首页|基于人工智能的临床决策支持系统早期临床评估的透明化报告

基于人工智能的临床决策支持系统早期临床评估的透明化报告

Transparent Reporting of the Early-stage Clinical Evaluation of Clinical Decision Support Systems Based on Artificial Intelligence

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随着人工智能(AI)在医学领域的广泛应用,越来越多基于AI的临床决策支持系统应用于临床诊断与筛查等.早期临床评估对于评价基于AI临床决策支持系统的临床性能、安全性和人为因素具有重要意义,有利于为进一步的大规模临床试验奠定基础,但相关临床研究报告的透明度和完整性尚待提高.2022 年 5 月,基于AI的临床决策支持系统早期临床评估报告指南(DECIDE-AI)正式在线发表.本文将结合DECIDE-AI中的AI相关报告项目及相关文献,探讨基于AI的临床决策支持系统早期临床评估的透明化报告,以期帮助我国系统开发者和研究者更好地理解与应用相关指南,提高基于AI的临床决策支持系统早期临床评估报告的透明度.
With the wide application of artificial intelligence(AI)in the medical field,more and more AI-based clinical decision support systems have been applied in the clinical diagnosis,screening,and other fields.Early-stage clinical evaluation is important for evaluating the clinical performance,safety,and human factors of AI-based clinical decision support systems,and laying the foundation for large-scale trials.However,the transparency and integrity of the clinical reports need to be improved.The Developmental and Exploratory Clinical Investigations of DEcision Support Systems Driven by Artificial Intelligence(DECIDE-AI)was officially published online in May 2022.Based on this guideline and relative literature,this paper explores the transparent reporting of early-stage clinical evaluation of AI-based clinical decision support systems,in order to help developers and researchers better understand and apply the relevant guidelines,and improve the reporting transparency of early-stage clinical evaluation of AI-based clinical decision support systems.

Artificial intelligenceDecision support systems,clinicalEarly-stage clinical evaluationDECIDE-AITransparency

雷芳、杜亮、董敏、刘雪梅

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610041 四川省成都市,四川大学华西医院华西医学期刊出版社

610041 四川省成都市,四川大学华西医院华西人工智能医疗器械临床试验中心

610041 四川省成都市,四川大学华西医院医疗器械监管研究与评价中心

610041 四川省成都市,四川大学华西医院中国循证医学中心

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人工智能 决策支持系统,临床 早期临床评估 DECIDE-AI 透明化

国家自然科学基金

72074161

2024

中国全科医学
中国医院协会

中国全科医学

CSTPCD北大核心
影响因子:2.04
ISSN:1007-9572
年,卷(期):2024.27(10)
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