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    Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy

    Access Status
    Fulltext not available
    Authors
    Godecke, E.
    Rai, T.
    Cadilhac, D.
    Armstrong, E.
    Middleton, S.
    Ciccone, N.
    Whitworth, Anne
    Rose, M.
    Holland, A.
    Ellery, F.
    Hankey, G.
    Bernhardt, J.
    Date
    2018
    Type
    Journal Article
    
    Metadata
    Show full item record
    Citation
    Godecke, E. and Rai, T. and Cadilhac, D. and Armstrong, E. and Middleton, S. and Ciccone, N. and Whitworth, A. et al. 2018. Statistical analysis plan (SAP) for the Very Early Rehabilitation in Speech (VERSE) after stroke trial: an international 3-arm clinical trial to determine the effectiveness of early, intensive, prescribed, direct aphasia therapy. International Journal of Stroke. 13 (8): pp. 863-880.
    Source Title
    International Journal of Stroke
    DOI
    10.1177/1747493018790055
    ISSN
    1747-4930
    School
    School of Occ Therapy, Social Work and Speech Path
    URI
    http://hdl.handle.net/20.500.11937/72814
    Collection
    • Curtin Research Publications
    Abstract

    © 2018 World Stroke Organization. Background: Limited evidence exists to support very early intensive aphasia rehabilitation after stroke. VERSE is a PROBE trial designed to determine whether two types of intensive aphasia therapy, beginning within 14 days of acute stroke, provide greater therapeutic and cost-effectiveness than usual care. Objective: To publish the detailed statistical analysis plan for the VERSE trial prior to unblinding. This statistical analysis plan was based on the published and registered VERSE trial protocol and was developed by the blinded steering committee and management team, led by the trial statistician. This plan was developed using outcome measures and trial data collection forms. Results: The VERSE statistical analysis plan is consistent with reporting standards for clinical trials and provides for clear and open reporting. Conclusions: Publication of a statistical analysis plan serves to reduce potential trial reporting bias and outlines transparent pre-specified analyses. Australian New Zealand Clinical Trials Registry (ANZCTR) Registration number: ACTRN12613000776707; Universal Trial Number (UTN) is U1111-1145-4130.

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