Miriam Sturkenboom1, Toon Braeye2, Lieke van der Aa3, Giorgia Danieli4, Caitlin Dodd5, Talita Duarte-Salles6, Hanne-Dorthe Emborg7, Marius Gheorghe8, Johnny Kahlert9, Rosa Gini10, Consuelo Huerta-Alvarez11, Elisa Martín-Merino12, Chris McGee13, Simon de Lusignan14, Gino Picelli15, Giuseppe Roberto16, Lara Tramontan17, Marco Villa18, Daniel Weibel19, Lina Titievsky20. 1. Julius Global Health, University Medical Center Utrecht, Heidelberglaan 100, the Netherlands; VACCINE.GRID, Basel, Switzerland VACCINE.GRID, Spitalstrasse 33, Basel, Switzerland; P-95, Leuven, Belgium Koning Leopold III laan, 1, 3001 Heverlee, Belgium. Electronic address: m.c.j.sturkenboom@umcutrecht.nl. 2. Sciensano, Rue Juliette Wytsmanstraat 14, 1050 Brussels, Belgium. Electronic address: toon.braeye@sciensano.be. 3. Sciensano, Rue Juliette Wytsmanstraat 14, 1050 Brussels, Belgium. Electronic address: lieke.vanderaa@sciensano.be. 4. Consorzio Arsenal.IT, Veneto Region, Italy; Epidemiological Information for Clinical Research from an Italian Network of Family Paediatricians (PEDIANET), Padova, Italy. Electronic address: gdanieli@consorzioarsenal.it. 5. Julius Global Health, University Medical Center Utrecht, Heidelberglaan 100, the Netherlands; Erasmus University Medical Center, PO Box 2014, 3000 CA Rotterdam, the Netherlands. Electronic address: c.n.dodd@umcutrecht.nl. 6. Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain. Electronic address: tduarte@idiapjgol.org. 7. Department of Infectious Disease Epidemiology and Prevention, Statens Serum Institut, Artillerivej 5, DK-2300, Denmark. Electronic address: hde@ssi.dk. 8. Erasmus University Medical Center, PO Box 2014, 3000 CA Rotterdam, the Netherlands. Electronic address: m.gheorge@erasmusmc.nl. 9. Aarhus University Hospital, Olof Palmes Alle 43-45, DK-8200 Aarhus, Denmark. Electronic address: jok@clin.au.dk. 10. Agenzia regionale di sanità della Toscana, Osservatorio di epidemiologia, Florence, Italy. Electronic address: rosa.gini@ars.toscana.it. 11. Spanish Agency of Medicines and Medical Devices, Madrid, Spain. Electronic address: chuerta@aemps.es. 12. Spanish Agency of Medicines and Medical Devices, Madrid, Spain. Electronic address: emartinm@aemps.es. 13. University of Surrey, Guildford, Surrey GU2 7XH, UK; Royal College of General Practitioners, Research and Surveillance Centre, 30 Euston Square, London NW1 2FB, UK. Electronic address: c.mcgee@surrey.ac.uk. 14. University of Surrey, Guildford, Surrey GU2 7XH, UK; Royal College of General Practitioners, Research and Surveillance Centre, 30 Euston Square, London NW1 2FB, UK. Electronic address: s.lusignan@surrey.ac.uk. 15. Epidemiological Information for Clinical Research from an Italian Network of Family Paediatricians (PEDIANET), Padova, Italy. Electronic address: g.picelli@virgilio.it. 16. Agenzia regionale di sanità della Toscana, Osservatorio di epidemiologia, Florence, Italy. Electronic address: giuseppe.roberto@ars.toscana.it. 17. Consorzio Arsenal.IT, Veneto Region, Italy; Epidemiological Information for Clinical Research from an Italian Network of Family Paediatricians (PEDIANET), Padova, Italy. Electronic address: ltramontan@consorzioarsenal.it. 18. ATS della Val Padana, Cremona, Italy. Electronic address: Marco.Villa@ats-valpadana.it. 19. VACCINE.GRID, Basel, Switzerland VACCINE.GRID, Spitalstrasse 33, Basel, Switzerland; Erasmus University Medical Center, PO Box 2014, 3000 CA Rotterdam, the Netherlands. 20. 219 East 42nd St, NY, NY 10017, USA. Electronic address: lina.titievsky@pfizer.com.
Abstract
INTRODUCTION: The public-private ADVANCE consortium (Accelerated development of vaccine benefit-risk collaboration in Europe) aimed to assess if electronic healthcare databases can provide fit-for purpose data for collaborative, distributed studies and monitoring of vaccine coverage, benefits and risks of vaccines. OBJECTIVE: To evaluate if European healthcare databases can be used to estimate vaccine coverage, benefit and/or risk using pertussis-containing vaccines as an example. METHODS: Characterisation was conducted using open-source Java-based (Jerboa) software and R scripts. We obtained: (i) The general characteristics of the database and data source (meta-data) and (ii) a detailed description of the database population (size, representatively of age/sex of national population, rounding of birth dates, delay between birth and database entry), vaccinations (number of vaccine doses, recording of doses, pattern of doses by age and coverage) and events of interest (diagnosis codes, incidence rates). A total of nine databases (primary care, regional/national record linkage) provided data on events (pertussis, pneumonia, death, fever, convulsions, injection site reactions, hypotonic hypo-responsive episode, persistent crying) and vaccines (acellular pertussis and whole cell pertussis) related to the pertussis proof of concept studies. RESULTS: The databases contained data for a total population of 44 million individuals. Seven databases had recorded doses of vaccines. The pertussis coverage estimates were similar to those reported by the World Health Organisation (WHO). Incidence rates of events were comparable in magnitude and age-distribution between databases with the same characteristics. Several conditions (persistent crying and somnolence) were not captured by the databases for which outcomes were restricted to hospital discharge diagnoses. CONCLUSION: The database characterisation programs and workflows allowed for an efficient, transparent and standardised description and verification of electronic healthcare databases which may participate in pertussis vaccine coverage, benefit and risk studies. This approach is ready to be used for other vaccines/events to create readiness for participation in other vaccine related studies. Crown
INTRODUCTION: The public-private ADVANCE consortium (Accelerated development of vaccine benefit-risk collaboration in Europe) aimed to assess if electronic healthcare databases can provide fit-for purpose data for collaborative, distributed studies and monitoring of vaccine coverage, benefits and risks of vaccines. OBJECTIVE: To evaluate if European healthcare databases can be used to estimate vaccine coverage, benefit and/or risk using pertussis-containing vaccines as an example. METHODS: Characterisation was conducted using open-source Java-based (Jerboa) software and R scripts. We obtained: (i) The general characteristics of the database and data source (meta-data) and (ii) a detailed description of the database population (size, representatively of age/sex of national population, rounding of birth dates, delay between birth and database entry), vaccinations (number of vaccine doses, recording of doses, pattern of doses by age and coverage) and events of interest (diagnosis codes, incidence rates). A total of nine databases (primary care, regional/national record linkage) provided data on events (pertussis, pneumonia, death, fever, convulsions, injection site reactions, hypotonic hypo-responsive episode, persistent crying) and vaccines (acellular pertussis and whole cell pertussis) related to the pertussis proof of concept studies. RESULTS: The databases contained data for a total population of 44 million individuals. Seven databases had recorded doses of vaccines. The pertussis coverage estimates were similar to those reported by the World Health Organisation (WHO). Incidence rates of events were comparable in magnitude and age-distribution between databases with the same characteristics. Several conditions (persistent crying and somnolence) were not captured by the databases for which outcomes were restricted to hospital discharge diagnoses. CONCLUSION: The database characterisation programs and workflows allowed for an efficient, transparent and standardised description and verification of electronic healthcare databases which may participate in pertussis vaccine coverage, benefit and risk studies. This approach is ready to be used for other vaccines/events to create readiness for participation in other vaccine related studies. Crown
Authors: Corinne Willame; Caitlin Dodd; Lieke van der Aa; Gino Picelli; Hanne-Dorthe Emborg; Johnny Kahlert; Rosa Gini; Consuelo Huerta; Elisa Martín-Merino; Chris McGee; Simon de Lusignan; Giuseppe Roberto; Marco Villa; Daniel Weibel; Lina Titievsky; Miriam C J M Sturkenboom Journal: Drug Saf Date: 2021-01-19 Impact factor: 5.606
Authors: Gayan Perera; P R Rijnbeek; Myriam Alexander; David Ansell; Paul Avillach; Talita Duarte-Salles; Mark Forrest Gordon; Francesco Lapi; Miguel Angel Mayer; Alessandro Pasqua; Lars Pedersen; Johan van Der Lei; Pieter Jelle Visser; Robert Stewart Journal: BMJ Open Date: 2020-11-14 Impact factor: 2.692