Recommendations for Intraoperative Adverse Events Data Collection in Clinical Studies and Study Protocols. An ICARUS Global Surgical Collaboration Study

Abstract

Introduction: Intraoperative adverse events (iAEs) occur and have the potential to impact the postoperative course. However, iAEs are underreported and are not routinely collected in the contemporary surgical literature. There is no widely utilized system for the collection of essential aspects of iAEs, and there is no established database for the standardization and dissemination of this data that likely have implications for outcomes and patient safety. The Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) Global Surgical Collaboration initiated a global effort to address these shortcomings, and the establishment of an adverse event data collection system is an essential step. In this study, we present the core-set variables for collecting iAEs that were based on the globally validated ICARUS criteria for surgical/interventional and anesthesiologic intraoperative adverse event collection and reporting. Material and Methods: This article includes three tools to capture the essential aspects of iAEs. The core-set variables were developed from the globally validated ICARUS criteria for reporting iAEs (item 1). Next, the summary table was developed to guide researchers in summarizing the accumulated iAE data in item 1 (item 2). Finally, this article includes examples of the method and results sections to include in a manuscript reporting iAE data (item 3). Then, 5 scenarios demonstrating best practices for completing items 1–3 were presented both in prose and in a video produced by the ICARUS collaboration. Dissemination: This article provides the surgical community with the tools for collecting essential iAE data. The ICARUS collaboration has already published the 13 criteria for reporting surgical adverse events, but this article is unique and essential as it actually provides the tools for iAE collection. The study team plans to collect feedback for future directions of adverse event collection and reporting. Highlights This article represents a novel, fully-encompassing system for the data collection of intraoperative adverse events. The presented core-set variables for reporting intraoperative adverse events are not based solely on our opinion, but rather are synthesized from the globally validated ICARUS criteria for reporting intraoperative adverse events. Together, the included text, figures, and ICARUS collaboration-produced video should equip any surgeon, anesthesiologist, or nurse with the tools to properly collect intraoperative adverse event data. Future directions include translation of this article to allow for the widest possible adoption of this important collection system.

Severity Grading Systems for Intraoperative Adverse Events. A Systematic Review of the Literature and Citation Analysis

“…Its mission is to establish best-practice guidelines to encourage consistency in the evaluation of iAEs and promote a constructive culture for reporting errors in surgical, interventional, and anesthesiologic procedures. 31 By ensuring consistency and accuracy in the assessment, 4,6,32,33 collection, 34 grading, 9 and reporting 35 of iAEs across various surgical, interventional, and anesthesiologic procedures, these guidelines have the potential to enhance patient safety and advance medical knowledge. Furthermore, the ICA-RUS Global Surgical Collaboration recognizes the critical role of dissemination and feasibility in implementing these guidelines effectively.…”

Patient safety in surgical settings: A study on the challenges and improvement strategies in adverse event reporting from a nursing perspective

“…Standardised resources and tools are recommended to monitor factors potentially harmful to patients (Turley et al, 2023;Urban et al, 2021). Despite the existence of internal reporting systems to identify patient safety threats and keep everyone involved informed (Cacciamani et al, 2023), various perceived barriers affect the reporting of AEs (Mansouri et al, 2019;Woo & Avery, 2021).…”

“…The dearth of AE reporting is symptomatic of a larger issue: a weak safety culture within healthcare teams. Despite the availability of resources and internal systems designed to track patient safety threats, barriers persist that impact the reporting processes and, consequently, the learning opportunities that arise from AEs (Cacciamani et al., 2023; Mansouri et al., 2019; Woo & Avery, 2021).…”

A Comprehensive Overview of Intraoperative Complications during Retzius-Sparing Robot-Assisted Radical Prostatectomy: Single Series from High-Volume Center

“…ICs were defined and categorized according to the Intraoperative Adverse Incident Classification (EAUiaiC) proposed by the European Association of Urology ad hoc Complications Guidelines Panel. The quality criteria for accurate and comprehensive reporting of intraoperative adverse events proposed by the Intraoperative Complications Assessment and Reporting with Universal Standards (ICARUS) Global Surgical Collaboration Project were fulfilled [16,17]. Complications were retrieved by two different urologists (AO and OM), and any discordance was judged and solved by a third expert physician (PDO).…”

“…Although flourishing research is available regarding the rates, classification, and prediction scores of postoperative complications after RARP [12][13][14], ICs are often under-reported [15]. Consequently, despite the recent endorsement of new classification systems, the current body of literature only invariably relies on ballpark estimates of ICs during RARP, especially in the specific setting of RS-RARP [16,17].…”