A Protocol for the Development of the Intraoperative Complications Assessment and Reporting With Universal Standards Criteria: The ICARUS Project

Introduction: Perioperative complications, especially intraoperative adverse events (iAEs), carry significant potential for long-term sequelae in a patient's postoperative course. These events represent a substantial gap in contemporary surgical literature, with only a fraction of publications reporting intraoperative complications as outcomes of interest. To date, there is no universal standard for comprehensively reporting intraoperative complications in surgical practice and literature beyond the systems developed for grading individual events. We aim to establish a set of best-practice criteria for iAE reporting known as the ntraoperative omplication ssessment and eporting with niversal tandards () Guidelines.

Methods And Analysis: We will generate the ICARUS reporting guidelines using the EQUATOR Network development framework and the SQUIRE Guidelines. The initial step involves an umbrella review and meta-analysis of systemic reviews (SRs) assessing the perioperative adverse events of common surgeries. Measures for assessing, collecting, grading, and reporting the iAEs will be merged into a comprehensive list of criteria. Using a modified Delphi methodology, a team of expert surgeons (≥ 200 inpatient procedures/years) will contribute to and evaluate the proposed reporting guidelines. The panel will evaluate both the clinical usefulness and quality assessment and improvement utility of each criterion using a 5-point Likert. We expect multiple survey rounds until consensus regarding the utility of the guidelines is reached.

Dissemination: We plan to share then validate the newly developed guidelines within each surgical field. Dissemination will involve publicly shared guidelines, simultaneous journal publications, conference presentations, encouragement for journal endorsement, and application for inclusion in the Equator Network database. The study team plans to continue collecting feedback for future extension of the intraoperative reporting guidelines.

Highlights: Intraoperative adverse events are underreported and lack homogeneity in surgical literatureWe aim to use a modified Delphi methodology to develop the consensus-based, intraoperative complications assessment and reporting with universal standards (ICARUS) guidelinesWe will disseminate the ICARUS guidelines through journal publications and presentations at national and international meetings; journals and professional organizations will be encouraged to endorse the ICARUS guidelines.