Tricco Andrea C, Zarin Wasifa, Lillie Erin, Pham Ba, Straus Sharon E
Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.
Epidemiology Division, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
BMJ Open. 2017 Jan 19;7(1):e013474. doi: 10.1136/bmjopen-2016-013474.
Adverse events associated with medications are under-reported in postmarketing surveillance systems. A systematic review of published data from 37 studies worldwide (including Canada) found the median under-reporting rate of adverse events to be 94% in spontaneous reporting systems. This scoping review aims to assess the utility of social media and crowd-sourced data to detect and monitor adverse events related to health products including pharmaceuticals, medical devices, biologics and natural health products.
Our review conduct will follow the Joanna Briggs Institute scoping review methods manual. Literature searches were conducted in MEDLINE, EMBASE and the Cochrane Library from inception to 13 May 2016. Additional sources included searches of study registries, conference abstracts, dissertations, as well as websites of international regulatory authorities (eg, Food and Drug Administration (FDA), the WHO, European Medicines Agency). Search results will be supplemented by scanning the references of relevant reviews. We will include all publication types including published articles, editorials, websites and book sections that describe use of social media and crowd-sourced data for surveillance of adverse events associated with health products. Two reviewers will perform study selection and data abstraction independently, and discrepancies will be resolved through discussion. Data analysis will involve quantitative (eg, frequencies) and qualitative (eg, content analysis) methods.
The summary of results will be sent to Health Canada, who commissioned the review, and other relevant policymakers involved with the Drug Safety and Effectiveness Network. We will compile and circulate a 1-page policy brief and host a 1-day stakeholder meeting to discuss the implications, key messages and finalise the knowledge translation strategy. Findings from this review will ultimately inform the design and development of a data analytics platform for social media and crowd-sourced data for pharmacovigilance in Canada and internationally.
Our protocol was registered prospectively with the Open Science Framework (https://osf.io/kv9hu/).
药品相关不良事件在上市后监测系统中的报告不足。一项对全球（包括加拿大）37项研究的已发表数据进行的系统评价发现，自发报告系统中不良事件的报告不足率中位数为94%。本范围综述旨在评估社交媒体和众包数据在检测和监测与健康产品（包括药品、医疗器械、生物制品和天然健康产品）相关不良事件方面的效用。
我们的综述将遵循乔安娜·布里格斯研究所范围综述方法手册。从创刊至2016年5月13日在MEDLINE、EMBASE和考科蓝图书馆进行文献检索。其他来源包括研究注册库、会议摘要、学位论文以及国际监管机构（如美国食品药品监督管理局（FDA）、世界卫生组织、欧洲药品管理局）的网站。通过浏览相关综述的参考文献来补充搜索结果。我们将纳入所有描述使用社交媒体和众包数据监测与健康产品相关不良事件的出版物类型，包括已发表文章、社论、网站和书籍章节。两名评审员将独立进行研究选择和数据提取，如有分歧将通过讨论解决。数据分析将涉及定量（如频率）和定性（如内容分析）方法。
结果摘要将发送给委托进行本综述的加拿大卫生部以及参与药品安全与有效性网络的其他相关政策制定者。我们将编写并分发一份1页的政策简报，并举办为期1天的利益相关者会议，以讨论其影响、关键信息并确定知识转化策略。本综述的结果最终将为加拿大及国际上用于药物警戒的社交媒体和众包数据分析平台的设计与开发提供信息。
我们的方案已在开放科学框架（https://osf.io/kv9hu/）上进行了前瞻性注册。
