Promoting safety and efficiency of surgical innovation:

: development of a method to improve the reporting of modifications

Abstract

Surgical innovation is crucial for advancing patient care; however, challenges persist in its evaluation and implementation. This Doctor of Medicine (MD) thesis sought to develop a checklist for reporting modifications to innovative surgical procedures and devices to improve safety and efficiency as they are developed, evaluated and introduced into clinical practice.

Study One assessed current practice around reporting modifications in surgical innovation literature through a systematic review of 104 publications that followed the IDEAL framework. Data revealed inconsistent and often inadequate reporting of modifications. Thematic analysis of extracted verbatim modifications and their context informed the development of a provisional reporting checklist. Study Two involved iteratively optimising the reporting checklist through feedback from key stakeholders. Twenty participants across the United Kingdom, including surgeons, methodologists and industry experts, participated in semi-structured think-aloud interviews. These interviews explored the usability and acceptability of the checklist, with findings informing iterative refinement until a finalised version was produced.

The resulting SMART (Surgical ModificAtion Reporting Tool) checklist provides a structured approach to reporting modifications to surgical innovations. It encompasses elements including the rationale for undertaking modifications, their impact on outcomes and the stage of innovation at which they occur. This research addresses a significant gap in surgical innovation evaluation and reporting by providing a standardised approach to reporting modifications. The SMART checklist is designed to be used by all clinicians, academics and other key stakeholders involved in surgical innovation when they come to publish research on an innovative procedure or device. In doing so, it has the potential to enhance transparency, facilitate shared learning and ultimately improve patient safety in the context of surgical innovation. Future work should focus on prospective testing and implementation of the checklist in real-world settings.

Date of Award	9 Dec 2025
Original language	English
Awarding Institution	University of Bristol
Sponsors	Royal College of Surgeons & Rosetrees Trust
Supervisor	Natalie S Blencowe (Supervisor), Kerry N L Avery (Supervisor), Rhiannon C Macefield (Supervisor) & Daisy Elliott (Supervisor)