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Problem: Recruitment to randomised trials is often difficult, and many important trials are not mounted because recruitment is thought to be “impossible.”

Design: Controversial ProtecT (prostate testing for cancer and treatment) trial embedded within qualitative research.

Background and setting: Screening for prostate cancer is hotly debated, and evidence from trials about the effectiveness of treatments (surgery, radiotherapy, and monitoring) is lacking. Mounting a treatment trial is controversial because of past failures and concerns that differences in complications of treatment but not survival make randomisation unacceptable to patients and clinicians, particularly for a trial including monitoring.

Strategy for change: In-depth interviews explored interpretation of study information. Audiotape recordings of recruitment appointments enabled scrutiny of content and presentation of study information by recruiters. Initial …