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Concise stakeholder-informed tool for reporting modifications to innovative surgical procedures and devices: Surgical
James B Olivier1, Rhiannon C Macefield1, Maeve Coyle1
1NIHR Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, UK.
Background:
Modifications to invasive procedures and devices are common during surgical innovation, yet reporting is frequently inconsistent and incomplete. The aim of this study was to develop a concise, stakeholder-informed checklist for reporting modifications in surgical innovation studies.
Methods:
A provisional checklist was developed from a systematic review of 104 IDEAL (Idea, Development, Exploration, Assessment, and Long-term study) studies, identifying substantial heterogeneity and deficits in modification reporting. Twenty stakeholders were purposively sampled for semi-structured interviews, including clinicians, methodologists, industry representatives, and governance professionals. Interviews explored views and subsequently optimized the checklist's content, wording, layout, scope, and usability. Data were analysed by thematic analysis and iteratively used to refine the checklist until no further required changes were identified.
Results:
Stakeholders endorsed the need for a dedicated modification reporting tool, emphasizing pragmatism and usability. Interview findings led to clarification of scope, refinement of terminology, and removal of ambiguous items. Greater emphasis was placed on describing the innovation's starting configuration, specifying the IDEAL stage, explicitly reporting both the presence and absence of modifications, and reflecting on procedural stability. Iterations condensed the checklist to a seven-item tool. The final Surgical ModificAtion Reporting Tool (SMART) specifies describing the starting point of the innovation, reporting modifications, and summarizing stability and shared learning.
Conclusion:
SMART is a concise, stakeholder-informed prepublication tool to guide prospective tracking and consistent reporting of modifications to innovative invasive procedures and devices. Used alongside the IDEAL framework, it has the potential to improve the quality and interpretability of surgical innovation research.
