Assefa Dawit Getachew, Tesefaye Tizalegn, Bekele Etaferaw, Geberemickeal Genet, Mebratu Andualem, Ejigu Aschalew Gossaye, Nigatu Tariku, Zeleke Eden Dagnachew
Department of Nursing, College of Health Science and Medicine, P.O. Box 419, Dilla University, Dilla, Ethiopia.
Department of Public Health, College of Health Science and Medicine, P.O. Box 419, Dilla University, Dilla, Ethiopia.
Int Health. 2025 Mar 4;17(2):195-204. doi: 10.1093/inthealth/ihae040.
Participant-centred active adverse event following immunization (AEFI) surveillance can offer real-time vaccine safety data and help in signal detection. This study aimed to evaluate the effectiveness of participant-centred active adverse events (AEs) surveillance following measles immunization in Gedeo Zone health facilities in Ethiopia.
An open-label, multicentred, three-arm randomized uncontrolled trial was conducted from 1 June to 21 October 2023. After assessing enrolment eligibility, the study participants were randomized into three groups (short message service [SMS], telephone interview, and diary card). They were expected to report AEs in children 1 week after receiving immunization. Binary and multivariable logistic regression and χ2 tests were used to analyse the data.
Among the 396 participants randomized into the three groups, 80.8% (320 participants) reported back about their children's AE status. Participants in the telephone interview group exhibited a substantially superior response rate (93.2% of 132 participants; p<0.00001) compared with the SMS (71.2%) and diary card (78%) groups. The likelihood of reporting the status of AEs experienced by children was lower by 77% (adjusted odds ratio 0.23 [95% confidence interval 0.1 to 0.52], p-value <0.00001) in the diary card group compared with the telephone interview group.
In this study, a telephone interview was found to be the best method for AEFI reporting. Participant-centred active AE surveillance could potentially permit more rapid identification of emerging safety signals. Trial registration: https://clinicaltrials.gov/ct2/show/NCT05803538.
以参与者为中心的免疫接种后主动不良事件监测（AEFI）可提供实时疫苗安全性数据并有助于信号检测。本研究旨在评估埃塞俄比亚盖德奥地区卫生机构中以参与者为中心的麻疹免疫接种后主动不良事件监测的有效性。
于2023年6月1日至10月21日进行了一项开放标签、多中心、三臂随机非对照试验。在评估入选资格后，研究参与者被随机分为三组（短信服务、电话访谈和日记卡）。他们需在儿童接种疫苗1周后报告不良事件。采用二元和多变量逻辑回归以及χ²检验对数据进行分析。
在随机分为三组的396名参与者中，80.8%（320名参与者）反馈了其子女的不良事件状况。电话访谈组的参与者的回应率（132名参与者中的93.2%；p<0.00001）显著高于短信组（71.2%）和日记卡组（78%）。与电话访谈组相比，日记卡组报告儿童经历不良事件状况的可能性低77%（调整优势比0.23[95%置信区间0.1至0.52]，p值<0.00001）。
在本研究中，发现电话访谈是AEFI报告的最佳方法。以参与者为中心的主动不良事件监测可能会更快识别新出现的安全信号。试验注册：https://clinicaltrials.gov/ct2/show/NCT05803538 。
