Evidence map›Paper›PMID 27993747›Full record

ArticleJournal of biomedical informatics2017

Accuracy of an automated knowledge base for identifying drug adverse reactions.

E A Voss, R D Boyce, P B Ryan, J van der Lei, P R Rijnbeek, M J Schuemie

Abstract read
In one paragraph

Article in Journal of biomedical informatics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 69 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 3 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

69 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Negative controls and how to use them: a guidance paper.International journal of epidemiology · 2026
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  11. Evaluating NLP Approaches to Extract Drug Indications.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2026
    Article
  12. Generative Transformers for Pharmacovigilance Signal Detection using Electronic Health Records.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2026
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  19. Assessing Covariate Balance with Small Sample Sizes.medRxiv : the preprint server for health sciences · 2025
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9 more citing papers are in PubMed but not listed here.

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

6 authors.

E A VossEpidemiology Analytics, Janssen Research & Development, LLC, Raritan, NJ, United States; Erasmus University Medical Center, Rotterdam, Netherlands; Observational Health Data Sciences and Informatics (OHDSI), New York, NY, United States. Electronic address: evoss3@its.jnj.com.
R D BoyceUniversity of Pittsburgh, Pittsburgh, PA, United States; Observational Health Data Sciences and Informatics (OHDSI), New York, NY, United States.
P B RyanEpidemiology Analytics, Janssen Research & Development, LLC, Raritan, NJ, United States; Columbia University, New York, NY, United States; Observational Health Data Sciences and Informatics (OHDSI), New York, NY, United States.
J van der LeiErasmus University Medical Center, Rotterdam, Netherlands; Observational Health Data Sciences and Informatics (OHDSI), New York, NY, United States.
P R RijnbeekErasmus University Medical Center, Rotterdam, Netherlands; Observational Health Data Sciences and Informatics (OHDSI), New York, NY, United States.
M J SchuemieEpidemiology Analytics, Janssen Research & Development, LLC, Raritan, NJ, United States; Observational Health Data Sciences and Informatics (OHDSI), New York, NY, United States.

Funding

Addressing gaps in clinically useful evidence on drug-drug interactionsR01LM011838 · NLM · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BOYCE, RICHARD DAVID · 2014 to 2017
$1.6M
Improving medication safety for nursing home residents prescribed psychotropic drK01AG044433 · NIA · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BOYCE, RICHARD DAVID · 2014 to 2016
$342k
NIA NIH HHS K01 AG044433NLM NIH HHS R01 LM011838
6 · The paper itself

Abstract

introductionDrug safety researchers seek to know the degree of certainty with which a particular drug is associated with an adverse drug reaction. There are different sources of information used in pharmacovigilance to identify, evaluate, and disseminate medical product safety evidence including spontaneous reports, published peer-reviewed literature, and product labels. Automated data processing and classification using these evidence sources can greatly reduce the manual curation currently required to develop reference sets of positive and negative controls (i.e. drugs that cause adverse drug events and those that do not) to be used in drug safety research.

methodsIn this paper we explore a method for automatically aggregating disparate sources of information together into a single repository, developing a predictive model to classify drug-adverse event relationships, and applying those predictions to a real world problem of identifying negative controls for statistical method calibration.

resultsOur results showed high predictive accuracy for the models combining all available evidence, with an area under the receiver-operator curve of ⩾0.92 when tested on three manually generated lists of drugs and conditions that are known to either have or not have an association with an adverse drug event.

conclusionsResults from a pilot implementation of the method suggests that it is feasible to develop a scalable alternative to the time-and-resource-intensive, manual curation exercise previously applied to develop reference sets of positive and negative controls to be used in drug safety research.

Indexed as

Drug-Related Side Effects and Adverse ReactionsElectronic Data ProcessingKnowledge BasesPharmacovigilanceAdverse Drug Reaction Reporting SystemsHumansAdverse drug reactionHealth outcomeKnowledge baseMachine-learning experimentPharmacovigilance

Identifiers

PMID27993747
PMCPMC5316295

What OpenQuestion holds

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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.