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Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03(A)-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study
BACKGROUND: 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 admini...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6501410/ https://www.ncbi.nlm.nih.gov/pubmed/31060567 http://dx.doi.org/10.1186/s12955-019-1147-4 |
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author | Standaert, B. Dort, T. Linden, J. Madan, A. Bart, S. Chu, L. Hayney, M. S. Kosinski, M. Kroll, R. Malak, J. Meier, G. Segall, N. Schuind, A. |
author_facet | Standaert, B. Dort, T. Linden, J. Madan, A. Bart, S. Chu, L. Hayney, M. S. Kosinski, M. Kroll, R. Malak, J. Meier, G. Segall, N. Schuind, A. |
author_sort | Standaert, B. |
collection | PubMed |
description | BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov. NCT01788228. Registered 11 February 2013. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12955-019-1147-4) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6501410 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-65014102019-05-10 Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03(A)-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study Standaert, B. Dort, T. Linden, J. Madan, A. Bart, S. Chu, L. Hayney, M. S. Kosinski, M. Kroll, R. Malak, J. Meier, G. Segall, N. Schuind, A. Health Qual Life Outcomes Research BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov. NCT01788228. Registered 11 February 2013. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12955-019-1147-4) contains supplementary material, which is available to authorized users. BioMed Central 2019-05-06 /pmc/articles/PMC6501410/ /pubmed/31060567 http://dx.doi.org/10.1186/s12955-019-1147-4 Text en © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Standaert, B. Dort, T. Linden, J. Madan, A. Bart, S. Chu, L. Hayney, M. S. Kosinski, M. Kroll, R. Malak, J. Meier, G. Segall, N. Schuind, A. Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03(A)-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study |
title | Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03(A)-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study |
title_full | Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03(A)-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study |
title_fullStr | Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03(A)-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study |
title_full_unstemmed | Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03(A)-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study |
title_short | Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03(A)-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study |
title_sort | usability of daily sf36 questionnaires to capture the qald variation experienced after vaccination with as03(a)-adjuvanted monovalent influenza a (h5n1) vaccine in a safety and tolerability study |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6501410/ https://www.ncbi.nlm.nih.gov/pubmed/31060567 http://dx.doi.org/10.1186/s12955-019-1147-4 |
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