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The goal of this blinded randomized controlled trial is to assess whether AI-assisted TTE interpretation can improve cardiologist efficiency and reduce interpretation variability while preserving accuracy compared to current methods in adult patients whose historical echocardiogram images were performed.
The main questions it aims to answer is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-Assisted Interpretation | Active Comparator | In AI-prelim arm, AI provides the preliminary interpretation which is finalized by a blinded cardiologist. |
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| Sonographer-Assisted Interpretation | Active Comparator | In Sonographer-prelim arm, sonographer provides the preliminary interpretation which is finalized by a blinded cardiologist. |
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| Cardiologist-Only Interpretation | Active Comparator | In cardiologist-prelim arm, cardiology provides the preliminary interpretation which is finalized by a blinded separate cardiologist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-Assisted Echocardiogram Interpretation | Other | Echocardiogram studies are pre-interpreted by the AI software and finalized by a blinded cardiologist. |
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of AI-Assisted Echocardiogram Interpretation Compared to Standard Workflows. | The accuracy rate is defined as the proportion of transthoracic echocardiogram (TTE) studies for which the final cardiologist interpretation is not significantly different from the preliminary interpretation. We will assess the accuracy rate in the AI-assisted arm for non-inferiority versus the pooled accuracy rate across both the sonographer-assisted and cardiologist-only arms. The investigators will measure the proportion of TTE studies for which the final cardiologist report is substantially different from the preliminary report (e.g., the rate of substantial change). We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventriuclar function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Measures of Accuracy (Superiority Analyses) | Accuracy rates will also be analyzed for superiority rather than non-inferiority. The proportion of TTE studies for which the final cardiologist interpretation is not significantly different from the preliminary interpretation will be compared individually between the AI-assisted arm and each comparator arm (sonographer-assisted and cardiologist-only).
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Ouyang | Kaiser Permanente | Principal Investigator |
| Keane K Lee | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California Division of Research | Pleasanton | California | 94588 | United States |
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| Sonographer-Assisted Echocardiogram Interpretation | Other | (Standard of Care 1): Echocardiogram studies are pre-interpreted by a sonographer and finalized by a blinded cardiologist. |
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| Cardiologist-Only Echocardiogram Interpretation | Other | (Standard of Care 2): Echocardiogram studies are interpreted solely by two cardiologists (one provides a preliminary interpretation another provides a blinded final interpretation). |
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| 6 months |
| Accuracy Compared with Historical Cardiologist Interpretations | Accuracy is defined as the proportion of TTE studies for which the final cardiologist report is substantially different from the historical report (e.g., the rate of substantial change). We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventriuclar function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure). | 6 months |
| Accuracy Compared with Consensus Cardiologist Interpretations | Accuracy is defined as the proportion of TTE studies for which the consensus cardiologist report is substantially different from the preliminary report (e.g., the rate of substantial change). We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventriuclar function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure). | 6 months |
| Evaluation requiring two-grade change in valve disease severity as substantial change | Accuracy is defined asthe proportion of TTE studies for which the final cardiologist report is substantially different from the preliminary report (e.g., the rate of substantial change). We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventricular function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure).
| 6 months |
| Cardiologist Overread Time (Efficiency) | To assess whether AI-assisted interpretation saves time, the investigators will compare the mean time in seconds required for the cardiologist to complete the overreading process across the three arms (i.e., TTE interpretation workflows) in our trial. Specifically, we will perform the following comparisons:
| 6 months |
| Comparison of Existing Standards of Care (Sonographer-Assisted vs Cardiologist-Only) | The investigators will measure the proportion of TTE studies for which the final cardiologist report is substantially different from the preliminary report (e.g., the rate of substantial change) in sonographer-prelim and cardiologist-prelim arms. We define a TTE report to be substantially different from another TTE interpretation if any of its key elements are substantially different (LVEF, right ventricular function, chamber size, valvular regurgitation severity, valvular stenosis severity, and right ventricular systolic pressure). | 6 months |
| Blinding | In each of the arms, at the completion of each study for the final cardiologist assessment, the cardiologist will be asked to guess whether the preliminary assessment was AI or human. This will be used to calculate a blinding index comparing the AI-prelim arm vs. a composite of the two standard of care arms, as well as comparing the AI-prelim arm with the sonographer-prelim arm individually and comparing the AI-prelim arm with the cardiologist-prelim arm individually. | 6 months |