Deep vein thrombosis Circulatory System Phlebitis and thrombophlebitis of other deep vessels of lower extremities
Conditions
Interventions
An AutoDVT software scan and remote radiology review are compared for accuracy with a clinical ultrasound scan. The study scan will not be used for diagnosis or to direct treatment.
Sponsors
Oxford University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The participant has the capacity to consent and consent is obtained 2. The participant is an adult (aged 18 years or older in the UK) 3. The participant has symptoms suggestive of a deep venous thrombosis (DVT) 4. The diagnostic DVT algorithm indicates that an ultrasound is needed
Exclusion criteria
Exclusion criteria: 1. Pregnant women at 12 weeks or more gestation 2. A d-dimer cannot be performed (e.g. due to prior anticoagulation) 3. The participant is found to have a distal DVT during the US scan (retrospective exclusion) 4. The participant has had a previous radiologically confirmed DVT in the symptomatic leg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sensitivity of AutoDVT within a treatment algorithm for the detection of a proximal DVT by non-radiology trained staff relative to two- or three-point compression ultrasound, at initial scan and 7 days 2. Sensitivity of AutoDVT within a treatment algorithm for the detection of a proximal DVT by non-radiology trained staff and remote diagnosis by a suitably qualified clinician with more than 1 year of experience diagnosing DVTs (e.g. sonographer or radiologist) retrospectively relative to two- or three-point compression ultrasound, at initial scan and 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Specificity of AutoDVT relative to two- or three-point compression ultrasound, at initial scan and 7 days 2. Diagnostic image quality of AutoDVT US data (using ACEP image quality scale) across all initial and 7-day scans 3. Positive and negative predictive values of AutoDVT relative to two- or three-point compression ultrasound, at initial scan and 7 days 4. Imaging failure rates (with reasons) recorded by the software across all initial and 7-day scans 5. Numbers of discrepant results (AutoDVT vs ultrasound) recorded by comparing the software and clinical diagnoses at initial and 7-day scans 6. Interoperator variability of AutoDVT results assessed using a kappa statistic for 10% of initial scans 7. Interobserver agreement in DVT diagnosis and image quality score between 5 reviewers of each scan at initial scan and 7 days 8. Numbers of eligible patients not enrolled (with reasons) recorded by the research staff at enrolment 9. Safety: number of subsequent venous thromboembolic events and/or death related to venous thromboembolism (VTE) recorded by contacting the patient and/or General Practitioner at 3 months 10. Feasibility of recording of AutoDVT scans assessed using recruitment, user feedback and scans missed at initial scan and 7 days 11. Duration of AutoDVT scans recorded by the software at initial and 7-day scans 12. Number of indeterminate and repeat scans recorded by the software at initial and 7-day scans 13. Feedback from the research nurses on ease of use of the software (PSSUQ version 3 score and qualitative feedback) provided after they have done all scanning in the project | — |
Countries
England, United Kingdom
Contacts
Public ContactFouad;Christopher Noor;Deane
;
Outcome results
None listed