title: Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials.
abstract: BACKGROUND
  Recruitment of sufficient participants in an efficient manner is still widely acknowledged to be a major challenge to the mounting and completion of randomised controlled trials (RCTs). Few recruitment interventions have involved staff undertaking recruitment. This study aimed i) to understand the recruitment process from the perspective of recruiters actively recruiting RCT participants in six pragmatic RCTs, and ii) to identify opportunities for interventions to improve recruitment.
  
  
  METHODS
  Interviews were undertaken with 72 individuals (32 doctors or RCT Chief investigators (CIs); 40 nurses/other health professionals) who were actively recruiting participants in six RCTs to explore their experiences of recruitment. The RCTs varied in scale, duration, and clinical contexts. Interviews were fully transcribed and analysed using qualitative content and thematic analytic methods derived from grounded theory. For this analysis, data were systematically extracted from each RCT and synthesised across all six RCTs to produce a detailed and nuanced understanding of the recruitment process from the perspectives of the recruiters.
  
  
  RESULTS
  Recruiters readily identified organisational difficulties, fewer than expected eligible patients, and patients' treatment preferences as the key barriers to recruitment. As they described their experiences of recruitment, several previously hidden issues related to their roles as researchers and clinicians emerged, imbued with discomfort and emotion. The synthesis across the RCTs showed that doctors were uncomfortable about aspects of patient eligibility and the effectiveness of interventions, whereas nurses were anxious about approaching potential RCT participants and conflicts between the research and their clinical responsibilities. Recruiters seemed unaware that their views contributed to recruitment difficulties. Their views were not known to RCT CIs. Training and support needs were identified for both groups of staff.
  
  
  CONCLUSIONS
  The synthesis showed that recruitment to these RCTs was a complex and fragile process. Clear obstacles were identified but hidden challenges related to recruiters' roles undermined recruitment, unbeknown to RCT CIs. Qualitative research can elicit and identify the hidden challenges. Training and support are then needed for recruiters to become more comfortable with the design and principles of RCTs, so that they can engage more openly with potentially eligible participants and create a more resilient recruitment process.
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, Bristol BS8 2PS, UK. jenny.donovan@bristol.ac.uk.
authors.forename: Jenny L
authors.initials: JL
authors.lastname: Donovan
authors.forename: Sangeetha
authors.initials: S
authors.lastname: Paramasivan
authors.forename: Isabel
authors.initials: I
authors.lastname: de Salis
authors.forename: Merran
authors.initials: M
authors.lastname: Toerien
mesh_terms: D001291:Attitude of Health Personnel; D016265:Conflict of Interest; D004644:Emotions; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D009723:Nurse-Patient Relations; D018579:Patient Selection; D010465:Perception; D010817:Physician-Patient Relations; D064792:Pragmatic Clinical Trials as Topic / Q000379:methods*; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012108:Research Personnel / Q000523:psychology*; D018401:Sample Size