Patient outcomes in historical comparators compared with randomised-controlled trials

Myzoon Ali, E. Jüttler, K. R. Lees, W. Hacke

    Research output: Contribution to journalArticle

    Abstract

    Decompressive hemicraniectomy for malignant middle cerebral artery infarction has long been controversial. Recently, data from randomised-controlled trials have shown that the procedure is life-saving and improves outcome. However, these randomised-controlled trials were difficult to conduct, because of ethical considerations due to high mortality in control groups. While the use of historical comparators may not be ideal for phase III efficacy trials, these data may be useful to inform the selection of trial populations. We sought to replicate the findings of the DESTINY trial of decompressive surgery in malignant middle cerebral artery infarction using the Virtual International Stroke Trials Archive, to determine whether historical comparators could be used as an alternative to control groups in situations where randomised-controlled trials are infeasible or regarded as unethical due to the high mortality under conservative treatment.

    Original languageEnglish
    Pages (from-to)10-15
    Number of pages6
    JournalInternational Journal of Stroke
    Volume5
    Issue number1
    DOIs
    Publication statusPublished - 1 Feb 2010

    Keywords

    • stroke
    • historical comparators
    • clinical trials

    Fingerprint Dive into the research topics of 'Patient outcomes in historical comparators compared with randomised-controlled trials'. Together they form a unique fingerprint.

  • Cite this