Background: There are unique practical and ethical challenges in clinical trials in critical care, including the time-sensitive nature of treatment and enrolling patients who lack capacity.1 Data exploring barriers to conducting clinical trials in this setting are scarce, but include managing changing clinical courses, communication breakdowns, and complexities around professional advice and personal consent, the optimal time-frame of which conflicts with time-critical interventions2. Our pilot study,3 demonstrated enhanced patient recruitment in centres valuing research with equal importance to clinical care, with the most commonly cited barriers insufficient human and financial resource, inadequate personnel funding, and limited career opportunities impeding staff retention.3 Several additional factors may also preclude recruitment, such as lack of clinician equipoise and competing clinical commitments.
Our primary objective was to identify variability in the research infrastructure of UK intensive care units (ICUs) and their ability to recruit patients into clinical trials through a qualitative meta-synthesis. Our secondary objective was to identify methods to address variability
We evaluated factors related to intensive care patient enrolment into clinical trials in the UK. This consisted of a qualitative synthesis carried out with two datasets of in-depth interviews conducted with 27 intensive care consultants, research nurses and trial coordinators from across the UK. Primary3 and secondary analysis of two datasets was undertaken in the thematic analysis and synthesis.
The synthesis yielded the following themes related to influencing factors: Organisational, Human, Study, Practical resources, Clinician, and Patient/family factors, with an overarching core theme of Normalising Research, which was characterised by motivations for driving research forward and fostering research-active cultures, within various resource constraints. There was a strong sense of trying to integrate research in routine practice. Facets of these themes and recommendations can be seen in Figure 1.
The central and transferable tenet of Normalising Research advocates the importance of developing a culture where research is inclusive alongside clinical practice in routine patient care, and is requisite for all healthcare individuals from organisational to direct patient contact level.