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.

Keywords: core set variables; database; intraoperative adverse event; intraoperative complications; patient data; protocol development; variables.

Figure 1

Intraoperative adverse event core set variables development and explanation.

Figure 2

Scenario n.1: No Intraoperative Adverse Events Occurred. iAEs: Intraoperative Adverse Events; Post-op: Post-operative; n/a: Not applicable.

Figure 3

Scenario n.2: One Intraoperative Adverse Event in One Patient. iAEs: Intraoperative Adverse Events; Post-op: Post-operative; Not applicable.

Figure 4

Scenario n.3: Multiple Intraoperative Adverse Events in One Patient. iAEs: Intraoperative Adverse Events; Post-op: Post-operative; n/a: Not applicable.

Figure 5

Scenario n.4: One Intraoperative Adverse Event in Different Patients. iAEs: Intraoperative Adverse Events; Post-op: Post-operative; n/a: Not applicable.

Figure 6

Scenario n.5: Multiple Intraoperative Adverse Events in Different Patients. iAEs: Intraoperative Adverse Events; Post-op: Post-operative; n/a: Not applicable.