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Clinical Review Understanding controlled trials

What is Zelen's design?

BMJ 1998; 316 doi: (Published 14 February 1998) Cite this as: BMJ 1998;316:606
  1. David J Torgerson, senior research fellowa,
  2. Martin Roland, director of research and developmentb
  1. a National Primary Care Research and Development Centre, Centre for Health Economics, University of York, York YO1 5DD
  2. b National Primary Care Research and Development Centre, University of Manchester, Manchester M13 9PL
  1. Correspondence to: Dr Torgerson.

    This is the fourth of an occasional series on the methods of randomised controlled trials

    When patients do not receive their preferred treatment in randomised trials there may be difficulties with patient recruitment and scientific problems with bias.1 For example, bias may occur when patients are aware of a new treatment not available to them and comply poorly with the standard treatment.

    Zelen's design can address these difficulties 2 3 by randomising patients before consent to participate has been sought. Two types of the design exist: double and single consent. In the double consent version patients are initially offered the treatment to which they were randomised; however, if they decline the randomised treatment, they can then be offered alternative therapies—including the experimental treatment. In …

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