背景:为了减轻安全隐患,监管机构必须就药物使用和不良药物事件(ADE)做出明智的决定。主要药物警戒数据来自卫生保健专业人员的自发报告。然而,漏报在当前系统中构成了一个显著的挑战。探索替代来源,包括电子病历和社交媒体,已经进行了。然而,社交媒体的潜力在现实世界中仍未开发。
目标:监管机构在使用社交媒体时面临的挑战主要归因于缺乏合适的工具来支持决策者。一个有效的工具应该能够通过图形用户界面获取信息,以用户友好的方式而不是以原始形式呈现数据。此界面应提供各种可视化选项,使用户能够选择最能传达数据并促进明智决策的表示。因此,这项研究旨在评估将社交媒体整合到药物警戒中的潜力,并利用这种新的数据源加强决策.为了实现这一点,我们的目标是开发和评估一个管道,从提取网络论坛帖子到生成指标和警报的可视化和交互式环境中处理数据。目标是创建一个用户友好的工具,使监管机构能够有效地做出更明智的决策。
方法:为了加强药物警戒工作,我们设计了一个包含4个不同模块的管道,每个可独立编辑,旨在有效分析与健康相关的法国网络论坛。这些模块是(1)网络论坛\'帖子提取,(2)网络论坛帖子注释,(3)统计与旌旗灯号检测算法,和(4)图形用户界面(GUI)。我们通过一个说明性案例研究展示了GUI的功效,该案例研究涉及在法国引入新的Levothyrox配方。这一事件导致向法国监管机构的报告激增。
结果:在2017年1月1日至2021年2月28日之间,从23个法国网络论坛中提取了2,081,296个帖子。这些帖子包含437,192对规范的药物-ADE夫妇,注释与解剖治疗化学(ATC)分类和医学词典的监管活动(MedDRA)。对Levothyrox新公式的分析揭示了一种显着的模式。2017年8月,社交媒体平台上与这种药物相关的帖子急剧增加,这与同期患者向国家监管机构提交的报告大幅增加相吻合。
结论:我们证明了使用GUI进行定量分析是简单的,不需要编码。结果与先前的研究一致,也提供了对药物相关问题的潜在见解。我们的假设得到了部分确认,因为最终用户没有参与评估过程。进一步研究,专注于人体工程学和对监管机构内专业人员的影响,对未来的研究工作至关重要。我们强调了我们方法的多功能性以及不同模块之间的无缝互操作性,而不是单个模块的性能。具体来说,注释模块在开发过程的早期被集成,并且可以通过利用根植于变形金刚架构中的当代技术进行实质性的增强。我们的管道在监管机构或制药公司的健康监测中具有潜在的应用,帮助识别安全问题。此外,研究小组可将其用于事件的回顾性分析.
BACKGROUND: To mitigate safety concerns, regulatory agencies must make informed decisions regarding drug usage and adverse drug events (ADEs). The primary pharmacovigilance data stem from spontaneous
reports by health care professionals. However, underreporting poses a notable challenge within the current system. Explorations into alternative sources, including electronic patient records and social media, have been undertaken. Nevertheless, social media\'s potential remains largely untapped in real-world scenarios.
OBJECTIVE: The challenge faced by regulatory agencies in using social media is primarily attributed to the absence of suitable tools to support decision makers. An effective tool should enable access to information via a graphical user interface, presenting data in a user-friendly manner rather than in their raw form. This interface should offer various visualization options, empowering users to choose representations that best convey the data and facilitate informed decision-making. Thus, this study aims to assess the potential of integrating social media into pharmacovigilance and enhancing decision-making with this novel data source. To achieve this, our objective was to develop and assess a pipeline that processes data from the extraction of web forum posts to the generation of indicators and alerts within a visual and interactive environment. The goal was to create a user-friendly tool that enables regulatory authorities to make better-informed decisions effectively.
METHODS: To enhance pharmacovigilance efforts, we have devised a pipeline comprising 4 distinct modules, each independently editable, aimed at efficiently analyzing health-related French web forums. These modules were (1) web forums\' posts extraction, (2) web forums\' posts annotation, (3) statistics and signal detection algorithm, and (4) a graphical user interface (GUI). We showcase the efficacy of the GUI through an illustrative
case study involving the introduction of the new formula of Levothyrox in France. This event led to a surge in
reports to the French regulatory authority.
RESULTS: Between January 1, 2017, and February 28, 2021, a total of 2,081,296 posts were extracted from 23 French web forums. These posts contained 437,192 normalized drug-ADE couples, annotated with the Anatomical Therapeutic Chemical (ATC) Classification and Medical Dictionary for Regulatory Activities (MedDRA). The analysis of the Levothyrox new formula revealed a notable pattern. In August 2017, there was a sharp increase in posts related to this medication on social media platforms, which coincided with a substantial uptick in
reports submitted by patients to the national regulatory authority during the same period.
CONCLUSIONS: We demonstrated that conducting quantitative analysis using the GUI is straightforward and requires no coding. The results aligned with prior research and also offered potential insights into drug-related matters. Our hypothesis received partial confirmation because the final users were not involved in the evaluation process. Further studies, concentrating on ergonomics and the impact on professionals within regulatory agencies, are imperative for future research endeavors. We emphasized the versatility of our approach and the seamless interoperability between different modules over the performance of individual modules. Specifically, the annotation module was integrated early in the development process and could undergo substantial enhancement by leveraging contemporary techniques rooted in the Transformers architecture. Our pipeline holds potential applications in health surveillance by regulatory agencies or pharmaceutical companies, aiding in the identification of safety concerns. Moreover, it could be used by research teams for retrospective analysis of events.