Evidence map›Paper›PMID 23703591›Full record

ArticleDrug safety2013

Application of information retrieval approaches to case classification in the vaccine adverse event reporting system.

Taxiarchis Botsis, Emily Jane Woo, Robert Ball

Abstract read
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In one paragraph

Article in Drug safety, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

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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

12 citing papers in PubMed.

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  10. Monitoring biomedical literature for post-market safety purposes by analyzing networks of text-based coded information.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2017
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4 · The record

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5 · Who and what money

Authors and funding

3 authors.

Taxiarchis BotsisOffice of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research CBER, US FDA, Woodmont Office Complex 1, Rm 306N, 1401 Rockville Pike, Rockville, MD 20852, USA. Taxiarchis.Botsis@fda.hhs.gov
Emily Jane Woo
Robert Ball

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAutomating the classification of adverse event reports is an important step to improve the efficiency of vaccine safety surveillance. Previously we showed it was possible to classify reports using features extracted from the text of the reports.

objectiveThe aim of this study was to use the information encoded in the Medical Dictionary for Regulatory Activities (MedDRA(®)) in the US Vaccine Adverse Event Reporting System (VAERS) to support and evaluate two classification approaches: a multiple information retrieval strategy and a rule-based approach. To evaluate the performance of these approaches, we selected the conditions of anaphylaxis and Guillain-Barré syndrome (GBS).

methodsWe used MedDRA(®) Preferred Terms stored in the VAERS, and two standardized medical terminologies: the Brighton Collaboration (BC) case definitions and Standardized MedDRA(®) Queries (SMQ) to classify two sets of reports for GBS and anaphylaxis. Two approaches were used: (i) the rule-based instruments that are available by the two terminologies (the Automatic Brighton Classification [ABC] tool and the SMQ algorithms); and (ii) the vector space model.

resultsWe found that the rule-based instruments, particularly the SMQ algorithms, achieved a high degree of specificity; however, there was a cost in terms of sensitivity in all but the narrow GBS SMQ algorithm that outperformed the remaining approaches (sensitivity in the testing set was equal to 99.06 % for this algorithm vs. 93.40 % for the vector space model). In the case of anaphylaxis, the vector space model achieved higher sensitivity compared with the best values of both the ABC tool and the SMQ algorithms in the testing set (86.44 % vs. 64.11 % and 52.54 %, respectively).

conclusionsOur results showed the superiority of the vector space model over the existing rule-based approaches irrespective of the standardized medical knowledge represented by either the SMQ or the BC case definition. The vector space model might make automation of case definitions for spontaneous report review more efficient than current rule-based approaches, allowing more time for critical assessment and decision making by pharmacovigilance experts.

Indexed as

Adverse Drug Reaction Reporting SystemsAnaphylaxisGuillain-Barre SyndromeHumansInformation Storage and RetrievalPharmacovigilanceVaccinesVaccines

Identifiers

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Registered trials

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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.