrombolysis · 2026Article
- Reply to Revol et al.: Interpreting fatality-reporting signals in checkpoint immunotherapy.Proceedings of the National Academy of Sciences of the United States of America · 2026Article
- Disproportionality analysis to investigate fatal adverse events with immune checkpoint inhibitors: Proceed with extreme caution.Proceedings of the National Academy of Sciences of the United States of America · 2026Article
- Multinational pharmacovigilance assessment of drug-associated esophageal ulceration and perforation: evidence from FAERS, JADER, and Canada Vigilance.BMC pharmacology & toxicology · 2026Article
- Multi-database pharmacovigilance identifies disproportionate reporting of hepatobiliary events with avacopan: an integrative study with network pharmacology and interpretable machine learning.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Redundant pharmacovigilance disproportionality analyses: Navigating between Scylla and Charybdis.Headache · 2026Article
- Pediatric hepatic laboratory reporting with CFTR modulators: a FAERS pharmacovigilance study.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Target-Specific Dermatological Adverse Event Reporting With T-Cell-Engaging Bispecific Antibodies: A Pharmacovigilance Analysis of FAERS and Canada Vigilance, 2016-2026.Cancer medicine · 2026Article
- Response to "Redundant pharmacovigilance disproportionality analyses: Navigating between Scylla and Charybdis".Headache · 2026Article
- Theoretical Framework and Key Considerations for Time-to-Onset Analysis in Spontaneous Reporting Systems.Drug safety · 2026Review
120 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
34 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimDisproportionality 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.
methodsWe 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.
resultsAmong 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.
conclusionsThe 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.