AbstractImproved surgical trial design and conduct is sought both to enhance the likelihood of main trial success and to reduce research waste. Surgical trials face unique and complex challenges that often hinder and obstruct their successful completion. Pilot and feasibility studies (PFS) are increasingly acknowledged as a methodological solution by presenting an opportunity to explore and address uncertainties around conducting a future main trial. Little research, however, has explored the optimal design, conduct and necessity of PFS for surgical trials. This work sought to provide a detailed understanding of the potential for PFS to optimise future surgical trials and provide clear recommendations for surgeons and study teams.
The thesis comprises three phases of work: a targeted review and systematic analysis of NIHR funded surgical PFS protocols; a qualitative interview study exploring the perceptions, views and experiences of key stakeholders involved in designing and conducting surgical PFS and; a synthesis and interpretation of findings from the first two phases, to produce recommendations for the optimisation of PFS in surgery.
The findings indicate a cyclical model of sub-optimisation, in which misunderstanding leads to sub-optimal design, conduct, reporting and consequent devaluation of PFS amongst the surgical research community. Confounding factors further preventing optimisation include cultural challenges historically inherent to the surgical community, and a lack of targeted and accessible guidance.
A set of recommendations have been produced for all key stakeholders for optimising the design and conduct of PFS to inform main trials in surgery. To operationalise and apply these recommendations, a brief set of practical top tips have also been developed targeted specifically at surgeons involved in designing and conducting surgical PFS. A key recommendation includes a proposal to develop and seek endorsement for formal, consensus-based accessible guidance for surgeons on the design and conduct of surgical PFS. Additional recommendations focus on improving cross-disciplinary collaboration within the surgical trials community, the reporting and dissemination of PFS, and the research funding infrastructure. Future implementation of these recommendations will enhance the quality of definitive surgical trials, strengthen the surgical evidence base and, ultimately, improve surgical practice and patient outcomes.
|Date of Award||28 Nov 2019|
|Supervisor||Kerry N L Avery (Supervisor), Jane M Blazeby (Supervisor), Shelley Potter (Supervisor) & Carrol Gamble (Supervisor)|