Suragh Tiffany A, Miller Elaine R, Hibbs Beth F, Winiecki Scott K, Zinderman Craig, Shimabukuro Tom T
Immunization Safety Office, Division of Health Care Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.
Immunization Safety Office, Division of Health Care Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.
Vaccine. 2017 Apr 25;35(18):2295-2297. doi: 10.1016/j.vaccine.2017.03.055. Epub 2017 Mar 25.
The Vaccine Adverse Event Reporting System (VAERS) is the spontaneous (passive) reporting system CDC and FDA use to monitor vaccine safety. We used cognitive testing to evaluate proposed revisions to the current VAERS form.
We conducted in-person cognitive interviews with 22 volunteers to evaluate proposed revisions in a prototype VAERS 2.0 form (new VAERS form). We analyzed data using thematic analysis.
Repeating themes included preferences for: brevity, simplicity and clarity; features to minimize time requirements and facilitate ease of completion; logical ordering of questions by topic and importance; and visual cues like color-coded highlighting. Interviews identified instances of discordance between the intended meaning questions (from the perspective of CDC and FDA) and interpretation by volunteers.
Cognitive testing yielded useful information to guide further revisions of the VAERS form. Cognitive testing can be an effective tool for public health programs interested in developing surveys and reporting forms.
疫苗不良事件报告系统（VAERS）是美国疾病控制与预防中心（CDC）和美国食品药品监督管理局（FDA）用于监测疫苗安全性的自发（被动）报告系统。我们采用认知测试来评估对当前VAERS表格的拟议修订内容。
我们对22名志愿者进行了面对面的认知访谈，以评估VAERS 2.0表格原型（新VAERS表格）中的拟议修订内容。我们使用主题分析法对数据进行了分析。
反复出现的主题包括对以下方面的偏好：简洁、简单和清晰；尽量减少时间要求并便于填写的功能；按主题和重要性对问题进行逻辑排序；以及颜色编码突出显示等视觉提示。访谈发现了预期问题含义（从CDC和FDA的角度）与志愿者解释之间存在不一致的情况。
认知测试产生了有用信息，可指导对VAERS表格进行进一步修订。对于有兴趣开发调查问卷和报告表格的公共卫生项目而言，认知测试可能是一种有效的工具。
