Development of a complex intervention improved randomization and informed consent in a randomized controlled trial.
OBJECTIVE: Multicenter randomized trials are required for pragmatic evaluations of health care interventions, but recruitment is difficult. Systematic reviews failed to identify robust strategies to improve recruitment. We developed and evaluated a complex intervention to increase levels of randomization and informed consent. STUDY DESIGN AND SETTING: The ProtecT (Prostate testing for cancer and Treatment) trial compares radical surgery, radical conformal radiotherapy, and active monitoring f...Expand abstract
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