About this trial
Quality improvement study with prospective observational design. The study monitors the diagnostic accuracy of an AI-assisted resident radiologist-termed the AI-ResRad diagnostic strategy-compared to an on-call specialist neuroradiologist-termed the SpecNeuroRad strategy-in interpreting stroke MRIs in patients with known onset.
The study includes a pre-planned sub-study evaluating the diagnostic accuracy of neurologists and AI-assisted neurologists.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Stroke team activation
Thrombolysis candidate
Known symptom onset
Disqualifiers
Prior inclusion
Previous MRI in the same course of hospitalization
No resident radiologist on call
Trial population
Adult patients suspected of stroke with known onset who meet the rapid response stroke activation and MRI criteria at Aarhus University Hospital and Gødstrup Regional Hospital will be included consecutively.
Trial design
Cohort
Prospective
Treatments tested in this trial
Index test (AI-ResRad)
Diagnostic testEligible residents will review MRI sequences from the local PACS as they become available. During this process, they will maintain real-time communication-in person or via phone-with the treating neurologist, who will provide relevant clinical information. Simultaneously, the resident will have access to the AI output. Residents will have full access to the patient's electronic medical record and prior imaging. After integrating these inputs, the resident will complete an AI-assisted MRI interpretation using a predefined survey structure.
Reference test (SpecNeuroRad)
Diagnostic testBefore any MRI sequences have been finalized, the resident will notify the on-call specialist neuroradiologist and pass on the clinical information received from the neurologist. The neuroradiologist will then independently review the MRI sequences as they become available in PACS, without access to the resident's interpretation or the AI results. They will also access the patient's electronic medical record and prior imaging. Once both parties have completed their respective surveys, the resident will call the neuroradiologist to jointly deliver an oral MRI interpretation to the neurologist. The radiologic information system's written radiology report may be completed by the neuroradiologist or the resident, with final sign-off by the neuroradiologist.
Comparative Index tests: ResRad and AI-SpecNeuroRad
Diagnostic testTwo additional comparative test strategies will be evaluated: * ResRad: Prior to accessing AI results, residents will complete a non-assisted MRI interpretation. * AI-SpecNeuroRad: After completing their initial non-assisted interpretation (SpecNeuroRad), the specialist neuroradiologist will be granted access to the AI output. They will then submit a second interpretation (AI-assisted) using the same survey platform. To enforce internal blinding between non-assisted and AI-assisted interpretations, AI outputs are only revealed upon manual activation, which is timestamped by the system. Interpretation surveys are also timestamped at submission. All non-assisted interpretations must be submitted prior to AI output activation to be considered valid. Cases that violate this timestamp sequence will be excluded from final analyses to ensure methodological integrity.
Neurologist Diagnostic Accuracy (Sub-study outcome)
Diagnostic testSimultaneously with the radiologists' MRI interpretations with and without AI assistance according to the study workflow, the neurologist responsible for patient management will complete a similar MRI interpretation survey. The neurologist will first interpret the MRI without AI assistance and subsequently with AI assistance, mirroring the radiologist study workflow. The neurologist will be blinded to the radiologists' interpretations while completing their assessments, and likewise, the radiologists will be blinded to the neurologist's interpretations.
Treatment groups
Trial outcomes
Primary outcomes
Composite agreement
Overall agreement is defined as the proportion of patients for whom the AI-ResRad and SpecNeuroRad agree on all MRI pattern items included in the MRI interpretation survey: (1) DWI lesion and (2) hemorrhage.
Secondary outcomes
Diagnostic Accuracy
The diagnostic accuracy of the AI-ResRad and ResRad strategies will be reported in terms of sensitivity, specificity, and positive and negative predictive values, using SpecNeuroRad as the reference standard. This will be assessed separately for each of the imaging patterns: 1) DWI lesion; and 2) hemorrhage.
Comparative Diagnostic Accuracy
Comparative diagnostic accuracy outcomes will be explored between the AI-ResRad and ResRad strategies, using SpecNeuroRad as the reference standard, including the net reclassification index, net benefit, and absolute difference in overall agreement (defined as described above for the primary outcome).
Concordance SpecNeuroRad
For the AI-SpecNeuroRad strategy, outcomes will include pairwise agreement with the original SpecNeuroRad interpretation, characterization of disagreement cases, and identification of AI-induced reclassifications.
Other outcomes
Neurologists' Diagnostic Accuracy (Sub-study)
The diagnostic accuracy of the neurologist's interpretations, both without AI assistance and with AI assistance, will be reported in terms of sensitivity, specificity, and positive and negative predictive values, using SpecNeuroRad as the reference standard. Accuracy will be assessed separately for each imaging pattern: (1) DWI lesion and (2) hemorrhage.
Neurologists' Composite Agreement (Sub-study)
Overall agreement will be defined as the proportion of patients for whom the neurologist's interpretations (with and without AI assistance) agree with the SpecNeuroRad on all MRI pattern items included in the MRI interpretation survey: (1) DWI lesion and (2) hemorrhage.
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