TY - JOUR
T1 - Patients or research subjects? A qualitative study of participation in a randomised controlled trial of a complex intervention
AU - Heaven, Ben
AU - Murtagh, Madeleine
AU - Rapley, Tim
AU - May, Carl
AU - Graham, Ruth
AU - Kaner, Eileen
AU - Thomson, Richard
N1 - Funding Information:
We gratefully acknowledge the co-operation and candour of participating patients who must necessarily remain anonymous, and the general practitioners David Whitford, Jonathan Tose and Julian Hargreaves. We acknowledge the financial support of the Wellcome Trust for the DARTSII trial (HSR GR065131/2/01/Z and A) and observational study (grant HSR GR068380/2/02/Z). CM's contribution to this paper was partly supported by an ESRC personal research fellowship (RES 000270084). EFK's contribution was supported by an NHS Career Scientist Award. We thank Emma Hutchinson and Margaret Childs for their secretarial support, Alison Stevens for reading and commenting on a draft of this paper, and the practice staff of contributing practices for aid in facilitating clinics. A version of this paper was given at the British Sociological Association's medical sociology conference in York, 2004.
Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.
PY - 2006/8/1
Y1 - 2006/8/1
N2 - 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. Conclusion: In our study, trial identity shaped participants' understandings regarding treatment decisions and all other aspects of the trial. Practice implications: 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.
AB - 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. Conclusion: In our study, trial identity shaped participants' understandings regarding treatment decisions and all other aspects of the trial. Practice implications: 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.
KW - Behaviour
KW - Chronic illness
KW - Complex intervention
KW - Identity
KW - Participation
KW - Qualitative research
KW - RCT
UR - http://www.scopus.com/inward/record.url?scp=33745677700&partnerID=8YFLogxK
U2 - 10.1016/j.pec.2005.07.013
DO - 10.1016/j.pec.2005.07.013
M3 - Article
C2 - 16181766
AN - SCOPUS:33745677700
SN - 0738-3991
VL - 62
SP - 260
EP - 270
JO - Patient Education and Counseling
JF - Patient Education and Counseling
IS - 2
ER -