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Patients or research subjects? A qualitative study of participation in a randomised controlled trial of a complex intervention

Lookup NU author(s): Dr Ben Heaven, Professor Madeleine Murtagh, Dr Tim Rapley, Professor Carl May, Dr Ruth Graham, Professor Eileen Kaner, Professor Richard Thomson

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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. 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. (c) 2005 Elsevier Ireland Ltd. All rights reserved.


Publication metadata

Author(s): Heaven BRJ, Murtagh MJ, Rapley TJ, May CR, Graham RH, Kaner EFS, Thomson RG

Publication type: Article

Publication status: Published

Journal: Patient Education and Counseling

Year: 2006

Volume: 62

Issue: 2

Pages: 260-270

ISSN (print): 0738-3991

ISSN (electronic): 1873-5134

URL: http://dx.doi.org/10.1016/j.pec.2005.07.013

DOI: 10.1016/j.pec.2005.07.013


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