Data Management & Analysis Centre, Discipline of Public Health, The University of Adelaide, Adelaide, SA 5005, Australia.
Vaccine. 2012 Jun 13;30(28):4167-74. doi: 10.1016/j.vaccine.2012.04.056. Epub 2012 Apr 27.
We sought community opinion on consent alternatives when linking childhood immunisation and hospital attendance records for the purpose of vaccine safety surveillance.
We conducted computer-assisted telephone interviewing (CATI) of a sample of rural and metropolitan residents of South Australia in 2011.
Of 2002 households interviewed (response rate 55.6%), 96.4% supported data linkage for postmarketing surveillance of vaccines; very few were completely opposed (1.5%) or undecided (2.2%). The majority (75.3%) trusted the privacy protections used in data linkage and most wished to have minimal or no direct involvement, preferring either opt-out consent (40.4%) or no consent (30.6%). A quarter of respondents (24.6%) favoured opt-in consent, but their preferences were divergent; half requested consent be sought prior to every use (11.4%) while the remainder preferred to give broad consent just once (3.4%) or renewed at periodic intervals (9.8%). Over half of the respondents gave higher priority to rapid vaccine safety surveillance (56.5%) rather than first seeking parental consent (26.6%) and one in seven was undecided (14.5%). Although 91.6% of respondents believed childhood vaccines are safe, over half (53.1%) were very or somewhat concerned that a vaccine could cause a serious reaction. Nevertheless, 92.4% of the parents in the sample (556/601) reported every child in their care as being fully immunised according to the National Immunisation Program schedule. Only 3.7% of parents (22/601) reported one or more children as under immunised, and 3.9% (23/601) reported that none of their children were immunised.
This survey demonstrates that data linkage for vaccine safety surveillance has substantial community support and that a system utilising opt-out consent or no consent was preferred to one using opt-in consent. These findings should inform public health policy and practice; data linkage should be established where feasible to address limitations in passive surveillance systems.
我们就链接儿童免疫和医院就诊记录以进行疫苗安全监测的情况下使用替代同意书的问题征求了社区意见。
我们于 2011 年对南澳大利亚州农村和城市居民进行了计算机辅助电话访谈（CATI）。
在接受访谈的 2002 户家庭中（应答率为 55.6%），96.4%的家庭支持将数据链接用于疫苗上市后监测；极少数人完全反对（1.5%）或尚未决定（2.2%）。大多数人（75.3%）信任数据链接中使用的隐私保护措施，大多数人希望尽可能减少或不直接参与，他们更愿意选择选择退出同意（40.4%）或不同意（30.6%）。四分之一的受访者（24.6%）赞成选择加入同意，但他们的偏好存在分歧；一半的人要求在每次使用前都要征得同意（11.4%），而其余的人则更愿意只进行一次广泛同意（3.4%）或定期更新（9.8%）。超过一半的受访者更优先考虑快速疫苗安全监测（56.5%），而不是首先寻求家长同意（26.6%），七分之一的人尚未决定（14.5%）。尽管 91.6%的受访者认为儿童疫苗是安全的，但超过一半（53.1%）的人非常担心或有些担心疫苗会引起严重反应。尽管如此，样本中的 92.4%（556/601）的父母报告说，他们所照顾的每个孩子都按照国家免疫计划的时间表完全接种了疫苗。只有 3.7%（22/601）的父母报告说有一个或多个孩子免疫不足，3.9%（23/601）的父母报告说他们的孩子没有一个人接种过疫苗。
这项调查表明，数据链接用于疫苗安全监测得到了社区的广泛支持，并且与选择加入同意书相比，选择退出同意书或不使用同意书的系统更受欢迎。这些结果应告知公共卫生政策和实践；应在可行的情况下建立数据链接，以解决被动监测系统的局限性。
