跳至主要内容
临床试验/NCT07766863
NCT07766863招募中不适用

Evaluation of AI Support for Differential Diagnosis in Emergency Medicine.

Region Stockholm1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
The proportion of physicians' differential diagnosis that change, in terms of the number of correct diagnoses, when they have access to AI-assisted differential diagnosis

研究概览

简要总结

The purpose of this study is to investigate whether the use of generative artificial intelligence (AI) as a support tool can improve physicians' ability to establish accurate differential diagnoses in emergency care.

The main questions it aims to answer are:

  • Is AI-assisted differential diagnosis more accurate than the differential diagnosis performed by physicians?
  • Does physicians' differential diagnosis change - in terms of the number of correct diagnoses - when they have access to AI-assisted differential diagnosis?

详细描述

The study is based on a prospective cohort of patients admitted through the emergency departments at Karolinska University Hospital in Huddinge and Solna. After completion of the hospital length of stay, excerpts from the medical record are collected according to a predefined variable list and used to create case descriptions corresponding to the information available at the initial assessment. Within this cohort, physicians will be randomized to evaluate patient cases either with or without AI support. The AI tool generates a structured list of likely differential diagnoses. Differential diagnoses proposed by physicians, AI alone, and physicians using AI support will be compared with the clinically established final diagnosis in the discharge summary. In a pilot material, the AI support has shown good agreement with final diagnoses and expert clinical assessment.

The results will be analyzed to assess AI's impact on physicians' diagnostic accuracy and decision-making in various scenarios and case presentations.

Given known challenges in diagnosing complex patients, the study is designed to account for variations in information quality and clinical complexity. Patient cases are presented in a standardized format, and it will be documented how much and what type of information is available in each case, such as symptoms, clinical findings, laboratory results, and disease progression. The analysis focuses on how this may affect the diagnostic suggestions. Difficult-to-diagnose cases are also included to clarify in which clinical situations the decision-support tool is useful, when it is not, and what informational requirements need to be met ahead of a future implementation study evaluating the impact of real-time AI support during the management of acutely ill patients.

There is a lack of large clinical studies that systematically evaluate how generative AI affects physicians' differential diagnostic performance in emergency medicine when used as a complement to clinical judgment. This project addresses this knowledge gap by examining the extent to which AI-generated differential diagnoses align with physicians' assessments and whether access to AI support can improve diagnostic precision.

The results will provide evidence on how AI-based decision support should be evaluated and potentially implemented within emergency care.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients >18 years admitted through the emergency departments at Karolinska University Hospital in Huddinge and Solna.

排除标准

  • Children <18 years
  • Patients without a recorded final diagnosis

结局指标

主要结局

The proportion of physicians' differential diagnosis that change, in terms of the number of correct diagnoses, when they have access to AI-assisted differential diagnosis

时间窗: After discharge from the hospital

This is meassured after the patient has been discharged from the hospital

The proportion of cases in which the final diagnosis is ranked highest by the physician and by the AI support, respectively

时间窗: At discharge from the hospital

Considering the final diagnosis after discharge from the hospital.

次要结局

未报告次要终点

研究者

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

Maria Ygland Rodstrom

Specialist in Emergency Medicine, PI, PhD

Region Stockholm

研究点 (1)

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