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）。我预计我将从综合已经使用NPT的外科试验的定性研究开始，并旨在利用NPT绘制尚未明确获得理论信息的领域的其他工作。我还将进行系统的文献综述（SLR），以研究用于优化试验实施的干预措施。在进行单反之前，有必要进行范围审查，以评估现有文献，以确定单反的范围和方法。下一步将与相关利益相关者进行半结构化访谈。面试日程将基于NPT结构和之前确定的不确定性。将使用演绎和归纳相结合的方法来分析记录的访谈。代码将与《不扩散条约》结构相联系，并允许根据数据产生进一步的代码。结合前几个阶段的发现并参考INDEX指南将有助于为试验设置“工具包”的开发提供信息。我将首先发展计划理论，以描述该工具包预计如何产生效果，以及在什么条件下产生效果。在整个开发过程中，通过使用数据收集方法和利益相关者的参与，程序理论可能会发生变化。利益相关者的协作是开发一种参与和有效的干预措施的关键，并将结合使用共同设计方法和共识方法。该过程的最后阶段是在少量试验中对工具包进行初步可行性评估。访谈和观察将评估该工具包在实践中的效果。工具包的优点和缺点将被识别，并且可能需要改进。

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.