Theme aim

This theme focused on the design and delivery of RCTs through optimising feasibility study designs and evaluating methods to improve trial conduct. 

Major achievements

• Developing a typology to standardise invasive interventions and concomitant procedures between trial sites and measure protocol fidelity. The typology has been used in several surgical trials and an interactive website will increase its uptake https://onlinelibrary.wiley.com/doi/full/10.1002/bjs.10254
• Maximising participant retention and outcome collection through a qualitative study of clinical staff attitudes towards follow up (https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2467-0) and an investigation of the utility of digital tools for recruitment and retention. Link to be added when available.
• Enhancing staff training at trial sites through a toolkit designed to identify training needs and methods of delivery based on a systematic review and qualitative research. Link to be added when available.
• Optimising trial oversight by evaluating the role of Trial Steering Committees (including PPI), using qualitative methods to revise the TSC Terms of Reference:
  • https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2305-9
  • https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1425-y
• Identifying successful strategies for surgical trainee networks to enhance clinicians’ engagement in trials through qualitative research and a survey of trainees with “digital stories” developed to enhance their uptake (https://www.methodologyhubs.mrc.ac.uk/resources/webinars/)