Head injury trials must be bigger and better

Millions of patients are treated each year for head injury, but few, if any, of the drug treatments for head injury are proved to be effective. As head injury is so common, even moderate treatment effects would be worth while. To detect moderate benefits, however, randomised controlled trials must be large and well designed. In a review of published studies Dickinson et al (p 1308) show that existing trials in head injury fail on both counts. The average number of randomised patients per trial was 82, and the largest study included only 1156 patients. Confusion about issues of consent in unconscious patients and the fact that funding for injury research is difficult to obtain probably explain why existing trials are so small.


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Relevant Article

Size and quality of randomised controlled trials in head injury: review of published studies
Karen Dickinson, Frances Bunn, Reinhard Wentz, Phil Edwards, and Ian Roberts
BMJ 2000 320: 1308-1311. [Abstract] [Full Text] [PDF]




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