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

   School of Medicine

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  Dr Nikki Rousseau  No more applications being accepted  Competition Funded PhD Project (Students Worldwide)

About the Project

Background to the project: Delivering surgical trials is challenging and many fail to recruit to time and/or target, leaving important questions regarding how best to deliver care for patients unanswered. While interventions have been developed to address challenges around recruitment, consent and equipoise, other factors that make the conduct of surgical trials challenging have received less attention to date. These ‘implementation challenges’, include the complexity of the intervention and the logistics of delivery, surgeon experience and learning curve, the interaction of multiple specialties, the timing of consent and randomisation, fit with established clinical pathways and limited research infrastructure in many surgical areas. These implementation challenges can make site set-up for surgical trials long and difficult, limit the number of sites willing to take part and make it harder for sites to deliver the trial once open. Understanding and addressing these challenges therefore provides an opportunity to improve the conduct, efficiency and overall success of surgical trials. Qualitative research has been used to identify implementation challenges in surgical trials, but sometimes too late to prevent trial failure. It is important that these issues are identified and addressed as early as possible in the trial development and delivery process, to reduce research waste.

Implementation theories can be useful to focus researchers’ and developers’ attention on potential challenges and their use has been recommended when conducting research and intervention development. Normalisation Process Theory (NPT) has been widely used to understand and address implementation challenges at both individual and organisational levels, including within surgical trials. In particular, NPT can be used to explore how likely an intervention is to become embedded in practice, and thus the feasibility of conducting a trial, and also to optimise the design and implementation of interventions to overcome implementation challenges. This studentship would build on previous work in this area to develop and evaluate a trial set-up ‘toolkit’ that uses NPT (and other relevant theories) to identify and address implementation barriers within surgical trials (with a particular focus on design and set-up). It is anticipated that the toolkit will be relevant for all stages of the evaluation pathway from feasibility studies and pilot trials to multi-centre definitive RCTs.

What the studentship will encompass: The exact plan for the studentship will be determined by both the student’s skills/interests and the logistics of fieldwork, but it is likely to include three broad elements:

1    Identifying key implementation challenges for surgical trials and their impact:

·    systematic review and qualitative synthesis of surgical trials literature (with a particular focus on qualitative research which has used theory to understand trial implementation)

·    review of current/past CTRU surgical trials portfolio

·    interviews/surveys with staff (e.g. CTU staff, chief investigators, research nurses, principal investigators and surgeons at sites) and other stakeholders (PPI, funders) involved in trials

2    Development of trial set-up toolkit:

·    Synthesis of findings from part one to develop a framework for the toolkit

·    toolkit development (using consensus-methods or co-design approaches)

3    Evaluation of proposed toolkit:

·    Feasibility assessment using one or more surgical trials via Leeds/Bristol Surgical Trials Centres

Supervision: Dr Rousseau has led qualitative research in multiple RCTs and co-leads the Qualitative Research in Trials Target Group within the Trial Conduct Working Group of the TMRP. Ruchi Higham has experience and expertise in both trial management and qualitative research. Susanne Coleman brings a clinical background and expertise in consensus methods. Leila Rooshenas has extensive experience of interventions to optimise recruitment, and co-leads the Recruitment Target Group within the Trial Conduct Working Group of the TMRP.

Planned fieldwork/secondments/placements: Fieldwork is likely to include interviews, focus groups and/or surveys and may incorporate a placement at University of Bristol.

Details of PPI: Although the majority of the toolkit is anticipated to be staff rather than patient facing, involving patients effectively is key to optimisation of surgical trial protocols and hence PPI will form part of the toolkit. A PPI group will be convened for this study consisting of people with a current or previous role as a PPI partner. Their role will include advice on recruitment and contributions to toolkit development.

Candidates should hold a first degree in a relevant discipline and/or a Masters in Health Services Research (or related subject).


You are applying for a PhD studentship from the MRC TMRP DTP. A list of potential projects and the application form is available online at:

Please complete the form fully. Incomplete forms will not be considered. CVs will not be accepted for this scheme.

Please apply giving details for your first choice project. You can provide details of up to two other TMRP DTP projects you may be interested in at section B of the application form.

Before making an application, applicants should contact the project primary supervisor to find out more about the project and to discuss their interests in the research.

The deadline for applications is 4pm (GMT) 18 February 2022. Late applications will not be considered.

Completed application forms must be returned to: [Email Address Removed]

Informal enquiries may be made to [Email Address Removed]

Funding Notes

Studentships are funded by the Medical Research Council (MRC) for 3 years. Funding will cover tuition fees at the UK rate only, a Research Training and Support Grant (RTSG) and stipend (stipend to include London Weighting where appropriate). We aim to support the most outstanding applicants from outside the UK and are able to offer a limited number of bursaries that will enable full studentships to be awarded to international applicants. These full studentships will only be awarded to exceptional quality candidates, due to the competitive nature of this scheme.

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