Assessing, grading, and reporting intraoperative adverse events during and after surgery

Abstract

Intraoperative adverse events (iAEs) are under-reported, have poorly standardized nomenclature, and are plagued by barriers to reporting and cultural acceptance. Not surprisingly, although surgeons are willing to report iAEs, they often under-report these events, especially those of lower severity, owing to perceived clinical insignificance1. Attempts to overcome reporting deficits with surgical black-box systems, otherwise known as medical data recorders, have continued to receive pushback despite the potential benefits for quality improvement2,3. Until these systems gain further traction, integration of iAE reporting into the sign-out portion of the WHO safety checklist might be a useful aide-memoire4,5. Barriers to reporting, such as institutional, emotional, and litigious concerns, remain challenging to overcome6. Further, the intransigent blame culture continues to detract from a universally shared goal of improved patient safety6. The, regrettably, common lack of institutional support for litigation concerns, and an absence of clear definitions of what should be reported and how to report, might be surmountable with improved awareness of available resources. There are several iAE classification systems available, including, but not limited to: Modified Satava, the iAE severity classification system (Massachusetts General Hospital), the European Association of Surgical Endoscopy classification7,8, intraoperative adverse incident classification (European Association of Urology)9, and the classification of intraoperative adverse events (ClassIntra®)10. These systems are universally available and can be used to clearly delineate what constitutes an iAE. However, with the exception of ClassIntra®, many of these systems have yet to be validated and are known to have high inter-rater variability10–13. In the absence of a single best system, a vital first step is to record and grade iAEs prospectively, regardless of which system is chosen, so that we can move on to understanding the real-world implications of iAEs. Although these classification systems are useful for grading iAEs, they stop short of providing guidelines for reporting in publications or daily practice. In the absence of guidelines for reporting iAEs in surgical practice and the literature, efforts are under way to develop a set of standardized criteria and guidelines that inform iAE reporting, regardless of classification system. A recently published protocol14 outlines the methodology for developing and validating these guidelines, known as the Intraoperative Complications Assessment and Reporting with Universal Standards (ICARUS) criteria; these have also been registered with the EQUATOR Network (https://www.equator-network.org/). Also under way is a cross-specialty, multinational survey of experiences and opinions on iAE reporting (ClinicalTrials.gov; NCT049943920). Addressing the gap in iAE reporting will not be an overnight transformation, but, rather, will require a series of changes in resources, guidelines, and perceptions, which could contribute to a real renaissance in the surgical safety arena2,5,15–17. Although routine reporting and grading will be the biggest hurdle to overcome, standardized reporting guidelines with endorsements from surgical journals and societies may serve as a necessary impetus for change. G. E. Cacciamani, T. N. Sholklapper (Keck School of Medicine, University of Southern California, Los Angeles, California, USA); S. Dell-Kuster (University Hospital Basle and Basle Institute for Clinical Epidemiology and Biostatistics, University of Basle, Basle, Switzerland); C. S. Biyani (St James’s University Hospital, Leeds, UK); N. Francis (Department of Colorectal Surgery, Yeovil District Hospital Foundation Trust, Yeovil, UK); H. M. Kaafarani (Massachusetts General Hospital, Boston, Massachusetts, USA); M. Desai, R. Sotelo, I. Gill (Keck School of Medicine, University of Southern California, Los Angeles, California, USA). Disclosure. The authors declare no conflict of interest.

Topics & Concepts