TY - JOUR AU - Nguyen, Minh Tam H AU - Krause, g rard AU - Keller-Stanislawski, Brigitte AU - Glöckner, Stephan AU - Mentzer, Dirk AU - Ott, Jördis J PY - 2021 DA - 2021/5/7 TI -基于移动健康App的流感疫苗上市后安全性监测:前瞻性纵向可行性研究JO - JMIR Mhealth Uhealth SP - e26289 VL - 9 IS - 5 KW - Mhealth KW -移动健康KW -数字健康KW -不良事件KW -免疫后不良事件KW -主动报告KW -药物警戒KW -治疗使用KW -不良反应AB -背景:对于许可后疫苗接种的安全监测，免疫后不良事件(AEFIs)的报告至关重要。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。因此，我们使用应用程序对流感疫苗接种者进行了可行性研究，以评估报告的aefi。目的:研究的目的是确定影响坚持和正确使用新开发的应用程序的因素，用于使用定期提醒功能的个人报告3个月的AEFI，确定AEFI发生的决定因素并定义报告的AEFI类型。方法:我们开发了应用程序(SafeVac)，并于2018年秋季将其提供给3个职业场所的流感疫苗接种者。在这项前瞻性纵向可行性研究中，通过SafeVac收集了3个月的aefi数据。使用逻辑回归和Cox回归，我们评估了应用程序依从性、正确应用程序输入、aefi和社会人口参数之间的关联。结果:在登录SafeVac的个人中，61.4%(207/337)在3个月内使用该应用程序。App使用依从性与女性性别呈负相关(比值比[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. SN - 2291-5222 UR - https://mhealth.www.mybigtv.com/2021/5/e26289 UR - https://doi.org/10.2196/26289 UR - http://www.ncbi.nlm.nih.gov/pubmed/33960950 DO - 10.2196/26289 ID - info:doi/10.2196/26289 ER -