Heaven Ben, Murtagh Madeleine, Rapley Tim, May Carl, Graham Ruth, Kaner Eileen, Thomson Richard
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.
Patient Educ Couns. 2006 Aug;62(2):260-70. doi: 10.1016/j.pec.2005.07.013. Epub 2005 Sep 21.
To explore participants' understandings regarding treatment decisions, made within an efficacy randomised controlled trial (RCT) of decision-support tools.
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.
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.
In our study, trial identity shaped participants' understandings regarding treatment decisions and all other aspects of the trial.
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.
探讨在决策支持工具的疗效随机对照试验（RCT）中参与者对治疗决策的理解。
定性研究：对参与者进行访谈（录音）。参与者在使用决策支持工具后3 - 5天接受访谈（n = 30），并在3个月时再次接受访谈（n = 26）。使用持续比较法对访谈记录进行分析。
参与者的理解受到他们对自身参与的理解方式的影响。参与者对自己的试验身份做出的归因处于一个连续体上。一端是将自己视为“经验丰富的医学志愿者”的参与者，另一端是将自己视为“真正患者”的参与者。在参与者的描述中，“患者”的试验身份伴随着一种期望，即决策支持工具提供了一种做出治疗决策的方式。然而，“志愿者”将干预措施视为为试验团队完成的任务。
在我们的研究中，试验身份塑造了参与者对治疗决策以及试验所有其他方面的理解。
对试验任务的适当反应的不同理解可能会影响行为，进而影响某些试验的结果。需要进一步研究以阐明试验身份、理解和行为之间的关系。
