Evidence map›Paper›PMID 23118093›Full record

ArticleJournal of the American Medical Informatics Association : JAMIA2013

Combing signals from spontaneous reports and electronic health records for detection of adverse drug reactions.

Rave Harpaz, Santiago Vilar, William Dumouchel, Hojjat Salmasian, Krystl Haerian, Nigam H Shah, Herbert S Chase, Carol Friedman

Abstract readEvaluation Study
In one paragraph

Article in Journal of the American Medical Informatics Association : JAMIA, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 90 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
90citing 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

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

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30 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

8 authors.

Rave HarpazDepartment of Biomedical Informatics, Columbia University Medical Center, New York, New York, USA. rharpaz@stanford.edu
Santiago Vilar
William Dumouchel
Hojjat Salmasian
Krystl Haerian
Nigam H Shah
Herbert S Chase
Carol Friedman

Funding

STANFORD COMPOSITE(RMI)U54HG004028 · NHGRI · STANFORD UNIVERSITY · PI MUSEN, MARK A · 2005 to 2014
$36.2M
Training in Biomedical Informatics at Columbia UniversityT15LM007079 · NLM · COLUMBIA UNIV NEW YORK MORNINGSIDE · PI NOEMIE ELHADAD, GEORGE M HRIPCSAK · 1992 to 2026
$28.9M
Pharmacovigilence using Natural Language Processing, Statistics, and the EHRR01LM010016 · NLM · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI FRIEDMAN, CAROL · 2009 to 2016
$3.4M
NHGRI NIH HHS U54 HG004028NLM NIH HHS 1R01LM010016NLM NIH HHS 3R01LM010016-01S1NLM NIH HHS 3R01LM010016-02S1NLM NIH HHS 5T15-LM007079-19NLM NIH HHS R01 LM010016NLM NIH HHS T15 LM007079
6 · The paper itself

Abstract

objectiveData-mining algorithms that can produce accurate signals of potentially novel adverse drug reactions (ADRs) are a central component of pharmacovigilance. We propose a signal-detection strategy that combines the adverse event reporting system (AERS) of the Food and Drug Administration and electronic health records (EHRs) by requiring signaling in both sources. We claim that this approach leads to improved accuracy of signal detection when the goal is to produce a highly selective ranked set of candidate ADRs. MATERIALS AND

methodsOur investigation was based on over 4 million AERS reports and information extracted from 1.2 million EHR narratives. Well-established methodologies were used to generate signals from each source. The study focused on ADRs related to three high-profile serious adverse reactions. A reference standard of over 600 established and plausible ADRs was created and used to evaluate the proposed approach against a comparator.

resultsThe combined signaling system achieved a statistically significant large improvement over AERS (baseline) in the precision of top ranked signals. The average improvement ranged from 31% to almost threefold for different evaluation categories. Using this system, we identified a new association between the agent, rasburicase, and the adverse event, acute pancreatitis, which was supported by clinical review.

conclusionsThe results provide promising initial evidence that combining AERS with EHRs via the framework of replicated signaling can improve the accuracy of signal detection for certain operating scenarios. The use of additional EHR data is required to further evaluate the capacity and limits of this system and to extend the generalizability of these results.

Indexed as

Adverse Drug Reaction Reporting SystemsElectronic Health RecordsDrug-Related Side Effects and Adverse ReactionsHumansPharmacovigilance

Identifiers

PMID23118093
PMCPMC3628045

What OpenQuestion holds

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Read underepoch 390

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.