Evidence map›Paper›PMID 24057195›Full record

SynthesisPediatric radiology2014

Pediatric nephrogenic systemic fibrosis is rarely reported: a RADAR report.

Beatrice Nardone, Elise Saddleton, Anne E Laumann, Beatrice J Edwards, Dennis W Raisch, June M McKoy, Steven M Belknap, Christian Bull, Anand Haryani, Shawn E Cowper and 5 more

Abstract readMeta-Analysis
In one paragraph

Synthesis in Pediatric radiology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 2 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

33 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

15 authors.

Beatrice NardoneDepartment of Dermatology, Northwestern University Feinberg School of Medicine, 676 N. Saint Clair St., Ste. 1600, Chicago, IL, 60611, USA.
Elise Saddleton
Anne E Laumann
Beatrice J Edwards
Dennis W Raisch
June M McKoy
Steven M Belknap
Christian Bull
Anand Haryani
Shawn E Cowper
Ali K Abu-Alfa
Frank H Miller
Victoria Godinez-Puig
Vikas R Dharnidharka
Dennis P West

Funding

Research for Adverse Drug-Events And Reports (RADAR)R01CA102713 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI WEST, DENNIS PAUL · 2003 to 2010
$3.2M
Research on Adverse Drug Events and Reports: Novel Multiple Myeloma DrugsR01CA125077 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI WEST, DENNIS PAUL · 2007 to 2009
$1.7M
Adverse Drug Reactions in Geriatric Cancer PatientsK01CA134554 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI MCKOY, JUNE M. · 2008 to 2012
$737k
NCI NIH HHS 1K01CA134554-01NCI NIH HHS 1 R01 CA125077-01A1NCI NIH HHS 2 R01CA102713-03A2NCI NIH HHS K01 CA134554NCI NIH HHS R01 CA102713NCI NIH HHS R01 CA125077
6 · The paper itself

Abstract

backgroundNephrogenic systemic fibrosis is a fibrosing disorder associated with exposure to gadolinium-based contrast agents in people with severely compromised renal function.

objectiveThe purpose of this study was to determine the reported number of cases of nephrogenic systemic fibrosis in children using three distinct publicly available data sources. MATERIALS AND

methodsWe conducted systematic searches of the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), the International Center for Nephrogenic Systemic Fibrosis Research (ICNSFR) registry and published literature from January 1997 through September 2012. We contacted authors of individual published cases to obtain follow-up data. Data sets were cross-referenced to eliminate duplicate reporting.

resultsWe identified 23 children with nephrogenic systemic fibrosis. Seventeen had documented exposure to gadolinium-based contrast agents. Six children had been reported in both the FAERS and the literature, four in the FAERS and the ICNSFR registry and five in all three data sources.

conclusionNephrogenic systemic fibrosis has been rarely reported in children. Although rules related to confidentiality limit the ability to reconcile reports, active pharmaco-vigilance using RADAR (Research on Adverse Drug events And Reports) methodology helped in establishing the number of individual pediatric cases within the three major data sources.

Indexed as

Mandatory ReportingAdolescentAdverse Drug Reaction Reporting SystemsAge DistributionChildFemaleGadoliniumHumansIncidenceMagnetic Resonance ImagingMaleNephrogenic Fibrosing DermopathyRisk AssessmentSex DistributionUnited StatesGadolinium

Identifiers

PMID24057195
PMCPMC3946726

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.