%0 Journal Article
%T Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03A-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study.
%A Standaert B
%A Dort T
%A Linden J
%A Madan A
%A Bart S
%A Chu L
%A Hayney MS
%A Kosinski M
%A Kroll R
%A Malak J
%A Meier G
%A Segall N
%A Schuind A
%J Health Qual Life Outcomes
%V 17
%N 1
%D May 2019 6
%M 31060567
%F 3.077
%R 10.1186/s12955-019-1147-4
%X <B>BACKGROUND: </B>This study aims to describe the short-term reactogenicity of the AS03-adjuvanted H5N1 vaccine expressed through adverse events (AEs) and quality-adjusted life-day (QALD) scores. The AEs are likely to be short-term and therefore the quality of life (QoL) questionnaire, SF-36v2, was administered daily to record changes over seven days. A more sensitive application of this instrument should allow for a better understanding of short-term tolerability of adjuvanted vaccines.<BR><B>METHODS: </B>Participants (N = 50) received a 2-dose vaccination schedule. Solicited (collected daily: days 0 to 7 [post dose 1] and 21 to 28 [post dose 2]) and unsolicited (collected weekly until day 21) AEs were collected via diary cards. The QoL questionnaires were completed daily (days 0-6) and weekly (days 0, 6, 21, 27) after dose one. Questionnaire data were transformed into SF-6D scores to report QALDs. It was hypothesized post-hoc that the QALD and daily AEs scores should correlate if discrete QoL-changes were captured.<BR><B>RESULTS: </B>Pain (92%) and muscle ache (66%) were the most commonly reported solicited local and general AEs respectively, neither increased in intensity nor in frequency after dose 2. No safety concerns were identified during the study. A correlation between the daily AEs and QALD scores existed (correlation coefficient, - 0.97 (p < 0.001)). The impact of the AEs scores on the QALD was marginal (- 0.02 max for one day).<BR><B>CONCLUSIONS: </B>Similarly with other H5N1 studies, no safety concern was identified throughout the study. Some time-limited variations in QALD-scores were reported. Our results imply that daily administration of the SF-36v2 captures changes in QALD-scores.<BR><B>BACKGROUND: </B>ClinicalTrials.gov . NCT01788228. Registered 11 February 2013.