Clinical trial NCT05270603: The Intraoperative Complication Assessment and Reporting With Universal Standards - Calculator (ICARUS-C)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intraoperative Complications
Surgery--Complications
Surgery
Surgical Procedure, Unspecified
Keywords: ICARUS
Intraoperative Complications
ICARUS Calculator
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study team will identify corresponding authors who have published articles at any point during 2019-2021 in key American and European scientific surgical journals. The study team plans to email up to 1500 authors from each of these journals - though, many of these journals will not likely have substantially fewer corresponding authors. Specifically, these journals will be associated with one or more of the following specialties:

Anesthesiology Interventional Radiology Interventional Cardiology Cardiothoracic Surgery Colon and rectal surgery General Surgery Gynecologic oncology Gynecology and obstetrics Neurological Surgery Ophthalmologic Surgery Oral and maxillofacial Surgery Orthopaedic Surgery Otorhinolaryngology Plastic Surgery Urology Vascular Surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Distribution of responses by count and percent
timeFrame: 03-01-2022 to 03-15-2022
measure: Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems in terms of Percent agreement of grade
timeFrame: 03-01-2022 to 03-15-2022
measure: Evaluate the consistency and inter-rater reliability of the 5 iAEs grading systems using the Cohen's Kappa
timeFrame: 03-01-2022 to 03-15-2022
measure: 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
timeFrame: 03-01-2022 to 03-15-2022
measure: Evaluate theTime to complete grading (minutes) using the 5 iAEs grading systems
timeFrame: 03-01-2022 to 03-15-2022
measure: Evaluate the consistency and inter-rater reliability of the ICARUS Calculator in term of Distribution of responses by count and percent
timeFrame: 03-16-2022- to 06-01-2022
measure: Evaluate the consistency and inter-rater reliability of the ICARUS Calculator in terms of Percent agreement of grade
timeFrame: 03-16-2022- to 06-01-2022
measure: Evaluate the consistency and inter-rater reliability of the ICARUS Calculator using Cohen's Kappa
timeFrame: 03-16-2022- to 06-01-2022
measure: 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
timeFrame: 03-16-2022- to 06-01-2022
measure: Evaluate Time to complete grading (minutes)using the ICARUS Calculator
timeFrame: 03-16-2022- to 06-01-2022
measure: Determination of benefit in efficiency, consistency, inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
timeFrame: 03-16-2022- to 06-01-2022
measure: Determination of benefit in efficiency of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
timeFrame: 03-16-2022- to 06-01-2022
measure: Determination of benefit in consistency of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
timeFrame: 03-16-2022- to 06-01-2022
measure: Determination of benefit in inter-rater reliability of the ICARUS Calculator compared to cognitively grading intraoperative adverse events
timeFrame: 03-16-2022- to 06-01-2022
Secondary outcomes:
measure: Evaluation of the experience using the ICARUS calculator by System Usability Scale (SUS) questionnaire
timeFrame: 03-16-2022- to 06-01-2022
measure: Evaluation of the experience using the ICARUS calculator by using the Usefulness, Satisfaction and Ease of Use (USE) questionnaire.
timeFrame: 03-16-2022- to 06-01-2022
measure: Evaluation of the experience using the ICARUS calculator by using Questionnaire for User Interaction Satisfaction (QUIS)
timeFrame: 03-16-2022- to 06-01-2022
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Giovanni Cacciamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biyani CS, Pecanka J, Roupret M, Jensen JB, Mitropoulos D. Intraoperative Adverse Incident Classification (EAUiaiC) by the European Association of Urology ad hoc Complications Guidelines Panel. Eur Urol. 2020 May;77(5):601-610. doi: 10.1016/j.eururo.2019.11.015. Epub 2019 Nov 29.
citation: Kaafarani HM, Mavros MN, Hwabejire J, Fagenholz P, Yeh DD, Demoya M, King DR, Alam HB, Chang Y, Hutter M, Antonelli D, Gervasini A, Velmahos GC. Derivation and validation of a novel severity classification for intraoperative adverse events. J Am Coll Surg. 2014 Jun;218(6):1120-8. doi: 10.1016/j.jamcollsurg.2013.12.060. Epub 2014 Feb 28.
citation: Kazaryan AM, Rosok BI, Edwin B. Morbidity assessment in surgery: refinement proposal based on a concept of perioperative adverse events. ISRN Surg. 2013 May 16;2013:625093. doi: 10.1155/2013/625093. Print 2013.
citation: Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gie O, Goebel B, Hahnloser D, Herbst F, Ioannidis O, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917.
citation: Francis NK, Curtis NJ, Conti JA, Foster JD, Bonjer HJ, Hanna GB; EAES committees. EAES classification of intraoperative adverse events in laparoscopic surgery. Surg Endosc. 2018 Sep;32(9):3822-3829. doi: 10.1007/s00464-018-6108-1. Epub 2018 Feb 12.
citation: Cacciamani G, Sholklapper T, Sotelo R, Desai M, Gill I. A Protocol for the Development of the Intraoperative Complications Assessment and Reporting With Universal Standards Criteria: The ICARUS Project. Int J Surg Protoc. 2021 Aug 6;25(1):160-164. doi: 10.29337/ijsp.155. eCollection 2021.