ArticleApplied clinical informatics2017
Harnessing scientific literature reports for pharmacovigilance. Prototype software analytical tool development and usability testing.
Article in Applied clinical informatics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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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.
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
6 citing papers in PubMed.
- Design Principles for Interactive Dashboards in Drug Safety Surveillance: Design Science Research.JMIR medical informatics · 2026Article
- A Visual Analytics Dashboard to Summarize Serial Anesthesia Records in Pediatric Radiation Treatment.Applied clinical informatics · 2019Article
- Decision-Centered Design of Patient Information Visualizations to Support Chronic Pain Care.Applied clinical informatics · 2019Article
- Ontology-Based Interactive Visualization of Patient-Generated Research Questions.Applied clinical informatics · 2019Article
- Quality Initiative Using Theory of Change and Visual Analytics to Improve Controlled Substance Documentation Discrepancies in the Operating Room.Applied clinical informatics · 2019Article
- Safeuristics! Do Heuristic Evaluation Violation Severity Ratings Correlate with Patient Safety Severity Ratings for a Native Electronic Health Record Mobile Application?Applied clinical informatics · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
objectivesWe seek to develop a prototype software analytical tool to augment FDA regulatory reviewers' capacity to harness scientific literature reports in PubMed/MEDLINE for pharmacovigilance and adverse drug event (ADE) safety signal detection. We also aim to gather feedback through usability testing to assess design, performance, and user satisfaction with the tool.
methodsA prototype, open source, web-based, software analytical tool generated statistical disproportionality data mining signal scores and dynamic visual analytics for ADE safety signal detection and management. We leveraged Medical Subject Heading (MeSH) indexing terms assigned to published citations in PubMed/MEDLINE to generate candidate drug-adverse event pairs for quantitative data mining. Six FDA regulatory reviewers participated in usability testing by employing the tool as part of their ongoing real-life pharmacovigilance activities to provide subjective feedback on its practical impact, added value, and fitness for use.
resultsAll usability test participants cited the tool's ease of learning, ease of use, and generation of quantitative ADE safety signals, some of which corresponded to known established adverse drug reactions. Potential concerns included the comparability of the tool's automated literature search relative to a manual 'all fields' PubMed search, missing drugs and adverse event terms, interpretation of signal scores, and integration with existing computer-based analytical tools.
conclusionsUsability testing demonstrated that this novel tool can automate the detection of ADE safety signals from published literature reports. Various mitigation strategies are described to foster improvements in design, productivity, and end user satisfaction.
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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.