title: Equipoise across the patient population: optimising recruitment to a randomised controlled trial.
abstract: This paper proposes a novel perspective on the value of qualitative research for improving trial design and optimising recruitment. We report findings from a qualitative study set within the OPEN trial, a surgical randomised controlled trial (RCT) comparing two interventions for recurrent bulbar urethral stricture, a common cause of urinary problems in men.
  
  
  
  Interviews were conducted with men meeting trial eligibility criteria (n = 19) to explore reasons for accepting or declining participation and with operating urologists (n = 15) to explore trial acceptability.
  
  
  
  Patients expressed various preferences and understood these in the context of relative severity and tolerability of their symptoms. Accounts suggest a common trajectory of worsening symptoms with a particular window within which either treatment arm would be considered acceptable. Interviews with clinician recruiters found that uncertainty varied between general and specialist sites, which reflect clinicians' relative exposure to different proportions of the patient population.
  
  
  
  Recruitment post referral, at specialist sites, was challenging due to patient (and clinician) expectations. Trial design, particularly where there are fixed points for recruitment along the care pathway, can enable or constrain the possibilities for effective accrual depending on how it aligns with the optimum point of patient equipoise. Qualitative recruitment investigations, often focussed on information provision and patient engagement, may also look to better understand the target patient population in order to optimise the point at which patients are approached.
  
  
  
  ISRCTN Registry, ISRCTN98009168 . Registered on 29 November 2012.
authors.affiliation: Newcastle University, Baddiley-Clark Building, Newcastle Upon Tyne, NE2 4AX, UK. paul.whybrow@bristol.ac.uk.|Present address: School for Social and Community Medicine, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. paul.whybrow@bristol.ac.uk.
authors.forename: Paul
authors.identifier: 0000-0002-6899-9581
authors.initials: P
authors.lastname: Whybrow
authors.affiliation: Institute of Cellular Medicine, The Medical School, Newcastle University, 3rd Floor William Leech Building, Newcastle upon Tyne, NE2 4HH, UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Pickard
authors.affiliation: Newcastle University, Baddiley-Clark Building, Newcastle Upon Tyne, NE2 4AX, UK.
authors.forename: Susan
authors.initials: S
authors.lastname: Hrisos
authors.affiliation: Newcastle University, Baddiley-Clark Building, Newcastle Upon Tyne, NE2 4AX, UK.
authors.forename: Tim
authors.initials: T
authors.lastname: Rapley
mesh_terms: D006801:Humans; D007407:Interviews as Topic; D008297:Male; D057240:Patient Preference; D018579:Patient Selection; D036301:Qualitative Research; D012008:Recurrence; D035842:Research Subjects / Q000523:psychology; D018401:Sample Size; D012720:Severity of Illness Index; D057212:Therapeutic Equipoise; D006113:United Kingdom; D014525:Urethral Stricture / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000601:surgery*; D013521:Urologic Surgical Procedures, Male / Q000009:adverse effects / Q000379:methods*
keywords: Equipoise; Multicentre; Patient preferences; Qualitative; Recruitment; Surgical trial; Trial design; Trials