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Multi-centre, multi-database studies with common protocols: Lessons learnt from the IMI PROTECT project

Autor: Klungel, Olaf H., Kurz, Xavier, de Groot, Mark C. H., Schlienger, Raymond G., Tcherny-Lessenot, Stephanie, Grimaldi, Lamiae, Ibáñez, Luisa, Groenwold, Rolf H. H., Reynolds, Robert F., Alvarez, Y., Candore, G., Durand, J., Slattery, J., Hasford, J., Rottenkolber, M., Schmiedl, S., de Abajo Iglesias, F., Gil, M., Gonzalez, R., Huerta Alvarez, C., Martin, E., Oliva, B., Requena, G., Amelio, J., Brauer, R., Downey, G., Feudjo-Tepie, M., Schoonen, M., Johansson, S., Robinson, J., Gallagher, A., Ng, E., van Staa, T.P., Davis, K., Abbing-Karahagopian, V., Ali, S., Belitser, S., de Boer, Anthonius, De Bruin, M.L., Egberts, A.C.G., van Dijk, L., Gardarsdottir, H., Leufkens, H.G.M., Souverein, P., Uddin, J., van den Ham, H.A., Voogd, E., de Vries, Frank, Udo, R., Sub Pharmacotherapy, Theoretical, Sub Gen. Pharmacoepi and Clinical Pharm, Sub Pharmacoepidemiology, Sub Clinical Pharmacy, Pharmacoepi, Pharmacoepidemiology and Clinical Pharmacology

Publikováno v: Pharmacoepidemiology and Drug Safety, 25(supplement S1), 156. John Wiley and Sons Ltd

Purpose: To assess the impact of a variety of methodological parameters on the association between six drug classes and five key adverse events in multiple databases. Methods: The selection of Drug-Adverse Event pairs was based on public health impac

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=narcis______::d0f52b7e343a34242499d148ebeec171
https://dspace.library.uu.nl/handle/1874/336990

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ADVANCE database characterisation and fit for purpose assessment for multi-country studies on the coverage, benefits and risks of pertussis vaccinations.

Autor: Sturkenboom M; 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., Braeye T; Sciensano, Rue Juliette Wytsmanstraat 14, 1050 Brussels, Belgium. Electronic address: toon.braeye@sciensano.be., van der Aa L; Sciensano, Rue Juliette Wytsmanstraat 14, 1050 Brussels, Belgium. Electronic address: lieke.vanderaa@sciensano.be., Danieli G; 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., Dodd C; 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., Duarte-Salles T; 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., Emborg HD; Department of Infectious Disease Epidemiology and Prevention, Statens Serum Institut, Artillerivej 5, DK-2300, Denmark. Electronic address: hde@ssi.dk., Gheorghe M; Erasmus University Medical Center, PO Box 2014, 3000 CA Rotterdam, the Netherlands. Electronic address: m.gheorge@erasmusmc.nl., Kahlert J; Aarhus University Hospital, Olof Palmes Alle 43-45, DK-8200 Aarhus, Denmark. Electronic address: jok@clin.au.dk., Gini R; Agenzia regionale di sanità della Toscana, Osservatorio di epidemiologia, Florence, Italy. Electronic address: rosa.gini@ars.toscana.it., Huerta-Alvarez C; Spanish Agency of Medicines and Medical Devices, Madrid, Spain. Electronic address: chuerta@aemps.es., Martín-Merino E; Spanish Agency of Medicines and Medical Devices, Madrid, Spain. Electronic address: emartinm@aemps.es., McGee C; 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., de Lusignan S; 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., Picelli G; Epidemiological Information for Clinical Research from an Italian Network of Family Paediatricians (PEDIANET), Padova, Italy. Electronic address: g.picelli@virgilio.it., Roberto G; Agenzia regionale di sanità della Toscana, Osservatorio di epidemiologia, Florence, Italy. Electronic address: giuseppe.roberto@ars.toscana.it., Tramontan L; 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., Villa M; ATS della Val Padana, Cremona, Italy. Electronic address: Marco.Villa@ats-valpadana.it., Weibel D; VACCINE.GRID, Basel, Switzerland VACCINE.GRID, Spitalstrasse 33, Basel, Switzerland; Erasmus University Medical Center, PO Box 2014, 3000 CA Rotterdam, the Netherlands., Titievsky L; 219 East 42nd St, NY, NY 10017, USA. Electronic address: lina.titievsky@pfizer.com.

Publikováno v: Vaccine [Vaccine] 2020 Dec 22; Vol. 38 Suppl 2, pp. B8-B21. Date of Electronic Publication: 2020 Feb 12.

Quantifying outcome misclassification in multi-database studies: The case study of pertussis in the ADVANCE project.

Autor: Gini R; Agenzia regionale di sanità della Toscana, Osservatorio di epidemiologia, Florence, Italy. Electronic address: rosa.gini@ars.toscana.it., Dodd CN; Erasmus University Medical Center, Post Box 2040, 3000 CA Rotterdam, Netherlands; Julius Global Health, University Medical Center, Utrecht, Heidelberglaan 100, the Netherlands., Bollaerts K; P95 Epidemiology and Pharmacovigilance, Koning Leopold III laan 1, 3001 Heverlee, Belgium. Electronic address: kaatje.bollaerts@p-95.com., Bartolini C; Agenzia regionale di sanità della Toscana, Osservatorio di epidemiologia, Florence, Italy. Electronic address: claudia.bartolini@ars.toscana.it., Roberto G; Agenzia regionale di sanità della Toscana, Osservatorio di epidemiologia, Florence, Italy. Electronic address: giuseppe.roberto@ars.toscana.it., Huerta-Alvarez C; BIFAP Database, Spanish Agency of Medicines and Medical Devices, Madrid, Spain. Electronic address: chuerta@aemps.es., Martín-Merino E; BIFAP Database, Spanish Agency of Medicines and Medical Devices, Madrid, Spain. Electronic address: emartinm@aemps.es., Duarte-Salles T; Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain. Electronic address: tduarte@idiapjgol.org., Picelli G; Epidemiological Information for Clinical Research from an Italian Network of Family Paediatricians (PEDIANET), Padova, Italy. Electronic address: g.picelli@virgilio.it., Tramontan L; Epidemiological Information for Clinical Research from an Italian Network of Family Paediatricians (PEDIANET), Padova, Italy; Consorzio Arsenal.IT, Veneto Region, Italy. Electronic address: ltramontan@consorzioarsenal.it., Danieli G; Epidemiological Information for Clinical Research from an Italian Network of Family Paediatricians (PEDIANET), Padova, Italy; Consorzio Arsenal.IT, Veneto Region, Italy., Correa A; University of Surrey, Guildford, Surrey GU2 7XH, UK. Electronic address: s.lusignan@surrey.ac.uk., McGee C; 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., Becker BFH; Erasmus University Medical Center, Post Box 2040, 3000 CA Rotterdam, Netherlands. Electronic address: benedikt.becker@posteo.de., Switzer C; Sanofi Pasteur, 1755 Steeles Ave W, North York, ON M2R 3T4, Canada., Gandhi-Banga S; Sanofi Pasteur, 1755 Steeles Ave W, North York, ON M2R 3T4, Canada. Electronic address: sonja.banga@sanofi.com., Bauwens J; University Children's Hospital, Basel, Switzerland; University of Basel, Switzerland; Brighton Collaboration Foundation, Switzerland. Electronic address: j.bauwens@brightoncollaboration.org., van der Maas NAT; University of Basel, Switzerland; Brighton Collaboration Foundation, Switzerland. Electronic address: nicoline.van.der.maas@rivm.nl., Spiteri G; European Centre for Disease Prevention and Control, Gustav III's Boulevard 40, 16973 Solna, Sweden. Electronic address: Gianfranco.Spiteri@ecdc.europa.eu., Sdona E; European Centre for Disease Prevention and Control, Gustav III's Boulevard 40, 16973 Solna, Sweden., Weibel D; Erasmus University Medical Center, Post Box 2040, 3000 CA Rotterdam, Netherlands. Electronic address: d.weibel@erasmusmc.nl., Sturkenboom M; Julius Global Health, University Medical Center, Utrecht, Heidelberglaan 100, the Netherlands; P95 Epidemiology and Pharmacovigilance, Koning Leopold III laan 1, 3001 Heverlee, Belgium; VACCINE.GRID Foundation, Spitalstrasse 33, Basel, Switzerland. Electronic address: m.c.j.sturkenboom@umcutrecht.nl.

Publikováno v: Vaccine [Vaccine] 2020 Dec 22; Vol. 38 Suppl 2, pp. B56-B64. Date of Electronic Publication: 2019 Oct 31.