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

^*Corresponding author for this work

Deanery of Molecular, Genetic and Population Health Sciences

Research output: Contribution to journal › Article › peer-review

Abstract / Description of output

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
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
Publication status	Published - 1 Jun 1999

Keywords / Materials (for Non-textual outputs)

Clinical trials
Head injury
Neuroprotection
Outcome
Prognosis
Statistical analysis

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10.1097/00006123-199906000-00076

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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.",

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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.

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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

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JF - Neurosurgery

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

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Keywords / Materials (for Non-textual outputs)

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