title: Cognitive testing to evaluate revisions to the Vaccine Adverse Event Reporting System (VAERS) reporting form.
abstract: 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.
authors.affiliation: 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. Electronic address: tsuragh@cdc.gov.
authors.forename: Tiffany A
authors.initials: TA
authors.lastname: Suragh
authors.affiliation: 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.
authors.forename: Elaine R
authors.initials: ER
authors.lastname: Miller
authors.affiliation: 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.
authors.forename: Beth F
authors.initials: BF
authors.lastname: Hibbs
authors.affiliation: Safe Use Team, Professional Affairs and Stakeholder Engagement Staff, Center for Drug Evaluation and Research, US Food and Drug Administration, United States.
authors.forename: Scott K
authors.initials: SK
authors.lastname: Winiecki
authors.affiliation: Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, United States.
authors.forename: Craig
authors.initials: C
authors.lastname: Zinderman
authors.affiliation: 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.
authors.forename: Tom T
authors.initials: TT
authors.lastname: Shimabukuro
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D006801:Humans; D007407:Interviews as Topic; D011358:Product Surveillance, Postmarketing; D014612:Vaccines / Q000009:adverse effects*; D014838:Volunteers
chemical_list: D014612:Vaccines
keywords: Cognitive testing; Thematic analysis; Vaccine Adverse Event Reporting System (VAERS); Vaccine safety