The integration of rapid qualitative research in clinical trials: Reflections from the ward-based goal-directed fluid therapy (GDFT) in acute pancreatitis feasibility trial

Abstract

Abstract Purpose There has been an increase in the integration of qualitative studies in randomised controlled trials. However, many of these studies do not produce findings at a time when they can be used to inform decision-making processes on trial design and delivery, allowing for changes in real time. The purpose of this article is to address this gap by reflecting on our experience of carrying out a rapid qualitative study during a feasibility trial of goal-directed fluid therapy (GDFT) in patients with acute pancreatitis. Methods The study was designed as a rapid feedback evaluation and combined interviews with staff and patients who took part in the trial with a telephone audit of patients who declined participation. Findings : The rapid qualitative study pointed to common problems in trial recruitment among multiple sites, where lack of engagement of clinical teams across sites might impact negatively on patient recruitment. The study also pointed to issues encountered while implementing the trial that will be useful for informing the potential scale-up of the trial in the near future. Conclusions The rapid qualitative design can generate findings at a time when these can be used to inform changes in trial design and delivery. Additional research is required to explore the implementation of this research design in other settings and trial designs.