Improving reporting and utility of evaluations of complex interventions.

Global healthcare systems are buckling under the increasing burden of chronic disease and multimorbidity. 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. Unfortunately, knowledge creation and dissemination is insufficient to affect behaviour, practice and policy change within diverse healthcare contexts. 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. 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, and planning and executing the study to ensure that the implementation efforts are context appropriate. 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. 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, 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). 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 engagement throughout the duration of the study. A significant advantage though, is that when successful, true engagement with the partner will allow the research to leverage existing resources of systems of care. This reduces cost of the research and increases the chance that the organisation will sustain successful changes once the research study is complete. If we are going to address the important mismatch between what patients and clinicians need, and what clinical researchers do, achieving reduction in the associated waste, we need to increase understanding of the importance of an integrated knowledge translation approach among researchers and the funders of research. Peters and colleagues in the BMJ in 2013 describe an approach to the incremental work required to explore the questions, contextual realities, and design of trials to test implementation of interventions in practice; a process that does not lend itself to a single trial, rather a comprehensive programme of research. Researcher education on the importance of: trial registration for non-medication interventions; an up to date systematic review of the topic; a solid theoretical underpinning for the intervention and dissemination and implementation approach; and, a complete description of the intervention, will improve quality in research design and reporting. Clear attention to all aspects of trial design that can reduce bias, as well as adoption of mixed methods evaluation to assess implementation process, fidelity, contextual stability and impacts of the intervention beyond the prespecified outcome measures will enrich the quality of the data from these trials. It is crucial that all components of the content of complex interventions and their implementation be reported. Inadequate reporting make it impossible to adjudicate efficacy, and impossible to translate interventions into clinical practice. 13 The CONSORT (CONsolidated Standards of Reporting Trials) 2010 states that “the interventions for each group should be presented with sufficient details to allow replication, including how and when they were actually administered”; however, the detail needed to replicate an intervention requires more than a short paragraph in a typical research trial report. Exciting new efforts to promote reporting of the content of complex interventions are underway. Paul Glasziou and Tammy Hoffman of Bond University, Australia are championing the call for improved reporting of non-drug interventions in trials. They have lead an international panel to create the TIDieR checklist and guide—a template for intervention description and replication. It is important that journals and funders support this work through increased expectations for reporting. They should require reporting of non-medication interventions in detail, in addition to reporting of the protocol. It is worth reflecting on the meaning of a ‘complex intervention’ and its implications. Adapting and extending existing concepts from other disciplines, we can consider the three following common properties of a complex intervention: