Methodologic challenges in the design and conduct of hyperacute stroke research

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Stroke is the third leading cause of death in the United States and the leading cause of adult disability, consistently ranking in the top 10 of leading diagnostic categories encountered by practitioners in emergency and critical care settings. Despite its prevalence and clinical significance, only tissue plasminogen activator for ischemic stroke has been shown to reduce 3-month mortality and disability in phase III clinical trials, whereas for hemorrhagic stroke, no medicinal treatment has yet to demonstrate a similar reduction in mortality or disability. This article describes challenges inherent in the design and conduct of hyperacute stroke trials. Sample heterogeneity associated with pathophysiologic stroke mechanisms, the neurovascular territory implicated, systemic and intracranial hemodynamics, risk factor profiles, and patient access to requisite healthcare services are reviewed as contributors challenging enrollment into well-designed studies. Current controversies associated with designation of endpoints are presented and strategies to enhance trial design, and subsequent enrollment, are discussed. Recommendations are made for future clinical research into phenomena associated with hyperacute stroke.

Original languageEnglish (US)
Pages (from-to)186-201
Number of pages16
JournalAACN Advanced Critical Care
Volume19
Issue number2
DOIs
StatePublished - Apr 1 2008

Fingerprint

Stroke
Research
Phase III Clinical Trials
Mortality
Emergency Medical Services
Tissue Plasminogen Activator
Critical Care
Cause of Death
Hemodynamics
Delivery of Health Care
Therapeutics

All Science Journal Classification (ASJC) codes

  • Emergency Medicine
  • Critical Care

Cite this

Methodologic challenges in the design and conduct of hyperacute stroke research. / Alexandrov, Anne.

In: AACN Advanced Critical Care, Vol. 19, No. 2, 01.04.2008, p. 186-201.

Research output: Contribution to journalArticle

@article{16acbd3cea09435c874a80a660aa77d1,
title = "Methodologic challenges in the design and conduct of hyperacute stroke research",
abstract = "Stroke is the third leading cause of death in the United States and the leading cause of adult disability, consistently ranking in the top 10 of leading diagnostic categories encountered by practitioners in emergency and critical care settings. Despite its prevalence and clinical significance, only tissue plasminogen activator for ischemic stroke has been shown to reduce 3-month mortality and disability in phase III clinical trials, whereas for hemorrhagic stroke, no medicinal treatment has yet to demonstrate a similar reduction in mortality or disability. This article describes challenges inherent in the design and conduct of hyperacute stroke trials. Sample heterogeneity associated with pathophysiologic stroke mechanisms, the neurovascular territory implicated, systemic and intracranial hemodynamics, risk factor profiles, and patient access to requisite healthcare services are reviewed as contributors challenging enrollment into well-designed studies. Current controversies associated with designation of endpoints are presented and strategies to enhance trial design, and subsequent enrollment, are discussed. Recommendations are made for future clinical research into phenomena associated with hyperacute stroke.",
author = "Anne Alexandrov",
year = "2008",
month = "4",
day = "1",
doi = "10.1097/01.AACN.0000318122.56759.55",
language = "English (US)",
volume = "19",
pages = "186--201",
journal = "AACN Advanced Critical Care",
issn = "1559-7768",
publisher = "Lippincott Williams and Wilkins",
number = "2",

}

TY - JOUR

T1 - Methodologic challenges in the design and conduct of hyperacute stroke research

AU - Alexandrov, Anne

PY - 2008/4/1

Y1 - 2008/4/1

N2 - Stroke is the third leading cause of death in the United States and the leading cause of adult disability, consistently ranking in the top 10 of leading diagnostic categories encountered by practitioners in emergency and critical care settings. Despite its prevalence and clinical significance, only tissue plasminogen activator for ischemic stroke has been shown to reduce 3-month mortality and disability in phase III clinical trials, whereas for hemorrhagic stroke, no medicinal treatment has yet to demonstrate a similar reduction in mortality or disability. This article describes challenges inherent in the design and conduct of hyperacute stroke trials. Sample heterogeneity associated with pathophysiologic stroke mechanisms, the neurovascular territory implicated, systemic and intracranial hemodynamics, risk factor profiles, and patient access to requisite healthcare services are reviewed as contributors challenging enrollment into well-designed studies. Current controversies associated with designation of endpoints are presented and strategies to enhance trial design, and subsequent enrollment, are discussed. Recommendations are made for future clinical research into phenomena associated with hyperacute stroke.

AB - Stroke is the third leading cause of death in the United States and the leading cause of adult disability, consistently ranking in the top 10 of leading diagnostic categories encountered by practitioners in emergency and critical care settings. Despite its prevalence and clinical significance, only tissue plasminogen activator for ischemic stroke has been shown to reduce 3-month mortality and disability in phase III clinical trials, whereas for hemorrhagic stroke, no medicinal treatment has yet to demonstrate a similar reduction in mortality or disability. This article describes challenges inherent in the design and conduct of hyperacute stroke trials. Sample heterogeneity associated with pathophysiologic stroke mechanisms, the neurovascular territory implicated, systemic and intracranial hemodynamics, risk factor profiles, and patient access to requisite healthcare services are reviewed as contributors challenging enrollment into well-designed studies. Current controversies associated with designation of endpoints are presented and strategies to enhance trial design, and subsequent enrollment, are discussed. Recommendations are made for future clinical research into phenomena associated with hyperacute stroke.

UR - http://www.scopus.com/inward/record.url?scp=48549095969&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=48549095969&partnerID=8YFLogxK

U2 - 10.1097/01.AACN.0000318122.56759.55

DO - 10.1097/01.AACN.0000318122.56759.55

M3 - Article

VL - 19

SP - 186

EP - 201

JO - AACN Advanced Critical Care

JF - AACN Advanced Critical Care

SN - 1559-7768

IS - 2

ER -