Standardizing The Intraoperative Adverse Events Assessment to Create a Positive Culture of Reporting Errors in Surgery and Anesthesiology

Surgical outcomes are traditionally reported using postoperative metrics. Routine data collection of postoperative complications and histological outcomes are widely used as surrogate markers of surgical quality. Although these measures can provide an overall account of surgical outcomes, they may not reliably reflect surgical skill and or competency as they may be influenced by factors outside of the operating theater or surgeon's control. Overall quality assurance of the intraoperative period is focused solely on major events and scrutiny of the intraoperative period could help quality advance the delivery of safe surgical interventions. Intraoperative adverse events (iAEs) are disproportionately underreported and understudied in surgical literature as compared to their postoperative counterparts (Fig. 1), and, therefore, represent a significant opportunity for surgical betterment.1,2 This underreporting is further plagued by heterogeneity in the surgical literature due to a poor standardization. Although others have speculated that the primary barrier to iAE reporting is the lack of iAE-specific classification systems,2 the biggest hurdle stems from longstanding systemic and cultural practices surrounding these events. The appropriate definition of each iAE, together with the prompt identification of risk situations and the establishment of standardized pathways for their management could represent the formula for creating a positive culture of reporting errors in surgery and anesthesiology. Properly reporting iAEs in academic literature is a natural starting point for understanding the true incidence and impact of these events.FIGURE 1: Citations of postoperative (A) and intraoperative (B) adverse event classifications systems over the last decade. Web of Science citation search (09/2021) comparing the usage of standardized postoperative and intraoperative events in clinical studies. The Clavien-Dindo classification system is cited in clinical research trials at approximately 270-times the rate of all intraoperative event classification systems combined.One of the most compelling arguments in favor of standardized iAE review stems from a handful of studies that have demonstrated an association between these events and 30-day postoperative morbidity, mortality and prolonged postoperative hospital length of stay.3 In addition to the potential connection between iAEs and the postoperative course, the act of reporting and communicating iAEs, a potential confounder in the aforementioned studies, has also been shown to improve surgical safety. Wanderer et al found that implementation of a mandatory reporting system led to a reduction in preventable iAEs.4 Tschan et al, found that instituting the intraoperative StOP? (Status, Objectives, potential Problems, and encouraging questions) protocol, aimed at improving intraoperative communication and debriefs, was associated with improved surgical-related mortality, reoperation, and length of stay.5 This raises the question as to the impact that standardized iAEs review can have, if implemented, on a larger scale, such as within the World health Organization's surgical safety checklist. Understanding the magnitude of iAE underreporting starts with examining standardized reporting relative to postoperative complications, as the Clavien-Dindo classification system, the dominant system used for postoperative complications.2 Comprehensibly, this classification-system preceded iAE classification systems by nearly a decade. Nevertheless, within the past ten years, a handful of –iAE classification systems have been published.6–9 Of the classification systems, ClassIntra is the only which has been prospectively validated against endpoints supporting criterion and construct validity, such as postoperative length of stay, duration and complexity of surgery, and, to a limited extent, postoperative mortality. There are several theories regarding the lack of iAE reporting ranging from a deficiency in classification systems or institutional support to emotional and litigation concerns. In the BISA study, about 84% of the surveyed surgeons and anesthesiologists reported significant emotional burden regarding reporting iAEs.1 The top 3 concerns shared by these surgeons concerning iAE reporting were legal consequences, lack of standardized reporting system, and absence of clear definitions.1 A lack of universally accepted, standardized and validated systems for classifying iAEs has been described as one of the primary reasons for the iAE reporting deficit.2 Despite the recent development of iAE classification-systems, there has been minimal penetration into clinical practice, which is reflected in the limited expansion of iAE reporting and bringing us to the remaining barriers. Institutional, emotional, and litigious concerns remain are some of the most challenging to overcome. Considering that there has been a decades long attempt in medicine to shift away from blame culture ("To Err is Human" in 2000), it seems that these concerns have still not adequately been addressed. We are neither the first nor last to suggest that a blame culture detracts from our universal pursuit of patient safety. The iAE classification-systems offer the ability to grade iAEs, however, they stop short of providing structured reporting systems or publication guidelines. Further, these schemata bear notable hetero- geneity, with wide-ranging inter-rater variability, and degree of association between grades and long-term clinical outcomes.3,6,8 Given the lack of reporting despite the existence of the above systems, there seems to be a real need to look deeply into this subject to present a globally acceptable system that can encourage clinicians to prospectively capture and report iAEs. The surgical community has already started looking at barriers and experiences related to iAE reporting.1 In collaboration with a global cohort of leaders in surgical quality and safety, we plan to take this even further establishing the Intraoperative Complications As-sessment and Reporting with Universal Standards (ICARUS) Global Surgical Collaboration.10 We have designed and will soon implement a cross-specialty, multi-national survey of experiences and opinions regarding iAE reporting (ClinicalTrials.gov; NCT049943920). Developing iAE classification systems was the first step to improving iAE reporting. International collaboration is required to improve these classification systems and test their reliability and validity. In the absence of guidelines for reporting iAEs in surgical practice and literature, the ICARUS Global Surgical Collaboration is working to develop a set of standardized criteria that inform iAE reporting within the surgical literature, regardless of classification system. Overlooking the intraoperative period makes it impossible to fully understand the nature and sequelae of surgical outcomes. The ICARUS Global Collaboration aims to bring together the interna-tional expertise and develop a universally acceptable system to capture, stratify and report intraoperative adverse events. Beginning with the evaluation of both minor and major iAEs, we aspire to integrate a standardized iAE assessment and grading as a part of day-to-day clinical practice. Long-term, this group will be working together with patient and public representatives and medicolegal team to ensure that the newly proposed framework is acceptable to patients and clinicians and support cultural changes of the entire surgical community towards open reporting of iAE. Ultimately, these discussions and forthcoming iAE-related findings will shape and inform the role of the ICARUS collaboration. As we collaborate to address the gap in iAE reporting through a series of resources and guidelines, we hope that further publications will encourage increased conversation regarding the value of accu-rate, timely, and standardized evaluation of iAEs and their role in the pursuit of high-reliability surgical practice. Presuming that future studies continue to demonstrate the relevance of iAEs, a cultural shift regarding reporting will surely follow.