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一种支持长新冠患者临床管理的人工智能驱动数字健康解决方案:一项前瞻性多中心观察性研究方案

An Artificial Intelligence-Driven Digital Health Solution to Support Clinical Management of Patients With Long COVID-19: Protocol for a Prospective Multicenter Observational Study.

作者信息

Fuster-Casanovas Aïna, Fernandez-Luque Luis, Nuñez-Benjumea Francisco J, Moreno Conde Alberto, Luque-Romero Luis G, Bilionis Ioannis, Rubio Escudero Cristina, Chicchi Giglioli Irene Alice, Vidal-Alaball Josep

机构信息

Unitat de Suport a la Recerca a la Catalunya Central, Gerència Territorial de la Catalunya Central, Institut Català de la Salut, Sant Fruitós de Bages, Spain.

Adhera Health Inc, Palo Alto, CA, United States.

出版信息

JMIR Res Protoc. 2022 Oct 14;11(10):e37704. doi: 10.2196/37704.

Abstract

BACKGROUND

COVID-19 pandemic has revealed the weaknesses of most health systems around the world, collapsing them and depleting their available health care resources. Fortunately, the development and enforcement of specific public health policies, such as vaccination, mask wearing, and social distancing, among others, has reduced the prevalence and complications associated with COVID-19 in its acute phase. However, the aftermath of the global pandemic has called for an efficient approach to manage patients with long COVID-19. This is a great opportunity to leverage on innovative digital health solutions to provide exhausted health care systems with the most cost-effective and efficient tools available to support the clinical management of this population. In this context, the SENSING-AI project is focused on the research toward the implementation of an artificial intelligence-driven digital health solution that supports both the adaptive self-management of people living with long COVID-19 and the health care staff in charge of the management and follow-up of this population.

OBJECTIVE

The objective of this protocol is the prospective collection of psychometric and biometric data from 10 patients for training algorithms and prediction models to complement the SENSING-AI cohort.

METHODS

Publicly available health and lifestyle data registries will be consulted and complemented with a retrospective cohort of anonymized data collected from clinical information of patients diagnosed with long COVID-19. Furthermore, a prospective patient-generated data set will be captured using wearable devices and validated patient-reported outcomes questionnaires to complement the retrospective cohort. Finally, the 'Findability, Accessibility, Interoperability, and Reuse' guiding principles for scientific data management and stewardship will be applied to the resulting data set to encourage the continuous process of discovery, evaluation, and reuse of information for the research community at large.

RESULTS

The SENSING-AI cohort is expected to be completed during 2022. It is expected that sufficient data will be obtained to generate artificial intelligence models based on behavior change and mental well-being techniques to improve patients' self-management, while providing useful and timely clinical decision support services to health care professionals based on risk stratification models and early detection of exacerbations.

CONCLUSIONS

SENSING-AI focuses on obtaining high-quality data of patients with long COVID-19 during their daily life. Supporting these patients is of paramount importance in the current pandemic situation, including supporting their health care professionals in a cost-effective and efficient management of long COVID-19.

TRIAL REGISTRATION

Clinicaltrials.gov NCT05204615; https://clinicaltrials.gov/ct2/show/NCT05204615.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37704.

摘要

背景

新冠疫情暴露出全球多数卫生系统的薄弱之处,使其陷入瘫痪并耗尽了可用的医疗资源。幸运的是,诸如疫苗接种、佩戴口罩和保持社交距离等特定公共卫生政策的制定与实施,降低了新冠急性期的患病率及相关并发症。然而,全球疫情的后续影响要求采取一种有效的方法来管理新冠长期症状患者。这是一个利用创新数字健康解决方案的绝佳机会,可为疲惫不堪的卫生系统提供最具成本效益和效率的工具,以支持对这一人群的临床管理。在此背景下,SENSING-AI项目专注于开展研究,以实施一种由人工智能驱动的数字健康解决方案,该方案既能支持新冠长期症状患者的适应性自我管理,又能为负责管理和跟踪这一人群的医护人员提供支持。

目的

本方案的目的是前瞻性收集10名患者的心理测量和生物特征数据,用于训练算法和预测模型,以补充SENSING-AI队列。

方法

将查阅公开可用的健康和生活方式数据登记处,并以从确诊患有新冠长期症状的患者临床信息中收集的匿名数据回顾性队列作为补充。此外,将使用可穿戴设备收集前瞻性患者生成的数据集,并通过经过验证的患者报告结局问卷进行补充,以完善回顾性队列。最后,将科学数据管理和监管的“可发现性、可访问性、互操作性和可重用性”指导原则应用于所得数据集,以鼓励整个研究界持续进行信息的发现、评估和重用过程。

结果

预计SENSING-AI队列将于2022年完成。预计将获得足够的数据,以生成基于行为改变和心理健康技术的人工智能模型,从而改善患者的自我管理,同时基于风险分层模型和病情加重的早期检测,为医护人员提供有用且及时的临床决策支持服务。

结论

SENSING-AI专注于在日常生活中获取新冠长期症状患者的高质量数据。在当前疫情形势下,支持这些患者至关重要,包括以具有成本效益和效率的方式支持医护人员对新冠长期症状进行管理。

试验注册

Clinicaltrials.gov NCT05204615;https://clinicaltrials.gov/ct2/show/NCT05204615。

国际注册报告识别码(IRRID):DERR1-10.2196/37704。

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