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NCT Number: NCT07414966

Scalable Clinical Oversight of Large Language Models Via Uncertainty Triangulation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Board-certified or in-training cardiologists at Fuwai Hospital
  • Spanning three experience strata: junior residents, senior residents, attending physicians

Exclusion criteria

  • Clinicians involved in the development or optimization of the SCOUT framework
  • Clinicians involved in the gold-standard adjudication process

Treatment and study plan

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.

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.

Primary outcomes

  1. Mean physician review time per case (minutes)

    Time frame: Through study completion, an average of 2 hours.

    Mean time spent by each clinician reviewing and rendering a diagnostic decision per case under each arm. Measured in minutes.

Secondary outcomes

  1. Diagnostic accuracy (%)

    Time frame: Through study completion, an average of 2 hours.

    Proportion of correct CHD subtype classifications (STEMI, NSTEMI, unstable angina, chronic coronary syndromes) under each arm.

  2. Computational Return on Investment (ROI)

    Time frame: Through study completion, an average of 2 hours.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaojin Gao, Dr.

CONTACT

[email protected]

+86 010 88322415

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

Prospective Evaluation of a Model-Agnostic Meta-Verification Framework (SCOUT) for Scalable Clinical Oversight of Large Language Model Outputs in Coronary Heart Disease Diagnosis: A Multi-Reader, Randomized, Crossover Trial

Acronym: SCOUT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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