Adapting the randomized consent (Zelen) design for trials of behavioural interventions for chronic disease: feasibility study.

@article{Campbell2005AdaptingTR,
  title={Adapting the randomized consent (Zelen) design for trials of behavioural interventions for chronic disease: feasibility study.},
  author={Rona Campbell and Tim Peters and Clare Grant and Brian Quilty and P. A. Dieppe},
  journal={Journal of health services research & policy},
  year={2005},
  volume={10 4},
  pages={220-5}
}
OBJECTIVES Standard randomized controlled trials of interventions for chronic conditions that involve behavioural change, or that are highly desired by participants, are difficult to undertake because of problems with recruitment and contamination. Alternatives include cluster-randomized trials or pre-randomization designs such as the Zelen design. The aim here was to develop a pre-randomization design that would overcome ethical and methodological problems associated with the conventional… CONTINUE READING

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