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.
BackgroundInterventions need to be developed prior to the feasibility and piloting phase of a study. There are a variety of published approaches to developing interventions, programmes or innovations to improve health. Identifying different types of approach, and synthesising the range of actions taken within this endeavour, can inform future intervention development.MethodsThis study is a systematic methods overview of approaches to intervention development. Approaches were considered for inclusion if they described how to develop or adapt an intervention in a book, website or journal article published after 2007, or were cited in a primary research study reporting the development of a specific intervention published in 2015 or 2016. Approaches were read, a taxonomy of approaches was developed and the range of actions taken across different approaches were synthesised.ResultsEight categories of approach to intervention development were identified. (1) Partnership, where people who will use the intervention participate equally with the research team in decision-making about the intervention throughout the development process. (2) Target population-centred, where the intervention is based on the views and actions of the people who will use it. (3) Evidence and theory-based, where the intervention is based on published research evidence and existing theories. (4) Implementation-based, where the intervention is developed with attention to ensuring it will be used in the real world. (5) Efficiency-based, where components of an intervention are tested using experimental designs to select components which will optimise efficiency. (6) Stepped or phased, where interventions are developed with an emphasis on following a systematic set of processes. (7) Intervention-specific, where an approach is constructed for a specific type of intervention. (8) Combination, where existing approaches to intervention development are formally combined. The actions from approaches in all eight categories were synthesised to identify 18 actions to consider when developing interventions.ConclusionsThis overview of approaches to intervention development can help researchers to understand the variety of existing approaches, and to understand the range of possible actions involved in intervention development, prior to assessing feasibility or piloting the intervention. Findings from this overview will contribute to future guidance on intervention development.Trial registrationPROSPERO CRD42017080553.Electronic supplementary materialThe online version of this article (10.1186/s40814-019-0425-6) contains supplementary material, which is available to authorized users.
[266 words]Background: Only one-third of patients with depression respond fully to antidepressant medication
ObjectiveTo improve the quality and consistency of intervention development reporting in health research.DesignThis was a consensus exercise consisting of two simultaneous and identical three-round e-Delphi studies (one with experts in intervention development and one with wider stakeholders including funders, journal editors and public involvement members), followed by a consensus workshop. Delphi items were systematically derived from two preceding systematic reviews and a qualitative interview study.ParticipantsIntervention developers (n=26) and wider stakeholders (n=18) from the UK, North America and Europe participated in separate e-Delphi studies. Intervention developers (n=13) and wider stakeholders (n=13) participated in a 1-day consensus workshop.Resultse-Delphi participants achieved consensus on 15 reporting items. Following feedback from the consensus meeting, the final inclusion and wording of 14 items with description and explanations for each item were agreed. Items focus on context, purpose, target population, approaches, evidence, theory, guiding principles, stakeholder contribution, changes in content or format during the development process, required changes for subgroups, continuing uncertainties, and open access publication. They form the GUIDED (GUIDance for the rEporting of intervention Development) checklist, which contains a description and explanation of each item, alongside examples of good reporting.ConclusionsConsensus-based reporting guidance for intervention development in health research is now available for publishers and researchers to use. GUIDED has the potential to lead to greater transparency, and enhance quality and improve learning about intervention development research and practice.
Objective To investigate the effectiveness of facilitated physical activity as an adjunctive treatment for adults with depression presenting in primary care.Design Pragmatic, multicentre, two arm parallel randomised controlled trial.Setting General practices in Bristol and Exeter.
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