Evidence map›Paper›PMID 25149292›Full record

ArticleBMC medical informatics and decision making2014

Concordance and predictive value of two adverse drug event data sets.

Aurel Cami, Ben Y Reis

Open access · goldAbstract read
In one paragraph

Article in BMC medical informatics and decision making, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 34% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Article
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

2 authors at 1 institution in 1 country.

Aurel CamiDivision of Emergency Medicine, Boston Children's Hospital, 1 Autumn Street, 5th Floor, Boston, MA 02215, USA. aurel.cami@childrens.harvard.edu.
Ben Y Reis
Boston Children's Hospital · US

Funding

Preclinical predictive markers of post-approval drug safetyR01GM085421 · NIGMS · BOSTON CHILDREN'S HOSPITAL · PI REIS, BEN Y · 2008 to 2011
$1.3M
Integrative Methods for Improved PharmacovigilanceR01GM089731 · NIGMS · BOSTON CHILDREN'S HOSPITAL · PI REIS, BEN Y · 2010 to 2012
$797k
Mapping the Drugome: predictive network approaches to drug safety surveillanceR00LM011014 · NLM · BOSTON CHILDREN'S HOSPITAL · PI CAMI, AUREL B. · 2013 to 2014
$432k
NIGMS NIH HHS 1R01GM085421NIGMS NIH HHS R01GM89731NLM NIH HHS 4R00LM011014NLM NIH HHS R00 LM011014
6 · The paper itself

Abstract

backgroundAccurate prediction of adverse drug events (ADEs) is an important means of controlling and reducing drug-related morbidity and mortality. Since no single "gold standard" ADE data set exists, a range of different drug safety data sets are currently used for developing ADE prediction models. There is a critical need to assess the degree of concordance between these various ADE data sets and to validate ADE prediction models against multiple reference standards.

methodsWe systematically evaluated the concordance of two widely used ADE data sets - Lexi-comp from 2010 and SIDER from 2012. The strength of the association between ADE (drug) counts in Lexi-comp and SIDER was assessed using Spearman rank correlation, while the differences between the two data sets were characterized in terms of drug categories, ADE categories and ADE frequencies. We also performed a comparative validation of the Predictive Pharmacosafety Networks (PPN) model using both ADE data sets. The predictive power of PPN using each of the two validation sets was assessed using the area under Receiver Operating Characteristic curve (AUROC).

resultsThe correlations between the counts of ADEs and drugs in the two data sets were 0.84 (95% CI: 0.82-0.86) and 0.92 (95% CI: 0.91-0.93), respectively. Relative to an earlier snapshot of Lexi-comp from 2005, Lexi-comp 2010 and SIDER 2012 introduced a mean of 1,973 and 4,810 new drug-ADE associations per year, respectively. The difference between these two data sets was most pronounced for Nervous System and Anti-infective drugs, Gastrointestinal and Nervous System ADEs, and postmarketing ADEs. A minor difference of 1.1% was found in the AUROC of PPN when SIDER 2012 was used for validation instead of Lexi-comp 2010.

conclusionsIn conclusion, the ADE and drug counts in Lexi-comp and SIDER data sets were highly correlated and the choice of validation set did not greatly affect the overall prediction performance of PPN. Our results also suggest that it is important to be aware of the differences that exist among ADE data sets, especially in modeling applications focused on specific drug and ADE categories.

Indexed as

Adverse Drug Reaction Reporting SystemsDatabases, FactualDatabases, PharmaceuticalHumansModels, Theoretical

Identifiers

PMID25149292
PMCPMC4150549
OpenAlexW2124359492

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.