Abstract
BACKGROUND: Innovative surgical procedures and devices are often modified throughout their development and introduction into clinical practice. A systematic approach to reporting modifications may support shared learning and foster safe and transparent innovation. Definitions of 'modifications', and how they are conceptualized and classified so they can be reported and shared effectively, however, are lacking. This study aimed to explore and summarize existing definitions, perceptions, classifications and views on modification reporting to develop a conceptual framework for understanding and reporting modifications. METHODS: A scoping review was conducted in accordance with PRISMA Extension for Scoping Reviews (PRISMA-ScR) guidelines. Targeted searches and two database searches were performed to identify relevant opinion pieces and review articles. Included were articles relating to modifications to surgical procedures/devices. Data regarding definitions, perceptions and classifications of modifications, and views on modification reporting were extracted verbatim. Thematic analysis was undertaken to identify themes, which informed development of the conceptual framework. RESULTS: Forty-nine articles were included. Eight articles included systems for classifying modifications, but no articles reported an explicit definition of modifications. Some 13 themes relating to perception of modifications were identified. The derived conceptual framework comprises three overarching components: baseline data about modifications, details about modifications and impact/consequences of modifications. CONCLUSION: A conceptual framework for understanding and reporting modifications that occur during surgical innovation has been developed. This is a first necessary step to support consistent and transparent reporting of modifications, to facilitate shared learning and incremental innovation of surgical procedures/devices. Testing and operationalization is now needed to realize the value of this framework.