title: Development of a complex intervention improved randomization and informed consent in a randomized controlled trial.
abstract: 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.
  
  
  METHODS
  The ProtecT (Prostate testing for cancer and Treatment) trial compares radical surgery, radical conformal radiotherapy, and active monitoring for men aged 50-69 years with localized prostate cancer. The intervention was developed using qualitative research methods (content, thematic and conversation analysis). Rates of randomization and immediate acceptance of allocation were measured every 6 months to evaluate the impact of the intervention.
  
  
  RESULTS
  The complex intervention comprised reviews of centers falling below study targets, training programmes, documents and individually tailored feedback. Over 65% of eligible participants consented to randomization. Trial participants became increasingly well informed as immediate acceptance of allocation rose from 65% to 81% between 2001 and 2005.
  
  
  CONCLUSIONS
  This complex intervention resulted in high levels of randomization and informed consent in a difficult trial. The generic aspects of the intervention could be applied to other trials to maximize randomization and informed consent, and allow the mounting of trials previously considered too difficult.
authors.affiliation: Department of Social Medicine, University of Bristol, Bristol BS8 2PR, UK. jenny.donovan@bristol.ac.uk
authors.forename: Jenny L
authors.initials: JL
authors.lastname: Donovan
authors.forename: J Athene
authors.initials: JA
authors.lastname: Lane
authors.forename: Tim J
authors.initials: TJ
authors.lastname: Peters
authors.forename: Lucy
authors.initials: L
authors.lastname: Brindle
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Salter
authors.forename: David
authors.initials: D
authors.lastname: Gillatt
authors.forename: Philip
authors.initials: P
authors.lastname: Powell
authors.forename: Prasad
authors.initials: P
authors.lastname: Bollina
authors.forename: David E
authors.initials: DE
authors.lastname: Neal
authors.forename: Freddie C
authors.initials: FC
authors.lastname: Hamdy
mesh_terms: D000368:Aged; D030881:Disclosure; D006801:Humans; D007258:Informed Consent; D008297:Male; D008485:Medical Audit; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods; D018579:Patient Selection; D011471:Prostatic Neoplasms / Q000628:therapy*; D036301:Qualitative Research; D011897:Random Allocation; D006113:United Kingdom