- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06410183
Inter-rater Reliability of Preoperative Mortality Risk Calculators
Inter-rater Reliability of Preoperative Mortality Risk Calculators Used for High-risk Noncardiac Surgical Patients
Study Overview
Detailed Description
Identifying high-risk patients for perioperative treatment and decision-making remains a challenge due to difficulty in reliably estimating morbidity and mortality risks. Assessing surgical risk helps allocating resources, obtaining informed consent, and making shared decisions with a multidisciplinary team (MDT). Multimorbidity is increasing globally in an ageing population with a growing burden of chronic diseases. It has been shown that high-risk non-cardiac surgical patients suffer disproportionally from perioperative complications. Preoperative mortality risk calculators are available and may help to identify high-risk non-cardiac surgical patients already before surgery, triggering efforts to lower the burden of possible complications, e.g., by extended monitoring or specified treatments. A systematic review suggested a significant risk of bias in developing current preoperative risk calculators due to lack of external validation, highlighting the need for enhanced performance and reliability to ensure their effectiveness in clinical practice. Low reliability and performance may, despite their general availability, be why that preoperative risk calculators are not yet consistently used in clinical practice. For daily clinical use, good predictive performance, low inter rater variability and user friendliness are essential. Discrepancies in predictor measurements can cause miscalibration, changes in discriminatory ability, and overall accuracy, leading to clinically relevant variability in risk calculator results. Previous studies have shown that physicians must trust a mortality risk calculator before utilization. High-risk patients suffer especially from complications, and it has been shown that the complications often result in death perioperatively. Therefore, adequate preoperative calculation of mortality risks and early recognition of high-risk non-cardiac surgical patients could benefit from reliable preoperative risk calculation. These high-risk patients can then be discussed in a preoperative multidisciplinary discussion to lower complications and perioperative deaths.
The current study evaluated the inter-rater reliability of calculating preoperative mortality risk scores for high-risk non-cardiac surgical patients in clinical practice among five anesthesiologists. The hypothesis was that the available risk calculators would show moderate to good reliability. For this purpose, five anesthesiologists used the following three risk calculators: the preoperative score to predict postoperative morbidity [POSPOM, the American College of Surgeons surgical risk calculator, and the surgical outcome risk tool [SORT].
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Gelderland
-
Arnhem, Gelderland, Netherlands, 6800 TA
- Rijnstate Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients discussed in a preoperative multidisciplinary team (MDT) meeting.
Exclusion Criteria:
- No complete patient file to calculate the mortality risks
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
inter-rater reliability of three risk calculators: POSPOM, SRC and SORT
Time Frame: After calculation of the mortality risks (1 month)
|
Five anesthesiologists calculated mortality risks retrospectively for 34 patients.
The intra-class correlation coefficient (ICC) was calculated per risk calculator
|
After calculation of the mortality risks (1 month)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality risk calculations or 34 patients
Time Frame: 1 month
|
the POSPOM, SRC and SORT mortality risk calculators were used for (retrospective) 30-day mortality risk calculation of 34 patients
|
1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jacqueline E. Vernooij, MD, MA, Rijnstate Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022-2161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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