Literature DB >> 16181766

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

Ben Heaven1, Madeleine Murtagh, Tim Rapley, Carl May, Ruth Graham, Eileen Kaner, Richard Thomson.   

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.

Entities:  

Mesh:

Year:  2005        PMID: 16181766     DOI: 10.1016/j.pec.2005.07.013

Source DB:  PubMed          Journal:  Patient Educ Couns        ISSN: 0738-3991


  18 in total

1.  Which patients improve: characteristics increasing sensitivity to a supportive patient-practitioner relationship.

Authors:  Lisa Ann Conboy; Eric Macklin; John Kelley; Efi Kokkotou; Anthony Lembo; Ted Kaptchuk
Journal:  Soc Sci Med       Date:  2009-11-10       Impact factor: 4.634

2.  A patient decision aid to support shared decision-making on anti-thrombotic treatment of patients with atrial fibrillation: randomised controlled trial.

Authors:  Richard G Thomson; Martin P Eccles; I Nick Steen; Jane Greenaway; Lynne Stobbart; Madeleine J Murtagh; Carl R May
Journal:  Qual Saf Health Care       Date:  2007-06

3.  Qualitative methods in a randomised controlled trial: the role of an integrated qualitative process evaluation in providing evidence to discontinue the intervention in one arm of a trial of a decision support tool.

Authors:  M J Murtagh; R G Thomson; C R May; T Rapley; B R Heaven; R H Graham; E F Kaner; L Stobbart; M P Eccles
Journal:  Qual Saf Health Care       Date:  2007-06

4.  Breaking the patientification process - through co-creation of care, using old arctic survival knowledge.

Authors:  Ulrika Sandén; Lars Harrysson; Hans Thulesius; Fredrik Nilsson
Journal:  Int J Qual Stud Health Well-being       Date:  2021-12

5.  Critically engaging: integrating the social and the biomedical in international microbicides research.

Authors:  Catherine M Montgomery; Robert Pool
Journal:  J Int AIDS Soc       Date:  2011-09-27       Impact factor: 5.396

6.  Social validity of randomised controlled trials in health services research and intellectual disabilities: a qualitative exploration of stakeholder views.

Authors:  Dan Robotham; Michael King; Anton Canagasabey; Sophie Inchley-Mort; Angela Hassiotis
Journal:  Trials       Date:  2011-06-09       Impact factor: 2.279

7.  Medical communication and technology: a video-based process study of the use of decision aids in primary care consultations.

Authors:  Eileen Kaner; Ben Heaven; Tim Rapley; Madeleine Murtagh; Ruth Graham; Richard Thomson; Carl May
Journal:  BMC Med Inform Decis Mak       Date:  2007-01-10       Impact factor: 2.796

8.  Mixing a grounded theory approach with a randomized controlled trial related to intimate partner violence: what challenges arise for mixed methods research?

Authors:  Cristina Catallo; Susan M Jack; Donna Ciliska; Harriet L Macmillan
Journal:  Nurs Res Pract       Date:  2013-03-20

Review 9.  Eliciting adverse effects data from participants in clinical trials.

Authors:  Elizabeth N Allen; Clare Ir Chandler; Nyaradzo Mandimika; Cordelia Leisegang; Karen Barnes
Journal:  Cochrane Database Syst Rev       Date:  2018-01-16

10.  Professional centred shared decision making: patient decision aids in practice in primary care.

Authors:  Duika Burges Watson; Richard G Thomson; Madeleine J Murtagh
Journal:  BMC Health Serv Res       Date:  2008-01-11       Impact factor: 2.655

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