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临床试验/NCT06774612
NCT06774612已完成不适用

Diagnostic Reasoning With and Without AI Support: A Randomized Controlled Trial of LLM-Trained Medical Doctors

Lahore University of Management Sciences2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Diagnostic reasoning

研究概览

简要总结

This study aims to evaluate whether large language model-trained medical doctors demonstrate enhanced diagnostic reasoning performance when utilizing ChatGPT-4o alongside conventional resources compared to using conventional resources alone.

详细描述

Diagnostic errors are a major source of preventable patient harm. Recent advances in Large Language Models (LLM), particularly ChatGPT-4o, have shown promise in enhancing medical decision-making. However, little is known about their impact on medical doctors' (e.g., physicians' and surgeons') diagnostic reasoning.

Diagnostic accuracy relies on complex clinical reasoning and careful evaluation of patient data. While AI assistance could potentially reduce errors and improve efficiency, ChatGPT-4o lacks medical validation and could introduce new risks through incorrect information generation (also known as hallucinations). To mitigate these risks, doctors need adequate training in understanding ChatGPT-4o's capabilities, limitations, and proper usage. Given these uncertainties and the importance of proper AI training, systematic evaluation is essential before clinical implementation.

This randomized study will assess whether ChatGPT-4o access improves LLM-trained medical doctors' diagnostic performance compared to conventional resources (e.g., textbooks, online medical databases) alone. All participating doctors will have completed at least a 10-hour training program covering ChatGPT-4o usage, prompt engineering techniques, and output evaluation strategies. Participants will provide differential diagnoses with supporting evidence and recommended next steps for clinical cases, with responses evaluated by blinded reviewers.

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
None

盲法说明

Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Full or Provisionally Registered Medical Practitioners with the Pakistan Medical and Dental Council (PMDC).
  • Completed Bachelor of Medicine, Bachelor of Surgery (MBBS) Exam. The equivalent degree of MBBS in US and Canada is called Doctor of Medicine (MD).
  • Participants must have completed a structured training program on the use of ChatGPT (or a comparable large language model), totaling at least 10 hours of instruction. The program must include hands-on practice related to LLM's aspects, specifically prompt engineering and content evaluation.

排除标准

  • Any other Registered Medical Practitioners (Full or Provisional) with PMDC (e.g., Professionals with Bachelor of Dental Surgery or BDS).

结局指标

主要结局

Diagnostic reasoning

时间窗: Assessed at a single time point for each case, during the scheduled diagnostic reasoning evaluation session, which takes place between 0-4 days after participant enrollment.

The primary outcome will be the percent correct for each case (range: 0 to 100). For each case, participants will be asked for three top diagnoses, findings from the case that support that diagnosis, and findings from the case that oppose that diagnosis. For each plausible diagnosis, participants will receive 1 point. Findings supporting the diagnosis and findings opposing the diagnosis will also be graded based on correctness, with 1 point for partially correct and 2 points for completely correct responses. Participants will then be asked to name their top diagnosis, earning one point for a reasonable response and two points for the most correct response. Finally participants will be asked to name up to 3 next steps to further evaluate the patient with one point awarded for a partially correct response and two points for a completely correct response. The primary outcome will be compared on the case-level by the randomized groups.

次要结局

  • Time Spent on Diagnosis(Assessed at a single time point for each case, during the scheduled diagnostic reasoning evaluation session, which takes place between 0-4 days after participant enrollment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ihsan Ayyub Qazi, PhD

Associate Professor, PhD

Lahore University of Management Sciences

研究点 (2)

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