An observational study in Intracranial Hemorrhages, Acute Ischemic Stroke and Hydrocephalus, sponsored by Oxford University Hospitals NHS Trust. Completed at 4 sites in United Kingdom. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Oxford University Hospitals NHS Trust · 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 purpose of the study is to assess the impact of an Artificial Intelligence (AI) tool called qER 2.0 EU on the performance of readers, including general radiologists, emergency medicine clinicians, and radiographers, in interpreting non-contrast CT head scans. The study aims to evaluate the changes in accuracy, review time, and diagnostic confidence when using the AI tool. It also seeks to provide evidence on the diagnostic performance of the AI tool and its potential to improve efficiency and patient care in the context of the National Health Service (NHS). The study will use a dataset of 150 CT head scans, including both control cases and abnormal cases with specific abnormalities. The results of this study will inform larger follow-up studies in real-life Emergency Department (ED) settings.
211 studies on the registry are indexed under Intracranial Hemorrhages; 62 are open to participants now.
This study's enrollment of 33 is below the median of 250 across 85 observational studies indexed under Intracranial Hemorrhages.
Browse Intracranial Hemorrhages studies →Oxford University Hospitals NHS Trust is the lead sponsor of 94 studies on the registry; 7 are open to participants now.
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Setting:
Readers will be recruited from the following four hospital Trusts (secondary and tertiary level:
Participants:
30 volunteer participant readers will be selected from the following groups:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
30 readers will be recruited across four NHS trusts including ten general radiologists, fifteen emergency medicine clinicians, and five CT radiographers of varying seniority. Readers will interpret each scan first without, then with, the assistance of the AI tool, with an intervening 4-week washout period. Using a panel of neuroradiologists as ground truth, the stand-alone performance of qER will be assessed, and its impact on the readers' performance will be analysed as change in accuracy, mean review time per scan, and self-reported diagnostic confidence. Subgroup analyses will be performed by reader professional group, reader seniority, pathological finding, and neuroradiologist-rated difficulty.
Other: Reading
Two Consultant neuroradiologists will independently review the images to establish the 'ground truth' findings on the CT scans which will be used as the reference standard. In the case of disagreement, a third senior neuroradiologist's opinion will be sought for arbitration. A difficulty score will be assigned to each scan by the ground truthers using a 5-point Likert scale.
Other: Ground truthing
Two Consultant neuroradiologists will independently review the images to establish the 'ground truth' findings on the CT scans which will be used as the reference standard. In the case of disagreement, a third senior neuroradiologist's opinion will be sought for arbitration.
All 30 readers will review all 150 cases, in each of two study phases. The readers will provide their opinion on the presence or absence of some acute abnormalities, including intracranial haemorrhage, infarct, midline shift and fracture. They will provide a confidence in their diagnosis (10-point visual analogue scale), and a single click point to mark the location of each abnormality that they consider as being present. The time taken for each scan will be automatically recorded.
Reader performance: Sensitivity, specificity, comparative between with and without AI assistance.
Reader performance will be evaluated as sensitivity, specificity, with and without AI assistance.
Time frame: During 6 weeks, which is the period for reading or reviewing the cases/scans.
Reader performance: Positive and negative predictive value, comparative between with and without AI assistance.
Reader performance will be evaluated as Positive Predictive Value (PPV) and negative predictive value (NPV), with and without AI assistance.
Time frame: During 6 weeks, which is the period for reading or reviewing the cases/scans.
Reader performance: Area Under Receiver Operating Characteristic Curve (AUROC), comparative between with and without AI assistance.
Reader performance will be evaluated as Area Under Receiver Operating Characteristic Curve (AUROC), with and without AI assistance.
Time frame: During 6 weeks, which is the period for reading or reviewing the cases/scans.
Reader speed: Mean time taken to review a scan, with versus without AI assistance.
Reader speed will be evaluated as the man time taken to review a scan, using time unite of seconds.
Time frame: During 6 weeks, which is the period for reading or reviewing the cases/scans.
Reader confidence: Self-reported diagnostic confidence on a 10 point visual analogue scale, with vs without AI assistance.
On the reading platform (RAIQC), one of the questions asks the level of confidence that the participant has in their diagnostic opinion. The question offers a scale of 1 to 10, where 1 is not confident, and 10 is highly confident.
Time frame: During 6 weeks, which is the period for reading or reviewing the cases/scans.
qER (AI algorithm) performance: Sensitivity and specificity
qER performance will be evaluated as sensitivity, specificity.
Time frame: During 6 weeks, which is the period for reading or reviewing the cases/scans.
qER (AI algorithm) performance: Positive and negative predictive value.
qER performance will be evaluated as Positive Predictive Value (PPV) and negative predictive value (NPV).
Time frame: During 6 weeks, which is the period for reading or reviewing the cases/scans.
qER (AI algorithm) performance: Area Under Receiver Operating Characteristic Curve (AUROC).
qER performance will be evaluated as Area Under Receiver Operating Characteristic Curve (AUROC)
Time frame: During 6 weeks, which is the period for reading or reviewing the cases/scans.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Oxford University Hospitals NHS Trust