Table 1

Framework of actions for intervention development

ActionConsider the relevance and importance of the following
Plan the development processIdentify the problem to be targeted and refine understanding of it throughout the process.
Assess whether the problem is a priority.
Consider which aspects of the problem are amenable to change.
Ask whether a new intervention is really needed and if the potential benefit of the new intervention justifies the cost of development.
Determine the time needed to undertake intervention development.
Obtain sufficient resources/funding for the intervention development study.
Draw on one or more of the many published intervention development approaches, recognising that there is no evidence about which approach is best and apply flexibly depending on the problem and context.
Involve stakeholders during the planning process (see next Action).
Produce a protocol detailing the processes to be undertaken to develop the intervention.
Involve stakeholders, including those who will deliver, use and benefit from the interventionWork closely with relevant stakeholders throughout the development process: patients, the public, the target population, service providers, those who pay for health and social services or interventions, policymakers and intervention design specialists.
Develop a plan at the start of the process to integrate public and patient involvement into the intervention development process.
Identify the best ways of working with each type of stakeholder, from consultation through to coproduction, acknowledging that different ways may be relevant for different stakeholders at different times.
Use creative activities within team meetings to work with stakeholders to understand the problem and generate ideas for the intervention.
Bring together a team and establish decision-making processesInclude within the development team individuals with relevant expertise: in the problem to be addressed by the intervention including those with personal experience of the problem, in behaviour change when the intervention aims to change behaviour, in maximising engagement of stakeholders and with a strong track record in designing complex interventions.
It may be hard to make final decisions about the content, format and delivery of the intervention, so only some team members may do this. There is no consensus about the size or constituency of the team that makes these final decisions, but it is important early on to agree a process for making decisions within the team.
Review published research evidenceReview published research evidence before starting to develop the intervention and throughout the development process for example, to identify existing interventions, to understand the evidence base for each proposed substantive intervention component.
Look for, and take into account, evidence that the proposed intervention may not work in the way intended.
Draw on existing theoriesIdentify an existing theory or framework of theories to inform the intervention at the start of the process, for example, behaviour change or implementation theory.
Where relevant, draw on more than one existing theory or framework of theories for example, both psychological and organisational theories.
Articulate programme theoryDevelop a programme theory. The programme theory may draw on existing theories. Aspects of the programme theory can be represented by a logic model or set of models.
Test and refine the programme theory throughout the development process.
Undertake primary data collectionUse a wide range of research methods throughout, for example, qualitative research to understand the context in which the intervention will operate, quantitative methods to measure change in intermediate outcomes.
Understand contextUnderstand the context in which the intervention will be implemented. Context may include population and individuals; physical location or geographical setting; social, economic, cultural and political influences and factors affecting implementation, for example, organisation, funding and policy.
Pay attention to future implementation of the intervention in the real worldFrom the start, understand facilitators and barriers to reaching the relevant population, future use of the intervention, ‘scale up’ and sustainability in real world contexts.
Design and refine the interventionGenerate ideas about content, format and delivery with stakeholders.
Once an early version or prototype of the intervention is available, refine or optimise it using a series of iterations. Each iteration includes an assessment of how acceptable, feasible and engaging the intervention is, including potential harms and unintended consequences, resulting in refinements to the intervention. Repeat the process until uncertainties are resolved.
Check that the proposed mechanisms of action are supported by early testing.
End the development phaseThere are no established criteria for stopping the intensive development phase and moving on to the feasibility/pilot or evaluation phases. The concepts of data saturation and information power may be useful when assessment of later iterations of the intervention produces few changes.
Describe the intervention to facilitate transferability of an intervention outside the original team and location in which it was developed.
Write up the intervention development process so that judgements can be made about the quality of the process, links can be made in the future between intervention development processes and the subsequent success of interventions, and others can learn how it can be done