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临床试验/NCT07374926
NCT07374926
已完成
不适用

The Big Unknown: A Journey Into Generative AI's Transformative Effect on Meical Professions

Maastricht University3 个研究点 分布在 3 个国家目标入组 249 人开始时间: 2024年8月1日最近更新:
干预措施GPT-4o

概览

阶段
不适用
状态
已完成
入组人数
249
试验地点
3
主要终点
Percentage Correct Score

概览

简要总结

A parallel group randomized controlled trial using a superiority framework. Clinical vignettes will be used to assess the impact of a large language model on the clinical reasoning of physicians. Quantitative analyses will be performed on graded vignette responses.

详细描述

This study is a multi-country, parallel-group randomized controlled trial designed to evaluate whether access to a large language model (LLM) improves physician clinical decision-making. The trial uses a superiority framework and compares physicians randomized to either complete standardized clinical vignettes with access to GPT-4o or without any AI assistance.

Clinical vignettes simulate common primary care conditions such as cardiovascular, respiratory, musculoskeletal, fatigue-related, and infectious diseases. Each vignette includes multiple steps in the clinical reasoning process, from initial history-taking to diagnosis, treatment, and follow-up. Physician responses are graded using rubrics developed from evidence-based, context-specific best-practice guidelines.

The study is conducted across three countries-Indonesia, Kenya, and the Netherlands-representing different income levels and health system contexts. The primary outcome is performance on clinical vignettes, defined as adherence to best-practice guidelines. Secondary objectives include examining cross-country variation in physician performance, variation in performance distributions, and the role of engagement with the LLM in shaping outcomes.

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)

入排标准

性别
All
接受健康志愿者

入选标准

  • Registered medical physicians
  • Training in internal or family medicine

排除标准

  • Not currently practicing clinically

研究组 & 干预措施

Own Knowlege

No Intervention

Group will not be given access to GPT-4 or other online resources

GPT-4o

Active Comparator

Group given GPT-4o access

干预措施: GPT-4o (Other)

结局指标

主要结局

Percentage Correct Score

时间窗: During Evaluation

Following Peabody et al (2000), the primary outcome is a percentage correct score across all steps in a vignette. This is generated by dividing the weighted total sum of rubric items assessed as present by the total number of rubric items possible in a vignette. Rubric items will be weighted with regards to their relevance by our expert panel.

次要结局

  • Quality Per Answer(During Evaluation)
  • Number of Answers(During evaluation)
  • Less obvious answers(During evaluation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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