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

Tiffany A Suragh; Elaine R Miller; Beth F Hibbs; Scott K Winiecki; Craig Zinderman; Tom T Shimabukuro

doi:10.1016/j.vaccine.2017.03.055

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

Vaccine. 2017 Apr 25;35(18):2295-2297. doi: 10.1016/j.vaccine.2017.03.055. Epub 2017 Mar 25.

Authors

Tiffany A Suragh¹, Elaine R Miller², Beth F Hibbs², Scott K Winiecki³, Craig Zinderman⁴, Tom T Shimabukuro²

Affiliations

¹ 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.
² 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.
³ Safe Use Team, Professional Affairs and Stakeholder Engagement Staff, Center for Drug Evaluation and Research, US Food and Drug Administration, United States.
⁴ Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, United States.

Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Cognitive testing; Thematic analysis; Vaccine Adverse Event Reporting System (VAERS); Vaccine safety.

Published by Elsevier Ltd.

MeSH terms

Adverse Drug Reaction Reporting Systems*
Humans
Interviews as Topic
Product Surveillance, Postmarketing*
Vaccines / adverse effects*
Volunteers

Substances

Vaccines

Grants and funding

CC999999/Intramural CDC HHS/United States