Evidence map›Paper›PMID 31060567›Full record

ArticleHealth and quality of life outcomes2019

Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03

B Standaert, T Dort, J Linden, A Madan, S Bart, L Chu, M S Hayney, M Kosinski, R Kroll, J Malak and 3 more

Registry-linked trialAbstract readValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Health and quality of life outcomes, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01788228 (Safety and Tolerability of GSK 1557484A Vaccine in Adults at Occupational Risk for Influenza A), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01788228 phase3completednot on this map

Safety and Tolerability of GSK 1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure

TypeinterventionalSponsorGlaxoSmithKlineRan2013 to 2015Enrolled50ConditionsInfluenza, Influenza VaccinesArmsInfluenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Current Status of COVID-19 (Pre)Clinical Vaccine Development.Angewandte Chemie (International ed. in English) · 2020
    Review
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

B StandaertGSK, 20 Avenue Fleming, 1300, Wavre, Belgium. BAUDOUIN.A.STANDAERT@GSK.COM.
T DortKeyrus Management SA c/o GSK, Wavre, Belgium.
J LindenGSK, Rockville, MD, USA.
A MadanGSK, Rockville, MD, USA.
S BartOptimal Research LLC, Rockville, MD, USA.
L ChuBenchmark Research, Austin, TX, USA.
M S HayneySchool of Pharmacy, University of Wisconsin-Madison, School of Medicine and Public Health, Madison, WI, USA.
M KosinskiOptum, Lincoln, RI, USA.
R KrollSeattle Women's: Health, Research, Gynecology, University of Washington, Seattle, WA, USA.
J MalakUniversity of Wisconsin-Madison, Madison, WI, USA.
G MeierEisai, Woodcliff Lake, NJ, USA.
N SegallClinical Research Atlanta, Stockbridge, GA, USA.
A SchuindGSK, Rockville, MD, USA.

Funding

Biomedical Advanced Research and Development Authority HHSO100200700029C
6 · The paper itself

Abstract

backgroundThis 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.

methodsParticipants (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.

resultsPain (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).

conclusionSimilarly 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 registrationClinicalTrials.gov . NCT01788228. Registered 11 February 2013.

Indexed as

Adjuvants, ImmunologicAdultFemaleHumansInfluenza A Virus, H5N1 SubtypeInfluenza, HumanInfluenza VaccinesMaleMiddle AgedQuality of LifeSurveys and QuestionnairesTime FactorsVaccinationAdjuvants, ImmunologicInfluenza VaccinesAdjuvanted vaccineAvian influenza AH5N1Quality of lifeReactogenicitySF-36v2 questionnaire

Identifiers

PMID31060567
PMCPMC6501410

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.