Clinical measurement, statistical analysis, and risk-benefit: controversies from trials of spinal injury.
BACKGROUND
The National Acute Spinal Cord Injury Studies have been a series of trials assessing the role of pharmacologic agents in the prevention of secondary neuronal damage after acute spinal cord injury.


METHODS
The trials were multicenter randomized, controlled studies.


RESULTS
Two trials have demonstrated the efficacy of high-dose methylprednisolone in improving neurologic and functional recovery and have shown a reassuring safety profile.


CONCLUSIONS
This study responds to a recent commentary on these trials and examines in particular the roles of clinical measurement, statistical analysis, and risk benefit in assembling evidence for or against innovative therapies.
Bracken
M B
MB
Department of Epidemiology, Yale University School of Medicine, New Haven, Connecticut 06520-8034, USA.
Aldrich
E F
EF
Herr
D L
DL
Hitchon
P W
PW
Holford
T R
TR
Marshall
L F
LF
Nockels
R P
RP
Pascale
V
V
Shepard
M J
MJ
Sonntag
V K
VK
Winn
H R
HR
Young
W
W
D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003627:Data Interpretation, Statistical; D004305:Dose-Response Relationship, Drug; D019317:Evidence-Based Medicine; D006801:Humans; D008775:Methylprednisolone / Q000009:adverse effects / Q000627:therapeutic use*; D009460:Neurologic Examination / Q000187:drug effects; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D013119:Spinal Cord Injuries / Q000188:drug therapy*; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D008775:Methylprednisolone