ADVANCE system testing: Can coverage of pertussis vaccination be estimated in European countries using electronic healthcare databases: An example
Emborg, Hanne-Dorthe; Kahlert, Johnny; Braeye, Toon; Bauwens, Jorgen; Bollaerts, Kaatje; Danieli, Giorgia; Duarte-Salles, Talita; Glismann, Steffen; Huerta, Consuelo; de Lusignan, Simon; Martin, Elisa; McGee, Chris; Correa, Ana; Tramontan, Lara; Weibel, Daniel; Sturkenboom, Miriam
(2020) Vaccine, volume 38 Suppl 2, issue 2, pp. B22 - B30
(Article)
Abstract
INTRODUCTION: The Accelerated Development of VAccine beNefit-risk Collaboration in Europe (ADVANCE) is a public-private collaboration aiming to develop and test a system for rapid benefit-risk (B/R) monitoring of vaccines, using existing healthcare databases in Europe. The objective of this paper was to assess the feasibility of using electronic healthcare databases
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to estimate dose-specific acellular pertussis (aP) and whole cell pertussis (wP) vaccine coverage. METHODS: Seven electronic healthcare databases in four European countries (Denmark (n = 2), UK (n = 2), Spain (n = 2) and Italy (n = 1)) participated in this study. Children were included from birth and followed up to age six years. Vaccination exposure was obtained from the databases and classified by type (aP or wP), and dose 1, 2 or 3. Coverage was estimated using period prevalence. For the 2006 birth cohort, two estimation methods for pertussis vaccine coverage, period prevalence and cumulative incidence were compared for each database. RESULTS: The majority of the 2,575,576 children included had been vaccinated at the country-specific recommended ages. Overall, the estimated dose 3 coverage was 88-97% in Denmark (birth cohorts from 2003 to 2014), 96-100% in the UK (2003-2014), 95-98% in Spain (2004-2014) and 94% in Italy (2006-2007). The estimated dose 3 coverage per birth cohort in Denmark and the UK differed by 1-6% compared with national estimates, with our estimates mostly higher. The estimated dose 3 coverage in Spain differed by 0-2% with no consistent over- or underestimation. In Italy, the estimates were 3% lower compared with the national estimates. Except for Italy, for which the two coverage estimation methods generated the same results, the estimated cumulative incidence coverages were consistently 1-10% lower than period prevalence estimates. CONCLUSION: This study showed that it was possible to provide consistent estimates of pertussis immunisation coverage from the electronic healthcare databases included, and that the estimates were comparable with the national estimates.
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Keywords: Acellular pertussis vaccination, Benchmarking, Database characteristics, Proof-of-concept study, Vaccination coverage estimation, Whole cell pertussis vaccination, Molecular Medicine, General Immunology and Microbiology, General Veterinary, Public Health, Environmental and Occupational Health, Infectious Diseases
ISSN: 0264-410X
Publisher: Elsevier
Note: Funding Information: Hanne-Dorthe Emborg, Toon Braeye, Jorgen Bauwens, Kaatje Bollaerts, Giorgia Danieli, Talita Duarte-Salles, Consuelo Huerta Elisa Martin, Chris McGee, Ana Correa and Lara Tramontan declared no conflicts of interest. Johnny Kahlert declared that although he does not personally receive fees, honoraria, or grants he is employed at Department of Clinical Epidemiology, Aarhus University Hospital that receives research grants from various pharmaceutical companies administered by Aarhus University. Steffen Glismann is employed by the GSK group of companies and holds company shares. Simon de Lusignan declared he has received funding through his University to conduct enhanced surveillance of influenza vaccine (GSK), and is a member of Seqirus and Sanofi Pasteur advisory boards for which he received personal payment within the limits defined by his university. Daniel Weibel declared that he has received consultancy fees from GSK unrelated to the submitted work. Miriam Sturkenboom declared that she has received grants from Novartis, CDC and Bill & Melinda Gates Foundation, for work unrelated to the submitted work. Funding Information: The authors would like to acknowledge Klára Berencsi who contributed to the project at AUH (Denmark); Rachel Byford, Mariya Hriskova, Filipa Ferreira, Ivelina Yonova, Sameera Pathirannehelage and Harshana Liyanage who contributed to the project at Surrey University/RCGP RSC (UK); Ana Llorente who contributed to the project at BIFAP (Spain); Yesika Díaz who contributed to the project at SIDIAP (Spain). They also acknowledge that, during preparation of this paper, Palle Valentiner-Branth (SSI, Denmark) and Signe Sørup (AUH, Denmark) provided general insights on the use of vaccines and the relevant literature. Lastly, they acknowledge Lina Titievsky (Pfizer, USA) who contributed as work package co-lead and through her assistance in writing the study report and Margaret Haugh (MediCom Consult, Villeurbanne, France) who provided editorial services for the study report and for this paper. The results described in this publication are from the proof of concept studies conducted as part of the IMI ADVANCE project with the aim of testing the methodological aspects of the design, conduct and reporting of studies for vaccine benefit-risk monitoring activities. The results presented relate solely to the methodological testing and are not intended to inform regulatory or clinical decisions on the benefits and risks of the exposures under investigation. This warning should accompany any use of the results from these studies and they should be used accordingly. The views expressed in this article are the personal views of the authors and should not be understood or quoted as being made on behalf of or reflecting the position of the agencies or organisations with which the authors are affiliated. Funding Information: The research leading to these results received support from the Innovative Medicines Initiative Joint Undertaking under the ADVANCE grant agreement n° 115557 through financial contributions from the European Union's Seventh Framework Programme (FP7/2007–2013) and in kind contribution from participating EFPIA companies. Publisher Copyright: © 2019 The Authors
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