Abstract
Complex health interventions (CHIs) are common in (public) health and social care practice and policy. A process evaluation (PE) is an essential part of designing and testing CHIs and questions what is implemented, the mechanisms of change, and how context affects implementation. The scale-up of CHIs is challenging and heterogeneous, making the accompanying PE unique to the nature of the inquiry. We conducted a scoping review to describe the current practice of conducting PEs alongside or following the scale-up of CHI. Eight primary data sources were searched and data extracted on study characteristics, intervention characteristics, methods used in relation to the PE, and stakeholders included. We reviewed 10,538 records and included 56 studies. Seven common thematic areas emerged in which CHIs were being scaled-up. The use of scale-up specific frameworks was rare, and common outcomes of the process evaluation focussed on barriers and facilitators in relation to the context; often obtained "once-off" using qualitative and quantitative data sources. Scale-up strategies reported were: supporting increased coverage, comprehensiveness, and institutionalisation; often simultaneously. Variations in the conduct of process evaluations during the scale-up phase of complex health interventions may reflect differences in context, conceptual challenges, the multi-dimensional nature of scale-up, and the point of engagement with the health care system (e.g., community-level). Ideally, a process evaluation is a recurrent continuous process, leveraging a systems-driven understanding and triangulation of qualitative and quantitative data, that takes place alongside the scale-up project to inform real-world adaptations of scale-up strategies and (untoward) mechanisms of impact when applicable.
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