Comparing the Reliability of a Web-based Intraoperative Adverse Event Assessment Tool With Standard Cognitive Grading. The Intraoperative Complication Assessment and Reporting With Universal Standards - Calculator (ICARUS-C)

University of Southern California1 个研究点分布在 1 个国家目标入组 2,000 人开始时间: 2022年3月15日最近更新: 2022年5月5日

适应症

试验速览

阶段: 不适用
发起方: University of Southern California
入组人数: 2,000
试验地点: 1
主要终点: Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Percent agreement of grade

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

As part of the initiative known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) project, the investigators are working to develop a set of tools to aid in improving the homogenous reporting of intraoperative adverse events (iAEs). Accordingly, the investigators developed a web-based tool, known as the ICARUS Calculator, that integrates the 5 published iAE grading systems. We plan to compare the consistency of grading responses between the ICARUS Calculator and the individual grading systems as presented in their respective publications.

The purpose of this study is two-fold. First, the investigators hope to evaluate the utility of a web-based intraoperative adverse event (iAE) grading system known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) calculator. Second, the investigators plan to evaluate the difference in iAE grading outcomes of the ICARUS calculator compared with standard iAE grading.

详细描述

Perioperative complications, especially intraoperative adverse events (iAEs), carry significant potential for long-term sequelae in a patient's postoperative course. Without consistent and homogenous reporting, these events represent a substantial gap in contemporary surgical literature and clinical practice. By definition, an iAE is any unplanned incident related to a surgical intervention occurring between skin incision and skin closure. Despite the availability of multiple intraoperative grading and classification systems, colloquiallary known as: EAUiaiC, iAE severity classification scheme, Modified Satava, EAES Grading system, and ClassIntra® (formerly CLASSIC) , the reporting of intraoperative adverse events remains exceedingly rare. Further, while most studies report postoperative adverse events, only a fraction of surgical publications report intraoperative complications as outcomes of interest.

As part of the initiative known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) project, the investigators are working to develop a set of tools to aid in improving the homogenous reporting of iAEs. Accordingly, the investigators developed a web-based tool, known as the ICARUS Calculator, that integrates the four aforementioned iAE grading systems. The investigators plan to compare the consistency of grading responses between the ICARUS Calculator and the individual grading systems as presented in their respective publications.

研究设计

研究类型: Observational
观察模型: Other
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Documented understanding, willingness, and agreement to participate in this study
•Males and females; age 18 or older
•Must be either English speaking or fluent with English medical terminology
•Currently or formerly practicing surgeon or proceduralist, regardless of the domain

排除标准

•Activity restrictions that limit one's ability to engage in online survey
•Adults not competent to consent
•Minors, human fetuses, neonates Prisoners/Detainees

结局指标

主要结局

Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Percent agreement of grade

时间窗: 03-01-2022 to 03-15-2022

Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Percent agreement of grade

Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems using the Intra-class correlation (ICC) with two-way, random effects to evaluate for consistency of grades

时间窗: 03-01-2022 to 03-15-2022

Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Intra-class correlation (ICC) with two-way, random effects to evaluate for consistency of grades

Evaluate theTime to complete grading (minutes) using the 5 iAEs grading systems

时间窗: 03-01-2022 to 03-15-2022

Primary data analysis will involve calculations i to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Time to complete grading (minutes)

Evaluate Time to complete grading (minutes)using the ICARUS Calculator