The Intraoperative Complication Assessment and Reporting With Universal Standards - Calculator (ICARUS-C)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Surgery, Intraoperative Complications, Surgery--Complications, Surgical Procedure, Unspecified

Intervention / Treatment
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* Other: ICARUS intraoperative adverse events calculator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Activity restrictions that limit one's ability to engage in online survey Adults not competent to consent Minors, human fetuses, neonates Prisoners/Detainees

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICARUS Calculator Raters (Intervention Group)<br>Surgeons and anesthesiologists will be asked to use the ICARUS Calculator to grade a subset of 10 clinical scenarios selected from a list of the clinical scenarios and examples from the publications of the 5iAE systems | Other: ICARUS intraoperative adverse events calculator<br>* The ICARUS calculator is a web-based tool that uses answers to Boolean, yes/no questions to determine the iAE grade (appendix I). The calculator providers iAE grade outputs for the 5 iAE classification systems. https://garnmile.com/iaecalc/ Development of the ICARUS calculator was performed as follows: Referencing the 5 classification systems, we first assembled a list of Boolean questions based on the iAE grade descriptions. This list was distilled to the minimum number of questions necessary to represent all descriptions in the combined list of iAE grades. Next, these questions were used to independently establish the conditional logic required to determine iAE grade for each classification system. The questions and logic were translated into Hypertext Preprocessor (PHP), a server-side programming language, and JavaScript, a client-side scripting language.<br>|
| Cognitive Grading Raters (Control Group)<br>Surgeons and anesthesiologists will be asked to use the ICARUS Calculator to grade a subset of 10 clinical scenarios (same as the Intervention group) selected from a list of the clinical scenarios and examples from the publications of the 5iAE systems | Other: ICARUS intraoperative adverse events calculator<br>* The ICARUS calculator is a web-based tool that uses answers to Boolean, yes/no questions to determine the iAE grade (appendix I). The calculator providers iAE grade outputs for the 5 iAE classification systems. https://garnmile.com/iaecalc/ Development of the ICARUS calculator was performed as follows: Referencing the 5 classification systems, we first assembled a list of Boolean questions based on the iAE grade descriptions. This list was distilled to the minimum number of questions necessary to represent all descriptions in the combined list of iAE grades. Next, these questions were used to independently establish the conditional logic required to determine iAE grade for each classification system. The questions and logic were translated into Hypertext Preprocessor (PHP), a server-side programming language, and JavaScript, a client-side scripting language.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Distribution of responses by count and percent | Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Distribution of responses by count and percent | 03-01-2022 to 03-15-2022 | 
| Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Percent agreement of grade | Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Percent agreement of grade | 03-01-2022 to 03-15-2022 | 
| Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems using the Cohen's Kappa | Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: - Cohen's Kappa | 03-01-2022 to 03-15-2022 | 
| 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 | 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 | 03-01-2022 to 03-15-2022 | 
| Evaluate theTime to complete grading (minutes) using the 5 iAEs grading systems | 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) | 03-01-2022 to 03-15-2022 | 
| Evaluate the consistency and inter-rater reliability of the ICARUS Calculator in term of Distribution of responses by count and percent | Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Distribution of responses by count and percent | 03-16-2022- to 06-01-2022 | 
| Evaluate the consistency and inter-rater reliability of the ICARUS Calculator in terms of Percent agreement of grade | Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Percent agreement of grade | 03-16-2022- to 06-01-2022 | 
| Evaluate the consistency and inter-rater reliability of the ICARUS Calculator using Cohen's Kappa | Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: - Cohen's Kappa | 03-16-2022- to 06-01-2022 | 
| Evaluate the consistency and inter-rater reliability of the ICARUS Calculator using Intra-class correlation (ICC) with two-way, random effects to evaluate for consistency of grades | 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 | 03-16-2022- to 06-01-2022 | 
| Evaluate Time to complete grading (minutes)using the ICARUS Calculator | Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: -Time to complete grading (minutes) | 03-16-2022- to 06-01-2022 | 
| Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events | Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events There will be 5 output groupings involving the grading systems: ICARUS calculator vs. EAUiaiC ICARUS calculator vs. iAE severity ICARUS calculator vs. Modified Satava ICARUS calculator vs. ClassIntra ICARUS calculator vs. EAES Classification | 03-16-2022- to 06-01-2022 | 
| Determination of benefit in efficiency of the ICARUS Calculator compared to cognitively grading intraoperative adverse events | Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events There will be 5 output groupings involving the grading systems: ICARUS calculator vs. EAUiaiC ICARUS calculator vs. iAE severity ICARUS calculator vs. Modified Satava ICARUS calculator vs. ClassIntra ICARUS calculator vs. EAES Classification | 03-16-2022- to 06-01-2022 | 
| Determination of benefit in consistency of the ICARUS Calculator compared to cognitively grading intraoperative adverse events | Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events There will be 5 output groupings involving the grading systems: ICARUS calculator vs. EAUiaiC ICARUS calculator vs. iAE severity ICARUS calculator vs. Modified Satava ICARUS calculator vs. ClassIntra ICARUS calculator vs. EAES Classification | 03-16-2022- to 06-01-2022 | 
| Determination of benefit in inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events | Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events There will be 5 output groupings involving the grading systems: ICARUS calculator vs. EAUiaiC ICARUS calculator vs. iAE severity ICARUS calculator vs. Modified Satava ICARUS calculator vs. ClassIntra ICARUS calculator vs. EAES Classification | 03-16-2022- to 06-01-2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the experience using the ICARUS calculator by System Usability Scale (SUS) questionnaire | Assess the physician satisfaction using a validated questionnaires System Usability Scale (SUS) questionnaire | 03-16-2022- to 06-01-2022 | 
| Evaluation of the experience using the ICARUS calculator by using the Usefulness, Satisfaction and Ease of Use (USE) questionnaire. | Assess the physician satisfaction using a validated questionnaires: Questionnaire for User Interaction Satisfaction (QUIS) and Usefulness, Satisfaction and Ease of Use (USE) questionnaire | 03-16-2022- to 06-01-2022 | 
| Evaluation of the experience using the ICARUS calculator by using Questionnaire for User Interaction Satisfaction (QUIS) | Assess the physician satisfaction using a validated questionnaires: Questionnaire for User Interaction Satisfaction (QUIS) | 03-16-2022- to 06-01-2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICARUS, Intraoperative Complications, ICARUS Calculator