Evidence map›Paper›PMID 29191852›Full record

Trial reportStroke2018

Challenge and Yield of Enrolling Racially and Ethnically Diverse Patient Populations in Low Event Rate Clinical Trials.

Alice J Sheffet, George Howard, Albert Sam, Zafar Jamil, Fred Weaver, David Chiu, Jenifer H Voeks, Virginia J Howard, Susan E Hughes, Linda Flaxman and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical TrialComparative StudyMulticenter Study
In one paragraph

Trial report in Stroke, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00004732 (Carotid Revascularization Endarterectomy Versus Stenting Trial), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 21% 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.

NCT00004732 nacompletednot on this map

Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

TypeinterventionalSponsorRutgers, The State University of New JerseyRan2000 to 2016Enrolled2,502ConditionsAtherosclerosis, Stroke, Carotid Stenosis, Cerebral InfarctionArmsCarotid Endarterectomy (CEA), Carotid Artery Stenting (CAS)
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
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  7. Observational
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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

13 authors at 5 institutions in 1 country.

Alice J SheffetFrom the Department of Surgery, Rutgers, the State University of New Jersey, Newark (A.J.S., S.E.H., L.F., T.G.B.); Departments of Biostatistics (G.H.) and Epidemiology, School of Public Health (V.J.H.), University of Alabama at Birmingham; Division of Vascular Surgery, Southern Connecticut Vascular Center, Middletown Hospital (A.S.); Section of Vascular Surgery, St. Michael's Medical Center, Newark, NJ (Z.J.); Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center, University of Southern California, Los Angeles (F.W.); Department of Neurology, Houston Methodist Neurological Institute, TX (D.C); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Mayo Clinic Florida, Jacksonville (M.E.L., T.G.B.).
George HowardFrom the Department of Surgery, Rutgers, the State University of New Jersey, Newark (A.J.S., S.E.H., L.F., T.G.B.); Departments of Biostatistics (G.H.) and Epidemiology, School of Public Health (V.J.H.), University of Alabama at Birmingham; Division of Vascular Surgery, Southern Connecticut Vascular Center, Middletown Hospital (A.S.); Section of Vascular Surgery, St. Michael's Medical Center, Newark, NJ (Z.J.); Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center, University of Southern California, Los Angeles (F.W.); Department of Neurology, Houston Methodist Neurological Institute, TX (D.C); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Mayo Clinic Florida, Jacksonville (M.E.L., T.G.B.).
Albert SamFrom the Department of Surgery, Rutgers, the State University of New Jersey, Newark (A.J.S., S.E.H., L.F., T.G.B.); Departments of Biostatistics (G.H.) and Epidemiology, School of Public Health (V.J.H.), University of Alabama at Birmingham; Division of Vascular Surgery, Southern Connecticut Vascular Center, Middletown Hospital (A.S.); Section of Vascular Surgery, St. Michael's Medical Center, Newark, NJ (Z.J.); Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center, University of Southern California, Los Angeles (F.W.); Department of Neurology, Houston Methodist Neurological Institute, TX (D.C); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Mayo Clinic Florida, Jacksonville (M.E.L., T.G.B.).
Zafar JamilFrom the Department of Surgery, Rutgers, the State University of New Jersey, Newark (A.J.S., S.E.H., L.F., T.G.B.); Departments of Biostatistics (G.H.) and Epidemiology, School of Public Health (V.J.H.), University of Alabama at Birmingham; Division of Vascular Surgery, Southern Connecticut Vascular Center, Middletown Hospital (A.S.); Section of Vascular Surgery, St. Michael's Medical Center, Newark, NJ (Z.J.); Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center, University of Southern California, Los Angeles (F.W.); Department of Neurology, Houston Methodist Neurological Institute, TX (D.C); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Mayo Clinic Florida, Jacksonville (M.E.L., T.G.B.).
Fred WeaverFrom the Department of Surgery, Rutgers, the State University of New Jersey, Newark (A.J.S., S.E.H., L.F., T.G.B.); Departments of Biostatistics (G.H.) and Epidemiology, School of Public Health (V.J.H.), University of Alabama at Birmingham; Division of Vascular Surgery, Southern Connecticut Vascular Center, Middletown Hospital (A.S.); Section of Vascular Surgery, St. Michael's Medical Center, Newark, NJ (Z.J.); Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center, University of Southern California, Los Angeles (F.W.); Department of Neurology, Houston Methodist Neurological Institute, TX (D.C); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Mayo Clinic Florida, Jacksonville (M.E.L., T.G.B.).
David ChiuFrom the Department of Surgery, Rutgers, the State University of New Jersey, Newark (A.J.S., S.E.H., L.F., T.G.B.); Departments of Biostatistics (G.H.) and Epidemiology, School of Public Health (V.J.H.), University of Alabama at Birmingham; Division of Vascular Surgery, Southern Connecticut Vascular Center, Middletown Hospital (A.S.); Section of Vascular Surgery, St. Michael's Medical Center, Newark, NJ (Z.J.); Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center, University of Southern California, Los Angeles (F.W.); Department of Neurology, Houston Methodist Neurological Institute, TX (D.C); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Mayo Clinic Florida, Jacksonville (M.E.L., T.G.B.).
Jenifer H VoeksFrom the Department of Surgery, Rutgers, the State University of New Jersey, Newark (A.J.S., S.E.H., L.F., T.G.B.); Departments of Biostatistics (G.H.) and Epidemiology, School of Public Health (V.J.H.), University of Alabama at Birmingham; Division of Vascular Surgery, Southern Connecticut Vascular Center, Middletown Hospital (A.S.); Section of Vascular Surgery, St. Michael's Medical Center, Newark, NJ (Z.J.); Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center, University of Southern California, Los Angeles (F.W.); Department of Neurology, Houston Methodist Neurological Institute, TX (D.C); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Mayo Clinic Florida, Jacksonville (M.E.L., T.G.B.).
Virginia J HowardFrom the Department of Surgery, Rutgers, the State University of New Jersey, Newark (A.J.S., S.E.H., L.F., T.G.B.); Departments of Biostatistics (G.H.) and Epidemiology, School of Public Health (V.J.H.), University of Alabama at Birmingham; Division of Vascular Surgery, Southern Connecticut Vascular Center, Middletown Hospital (A.S.); Section of Vascular Surgery, St. Michael's Medical Center, Newark, NJ (Z.J.); Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center, University of Southern California, Los Angeles (F.W.); Department of Neurology, Houston Methodist Neurological Institute, TX (D.C); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Mayo Clinic Florida, Jacksonville (M.E.L., T.G.B.).
Susan E HughesFrom the Department of Surgery, Rutgers, the State University of New Jersey, Newark (A.J.S., S.E.H., L.F., T.G.B.); Departments of Biostatistics (G.H.) and Epidemiology, School of Public Health (V.J.H.), University of Alabama at Birmingham; Division of Vascular Surgery, Southern Connecticut Vascular Center, Middletown Hospital (A.S.); Section of Vascular Surgery, St. Michael's Medical Center, Newark, NJ (Z.J.); Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center, University of Southern California, Los Angeles (F.W.); Department of Neurology, Houston Methodist Neurological Institute, TX (D.C); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Mayo Clinic Florida, Jacksonville (M.E.L., T.G.B.).
Linda FlaxmanFrom the Department of Surgery, Rutgers, the State University of New Jersey, Newark (A.J.S., S.E.H., L.F., T.G.B.); Departments of Biostatistics (G.H.) and Epidemiology, School of Public Health (V.J.H.), University of Alabama at Birmingham; Division of Vascular Surgery, Southern Connecticut Vascular Center, Middletown Hospital (A.S.); Section of Vascular Surgery, St. Michael's Medical Center, Newark, NJ (Z.J.); Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center, University of Southern California, Los Angeles (F.W.); Department of Neurology, Houston Methodist Neurological Institute, TX (D.C); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Mayo Clinic Florida, Jacksonville (M.E.L., T.G.B.).
Mary E LongbottomFrom the Department of Surgery, Rutgers, the State University of New Jersey, Newark (A.J.S., S.E.H., L.F., T.G.B.); Departments of Biostatistics (G.H.) and Epidemiology, School of Public Health (V.J.H.), University of Alabama at Birmingham; Division of Vascular Surgery, Southern Connecticut Vascular Center, Middletown Hospital (A.S.); Section of Vascular Surgery, St. Michael's Medical Center, Newark, NJ (Z.J.); Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center, University of Southern California, Los Angeles (F.W.); Department of Neurology, Houston Methodist Neurological Institute, TX (D.C); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Mayo Clinic Florida, Jacksonville (M.E.L., T.G.B.).
Thomas G BrottFrom the Department of Surgery, Rutgers, the State University of New Jersey, Newark (A.J.S., S.E.H., L.F., T.G.B.); Departments of Biostatistics (G.H.) and Epidemiology, School of Public Health (V.J.H.), University of Alabama at Birmingham; Division of Vascular Surgery, Southern Connecticut Vascular Center, Middletown Hospital (A.S.); Section of Vascular Surgery, St. Michael's Medical Center, Newark, NJ (Z.J.); Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center, University of Southern California, Los Angeles (F.W.); Department of Neurology, Houston Methodist Neurological Institute, TX (D.C); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Mayo Clinic Florida, Jacksonville (M.E.L., T.G.B.). brott.thomas@mayo.edu.
CREST Investigators
University of Alabama at Birmingham · USHouston Methodist · USMedical University of South Carolina · USSaint Michael's Medical Center · USUniversity of Southern California · US

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 NS038384
6 · The paper itself

Abstract

background and purposeWe report patient enrollment and retention by race and ethnicity in the CREST (Carotid Revascularization Endarterectomy Versus Stent Trial) and assess potential effect modification by race/ethnicity. In addition, we discuss the challenge of detecting differences in study outcomes when subgroups are small and the event rate is low.

methodsWe compared 2502 patients by race, ethnicity, baseline characteristics, and primary outcome (any periprocedural stroke, death, or myocardial infarction and subsequent ipsilateral stroke up to 10 years).

resultsTwo hundred forty (9.7%) patients were minority by race (6.1%) or ethnicity (3.6%); 109 patients (4.4%) were black, 32 (1.3%) Asian, 2332 (93.4%) white, 11 (0.4%) other, and 18 (0.7%) unknown. Ninety (3.6%) were Hispanic, 2377 (95%) non-Hispanic, and 35 (1.4%) unknown. The rate of the primary end point for all patients was 10.9%±0.9% at 10 years and did not differ by race or ethnicity (

conclusionsThe proportion of minorities recruited to CREST was below their representation in the general population, and retention of minority patients was lower than for whites. Primary outcomes did not differ by race or ethnicity. However, in CREST (like other studies), the lack of evidence of a racial/ethnic difference in the treatment effect should be interpreted with caution because of low statistical power to detect such a difference. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.

Indexed as

Myocardial InfarctionPatient ParticipationPostoperative ComplicationsRacial GroupsStrokeAgedEndarterectomy, CarotidFemaleHumansMaleMiddle AgedStentscarotid arteriesdiversityendarterectomymyocardial infarctionstentsstroke

Identifiers

PMID29191852
PMCPMC5823533
OpenAlexW2772457479

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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.