title: Patients or research subjects? A qualitative study of participation in a randomised controlled trial of a complex intervention.
abstract: OBJECTIVE
  To explore participants' understandings regarding treatment decisions, made within an efficacy randomised controlled trial (RCT) of decision-support tools.
  
  
  METHODS
  Qualitative study: interviews (audio-recorded) with participants. Participants were interviewed 3-5 days after using a decision-support tool (n=30) and again at 3 months (n=26). Transcripts were analysed using a constant comparative approach.
  
  
  RESULTS
  Participants' understandings were shaped by the ways in which they made sense of their participation. Participants made attributions about their trial identity that fell on a continuum. At one end we found participants who identified as 'experienced medical volunteers', and at the other those who identified as 'real patients'. In the participants' accounts, a trial identity of 'patient' accompanied an expectation that the decision-support tools offered a means of making treatment decisions. 'Volunteers', however, saw the interventions as tasks to be completed for the purposes of the trial team.
  
  
  CONCLUSIONS
  In our study, trial identity shaped participants' understandings regarding treatment decisions and all other aspects of the trial.
  
  
  CONCLUSIONS
  Different understandings regarding the appropriate response to trial tasks may affect behaviour and therefore outcomes in some trials. Further research is required to unravel the relationship between trial identities, understanding and behaviour.
authors.affiliation: Health Technologies and Human Relations Research Group, Centre for Health Services Research, School of Population and Health Sciences, University of Newcastle upon Tyne, 21 Claremont Place, Newcastle upon Tyne, NE2 4AA, UK. B.R.J.Heaven@ncl.ac.uk
authors.forename: Ben
authors.initials: B
authors.lastname: Heaven
authors.forename: Madeleine
authors.initials: M
authors.lastname: Murtagh
authors.forename: Tim
authors.initials: T
authors.lastname: Rapley
authors.forename: Carl
authors.initials: C
authors.lastname: May
authors.forename: Ruth
authors.initials: R
authors.lastname: Graham
authors.forename: Eileen
authors.initials: E
authors.lastname: Kaner
authors.forename: Richard
authors.initials: R
authors.lastname: Thomson
mesh_terms: D000533:Altruism; D001281:Atrial Fibrillation / Q000523:psychology / Q000628:therapy; D003299:Cooperative Behavior; D003657:Decision Making; D003661:Decision Support Techniques; D005260:Female; D005500:Follow-Up Studies; D006805:Human Experimentation; D006801:Humans; D008297:Male; D009042:Motivation; D010358:Patient Participation / Q000523:psychology*; D018579:Patient Selection; D010549:Personal Satisfaction; D010817:Physician-Patient Relations; D017410:Practice Guidelines as Topic; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D035842:Research Subjects / Q000523:psychology*; D012649:Self Concept; D012933:Social Identification; D011795:Surveys and Questionnaires; D006113:United Kingdom; D014743:Videotape Recording