BMJ 1998;316:606-606 ( 21 February )

Clinical review

Understanding controlled trials

What is Zelen's design?

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

David J Torgerson, senior research fellow, ^a Martin Roland, director of research and development. ^b

^a National Primary Care Research and Development Centre, Centre for Health Economics, University of York, York YO1 5DD, ^b National Primary Care Research and Development Centre, University of Manchester, Manchester M13 9PL

Correspondence to: Dr Torgerson.

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

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 therapiesincluding the experimental treatment. In the single consent version only patients offered the experimental treatment are told there is an alternative treatment (the control) available. Patients randomised to the control treatment are not allowed the experimental treatment (although they are given unhindered access to any usual treatment . . . [Full text of this article]

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