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电子患者报告结局症状监测器:中国快速开发即用型症状监测器的经验。

An electronic patient-reported outcome symptom monitor: the Chinese experience with rapid development of a ready-to-go symptom monitor.

机构信息

State Key Laboratory of Ultrasound in Medicine and Engineering, College of Biomedical Engineering, Chongqing Medical University, No. 1, Medical College Road, Yuzhong District, Chongqing, 400016, China.

ePRO Vision (Beijing) Health Technology Co., Ltd., Beijing, China.

出版信息

BMC Public Health. 2024 Oct 29;24(1):2989. doi: 10.1186/s12889-024-20518-5.

Abstract

BACKGROUND

Monitoring symptoms is crucial for the early detection of disease progression and timely intervention, which is essential for reducing severe cases and mortality rates in rapidly spreading pandemics, such as COVID-19. Therefore, during infectious disease pandemics, the rapid development of real-time symptom monitoring platforms is essential. This study aimed to explore the urgent development process of an electronic system for patient-reported outcome monitoring in emergency situations.

METHODS

The development of the electronic patient-reported outcome COVID-19 symptom monitoring platform (ePRO-CoV-SM) included the following steps: (1) modifying an electronic patient-reported outcome symptom-reporting platform to assess patients with COVID-19 and validating its feasibility and sensitivity for longitudinal symptom measurement; (2) updating the system to accommodate the newly emerged severe acute respiratory syndrome coronavirus 2 BA.2.2 variant; and (3) applying it in real-world settings. Literature review, expert consultation, and subject-group discussions were used to develop symptom items. Response rate and missing item rate were used as validation indicators for ePRO-CoV-SM.

RESULTS

The ePRO-CoV-SM (2.0) consists of a core set of symptom items, a WeChat mini program, an online project design backend, a management and communication front, and a database. During the 2020 verification, the response rate of ePRO symptom monitoring reached 89.47% and the item missing rate was 0.33%, the monitoring revealed that a considerable number of asymptomatic patients were experiencing undesirable symptoms during the isolation period. In its real-world application in 2022, the response rate was 85.93% and the item missing rate was 4.84%, the monitoring found the symptom burden was higher in the younger group (18-40 years old) than in the older group (40-67 years old), and over 30% of patients reported symptoms such as cough (36.08%), dry mouth (35.67%), sleep disorders (32.27%), appetite loss (32.17%), and sputum (30.79%) during the isolation period.

CONCLUSIONS

Electronic patient-reported outcome measurement was demonstrated to be sensitive and feasible for monitoring symptoms in patients with COVID-19. By integrating smartphone-based data collection with real-time online data transmission and secure data storage using Secure Sockets Layer encryption, an electronic platform for monitoring critical symptoms can be rapidly established in emergency situations.

摘要

背景

监测症状对于早期发现疾病进展和及时干预至关重要,这对于减少 COVID-19 等快速传播的大流行病中的重症病例和死亡率至关重要。因此,在传染病大流行期间,快速开发实时症状监测平台至关重要。本研究旨在探讨在紧急情况下开发电子患者报告结局监测系统的紧迫过程。

方法

电子患者报告结局 COVID-19 症状监测平台(ePRO-CoV-SM)的开发包括以下步骤:(1)修改电子患者报告结局症状报告平台,以评估 COVID-19 患者,并验证其对纵向症状测量的可行性和敏感性;(2)更新系统以适应新出现的严重急性呼吸系统综合征冠状病毒 2 BA.2.2 变体;(3)将其应用于真实环境中。文献回顾、专家咨询和专题小组讨论用于开发症状项目。ePRO-CoV-SM 的应答率和缺失项目率被用作验证指标。

结果

ePRO-CoV-SM(2.0)由一组核心症状项目、一个微信小程序、一个在线项目设计后端、一个管理和通信前端以及一个数据库组成。在 2020 年验证期间,ePRO 症状监测的应答率达到 89.47%,缺失项目率为 0.33%,监测结果显示,相当数量的无症状患者在隔离期间出现了不良症状。在 2022 年的实际应用中,应答率为 85.93%,缺失项目率为 4.84%,监测结果发现,年轻组(18-40 岁)的症状负担高于年龄较大组(40-67 岁),超过 30%的患者报告在隔离期间出现咳嗽(36.08%)、口干(35.67%)、睡眠障碍(32.27%)、食欲减退(32.17%)和咳痰(30.79%)等症状。

结论

电子患者报告结局测量被证明对监测 COVID-19 患者的症状敏感且可行。通过将基于智能手机的数据收集与实时在线数据传输以及使用安全套接字层加密进行安全的数据存储相结合,可以在紧急情况下快速建立用于监测关键症状的电子平台。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/35e4/11520658/98751e6f8a8c/12889_2024_20518_Fig1_HTML.jpg

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