智能手机技术可以支持药物不良反应(ADR)的无纸化报告。本研究的目的是系统地评估智能手机ADR报告应用,了解它们对ADR报告的定性和定量影响,并从业主和开发商那里获得重要的经验教训。
这项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人员和所有者的经验的在线调查,和(3)搜索VigiBase,世界卫生组织全球个案安全报告数据库(ICSRs),观察针对实施应用程序的国家的ADR报告数量的趋势。
包括22个应用程序。22个应用程序中有8个是针对世卫组织非洲区域的国家。观察到的特征包括E2B数据元素(E代表功效)和支持报告和用户参与的功能。17个应用程序开发人员和所有者回答了调查,并报告了应用程序功能的总体积极体验。以及发射后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,与年龄较大或更厌恶技术的人相比,年轻人和/或有使用技术倾向的人更有可能使用应用程序。而互联网连接有限的国家的受访者表示,在应用程序使用方面存在持续困难。
与传统报告工具相比,用于报告ADR的智能手机应用程序提供了附加价值。报告工具应根据界面功能和可能影响应用程序使用的因素进行选择。
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.
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.
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.
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.