TY - JOUR AU - Di Filippo, Marzia AU - Avellone, Alessandro AU - Belingheri, Michael AU - Paladino, Maria Emilia AU - Riva, Michele Augusto AU - Zambon, Antonella AU - Pescini, Dario PY - 2022 DA - 2022/11/4 TI -利用公民参与在COVID-19药物不良反应监测背景下进行匿名纵向研究的移动应用程序:开发和可用性研究JO - JMIR Hum Factors SP - e38701 VL - 9 IS - 4 KW -不良反应报告KW -药物不良反应报告系统KW -移动应用程序KW -纵向研究KW - COVID-19疫苗接种运动KW - COVID-19疫苗KW -应用程序KW -药物不良反应KW -药物警戒KW -匿名AB -在过去几年中，研究越来越集中于开发移动应用程序，作为现有传统药物警戒监测系统的补充工具，以改进和促进药物不良反应(ADR)报告。目的:在本研究中，我们评估了一个新的移动应用程序(vaxEffect@UniMiB)进行纵向研究的潜力，同时保留了受访者的匿名性。我们在意大利人口样本中应用该应用程序监测COVID-19疫苗接种运动期间的不良反应。方法:我们对意大利国家疫苗接种运动期间在米兰-比可卡大学中心接种COVID-19疫苗的学术受试者进行vaxEffect@UniMiB接种。vaxEffect@UniMiB是为Android和iOS设备开发的。该移动应用程序要求用户发送他们的病史，并在每次接种疫苗时发送他们的疫苗接种数据和疫苗接种后7天内发生的不良反应，从而可以跟踪每个应答者的不良反应动态。该应用程序通过web向应用服务器发送数据。该服务器在接收所有用户数据的同时，将数据保存在SQL数据库服务器中，并通过Firebase Cloud Messaging (FCM)向移动应用程序发送推送通知，提醒患者提交疫苗和ADR数据。 On initial startup of the app, a unique user identifier (UUID) was generated for each respondent, so its anonymity was completely ensured, while enabling longitudinal studies. Results: A total of 3712 people were vaccinated during the first vaccination wave. A total of 2733 (73.6%) respondents between the ages of 19 and 80 years, coming from the University of Milano-Bicocca (UniMiB) and the Politecnico of Milan (PoliMi), participated in the survey. Overall, we collected information about vaccination and ADRs to the first vaccine dose for 2226 subjects (60.0% of the first dose vaccinated), to the second dose for 1610 subjects (43.4% of the second dose vaccinated), and, in a nonsponsored fashion, to the third dose for 169 individuals (4.6%). Conclusions: vaxEffect@UniMiB was revealed to be the first attempt in performing longitudinal studies to monitor the same subject over time in terms of the reported ADRs after each vaccine administration, while guaranteeing complete anonymity of the subject. A series of aspects contributed to the positive involvement from people in using this app to report their ADRs to vaccination: ease of use, availability from multiple platforms, anonymity of all survey participants and protection of the submitted data, and the health care workers’ support. SN - 2292-9495 UR - https://humanfactors.www.mybigtv.com/2022/4/e38701 UR - https://doi.org/10.2196/38701 UR - http://www.ncbi.nlm.nih.gov/pubmed/35930561 DO - 10.2196/38701 ID - info:doi/10.2196/38701 ER -