| Popis: |
The study had three components: (i) an overview of the literature on participant involvement in RCTs; (ii) a meta-ethnography focusing on factors impacting on participant recruitment to RCTs; and (iii) an embedded qualitative study investigating recruitment and participation in an ongoing UK multicentre trial. Non participant observation of trial recruitment consultations and in-depth interviews were conducted with patients invited to participate in the trial from two recruitment sites. Decisions about trial participation took part in a broad personal context, such as perceptions of treatment, levels of symptoms control, and prior experience of interventions. Views about the trial procedures, treatment interventions, and impressions of recruiting staff were also found to be salient. Although altruism was identified as a factor impacting on trial participation, this tended to be ‘conditional altruism’, dependent on expectations of personally benefiting from participating in a trial. Perceptions of benefiting personally from a trial were linked to the trial intervention(s) and also towards the trial process. Despite agreeing to be randomised it was apparent that some patients harboured a ‘preference’ for a treatment. However, people subsequently seemed able to adjust to their allocated treatment, although there were misconceptions about how treatment decisions had been reached. Perceptions of trial involvement, and having directly benefited from trial participation seemed particularly dependent on which treatment people were allocated to. Crucially, the findings have emphasised that trials are not simply an experimental tool operating in a vacuum, independent of the view and experiences of participants; and offer rich insights, which are likely to benefit people recruiting in future trials, and for future trial participants. |
