Fracture Clinical Trial
— FRACT-AIOfficial title:
FRACT-AI: Evaluating the Impact of Artificial Intelligence-Enhanced Image Analysis on the Diagnostic Accuracy of Frontline Clinicians in the Detection of Fractures on Plain X-Ray
NCT number | NCT06130397 |
Other study ID # | 310995-C |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 8, 2024 |
Est. completion date | June 2025 |
This study has been added as a sub study to the Simulation Training for Emergency Department Imaging 2 study (ClinicalTrials.gov ID NCT05427838). This work aims to evaluate the impact of an Artificial Intelligence (AI)-enhanced algorithm called Boneview on the diagnostic accuracy of clinicians in the detection of fractures on plain XR (X-Ray). The study will create a dataset of 500 plain X-Rays involving standard images of all bones other than the skull and cervical spine, with 50% normal cases and 50% containing fractures. A reference 'ground truth' for each image to confirm the presence or absence of a fracture will be established by a senior radiologist panel. This dataset will then be inferenced by the Gleamer Boneview algorithm to identify fractures. Performance of the algorithm will be compared against the reference standard. The study will then undertake a Multiple-Reader Multiple-Case study in which clinicians interpret all images without AI and then subsequently with access to the output of the AI algorithm. 18 clinicians will be recruited as readers with 3 from each of six distinct clinical groups: Emergency Medicine, Trauma and Orthopedic Surgery, Emergency Nurse Practitioners, Physiotherapy, Radiology and Radiographers, with three levels of seniority in each group. Changes in reporting accuracy (sensitivity, specificity), confidence, and speed of readers in two sessions will be compared. The results will be analyzed in a pooled analysis for all readers as well as for the following subgroups: Clinical role, Level of seniority, Pathological finding, Difficulty of image. The study will demonstrate the impact of an AI interpretation as compared with interpretation by clinicians, and as compared with clinicians using the AI as an adjunct to their interpretation. The study will represent a range of professional backgrounds and levels of experience among the clinical element. The study will use plain film x-rays that will represent a range of anatomical views and pathological presentations, however x-rays will present equal numbers of pathological and non-pathological x-rays, giving equal weight to assessment of specificity and sensitivity. Ethics approval has already been granted, and the study will be disseminated through publication in peer-reviewed journals and presentation at relevant conferences.
Status | Recruiting |
Enrollment | 21 |
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: - Emergency medicine doctors, trauma and orthopaedic surgeons, emergency nurse practitioners, physiotherapists, general radiologists and radiographers reviewing X-rays as part of their routine clinical practice. - Currently working in the National Health Service (NHS). Exclusion Criteria: - Non-radiology physicians with previous formal postgraduate XR reporting training. - Non-radiology physicians with previous career in radiology |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Oxford University Hospitals NHS Foundation Trust | Oxford | Oxfordshire |
United Kingdom | Oxford University Hospitals NHS Foundation Trust | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
Oxford University Hospitals NHS Trust | Gleamer |
United Kingdom,
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* Note: There are 13 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 Gleamer Boneview 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 Gleamer Boneview 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 Gleamer Boneview algorithm will be performed comparing it to the reference standard. Continuous probability score from the algorithm will be utilised 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 18 readers reviewing all 500 XR 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 18 readers reviewing all 500 XR 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 18 readers reviewing all 500 XR 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 XR, with vs without AI assistance. | During 4 weeks of reading time |
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