Why Have Recent Trials of Neuroprotective Agents in Head Injury Failed to Show Convincing Efficacy? A Pragmatic Analysis and Theoretical Considerations

Why Have Recent Trials of Neuroprotective Agents in Head Injury Failed to Show Convincing... AbstractAN 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. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Neurosurgery Oxford University Press

Why Have Recent Trials of Neuroprotective Agents in Head Injury Failed to Show Convincing Efficacy? A Pragmatic Analysis and Theoretical Considerations

Why Have Recent Trials of Neuroprotective Agents in Head Injury Failed to Show Convincing Efficacy? A Pragmatic Analysis and Theoretical Considerations

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, M.D., Ph.D., Ewout W . Steyerberg, Ph.D., Gordon D. Murray, Ph.D., Ross Bullock, M.D., Ph.D., Alexander Baethmann, Ph.D., Lawrence F. Marshall, M.D., Graham M. Teasdale, F.R.C.P., F.R.C.S. Department of Neurosurgery (AIRM ), A cad em ic Hospital Rotterdam, Rotterdam, The Netherlands; Department of Public Health (EW S), Center for C lin ic a l D ecisio n Sciences, Erasmus U niversity, Rotterdam, The Netherlands; M edical Statistics Unit (C D M ), U niversity of Edinburgh, School of M ed icin e, Edinburgh, Scotland; Department of Neurosurgery (G M T ), U niversity of G lasg o w , G lasg o w , Scotland; Department of Neurosurgery (RB), M edical College of V irg inia, Richm ond, V irg in ia ; Klinikum Grosshadern (AB), Institut fur C hirurgische Forschung, Ludw ig M a xim ilia n s Universitat M unchen, M unchen, G erm an y; Department of N eurological Surgery (LFM ), U niversity of C alifo rn ia, San Diego, San Diego, C alifo rn ia AN O V E R V IE W O F 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 w ith 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 im portance of baseline prognostic indicators, and the problems caused by the distribution of outcome and the dichotom ization of these outcomes in the Glasgow O utcom e Scale. Recom m endations are presented for consider­ ation in the design and analysis of future trials in head injury. (N e u r o s u r g e r y 4 4 : 1 2 8 6 - 1 2 9 8 , 1999) Key words: Clinical trials, Head injury, Neuroprotection, Outcom e, Prognosis, Statistical analysis he management of head-injured patients is leased on the N rneth y l- D - a...
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Publisher
Oxford University Press
Copyright
© Published by Oxford University Press.
ISSN
0148-396X
eISSN
1524-4040
D.O.I.
10.1097/00006123-199906000-00076
Publisher site
See Article on Publisher Site

Abstract

AbstractAN 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.

Journal

NeurosurgeryOxford University Press

Published: Jun 1, 1999

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