VALIDATION OF A NEW CLINICAL OUTCOME ASSESSMENT: THE VACCINATION EXPERIENCE QUESTIONNAIRE (VEQ)
Author(s)
Brooke M. Currie, MPH1, David A. Andrae, PhD2, Wen-Hung Chen, PhD1, Ekkehard Beck, PhD3, Danielle N. Rodriguez, PhD2, Ismail Budhiarso, MA2, Shweta Bapat, PhD2, Irshaad Jansen, MSc3, Efstathios Zikos, MA, MSc3, Shahina Begum, PhD4, Eliana Biundo, PhD3;
1GSK, Collegeville, PA, USA, 2Thermo Fisher Scientific, Waltham, MA, USA, 3GSK, Wavre, Belgium, 4GSK, London, United Kingdom
1GSK, Collegeville, PA, USA, 2Thermo Fisher Scientific, Waltham, MA, USA, 3GSK, Wavre, Belgium, 4GSK, London, United Kingdom
OBJECTIVES: The Vaccination Experience Questionnaire (VEQ) is a novel tool designed to capture vaccine recipients’ experiences beyond traditional adverse event reporting. By assessing the impact of post-vaccination side effects on health-related quality of life (HRQoL) and work, as well as perceptions of side effect acceptability and willingness to re-vaccinate, the VEQ aims to address data gaps in vaccine trials and may even inform strategies to address vaccine hesitancy, a major public health challenge.
METHODS: A mixed-methods, non-interventional study was conducted in 2022 in 2 phases. Phase 1 included 210 adults in the United States who completed a daily web-survey, including the VEQ, specific injection reaction questions, and established patient-reported-outcome (PRO) instruments (VAPI, EQ-5D-3L, SF-36v2), for 7 days after receiving standard-of-care COVID-19 mRNA vaccines. Confirmatory factor analysis (CFA), reliability, validity, responsiveness of the VEQ were evaluated, and initial guidelines for score interpretation were explored. Phase 2 involved qualitative interviews with a subset of 22 participants to assess the VEQ’s content validity.
RESULTS: The CFA supported the VEQ’s 2-factor structure (QoL and work-related interference subscales), with acceptable model fit indices (Tucker-Lewis index=0.978; comparative fit index=0.985 [Day 1]). Internal consistency was high (Cronbach’s α ≥0.7), and convergent/discriminant validity was demonstrated through correlations with established PROs. VEQ scores were responsive to changes in side effect severity over time. On Day 1 post-vaccination, >80% of participants found side effects “mostly” or “completely” acceptable, increasing to >90% by Day 7. Minimal interference with QoL and work was observed. Qualitative interviews confirmed strong content validity and led to minor refinements to improve clarity.
CONCLUSIONS: The VEQ is a psychometrically sound, fit-for-purpose measure that captures the acceptability and impact of vaccination-related side effects, supporting its use in future vaccine trials and even real-world studies. VEQ data may inform healthcare professionals and advisory bodies in developing patient-centered vaccination strategies to improve vaccine uptake.
METHODS: A mixed-methods, non-interventional study was conducted in 2022 in 2 phases. Phase 1 included 210 adults in the United States who completed a daily web-survey, including the VEQ, specific injection reaction questions, and established patient-reported-outcome (PRO) instruments (VAPI, EQ-5D-3L, SF-36v2), for 7 days after receiving standard-of-care COVID-19 mRNA vaccines. Confirmatory factor analysis (CFA), reliability, validity, responsiveness of the VEQ were evaluated, and initial guidelines for score interpretation were explored. Phase 2 involved qualitative interviews with a subset of 22 participants to assess the VEQ’s content validity.
RESULTS: The CFA supported the VEQ’s 2-factor structure (QoL and work-related interference subscales), with acceptable model fit indices (Tucker-Lewis index=0.978; comparative fit index=0.985 [Day 1]). Internal consistency was high (Cronbach’s α ≥0.7), and convergent/discriminant validity was demonstrated through correlations with established PROs. VEQ scores were responsive to changes in side effect severity over time. On Day 1 post-vaccination, >80% of participants found side effects “mostly” or “completely” acceptable, increasing to >90% by Day 7. Minimal interference with QoL and work was observed. Qualitative interviews confirmed strong content validity and led to minor refinements to improve clarity.
CONCLUSIONS: The VEQ is a psychometrically sound, fit-for-purpose measure that captures the acceptability and impact of vaccination-related side effects, supporting its use in future vaccine trials and even real-world studies. VEQ data may inform healthcare professionals and advisory bodies in developing patient-centered vaccination strategies to improve vaccine uptake.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR72
Topic
Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes
Disease
STA: Vaccines