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

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, saf...

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Main Author: LEI Fang, DU Liang, DONG Min, LIU Xuemei
Format: Article
Language:zho
Published: Chinese General Practice Publishing House Co., Ltd 2024-04-01
Series:Zhongguo quanke yixue
Subjects:
Online Access:https://www.chinagp.net/fileup/1007-9572/PDF/20230668.pdf
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author LEI Fang, DU Liang, DONG Min, LIU Xuemei
author_facet LEI Fang, DU Liang, DONG Min, LIU Xuemei
author_sort LEI Fang, DU Liang, DONG Min, LIU Xuemei
collection DOAJ
description 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.
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spelling doaj.art-0da0d71fb0a74631a94fd6a186f7b08f2024-04-09T09:17:35ZzhoChinese General Practice Publishing House Co., LtdZhongguo quanke yixue1007-95722024-04-0127101267127010.12114/j.issn.1007-9572.2023.0668Transparent Reporting of the Early-stage Clinical Evaluation of Clinical Decision Support Systems Based on Artificial IntelligenceLEI Fang, DU Liang, DONG Min, LIU Xuemei01. 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, ChinaWith 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.https://www.chinagp.net/fileup/1007-9572/PDF/20230668.pdfartificial intelligence|decision support systems, clinical|early-stage clinical evaluation|decide-ai|transparency
spellingShingle LEI Fang, DU Liang, DONG Min, LIU Xuemei
Transparent Reporting of the Early-stage Clinical Evaluation of Clinical Decision Support Systems Based on Artificial Intelligence
Zhongguo quanke yixue
artificial intelligence|decision support systems, clinical|early-stage clinical evaluation|decide-ai|transparency
title Transparent Reporting of the Early-stage Clinical Evaluation of Clinical Decision Support Systems Based on Artificial Intelligence
title_full Transparent Reporting of the Early-stage Clinical Evaluation of Clinical Decision Support Systems Based on Artificial Intelligence
title_fullStr Transparent Reporting of the Early-stage Clinical Evaluation of Clinical Decision Support Systems Based on Artificial Intelligence
title_full_unstemmed Transparent Reporting of the Early-stage Clinical Evaluation of Clinical Decision Support Systems Based on Artificial Intelligence
title_short Transparent Reporting of the Early-stage Clinical Evaluation of Clinical Decision Support Systems Based on Artificial Intelligence
title_sort transparent reporting of the early stage clinical evaluation of clinical decision support systems based on artificial intelligence
topic artificial intelligence|decision support systems, clinical|early-stage clinical evaluation|decide-ai|transparency
url https://www.chinagp.net/fileup/1007-9572/PDF/20230668.pdf
work_keys_str_mv AT leifangduliangdongminliuxuemei transparentreportingoftheearlystageclinicalevaluationofclinicaldecisionsupportsystemsbasedonartificialintelligence