Evaluating risk of bias using ROBINS-I tool in nonrandomized studies of adjuvanted influenza vaccine.
Bias
Epidemiology
MF59 Adjuvant
Observational studies
Risk of bias
Journal
Vaccine
ISSN: 1873-2518
Titre abrégé: Vaccine
Pays: Netherlands
ID NLM: 8406899
Informations de publication
Date de publication:
30 Nov 2023
30 Nov 2023
Historique:
received:
09
07
2023
revised:
31
10
2023
accepted:
01
11
2023
medline:
28
11
2023
pubmed:
13
11
2023
entrez:
12
11
2023
Statut:
ppublish
Résumé
Seasonal variation in influenza vaccine effectiveness (VE) makes real-world evidence (RWE) useful in supplementing the clinical-evidence base from randomized clinical trials. Adjuvanted inactivated influenza vaccine (aIIV) VE has been evaluated in multiple nonrandomized RWE studies. A systematic literature review of RWE studies evaluating the absolute or relative VE of aIIV was conducted. Identified studies were assessed by evaluators for risk of bias (RoB) by means of the ROBINS-I (Reduction of Bias In Non-randomized Studies of Interventions) tool to inform evidence-based medicine deliberations. Differences in evaluator assessments were resolved by consensus. The literature review yielded 14 follow-up studies, seven test-negative case-control (TNCC) studies, five traditional case-control studies, and one cluster-randomized clinical trial. Most follow-up studies and three TNCC studies were judged at low RoB. Issues increasing RoB included inadequate control of confounding, selection of controls, and reliance on recall of vaccination. The concerns identified in any of the designs could be mitigated with straightforward revisions to design or implementation. 17 of 27 nonrandomized studies of adjuvanted influenza-vaccine effectiveness, some from each of four study designs, were judged at low risk of material bias. These studies merit credence in assessing aIIV effectiveness relative to other influenza vaccines.
Identifiants
pubmed: 37953097
pii: S0264-410X(23)01302-6
doi: 10.1016/j.vaccine.2023.11.005
pii:
doi:
Substances chimiques
Influenza Vaccines
0
Adjuvants, Immunologic
0
Vaccines, Inactivated
0
Types de publication
Systematic Review
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
7409-7418Informations de copyright
Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: John D. Grabenstein reports financial support was provided by CSL Seqirus. John D. Grabenstein reports a relationship with GSK that includes: consulting or advisory. John D. Grabenstein reports receiving compensation for consulting services from GSK, Janssen, CSL Seqirus, Takeda, Valneva, and VBI Vaccines.