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 |
|---|---|
| Pages (from-to) | 1286-1298 |
| Number of pages | 13 |
| Journal | Neurosurgery |
| Volume | 44 |
| Issue number | 6 |
| DOIs | |
| State | Published - Jun 1 1999 |
| Externally published | Yes |
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Keywords
- Clinical trials
- Head injury
- Neuroprotection
- Outcome
- Prognosis
- Statistical analysis
ASJC Scopus subject areas
- Clinical Neurology
- Surgery
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, 01.06.1999, p. 1286-1298.Research output: Contribution to journal › Article
}
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 - 1999/6/1
Y1 - 1999/6/1
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 - Article
AN - SCOPUS:0033015939
VL - 44
SP - 1286
EP - 1298
JO - Neurosurgery
JF - Neurosurgery
SN - 0148-396X
IS - 6
ER -