The collaborative working group method for pre-trial knowledge mobilisation: a qualitative evaluation of a structured process for iteratively refining a complex intervention (DAFNEplus).

backgroundThere is a lack of practical guidance about how to effectively mobilise knowledge at the pre-trial stage. Despite increased guidance on developing complex interventions in recent years, much of this focuses on the theory and principles behind high-quality intervention development, rather than the practical aspects of how this should be achieved. This paper shares the findings from an embedded, qualitative evaluation of the Collaborative Working Group (CWG) process, a structured approach we developed to iteratively refine a complex intervention prior to a randomised controlled trial.

methodsThe CWG was designed and delivered to support iterative refinements to a complex intervention pre-trial as part of the DAFNEplus research programme, a large intervention development study to refine and pilot a self-management education programme for people with type 1 diabetes. The CWG comprised monthly teleconferences and four strategically timed face-to-face meetings throughout the pre-trial period to support knowledge sharing between the practitioners delivering the pilot intervention and the researchers evaluating it. We conducted an embedded qualitative study to elicit CWG members' experiences and to hear their views of the acceptability, feasibility and effectiveness of the approach. Data were generated through two focus groups with CWG members, four individual interviews with CWG facilitators and documentary analysis of meeting materials.

resultsThis qualitative evaluation shows that participants generally found the CWG to be an acceptable, feasible and useful approach to supporting complex intervention refinement pre-trial. The qualitative findings highlight five critical elements that shape the success and acceptability of the CWG approach: funnelling knowledge over time, negotiating trust, balancing practicalities, making epistemic compromises and managing power and hierarchy in decision-making. The findings highlight the need to build in adequate time and resources to support trust-building and knowledge sharing throughout each stage in the research process, in addition to the benefits of creating boundary-spanning roles.

conclusionsThis paper showcases a practical approach to operationalising collaborative intervention refinement and development pre-trial, with tangible lessons and recommendations for future research teams. The paper adds new insights and practical guidance to the intervention development and knowledge mobilisation fields.