Liu Guina, Li Nian, Chen Lingmin, Yang Yi, Zhang Yonggang
Department of Periodical Press and National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, China.
West China School of Medicine, Sichuan University, Chengdu, China.
Front Med (Lausanne). 2021 Mar 24;8:634197. doi: 10.3389/fmed.2021.634197. eCollection 2021.
Clinical trials contribute to the development of clinical practice. However, little is known about the current status of trials on artificial intelligence (AI) conducted in emergency department and intensive care unit. The objective of the study was to provide a comprehensive analysis of registered trials in such field based on ClinicalTrials.gov. Registered trials on AI conducted in emergency department and intensive care unit were searched on ClinicalTrials.gov up to 12th January 2021. The characteristics were analyzed using SPSS21.0 software. A total of 146 registered trials were identified, including 61 in emergency department and 85 in intensive care unit. They were registered from 2004 to 2021. Regarding locations, 58 were conducted in Europe, 58 in America, 9 in Asia, 4 in Australia, and 17 did not report locations. The enrollment of participants was from 0 to 18,000,000, with a median of 233. Universities were the primary sponsors, which accounted for 43.15%, followed by hospitals (35.62%), and industries/companies (9.59%). Regarding study designs, 85 trials were interventional trials, while 61 were observational trials. Of the 85 interventional trials, 15.29% were for diagnosis and 38.82% for treatment; of the 84 observational trials, 42 were prospective, 14 were retrospective, 2 were cross-sectional, 2 did not report clear information and 1 was unknown. Regarding the trials' results, 69 trials had been completed, while only 10 had available results on ClinicalTrials.gov. Our study suggest that more AI trials are needed in emergency department and intensive care unit and sponsors are encouraged to report the results.
临床试验有助于临床实践的发展。然而，对于急诊科和重症监护病房开展的人工智能（AI）试验的现状却知之甚少。本研究的目的是基于ClinicalTrials.gov对该领域已注册的试验进行全面分析。截至2021年1月12日，在ClinicalTrials.gov上搜索了在急诊科和重症监护病房开展的关于AI的已注册试验。使用SPSS21.0软件对其特征进行分析。共识别出146项已注册试验，其中61项在急诊科，85项在重症监护病房。它们于2004年至2021年期间注册。关于地点，58项在欧洲开展，58项在美国开展，9项在亚洲开展，4项在澳大利亚开展，17项未报告地点。参与者的招募人数从0到1800万，中位数为233。大学是主要赞助商，占43.15%，其次是医院（35.62%）和行业/公司（9.59%）。关于研究设计，85项试验为干预性试验，61项为观察性试验。在85项干预性试验中，15.29%用于诊断，38.82%用于治疗；在84项观察性试验中，42项为前瞻性试验，14项为回顾性试验，2项为横断面试验，2项未报告明确信息，1项情况不明。关于试验结果，69项试验已完成，但在ClinicalTrials.gov上只有10项有可用结果。我们的研究表明，急诊科和重症监护病房需要更多的AI试验，并鼓励赞助商报告结果。
