Developing a toolkit to facilitate surgical trial implementation and delivery- applying knowledge from qualitative research in trials

为了确定外科试验的关键实施挑战，我将首先进行定性证据合成(QES)。我预计我将首先综合已经使用NPT的外科试验中的定性研究，目标是利用NPT绘制该领域中其他理论上没有明确了解的工作。我还打算进行一次系统的文献回顾(SLR)，以查看用于优化试验实施的干预措施。在继续进行SLR之前，有必要对现有文献进行范围评估，以确定SLR的范围和方法。下一步将是与相关利益相关者进行半结构化访谈。面谈日程将以先前确定的《不扩散条约》的结构和不确定性为基础。将采用演绎和归纳相结合的方法对转录后的访谈进行分析。代码将与《不扩散核武器条约》的构造相联系，并允许根据数据产生更多的代码。将前几个阶段的调查结果结合起来，并参考索引指导，将有助于为建立“工具包”的试验提供信息。我将首先发展方案理论，描述工具包预计将如何产生其影响，以及在什么条件下。在整个发展过程中，方案理论可能会通过使用数据收集方法和利益攸关方的参与而发生变化。利益攸关方的协作是制定一种有吸引力和有效的干预措施的关键，并将使用共同设计方法和协商一致的方法相结合。这一进程的最后阶段是对该工具包进行少量试验的初步可行性评估。访谈和观察将评估该工具包在实践中的效果如何。将确定该工具包的优点和缺点，并可能需要进行改进。

To identify key implementation challenges for surgical trials, I would first conduct a qualitative evidence synthesis (QES). I anticipate I would start by synthesising qualitative research in surgical trials that has already used NPT and aim to map other work in the field that hasn't been explicitly theoretically informed, using NPT. I would also aim to conduct a systematic literature review (SLR) to look at interventions used to optimise trial implementation. Before proceeding with the SLR, a scoping review is necessary to assess the available literature, in order to define the scope and methods of the SLR. The next step will be semi-structured interviews with relevant stakeholders. The interview schedule will be based on NPT constructs and uncertainties identified previously. The transcribed interviews will be analysed using a combination of a deductive and inductive approaches. Codes will be linked to NPT constructs and allow for further codes to emerge as a result of the data. Combining the findings from the previous stages and referring to INDEX guidance would help inform the development of the trial set up 'toolkit'. I would begin by developing programme theory to describe how the toolkit is expected to lead to its effects and under what conditions. The programme theory is subject to change throughout the development process using data collection methods and through stakeholder involvement. Stakeholder collaboration is key in order to develop an intervention which is engaging and effective and will be utilised using a combination of co-design approaches and consensus methods. The final stage of the process is the preliminary feasibility assessment of the toolkit in a small number of trials. Interviews, and observations will assess how well the toolkit works in practice. The strength and weaknesses of the toolkit will be identified, and refinement may be necessary.