Identifying and critiquing different approaches to developing complex interventions (INDEX study)

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BackgroundThere is increasing recognition of the importance of carefully developing and evaluating complex interventions, the argument being that attention to these tasks will increase the chance of interventions being effective within trials, and being adopted widely in the real world. Poor intervention development may lead to wasted tax payers' money if expensive trials show that these interventions are flawed, or that effective interventions have limited impact in the real world. The MRC framework provides very broad guidance for intervention development (Craig 2008). In addition, researchers have documented a variety of approaches to intervention development such as theory-based, person-based, paradigm-based, and evidence-based. They have also described how to use a range of methods within intervention development e.g. qualitative methods, usability testing, evidence synthesis, causal modelling and consensus methods. However, there is no overview of the range of approaches available to researchers, which approach or combination of approaches may be most useful in what circumstances, and how the MRC framework has been operationalised. Guidance on intervention development may help researchers and research funders to make informed decisions about how to develop interventions and also help less experienced researchers build on the good practice of researchers who have this expertise.ObjectivesThe aim is to produce guidance for researchers on how to develop complex interventions to improve health or health care outcomes. The objectives are to:1. Identify and describe the different approaches taken to intervention development, the rationales for their use, and any implications for the future utility of the interventions.2. Compare and contrast different intervention development approaches, and their methods of data collection and analysis, considering strengths and limitations overall and for different contexts. 3. Understand the history and challenges of intervention development from the perspectives of experienced researchers and wider stakeholders.4. Measure stakeholder consensus on the key aspects of intervention development and explore the reasons for any lack of consensus.5. Offer guidance to researchers on good practice, with examples from different approaches.Methods The design is a sequential mixed methods study in 3 phases. Phase 1: A methodological review of published journal articles, book chapters, books and reports which describe and critique different approaches to intervention development in health, education and social research. Concurrently we will undertake a systematic mapping review of primary research to identify examples of different approaches to intervention development undertaken in health research 2006-2015. From these two reviews we will also identify the range of data collection, analysis and decision making methods used across all approaches and detail strengths, limitations and challenges of each.Phase 2: A qualitative interview study with 20-25 researchers and wider stakeholders including funding panel members, patient and public representatives, and local and national policy makers to understand the challenges of intervention development. This will start in phase 2 and continue in Phase 3. From phase 1 and early interviews we will construct a preliminary typology of approaches. For each type we will identify the rationale for selecting it, strengths and limitations, contexts best used for, and display detailed examples. We will then hold a stakeholder workshop (n=20) to discuss the preliminary typology, sampling strategy for further interviews, and preliminary items for our later consensus group. Phase 3: Consensus group to identify core aspects of intervention development. An E-Delphi of 30 experts will be followed by a consensus implementation workshop with 30-35 different stakeholders.