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一种针对SARS-CoV-2自我采样的综合远程医疗方法的实施与用户满意度:单中心、前瞻性、干预性、开放标签、对照、双臂可行性研究。

Implementation and User Satisfaction of a Comprehensive Telemedicine Approach for SARS-CoV-2 Self-Sampling: Monocentric, Prospective, Interventional, Open-Label, Controlled, Two-Arm Feasibility Study.

作者信息

Voit Florian, Erber Johanna, Egert-Schwender Silvia, Hanselmann Michael, Laxy Michael, Kehl Victoria, Hoffmann Dieter, Jeske Samuel D, Michler Thomas, Protzer Ulrike, Kohlmayer Florian, Schmid Roland M, Spinner Christoph D, Weidlich Simon

机构信息

Clinical Department for Internal Medicine II - Department of Clinical Medicine, TUM School of Medicine and Health, Technical University of Munich, Munich, Germany.

Muenchner Studienzentrum, TUM School of Medicine and Health, Technical University of Munich, Munich, Germany.

出版信息

JMIR Form Res. 2024 Dec 11;8:e57608. doi: 10.2196/57608.

DOI:10.2196/57608
PMID:39661941
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11655044/
Abstract

BACKGROUND

The universal availability of smartphones has created new opportunities for innovative telemedicine applications in health care. The COVID-19 pandemic has heightened the demand for contactless health care services, making SARS-CoV-2 polymerase chain reaction (PCR) testing a crucial component of pandemic containment.

OBJECTIVE

This feasibility study aimed to examine a comprehensive telemedicine approach for SARS-CoV-2 testing, focusing on the practicality, user satisfaction, and economic implications of self-sampling guided by a telemedicine platform.

METHODS

The study process involved shipping self-sampling kits, providing instructions for at-home sample collection, processing biomaterials (swabs and capillary blood), communicating test results, and providing interoperable data for clinical routine and research through a medical mobile app. A total of 100 individuals were randomly assigned to either the conventional health care professional (HCP)-performed SARS-CoV-2 testing group (conventional testing group, CG) or the telemedicine-guided SARS-CoV-2 self-sampling approach (telemedicine group, TG). Feasibility of the TG approach, user satisfaction, user-centered outcomes, and economic aspects were assessed and compared between the groups.

RESULTS

In the TG group, 47 out of 49 (95%) individuals received a self-sampling kit via mail, and 37out of 49 (76%) individuals successfully returned at least one sample for diagnostics. SARS-CoV-2 PCR tests were conducted in 95% (35/37) of TG cases compared with 88% (44/50) in the CG. Users in the TG reported high satisfaction levels with ease of use (5.2/7), interface satisfaction (5.2/7), and usefulness (4.3/7). A microcosting model indicated a slightly higher cost for the TG approach than the CG approach. The TG demonstrated the potential to facilitate interoperable data transmission by providing anonymized, standardized datasets for extraction using Health Level 7-Fast Healthcare Interoperability Resources. This supports the national COVID-19 Data Exchange Platform and facilitates epidemiological evaluation based on the German COVID Consensus dataset.

CONCLUSIONS

These preliminary findings suggest that a telemedicine-based approach to SARS-CoV-2 testing is feasible and could be integrated into existing hospital data infrastructures. This model has the potential for broader application in medical care, offering a scalable solution that could improve user satisfaction and treatment quality in the future.

摘要

背景

智能手机的广泛普及为医疗保健领域创新的远程医疗应用创造了新机遇。新型冠状病毒肺炎(COVID-19)大流行增加了对非接触式医疗服务的需求,使严重急性呼吸综合征冠状病毒2(SARS-CoV-2)聚合酶链反应(PCR)检测成为疫情防控的关键组成部分。

目的

本可行性研究旨在探讨一种针对SARS-CoV-2检测的综合远程医疗方法,重点关注由远程医疗平台指导的自我采样的实用性、用户满意度和经济影响。

方法

研究过程包括运送自我采样试剂盒、提供家庭样本采集说明、处理生物材料(拭子和毛细血管血)、传达检测结果,以及通过一款医疗移动应用为临床常规和研究提供可互操作的数据。总共100名个体被随机分配到传统医疗保健专业人员(HCP)进行SARS-CoV-2检测组(传统检测组,CG)或远程医疗指导的SARS-CoV-2自我采样方法组(远程医疗组,TG)。评估并比较两组之间TG方法的可行性、用户满意度、以用户为中心的结果和经济方面。

结果

在TG组中,49名个体中有47名(95%)通过邮件收到了自我采样试剂盒,49名个体中有37名(76%)成功返回了至少一份用于诊断的样本。TG组95%(35/37)的病例进行了SARS-CoV-2 PCR检测,而CG组为88%(44/50)。TG组的用户对易用性(5.2/7)、界面满意度(5.2/7)和有用性(4.3/7)报告了较高的满意度。微观成本核算模型表明,TG方法的成本略高于CG方法。TG通过提供匿名的、标准化的数据集以便使用卫生信息标准7-快速医疗保健互操作性资源进行提取,展示了促进可互操作数据传输的潜力。这支持了国家COVID-19数据交换平台,并便于基于德国COVID共识数据集进行流行病学评估。

结论

这些初步发现表明,基于远程医疗的SARS-CoV-2检测方法是可行的,并且可以整合到现有的医院数据基础设施中。这种模式在医疗保健领域具有更广泛应用的潜力,提供了一种可扩展的解决方案,未来可能会提高用户满意度和治疗质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40ac/11655044/0973189bcfae/formative-v8-e57608-g005.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40ac/11655044/2e48341db89f/formative-v8-e57608-g001.jpg
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