title: Qualitative research to improve RCT recruitment: issues arising in establishing research collaborations.
abstract: BACKGROUND
  Strategies to improve recruitment to RCTs (randomised controlled trials) are limited. The ProtecT (Prostate testing for cancer and Treatment) study successfully developed a complex intervention based on qualitative research methods to increase recruitment rates. The Quartet study (Qualitative Research to Improve Recruitment to RCTs) was established to evaluate whether the ProtecT qualitative methods could be transferred into other RCTs. This paper reports on the barriers and facilitators in setting up these collaborations.
  
  
  METHODS
  The Quartet study collaborated with five RCTs. Qualitative methods used were: interviews and focus groups with RCT staff; audio-recording recruitment interactions; and feedback sessions for RCT staff based on qualitative findings. Data were audio-recorded, transcribed and analysed using content and thematic analyses. Issues arising during establishment of collaborations were recorded and analysed.
  
  
  RESULTS
  Establishing collaborations proved challenging and not always surmountable. Difficulties were encountered in gaining agreement of RCT staff to participate because of central RCT staff's lack of authority over recruitment staff, poor communication within RCTs and recruiters' reluctance to have their practice scrutinised. The complexity of the recruitment process also hindered translation of ProtecT methods. Although Quartet enabled significant recruitment issues to surface, the bureaucratic tasks involved in securing governance approval delayed onset of collaborations, reducing the time to address issues and evaluate Quartet's impact.
  
  
  CONCLUSIONS
  The Quartet study established collaborations with a range of RCTs and gained valuable insights for future collaborations between qualitative researchers and RCTs. Qualitative research methods need to be included at the feasibility stage of a RCT or fully integrated into the RCT, as in the ProtecT study, with routine audio-recording for monitoring and training purposes. Quartet-like collaborations could then be established without delay, and recruitment processes of RCTs could become transparent, monitored and improved.
authors.affiliation: Department of Social Medicine, University of Bristol, Canynge Hall, Whiteladies Road, Bristol, BS8 2PR, United Kingdom.
authors.forename: Isabel
authors.initials: I
authors.lastname: de Salis
authors.forename: Zelda
authors.initials: Z
authors.lastname: Tomlin
authors.forename: Merran
authors.initials: M
authors.lastname: Toerien
authors.forename: Jenny
authors.initials: J
authors.lastname: Donovan
mesh_terms: D035843:Biomedical Research / Q000379:methods*; D003256:Community Participation; D003299:Cooperative Behavior; D006801:Humans; D007258:Informed Consent; D018579:Patient Selection; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D006113:United Kingdom