Evidence map›Paper›PMID 30043385›Full record

ArticleDrug safety2018

Assessment of the Utility of Social Media for Broad-Ranging Statistical Signal Detection in Pharmacovigilance: Results from the WEB-RADR Project.

Ola Caster, Juergen Dietrich, Marie-Laure Kürzinger, Magnus Lerch, Simon Maskell, G Niklas Norén, Stéphanie Tcherny-Lessenot, Benoit Vroman, Antoni Wisniewski, John van Stekelenborg

Abstract read
In one paragraph

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 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
–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

31 citing papers in PubMed.

  1. Article
  2. Review
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  5. Pharmacovigilance in the digital age: gaining insight from social media data.Experimental biology and medicine (Maywood, N.J.) · 2025
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Ola CasterUppsala Monitoring Centre, Box 1051, Uppsala, 75140, Sweden. ola.caster@who-umc.org.ORCID http://orcid.org/0000-0002-2259-1716
Juergen DietrichBayer AG, Berlin, Germany.
Marie-Laure KürzingerSanofi, Epidemiology and Benefit-Risk Evaluation, Chilly-Mazarin Cedex, France.
Magnus LerchLenolution GmbH, Berlin, Germany.
Simon MaskellUniversity of Liverpool, Liverpool, UK.
G Niklas NorénUppsala Monitoring Centre, Box 1051, Uppsala, 75140, Sweden.ORCID http://orcid.org/0000-0002-4595-230X
Stéphanie Tcherny-LessenotSanofi, Epidemiology and Benefit-Risk Evaluation, Chilly-Mazarin Cedex, France.
Benoit VromanUCB Pharma, Braine-l'Alleud, Belgium.
Antoni WisniewskiAstraZeneca Global Regulatory Affairs, Cambridge, UK.
John van StekelenborgJanssen R&D, Horsham, PA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

INTRODUCTION AND

objectiveSocial media has been proposed as a possibly useful data source for pharmacovigilance signal detection. This study primarily aimed to evaluate the performance of established statistical signal detection algorithms in Twitter/Facebook for a broad range of drugs and adverse events.

methodsPerformance was assessed using a reference set by Harpaz et al., consisting of 62 US Food and Drug Administration labelling changes, and an internal WEB-RADR reference set consisting of 200 validated safety signals. In total, 75 drugs were studied. Twitter/Facebook posts were retrieved for the period March 2012 to March 2015, and drugs/events were extracted from the posts. We retrieved 4.3 million and 2.0 million posts for the WEB-RADR and Harpaz drugs, respectively. Individual case reports were extracted from VigiBase for the same period. Disproportionality algorithms based on the Information Component or the Proportional Reporting Ratio and crude post/report counting were applied in Twitter/Facebook and VigiBase. Receiver operating characteristic curves were generated, and the relative timing of alerting was analysed.

resultsAcross all algorithms, the area under the receiver operating characteristic curve for Twitter/Facebook varied between 0.47 and 0.53 for the WEB-RADR reference set and between 0.48 and 0.53 for the Harpaz reference set. For VigiBase, the ranges were 0.64-0.69 and 0.55-0.67, respectively. In Twitter/Facebook, at best, 31 (16%) and four (6%) positive controls were detected prior to their index dates in the WEB-RADR and Harpaz references, respectively. In VigiBase, the corresponding numbers were 66 (33%) and 17 (27%).

conclusionsOur results clearly suggest that broad-ranging statistical signal detection in Twitter and Facebook, using currently available methods for adverse event recognition, performs poorly and cannot be recommended at the expense of other pharmacovigilance activities.

Indexed as

PharmacovigilanceAdverse Drug Reaction Reporting SystemsData CollectionDrug-Related Side Effects and Adverse ReactionsHumansInformation Storage and RetrievalROC CurveSocial Media

Identifiers

PMID30043385
PMCPMC6223695

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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.