Intra-Operative Complication Assessment and Reporting With Universal Standards: Survey
- Conditions
- SurgeryIntraoperative ComplicationsSurgery--ComplicationsSurgical Procedure, Unspecified
- Registration Number
- NCT04994392
- Lead Sponsor
- University of Southern California
- Brief Summary
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 classification systems, 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. Many reasons could be related to this dearth in iAE reporting, ranging from a lack of clear iAE definitions to a fear of litigation. Broadly speaking, iAEs are negative outcomes, which, on the whole, epitomize a paradoxically well-documented bias in the literature.
The investigators performed an umbrella review and meta-analysis of prior systematic reviews of complication reporting in a number of key urologic surgical domains. The investigators have since worked with academic surgeons to produce a set of iAE reporting guidelines known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) Guidelines. These reporting criteria were developed using the reporting guidelines using the framework outlined by the EQUATOR Network (Enhancing the QUAlity and Transparency Of health Research; www.equator-network.org/).
As part of a prospective effort to evaluate the utility of these new guidelines, the investigators are performing a study of surgeons, anesthesiologists,s and nurses perceptions regarding iAE reporting and the global applicability of the new iAE reporting guidelines.
In part one of this study, a series of survey questions will be used to better elucidate surgeon perceptions underlying the contemporary deficit in iAE reporting. In part two of this study, a set of assessments to representatives within various surgical specialties to assess the global applicability of the newly developed iAE reporting guidelines.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4821
- 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
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Activity restrictions that limit one's ability to engage in online survey
-
Adults not competent to consent
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Minors, human fetuses, neonates
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Prisoners/Detainees
The sample size of the survey is calculated as reported by Taherdoost, Hamed et al. Determining Sample Size; How to Calculate Survey Sample Size (2017). International Journal of Economics and Management Systems, Vol. 2, 2017, considering the worldwide surgeons and anesthesiologists population (n. 1,853,842) accordingly to the most recent WHO Surgical workforce Census (https://apps.who.int/gho/data/view.main.HRSWF),with a 95% Level and 2% marginal error.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Global applicability of the ICARUS reporting criteria July 30th 2021 till September 30th 2021 Determination of global applicability (clinical utility and quality improvement utility) of the ICARUS reporting criteria as determined by subjective 5-point Likert scale assessments. Outcomes to be assessed by percent agreement and interrater consistency.
Global perception of intraoperative adverse event reporting July 30th 2021 till September 30th 2021 A series of 5-point Likert scale assessments relating to surgeon perception of intraoperative adverse assessment as it related to the following domains: reporting habits, practical considerations, clinical and quality improvement utility, emotional response, and perceived consequences. The questions do not include any validated questionnaires or psychometric evaluations. Descriptive statistical assessment of responses.
- Secondary Outcome Measures
Name Time Method Specialty-specific applicability of ICARUS guidelines July 30th 2021 till September 30th 2021 Determination of specialty specific applicability (clinical utility and quality improvement utility) of the ICARUS reporting criteria as determined by subjective 5-point Likert scale assessments. Outcomes to be assessed by percent agreement and interrater consistency.
Specialty specific perception of intraoperative adverse event reporting July 30th 2021 till September 30th 2021 A series of 5-point Likert scale assessments relating to surgeon perception of intraoperative adverse assessment as it related to the following domains: reporting habits, practical considerations, clinical and quality improvement utility, emotional response, and perceived consequences. The questions do not include any validated questionnaires or psychometric evaluations. Descriptive statistical assessment of responses.
Trial Locations
- Locations (1)
University of Southern California
🇺🇸Los Angeles, California, United States