title: Training recruiters to randomized trials to facilitate recruitment and informed consent by exploring patients' treatment preferences.
abstract: BACKGROUND
  Patients' treatment preferences are often cited as barriers to recruitment in randomized controlled trials (RCTs). We investigated how RCT recruiters reacted to patients' treatment preferences and identified key strategies to improve informed decision-making and trial recruitment.
  
  
  METHODS
  Audio-recordings of 103 RCT recruitment appointments with 96 participants in three UK multicenter pragmatic RCTs were analyzed using content and thematic analysis. Recruiters' responses to expressed treatment preferences were assessed in one RCT (ProtecT - Prostate testing for cancer and Treatment) in which training on exploring preferences had been given, and compared with two other RCTs where this specific training had not been given.
  
  
  RESULTS
  Recruiters elicited treatment preferences similarly in all RCTs but responses to expressed preferences differed substantially. In the ProtecT RCT, patients' preferences were not accepted at face value but were explored and discussed at length in three key ways: eliciting and acknowledging the preference rationale, balancing treatment views, and emphasizing the need to keep an open mind and consider all treatments. By exploring preferences, recruiters enabled participants to become clearer about whether their views were robust enough to be sustained or were sufficiently weak that participation in the RCT became possible. Conversely, in the other RCTs, treatment preferences were often readily accepted without further discussion or understanding the reasoning behind them, suggesting that patients were not given the opportunity to fully consider all treatments and trial participation.
  
  
  CONCLUSIONS
  Recruiters can be trained to elicit and address patients' treatment preferences, enabling those who may not have considered trial participation to do so. Without specific guidance, some RCT recruiters are likely to accept initial preferences at face value, missing opportunities to promote more informed decision-making. Training interventions for recruiters that incorporate key strategies to manage treatment preferences, as in the ProtecT study, are required to facilitate recruitment and informed consent.
  
  
  BACKGROUND
  ProtecT RCT: Current Controlled Trials ISRCTN20141297. The other two trials are registered but have asked to be anonymized.
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS, UK. nicola.mills@bristol.ac.uk.
authors.forename: Nicola
authors.initials: N
authors.lastname: Mills
authors.forename: Jane M
authors.initials: JM
authors.lastname: Blazeby
authors.forename: Freddie C
authors.initials: FC
authors.lastname: Hamdy
authors.forename: David E
authors.initials: DE
authors.lastname: Neal
authors.forename: Bruce
authors.initials: B
authors.lastname: Campbell
authors.forename: Caroline
authors.initials: C
authors.lastname: Wilson
authors.forename: Sangeetha
authors.initials: S
authors.lastname: Paramasivan
authors.forename: Jenny L
authors.initials: JL
authors.lastname: Donovan
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D057240:Patient Preference; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic