Skip to content

Evaluation of AI Large Models for Diagnosis and Treatment in Real-World Cases: Multicenter Retrospective Study

Evaluation of AI Large Models for Diagnosis and Treatment in Real-World Cases: Multicenter Retrospective Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07378358
Enrollment
800
Registered
2026-01-30
Start date
2026-01-01
Completion date
2026-06-01
Last updated
2026-01-30

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

Conditions

Urologic Diseases

Keywords

Large Language Models, Urologic Diseases, Clinical Decision Support, Retrospective Study

Brief summary

This multicenter retrospective study aims to evaluate the diagnostic and therapeutic performance of three large language models-ChatGPT, Gemini and Deepseek-using 800 archived inpatient medical records from urology departments across four tertiary hospitals. The study will focus on the accuracy and applicability of these models in disease recognition, preliminary diagnosis and treatment recommendation generation, in order to explore their potential value and limitations in supporting clinical decision-making in real-world settings.

Interventions

OTHERLarge Language Model Assessment (ChatGPT, Gemini, DeepSeek)

De-identified inpatient medical records were retrospectively collected from the urology departments of four tertiary hospitals (200 cases per site, 800 in total). Each case included standardized clinical information such as demographics, chief complaint, history of present illness, past medical history, physical examination, laboratory and imaging findings, discharge diagnosis and treatment plan. To simulate the role of an AI system in a "first-visit physician" scenario, all diagnostic conclusions, differential diagnoses and treatment plans were removed before being input into the models. Three large language models (ChatGPT, Gemini and DeepSeek) were prompted with a standardized instruction: "Based on the above clinical information, provide your preliminary diagnosis, differential diagnoses and treatment recommendations." Each model generated outputs including (i) primary and secondary diagnoses, (ii) differential diagnosis lists with reasoning and (iii) preliminary treatment suggesti

Sponsors

First Affiliated Hospital of Fujian Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* The case data is sourced from the four hospitals involved in the study, with complete and authentic diagnosis and treatment records. * Patients must be 18 years or older, with no gender restrictions. * Complete medical records, including the following core information: patient' s basic information, present illness history, past medical history, physical examination, and auxiliary examinations (including laboratory and imaging tests). * A clear discharge diagnosis and treatment plan (including therapeutic measures and follow-up arrangements). * Medical records have been archived, with objective and accurate information that has not been altered. * The patient or their legal representative has provided informed consent, agreeing to the use of their anonymized medical data for research analysis.

Exclusion criteria

* Medical records with significant missing information, such as key clinical details (present illness history, diagnostic or treatment records, etc.). * Cases where the diagnosis or treatment plan is unclear, or where treatment has not been fully completed for an initial diagnosis. * Cases where the primary diagnosis is not urological. * Cases with major errors or inconsistencies in the records that could affect further assessment. * Medical records in special formats or images that are not readable (e.g., handwritten notes, non-standard documentation). * Patients who have not signed the informed consent form or who refuse to allow their medical data to be used for research.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Accuracy: Assessed by Top-1 accuracyThrough study completion, an average of 3 monthsTop-1: Proportion of cases where the model's first diagnosis matches the true primary diagnosis.
Diagnostic Accuracy: Assessed by Top-3 accuracyThrough study completion, an average of 3 monthsTop-3: Proportion of cases where the true diagnosis appears in the model's top 3.
Diagnostic CompletenessThrough study completion, an average of 3 monthsProportion of the model's diagnoses that overlap with all diagnoses (primary and secondary) in the case.
Differential Diagnosis QualityThrough study completion, an average of 3 monthsEvaluated by experts using a Likert 5-point scale, considering factors like common disease coverage, logical clarity, and specificity
Treatment Plan QualityThrough study completion, an average of 3 monthsAssesses whether the model's treatment suggestions align with clinical guidelines, scored by experts on completeness, appropriateness, and safety.
Analysis TimeThrough study completion, an average of 3 months5.Time taken by the AI model to provide diagnoses and treatment suggestions (in seconds), reflecting real-time capability.

Countries

China

Contacts

CONTACTNing Xu
drxun@fjmu.edu.cn+86-13235907575

Outcome results

None listed

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