Cognitive testing to evaluate revisions to the Vaccine Adverse Event Reporting System (VAERS) reporting form

Publication date: Available online 25 March 2017
Source:Vaccine
Author(s): Tiffany A. Suragh, Elaine R. Miller, Beth F. Hibbs, Scott K. Winiecki, Craig Zinderman, Tom T. Shimabukuro
IntroductionThe 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.MethodsWe 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.ResultsRepeating 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.ConclusionsCognitive 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.



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