Sáez-Llorens Xavier, De León Tirza, Añino Yostin Jesús, Vega Natalia, Prada Laura, Rebollón Gabriel, DeAntonio Rodrigo
Cevaxin, Centro de Vacunación e Investigación, Av. 3a Oeste, David, Chiriquí, Panama-Cevaxin, Centro de Vacunación e Investigación, Avenida Mexico, Calle 33, Calidonia, Panama City, Panama.
Hospital del Niño Dr. José Renán Esquivel, Avenida Balboa, Calle 34, Panama City, Panama - Sistema Nacional de Investigación, Edificio 205, Ciudad del Saber, Clayton, Panama City, Panama.
Prev Med Rep. 2025 Mar 29;53:103056. doi: 10.1016/j.pmedr.2025.103056. eCollection 2025 May.
Monitoring adverse reactions is essential to confirm vaccine safety profiles. Studies using electronic tools for data collection may reach a broader audience, improving data efficiency and integrity, reducing study costs and simplifying data collection compared with nonelectronic methods. This study aimed to validate electronic versus paper diaries for reporting postimmunization reactions in Panama.
An experimental design was conducted with three groups (children, pregnant women, and older adults). Groups were divided into one subgroup using paper diary and one using electronic diary. Diary assignments were subsequently reversed in children group, which parents completed. Symptoms and reporting frequency were collected in 2020 and 2021. Information reported in paper diaries was entered into an electronic case report form and reconciled. Users' adherence, differences between reported symptom frequency and users' acceptability of diaries were evaluated.
A total of 180 participants were included: 79 children, 21 pregnant women, 80 older adults. Children group showed greater adherence to both diaries. No significant differences were found in response times in the electronic diary between groups. More symptoms were reported in the electronic diary. The experience of using diaries, no matter which one, was similar.
Results indicate young people adapt better to technological tools than older adults, suggesting tools should be adjusted according to the user's age. Furthermore, electronic applications for reporting postimmunization reactions offer suitable pharmacovigilance alternatives, providing real-time information, and requiring fewer staff, leading to improved health outcomes, patient compliance, and data for research and public health analysis, supporting global vaccine development.
监测不良反应对于确认疫苗安全性至关重要。与非电子方法相比,使用电子工具进行数据收集的研究可能会覆盖更广泛的受众,提高数据效率和完整性,降低研究成本并简化数据收集。本研究旨在验证在巴拿马使用电子日记与纸质日记报告免疫后反应的情况。
采用实验设计,分为三组(儿童、孕妇和老年人)。每组再分为一个使用纸质日记的亚组和一个使用电子日记的亚组。随后儿童组的日记分配进行了互换,由家长完成。在2020年和2021年收集症状和报告频率。将纸质日记中报告的信息录入电子病例报告表并进行核对。评估用户的依从性、报告症状频率之间的差异以及用户对日记的可接受性。
共纳入180名参与者:79名儿童、21名孕妇、80名老年人。儿童组对两种日记的依从性更高。各年龄组之间电子日记的响应时间无显著差异。电子日记中报告的症状更多。无论使用哪种日记,使用体验相似。
结果表明年轻人比老年人更能适应技术工具,这表明工具应根据用户年龄进行调整。此外,用于报告免疫后反应的电子应用程序提供了合适的药物警戒替代方案,可提供实时信息,所需工作人员更少,从而改善健康结果、提高患者依从性,并为研究和公共卫生分析提供数据,支持全球疫苗研发。