人工智能在临床实践中的随机对照试验：系统评价。
Randomized Controlled Trials of Artificial Intelligence in Clinical Practice: Systematic Review.
机构信息
The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong, Hong Kong.
Stanley Ho Big Data Decision Analytics Research Centre, The Chinese University of Hong Kong., Hong Kong, Hong Kong.
出版信息
J Med Internet Res. 2022 Aug 25;24(8):e37188. doi: 10.2196/37188.
BACKGROUND
The number of artificial intelligence (AI) studies in medicine has exponentially increased recently. However, there is no clear quantification of the clinical benefits of implementing AI-assisted tools in patient care.
OBJECTIVE
This study aims to systematically review all published randomized controlled trials (RCTs) of AI-assisted tools to characterize their performance in clinical practice.
METHODS
CINAHL, Cochrane Central, Embase, MEDLINE, and PubMed were searched to identify relevant RCTs published up to July 2021 and comparing the performance of AI-assisted tools with conventional clinical management without AI assistance. We evaluated the primary end points of each study to determine their clinical relevance. This systematic review was conducted following the updated PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines.
RESULTS
Among the 11,839 articles retrieved, only 39 (0.33%) RCTs were included. These RCTs were conducted in an approximately equal distribution from North America, Europe, and Asia. AI-assisted tools were implemented in 13 different clinical specialties. Most RCTs were published in the field of gastroenterology, with 15 studies on AI-assisted endoscopy. Most RCTs studied biosignal-based AI-assisted tools, and a minority of RCTs studied AI-assisted tools drawn from clinical data. In 77% (30/39) of the RCTs, AI-assisted interventions outperformed usual clinical care, and clinically relevant outcomes improved with AI-assisted intervention in 70% (21/30) of the studies. Small sample size and single-center design limited the generalizability of these studies.
CONCLUSIONS
There is growing evidence supporting the implementation of AI-assisted tools in daily clinical practice; however, the number of available RCTs is limited and heterogeneous. More RCTs of AI-assisted tools integrated into clinical practice are needed to advance the role of AI in medicine.
TRIAL REGISTRATION
PROSPERO CRD42021286539; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=286539.
背景
最近，医学领域的人工智能（AI）研究数量呈指数级增长。然而，目前尚不清楚在患者护理中实施 AI 辅助工具的临床获益。
目的
本研究旨在系统综述所有已发表的 AI 辅助工具的随机对照试验（RCT），以描述其在临床实践中的表现。
方法
检索 CINAHL、Cochrane 中央、Embase、MEDLINE 和 PubMed，以确定截至 2021 年 7 月发表的相关 RCT，并比较 AI 辅助工具与没有 AI 辅助的常规临床管理的性能。我们评估了每项研究的主要终点，以确定其临床相关性。本系统评价遵循更新的 PRISMA（系统评价和荟萃分析的首选报告项目）2020 指南进行。
结果
在检索到的 11839 篇文章中，仅纳入 39 项（0.33%）RCT。这些 RCT 分别来自北美、欧洲和亚洲，分布大致均衡。AI 辅助工具应用于 13 个不同的临床专业。大多数 RCT 发表于胃肠病学领域，有 15 项研究涉及 AI 辅助内镜。大多数 RCT 研究的是基于生物信号的 AI 辅助工具，少数 RCT 研究的是来自临床数据的 AI 辅助工具。在 77%（30/39）的 RCT 中，AI 辅助干预优于常规临床护理，在 70%（21/30）的研究中，AI 辅助干预改善了临床相关结局。样本量小和单中心设计限制了这些研究的推广。
结论
越来越多的证据支持在日常临床实践中实施 AI 辅助工具；然而，可用的 RCT 数量有限且存在异质性。需要更多将 AI 辅助工具纳入临床实践的 RCT，以推进 AI 在医学中的作用。
试验注册
PROSPERO CRD42021286539；https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=286539。
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