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在临床实践中表征用于检测未诊断心房颤动的消费者可穿戴设备的真实世界应用:针对性文献综述

Characterizing Real-World Implementation of Consumer Wearables for the Detection of Undiagnosed Atrial Fibrillation in Clinical Practice: Targeted Literature Review.

作者信息

Simonson Julie K, Anderson Misty, Polacek Cate, Klump Erika, Haque Saira N

机构信息

Pfizer Inc, New York City, NY, United States.

Premier Inc, Charlotte, NC, United States.

出版信息

JMIR Cardio. 2023 Nov 3;7:e47292. doi: 10.2196/47292.

Abstract

BACKGROUND

Atrial fibrillation (AF), the most common cardiac arrhythmia, is often undiagnosed because of lack of awareness and frequent asymptomatic presentation. As AF is associated with increased risk of stroke, early detection is clinically relevant. Several consumer wearable devices (CWDs) have been cleared by the US Food and Drug Administration for irregular heart rhythm detection suggestive of AF. However, recommendations for the use of CWDs for AF detection in clinical practice, especially with regard to pathways for workflows and clinical decisions, remain lacking.

OBJECTIVE

We conducted a targeted literature review to identify articles on CWDs characterizing the current state of wearable technology for AF detection, identifying approaches to implementing CWDs into the clinical workflow, and characterizing provider and patient perspectives on CWDs for patients at risk of AF.

METHODS

PubMed, ClinicalTrials.gov, UpToDate Clinical Reference, and DynaMed were searched for articles in English published between January 2016 and July 2023. The searches used predefined Medical Subject Headings (MeSH) terms, keywords, and search strings. Articles of interest were specifically on CWDs; articles on ambulatory monitoring tools, tools available by prescription, or handheld devices were excluded. Search results were reviewed for relevancy and discussed among the authors for inclusion. A qualitative analysis was conducted and themes relevant to our study objectives were identified.

RESULTS

A total of 31 articles met inclusion criteria: 7 (23%) medical society reports or guidelines, 4 (13%) general reviews, 5 (16%) systematic reviews, 5 (16%) health care provider surveys, 7 (23%) consumer or patient surveys or interviews, and 3 (10%) analytical reports. Despite recognition of CWDs by medical societies, detailed guidelines regarding CWDs for AF detection were limited, as was the availability of clinical tools. A main theme was the lack of pragmatic studies assessing real-world implementation of CWDs for AF detection. Clinicians expressed concerns about data overload; potential for false positives; reimbursement issues; and the need for clinical tools such as care pathways and guidelines, preferably developed or endorsed by professional organizations. Patient-facing challenges included device costs and variability in digital literacy or technology acceptance.

CONCLUSIONS

This targeted literature review highlights the lack of a comprehensive body of literature guiding real-world implementation of CWDs for AF detection and provides insights for informing additional research and developing appropriate tools and resources for incorporating these devices into clinical practice. The results should also provide an impetus for the active involvement of medical societies and other health care stakeholders in developing appropriate tools and resources for guiding the real-world use of CWDs for AF detection. These resources should target clinicians, patients, and health care systems with the goal of facilitating clinician or patient engagement and using an evidence-based approach for establishing guidelines or frameworks for administrative workflows and patient care pathways.

摘要

背景

心房颤动(AF)是最常见的心律失常,由于认识不足和频繁的无症状表现,常常未被诊断出来。由于AF与中风风险增加相关,早期检测具有临床意义。几种消费级可穿戴设备(CWD)已获得美国食品药品监督管理局批准,用于检测提示AF的心律不齐。然而,在临床实践中使用CWD进行AF检测的建议,尤其是关于工作流程和临床决策途径的建议,仍然缺乏。

目的

我们进行了一项有针对性的文献综述,以识别有关CWD的文章,这些文章描述了用于AF检测的可穿戴技术的当前状态,确定将CWD纳入临床工作流程的方法,并描述提供者和患者对有AF风险患者使用CWD的看法。

方法

在PubMed、ClinicalTrials.gov、UpToDate临床参考资料和DynaMed中搜索2016年1月至2023年7月期间发表的英文文章。搜索使用了预定义的医学主题词(MeSH)、关键词和搜索字符串。感兴趣的文章专门针对CWD;排除关于动态监测工具、处方可用工具或手持设备的文章。对搜索结果进行相关性审查,并在作者之间进行讨论以确定是否纳入。进行了定性分析,并确定了与我们研究目标相关的主题。

结果

共有31篇文章符合纳入标准:7篇(23%)医学协会报告或指南、4篇(13%)综合综述、5篇(16%)系统综述、5篇(16%)医疗保健提供者调查、7篇(23%)消费者或患者调查或访谈以及3篇(10%)分析报告。尽管医学协会认可CWD,但关于用于AF检测的CWD的详细指南有限,临床工具的可用性也有限。一个主要主题是缺乏评估CWD在AF检测中的实际应用的务实研究。临床医生对数据过载、假阳性可能性、报销问题以及对临床工具(如护理途径和指南)的需求表示担忧,最好由专业组织制定或认可。面向患者的挑战包括设备成本以及数字素养或技术接受度的差异。

结论

这项有针对性的文献综述突出了缺乏指导CWD在AF检测中的实际应用的全面文献,并为开展更多研究以及开发将这些设备纳入临床实践的适当工具和资源提供了见解。研究结果还应促使医学协会和其他医疗保健利益相关者积极参与开发适当的工具和资源,以指导CWD在AF检测中的实际应用。这些资源应以临床医生、患者和医疗保健系统为目标,以促进临床医生或患者的参与,并采用基于证据的方法来建立行政工作流程和患者护理途径的指南或框架。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa12/10656655/fd0ff0e2920b/cardio_v7i1e47292_fig1.jpg

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