| dc.description.abstract | Background Process evaluations are often conducted with pragmatic randomised controlled trials (RCTs) of complex healthcare interventions. Pragmatic RCTs aim to evaluate intervention effectiveness in real-world contexts, and process evaluations aim to provide understanding of how interventions achieve outcomes. However, the scope of process evaluation is broad and there lacks a clear definition. Their value in the context of pragmatic RCTs of complex healthcare interventions has received little critical attention, and little is known about how process evaluations are shaped in this context. The question posed by this thesis is: how are process evaluations defined, valued, and shaped when conducted within pragmatic RCTs of complex healthcare interventions? Methods 1) Critical interpretive synthesis of process evaluation methodology literature 2) Systematic review of process evaluation conducted within a sample of pragmatic RCTs 3) Focused ethnographic case studies of 3 UK process evaluations Findings In this context the scope of process evaluation is very broad and there lacks a clear definition. Value and negative consequences may stem from socio-technical processes enacting process evaluations, and formative or summative knowledge use. Different types of knowledge are perceived as more or less valuable. Value is subjective and context dependent, and there are tensions between values. 4 Process evaluations are shaped by the negotiation of multiple values held by researchers and other stakeholders. The real-world healthcare research contexts in which they are conducted and the abilities of researchers to navigate these also significant. Findings contribute practical frameworks for researchers and other stakeholders planning process evaluations to plan for the value they wish to gain from process evaluations. Conclusion Findings provide practical and theoretical contributions to advance the methodological knowledge base of process evaluations in pragmatic RCTs, and process evaluation more broadly. The following key recommendations are drawn: Researchers should plan the value they wish to create from the outset of planning a process evaluation, to then inform decisions about how to design and conduct the process evaluation to create this value. When planning and conducting process evaluations in practice, and in theoretical discussions of process evaluation, researchers should consider: o How they define process evaluation o The role of a process evaluation within a pragmatic RCT o The kind of knowledge that is perceived as valuable for process evaluations to produce, including ontology, epistemology, and complexity, and how this may be reconciled with different scenarios of RCT outcome results Process evaluation teams should pay attention to the social processes underlying their idea sharing and decision-making and the social and physical/virtual contexts in which this takes place, with measures to promote equal and open discussions recommended. 5 Barriers to conducting process evaluations efficiently and to their full potential exist in the organisations supporting healthcare research, and these should be further examined and addressed. | en_US |
