跳至主要内容
临床试验/NCT07166692
NCT07166692尚未招募不适用

Evaluation of a Retrieval Augmented Large Language Model as a Diagnostic Copilot in Rheumatology

Philipps University Marburg2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年10月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
82
试验地点
2
主要终点
Diagnostic accuracy of top diagnosis

研究概览

简要总结

This trial evaluates whether providing physicians with access to Prof. Valmed, a clinical decision support medical product, improves identification of rheumatic diseases and formulation of differential diagnoses compared with conventional decision support.

详细描述

Advanced AI, particularly large language models, shows promise for enhancing clinical reasoning, yet most systems such as ChatGPT are not certified as medical products. Prof. Valmed is a clinical decision support medical product designed to assist physicians in diagnostic decision making. Given frequent referral problems and diagnostic delays in rheumatology, evaluating such support is highly relevant for clinical workflows.

This randomized controlled trial will test whether access to Prof. Valmed improves physicians' diagnostic performance in cases of suspected rheumatic disease compared with conventional decision support. Participants will be randomized to either use Prof. Valmed or rely on conventional tools while working through standardized clinical cases. For each case, participants will submit up to three differential diagnoses and a confidence rating. Independent reviewers, blinded to group allocation, will adjudicate accuracy. Findings will clarify the benefits and limitations of integrating Prof. Valmed into routine practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

The evaluation of responses will be performed by assessors blinded to participant identity and treatment assignment.

入排标准

性别
All
接受健康志愿者

入选标准

  • Participants must be licensed physicians.
  • Training in rheumatology, internal medicine, emergency medicine, family medicine, dermatology or orthopedics.

排除标准

  • Not currently practicing clinically.

结局指标

主要结局

Diagnostic accuracy of top diagnosis

时间窗: directly (within 10 minutes) after Intervention

Participants in each group will make at least one disease suggestion (top diagnosis) and up to a total of a maximum of 3 suggestions. Percentage of exact matches of the top suggestion with the actual diagnosis will be analyzed

次要结局

  • Diagnostic accuracy of top 3 suggestions(directly (within 10 minutes) after Intervention)
  • Diagnostic confidence(directly (within 10 minutes) after Intervention)
  • Time spent for diagnosis(directly (within 10 minutes) after Intervention)
  • Perceived Information Timeliness(directly (within 10 minutes) after Intervention)
  • Perceived diagnostic support quality(directly (within 10 minutes) after Intervention)
  • Diagnostic reasoning(during evaluation)

研究者

发起方
Philipps University Marburg
申办方类型
Other
责任方
Sponsor

研究点 (2)

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