Breckenridge Jenna P, Gianfrancesco Carla, de Zoysa Nicole, Lawton Julia, Rankin David, Coates Elizabeth
1School of Nursing and Health Sciences, University of Dundee, 11 Airlie Place, Dundee, DD1 4HJ UK.
2Sheffield Diabetes and Endocrine Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Northern General Hospital, Herries Road, Sheffield, S5 7AU UK.
Pilot Feasibility Stud. 2018 Jul 3;4:120. doi: 10.1186/s40814-018-0314-4. eCollection 2018.
Randomised controlled trials (RCTs) of complex interventions often begin with a pilot phase to test the proposed methods and refine the intervention before it is trialled. Although the Medical Research Council (MRC) recommends regular communication between the practitioners delivering the intervention and the researchers evaluating it during the pilot phase, there is a lack of practical guidance about how to undertake this aspect of pre-trial work. This paper describes a novel structured process for collaborative working, which we developed to iteratively refine a complex intervention prior to an RCT. We also describe an in-built qualitative study to learn lessons about how this approach could be used by future study teams.
This work forms part of a broader research programme to develop and trial a complex intervention for people with type 1 diabetes, called DAFNE. The intervention is being piloted in three National Health Service (NHS) diabetes centres in two waves, with refinements being incrementally implemented between each wave in response to real-time, collective learning (combining practitioner experience, process evaluation data and patient and public involvement via an advisory group). A structured 'Collaborative Working Group' (CWG) process, comprising monthly teleconferences and four strategically timed face-to-face meetings, is being used to identify and respond systematically to emerging implementation challenges and research findings. The group involves 25 members of the study team, including the multi-disciplinary practitioners delivering the intervention, the research teams conducting the process evaluation, the study manager and Chief Investigator. An in-built qualitative study comprising documentary analysis of meeting materials, discourse analysis of meeting transcripts, reflexive note taking, and thematic analysis of focus groups and interviews with CWG members is being undertaken to explore how the CWG works and how its processes and procedures might be improved.
The CWG process offers a potential model for collaborative working in future pre-trial pilot phases and intervention development studies that operationalises MRC guidance to progressively develop a complex intervention and foster shared ownership through genuine collaboration. The findings from the qualitative study will provide insight into how to best support collaborative working to achieve optimal intervention design.
复杂干预措施的随机对照试验（RCTs）通常始于一个试点阶段，以便在进行试验之前测试所提议的方法并完善干预措施。尽管医学研究理事会（MRC）建议在试点阶段，实施干预措施的从业者与评估干预措施的研究人员之间应定期沟通，但对于如何开展这一试验前工作的具体方面，缺乏实际指导。本文描述了一种新颖的协作工作结构化流程，该流程是我们为在RCT之前迭代完善复杂干预措施而开发的。我们还描述了一项内置的定性研究，以汲取经验教训，供未来的研究团队参考如何使用这种方法。
这项工作是一个更广泛研究项目的一部分，该项目旨在开发并试验一种针对1型糖尿病患者的复杂干预措施，称为DAFNE。该干预措施正在两个国家医疗服务体系（NHS）糖尿病中心分两波进行试点，每一波之间根据实时的集体学习（结合从业者经验、过程评估数据以及通过咨询小组让患者和公众参与）逐步实施改进。一个结构化的“协作工作组”（CWG）流程，包括每月的电话会议和四次按战略时间安排的面对面会议，正被用于系统地识别并应对新出现的实施挑战和研究结果。该小组由研究团队的25名成员组成，包括实施干预措施的多学科从业者、进行过程评估的研究团队、研究经理和首席研究员。正在进行一项内置的定性研究，包括对会议材料的文献分析、会议记录的话语分析、反思性笔记记录，以及对焦点小组的主题分析和对CWG成员的访谈，以探讨CWG的工作方式以及如何改进其流程和程序。
CWG流程为未来试验前试点阶段和干预措施开发研究中的协作工作提供了一个潜在模式，该模式将MRC的指导意见付诸实践，以逐步开发复杂干预措施，并通过真正的协作培养共同所有权。定性研究的结果将为如何最好地支持协作工作以实现最佳干预设计提供见解。
