Breckenridge J P, Gossage-Worrall R, Chadwick P, De Zoysa N, Elliott J, Gianfrancesco C, Hamilton K, Heller S, Lawton J, Rankin D, Stanton-Fay S, Coates E
School of Health Sciences, University of Dundee, Dundee, UK.
Sheffield Centre for Health and Related Research, University of Sheffield, Sheffield, UK.
Pilot Feasibility Stud. 2024 Dec 21;10(1):154. doi: 10.1186/s40814-024-01576-3.
There 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.
The 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.
This 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.
This 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.
在如何在试验前阶段有效调动知识方面，缺乏实际指导。尽管近年来关于开发复杂干预措施的指导有所增加，但其中大部分侧重于高质量干预措施开发背后的理论和原则，而非如何实现这一点的实际方面。本文分享了对协作工作组（CWG）流程进行嵌入式定性评估的结果，CWG流程是我们开发的一种结构化方法，用于在随机对照试验之前迭代完善复杂干预措施。
作为DAFNEplus研究项目的一部分，设计并实施了CWG，以支持对复杂干预措施进行试验前的迭代完善，DAFNEplus是一项大型干预措施开发研究，旨在完善并试点针对1型糖尿病患者的自我管理教育项目。CWG在整个试验前阶段包括每月一次的电话会议和四次经过战略安排的面对面会议，以支持实施试点干预措施的从业者与评估该措施的研究人员之间的知识共享。我们进行了一项嵌入式定性研究，以了解CWG成员的经历，并听取他们对该方法的可接受性、可行性和有效性的看法。通过与CWG成员进行的两个焦点小组讨论、对CWG协调员进行的四次个人访谈以及对会议材料的文献分析来收集数据。
这项定性评估表明，参与者普遍认为CWG是一种可接受、可行且有用的方法，有助于在试验前支持复杂干预措施的完善。定性研究结果突出了塑造CWG方法成功与可接受性的五个关键要素：随着时间推移汇聚知识、协商信任、平衡实际情况、做出认知妥协以及在决策中管理权力和层级。研究结果强调，除了设立跨界角色的好处外，还需要在研究过程的每个阶段投入足够的时间和资源来支持建立信任和知识共享。
本文展示了一种在试验前实施协作式干预措施完善与开发的实用方法，并为未来的研究团队提供了切实的经验教训和建议。本文为干预措施开发和知识调动领域增添了新的见解和实用指导。
