@Article{info:doi/10.2196/26289，作者=“Nguyen, Minh Tam H and Krause, G{\'e}rard and Keller-Stanislawski, Brigitte and Gl{\ ' o ' ckner, Stephan and Mentzer, Dirk and Ott, J{\ ' o ' rdis J”，标题=“使用移动健康App进行流感疫苗接种后上市后安全性监测:前瞻性纵向可行性研究”，期刊=“JMIR Mhealth Uhealth”，年=“2021”，月=“5”，日=“7”，卷=“9”，数=“5”，页=“e26289”，关键词=“Mhealth;移动健康;数字健康;不良事件;免疫接种后不良事件;活动报告;药物警戒;治疗使用;背景:对于疫苗许可后的安全性监测，免疫后不良事件(AEFIs)的报告是至关重要的。数字移动应用程序等新技术可以作为捕捉这些事件的主动方法。 We therefore conducted a feasibility study among recipients of the influenza vaccination using an app for assessment of the reporting of AEFIs. Objective: The goal of the research was to determine factors influencing adherence to and correct use of a newly developed app for individuals to report AEFI for 3 months using regular reminder functions, to identify determinants of AEFI occurrence and define reported AEFI types. Methods: We developed the app (SafeVac) and offered it to recipients of the influenza vaccination in 3 occupational settings in fall 2018. In this prospective longitudinal feasibility study, data on AEFIs were generated through SafeVac for 3 months. Using logistic and Cox regression, we assessed associations between app adherence, correct app entry, AEFIs, and sociodemographic parameters. Results: Of the individuals who logged into SafeVac, 61.4{\%} (207/337) used the app throughout a 3-month period. App use adherence was negatively associated with female sex (odds ratio [OR] 0.47; CI 0.25-0.91) and correct app entry was negatively associated with older age (OR 0.96; CI 0.93-0.99) and lower education (OR 0.31; CI 0.13-0.76). AEFI occurrence was associated with female sex (hazard ratio 1.41; CI 1.01-1.96) and negatively with older age (hazard ratio 0.98; CI 0.97-0.99). The most common AEFIs reported were injection site pain (106/337), pain in extremity (103/337), and fatigue/asthenia (73/337). Conclusions: Digital AEFI reporting was feasible with SafeVac and generated plausible results for this observation period and setting. Studies directly comparing SafeVac with conventional passive reporting schemes could determine whether such digital approaches improve completeness, timeliness, and sensitivity of vaccine vigilance. Further studies should evaluate if these results are transferable to other vaccinations and populations and if introduction of such a tool has an influence on vaccination readiness and therefore vaccine safety. ", issn="2291-5222", doi="10.2196/26289", url="https://mhealth.www.mybigtv.com/2021/5/e26289", url="https://doi.org/10.2196/26289", url="http://www.ncbi.nlm.nih.gov/pubmed/33960950" }