SPIRIT: Surgeon's Performance in Predicting Postoperative Infections
Study Details
Study Description
Brief Summary
Post-surgical (bacterial) infections are the most frequent post-surgical complications, including deep or superficial wound infections, urinary tract infections, pneumonia, and even sepsis. Approximately 6.5-25% of all surgical patients will develop any type of bacterial infection. To personalize surgical infection management, (Artificial Intelligence) models are in the making to predict which patients are at high or low risk of developing a post-surgical infection. In order to benchmark these prediction models to the predictive capabilities of surgeons, the investigators aim to investigate the performance of surgeons in predicting the risk of a patient developing (any type) of post-surgical infection within 30 days.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
A prospective non-interventional study is performed to collect surgeons' predictions on the risk of a patient developing a postoperative infection within 30 days of surgery. Surgeons are asked to fill in a short questionnaire asking about the estimated infection risk. The actual outcome (infection < 30 days of surgery) of a patient will be collected retrospectively after completion of the study. This study will have no effect on standard care: surgical interventions and postoperative care will be carried out according to standard clinical practice. Besides a one-time estimate of the surgeon, immediately after the surgical procedure, no other interventions will be performed and surgical specialists will carry out their normal post-surgical care, including screening and treating (if necessary) their patients for postoperative infections.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Surgeons estimate of postoperative infection All surgeons will be asked to fill in a questionnaire, containing 5 questions, pertaining to the estimated risk of postoperative infection (within 30days). Thus there is a single arm and no comparison. |
Behavioral: Questionnaire
Surgeons will be asked to fill in a short questionnaire after surgery on risk of postoperative infection
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Outcome Measures
Primary Outcome Measures
- The discriminative predictive performance of surgeons with respect to estimating the risk of developing (any type) bacterial post-surgical within 30 days of surgery [30 days]
The primary outcome measure of discrimination are area under the receiving operating characteristic curve (AUROC). Predictions are compared to the occurrence of a postoperative infection requiring treatment, surgical intervention or registration within 30 days of surgery.
- The calibration properties of surgeons with respect to estimating the risk of developing (any type) bacterial post-surgical within 30 days of surgery [30 days]
Calibration plots with slope and intercept
Secondary Outcome Measures
- Relationship between the certainty in estimate and the predictive performance of surgeons [30 days]
Surgeons are questioned on their certainty in the provided estimate
- Relationship between patient factors and predicted risk [30 days]
Surgeons are questioned to indicate for a list of patient factors whether they were of impact to the decision
- Predictive performance per surgeons and patients subgroups [30 days]
Surgeons subgroups are based on specialty, years of experience, level of experience, sex. Patient subgroups include, surgical specialty, age groups, type of surgical procedure, planned or emergency intervention.
- Relationship between predicted risk of surgeons and if they perform additional actions [30 days]
Surgeons are asked to indicate whether they performed additional actions for this patient in the questionnaire.
Eligibility Criteria
Criteria
Predictions are made for patients with the following inclusion and exclusion criteria:
Inclusion Criteria:
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Adult patients (>18 years old)
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Acute or elective surgery
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Invasive or minimally invasive surgical procedures
Exclusion Criteria:
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Outpatient procedures or procedures not requiring any form of monitoring/anesthesia
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Procedures for which the primary indication is (treatment for) an infection
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Radiological procedures
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Cardiological catheterization procedures
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Psychiatric treatment under anaesthesia (i.e. electroconvulsive therapy)
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Sole anaesthetic procedures except for implantation of a neurostimulator
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Brachytherapy procedures
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Endoscopic procedures for diagnostic purposes only
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Procedures that only entail the taking of a biopsy for diagnostic purposes
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Patients that are pregnant
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Procedures out of office hours (before 8.00 am or after 5.00 pm)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sesmu Arbous | Leiden | Zuid-holland | Netherlands | 2333 ZA |
Sponsors and Collaborators
- Leiden University Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-64