BMJ 2000;321:1223 ( 11 November )

Letters

Quality of randomised controlled trials in head injury

    Trials in head injury are more complex than review suggests
    Authors' reply
    If in doubt, declare competing interests

Trials in head injury are more complex than review suggests

The first 150 words of the full text of this article appear below.

EDITOR---The review by Dickinson and colleagues1 shows a remarkably narrow view of research in head injury and virtually ignores the need to match the design to the research question. Historically, many clinical trials have been underpowered, but the authors' premise that the main aim of head injury trials should be to detect changes of "a few per cent" in the rate of death or disability does not apply, for example, to phase I/II trials in the acute stage nor the later interventions used in many of their reviewed trials. The authors might find it useful to reread the article "Why do we need some large, simple randomized trials?" by Yusuf et al (note the word "some" in the title).2

Several factors influence the relevant effect size and hence the size of the trial. Some potentially powerful interventions in severe head injury are not widely practicable and are likely . . . [Full text of this article]


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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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