Qualitative methods to optimise design and conduct of randomised controlled trials with clinical populations

Quantitative clinical research is based on clearly defined protocols as to how study procedures, processes and measurements will be conducted in a uniform manner for all participants. With reference to ongoing doctoral research, this chapter challenges this reductionist view of clinical research and highlights the sensitive, relational and responsive approach that is required to recruit and work with frail and vulnerable stroke patients in hospital settings. Linking personal experience with existing research on the challenges of recruiting to stroke trials, this chapter argues the case for a mixed-methods approach to enhancing the recruitment and retention of patients. This chapter sets out the ways in which qualitative methods can be incorporated into clinical trials to form mixed-methods designs. Clinical trials continue to be the gold standard for answering clinical research questions, with randomised controlled trials the most effective way of demonstrating the safety and effectiveness of interventions. The chapter takes a broadly reflective structure and highlights the realities of trying to recruit, work with and retain clinical populations. It discusses a range of issues that can arise for trialists, prompted by personal research experiences, and reflects on strategies, including the use of qualitative techniques that may be useful in addressing these. As an undergraduate or postgraduate student or even an early career academic, group reflective practice can greatly benefit personal development and improve confidence as a researcher. All methods of research have particular strengths and specific limitations, so combining these methods can lead to optimal research strategies in terms of data collection and participant.