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

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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.