Intraoperative Complications, Surgery, Surgery--Complications, Surgical Procedure, Unspecified
Conditions
Keywords
ICARUS, Intraoperative Complications, ICARUS Calculator
Brief summary
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
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.
Interventions
OTHERICARUS intraoperative adverse events calculator
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.
Sponsors
University of Southern California
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of benefit in inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events | 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 There will be 5 output groupings involving the grading systems: 1. ICARUS calculator vs. EAUiaiC 2. ICARUS calculator vs. iAE severity 3. ICARUS calculator vs. Modified Satava 4. ICARUS calculator vs. ClassIntra 5. ICARUS calculator vs. EAES Classification |
| Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events | 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 There will be 5 output groupings involving the grading systems: 1. ICARUS calculator vs. EAUiaiC 2. ICARUS calculator vs. iAE severity 3. ICARUS calculator vs. Modified Satava 4. ICARUS calculator vs. ClassIntra 5. ICARUS calculator vs. EAES Classification |
| Determination of benefit in efficiency of the ICARUS Calculator compared to cognitively grading intraoperative adverse events | 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 There will be 5 output groupings involving the grading systems: 1. ICARUS calculator vs. EAUiaiC 2. ICARUS calculator vs. iAE severity 3. ICARUS calculator vs. Modified Satava 4. ICARUS calculator vs. ClassIntra 5. ICARUS calculator vs. EAES Classification |
| Determination of benefit in consistency of the ICARUS Calculator compared to cognitively grading intraoperative adverse events | 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 There will be 5 output groupings involving the grading systems: 1. ICARUS calculator vs. EAUiaiC 2. ICARUS calculator vs. iAE severity 3. ICARUS calculator vs. Modified Satava 4. ICARUS calculator vs. ClassIntra 5. ICARUS calculator vs. EAES Classification |
| Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Distribution of responses by count and percent | 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: -Distribution of responses by count and percent |
| Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Percent agreement of grade | 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 Cohen's Kappa | 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: \- Cohen's Kappa |
| 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 | 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 | 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 the consistency and inter-rater reliability of the ICARUS Calculator in term of Distribution of responses by count and percent | 03-16-2022- to 06-01-2022 | 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 |
| Evaluate the consistency and inter-rater reliability of the ICARUS Calculator in terms of Percent agreement of grade | 03-16-2022- to 06-01-2022 | 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 ICARUS Calculator using Cohen's Kappa | 03-16-2022- to 06-01-2022 | Primary data analysis will involve calculations to evaluate the consistency and inter-rater agreement for each grading system, as follows: \- Cohen's Kappa |
| 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 | 03-16-2022- to 06-01-2022 | 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 Time to complete grading (minutes)using the ICARUS Calculator | 03-16-2022- to 06-01-2022 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the experience using the ICARUS calculator by using the Usefulness, Satisfaction and Ease of Use (USE) questionnaire. | 03-16-2022- to 06-01-2022 | Assess the physician satisfaction using a validated questionnaires: Questionnaire for User Interaction Satisfaction (QUIS) and Usefulness, Satisfaction and Ease of Use (USE) questionnaire |
| Evaluation of the experience using the ICARUS calculator by using Questionnaire for User Interaction Satisfaction (QUIS) | 03-16-2022- to 06-01-2022 | Assess the physician satisfaction using a validated questionnaires: Questionnaire for User Interaction Satisfaction (QUIS) |
| Evaluation of the experience using the ICARUS calculator by System Usability Scale (SUS) questionnaire | 03-16-2022- to 06-01-2022 | Assess the physician satisfaction using a validated questionnaires System Usability Scale (SUS) questionnaire |
Countries
United States
Outcome results
None listed