Evidence map›Paper›PMID 29181582›Full record

Trial reportPediatric radiology2018

Contrast-enhanced voiding urosonography (ceVUS) with the intravesical administration of the ultrasound contrast agent Optison™ for vesicoureteral reflux detection in children: a prospective clinical trial.

Aikaterini Ntoulia, Susan J Back, Sphoorti Shellikeri, Laura Poznick, Trudy Morgan, Joanne Kerwood, J Christopher Edgar, Richard D Bellah, Janet R Reid, Diego Jaramillo and 2 more

Abstract readClinical TrialComparative Study
PubMed Publisher
In one paragraph

Trial report in Pediatric radiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing 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

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

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  6. Renal Ultrasonography in Children: Principles and Emerging Techniques.Current treatment options in pediatrics · 2024
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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

12 authors.

Aikaterini NtouliaDepartment of Radiology, The Children's Hospital of Philadelphia, 34th Street & Civic Center Boulevard, Philadelphia, PA, 19104, USA. ntouliaa@email.chop.edu.ORCID 0000-0002-9853-4873
Susan J BackDepartment of Radiology, The Children's Hospital of Philadelphia, 34th Street & Civic Center Boulevard, Philadelphia, PA, 19104, USA.
Sphoorti ShellikeriDepartment of Radiology, The Children's Hospital of Philadelphia, 34th Street & Civic Center Boulevard, Philadelphia, PA, 19104, USA.
Laura PoznickDepartment of Radiology, The Children's Hospital of Philadelphia, 34th Street & Civic Center Boulevard, Philadelphia, PA, 19104, USA.
Trudy MorganDepartment of Radiology, The Children's Hospital of Philadelphia, 34th Street & Civic Center Boulevard, Philadelphia, PA, 19104, USA.
Joanne KerwoodDepartment of Radiology, The Children's Hospital of Philadelphia, 34th Street & Civic Center Boulevard, Philadelphia, PA, 19104, USA.
J Christopher EdgarDepartment of Radiology, The Children's Hospital of Philadelphia, 34th Street & Civic Center Boulevard, Philadelphia, PA, 19104, USA.
Richard D BellahDepartment of Radiology, The Children's Hospital of Philadelphia, 34th Street & Civic Center Boulevard, Philadelphia, PA, 19104, USA.
Janet R ReidDepartment of Radiology, The Children's Hospital of Philadelphia, 34th Street & Civic Center Boulevard, Philadelphia, PA, 19104, USA.
Diego JaramilloDepartment of Radiology, The Children's Hospital of Philadelphia, 34th Street & Civic Center Boulevard, Philadelphia, PA, 19104, USA.
Douglas A CanningPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Kassa DargeDepartment of Radiology, The Children's Hospital of Philadelphia, 34th Street & Civic Center Boulevard, Philadelphia, PA, 19104, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundContrast-enhanced voiding urosonography (ceVUS) is widely used outside the United States to diagnose vesicoureteral reflux (VUR) in children and is highly sensitive while avoiding exposure to ionizing radiation. At the onset of this study, two ultrasound (US) contrast agents were available in the United States. Pediatric safety data for intravenous administration was published for one, Optison™.

objectiveThis study aimed to evaluate the diagnostic performance and safety of ceVUS using Optison™ and compare its diagnostic efficacy with voiding cystourethrogram (VCUG) for VUR detection and grading in children. MATERIALS AND

methodsThe United States Food and Drug Administration and institutional Investigational New Drug authorizations were obtained to conduct a prospective comparative study of ceVUS with Optison™ and VCUG. CeVUS was performed with intravesical administration of 0.2% Optison™/normal saline solution. A standard VCUG followed. Safety assessment included physical examination, and heart rate, pulse oximetry and adverse reactions monitoring before, during and immediately after the examinations. A follow-up questionnaire was completed by telephone 48-h after the studies.

resultsSixty-two pelviureteric units were studied in 30 patients with a mean age of 3.5 years (range: 0.1-17 years) including 21 girls and 9 boys. No severe adverse events occurred. All patients had normal heart rate and blood oxygenation saturation prior to, during and after the studies. At the 48-h follow-up, one patient (3.3%) reported transient dysuria. Taking the VCUG as the reference standard, ceVUS had a sensitivity of 91.7% (95%; confidence interval [CI]: 61.5%-99.8%) and specificity of 98% (95%; CI: 89.4%-99.9%). The concordance between ceVUS and VCUG for VUR detection and grading was 84.3% and 81.8%, respectively. VUR grades were discrepant in 4/11 refluxing pelviureteric units, with VCUG upgrading VUR in 2.

conclusionDetection of VUR with Optison™ ceVUS was comparable to VCUG without exposure to ionizing radiation. CeVUS with Optison™ is a well-tolerated diagnostic procedure with a favorable safety profile.

Indexed as

Administration, IntravesicalAdolescentAlbuminsChildChild, PreschoolContrast MediaFemaleFluorocarbonsHumansInfantMaleProspective StudiesSensitivity and SpecificityVesico-Ureteral RefluxAlbuminsContrast MediaFluorocarbonsFS 069ChildrenContrast agentContrast-enhanced voiding urosonographyDiagnosisGradingOptison™Vesicoureteral reflux

Identifiers

PMID29181582

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.