title: Why do patients decline surgical trials? Findings from a qualitative interview study embedded in the Cancer Research UK BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy).
abstract: BACKGROUND
  Surgical trials have typically experienced recruitment difficulties when compared with other types of oncology trials. Qualitative studies have an important role to play in exploring reasons for low recruitment, although to date few such studies have been carried out that are embedded in surgical trials. The BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy) is a study to determine the feasibility of randomisation to open versus laparoscopic access/robotic cystectomy in patients with bladder cancer. We describe the results of a qualitative study embedded within the clinical trial that explored why patients decline randomisation.
  
  
  METHODS
  Ten semi-structured interviews with patients who declined randomisation to the clinical trial, and two interviews with recruiting research nurses were conducted. Data were analysed for key themes.
  
  
  RESULTS
  The majority of patients declined the trial because they had preferences for a particular treatment arm, and in usual practice could choose which surgical method they would be given. In most cases the robotic option was preferred. Patients described an intuitive 'sense' that favoured the new technology and had carried out their own inquiries, including Internet research and talking with previous patients and friends and family with medical backgrounds. Medical histories and lifestyle considerations also shaped these personalised choices. Of importance too, however, were the messages patients perceived from their clinical encounters. Whilst some patients felt their surgeon favoured the robotic option, others interpreted 'indirect' cues such as the 'established' reputation of the surgeon and surgical method and comments made during clinical assessments. Many patients expressed a wish for greater direction from their surgeon when making these decisions.
  
  
  CONCLUSIONS
  For trials where the 'new technology' is available to patients, there will likely be difficulties with recruitment. Greater attention could be paid to how messages about treatment options and the trial are conveyed across the whole clinical setting. However, if it is too difficult to challenge such messages, then questions should be asked about whether genuine and convincing equipoise can be presented and perceived in such trials. This calls for consideration of whether alternative methods of generating evidence could be used when evaluating surgical techniques which are established and routinely available.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  ISRCTN38528926 (11 December 2008).
authors.affiliation: Marie Curie Palliative Care Research Centre, Cardiff University School of Medicine, Division of Population Medicine, 1st Floor Neuadd Meirionydd, Heath Park Way, Cardiff, CF14 4YS, UK. harrope@cardiff.ac.uk.
authors.forename: Emily
authors.initials: E
authors.lastname: Harrop
authors.affiliation: Division of Surgery and Interventional Science, UCL Medical School, University College London, 74 Huntley Street, London, WC1E 6AU, UK. j.d.kelly@ucl.ac.uk.
authors.forename: John
authors.initials: J
authors.lastname: Kelly
authors.affiliation: Southampton Clinical Trials Unit, Faculty of Medicine, University of Southampton, Southampton, SO16 6YD, UK. G.O.Griffiths@soton.ac.uk.
authors.forename: Gareth
authors.initials: G
authors.lastname: Griffiths
authors.affiliation: Wales Cancer Trials Unit, Cardiff University School of Medicine, 6th Floor Neuadd Meirionydd, Heath Park Way, Cardiff, CF14 4YS, UK. CasbardAC@cardiff.ac.uk.
authors.forename: Angela
authors.initials: A
authors.lastname: Casbard
authors.affiliation: Marie Curie Palliative Care Research Centre, Cardiff University School of Medicine, Division of Population Medicine, 1st Floor Neuadd Meirionydd, Heath Park Way, Cardiff, CF14 4YS, UK. NelsonA9@cf.ac.uk.
authors.forename: Annmarie
authors.initials: A
authors.lastname: Nelson
mesh_terms: D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic / Q000523:psychology*; D015653:Cystectomy; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D036301:Qualitative Research; D065287:Robotic Surgical Procedures; D006113:United Kingdom; D001749:Urinary Bladder Neoplasms / Q000601:surgery*