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This prospective, multi-reader, randomized crossover trial evaluates SCOUT (Scalable Clinical Oversight via Uncertainty Triangulation), a model-agnostic meta-verification framework that selectively defers unreliable large language model (LLM) predictions to clinicians by triangulating three orthogonal uncertainty signals: model heterogeneity, stochastic inconsistency, and reasoning critique. The trial assesses whether SCOUT-assisted review can reduce physician review time compared with standard manual review of AI-generated diagnoses while maintaining non-inferior diagnostic accuracy in coronary heart disease (CHD) subtyping.
Background: Large language models are increasingly deployed in clinical workflows, yet requiring clinician review of every AI output negates the efficiency gains that motivate their adoption. SCOUT addresses this efficiency-safety paradox through algorithmic meta-verification.
The SCOUT framework triangulates three orthogonal external signals to determine case-level uncertainty: (1) Model Heterogeneity - whether a structurally different auxiliary LLM agrees with the primary model; (2) Stochastic Inconsistency - whether repeated sampling from the same model yields divergent outputs; (3) Reasoning Critique - whether an external checker model identifies logical flaws in the chain-of-thought reasoning.
In this crossover trial, 7 clinicians of varying seniority (2 junior residents, 3 senior residents, 2 attending physicians) each review all 110 cases under both standard manual review and SCOUT-assisted review workflows. The study evaluates workflow efficiency (primary endpoint) and diagnostic accuracy (secondary endpoint).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (Standard Manual Review) | Active Comparator | Physicians manually review all cases in the control set (n=54) with access to AI predictions and reasoning. No selective deferral. |
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| Experimental (SCOUT-Assisted Review) | Experimental | Physicians process the intervention set (n=56) through the SCOUT framework. Low-uncertainty cases are auto-accepted; high-uncertainty cases undergo physician review with full audit trail. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCOUT-Assisted Review Workflow | Diagnostic Test | SCOUT-Assisted Review (Intervention Arm): Physicians review 56 cases processed through the SCOUT framework. For cases classified as low-uncertainty (D(x)=0), the AI prediction is auto-accepted without physician review. For high-uncertainty cases (D(x)=1), the physician reviews the case with access to the main model's chain-of-thought reasoning and the meta-verification audit results. The main model is DeepSeek-V3.1 with chain-of-thought prompting. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean physician review time per case (minutes) | Mean time spent by each clinician reviewing and rendering a diagnostic decision per case under each arm. Measured in minutes. | Through study completion, an average of 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy (%) | Proportion of correct CHD subtype classifications (STEMI, NSTEMI, unstable angina, chronic coronary syndromes) under each arm. | Through study completion, an average of 2 hours. |
| Computational Return on Investment (ROI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojin Gao, Dr. | Contact | +86 010 88322415 | sophie_gao@sina.com |
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De-identified individual participant data underlying the results reported in this study will be made available.
Beginning 1 months after publication of the primary results and available for up to 60 months.
Data are available from the corresponding author upon reasonable request. Requestors will need to provide a methodologically sound research proposal and sign a data use agreement.
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Standard Manual Review Workflow | Diagnostic Test | Physicians perform a full manual review of 54 cases using raw medical records with access to the AI model's predictions and reasoning, but without SCOUT uncertainty stratification or selective deferral. |
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Ratio of physician time savings (valued at standardized minute-wages from Sanming healthcare reform benchmarks) to computational cost of SCOUT inference, stratified by clinician seniority level.
| Through study completion, an average of 2 hours. |