Evidence map›Paper›PMID 24055515›Full record

Trial reportJournal of vascular surgery2014

Agreement between site-reported and ultrasound core laboratory results for duplex ultrasound velocity measurements in the Carotid Revascularization Endarterectomy versus Stenting Trial.

R Eugene Zierler, Kirk W Beach, Robert O Bergelin, Brajesh K Lal, Wesley S Moore, Gary S Roubin, Jenifer H Voeks, Thomas G Brott, CREST Investigators

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of vascular surgery, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Non-invasive imaging of vascular inflammation.Frontiers in immunology · 2014
    Review
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

9 authors.

R Eugene ZierlerD. E. Strandness, Jr. Vascular Laboratory, University of Washington, Seattle, Wash.
Kirk W BeachD. E. Strandness, Jr. Vascular Laboratory, University of Washington, Seattle, Wash.
Robert O BergelinD. E. Strandness, Jr. Vascular Laboratory, University of Washington, Seattle, Wash.
Brajesh K LalDivision of Vascular Surgery, Department of Surgery, University of Maryland Medical School, Baltimore, MD.
Wesley S MooreDivision of Vascular Surgery, University of California Los Angeles, Los Angeles, Calif.
Gary S RoubinContinuum Cardiovascular Centers of New York, New York, NY.
Jenifer H VoeksNeurosciences Department, Medical University of South Carolina, Charleston, SC.
Thomas G BrottDepartment of Neurology, Mayo Clinic, Jacksonville, Fla. Electronic address: brott.thomas@mayo.edu.
CREST Investigators

Funding

Carotid Revascularization Endarterectomy vs. Stenting Trial: Long Term Follow-upU01NS038384 · NINDS · UNIV OF MED/DENT OF NJ-NJ MEDICAL SCHOOL · PI BROTT, THOMAS G, SHEFFET, ALICE J · 2011 to 2016
$15.4M
NINDS NIH HHS U01 NS 038384NINDS NIH HHS U01 NS038384
6 · The paper itself

Abstract

objectivePatients in the Carotid Revascularization Endarterectomy vs Stenting Trial (CREST) had duplex ultrasound (DU) scans prior to treatment and during follow-up to document the severity of carotid disease and the anatomic outcome of carotid endarterectomy (CEA) or carotid artery stenting (CAS). An ultrasound core laboratory (UCL) reviewed DU data from the clinical sites. This analysis was done to determine the agreement between site-reported and UCL-verified DU velocity measurements.

methodsClinical site DU worksheets, B-mode images, and Doppler velocity waveforms for the treated carotid arteries were reviewed at the UCL. The highest internal carotid artery peak systolic velocity (PSV) and associated Doppler angle were verified. If the angle was misaligned by >3 degrees, it was remeasured at the UCL and the PSV was recalculated. Agreement for PSV was defined as site-reported PSV within ± 5% of UCL-verified PSV. Transcription errors were corrected by the UCL but were not considered as disagreements. Follow-up analysis was limited to patients who received the assigned treatment.

resultsThe UCL reviewed 1702 prior-to-treatment and 1743 12-month follow-up DU scans (873 CEA, 870 CAS) from 111 clinical sites. Site-reported and UCL-verified PSV agreed in 1124 (66%) of the prior-to-treatment scans and 1200 (69%) of the follow-up scans. In those cases with a disagreement, Doppler angle accounted for disagreement in 339 (59%) of the prior-to-treatment scans and 277 (51%) of the follow-up scans. Based on a threshold PSV for ≥ 70% stenosis of ≥ 230 cm/s on the prior-to-treatment scans and ≥ 300 cm/s on the follow-up scans, UCL review resulted in reclassification of stenosis severity in 75 (4.4%) of the prior-to-treatment scans and 13 (0.75%) of the follow-up scans. There is evidence that the proportion of reclassification at follow-up was greater for CAS (10 scans; 1.2%) than for CEA (three scans; 0.34%) (P = .057).

conclusionsThere was a high rate of agreement between site-reported and UCL-verified DU results in CREST, and UCL review was associated with a low rate of stenosis reclassification. However, angle alignment errors were quite common and prompted recalculation of velocity in 20% of prior-to-treatment scans and 18% of follow-up scans. The use of a UCL provides a uniform process for DU interpretation and can identify sources of error and suggest technical improvements for future studies.

Indexed as

Endarterectomy, CarotidStentsUltrasonography, Doppler, DuplexAgedBlood Flow VelocityCarotid StenosisChi-Square DistributionEndovascular ProceduresFemaleHumansLaboratory Proficiency TestingMaleMiddle AgedObserver VariationPredictive Value of TestsProspective Studies

Identifiers

PMID24055515
PMCPMC3912997

What OpenQuestion holds

Textmetadata
LicenceTDM
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.