Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:59 AM
Study NCT ID:
NCT07414966
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scalable Clinical Oversight of Large Language Models Via Uncertainty Triangulation
Sponsor:
China National Center for Cardiovascular Diseases
Organization:
Study Overview
Official 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCOUT
Brief Summary:
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.
Detailed Description:
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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: