ArticleDrug safety2018
Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study.
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 16 papers.
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Who cites it
16 citing papers in PubMed.
- Adverse drug reaction reporting with the Med Safety app in Uganda: a cluster-randomised, controlled trial.The Lancet. Global health · 2025Trial
- Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial.Drug safety · 2021Trial
- Pregnancy adverse events with immune checkpoint inhibitors in monotherapy and combination therapy in cancer: a disproportionality analysis.EClinicalMedicine · 2026Article
- Employing bibliometrics and natural language processing (NLP) to analyse real-world applications of adverse drug reaction.Exploratory research in clinical and social pharmacy · 2025Article
- Innovations in pharmacovigilance studies of medicines in older people.British journal of clinical pharmacology · 2025Review
- Evaluating Adverse Drug Reactions, Their Reporting Rates and Their Impact on Attitudes Toward Pharmacotherapy Among Female Patients with Schizophrenia: Insights and Implications from a Cross-Sectional Study.Healthcare (Basel, Switzerland) · 2024Article
- Trends in Adverse Event Reporting Before and After the Introduction of the Med Safety App in Nigeria.Pharmaceutical medicine · 2024Observational
- Data-Driven Identification of Factors That Influence the Quality of Adverse Event Reports: 15-Year Interpretable Machine Learning and Time-Series Analyses of VigiBase and QUEST.JMIR medical informatics · 2024Article
- Article
- Mobile apps for quick adverse drug reaction report: A scoping review.Pharmacoepidemiology and drug safety · 2023Article
- Article
- Smartphone-based mobile applications for adverse drug reactions reporting: global status and country experience.BMC medical informatics and decision making · 2022Article
- Public-private partnership (3Ps) in ensuring safe use of medicines: An Indian experience.Frontiers in public health · 2022Article
- Article
- Analysis of spontaneous reporting of suspected adverse drug reactions for non-analgesic over-the-counter drugs from 2008 to 2017.BMC pharmacology & toxicology · 2019Article
- Recommendations on the Use of Mobile Applications for the Collection and Communication of Pharmaceutical Product Safety Information: Lessons from IMI WEB-RADR.Drug safety · 2019Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSpontaneous reporting of suspected adverse drug reactions is key for efficient post-marketing safety surveillance. To increase usability and accessibility of reporting tools, the Web-Recognising Adverse Drug Reactions (WEB-RADR) consortium developed a smartphone application (app) based on a simplified reporting form.
objectiveThe objective of this study was to evaluate the characteristics, quality and contribution to signals of reports submitted via the WEB-RADR app.
methodsThe app was launched in the UK, the Netherlands and Croatia between July 2015 and May 2016. Spontaneous reports submitted until September 2016 with a single reporter were included. For each country, app reports and reports received through conventional means in the same time period were compared to identify characteristic features. A random subset of reports was assessed for clinical quality and completeness. The contribution to signal detection was assessed by a descriptive analysis.
resultsHigher proportions of app reports were submitted by patients in the UK (28 vs. 18%) and Croatia (32 vs. 7%); both p < 0.01. In the Netherlands, the difference was small (60 vs. 57%; p = 0.5). The proportion of female patients and the median patient ages in app reports submitted by patients were similar to the reference. The proportion of reports of at least moderate quality was high in both samples (app: 78-85%, reference: 78-98%), for all countries. App reports contributed to detecting eight potential safety signals at the national level, four of which were eventually signalled.
conclusionThe WEB-RADR app offers a new route of spontaneous reporting that shows promise in attracting reports from patients and that could become an important tool in the future. Patient demographics are similar to conventional routes, report quality is sufficient despite a simplified reporting form, and app reports show potential in contributing to signal detection.
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