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

doi:10.12114/j.issn.1007-9572.2023.0668

Chinese General Practice ›› 2024, Vol. 27 ›› Issue (10): 1267-1270.DOI: 10.12114/j.issn.1007-9572.2023.0668

Special Issue: 数智医疗最新文章合辑

• Digital and Smart Healthcare & Informationization • Previous Articles Next Articles

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

1. West China Medical Publishers of West China Hospital, Sichuan University, Chengdu 610041, China
2. Clinical Trials Center for Artificial Intelligence Medical Device, West China Hospital, Sichuan University, Chengdu 610041, China
3. Medical Device Regulatory Research and Evaluation Center, West China Hospital, Sichuan University, Chengdu 610041, China
4. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China

Received:2023-10-09 Revised:2023-10-13 Published:2024-04-05 Online:2024-01-25
Contact: LIU Xuemei

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

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人工智能医疗器械临床试验中心
3．610041　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
4．610041　四川省成都市，四川大学华西医院中国循证医学中心

通讯作者: 刘雪梅
作者简介:
作者贡献：雷芳负责论文的构思与设计、初稿撰写；杜亮负责论文修订、质量控制及审校；董敏负责资料收集与整理、论文修改；刘雪梅负责论文设计与修改，对文章整体负责。
基金资助:
国家自然科学基金资助项目(72074161)

Abstract

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.

Key words: Artificial intelligence, Decision support systems, clinical, Early-stage clinical evaluation, DECIDE-AI, Transparency

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。

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

LEI Fang,DU Liang,DONG Min, et al. Transparent Reporting of the Early-stage Clinical Evaluation of Clinical Decision Support Systems Based on Artificial Intelligence[J]. Chinese General Practice, 2024, 27(10): 1267-1270. DOI: 10.12114/j.issn.1007-9572.2023.0668.
雷芳,杜亮,董敏等. 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[J]. 中国全科医学, 2024, 27(10): 1267-1270. DOI: 10.12114/j.issn.1007-9572.2023.0668.

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

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

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