Pleural Effusion Clinical Trial
— AID-CXROfficial title:
Utility of an AI-based CXR Interpretation Tool in Assisting Diagnostic Accuracy, Speed, and Confidence of Healthcare Professionals: a Study Using 500 Retrospectively Collected Inpatient and Emergency Department CXRs From Two UK Hospital Trusts
Verified date | June 2024 |
Source | Oxford University Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study has been added as a sub study to the Simulation Training for Emergency Department Imaging 2 study (ClinicalTrials.gov ID NCT05427838). The Lunit INSIGHT CXR is a validation study that aims to assess the utility of an Artificial Intelligence-based (AI) chest X-ray (CXR) interpretation tool in assisting the diagnostic accuracy, speed, and confidence of a varied group of healthcare professionals. The study will be conducted using 500 retrospectively collected inpatient and emergency department CXRs from two United Kingdom (UK) hospital trusts. Two fellowship trained thoracic radiologists will independently review all studies to establish the ground truth reference standard. The Lunit INSIGHT CXR tool will be used to analyze each CXR, and its performance will be measured against the expert readers. The study will evaluate the utility of the algorithm in improving reader accuracy and confidence as measured by sensitivity, specificity, positive predictive value, and negative predictive value. The study will measure the performance of the algorithm against ten abnormal findings, including pulmonary nodules/mass, consolidation, pneumothorax, atelectasis, calcification, cardiomegaly, fibrosis, mediastinal widening, pleural effusion, and pneumoperitoneum. The study will involve readers from various clinical professional groups with and without the assistance of Lunit INSIGHT CXR. The study will provide evidence on the impact of AI algorithms in assisting healthcare professionals such as emergency medicine and general medicine physicians who regularly review images in their daily practice.
Status | Active, not recruiting |
Enrollment | 33 |
Est. completion date | June 2025 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - General radiologists/radiographers/physicians who review CXRs as part of their routine clinical practice Exclusion Criteria: - Thoracic radiologists - Non-radiology physicians with previous formal postgraduate CXR reporting training. - Non-radiology physicians with previous career in radiology, respiratory medicine or thoracic surgery to registrar or consultant level |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Oxford University Hospitals NHS Foundation Trust | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
Oxford University Hospitals NHS Trust |
United Kingdom,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Performance of AI algorithm: sensitivity | Evaluation of the Lunit INSIGHT CXR algorithm will be performed comparing it to the reference standard in order to determine sensitivity. | During 4 weeks of reading time | |
Primary | Performance of AI algorithm: specificity | Evaluation of the Lunit INSIGHT CXR algorithm will be performed comparing it to the reference standard in order to determine specificity. | During 4 weeks of reading time | |
Primary | Performance of AI algorithm: Area under the ROC Curve (AU ROC) | Evaluation of the Lunit INSIGHT CXR algorithm will be performed comparing it to the reference standard. Continuous probability score from the algorithm will be utilized for the ROC analyses, while binary classification results with a predefined operating cut-off will be used for evaluation of sensitivity, specificity, positive predictive value, and negative predictive value. | During 4 weeks of reading time | |
Primary | Performance of readers with and without AI assistance: Sensitivity | The study will include two sessions (with and without AI overlay), with all 30 readers reviewing all 500 CXR cases each time separated by a washout period to mitigate recall bias. The cases will be randomised between the two reads and for every reader. | During 4 weeks of reading time | |
Primary | Performance of readers with and without AI assistance: Specificity | The study will include two sessions (with and without AI overlay), with all 30 readers reviewing all 500 CXR cases each time separated by a washout period to mitigate recall bias. The cases will be randomised between the two reads and for every reader. | During 4 weeks of reading time | |
Primary | Performance of readers with and without AI assistance: Area under the ROC Curve (AU ROC) | The study will include two sessions (with and without AI overlay), with all 30 readers reviewing all 500 CXR cases each time separated by a washout period to mitigate recall bias. The cases will be randomised between the two reads and for every reader. | During 4 weeks of reading time | |
Primary | Reader speed with vs without AI assistance. | Mean time taken to review a scan, with vs without AI assistance. | During 4 weeks of reading time |
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