Mobilising knowledge between practitioners and researchers to iteratively refine a complex intervention (DAFNEplus)...

Area of Science:

• Health Services Research
• Clinical Trial Methodology
• Intervention Development

Background:

• Randomised controlled trials (RCTs) of complex interventions require robust pilot phases for refinement.
• Existing guidance lacks practical methods for practitioner-researcher communication during pre-trial work.
• This paper introduces a structured process to address these gaps in intervention development.

Purpose of the Study:

• To describe a novel structured process for collaborative working to refine complex interventions before RCTs.
• To present findings from an in-built qualitative study on the effectiveness of this collaborative approach.
• To provide practical guidance for future study teams undertaking intervention development.

Main Methods:

• Development and application of a Collaborative Working Group (CWG) process with regular teleconferences and face-to-face meetings.
• Iterative refinement of the DAFNEplus complex intervention for type 1 diabetes across three NHS centres.
• An embedded qualitative study involving documentary analysis, discourse analysis, reflexive notes, and focus groups/interviews with CWG members.

Main Results:

• The CWG process facilitated systematic identification and response to implementation challenges and research findings.
• Collective learning from practitioner experience, process evaluation, and patient involvement informed intervention refinements.
• The qualitative study explored the dynamics and potential improvements of the CWG approach.

Conclusions:

• The CWG process provides a model for operationalizing Medical Research Council (MRC) guidance on collaborative pre-trial work.
• This structured approach fosters shared ownership and progressive development of complex interventions.
• Findings from the qualitative study will inform optimal support for collaborative working in intervention design.