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Development and Evaluation of an Intelligent Simulated Patient System Based on Large Language Models for Gastroenterology History-Taking Education: A Prospective Randomized Controlled Trial

ClinicalTrials.gov · COMPLETED, 2026

90 participants

Abstract

This randomized controlled trial evaluated a large language model-based Intelligent Simulated Patient System (ISPS) for gastroenterology history-taking education. Ninety medical students were randomly assigned in a 1:1 ratio to 4 weeks of conventional clinical learning or ISPS-assisted training.

The ISPS used teacher-defined structured case information to support simulated patient interactions and generated item-level formative feedback using predefined scoring rubrics. The implemented system did not use external electronic health record retrieval, retrieval-augmented generation, a vector database, or semantic-similarity threshold scoring.

The primary outcomes were post-intervention medical history-taking performance and clinical diagnostic accuracy. History-taking performance was assessed in a standardized Objective Structured Clinical Examination by two senior physicians who were blinded to group allocation. Secondary outcomes included patient-centered communication competence and participants' acceptance of the ISPS.

Conditions: Medical Education, Clinical Competence, History Taking.

Primary outcome: Diagnostic accuracy; History-taking completeness score.

Enrollment: 90 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 90 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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