Evidence map›Paper›PMID 28768800›Full record

ArticleStroke2017

Factors Associated With Time to Site Activation, Randomization, and Enrollment Performance in a Stroke Prevention Trial.

Bart M Demaerschalk, Robert D Brown, Gary S Roubin, Virginia J Howard, Eldina Cesko, Kevin M Barrett, Mary E Longbottom, Jenifer H Voeks, Seemant Chaturvedi, Thomas G Brott and 4 more

Registry-linked trialOpen access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Stroke, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02089217 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 33% 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.

NCT02089217 nacompletednot on this map

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

TypeinterventionalSponsorMayo ClinicRan2014 to 2025Enrolled2,486ConditionsCarotid StenosisArmsCarotid endarterectomy (CEA), Carotid Stenting (CAS), Intensive Medical Management - no CEA, Intensive Medical Management - no CAS
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 1 country.

Bart M DemaerschalkFrom the Department of Neurology, Mayo Clinic, Phoenix, AZ (B.M.D.); Department of Neurology, Mayo Clinic, Rochester, MN (R.D.B.); Department of Cardiology, Brookwood Medical Center, Birmingham, AL (G.S.R.); Department of Epidemiology, University of Alabama, Birmingham (V.J.H.); Department of Neurology, Mayo Clinic, Jacksonville, FL (E.C., K.M.B., M.E.L., T.G.B., J.F.M.); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); Department of Neurology and Stroke Program, University of Miami Miller School of Medicine, FL (S.C.); Department of Surgery, University of Maryland, Baltimore (B.K.L.); and Department of Biostatistics, University of Alabama at Birmingham (G.H.).
Robert D BrownFrom the Department of Neurology, Mayo Clinic, Phoenix, AZ (B.M.D.); Department of Neurology, Mayo Clinic, Rochester, MN (R.D.B.); Department of Cardiology, Brookwood Medical Center, Birmingham, AL (G.S.R.); Department of Epidemiology, University of Alabama, Birmingham (V.J.H.); Department of Neurology, Mayo Clinic, Jacksonville, FL (E.C., K.M.B., M.E.L., T.G.B., J.F.M.); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); Department of Neurology and Stroke Program, University of Miami Miller School of Medicine, FL (S.C.); Department of Surgery, University of Maryland, Baltimore (B.K.L.); and Department of Biostatistics, University of Alabama at Birmingham (G.H.).
Gary S RoubinFrom the Department of Neurology, Mayo Clinic, Phoenix, AZ (B.M.D.); Department of Neurology, Mayo Clinic, Rochester, MN (R.D.B.); Department of Cardiology, Brookwood Medical Center, Birmingham, AL (G.S.R.); Department of Epidemiology, University of Alabama, Birmingham (V.J.H.); Department of Neurology, Mayo Clinic, Jacksonville, FL (E.C., K.M.B., M.E.L., T.G.B., J.F.M.); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); Department of Neurology and Stroke Program, University of Miami Miller School of Medicine, FL (S.C.); Department of Surgery, University of Maryland, Baltimore (B.K.L.); and Department of Biostatistics, University of Alabama at Birmingham (G.H.).
Virginia J HowardFrom the Department of Neurology, Mayo Clinic, Phoenix, AZ (B.M.D.); Department of Neurology, Mayo Clinic, Rochester, MN (R.D.B.); Department of Cardiology, Brookwood Medical Center, Birmingham, AL (G.S.R.); Department of Epidemiology, University of Alabama, Birmingham (V.J.H.); Department of Neurology, Mayo Clinic, Jacksonville, FL (E.C., K.M.B., M.E.L., T.G.B., J.F.M.); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); Department of Neurology and Stroke Program, University of Miami Miller School of Medicine, FL (S.C.); Department of Surgery, University of Maryland, Baltimore (B.K.L.); and Department of Biostatistics, University of Alabama at Birmingham (G.H.).
Eldina CeskoFrom the Department of Neurology, Mayo Clinic, Phoenix, AZ (B.M.D.); Department of Neurology, Mayo Clinic, Rochester, MN (R.D.B.); Department of Cardiology, Brookwood Medical Center, Birmingham, AL (G.S.R.); Department of Epidemiology, University of Alabama, Birmingham (V.J.H.); Department of Neurology, Mayo Clinic, Jacksonville, FL (E.C., K.M.B., M.E.L., T.G.B., J.F.M.); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); Department of Neurology and Stroke Program, University of Miami Miller School of Medicine, FL (S.C.); Department of Surgery, University of Maryland, Baltimore (B.K.L.); and Department of Biostatistics, University of Alabama at Birmingham (G.H.).
Kevin M BarrettFrom the Department of Neurology, Mayo Clinic, Phoenix, AZ (B.M.D.); Department of Neurology, Mayo Clinic, Rochester, MN (R.D.B.); Department of Cardiology, Brookwood Medical Center, Birmingham, AL (G.S.R.); Department of Epidemiology, University of Alabama, Birmingham (V.J.H.); Department of Neurology, Mayo Clinic, Jacksonville, FL (E.C., K.M.B., M.E.L., T.G.B., J.F.M.); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); Department of Neurology and Stroke Program, University of Miami Miller School of Medicine, FL (S.C.); Department of Surgery, University of Maryland, Baltimore (B.K.L.); and Department of Biostatistics, University of Alabama at Birmingham (G.H.).
Mary E LongbottomFrom the Department of Neurology, Mayo Clinic, Phoenix, AZ (B.M.D.); Department of Neurology, Mayo Clinic, Rochester, MN (R.D.B.); Department of Cardiology, Brookwood Medical Center, Birmingham, AL (G.S.R.); Department of Epidemiology, University of Alabama, Birmingham (V.J.H.); Department of Neurology, Mayo Clinic, Jacksonville, FL (E.C., K.M.B., M.E.L., T.G.B., J.F.M.); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); Department of Neurology and Stroke Program, University of Miami Miller School of Medicine, FL (S.C.); Department of Surgery, University of Maryland, Baltimore (B.K.L.); and Department of Biostatistics, University of Alabama at Birmingham (G.H.).
Jenifer H VoeksFrom the Department of Neurology, Mayo Clinic, Phoenix, AZ (B.M.D.); Department of Neurology, Mayo Clinic, Rochester, MN (R.D.B.); Department of Cardiology, Brookwood Medical Center, Birmingham, AL (G.S.R.); Department of Epidemiology, University of Alabama, Birmingham (V.J.H.); Department of Neurology, Mayo Clinic, Jacksonville, FL (E.C., K.M.B., M.E.L., T.G.B., J.F.M.); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); Department of Neurology and Stroke Program, University of Miami Miller School of Medicine, FL (S.C.); Department of Surgery, University of Maryland, Baltimore (B.K.L.); and Department of Biostatistics, University of Alabama at Birmingham (G.H.).
Seemant ChaturvediFrom the Department of Neurology, Mayo Clinic, Phoenix, AZ (B.M.D.); Department of Neurology, Mayo Clinic, Rochester, MN (R.D.B.); Department of Cardiology, Brookwood Medical Center, Birmingham, AL (G.S.R.); Department of Epidemiology, University of Alabama, Birmingham (V.J.H.); Department of Neurology, Mayo Clinic, Jacksonville, FL (E.C., K.M.B., M.E.L., T.G.B., J.F.M.); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); Department of Neurology and Stroke Program, University of Miami Miller School of Medicine, FL (S.C.); Department of Surgery, University of Maryland, Baltimore (B.K.L.); and Department of Biostatistics, University of Alabama at Birmingham (G.H.).
Thomas G BrottFrom the Department of Neurology, Mayo Clinic, Phoenix, AZ (B.M.D.); Department of Neurology, Mayo Clinic, Rochester, MN (R.D.B.); Department of Cardiology, Brookwood Medical Center, Birmingham, AL (G.S.R.); Department of Epidemiology, University of Alabama, Birmingham (V.J.H.); Department of Neurology, Mayo Clinic, Jacksonville, FL (E.C., K.M.B., M.E.L., T.G.B., J.F.M.); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); Department of Neurology and Stroke Program, University of Miami Miller School of Medicine, FL (S.C.); Department of Surgery, University of Maryland, Baltimore (B.K.L.); and Department of Biostatistics, University of Alabama at Birmingham (G.H.). Brott.Thomas@mayo.edu.
Brajesh K LalFrom the Department of Neurology, Mayo Clinic, Phoenix, AZ (B.M.D.); Department of Neurology, Mayo Clinic, Rochester, MN (R.D.B.); Department of Cardiology, Brookwood Medical Center, Birmingham, AL (G.S.R.); Department of Epidemiology, University of Alabama, Birmingham (V.J.H.); Department of Neurology, Mayo Clinic, Jacksonville, FL (E.C., K.M.B., M.E.L., T.G.B., J.F.M.); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); Department of Neurology and Stroke Program, University of Miami Miller School of Medicine, FL (S.C.); Department of Surgery, University of Maryland, Baltimore (B.K.L.); and Department of Biostatistics, University of Alabama at Birmingham (G.H.).
James F MeschiaFrom the Department of Neurology, Mayo Clinic, Phoenix, AZ (B.M.D.); Department of Neurology, Mayo Clinic, Rochester, MN (R.D.B.); Department of Cardiology, Brookwood Medical Center, Birmingham, AL (G.S.R.); Department of Epidemiology, University of Alabama, Birmingham (V.J.H.); Department of Neurology, Mayo Clinic, Jacksonville, FL (E.C., K.M.B., M.E.L., T.G.B., J.F.M.); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); Department of Neurology and Stroke Program, University of Miami Miller School of Medicine, FL (S.C.); Department of Surgery, University of Maryland, Baltimore (B.K.L.); and Department of Biostatistics, University of Alabama at Birmingham (G.H.).
George HowardFrom the Department of Neurology, Mayo Clinic, Phoenix, AZ (B.M.D.); Department of Neurology, Mayo Clinic, Rochester, MN (R.D.B.); Department of Cardiology, Brookwood Medical Center, Birmingham, AL (G.S.R.); Department of Epidemiology, University of Alabama, Birmingham (V.J.H.); Department of Neurology, Mayo Clinic, Jacksonville, FL (E.C., K.M.B., M.E.L., T.G.B., J.F.M.); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); Department of Neurology and Stroke Program, University of Miami Miller School of Medicine, FL (S.C.); Department of Surgery, University of Maryland, Baltimore (B.K.L.); and Department of Biostatistics, University of Alabama at Birmingham (G.H.).
CREST-2 Investigators
University of Alabama at Birmingham · USUniversity of Maryland, Baltimore · USMayo Clinic in Arizona · USUniversity of Miami · USMedical University of South Carolina · US

Funding

CREST-2 Clinical Coordinating CenterU01NS080168 · NINDS · MAYO CLINIC JACKSONVILLE · PI Thomas G Brott, JAMES F MESCHIA · 2014 to 2026
$56.3M
CREST-2 Statistical and Data Coordinating Center - SDCCU01NS080165 · NINDS · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI EDWARDS, LLOYD J · 2014 to 2025
$15.0M
NINDS NIH HHS U01 NS080165NINDS NIH HHS U01 NS080168
6 · The paper itself

Abstract

background and purposeMulticenter clinical trials attempt to select sites that can move rapidly to randomization and enroll sufficient numbers of patients. However, there are few assessments of the success of site selection.

methodsIn the CREST-2 (Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trials), we assess factors associated with the time between site selection and authorization to randomize, the time between authorization to randomize and the first randomization, and the average number of randomizations per site per month. Potential factors included characteristics of the site, specialty of the principal investigator, and site type.

resultsFor 147 sites, the median time between site selection to authorization to randomize was 9.9 months (interquartile range, 7.7, 12.4), and factors associated with early site activation were not identified. The median time between authorization to randomize and a randomization was 4.6 months (interquartile range, 2.6, 10.5). Sites with authorization to randomize in only the carotid endarterectomy study were slower to randomize, and other factors examined were not significantly associated with time-to-randomization. The recruitment rate was 0.26 (95% confidence interval, 0.23-0.28) patients per site per month. By univariate analysis, factors associated with faster recruitment were authorization to randomize in both trials, principal investigator specialties of interventional radiology and cardiology, pre-trial reported performance >50 carotid angioplasty and stenting procedures per year, status in the top half of recruitment in the CREST trial, and classification as a private health facility. Participation in StrokeNet was associated with slower recruitment as compared with the non-StrokeNet sites.

conclusionsOverall, selection of sites with high enrollment rates will likely require customization to align the sites selected to the factor under study in the trial. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT02089217.

Indexed as

Endarterectomy, CarotidMulticenter Studies as TopicPatient SelectionRandomized Controlled Trials as TopicAngioplastyCarotid StenosisHumansStentsStrokecarotid arteriescarotid stenosisclinical trialendarterectomy, carotidmulticenter studyrandomized controlled trialvascular diseases

Identifiers

PMID28768800
PMCPMC5575963
OpenAlexW2740267754

What OpenQuestion holds

Textmetadata
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Read underepoch 390

Registered trials

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.