Nguyen M T H, Ott J J, Caputo M, Keller-Stanislawski B, Klett-Tammen C J, Linnig S, Mentzer D, Krause G
Pharmazie. 2020 Jan 2;75(1):27-31. doi: 10.1691/ph.2020.9734.
The passive surveillance system is an important tool in pharmacovigilance of vaccines. However, reporting of adverse events following immunization (AEFI) post-marketing has limitations regarding under-reporting, biased reports and lack of exposure data resulting in imprecise estimates. New mobile application technology may provide an opportunity for an enhanced surveillance. A pre-requisite for the use of new app-based technology is to identify practical challenges and end users' preferences for design of app-features. The objectives were (i) to investigate the recruitment and feasibility of an app-based study in Germany, (ii) to assess individuals' motivation to participate in such a study and (iii) to identify app-features for reporting AEFI. We conducted a cross-sectional study among employees of a financial institution who attended the occupational health office during the seasonal influenza vaccination in November 2017. Participants tested feasibility and assessed an app prototype for AEFI reporting by using a case vignette and a questionnaire. Of the 153 attending employees, 65 (42%) agreed to participate and returned the questionnaire. Twenty-three (63%) rated the experience of reporting AEFI with the app prototype to be positive. Among three features offered for gamification, collecting points was most frequently chosen (n=22, 34%). The main reason for declining participation was the apprehension about data protection (n=28, 43%). Results suggest that the app-based technology was well accepted and is a suitable supplement for AEFI reporting and in our study. A convincing data protection concept is likely to enhance acceptability of such a system.
被动监测系统是疫苗药物警戒中的一项重要工具。然而,疫苗上市后免疫接种后不良事件(AEFI)的报告在漏报、报告偏差以及缺乏暴露数据方面存在局限性,导致估计不准确。新的移动应用技术可能为加强监测提供契机。使用基于新应用程序的技术的一个先决条件是确定实际挑战以及终端用户对应用程序功能设计的偏好。目标是:(i)调查在德国开展一项基于应用程序的研究的招募情况和可行性;(ii)评估个人参与此类研究的动机;(iii)确定报告AEFI的应用程序功能。我们对一家金融机构的员工进行了一项横断面研究,这些员工在2017年11月季节性流感疫苗接种期间前往职业健康办公室。参与者通过使用病例 vignette 和问卷测试了可行性,并评估了用于AEFI报告的应用程序原型。在153名参与的员工中,65名(42%)同意参与并返回了问卷。23名(63%)将使用应用程序原型报告AEFI的体验评为积极。在为游戏化提供的三个功能中,收集积分是最常被选择的(n = 22,34%)。拒绝参与的主要原因是对数据保护的担忧(n = 28,43%)。结果表明,基于应用程序的技术在我们的研究中得到了很好的接受,是AEFI报告的合适补充。一个令人信服的数据保护概念可能会提高此类系统的可接受性。