Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations

Andrew I.R. Maas; Ewout W. Steyerberg; Gordon D. Murray; Ross Bullock; Alexander Baethmann; Lawrence F. Marshall; Graham M. Teasdale

doi:10.1097/00006123-199906000-00076

Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations

Andrew I.R. Maas, Ewout W. Steyerberg, Gordon D. Murray, Ross Bullock, Alexander Baethmann, Lawrence F. Marshall, Graham M. Teasdale

Neurological Surgery

Research output: Contribution to journal › Review article › peer-review

128 Scopus citations

Abstract

AN OVERVIEW OF the results of recent trials of neuroprotective agents in head injury is presented. None of the trials showed efficacy in the general population of patients with a severe head injury. A critical analysis of the possible reasons for this failure is given. Specific attention is focused on the heterogeneity of the patient population, the importance of baseline prognostic indicators, and the problems caused by the distribution of outcome and the dichotomization of these outcomes in the Glasgow Outcome Scale. Recommendations are presented for consideration in the design and analysis of future trials in head injury.

Original language	English (US)
Pages (from-to)	1286-1298
Number of pages	13
Journal	Neurosurgery
Volume	44
Issue number	6
DOIs	https://doi.org/10.1097/00006123-199906000-00076
State	Published - Jun 1999

Keywords

Clinical trials
Head injury
Neuroprotection
Outcome
Prognosis
Statistical analysis

ASJC Scopus subject areas

Clinical Neurology
Surgery

Access to Document

10.1097/00006123-199906000-00076

Fingerprint Dive into the research topics of 'Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations'. Together they form a unique fingerprint.

Cite this

Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations. / Maas, Andrew I.R.; Steyerberg, Ewout W.; Murray, Gordon D.; Bullock, Ross; Baethmann, Alexander; Marshall, Lawrence F.; Teasdale, Graham M.

In: Neurosurgery, Vol. 44, No. 6, 06.1999, p. 1286-1298.

Research output: Contribution to journal › Review article › peer-review

@article{48df83ca82b34f1fa276a1aa46e50900,

title = "Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations",

abstract = "AN OVERVIEW OF the results of recent trials of neuroprotective agents in head injury is presented. None of the trials showed efficacy in the general population of patients with a severe head injury. A critical analysis of the possible reasons for this failure is given. Specific attention is focused on the heterogeneity of the patient population, the importance of baseline prognostic indicators, and the problems caused by the distribution of outcome and the dichotomization of these outcomes in the Glasgow Outcome Scale. Recommendations are presented for consideration in the design and analysis of future trials in head injury.",

keywords = "Clinical trials, Head injury, Neuroprotection, Outcome, Prognosis, Statistical analysis",

author = "Maas, {Andrew I.R.} and Steyerberg, {Ewout W.} and Murray, {Gordon D.} and Ross Bullock and Alexander Baethmann and Marshall, {Lawrence F.} and Teasdale, {Graham M.}",

year = "1999",

month = jun,

doi = "10.1097/00006123-199906000-00076",

language = "English (US)",

volume = "44",

pages = "1286--1298",

journal = "Neurosurgery",

issn = "0148-396X",

publisher = "Lippincott Williams and Wilkins",

number = "6",

}

TY - JOUR

T1 - Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations

AU - Maas, Andrew I.R.

AU - Steyerberg, Ewout W.

AU - Murray, Gordon D.

AU - Bullock, Ross

AU - Baethmann, Alexander

AU - Marshall, Lawrence F.

AU - Teasdale, Graham M.

PY - 1999/6

Y1 - 1999/6

N2 - AN OVERVIEW OF the results of recent trials of neuroprotective agents in head injury is presented. None of the trials showed efficacy in the general population of patients with a severe head injury. A critical analysis of the possible reasons for this failure is given. Specific attention is focused on the heterogeneity of the patient population, the importance of baseline prognostic indicators, and the problems caused by the distribution of outcome and the dichotomization of these outcomes in the Glasgow Outcome Scale. Recommendations are presented for consideration in the design and analysis of future trials in head injury.

AB - AN OVERVIEW OF the results of recent trials of neuroprotective agents in head injury is presented. None of the trials showed efficacy in the general population of patients with a severe head injury. A critical analysis of the possible reasons for this failure is given. Specific attention is focused on the heterogeneity of the patient population, the importance of baseline prognostic indicators, and the problems caused by the distribution of outcome and the dichotomization of these outcomes in the Glasgow Outcome Scale. Recommendations are presented for consideration in the design and analysis of future trials in head injury.

KW - Clinical trials

KW - Head injury

KW - Neuroprotection

KW - Outcome

KW - Prognosis

KW - Statistical analysis

UR - http://www.scopus.com/inward/record.url?scp=0033015939&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0033015939&partnerID=8YFLogxK

U2 - 10.1097/00006123-199906000-00076

DO - 10.1097/00006123-199906000-00076

M3 - Review article

AN - SCOPUS:0033015939

VL - 44

SP - 1286

EP - 1298

JO - Neurosurgery

JF - Neurosurgery

SN - 0148-396X

IS - 6

ER -

Why have recent trials of neuroprotective agents in head injury failed to show convincing efficacy? A pragmatic analysis and theoretical considerations

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Cite this