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基于智能手机的药物不良反应报告移动应用程序:全球现状和国家经验。

Smartphone-based mobile applications for adverse drug reactions reporting: global status and country experience.

机构信息

Regulation and Safety, World Health Organization, Avenue Appia 20, 1211, Geneva, Switzerland.

出版信息

BMC Med Inform Decis Mak. 2022 May 2;22(1):118. doi: 10.1186/s12911-022-01832-7.

Abstract

BACKGROUND

Smartphone technology can support paperless reporting of adverse drug reactions (ADRs). The aims of this study were to systematically assess smartphone ADR-reporting applications, understand their qualitative and quantitative impact on ADR reporting, and garner key lessons from owners and developers.

METHODS

This study had three components: (1) An assessment of ADR-reporting apps, (2) an online survey on the impact of app implementation on ADR reporting and the experiences of app developers and owners, and (3) a search of VigiBase, the World Health Organization global database of individual case safety reports (ICSRs), to observe trends in the number of ADR reports targeting countries where the apps were implemented.

RESULTS

Twenty-two apps were included. Eight out of the 22 apps were for countries in the WHO African region. Features observed included E2B data elements (E stands for efficacy) and functions supporting reporting and user engagement. Seventeen app developers and owners answered to the survey and reported overall positive experiences with app features, and post-launch increases in the total number of ICSRs. User type and user environment were cited as factors influencing app use: Respondents said younger people and/or those with an inclination to use technology were more likely to use apps compared to older or more technology-averse people, while respondents in countries with limited internet connectivity reported persistent difficulties in app use.

CONCLUSIONS

Smartphone apps for reporting ADRs offer added value compared to conventional reporting tools. Reporting tools should be selected based on interface features and factors that may influence app usage.

摘要

背景

智能手机技术可以支持药物不良反应(ADR)的无纸化报告。本研究旨在系统评估智能手机 ADR 报告应用程序,了解它们对 ADR 报告的定性和定量影响,并从所有者和开发者那里获取关键经验。

方法

本研究有三个组成部分:(1)对 ADR 报告应用程序的评估,(2)关于应用程序实施对 ADR 报告的影响以及应用程序开发者和所有者经验的在线调查,(3)在世界卫生组织个体病例安全报告(ICSR)全球数据库 VigiBase 中搜索,以观察针对实施应用程序的国家的 ADR 报告数量的趋势。

结果

共纳入 22 个应用程序。其中 8 个应用程序针对世卫组织非洲区域的国家。观察到的功能包括 E2B 数据元素(E 代表疗效)和支持报告和用户参与的功能。17 名应用程序开发者和所有者对调查做出了回应,并报告了应用程序功能的总体积极体验,以及发布后 ICSR 总数的增加。用户类型和用户环境被认为是影响应用程序使用的因素:受访者表示,与年龄较大或对技术更反感的人相比,年轻人和/或倾向于使用技术的人更有可能使用应用程序,而在互联网连接有限的国家的受访者报告说,他们在应用程序使用方面持续存在困难。

结论

与传统报告工具相比,用于报告 ADR 的智能手机应用程序具有附加价值。应根据界面功能和可能影响应用程序使用的因素选择报告工具。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cfca/9063059/303b4085c00c/12911_2022_1832_Fig1_HTML.jpg

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