title: Understanding involvement in surgical orthopaedic randomized controlled trials: A qualitative study of patient and health professional views and experiences.
abstract: BACKGROUND
  Factors influencing patients' motivations for enrolling in, and their experiences of, orthopaedic randomized controlled trials (RCTs) are not fully understood. Less is known about healthcare professionals' (HCP) experiences of RCT involvement.
  
  
  OBJECTIVE
  This study investigates patients' and HCPs' views and experiences of RCT participation and delivery to inform the planning of future RCTs.
  
  
  METHODS
  Total hip or knee replacement patients (n = 24) participating in the single-center double-blind APEX RCTs of an intra-operative anesthetic intervention and HCPs (n = 15) involved in trial delivery were interviewed. Data were audio-recorded, transcribed, anonymized and thematically analyzed.
  
  
  RESULTS
  Although altruistic reasons for RCT participation were common, patients also weighed up demands of the RCT with the potential benefits of taking part, demonstrating the complex and conditional nature of trial participation. HCPs were interested in RCT involvement as a means of contributing towards advances in medical knowledge and also considered the costs and benefits of RCT involvement.
  
  
  CONCLUSIONS
  Patients and HCPs value involvement in RCTs that they see as relevant and of value, while imposing minimum burden. These findings have important implications for the design of methods to recruit patients to RCTs and for planning how an RCT might best interface with HCP clinical commitments.
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK. Electronic address: j.horwood@bristol.ac.uk.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Horwood
authors.affiliation: School of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
authors.forename: Emma
authors.initials: E
authors.lastname: Johnson
authors.affiliation: Musculoskeletal Research Unit, School of Clinical Sciences, University of Bristol, Learning and Research Building, Level 1, Southmead Hospital, Bristol BS10 5NB, UK.
authors.forename: Rachael
authors.initials: R
authors.lastname: Gooberman-Hill
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001291:Attitude of Health Personnel; D004311:Double-Blind Method; D005260:Female; D006282:Health Personnel / Q000523:psychology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009985:Orthopedics / Q000458:organization & administration*; D010358:Patient Participation / Q000523:psychology*; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D011795:Surveys and Questionnaires
keywords: Joint replacement surgery; Orthopaedics; Qualitative; Randomized controlled trials; Views