title: What can we learn from trial decliners about improving recruitment? Qualitative study.
abstract: Trials increasingly experience problems in recruiting participants. Understanding the causes of poor recruitment is critical to developing solutions. We interviewed people who had declined a trial of an innovative psychological therapy for depression (REFRAMED) about their response to the trial invitation, in order to understand their decision and identify ways to improve recruitment.
  
  
  
  Of 214 people who declined the trial, 35 (16 %) gave permission to be contacted about a qualitative study to explore their decision. Analysis of transcripts of semi-structured interviews was informed by grounded theory.
  
  
  
  We interviewed 20 informants: 14 women and six men, aged 18 to 77 years. Many interviewees had prior experience of research participation and positive views of the trial. Interviewees' decision making resembled a four-stage sequential process; in each stage they either decided not to participate in the trial or progressed to the next stage. In stage 1, interviewees assessed the invitation in the context of their experiences and attitudes; we term those who opted out at this stage 'prior decliners' as they had an established position of declining trials. In stage 2, interviewees assessed their own eligibility; those who judged themselves ineligible and opted out at this stage are termed 'self-excluders'. In stage 3, interviewees assessed their need for the trial therapy and potential to benefit; we term those who decided they did not need the trial therapy and opted out at this stage 'treatment decliners'. In stage 4, interviewees deliberated the benefits and costs of trial participation; those who opted out after judging that disadvantages outweighed advantages are termed 'trial decliners'. Across all stages, most individuals declined because they judged themselves ineligible or not in need of the trial therapy. While 'prior decliners' are unlikely to respond to any trial recruitment initiative, the factors leading others to decline are amenable to amelioration as they do not arise from a rejection of trials or a personal stance.
  
  
  
  To improve recruitment in similar trials, the most successful interventions are likely to address patients' assessments of their eligibility and their potential to benefit from the trial treatment, rather than reducing trial burden.
  
  
  
  International Standard Randomised Controlled Trial Number: ISRCTN85784627 . Registration date 10 August 2011.
authors.affiliation: MRC North West Hub for Trials Methodology Research, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, M13 9PT, UK. adwoa.hughes-morley@york.ac.uk.|York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK. adwoa.hughes-morley@york.ac.uk.
authors.forename: Adwoa
authors.identifier: 0000-0002-2880-3935
authors.initials: A
authors.lastname: Hughes-Morley
authors.affiliation: MRC North West Hub for Trials Methodology Research, Department of Psychology, Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.
authors.forename: Bridget
authors.initials: B
authors.lastname: Young
authors.affiliation: School of Psychology, University of Southampton, Southampton, SO17 1BJ, UK.
authors.forename: Roelie J
authors.initials: RJ
authors.lastname: Hempel
authors.affiliation: Swansea University Medical School, Swansea University, Swansea, SA2 8PP, UK.
authors.forename: Ian T
authors.initials: IT
authors.lastname: Russell
authors.affiliation: NIHR School for Primary Care Research, Manchester Academic Health Science Centre, The University of Manchester, Williamson Building, Manchester, M13 9PT, UK.
authors.forename: Waquas
authors.initials: W
authors.lastname: Waheed
authors.affiliation: MRC North West Hub for Trials Methodology Research, Manchester Academic Health Science Centre, University of Manchester, Oxford Road, Manchester, M13 9PT, UK.|NIHR School for Primary Care Research, Manchester Academic Health Science Centre, The University of Manchester, Williamson Building, Manchester, M13 9PT, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Bower
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003863:Depression / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D004608:Eligibility Determination; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007407:Interviews as Topic; D007600:Judgment; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D035842:Research Subjects / Q000523:psychology*; D018570:Risk Assessment; D016312:Treatment Refusal; D055815:Young Adult
keywords: Depression; Non-participation; Qualitative research; Randomised controlled trials; Recruitment