The new Framework and the Core Elements of complex intervention research

Abstract

Abstract The new framework will be presented. The main phases of intervention research: development or identification, feasibility, evaluation and implementation are connected to 6 core elements: Context: any feature of the circumstances in which an intervention is conceived, developed, evaluated and implemented Programme theory: how an intervention is expected to lead to its effects and under what conditions. Programme theory should be tested and refined at all stages and used to guide the identification of uncertainties and research questions Stakeholders: those who are targeted by the intervention, involved in its development or delivery, or more broadly those whose personal or professional interests are affected, that is who have a stake in the topic. This includes patients, the public, and professionals Refinement: the process of ‘fine tuning' or making changes to the intervention once a preliminary version has been developed Uncertainties: identifying key uncertainties that exist given what is already known and what the programme theory, researchers and stakeholders identify as being most important to find out. These judgements inform the framing of research questions that, in turn, govern research perspective choice Economic considerations: exploring the comparative resource and outcome consequences of the interventions for those people and organisations affected The presentation will discuss how to use the framework, highlighting that complex intervention research can be an iterative process. Repeating of phases is preferable to automatic progression to the next phase if uncertainties remain unresolved. Main messages Complex intervention research may begin at any phase, depending on what is appropriate for the intervention in question, and does not necessarily move sequentially through the phases. The core elements should be considered early and revisited continually throughout, as this will make it most likely that the intervention will be implementable in practice.