Discipline of Paediatrics, Adelaide Medical School, University of Adelaide, South Australia, Australia.
Australia and New Zealand Dialysis and Transplant Registry, South Australian Health and Medical Research Institute, Adelaide, Australia.
Vaccine. 2021 Jan 8;39(2):237-246. doi: 10.1016/j.vaccine.2020.12.011. Epub 2020 Dec 10.
Monitoring for adverse events following immunisation (AEFI) is critical for vaccine pharmacovigilance. Given the global and expanding availability of mobile phones their utility for consumer-based vaccine safety surveillance is of interest but little is known about consumer acceptability. This study nested within the Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) randomised control trial sought to evaluate the acceptability of SMS for AEFI surveillance.
The primary STARSS study was a multi-centre RCT evaluating the efficacy of repeated SMS prompts for AEFI surveillance with participants being adult vaccinees or parents of children receiving any vaccine. This nested study enrolled primary RCT participants who completed a detailed computer assisted telephone interview to determine their attitudes towards SMS-based surveillance and ascertain their knowledge and attitudes toward vaccine safety, efficacy, data privacy and use of electronic health records. Attitudes to surveillance and related behaviour were used as measures of acceptability.
20% (1200/6555) of the participants were enrolled and 1139 completed the full-length questionnaire. 96% indicated that SMS-based surveillance after immunisation to check the safety of the vaccine "should be done" but 62% of all respondents said it should be done but consent should be sought first. Neither vaccine safety attitudes nor attitudes toward privacy were associated with opposition to SMS-based surveillance. In terms of SMS related behaviour demographic rather than attitudinal factors were associated with non-compliance.
Overall, the attitude towards SMS-based surveillance was very favourable. Experiencing the SMS surveillance has the effect of reducing opposition to an SMS surveillance system, and at the same time increasing the likelihood of a preference for prior consent. Detection of a vaccine safety signal could be impeded in particular demographic groups who are non-compliant and we should undertake further research to understand why these groups are non-compliant and how this can be improved.
疫苗不良事件监测（AEFI）对于疫苗药物警戒至关重要。鉴于全球和不断扩大的移动电话的可用性，它们在基于消费者的疫苗安全监测方面的实用性引起了人们的兴趣，但对于消费者的可接受性却知之甚少。这项研究嵌套在刺激电话辅助快速安全监测（STARSS）随机对照试验中，旨在评估短信用于 AEFI 监测的可接受性。
主要的 STARSS 研究是一项多中心 RCT，评估了重复短信提示对 AEFI 监测的效果，参与者为接受任何疫苗的成年疫苗接种者或儿童的父母。这项嵌套研究招募了主要 RCT 参与者，他们完成了详细的计算机辅助电话访谈，以确定他们对基于短信的监测的态度，并了解他们对疫苗安全性、疗效、数据隐私和电子健康记录使用的态度。监测和相关行为的态度被用作可接受性的衡量标准。
20%（1200/6555）的参与者被纳入研究，1139 人完成了完整的问卷。96%的人表示，接种疫苗后进行基于短信的监测以检查疫苗的安全性“应该进行”，但 62%的受访者表示应该进行，但首先应该征得同意。疫苗安全性态度和对隐私的态度都与反对基于短信的监测无关。就短信相关行为而言，与不遵守规定相关的是人口统计学因素，而不是态度因素。
总体而言，对基于短信的监测的态度非常有利。体验短信监测会降低对短信监测系统的反对，同时增加对事先同意的偏好。在某些不遵守规定的特定人群中，可能会阻碍对疫苗安全信号的检测，我们应该进一步研究，以了解为什么这些人群不遵守规定，以及如何改进这一点。
