title: Quality improvement report: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult.
abstract: OBJECTIVE
  Recruitment to randomised trials is often difficult, and many important trials are not mounted because recruitment is thought to be "impossible."
  
  
  METHODS
  Controversial ProtecT (prostate testing for cancer and treatment) trial embedded within qualitative research.
  
  
  METHODS
  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.
  
  
  METHODS
  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 qualitative findings showed that recruiters had difficulty discussing equipoise and presenting treatments equally; they unknowingly used terminology that was misinterpreted by participants. Findings were used to determine changes to content and presentation of information.
  
  
  RESULTS
  Changes to the order of presenting treatments encouraged emphasis on equivalence, misinterpreted terms were avoided, the non-radical arm was redefined, and randomisation and clinical equipoise were presented more convincingly. The randomisation rate increased from 40% to 70%, all treatments became acceptable, and the three arm trial became the preferred design.
  
  
  CONCLUSIONS
  Changes to information and presentation resulted in efficient recruitment acceptable to patients and clinicians. Embedding this controversial trial within qualitative research improved recruitment. Such methods probably have wider applicability and may enable even the most difficult evaluative questions to be tackled.
mesh_terms: D006801:Humans; D007258:Informed Consent; D008297:Male; D018579:Patient Selection; D011471:Prostatic Neoplasms / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*; D012107:Research Design; D009626:Terminology as Topic
keywords: Biomedical and Behavioral Research; Empirical Approach