Evidence map›Paper›PMID 25749722›Full record

ArticleDrug safety2015

Computational approaches for pharmacovigilance signal detection: toward integrated and semantically-enriched frameworks.

Vassilis G Koutkias, Marie-Christine Jaulent

Abstract read
In one paragraph

Article in Drug safety, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Clinical Research Informatics: a Decade-in-Review.Yearbook of medical informatics · 2024
    Review
  7. Editorial: Traditional and innovative approaches for signal detection.Frontiers in drug safety and regulation · 2024
    Article
  8. Review
  9. Exploring Novel Computable Knowledge in Structured Drug Product Labels.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2020
    Article
  10. Review
  11. New Insights in Computational Methods for Pharmacovigilance:International journal of environmental research and public health · 2019
    Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Frontiers in pharmacology · 2018
    Article
  18. Article
  19. Clinical Research Informatics Contributions from 2015.Yearbook of medical informatics · 2016
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Vassilis G KoutkiasINSERM, U1142, LIMICS, Campus des Cordeliers, 15 rue de l' École de Médecine, 75006, Paris, France, vasileios.koutkias@inserm.fr.
Marie-Christine Jaulent

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Computational signal detection constitutes a key element of postmarketing drug monitoring and surveillance. Diverse data sources are considered within the 'search space' of pharmacovigilance scientists, and respective data analysis methods are employed, all with their qualities and shortcomings, towards more timely and accurate signal detection. Recent systematic comparative studies highlighted not only event-based and data-source-based differential performance across methods but also their complementarity. These findings reinforce the arguments for exploiting all possible information sources for drug safety and the parallel use of multiple signal detection methods. Combinatorial signal detection has been pursued in few studies up to now, employing a rather limited number of methods and data sources but illustrating well-promising outcomes. However, the large-scale realization of this approach requires systematic frameworks to address the challenges of the concurrent analysis setting. In this paper, we argue that semantic technologies provide the means to address some of these challenges, and we particularly highlight their contribution in (a) annotating data sources and analysis methods with quality attributes to facilitate their selection given the analysis scope; (b) consistently defining study parameters such as health outcomes and drugs of interest, and providing guidance for study setup; (c) expressing analysis outcomes in a common format enabling data sharing and systematic comparisons; and (d) assessing/supporting the novelty of the aggregated outcomes through access to reference knowledge sources related to drug safety. A semantically-enriched framework can facilitate seamless access and use of different data sources and computational methods in an integrated fashion, bringing a new perspective for large-scale, knowledge-intensive signal detection.

Indexed as

Computing MethodologiesPharmacovigilanceSemanticsDiffusion of InnovationDrug MonitoringHumansInformation DisseminationInformation Storage and RetrievalProduct Surveillance, Postmarketing

Identifiers

PMID25749722
PMCPMC4374117

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.