ReviewJournal of applied biomedicine2023
Causality assessment of adverse drug reaction: A narrative review to find the most exhaustive and easy-to-use tool in post-authorization settings.
Review in Journal of applied biomedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 13 citations in OpenAlex.
- A Scoping Review of Case-Level Causality Assessment Tools Developed Between 2008 and 2023; Strengths, Weaknesses and Potential Future Improvements.Drug safety · 2026Article
- Clozapine-Induced Gastrointestinal Hypoperfusion Leading to Bowel Ischemia and Secondary Atrial Fibrillation: A Case Report.Case reports in psychiatry · 2026Article
- A descriptive, retrospective analysis of the quality of spontaneous adverse event reporting to the Côte d'Ivoire Pharmaceutical and Regulatory Authority and its impact on the causality assessment.Therapeutic advances in drug safety · 2026Article
- Pantoprazole-induced anaphylactic asthma and Type I Kounis syndrome: a case report and literature review.Frontiers in cardiovascular medicine · 2026Article
- Serious Adverse Events: A Replicability and Validation Study of Naranjo Causality Assessment Tool in a Canadian Clinical Setting.Journal of evaluation in clinical practice · 2025Article
- Methods for causality assessment of idiosyncratic drug-induced liver injury.Liver international : official journal of the International Association for the Study of the Liver · 2025Review
- Risk factors for severe adverse drug reactions in hospitalized patients.Open medicine (Warsaw, Poland) · 2025Article
- Review
- Article
- Omeprazole was safely reused in a rhabdomyolysis patient associated with proton pump inhibitors: A case report.Clinical case reports · 2023Article
- Genetic polymorphisms in ABCB1 are correlated with the increased risk of atorvastatin-induced muscle side effects: a cross-sectional study.Scientific reports · 2023Article
- Tools for Etiologic Diagnosis of Drug-Induced Allergic Conditions.International journal of molecular sciences · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe core motive of pharmacovigilance is the detection and prevention of adverse drug reactions (ADRs), to improve the risk-benefit balance of the drug. However, the causality assessment of ADRs remains a major challenge among clinicians, and none of the available tools of causality assessment used for assessing ADRs have been universally accepted.
objectiveTo provide an up-to-date overview of the different causality assessment tools.
methodsWe conducted electronic searches in MEDLINE, EMBASE, and the Cochrane database. The eligibility of each tool was screened by three reviewers. Each eligible tool was then scrutinized for its domains (the reported specific set of questions/areas used for calculating the likelihood of cause-and-effect relation of an ADR) to discover the most comprehensive tool. Finally, we subjectively assessed the tool's ease-of-use in a Canadian, Indian, Hungarian, and Brazilian clinical context.
resultsTwenty-one eligible causality assessment tools were retrieved. Naranjo's tool and De Boer's tool appeared the most comprehensive among all the tools, covering 10 domains each. Regarding "ease-of-use" in a clinical setting, we judged that many tools were hard to implement in a clinical context because of their complexity and/or lengthiness. Naranjo's tool, Jones's tool, Danan and Benichou's tool, and Hsu and Stoll's tool appeared to be the easiest to implement into various clinical contexts.
conclusionAmong the many tools identified, 1981 Naranjo's scale remains the most comprehensive and easy to use for performing causality assessment of ADRs. Upcoming analysis should compare the performance of each ADR tool in clinical settings.
Indexed as
Identifiers
What OpenQuestion holds
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.