Controlled clinical trials
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Control Clin Trials · Jun 2003
Randomized Controlled Trial Clinical TrialPerceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT study.
Recruitment to trials is known to be difficult. Previous research suggests that a crucial factor may be participants' difficulty with the concept of randomization. This study explored patients' perceptions of randomization and reasons for consent or refusal to participate in the ProtecT study (a randomized trial of surgery, radiotherapy, and monitoring for localized prostate cancer). ⋯ Belief in clinical equipoise was key to participants' consent to randomization. Ensuring patients understand and accept equipoise may thus increase their readiness to consent to participate in trials. A priority for future research is to focus on the provision and presentation of suitable and effective trial information, concentrating in particular on the neglected concept of clinical equipoise.