Evidence map›Paper›PMID 37694403›Full record

ReviewStroke2023

Enhancing Enrollment in Acute Stroke Trials: Current State and Consensus Recommendations.

Joseph P Broderick, Gisele Sampaio Silva, Magdy Selim, Scott E Kasner, Yasmin Aziz, Jocelyn Sutherland, Edward C Jauch, Opeolu M Adeoye, Michael D Hill, Eva A Mistry and 7 more

Open access · greenAbstract readReviewConsensus Statement
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. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 9% 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.

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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
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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

17 authors at 13 institutions in 4 countries.

Joseph P Broderick *Department of Neurology and Rehabilitation Medicine, University of Cincinnati Gardner Neuroscience Institute, OH (J.P.B., Y.A., E.A.M.).ORCID 0000-0002-7323-7709
Gisele Sampaio SilvaFederal University of São Paulo, Clinical Trialist/Neurology, Albert Einstein Hospital, São Paulo, Brazil (G.S.S.).ORCID 0000-0002-3247-3123
Magdy SelimDepartment of Neurology, Division of Stroke and Cerebrovascular Disease, Harvard Medical School/Beth Israel Deaconess Medical Center (M.S.).ORCID 0000-0002-1936-3173
Scott E KasnerDepartment of Neurology, University of Pennsylvania, Philadelphia (S.E.K.).ORCID 0000-0003-0418-6917
Yasmin AzizDepartment of Neurology and Rehabilitation Medicine, University of Cincinnati Gardner Neuroscience Institute, OH (J.P.B., Y.A., E.A.M.).ORCID 0000-0002-3515-4005
Jocelyn SutherlandClinical Operations Manager, Revalesio (J.S.).ORCID 0009-0006-1258-2345
Edward C JauchChair, Department of Research and Evaluation Sciences, University of North Carolina at MAHEC (E.C.J.).ORCID 0000-0002-3533-4364
Opeolu M AdeoyeDepartment of Emergency Medicine, Washington University School of Medicine, Emergency Physician-in-Chief, Barnes-Jewish Hospital, St. Louis, MO (O.M.A.).ORCID 0000-0001-8666-5369
Michael D HillDepartment of Clinical Neurosciences and Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary and Foothills Medical Centre, AB, Canada (M.D.H.).ORCID 0000-0002-6269-1543
Eva A MistryDepartment of Neurology and Rehabilitation Medicine, University of Cincinnati Gardner Neuroscience Institute, OH (J.P.B., Y.A., E.A.M.).ORCID 0000-0002-7426-3650
Patrick D LydenZilkha Neurogenetic Institute, Keck School of Medicine of USC (P.D.L.).ORCID 0000-0001-6170-4042
J MoccoDepartment of Neurological Surgery, Mount Sinai Health System, New York (J.M.).ORCID 0000-0001-5489-2524
Elaine M SmithNeuroscience Development, AbbVie, Inc (E.M.S.).
Macarena Hernandez-JimenezaptaTargets S.L., Madrid, Spain (M.H.-J.).ORCID 0000-0003-3329-3965
Emir DeljkichClinical Affairs, Imperative Care (E.D.).ORCID 0009-0009-4785-5683
Hooman Kamel *Department of Neurology, Weill Cornell Medicine, New York (H.K.).ORCID 0000-0002-5745-0307
STAIR XII Participants
Twitter (United States) · USAbbVie (United States) · USBarnes-Jewish Hospital · USBeth Israel Deaconess Medical Center · USCornell University · USFoothills Medical Centre · CAHospital Israelita Albert Einstein · BRHoward University · USKeck Hospital of USC · USMount Sinai Health System · USPrecision Optics Corporation (United States) · USUniversidad Complutense de Madrid · ESUniversity of Pennsylvania · US

Funding

NSTN National Clinical Coordinating CenterU01NS086872 · NINDS · UNIVERSITY OF CINCINNATI · PI Joseph Paul Broderick, Pooja Khatri · 2013 to 2026
$32.3M
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
ZZ-3K3A-301: A multicenter, randomized, placebo-controlled, double-blinded, Phase 3 study to evaluate the efficacy and safety of 3K3A-APC (RHAPSODY-2)UG3NS119199 · NINDS · UNIVERSITY OF SOUTHERN CALIFORNIA · PI LYDEN, PATRICK D · 2022 to 2022
$4.0M
MRI Detection of CarotId Plaques as a mecHanism for Embolic strokes of undeteRmined source (MRI DECIPHER)R01HL144541 · NHLBI · WEILL MEDICAL COLL OF CORNELL UNIV · PI GUPTA, AJAY, KAMEL, HOOMAN · 2019 to 2023
$3.9M
Quantitative Susceptibility Mapping for Stroke Risk Prediction of Vulnerable Carotid PlaquesR01NS123576 · NINDS · WEILL MEDICAL COLL OF CORNELL UNIV · PI Ajay Gupta, Hooman Kamel · 2022 to 2026
$3.3M
NHLBI NIH HHS R01 HL144541NINDS NIH HHS R01 NS123576NINDS NIH HHS U01 NS086872NINDS NIH HHS U01 NS095869NINDS NIH HHS U01 NS100699NINDS NIH HHS U01 NS106513NINDS NIH HHS U01 NS110772NINDS NIH HHS UG3 NS119199
6 · The paper itself

Abstract

The Stroke Treatment Academic Industry Roundtable (STAIR) convened a session and workshop regarding enrollment in acute stroke trials during the STAIR XII meeting on March 22, 2023. This forum brought together stroke physicians and researchers, members of the National Institute of Neurological Disorders and Stroke, industry representatives, and members of the US Food and Drug Administration to discuss the current status and opportunities for improving enrollment in acute stroke trials. The workshop identified the most relevant issues impacting enrollment in acute stroke trials and addressed potential action items for each. Focus areas included emergency consent in the United States and other countries; careful consideration of eligibility criteria to maximize enrollment and representativeness; investigator, study coordinator, and pharmacist availability outside of business hours; trial enthusiasm/equipoise; site start-up including contractual issues; site champions; incorporation of study procedures into standard workflow as much as possible; centralized enrollment at remote sites by study teams using telemedicine; global trials; and coenrollment in trials when feasible. In conclusion, enrollment of participants is the lifeblood of acute stroke trials and is the rate-limiting step for testing an exciting array of new approaches to improve patient outcomes. In particular, efforts should be undertaken to broaden the medical community's understanding and implementation of emergency consent procedures and to adopt designs and processes that are easily incorporated into standard workflow and that improve trials' efficiencies and execution. Research and actions to improve enrollment in ongoing and future trials will improve stroke outcomes more broadly than any single therapy under consideration.

Indexed as

PhysiciansStrokeEligibility DeterminationHumansNational Institute of Neurological Disorders and Stroke (U.S.)United Statesenrollmentinformed consentrandomized controlled trialstrokestudy design

Identifiers

PMID37694403
PMCPMC10542906
OpenAlexW4386591854

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.