ArticleDrug safety2018
Safety Concerns Reported by Patients Identified in a Collaborative Signal Detection Workshop using VigiBase: Results and Reflections from Lareb and Uppsala Monitoring Centre.
Article in Drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 2 of them syntheses that pooled it.
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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.
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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
32 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Empowering citizens to spontaneously report suspected adverse drug reaction: Systematic literature review of interventions and their impact.British journal of clinical pharmacology · 2026Pooled it
- Factors that influence patient and public adverse drug reaction reporting: a systematic review using the theoretical domains framework.International journal of clinical pharmacy · 2023Pooled it
- Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial.Drug safety · 2021Trial
- VigiBase: Resource Profile Update with a Summary of Global Patterns and Trends in Adverse Event Reports for Medicines and Vaccines.Drug safety · 2026Review
- A real-world pharmacovigilance study of four anti-non-small cell lung cancer drugs using the WHO-VigiAccess database.Medicine · 2026Article
- Characterization of adverse reactions to two antihistamine drugs: A descriptive analysis from WHO-VigiAccess.PloS one · 2026Article
- Factors associated with the completeness of information provided in adverse drug reaction reports of physicians, pharmacists and consumers from Germany.Scientific reports · 2025Article
- Adverse reactions of four multi-targeted tyrosine kinase inhibitors: a descriptive analysis of the WHO-VigiAccess database.Frontiers in pharmacology · 2025Article
- The characteristics of adverse reactions of three anti-prostate cancer drugs based on Vigiaccess database and bibliometric analysis.Frontiers in pharmacology · 2025Article
- Adverse event profile of lomustine and temozolomide: a descriptive analysis from WHO-VigiAccess.Frontiers in pharmacology · 2025Article
- Unveiling the Burden of Drug-Induced Impulsivity: A Network Analysis of the FDA Adverse Event Reporting System.Drug safety · 2024Article
- A real-world data analysis of ocular adverse events linked to anti-VEGF drugs: a WHO-VigiAccess study.Frontiers in pharmacology · 2024Article
- Conducting and interpreting disproportionality analyses derived from spontaneous reporting systems.Frontiers in drug safety and regulation · 2023Review
- Characteristic analysis of adverse reactions of five anti-TNFɑ agents: a descriptive analysis from WHO-VigiAccess.Frontiers in pharmacology · 2023Article
- Article
- Strengthening therapeutic adherence and pharmacovigilance to antimalarial treatment in Manaus, Brazil: a multicomponent strategy using mHealth.Malaria journal · 2022Article
- The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process.International journal of environmental research and public health · 2021Review
- A patient-centred web-based adverse drug reaction reporting system identifies not yet labelled potential safety issues.European journal of clinical pharmacology · 2021Article
- A VigiBase descriptive study of fluoroquinolone induced disabling and potentially permanent musculoskeletal and connective tissue disorders.Scientific reports · 2021Article
- Direct reporting of adverse drug reactions by healthcare consumers in Africa: a narrative review.International journal of clinical pharmacy · 2021Review
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPatient reporting in pharmacovigilance is important and contributes to signal detection. However, descriptions of methodologies for using patient reports in signal detection are scarce, and published experiences of how patient reports are used in pharmacovigilance are limited to a few individual countries.
objectiveOur objective was to explore the contribution of patient reports to global signal detection in VigiBase.
methodsData were retrieved from VigiBase in September 2016. Drug-event-combination series were restricted to those with >50% patient reports, defined as reporter type "Consumer/non-health professional" per E2B reporting standard. vigiRank was applied to patient reports to prioritize combinations for assessment. Product information for healthcare professionals (HCPs) as well as patient information leaflets (PILs) were used as reference for information on adverse drug reactions (ADRs). Staff from the Uppsala Monitoring Centre and the Netherlands Pharmacovigilance Centre Lareb categorized the combinations. Potential signals proceeded to a more in-depth clinical review to determine whether the safety concern should be communicated as a "signal."
resultsOf the 212 combinations assessed, 20 (9%) resulted in eight signals communicated within the World Health Organization (WHO) programme for international drug monitoring. Review of PILs revealed insufficient ADR descriptions for patients and examples of poor consistency with product information for HCPs. Patient narratives provided details regarding the experience and impact of ADRs and evidence that patients make causality and personal risk assessments.
conclusionsSafety concerns described in patient reports can be identified in a global database including previously unknown ADRs as well as new aspects of known ADRs. Patient reports provide unique information valuable in signal assessment and should be included in signal detection. Novel approaches to highlighting patient reports in statistical signal detection can further improve the contribution of patient reports to pharmacovigilance.
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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.