101 Stakeholder Perspectives on Improving Modification Reporting in Surgical Innovation: A Qualitative Study

Abstract Aim To explore the views of key stakeholders on the usability and acceptability of a provisional checklist for reporting modifications in surgical innovation, with a focus on its relevance to upper gastrointestinal (UGI) surgery. Method A qualitative study was conducted using semi-structured, think-aloud interviews with 20 stakeholders from across the UK, including UGI surgeons, methodologists, industry experts, and governance professionals. Participants were purposively sampled to ensure diversity in clinical experience and professional background. Interviews focused on the comprehensiveness, clarity, and practicality of the provisional checklist. Data were analysed using reflexive thematic analysis, with iterative refinement of the checklist based on participant feedback. Results Stakeholders welcomed the checklist, emphasising its potential to address a significant gap in the reporting of modifications. Key themes included the need for a tool that is both comprehensive and pragmatic, clear in its definitions, and adaptable to various surgical contexts, such as those involving complex and evolving UGI procedures. Feedback led to substantial improvements in the checklist’s structure, contents and layout. The process underscored the importance of capturing the rationale, timing, and impact of modifications, while also providing space for reflective learning and shared experiences. Conclusions Engagement with a diverse group of stakeholders, including UGI surgeons, was critical in shaping a user-friendly and comprehensive checklist for modification reporting. The findings highlight the value of co-design and iterative feedback in developing tools that are both relevant and practical for clinical innovators in UGI surgery.