title: The Patient Deficit Model Overturned: a qualitative study of patients' perceptions of invitation to participate in a randomized controlled trial comparing selective bladder preservation against surgery in muscle invasive bladder cancer (SPARE, CRUK/07/011).
abstract: BACKGROUND
  Evidence suggests that poor recruitment into clinical trials rests on a patient 'deficit' model - an inability to comprehend trial processes. Poor communication has also been cited as a possible barrier to recruitment. A qualitative patient interview study was included within the feasibility stage of a phase III non-inferiority Randomized Controlled Trial (RCT) (SPARE, CRUK/07/011) in muscle invasive bladder cancer. The aim was to illuminate problems in the context of randomization.
  
  
  METHODS
  The qualitative study used a 'Framework Analysis' that included 'constant comparison' in which semi-structured interviews are transcribed, analyzed, compared and contrasted both between and within transcripts. Three researchers coded and interpreted data.
  
  
  RESULTS
  Twenty-four patients agreed to enter the interview study; 10 decliners of randomization and 14 accepters, of whom 2 subsequently declined their allocated treatment.The main theme applying to the majority of the sample was confusion and ambiguity. There was little indication that confusion directly impacted on decisions to enter the SPARE trial. However, confusion did appear to impact on ethical considerations surrounding 'informed consent', as well as cause a sense of alienation between patients and health personnel.Sub-optimal communication in many guises accounted for the confusion, together with the logistical elements of a trial that involved treatment options delivered in a number of geographical locations.
  
  
  CONCLUSIONS
  These data highlight the difficulty of providing balanced and clear trial information within the UK health system, despite best intentions. Involvement of multiple professionals can impact on communication processes with patients who are considering participation in RCTs. Our results led us to question the 'deficit' model of patient behavior. It is suggested that health professionals might consider facilitating a context in which patients feel fully included in the trial enterprise and potentially consider alternatives to randomization where complex interventions are being tested.
  
  
  BACKGROUND
  ISRCTN61126465.
authors.affiliation: Institute of Cancer Research, London, UK. Clare.Moynihan@icr.ac.uk
authors.forename: Clare
authors.initials: C
authors.lastname: Moynihan
authors.forename: Rebecca
authors.initials: R
authors.lastname: Lewis
authors.forename: Emma
authors.initials: E
authors.lastname: Hall
authors.forename: Emma
authors.initials: E
authors.lastname: Jones
authors.forename: Alison
authors.initials: A
authors.lastname: Birtle
authors.forename: Robert
authors.initials: R
authors.lastname: Huddart
mesh_terms: D000368:Aged; D001291:Attitude of Health Personnel; D017024:Chemotherapy, Adjuvant; D003142:Communication; D032882:Comprehension; D003221:Confusion; D015653:Cystectomy / Q000379:methods*; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D008960:Models, Psychological; D020360:Neoadjuvant Therapy; D009361:Neoplasm Invasiveness; D059351:Organ Sparing Treatments; D010342:Patient Acceptance of Health Care; D018579:Patient Selection; D010465:Perception; D011369:Professional-Patient Relations; D036301:Qualitative Research; D018714:Radiotherapy, Adjuvant; D035842:Research Subjects / Q000523:psychology*; D057212:Therapeutic Equipoise; D006113:United Kingdom; D001743:Urinary Bladder / Q000473:pathology / Q000601:surgery*; D001749:Urinary Bladder Neoplasms / Q000473:pathology / Q000601:surgery*