首页|基于人工智能的临床辅助决策系统早期临床评价研究的报告规范(DECIDE-AI)解读

基于人工智能的临床辅助决策系统早期临床评价研究的报告规范(DECIDE-AI)解读

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近年来人工智能在医疗服务领域应用愈发广泛,基于人工智能的临床决策辅助系统是其主要应用形式之一.基于人工智能临床决策辅助系统的早期临床评价介于临床前开发(计算机模拟)、离线验证和临床试验之间,但目前少有人工智能相关临床研究涉及人因学评价,且缺少与人工智能系统运行环境、用户特征、选择过程及算法识别等方面的报告.为缩小人工智能辅助决策系统在开发与实际临床应用间的差距,提高人工智能系统临床研究的透明性和规范性,2022年,BMJ发表了基于人工智能的临床辅助决策系统早期临床评价研究的报告规范(DECIDE-AI).本文就指南的制订背景、制订过程和重点内容进行解读,以期促进该报告规范在国内研究人员中的理解与应用.
Interpretation of the DECIDE-AI guideline:a reporting guideline for the early-stage clinical evaluation of decision support systems driven by artificial intelligence
Artificial intelligence has been extensively applied in healthcare services recently,and clinical decision support systems driven by artificial intelligence are one of the applications.Early-stage clinical evaluation of artificial intelligence(AI)-based clinical decision support systems lies between preclinical development(in silico),offline validation,and large-scale trials,but few AI-related clinical studies have addressed human factors evaluations and reported the implementation environment,user characteristics,selection process and algorithm identification of AI systems.In order to bridge the development-to-implementation gap in clinical artificial intelligence and to promote the transparent and standardized reporting of early-stage clinical studies of AI-based decision support systems.A reporting guideline for the developmental and exploratory clinical investigations of decision support systems driven by artificial intelligence(DECIDE-AI)was published in 2022.This paper aimed to interpret the background,development process and key items of the DECIDE-AI guideline and promote its understanding as well as dissemination in China.

Reporting guidelineArtificial intelligenceDecision support systemsEarly-stage clinical evaluationInterpretation

陈泞夙、赵凯、薛心雨、齐亚娜、喻佳洁

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四川大学华西医院临床营养科(成都 610041)

四川大学华西医院临床流行病学与循证医学研究中心/中国循证医学中心(成都 610041)

报告规范 人工智能 辅助决策系统 早期临床评价 解读

四川省自然科学基金项目

2023NSFC0520

2024

中国循证医学杂志
四川大学

中国循证医学杂志

CSTPCD北大核心
影响因子:1.761
ISSN:1672-2531
年,卷(期):2024.24(9)
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