Evidence map›Paper›PMID 30131701›Full record

ArticleFrontiers in pharmacology2018

Detecting Pharmacovigilance Signals Combining Electronic Medical Records With Spontaneous Reports: A Case Study of Conventional Disease-Modifying Antirheumatic Drugs for Rheumatoid Arthritis.

Liwei Wang, Majid Rastegar-Mojarad, Zhiliang Ji, Sijia Liu, Ke Liu, Sungrim Moon, Feichen Shen, Yanshan Wang, Lixia Yao, John M Davis Iii and 1 more

Open access · goldAbstract read
In one paragraph

Article in Frontiers in pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 10% of its field
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

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.

  1. Pooled it
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  13. Social Media Analytics for Pharmacovigilance of Antiepileptic Drugs.Computational and mathematical methods in medicine · 2022
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  18. Integrating Electronic Health Record Data into the ADEpedia-on-OHDSI Platform for Improved Signal Detection: A Case Study of Immune-related Adverse Events.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2020
    Article
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  20. Evaluating the Impact of Dictionary Updates on Automatic Annotations Based on Clinical NLP Systems.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2019
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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

11 authors at 2 institutions in 2 countries.

Liwei WangDepartment of Health Sciences Research, Mayo Clinic College of Medicine, Rochester, MN, United States.
Majid Rastegar-MojaradDepartment of Health Sciences Research, Mayo Clinic College of Medicine, Rochester, MN, United States.
Zhiliang JiState Key Laboratory of Cellular Stress Biology, School of Life Sciences, Xiamen University, Xiamen, China.
Sijia LiuDepartment of Health Sciences Research, Mayo Clinic College of Medicine, Rochester, MN, United States.
Ke LiuState Key Laboratory of Cellular Stress Biology, School of Life Sciences, Xiamen University, Xiamen, China.
Sungrim MoonDepartment of Health Sciences Research, Mayo Clinic College of Medicine, Rochester, MN, United States.
Feichen ShenDepartment of Health Sciences Research, Mayo Clinic College of Medicine, Rochester, MN, United States.
Yanshan WangDepartment of Health Sciences Research, Mayo Clinic College of Medicine, Rochester, MN, United States.
Lixia YaoDepartment of Health Sciences Research, Mayo Clinic College of Medicine, Rochester, MN, United States.
John M Davis IiiDepartment of Health Sciences Research, Mayo Clinic College of Medicine, Rochester, MN, United States.
Hongfang LiuDepartment of Health Sciences Research, Mayo Clinic College of Medicine, Rochester, MN, United States.
Mayo Clinic · USXiamen University · CN

Funding

Yale-Mayo FDA Center for Excellence in Regulatory Science and InnovationU01FD005938 · FDA · YALE UNIVERSITY · PI Joseph Solomon Ross · 2016 to 2026
$25.4M
Open Health Natural Language Processing CollaboratoryU01TR002062 · NCATS · MAYO CLINIC ROCHESTER · PI JIANG, XIAOQIAN, LIU, HONGFANG · 2017 to 2021
$7.6M
Semi-structured Information Retrieval in Clinical Text for Cohort IdentificationR01LM011934 · NLM · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI HERSH, WILLIAM R, LIU, HONGFANG · 2014 to 2025
$5.1M
Methods for generalized ontology terms enrichment analysisR01LM011369 · NLM · STANFORD UNIVERSITY · PI SHAH, NIGAM H · 2013 to 2020
$5.0M
Secondary use of EMRs for surgical complication surveillanceR01EB019403 · NIBIB · MAYO CLINIC ROCHESTER · PI LIU, HONGFANG, STORLIE, CURTIS · 2015 to 2022
$3.8M
Advancing Cancer Pharmacoepidemiology Research Through EHRs and InformaticsU24CA194215 · NCI · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI TAO, CUI, YANG, PING · 2016 to 2020
$3.3M
Natural language processing for clinical and translational researchR01GM102282 · NIGMS · MAYO CLINIC ROCHESTER · PI LIU, HONGFANG, PAKHOMOV, SERGUEI VS · 2013 to 2016
$2.5M
Patient Medical History Representation, Extraction, and Inference from EHR DataR01LM011829 · NLM · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI TAO, CUI · 2014 to 2018
$1.7M
FDA HHS U01 FD005938NCATS NIH HHS U01 TR002062NCI NIH HHS U24 CA194215NIBIB NIH HHS R01 EB019403NIGMS NIH HHS R01 GM102282NLM NIH HHS R01 LM011369NLM NIH HHS R01 LM011829NLM NIH HHS R01 LM011934
6 · The paper itself

Abstract

Multiple data sources are preferred in adverse drug event (ADEs) surveillance owing to inadequacies of single source. However, analytic methods to monitor potential ADEs after prolonged drug exposure are still lacking. In this study we propose a method aiming to screen potential ADEs by combining FDA Adverse Event Reporting System (FAERS) and Electronic Medical Record (EMR). The proposed method uses natural language processing (NLP) techniques to extract treatment outcome information captured in unstructured text and adopts case-crossover design in EMR. Performances were evaluated using two ADE knowledge bases: Adverse Drug Reaction Classification System (ADReCS) and SIDER. We tested our method in ADE signal detection of conventional disease-modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis patients. Findings showed that recall greatly increased when combining FAERS with EMR compared with FAERS alone and EMR alone, especially for flexible mapping strategy. Precision (FAERS + EMR) in detecting ADEs improved using ADReCS as gold standard compared with SIDER. In addition, signals detected from EMR have considerably overlapped with signals detected from FAERS or ADE knowledge bases, implying the importance of EMR for pharmacovigilance. ADE signals detected from EMR and/or FAERS but not in existing knowledge bases provide hypothesis for future study.

Indexed as

adverse drug eventdisease-modifying antirheumatic drug (DMARD)Electronic Medical Records (EMR)FDA Adverse Event Reporting System (FAERS)natural language processingpharmacovigilance

Identifiers

PMID30131701
PMCPMC6090179
OpenAlexW2886698710

What OpenQuestion holds

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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.