Designing a process evaluation framework for understanding factors that impact on the successful delivery of trials investigating complex critical care interventions

The aim of this PhD was to design a process evaluation framework which could be used to identify factors that impact upon the successful delivery of complex trials in critical care and provide practical guidance for conducting process evaluations in future such work. <br><br>This programme of research was conducted in four stages.<br><br>1. Two literature reviews were undertaken to explore i) the existing evidence relating to process evaluation frameworks or guidance, and ii) the inclusion of process evaluations in critical care trials.<br>2.

Drawing insights from the two literature reviews, a prototype framework was developed.<br>3. The prototype framework was applied within two UK-wide critical care complex intervention trials to guide the process evaluations.<br>4. The findings from the two process evaluations, and the framework’s usefulness, were synthesised to refine the framework, identify factors common across trials, and provide guidance for future process evaluations in complex critical care trials.<br><br>The prototype framework identified factors common across both trials and was adapted to produce the PrOcess Evaluation for Trials In Critical care (POETIC) framework.