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    The use of unequal randomisation in clinical trials — An update.

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    Authors
    Peckham, Emily
    Brabyn, Sally
    Cook, Liz
    Devlin, Thomas
    Dumville, Jo
    Torgerson, David J.
    Affiliation
    University of York
    University of Manchester
    Issue Date
    2015-11
    
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    Abstract
    Objective To update a 2005 review of the reasons researchers have given for the use of unequal randomisation in randomised controlled trials (RCTs). Main measures Intervention being tested; type of study; number of participants; randomisation ratio; sample size calculation and reason given for using unequal randomisation. Methods Review of trials using unequal randomisation. Databases and sources Cochrane library, Medline and CINAHL. Results A total of 86 trials were identified. Of these 82 trials (95%) recruited patients in favour of the experimental group. Various reasons for the use of unequal randomisation were given including: gaining treatment experience; identification of adverse events; ethical; logistic and enhancing recruitment. No trial reported explicitly used it for cost-effectiveness. Most of the papers (i.e. 47, 55%) did not state why they had used unequal randomisation and only 38 trials (44%) appeared to have taken the unequal randomisation into account in their sample size calculation. Conclusion Most studies did not mention the rationale for unequal allocation, and a significant proportion did not appear to account for it in the sample size calculations. Unlike the previous review economic considerations were not stated as a rationale for its use. A number of trials used it to enhance recruitment, although this has not been tested.
    Citation
    Peckham, E. et al (2015) 'The use of unequal randomisation in clinical trials — An update', Contemporary Clinical Trials, 45:113 .
    Publisher
    Elsevier
    Journal
    Contemporary Clinical Trials
    URI
    http://hdl.handle.net/10545/622278
    DOI
    10.1016/j.cct.2015.05.017
    Additional Links
    http://linkinghub.elsevier.com/retrieve/pii/S155171441530015X
    Type
    Article
    Language
    en
    ISSN
    15517144
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.cct.2015.05.017
    Scopus Count
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    Department of Humanities

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