CTEPH Differential Diagnosis Assisted by Enhanced Large Language Model Support

Condition(s) studied

Investigational drug(s) / intervention(s)

Locked CTEPH-LLM Diagnostic Decision Support: A locked LLM-based decision support system will process the same staged clinical information reviewed by participating clinicians. For each case and stage, the system will display a pre-generated Top-1 diagnosis among CTEPH, acute PE, and PAS; key evidence supporting and opposing that diagnosis; and a referral recommendation. Before randomization, the model name and version, call date, system and user prompts, input fields, context organization, sampling parameters, output format, risk thresholds, and all case-stage outputs will be locked. Outputs will not be selected, repeated, or modified on the basis of participant responses during the study.

Study summary

This randomized controlled trial aims to evaluate whether a locked large language model (LLM)-based clinical decision support system improves the differential diagnosis of pulmonary artery filling defects among physicians who do not specialize in pulmonary vascular diseases. Participants will evaluate 30 de-identified clinical cases involving chronic thromboembolic pulmonary hypertension (CTEPH), acute pulmonary embolism (PE), and pulmonary artery sarcoma (PAS), with or without LLM assistance. The primary outcome is sensitivity for identifying CTEPH, while secondary outcomes include overall diagnostic accuracy, time to diagnosis, appropriateness of referral recommendations, and AI-related diagnostic errors.

Eligibility

Primary outcome measure(s)

• Stage 4 CTEPH Identification Sensitivity — At completion of Stage 4 for each case, within 14 days after the clinician's first formal case-reading session
  The proportion of evaluable physician-case judgments for the 10 reference-standard CTEPH cases in which the physician's final Top-1 diagnosis after Stage 4 is CTEPH. The numerator is the number of correct CTEPH identifications and the denominator is the number of evaluable Stage 4 judgments for CTEPH cases. The between-group comparison will account for clustering by physician and case.
• Stage 4 Three-Class Top-1 Diagnostic Accuracy — During the two formal case-reading sessions, completed within 14 days after the first session
  The proportion of evaluable Stage 4 physician-case judgments in which the clinician's Top-1 diagnosis matches the reference diagnosis among CTEPH, acute PE, and PAS.

Trial sites (1)

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