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
雷芳 1杜亮 2董敏 1刘雪梅1
作者信息
- 1. 610041 四川省成都市,四川大学华西医院华西医学期刊出版社
- 2. 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
- 折叠
摘要
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.
Abstract
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.
关键词
人工智能/决策支持系统,临床/早期临床评估/DECIDE-AI/透明化Key words
Artificial intelligence/Decision support systems,clinical/Early-stage clinical evaluation/DECIDE-AI/Transparency引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
维普
万方数据