Evidence map›Paper›PMID 37078281›Full record

ReviewStroke2023

Optimal Randomization Designs for Large Multicenter Clinical Trials: From the National Institutes of Health Stroke Trials Network Funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke Experience.

Wenle Zhao, Sharon D Yeatts, Joseph P Broderick, Magdy H Selim, Opeolu M Adeoye, Valerie L Durkalski-Mauldin, Caitlyn N Meinzer, Reneé H Martin, Catherine R Dillon, Christy N Cassarly and 2 more

Registry-linked trialAbstract readReview
In one paragraph

Review in Stroke, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03936361 (STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 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.

NCT03936361 phase3recruitingnot on this map

Statins use in intracerebral hemorrhage patients

TypeinterventionalSponsorBeth Israel Deaconess Medical CenterRan2020 to 2029Enrolled1,456ConditionsIntracerebral HemorrhageArmsStatins
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
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.

Wenle ZhaoDepartment of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).ORCID 0000-0003-0496-9700
Sharon D YeattsDepartment of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).ORCID 0000-0001-9235-0670
Joseph P BroderickDepartments of Neurology and Rehabilitation Medicine, University of Cincinnati Neuroscience Institute, University of Cincinnati Academic Health Center, OH (J.P.B.).ORCID 0000-0002-7323-7709
Magdy H SelimDepartment of Neurology, Beth Israel Deaconess Medical Center, Boston, MA (M.H.S.).ORCID 0000-0002-1936-3173
Opeolu M AdeoyeDepartment of Emergency Medicine, Washington University School of Medicine, St. Louis, MO (O.M.A.).ORCID 0000-0001-8666-5369
Valerie L Durkalski-MauldinDepartment of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).
Caitlyn N MeinzerDepartment of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).
Reneé H MartinDepartment of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).ORCID 0000-0002-9589-681X
Catherine R DillonDepartment of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).ORCID 0000-0003-2415-8999
Christy N CassarlyDepartment of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).ORCID 0000-0002-0304-9833
Keith H PaulsDepartment of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).
Jordan J ElmDepartment of Public Health Sciences, Medical University of South Carolina, Charleston (W.Z., S.D.Y., V.L.D.-M., C.N.M., R.H.M., C.R.D., C.N.C., K.H.P., J.J.E.).ORCID 0000-0002-4893-8474

Funding

NSTN National Clinical Coordinating CenterU01NS086872 · NINDS · UNIVERSITY OF CINCINNATI · PI Joseph Paul Broderick, Pooja Khatri · 2013 to 2026
$32.3M
Sleep for Stroke Management And Recovery Trial (Sleep SMART)U01NS099043 · NINDS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI DEVIN L BROWN, RONALD D CHERVIN · 2018 to 2026
$31.7M
Making Acute Stroke Trials Succeed: Challenges and Potential SolutionsU01NS110772 · NINDS · UNIVERSITY OF CINCINNATI · PI Joseph Paul Broderick, Jordan J. Elm · 2020 to 2026
$24.3M
AtRial Cardiopathy and Antithrombotic Drugs In prevention After cryptogenicstroke (ARCADIA)U01NS095869 · NINDS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI BRODERICK, JOSEPH PAUL, KAMEL, HOOMAN · 2017 to 2022
$22.0M
Anticoagulation in ICH Survivors for Prevention and Recovery (ASPIRE)U01NS106513 · NINDS · YALE UNIVERSITY · PI Hooman Kamel, Kevin Navin Sheth · 2019 to 2026
$20.6M
Multi-arm Optimization of Stroke Thrombolysis (MOST) Stroke TrialU01NS100699 · NINDS · WASHINGTON UNIVERSITY · PI ADEOYE, OPEOLU M, BARRETO, ANDREW D · 2018 to 2021
$18.8M
StATins Use in intRacerebral hemorrhage patieNts (SATURN)U01NS102289 · NINDS · BETH ISRAEL DEACONESS MEDICAL CENTER · PI Magdy H Selim · 2019 to 2026
$15.7M
StrokeNet I-ACQUIRE 12-month Follow-up StudyU01NS106655 · NINDS · VIRGINIA POLYTECHNIC INST AND ST UNIV · PI LO, WARREN DAVID, RAMEY, SHARON LANDESMAN · 2019 to 2024
$15.2M
Workshop to Identify Collaborative Project(s) for the NIH StrokeNet and the Japan NEtwork for Clinical Stroke Trials (NECST)U01NS087748 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI Catherine R. Dillon, Jordan J. Elm · 2014 to 2026
$14.1M
TRANScranial direct current stimulation for POst-stroke motor Recover - a phase II sTudy (TRANSPORT 2)U01NS102353 · NINDS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI FENG, WUWEI, SCHLAUG, GOTTFRIED · 2018 to 2023
$8.5M
Telerehabilitation for Patients with StrokeU01NS091951 · NINDS · UNIVERSITY OF CALIFORNIA-IRVINE · PI CRAMER, STEVEN C. · 2014 to 2018
$2.6M
Stanford University Regional Coordinating Stroke Center for the NINDS Stroke TriaU10NS086487 · NINDS · STANFORD UNIVERSITY · PI ALBERS, GREGORY W · 2013 to 2017
$1.9M
NINDS NIH HHS U01 NS086872NINDS NIH HHS U01 NS087748NINDS NIH HHS U01 NS091951NINDS NIH HHS U01 NS095869NINDS NIH HHS U01 NS099043NINDS NIH HHS U01 NS100699NINDS NIH HHS U01 NS102289NINDS NIH HHS U01 NS102353NINDS NIH HHS U01 NS106513NINDS NIH HHS U01 NS106655NINDS NIH HHS U01 NS110772NINDS NIH HHS U10 NS086487
6 · The paper itself

Abstract

From 2016 to 2021, the National Institutes of Health Stroke Trials Network funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke initiated ten multicenter randomized controlled clinical trials. Optimal subject randomization designs are demanded with 4 critical properties: (1) protection of treatment assignment randomness, (2) achievement of the desired treatment allocation ratio, (3) balancing of baseline covariates, and (4) ease of implementation. For acute stroke trials, it is necessary to minimize the time between eligibility assessment and treatment initiation. This article reviews the randomization designs for 3 trials currently enrolling in Stroke Trials Network funded by National Institutes of Health/National Institute of Neurological Disorders and Stroke, the SATURN (Statins in Intracerebral Hemorrhage Trial), the MOST (Multiarm Optimization of Stroke Thrombolysis Trial), and the FASTEST (Recombinant Factor VIIa for Hemorrhagic Stroke Trial). Randomization methods utilized in these trials include minimal sufficient balance, block urn design, big stick design, and step-forward randomization. Their advantages and limitations are reviewed and compared with traditional stratified permuted block design and minimization.

Indexed as

National Institute of Neurological Disorders and Stroke (U.S.)StrokeCerebral HemorrhageHumansMulticenter Studies as TopicNational Institutes of Health (U.S.)Random AllocationRandomized Controlled Trials as TopicUnited Statesallocation randomnesscovariate balanceemergency treatmentmulticenter clinical trialrandomizationresponse adaptive randomization

Identifiers

PMID37078281
PMCPMC10343960

What OpenQuestion holds

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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.