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Global healthcare systems are buckling under the increasing burden of chronic disease and multimorbidity.1 Research into the efficacy of interventions to address chronic disease are needed. These potential solutions often include consideration of questions of complex, non-drug interventions such as processes of care, diet, exercise and behavioural interventions; areas with a deficit of study.2 Unfortunately, knowledge creation and dissemination is insufficient to affect behaviour, practice and policy change within diverse healthcare contexts.3 ,4 There is a need to study in situ—in multiple contexts—the impact of interventions. However, there have been concerns with the current reporting and quality of studies in these areas.2 ,5
In the design of studies on real-world interventions, researchers must move beyond unidirectional models of behaviour change and instead look to engaging evidence users, patients and clinicians, in: identifying questions and interventions of interest,6 and planning and executing the study to ensure that the implementation efforts are context appropriate.7–9 Co-creation in this way will increase the likelihood that the problems identified, and the solutions, resonate with the patients and clinicians; increasing the likelihood that there will be strong participant engagement and effort to implement and sustain the clinical change.8 ,9
From a researcher perspective there are significant challenges to undertaking work in this way. Non-medication interventions are of keen interest to patients and clinicians,6 but it is methodologically much easier to design a trial to evaluate a regulated intervention (medication, device and procedure), than it is to design and evaluate an assessment of non-regulated interventions (ie, service delivery, behavioural interventions, physical therapies).6 The significant up front engagement work of this approach is time consuming, challenging to achieve in research funding cycles, and high-risk because it requires contextual stability from real-world clinical care organisations to maintain …