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Physician Diagnosis of Neurologic Cases With Large Language Models

Physician Diagnosis of Neurologic Cases Assisted by Large Language Models: A Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07344792
Enrollment
40
Registered
2026-01-15
Start date
2026-01-17
Completion date
2026-01-28
Last updated
2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurology

Brief summary

This study is a prospective randomized controlled trial that aims to evaluate whether large language model (LLM) assistance improves physicians' diagnostic performance compared with conventional assistance.

Detailed description

The study population consists of licensed physicians who have completed at least two years of neurology training. Participants are randomly assigned in a 1:1 ratio to the LLM assistance group or the conventional assistance group. In the LLM assistance group, physicians are assisted by an in-house LLM and are allowed to use conventional resources (e.g., search engines, UpToDate, or clinical guidelines) before submitting a final diagnosis. Access to any other LLMs is not permitted. In the conventional assistance group, physicians use only conventional resources and do not have access to the in-house LLM or any other LLMs at any point during the study. The primary outcome is top-1 diagnostic accuracy. Secondary outcomes include top-3 diagnostic accuracy, the time required to complete each case, and physicians' diagnostic confidence.

Interventions

OTHERLLM assistance

Physicians are assisted by an in-house large language model and are allowed to use conventional resources. Access to any other LLMs is not permitted.

Sponsors

Capital Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Licensed physicians who have completed at least two years of neurology training. * Willing to participate in the study and able to provide written informed consent.

Exclusion criteria

* Physicians who have previously participated in the development of the in-house LLM or the construction of datasets used in this study. * Physicians who were involved in the clinical care of patients whose cases were used to construct the case dataset for this study. * Physicians who are known to have previously reviewed or been exposed to the specific cases used in this study.

Design outcomes

Primary

MeasureTime frameDescription
Top-1 diagnostic accuracyBaselineTop-1 diagnosis is considered correct if the physician's final top-ranked diagnosis matches the reference diagnosis or a clinically similar diagnosis judged as equivalent by neurologists.

Secondary

MeasureTime frameDescription
Diagnostic confidenceBaselinePhysicians' diagnostic confidence will be measured using a five-point Likert scale (1=very unsure, 5=very sure).
Top-3 diagnostic accuracyBaselineTop-3 diagnosis is considered correct if the reference diagnosis or a clinically similar diagnosis judged as equivalent by neurologists appears among the physician's top three final diagnoses.
Time spent on diagnosisBaselineTime participants spend per case.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026