Hope and despair: a qualitative exploration of the experiences and impact of trial processes in a rehabilitation trial

Abstract

Background: Unanticipated responses by research participants can influence randomised controlled trials in multiple ways, many of which are poorly understood. This study used qualitative interviews as part of an embedded process evaluation to explore the impact participants may have on the study, but also unintended impacts the study may have on them. Aim: To explore participants’ experiences and impact of trial involvement in a pilot randomised controlled trial (RCT) in order to inform the designing and delivery of a definitive RCT. Methods: In-depth interviews with 20 participants (10 intervention and 10 control group) enrolled in a stroke rehabilitation pilot trial. Analysis of transcripts used a modified framework approach. Results: Participation in the study was motivated partly by a desperation to get further rehabilitation after discharge. Responses to allocation to the control group included an increased commitment to self-treatment, and negative psychological consequences were also described. Accounts of participants in both control and intervention groups challenge the presumption that they were neutral, or in equipoise, regarding group allocation prior to consenting to randomisation. Conclusions: Considering and exploring participant and participation effects, particularly in the control group, highlights numerous issues regarding interpretation of trial studies, as 3 well as the ethics of randomised controlled trials more generally. While suggestions for a definitive trial design are given, further research is required to investigate the significant implications these findings may have for trial design, monitoring and funding.