Guidance on how to develop complex interventions to improve health and healthcare

Abstract

ObjectiveTo provide researchers with guidance on actions to take during intervention development.Summary of key pointsBased on a consensus exercise informed by reviews and qualitative interviews, we present key principles and actions for consideration when developing interventions to improve health. These include seeing intervention development as a dynamic iterative process, involving stakeholders, reviewing published research evidence, drawing on existing theories, articulating programme theory, undertaking primary data collection, understanding context, paying attention to future implementation in the real world and designing and refining an intervention using iterative cycles of development with stakeholder input throughout.ConclusionResearchers should consider each action by addressing its relevance to a specific intervention in a specific context, both at the start and throughout the development process.

The effectiveness and complexity of interventions targeting sedentary behaviour across the lifespan: a systematic review and meta-analysis

“…One of the main challenges when assessing the effectiveness of interventions, is addressing the issues that arise when a range of approaches have been applied and a variety of components are included in the intervention design to improve the same outcome. The Medical Research Council (MRC) published an updated framework for the development and evaluation of complex interventions in 2019 [28]. Within this framework, one of the key considerations is understanding the range of effects and how they vary dependent on the context (i.e.…”

“…In addition, the guidelines consider the active components (i.e. variants of a package of care) and complexity of the intervention and how they influence or impact the effect [28]. One of the novel aspects of this review is that, in addition to establishing effectiveness, this review aims to understand the causal mechanisms (i.e.…”

The development of a theory informed behaviour change intervention to improve adherence to dietary and physical activity treatment guidelines in individuals with familial hypercholesterolaemia (FH)

“…The specific intervention content designed to bring about behaviour change (i.e. the active ingredients) should be driven by theory and take into account situational contexts in which the intervention will be delivered and received [17,18]. Several aspects of FH, an inherited condition, contribute to a unique context that determines the extent to which these individuals with FH will engage in physical activity and dietary behaviours.…”

“…These include its asymptomatic nature if compliant with treatment, comparisons with high cholesterol levels caused by lifestyle factors alone, lifelong treatment, outpatient management with infrequent contact with healthcare professionals and a genetic inheritance pattern resulting in each affected individual having at least one affected parent [16]. Due to these several interacting components and the multiple behaviours required to be targeted, the development of a complex intervention is required [17,18]. While complex interventions are common within health research, it is often difficult to evaulate their effectiveness due to the presence of several, often interacting, components [19,20].…”

“…In the guidance, the MRC recommends including theory in the development of complex interventions, however it does not specify which of the many theories of behaviour change should be used or how the most appropriate theoretical model should be selected [17,18]. In the absence of a theoretical evaluation and understanding of the target behaviour(s) within the FH population to guide the selection of a theoretical model, any one theory chosen may not encompass all the relevant theoretical constructs required to bring about effective behaviour change and/or include unnecessary constructs [21].…”