Search

Your search keyword '"Weibel, Daniel"' showing total 191 results
Start Over Author "Weibel, Daniel" Search Limiters Available in Library Collection
191 results on '"Weibel, Daniel"'

4. COVID-19 Vaccine Safety Monitoring Studies in Low- and Middle-Income Countries (LMICs)-A Systematic Review of Study Designs and Methods

Author

Data Science & Biostatistiek, RWE/Causal inference, Child Health, CTM & Statistical consultation, Cancer, Sisay, Malede Mequanent, Montesinos-Guevara, Camila, Osman, Alhadi Khogali, Saraswati, Putri Widi, Tilahun, Binyam, Ayele, Tadesse Awoke, Ahmadizar, Fariba, Durán, Carlos E, Sturkenboom, Miriam C J M, van de Ven, Peter, Weibel, Daniel, Data Science & Biostatistiek, RWE/Causal inference, Child Health, CTM & Statistical consultation, Cancer, Sisay, Malede Mequanent, Montesinos-Guevara, Camila, Osman, Alhadi Khogali, Saraswati, Putri Widi, Tilahun, Binyam, Ayele, Tadesse Awoke, Ahmadizar, Fariba, Durán, Carlos E, Sturkenboom, Miriam C J M, van de Ven, Peter, and Weibel, Daniel

Published
2023

5. COVID-19 Vaccine Safety Monitoring Studies in Low- and Middle-Income Countries (LMICs)—A Systematic Review of Study Designs and Methods

Author

Sisay, Malede Mequanent, primary, Montesinos-Guevara, Camila, additional, Osman, Alhadi Khogali, additional, Saraswati, Putri Widi, additional, Tilahun, Binyam, additional, Ayele, Tadesse Awoke, additional, Ahmadizar, Fariba, additional, Durán, Carlos E., additional, Sturkenboom, Miriam C. J. M., additional, van de Ven, Peter, additional, and Weibel, Daniel, additional

Published
2023
Full Text
View/download PDF

9. Random demographic household surveys in highly mobile pastoral communities in Chad/Enquetes demographiques aleatoires aupres des menages dans les communautes pastorales hautement nomades du Tchad/Encuestas demograficas domiciliarias y aleatorizadas en comunidades pecuarias de elevada movilidad en Chad

Author

Weibel, Daniel, Bechir, Mahamat, Hattendorf, Jan, Bonfoh, Bassirou, Zinsstag, Jakob, and Schelling, Esther

Subjects
Analysis, Surveys, Health surveys -- Analysis, Health planning -- Surveys, Vaccination -- Surveys
Abstract

Problem An estimated 50 million pastoralists live in sub-Saharan Africa. Extensive mobile livestock production systems in sub-Saharan arid and semi-arid zones are important drivers in national economies as fundamental and [...], Problem Reliable demographic data is a central requirement for health planning and management, and for the implementation of adequate interventions. This study addresses the lack of demographic data on mobile pastoral communities in the Sahel. Approach A total of 1081 Arab, Fulani and Gorane women and 2541 children (1336 boys and 1205 girls) were interviewed and registered by a biometric fingerprint scanner in five repeated random transect demographic and health surveys conducted from March 2007 to January 2008 in the Lake Chad region in Chad. Local setting Important determinants for the planning and implementation of household surveys among mobile pastoral communities include: environmental factors; availability of women for interviews; difficulties in defining "own" children; the need for information-education-communication campaigns; and informed consent of husbands in typically patriarchal societies. Relevant changes Due to their high mobility, only 5% (56/1081) of registered women were encountered twice. Therefore, it was not possible to establish a demographic and health cohort. Lessons learnt Prospective demographic and health cohorts are the most accurate method to assess child mortality and other demographic indices. However, their feasibility in a highly mobile pastoral setting remains to be shown. Future interdisciplinary scientific efforts need to target innovative methods, tools and approaches to include marginalized communities in operational health and demographic surveillance systems. Probleme La fiabilite des donnees demographiques constitue un critere majeur, tant pour la planification et la gestion sanitaire que pour la raise en oeuvre d&apos;interventions adequates. Cette etude s&apos;interesse au manque de donnees demographiques concernant les communautes pastorales nomades du Sahel. Approche Au total, 1 081 femmes et 2 541 enfants (1 336 garcons et 1 205 filles) arabes, foulani et goranes ont ete interroges et enregistres I&apos;aide d&apos;un lecteur biometrique d&apos;empreintes digitales, au cours de cinq enquetes sanitaires et demographiques transversales aleatoires successives, realisees entre mars 2007 et janvier 2008 dans la region du lac Tchad au Tchad. Environnement locale Les facteurs determinants pour la planification et la raise en ceuvre d&apos;enquetes aupres des menages des communautes pastorales nomades comprennent: les facteurs environnementaux, la disponibilite des femmes pour les entretiens, les difficultes a identifier leurs <> enfants, le besoin en campagnes d&apos;information, d&apos;education et de communication, ainsi que le consentement eclaire des epoux au sein de ces societes typiquement patriarcales. Changements significatifs Du fair de leur grande mobilite, seulement 5% (56/1 081) des femmes enregistrees ont ete rencontrees a deux reprises. II n&apos;a donc pas ete possible d&apos;etablir de cohorte demographique et sanitaire. Legons tirees Les cohortes demographiques et sanitaires prospectives constituent la methode la plus precise pour evaluer la mortalite infantile et les autres indices demographiques. Cependant, leur faisabilite dans un contexte pastoral hautement nomade reste a prouver. Les prochains efforts scientifiques interdisciplinaires devront cibler des methodes, des outils et des approches novateurs, permettant d&apos;inclure les communautes rnarginalisees dans des systemes de surveillance demographique et sanitaire operationnels. Situacion Contar con datos demograficos fiables es un requisito fundamental para la planificacion y la gestion sanitarias, asi como para la puesta en marcha de las medidas necesarias. El estudio aborda la falta de datos demograficos en las comunidades nomadas de pastores de la region del Sahel. Enfoque Se realizaron entrevistas a un total de 1081 mujeres y de 2541 ninos (1336 ninos y 1205 ninas) arabes, fulanis y goraneses, y se les incluyo en un registro mediante un lector optico-biometrico de las huellas dactilares en cinco encuestas demograficas y de salud aleatorias, repetidas y transversales que se realizaron entre marzo de 2007 y enero de 2008 en la region del Lago Chad, en Chad. Marco regional Entre los determinantes mas importantes de la planificacion y la puesta en marcha de las encuestas domiciliarias en las comunidades nomadas pastoriles se encuentran: los factores medioambientales, la disponibilidad de las mujeres para realizar las entrevistas, las dificultades para definir cuales son <> hijos, la necesidad de desarrollar campanas de informacion-educacion-comunicacion y la obtencion de los consentimientos informados de los maridos en las sociedades patriarcales tipicas. Carnbios importantes Debido a su elevada movilidad, solo pudimos volver a encontrarnos con el 5% (56:1081) de las mujeres registradas. Por Io tanto, no fue posible establecer una cohorte demografica y sanitaria. Lecciones aprendidas Las cohortes prospectivas de caracter demografico y sanitario son el metodo mas preciso para evaluar la mortalidad infantil y otros indices demograficos. No obstante, sigue sin demostrarse su viabilidad en grupos de pastores que se desplazan mucho. Los futuros esfuerzos cientificos interdisciplinarios deben dirigirse a la obtencion de metodos, herramientas y enfoques innovadores que incluyan alas comunidades marginadas en los sistemas operativos de control demografico y sanitario.

Published
2011
Full Text
View/download PDF

11. Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project

Author

Willame, C, Dodd, C, van der Aa, L, Picelli, G, Emborg, HD, Kahlert, J, Gini, R, Huerta, C, Martin-Merino, E, McGee, C, de Lusignan, S, Roberto, G, Villa, M, Weibel, Daniel, Titievsky, L, Sturkenboom, M, Willame, C, Dodd, C, van der Aa, L, Picelli, G, Emborg, HD, Kahlert, J, Gini, R, Huerta, C, Martin-Merino, E, McGee, C, de Lusignan, S, Roberto, G, Villa, M, Weibel, Daniel, Titievsky, L, and Sturkenboom, M

Abstract

Introduction: The public–private ADVANCE collaboration developed and tested a system to generate evidence on vaccine benefits and risks using European electronic healthcare databases. In the safety of vaccines, background incidence rates are key to allow proper monitoring and assessment. The goals of this study were to compute age-, sex-, and calendar-year stratified incidence rates of nine autoimmune diseases in seven European healthcare databases from four countries and to assess validity by comparing with published data. Methods: Event rates were calculated for the following outcomes: acute disseminated encephalomyelitis, Bell’s palsy, Guillain–Barré syndrome, immune thrombocytopenia purpura, Kawasaki disease, optic neuritis, narcolepsy, systemic lupus erythematosus, and transverse myelitis. Cases were identified by diagnosis codes. Participating organizations/databases originated from Denmark, Italy, Spain, and the UK. The source population comprised all persons registered, with at least 1 year of data prior to the study start, or follow-up from birth. Stratified incidence rates were computed per database over the period 2003 to 2014. Results: Between 2003 and 2014, 148,947 incident cases of nine autoimmune diseases were identified. Crude incidence rates were highest for Bell’s palsy [23.8/100,000 person-years (PYs), 95% confidence interval (CI) 23.6–24.1] and lowest for Kawasaki disease (0.7/100,000 PYs, 95% CI 0.6–0.7). Specific patterns were observed by sex, age, calendar time, and data sources. Rates were comparable with published estimates. Conclusion: A range of autoimmune events could be identified in the ADVANCE system. Estimation of rates indicated consistency across selected European healthcare databases, as well as consistency with US published data.

Published
2021

12. Diurnal variations in multi-sensor wearable-derived sleep characteristics in morning- and evening-type shift workers under naturalistic conditions

Author

Clark, Ian, Stucky, Benjamin, Azza, Yasmine, Schwab, Patrick, Müller, Stefan, Weibel, Daniel, Button, Daniel, Karlen, Walter, Seifritz, Erich, Kleim, Birgit, Landolt, Hans-Peter; https://orcid.org/0000-0003-0887-9403, Clark, Ian, Stucky, Benjamin, Azza, Yasmine, Schwab, Patrick, Müller, Stefan, Weibel, Daniel, Button, Daniel, Karlen, Walter, Seifritz, Erich, Kleim, Birgit, and Landolt, Hans-Peter; https://orcid.org/0000-0003-0887-9403

Abstract

Consumer-grade, multi-sensor, rest-activity trackers may be powerful tools, to help optimize rest-activity management in shiftwork populations undergoing circadian misalignment. Nevertheless, performance testing of such devices under field conditions is scarce. We previously validated Fitbit Charge 2TM against home polysomnography and now evaluated the potential of this device to document differences in rest-activity behavior, including sleep macrostructure, in first-responder shift workers in an operational setting. We continuously monitored 89 individuals (54% females; mean age: 33.9 ± 7.7 years) for 32.5 ± 9.3 days and collected 2,974 individual sleep episodes scattered around the clock. We stratified the study participants according to their self-reported circadian preference on the reduced Horne-Östberg Morningness-Evening Questionnaire (rMEQ; the scores from 4 participants were missing). Fitbit estimates of sleep duration, wakefulness after sleep onset (WASO), REM sleep percentage in the first NREM-REM sleep cycle, and REM sleep latency formed approximately sinusoidal oscillations across 24 hours. Generalized additive mixed model analyses revealed that the phase position of sleep duration minimum was delayed by 2.8 h in evening types (ET; rMEQ ≤ 11; n = 20) and by 2.6 h in intermediate types (IT; 11 < rMEQ < 18; n = 45) when compared to morning types (MT; rMEQ ≥ 18; n = 20). Similarly, the phase position of WASO was delayed by 2.7 h in ET compared to MT. While nocturnal sleep duration did not differ among the three groups, sleep episodes during the biological day decreased in duration from ET to IT to MT. Together, the findings support the notion that a consumer-grade, rest-activity tracker allows estimation of behavioral sleep/wake cycles and sleep macrostructure in shift workers under naturalistic conditions that are consistent with their self-reported chronotype.

Published
2021

13. Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project

Author

RWE/Causal inference, Epi Infectieziekten Team 2, Data Science & Biostatistiek, JC onderzoeksprogramma Cardiovascular Health, Willame, Corinne, Dodd, Caitlin, van der Aa, Lieke, Picelli, Gino, Emborg, Hanne-Dorthe, Kahlert, Johnny, Gini, Rosa, Huerta, Consuelo, Martín-Merino, Elisa, McGee, Chris, de Lusignan, Simon, Roberto, Giuseppe, Villa, Marco, Weibel, Daniel, Titievsky, Lina, Sturkenboom, Miriam C J M, RWE/Causal inference, Epi Infectieziekten Team 2, Data Science & Biostatistiek, JC onderzoeksprogramma Cardiovascular Health, Willame, Corinne, Dodd, Caitlin, van der Aa, Lieke, Picelli, Gino, Emborg, Hanne-Dorthe, Kahlert, Johnny, Gini, Rosa, Huerta, Consuelo, Martín-Merino, Elisa, McGee, Chris, de Lusignan, Simon, Roberto, Giuseppe, Villa, Marco, Weibel, Daniel, Titievsky, Lina, and Sturkenboom, Miriam C J M

Published
2021

15. Bridging research integrity and global health epidemiology (BRIDGE) statement: guidelines for good epidemiological practice

Author

Alba, Sandra, primary, Verdonck, Kristien, additional, Lenglet, Annick, additional, Rumisha, Susan F, additional, Wienia, Martijn, additional, Teunissen, Imre, additional, Straetemans, Masja, additional, Mendoza, Walter, additional, Jeannetot, Daniel, additional, Weibel, Daniel, additional, Mayanja-Kizza, Harriet, additional, and Juvekar, Sanjay, additional

Published
2020
Full Text
View/download PDF

17. Systematic Review and Meta-analysis of Postlicensure Observational Studies on Human Papillomavirus Vaccination and Autoimmune and Other Rare Adverse Events

Author

Global Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Willame, Corinne, Gadroen, Kartini, Bramer, Wichor, Weibel, Daniel, Sturkenboom, Miriam, Global Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Willame, Corinne, Gadroen, Kartini, Bramer, Wichor, Weibel, Daniel, and Sturkenboom, Miriam

Published
2020

18. Advance system testing: Vaccine benefit studies using multi-country electronic health data:The example of pertussis vaccination

Author

Tin Tin Htar, Myint, de Ridder, Maria, Braeye, Toon, Correa, Ana, McGee, Chris, de Lusignan, Simon, Duarte-Salles, Talita, Huerta-Alvarez, Consuelo, Martín-Merino, Elisa, Tramontan, Lara, Danieli, Giorgia, Picelli, Gino, van der Maas, Nicoline, Berencsi, Klara, Arnheim-Dahlström, Lisen, Heininger, Ulrich, Emborg, Hanne Dorthe, Weibel, Daniel, Bollaerts, Kaatje, Sturkenboom, M, Tin Tin Htar, Myint, de Ridder, Maria, Braeye, Toon, Correa, Ana, McGee, Chris, de Lusignan, Simon, Duarte-Salles, Talita, Huerta-Alvarez, Consuelo, Martín-Merino, Elisa, Tramontan, Lara, Danieli, Giorgia, Picelli, Gino, van der Maas, Nicoline, Berencsi, Klara, Arnheim-Dahlström, Lisen, Heininger, Ulrich, Emborg, Hanne Dorthe, Weibel, Daniel, Bollaerts, Kaatje, and Sturkenboom, M

Published
2020

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

Author

Gini, Rosa, Dodd, Caitlin, Bollaerts, Kaatje, Bartolini, Claudia, Roberto, Guiseppe, Huerta-Alvarez, Consuelo, Martín-Merino, Elisa, Duarte-Salles, Talita, Picelli, Gino, Tramontan, Lara, Danieli, Giorgia, Correa, Ana, McGee, Chris, Becker, Benedikt F.H., Switzer, Charlotte, Gandhi-Banga, Sonja, Bauwens, Jorgen, van der Maas, Nicoline A.T., Spiteri, Gianfranco, Sdona, Emmanouela, Weibel, Daniel, Sturkenboom, Miriam, Gini, Rosa, Dodd, Caitlin, Bollaerts, Kaatje, Bartolini, Claudia, Roberto, Guiseppe, Huerta-Alvarez, Consuelo, Martín-Merino, Elisa, Duarte-Salles, Talita, Picelli, Gino, Tramontan, Lara, Danieli, Giorgia, Correa, Ana, McGee, Chris, Becker, Benedikt F.H., Switzer, Charlotte, Gandhi-Banga, Sonja, Bauwens, Jorgen, van der Maas, Nicoline A.T., Spiteri, Gianfranco, Sdona, Emmanouela, Weibel, Daniel, and Sturkenboom, Miriam

Published
2020

20. Age-specific vaccination coverage estimates for influenza, human papillomavirus and measles containing vaccines from seven population-based healthcare databases from four EU countries - The ADVANCE project

Author

Braeye, T, Emborg, HD, Llorente-Garcia, A, Huerta, C, Martin-Merino, E, Duarte-Salles, T, Danieli, G, Tramontan, L, Weibel, Daniel, McGee, C, Villa, M, Gini, R, Lehtinen, M, Titievsky, L, Sturkenboom, M, Braeye, T, Emborg, HD, Llorente-Garcia, A, Huerta, C, Martin-Merino, E, Duarte-Salles, T, Danieli, G, Tramontan, L, Weibel, Daniel, McGee, C, Villa, M, Gini, R, Lehtinen, M, Titievsky, L, and Sturkenboom, M

Published
2020

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

Author

Sturkenboom, M, Braeye, T, van der Aa, L, Danieli, G, Dodd, Caitlin, Duarte-Salles, T, Emborg, HD, Gheorghe, M, Kahlert, J, Gini, R, Huerta-Alvarez, C, Martín-Merino, E, McGee, C, de Lusignan, S, Picelli, G, Roberto, G, Tramontan, L, Villa, M, Weibel, Daniel, Titievsky, L, Sturkenboom, M, Braeye, T, van der Aa, L, Danieli, G, Dodd, Caitlin, Duarte-Salles, T, Emborg, HD, Gheorghe, M, Kahlert, J, Gini, R, Huerta-Alvarez, C, Martín-Merino, E, McGee, C, de Lusignan, S, Picelli, G, Roberto, G, Tramontan, L, Villa, M, Weibel, Daniel, and Titievsky, L

Published
2020

22. ADVANCE system testing: Can safety studies be conducted using electronic healthcare data?:An example using pertussis vaccination

Author

Weibel, Daniel, Dodd, Caitlin, Mahaux, Olivia, Haguinet, Francois, De Smedt, Tom, Duarte-Salles, Talita, Picelli, Gino, Tramontan, Lara, Danieli, Giorgio, Correa, Ana, McGee, Chris, Martín-Merino, Elisa, Huerta-Alvarez, Consuelo, Berencsi, Klara, Emborg, Hanne Dorthe, Bollaerts, Kaatje, Bauchau, Vincent, Titievsky, Lina, Sturkenboom, MCJM, Weibel, Daniel, Dodd, Caitlin, Mahaux, Olivia, Haguinet, Francois, De Smedt, Tom, Duarte-Salles, Talita, Picelli, Gino, Tramontan, Lara, Danieli, Giorgio, Correa, Ana, McGee, Chris, Martín-Merino, Elisa, Huerta-Alvarez, Consuelo, Berencsi, Klara, Emborg, Hanne Dorthe, Bollaerts, Kaatje, Bauchau, Vincent, Titievsky, Lina, and Sturkenboom, MCJM

Published
2020

23. ADVANCE system testing: Benefit-risk analysis of a marketed vaccine using multi-criteria decision analysis and individual-level state transition modelling

Author

Bollaerts, K, Ledent, E, De Smedt, T, Weibel, Daniel, Emborg, HD, Danieli, G, Duarte-Salles, T, Huerta-Alvarez, C, Martín-Merino, E, Picelli, G, Tramontan, L, Sturkenboom, MCJM, Bauchau, V, Bollaerts, K, Ledent, E, De Smedt, T, Weibel, Daniel, Emborg, HD, Danieli, G, Duarte-Salles, T, Huerta-Alvarez, C, Martín-Merino, E, Picelli, G, Tramontan, L, Sturkenboom, MCJM, and Bauchau, V

Published
2020

24. ADVANCE system testing: Estimating the incidence of adverse events following pertussis vaccination in healthcare databases with incomplete exposure data

Author

Dodd, Caitlin, de Ridder, Maria, Weibel, Daniel, Mahaux, O, Haguinet, F, De Smedt, T, de Lusignan, S, McGee, C, Duarte-Salles, T, Emborg, HD, Huerta-Alvarez, C, Martín-Merino, E, Picelli, G, Berencsi, K, Danieli, G, Sturkenboom, MCJM, Dodd, Caitlin, de Ridder, Maria, Weibel, Daniel, Mahaux, O, Haguinet, F, De Smedt, T, de Lusignan, S, McGee, C, Duarte-Salles, T, Emborg, HD, Huerta-Alvarez, C, Martín-Merino, E, Picelli, G, Berencsi, K, Danieli, G, and Sturkenboom, MCJM

Published
2020

25. ADVANCE system testing: Can coverage of pertussis vaccination be estimated in European countries using electronic healthcare databases:An example

Author

Emborg, HD, Kahlert, Johnny, Braeye, Toon, Bauwens, Jorgen, Bollaerts, Kaatje, Danieli, Giorgia, Duarte-Salles, Talita, Glismann, Steffen, Huerta-Alvarez, Consuelo, de Lusignan, Simon, Martín-Merino, Elisa, McGee, Chris, Correa, Ana, Tramontan, Lara, Weibel, Daniel, Sturkenboom, M, Emborg, HD, Kahlert, Johnny, Braeye, Toon, Bauwens, Jorgen, Bollaerts, Kaatje, Danieli, Giorgia, Duarte-Salles, Talita, Glismann, Steffen, Huerta-Alvarez, Consuelo, de Lusignan, Simon, Martín-Merino, Elisa, McGee, Chris, Correa, Ana, Tramontan, Lara, Weibel, Daniel, and Sturkenboom, M

Published
2020

26. ADVANCE system testing: Estimating the incidence of adverse events following pertussis vaccination in healthcare databases with incomplete exposure data

Author

Global Health, RWE/Causal inference, Data Science & Biostatistiek, JC onderzoeksprogramma Cardiovascular Health, Dodd, Caitlin, de Ridder, Maria, Weibel, Daniel, Mahaux, Olivia, Haguinet, Francois, de Smedt, Tom, de Lusignan, Simon, McGee, Chris, Duarte-Salles, Talita, Emborg, Hanne-Dorthe, Huerta-Alvarez, Consuelo, Martín-Merino, Elisa, Picelli, Gino, Berencsi, Klara, Danieli, Giorgia, Sturkenboom, Miriam, Global Health, RWE/Causal inference, Data Science & Biostatistiek, JC onderzoeksprogramma Cardiovascular Health, Dodd, Caitlin, de Ridder, Maria, Weibel, Daniel, Mahaux, Olivia, Haguinet, Francois, de Smedt, Tom, de Lusignan, Simon, McGee, Chris, Duarte-Salles, Talita, Emborg, Hanne-Dorthe, Huerta-Alvarez, Consuelo, Martín-Merino, Elisa, Picelli, Gino, Berencsi, Klara, Danieli, Giorgia, and Sturkenboom, Miriam

Published
2020

27. Vaccines safety and maternal knowledge for enhanced maternal immunization acceptability in rural Uganda: A qualitative study approach

Author

Global Health, Global Health team 1, RWE/Causal inference, Data Science & Biostatistiek, Kajungu, Dan, Muhoozi, Michael, Stark, James, Weibel, Daniel, Sturkenboom, Miriam C J M, Global Health, Global Health team 1, RWE/Causal inference, Data Science & Biostatistiek, Kajungu, Dan, Muhoozi, Michael, Stark, James, Weibel, Daniel, and Sturkenboom, Miriam C J M

Published
2020

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

Author

Global Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Sturkenboom, Miriam, Braeye, Toon, van der Aa, Lieke, Danieli, Giorgia, Dodd, Caitlin, Duarte-Salles, Talita, Emborg, Hanne-Dorthe, Gheorghe, Marius, Kahlert, Johnny, Gini, Rosa, Huerta, Consuelo, Martín-Merino, Elisa, McGee, Chris, de Lusignan, Simon, Picelli, Gino, Roberto, Giuseppe, Tramontan, Lara, Villa, Marco, Weibel, Daniel, Titievsky, Lina, Global Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Sturkenboom, Miriam, Braeye, Toon, van der Aa, Lieke, Danieli, Giorgia, Dodd, Caitlin, Duarte-Salles, Talita, Emborg, Hanne-Dorthe, Gheorghe, Marius, Kahlert, Johnny, Gini, Rosa, Huerta, Consuelo, Martín-Merino, Elisa, McGee, Chris, de Lusignan, Simon, Picelli, Gino, Roberto, Giuseppe, Tramontan, Lara, Villa, Marco, Weibel, Daniel, and Titievsky, Lina

Published
2020

29. ADVANCE system testing: Benefit-risk analysis of a marketed vaccine using multi-criteria decision analysis and individual-level state transition modelling

Author

Global Health, JC onderzoeksprogramma Infectieziekten, Bollaerts, Kaatje, Ledent, Edouard, de Smedt, Tom, Weibel, Daniel, Emborg, Hanne-Dorthe, Danieli, Giorgia, Duarte-Salles, Talita, Huerta, Consuelo, Martín-Merino, Elisa, Picelli, Gino, Tramontan, Lara, Sturkenboom, Miriam, Bauchau, Vincent, Global Health, JC onderzoeksprogramma Infectieziekten, Bollaerts, Kaatje, Ledent, Edouard, de Smedt, Tom, Weibel, Daniel, Emborg, Hanne-Dorthe, Danieli, Giorgia, Duarte-Salles, Talita, Huerta, Consuelo, Martín-Merino, Elisa, Picelli, Gino, Tramontan, Lara, Sturkenboom, Miriam, and Bauchau, Vincent

Published
2020

30. Advance system testing: Vaccine benefit studies using multi-country electronic health data - The example of pertussis vaccination

Author

Global Health, JC onderzoeksprogramma Infectious Diseases, Tin Tin Htar, Myint, de Ridder, Maria, Braeye, Toon, Correa, Ana, McGee, Chris, de Lusignan, Simon, Duarte-Salles, Talita, Huerta, Consuelo, Martín-Merino, Elisa, Tramontan, Lara, Danieli, Giorgia, Picelli, Gino, van der Maas, Nicoline, Berencsi, Klara, Arnheim-Dahlström, Lisen, Heininger, Ulrich, Emborg, Hanne-Dorthe, Weibel, Daniel, Bollaerts, Kaatje, Sturkenboom, Miriam, Global Health, JC onderzoeksprogramma Infectious Diseases, Tin Tin Htar, Myint, de Ridder, Maria, Braeye, Toon, Correa, Ana, McGee, Chris, de Lusignan, Simon, Duarte-Salles, Talita, Huerta, Consuelo, Martín-Merino, Elisa, Tramontan, Lara, Danieli, Giorgia, Picelli, Gino, van der Maas, Nicoline, Berencsi, Klara, Arnheim-Dahlström, Lisen, Heininger, Ulrich, Emborg, Hanne-Dorthe, Weibel, Daniel, Bollaerts, Kaatje, and Sturkenboom, Miriam

Published
2020

31. ADVANCE system testing: Can safety studies be conducted using electronic healthcare data? An example using pertussis vaccination

Author

Global Health, JC onderzoeksprogramma Infectious Diseases, Weibel, Daniel, Dodd, Caitlin, Mahaux, Olivia, Haguinet, Francois, De Smedt, Tom, Duarte-Salles, Talita, Picelli, Gino, Tramontan, Lara, Danieli, Giorgia, Correa, Ana, McGee, Chris, Martín-Merino, Elisa, Huerta, Consuelo, Berencsi, Klara, Emborg, Hanne-Dorthe, Bollaerts, Kaatje, Bauchau, Vincent, Titievsky, Lina, Sturkenboom, Miriam, Global Health, JC onderzoeksprogramma Infectious Diseases, Weibel, Daniel, Dodd, Caitlin, Mahaux, Olivia, Haguinet, Francois, De Smedt, Tom, Duarte-Salles, Talita, Picelli, Gino, Tramontan, Lara, Danieli, Giorgia, Correa, Ana, McGee, Chris, Martín-Merino, Elisa, Huerta, Consuelo, Berencsi, Klara, Emborg, Hanne-Dorthe, Bollaerts, Kaatje, Bauchau, Vincent, Titievsky, Lina, and Sturkenboom, Miriam

Published
2020

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

Author

Global Health, JC onderzoeksprogramma Infectieziekten, Gini, Rosa, Dodd, Caitlin N, Bollaerts, Kaatje, Bartolini, Claudia, Roberto, Giuseppe, Huerta-Alvarez, Consuelo, Martín-Merino, Elisa, Duarte-Salles, Talita, Picelli, Gino, Tramontan, Lara, Danieli, Giorgia, Correa, Ana, McGee, Chris, Becker, Benedikt F H, Switzer, Charlotte, Gandhi-Banga, Sonja, Bauwens, Jorgen, van der Maas, Nicoline A T, Spiteri, Gianfranco, Sdona, Emmanouela, Weibel, Daniel, Sturkenboom, Miriam, Global Health, JC onderzoeksprogramma Infectieziekten, Gini, Rosa, Dodd, Caitlin N, Bollaerts, Kaatje, Bartolini, Claudia, Roberto, Giuseppe, Huerta-Alvarez, Consuelo, Martín-Merino, Elisa, Duarte-Salles, Talita, Picelli, Gino, Tramontan, Lara, Danieli, Giorgia, Correa, Ana, McGee, Chris, Becker, Benedikt F H, Switzer, Charlotte, Gandhi-Banga, Sonja, Bauwens, Jorgen, van der Maas, Nicoline A T, Spiteri, Gianfranco, Sdona, Emmanouela, Weibel, Daniel, and Sturkenboom, Miriam

Published
2020

33. ADVANCE system testing: Can coverage of pertussis vaccination be estimated in European countries using electronic healthcare databases: An example

Author

Global Health, JC onderzoeksprogramma Infectious Diseases, 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, Global Health, JC onderzoeksprogramma Infectious Diseases, 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, and Sturkenboom, Miriam

Published
2020

35. Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines – Multi-country assessment

Author

Weibel, Daniel, Sturkenboom, Miriam, Black, Steven, de Ridder, Maria A. J., Dodd, Caitlin, Bonhoeffer, Jan, Vanrolleghem, Ann, van der Maas, Nicoline, Lammers, Gert Jan, Overeem, Sebastiaan, Gentile, Angela, Giglio, Norberto, Castellano, Vanesa, Kwong, Jeffrey C., Murray, Brian J., Cauch-Dudek, Karen, Juhasz, Diana, Campitelli, Michael, Datta, Alexandre N., Kallweit, Ulf, Huang, Wan-Ting, Huang, Yu-Shu, Hsu, Chung-Yao, Chen, Hsi-Chung, Giner-Soriano, Maria, Morros, Rosa, Gaig, Carles, Tió, Ester, Perez-Vilar, Silvia, Diez-Domingo, Javier, Puertas, Francisco Javier, Svenson, Lawrence W., Mahmud, Salaheddin M., Carleton, Bruce, Naus, Monika, Arnheim-Dahlström, Lisen, Pedersen, Lars, DeStefano, Frank, Shimabukuro, Tom T., Universitat Autònoma de Barcelona, [Weibel D, de Ridder M, Dodd C, Vanrolleghem A, Perez-Vilar S] Medical Informatics Department, Erasmus Medical Center, Rotterdam, The Netherlands. [Sturkenboom M] Julius Global Health, University Utrecht Medical Center, Utrecht, The Netherlands. [Black S] Cincinnati Children’s Hospital, Cincinnati, OH, USA. [Bonhoeffer J] Infectiology and Vaccinology University Children’s Hospital, Basel, Switzerland. Brighton Collaboration Foundation, Basel, Switzerland. [van der Maas N] Dept. Epidemiology and Surveillance, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands. [Lammers GJ] Leiden University Medical Centre, Leiden, The Netherlands. Sleep-Wake Center SEIN, Heemstede, The Netherlands. [Overeem S] Sleep Medicine Centre Kempenhaeghe, Heeze, The Netherlands. [Gentile A, Giglio N, Castellano V] Hospital de Niños Ricardo Gutiérrez, Ciudad Autónoma de Buenos Aires, Argentina. [Kwong JC, Cauch-Dudek K, Juhasz D, Campitelli M] Institute for Clinical Evaluative Sciences (ICES), Ontario, Canada. [Murray BJ] Division of Neurology, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Canada. [Datta AN] University Hospital Basel, Basel, Switzerland. [Kallweit U] Bern University Hospital and University of Bern, Bern, Switzerland. Witten/Herdecke University, Department of Rehabilitation, Witten/Herdecke, Germany. [Huang WT] Taiwan Centers for Disease Control, Taipei, Taiwan. [Huang YS] Department of Child Psychiatry and Sleep Center, Chang Gung Memorial Hospital and University, Taoyuan, Taiwan. [Hsu CY] Department of Neurology and Sleep Disorders Center, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan. [Chen HC] Department of Psychiatry and Center of Sleep Disorders, National Taiwan University Hospital, Taipei, Taiwan. [Giner-Soriano M, Morros R] Institut Universitari d’Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain. [Gaig C] Neurology Service and Multidisciplinary Sleep Disorders Unit, Hospital Clinic of Barcelona, Barcelona, Spain. [Tió E] Althaia Xarxa Assistencial Universitària de Manresa, Neurology Service, Manresa, Barcelona, Spain. [Perez-Vilar S, Diez-Domingo J] Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (FISABIO), Vaccine Research, Valencia, Spain. [Puertas FJ] Servicio de Neurofisiologia, Hospital Universitari de la Ribera, Valencia, Spain. [Svenson LW] Division of Preventive Medicine, University of Alberta, Alberta, Canada. [Mahmud SM] Vaccine and Drug Evaluation Centre, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Manitoba, Canada. [Carleton B] Faculty of Medicine, University of British Columbia, British Columbia, Canada. [Arnheim-Dahlström L] Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden. [Pedersen L] Clinical Medicine/Epidemiology, Aarhus University, Aarhus, Denmark. [DeStefano F, Shimabukuro TT] Centers for Disease Control and Prevention (CDC), Immunization Safety Office, Atlanta, USA, IDIAP Jordi Gol, Medical Informatics, Signal Processing Systems, Eindhoven MedTech Innovation Center, and Biomedical Diagnostics Lab

Subjects
Narcolepsy/immunology, MF59, Grip A (H1N1) - Vacunació - Estudi de casos, SDG 3 – Goede gezondheid en welzijn, Otros calificadores::Otros calificadores::/efectos adversos [Otros calificadores], AS03, Influenza Vaccines/therapeutic use, Nervous System Diseases::Sleep Wake Disorders::Dyssomnias::Sleep Disorders, Intrinsic::Disorders of Excessive Somnolence::Narcolepsy [DISEASES], 0302 clinical medicine, Influenza A Virus, H1N1 Subtype, Pandemic, Influenza, Human/immunology, Influenza A Virus, Pandemrix, Medicine, Enfermedades del Sistema Nervioso::Trastornos del Sueño-Vigilia::Disomnias::Trastornos Intrínsecos del Sueño::Trastornos de Somnolencia Excesiva::Narcolepsia [ENFERMEDADES], 030212 general & internal medicine, virus::virus ARN::Orthomyxoviridae::Influenzavirus A::virus de la gripe A::virus de la gripe A del subtipo H1N1 [ORGANISMOS], Adjuvant, Incidence (epidemiology), Vaccination, Human/immunology, Infectious Diseases, Influenza A Virus, H1N1 Subtype/immunology, Influenza Vaccines, Adjuvants immunològics, técnicas de investigación::métodos epidemiológicos::características de los estudios epidemiológicos::estudios epidemiológicos::estudios de cohortes [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Molecular Medicine, Public Health, Immunologic/therapeutic use, Terapéutica::Terapia Biológica::Inmunomodulación::Inmunoterapia::Inmunización::Inmunoterapia Activa::Vacunación [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Narcolèpsia, Virus::Virus ARN::Orthomyxoviridae::Influenzavirus A::Virus de la Influenza A::Subtipo H1N1 del Virus de la Influenza A [ORGANISMOS], Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics::Epidemiologic Studies::Cohort Studies [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT], Técnicas de Investigación::Métodos Epidemiológicos::Características de Estudios Epidemiológicos::Estudios Epidemiológicos::Estudios de Cohortes [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Article, 03 medical and health sciences, SDG 3 - Good Health and Well-being, Adjuvants, Immunologic, Environmental health, Immunology and Microbiology(all), Influenza, Human, Other subheadings::Other subheadings::/adverse effects [Other subheadings], Humans, Adjuvants, H1N1 Subtype/immunology, Narcolepsy, Retrospective Studies, General Veterinary, General Immunology and Microbiology, Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy::Immunization::Immunotherapy, Active::Vaccination [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT], business.industry, terapéutica::terapia biológica::inmunomodulación::inmunoterapia::inmunización::inmunoterapia activa::vacunación [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Environmental and Occupational Health, Public Health, Environmental and Occupational Health, Retrospective cohort study, Pandemic H1N1 influenza, medicine.disease, Adjuvants, Immunologic/therapeutic use, veterinary(all), Influenza, Viruses::RNA Viruses::Orthomyxoviridae::Influenzavirus A::Influenza A virus::Influenza A Virus, H1N1 Subtype [ORGANISMS], Case-Control Studies, business, 030217 neurology & neurosurgery
Abstract

Altres ajuts: This study was funded by the Centers for Disease Control and Prevention (CDC), Atlanta, USA, under CDC contract number 200-2012-53425_addendum 0001. This study was also supported by Public Health Ontario (PHO) and the Institute for Clinical Evaluative Sciences (ICES), which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care (MOHLTC). In 2010, a safety signal was detected for narcolepsy following vaccination with Pandemrix, an AS03-adjuvanted monovalent pandemic H1N1 influenza (pH1N1) vaccine. To further assess a possible association and inform policy on future use of adjuvants, we conducted a multi-country study of narcolepsy and adjuvanted pH1N1 vaccines. We used electronic health databases to conduct a dynamic retrospective cohort study to assess narcolepsy incidence rates (IR) before and during pH1N1 virus circulation, and after pH1N1 vaccination campaigns in Canada, Denmark, Spain, Sweden, Taiwan, the Netherlands, and the United Kingdom. Using a case-control study design, we evaluated the risk of narcolepsy following AS03- and MF59-adjuvanted pH1N1 vaccines in Argentina, Canada, Spain, Switzerland, Taiwan, and the Netherlands. In the Netherlands, we also conducted a case-coverage study in children born between 2004 and 2009. No changes in narcolepsy IRs were observed in any periods in single study sites except Sweden and Taiwan; in Taiwan incidence increased after wild-type pH1N1 virus circulation and in Sweden (a previously identified signaling country), incidence increased after the start of pH1N1 vaccination. No association was observed for Arepanrix-AS03 or Focetria-MF59 adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the case-control study nor for children born between 2004 and 2009 in the Netherlands case-coverage study for Pandemrix-AS03. Other than elevated narcolepsy IRs in the period after vaccination campaigns in Sweden, we did not find an association between AS03- or MF59-adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the sites studied, although power to evaluate the AS03-adjuvanted Pandemrix brand vaccine was limited in our study.

Published
2018
Full Text
View/download PDF

37. Impact and longevity of measles-associated immune suppression: a matched cohort study using data from the THIN general practice database in the UK

Author

Gadroen, Kartini, primary, Dodd, Caitlin N, additional, Masclee, Gwen M C, additional, de Ridder, Maria A J, additional, Weibel, Daniel, additional, Mina, Michael J, additional, Grenfell, Bryan T, additional, Sturkenboom, Miriam C J M, additional, van de Vijver, David A M C, additional, and de Swart, Rik L, additional

Published
2018
Full Text
View/download PDF

38. Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study

Author

Dodd, Caitlin N., primary, de Ridder, Maria, additional, Huang, Wan-Ting, additional, Weibel, Daniel, additional, Giner-Soriano, Maria, additional, Perez-Vilar, Silvia, additional, Diez-Domingo, Javier, additional, Svenson, Lawrence W., additional, Mahmud, Salahddin M., additional, Carleton, Bruce, additional, Naus, Monika, additional, Kwong, Jeffrey C., additional, Murray, Brian J., additional, Arnheim-Dahlstrom, Lisen, additional, Pedersen, Lars, additional, Morros, Rosa, additional, Puertas, Francisco Javier, additional, Black, Steven, additional, and Sturkenboom, Miriam, additional

Published
2018
Full Text
View/download PDF

39. Assessing feasibility of resources at health facilities in Uganda to diagnose pregnancy and neonatal outcomes

Author

Stark, James H, primary, Wool, Eve, additional, Tran, Lena, additional, Robinson, Elizabeth, additional, Chemelski, Meaghan, additional, Weibel, Daniel, additional, Huang, Wan-Ting, additional, Kochhar, Sonali, additional, Hardy, Janet R, additional, Bailey, Steven, additional, Galiwango, Edward, additional, and Kajungu, Dan, additional

Published
2018
Full Text
View/download PDF

40. Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe : The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study

Author

Dodd, Caitlin N, de Ridder, Maria, Huang, Wan-Ting, Weibel, Daniel, Giner-Soriano, Maria, Perez-Vilar, Silvia, Diez-Domingo, Javier, Svenson, Lawrence W, Mahmud, Salahddin M, Carleton, Bruce, Naus, Monika, Kwong, Jeffrey C, Murray, Brian J, Arnheim-Dahlstrom, Lisen, Pedersen, Lars, Morros, Rosa, Puertas, Francisco Javier, Black, Steven, Sturkenboom, Miriam, Dodd, Caitlin N, de Ridder, Maria, Huang, Wan-Ting, Weibel, Daniel, Giner-Soriano, Maria, Perez-Vilar, Silvia, Diez-Domingo, Javier, Svenson, Lawrence W, Mahmud, Salahddin M, Carleton, Bruce, Naus, Monika, Kwong, Jeffrey C, Murray, Brian J, Arnheim-Dahlstrom, Lisen, Pedersen, Lars, Morros, Rosa, Puertas, Francisco Javier, Black, Steven, and Sturkenboom, Miriam

Published
2018

42. Operational lessons learned in conducting a multi-country collaboration for vaccine safety signal verification and hypothesis testing : The global vaccine safety multi country collaboration initiative

Author

Guillard-Maure, Christine, Elango, Varalakshmi, Black, Steven, Perez-Vilar, Silvia, Castro, Jose Luis, Bravo-Alcántara, Pamela, Molina-León, Helvert Felipe, Weibel, Daniel, Sturkenboom, Miriam, Zuber, Patrick L.F., WHO Global Vaccine Safety-Multi Country Collaboration, Guillard-Maure, Christine, Elango, Varalakshmi, Black, Steven, Perez-Vilar, Silvia, Castro, Jose Luis, Bravo-Alcántara, Pamela, Molina-León, Helvert Felipe, Weibel, Daniel, Sturkenboom, Miriam, Zuber, Patrick L.F., and WHO Global Vaccine Safety-Multi Country Collaboration

Published
2018

44. Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe : The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study

Author

Dodd, Caitlin N., de Ridder, Maria, Huang, Wan-Ting, Weibel, Daniel, Giner-Soriano, Maria, Perez-Vilar, Silvia, Diez-Domingo, Javier, Svenson, Lawrence W., Mahmud, Salahddin M., Carleton, Bruce, Naus, Monika, Kwong, Jeffrey C., Murray, Brian J., Arnheim-Dahlstrom, Lisen, Pedersen, Lars, Morros, Rosa, Puertas, Francisco Javier, Black, Steven, Sturkenboom, Miriam, Dodd, Caitlin N., de Ridder, Maria, Huang, Wan-Ting, Weibel, Daniel, Giner-Soriano, Maria, Perez-Vilar, Silvia, Diez-Domingo, Javier, Svenson, Lawrence W., Mahmud, Salahddin M., Carleton, Bruce, Naus, Monika, Kwong, Jeffrey C., Murray, Brian J., Arnheim-Dahlstrom, Lisen, Pedersen, Lars, Morros, Rosa, Puertas, Francisco Javier, Black, Steven, and Sturkenboom, Miriam

Abstract

Vaccine safety signals require investigation, which may be done rapidly at the population level using ecological studies, before embarking on hypothesis-testing studies. Incidence rates were used to assess a signal of narcolepsy following AS03-adjuvanted monovalent pandemic H1N1 (pH1N1) influenza vaccination among children and adolescents in Sweden and Finland in 2010. We explored the utility of ecological data to assess incidence of narcolepsy following exposure to pandemic H1N1 virus or vaccination in 10 sites that used different vaccines, adjuvants, and had varying vaccine coverage. We calculated incidence rates of diagnosed narcolepsy for periods defined by influenza virus circulation and vaccination campaign dates, and used Poisson regression to estimate incidence rate ratios (IRRs) comparing the periods during which wild-type virus circulated and after the start of vaccination campaigns vs. the period prior to pH1N1 virus circulation. We used electronic health care data from Sweden, Denmark, the United Kingdom, Canada (3 provinces), Taiwan, Netherlands, and Spain (2 regions) from 2003 to 2013. We investigated interactions between age group and adjuvant in European sites and conducted a simulation study to investigate how vaccine coverage, age, and the interval from onset to diagnosis may impact the ability to detect safety signals. Incidence rates of narcolepsy varied by age, continent, and period. Only in Taiwan and Sweden were significant time-period-by-age-group interactions observed. Associations were found for children in Taiwan (following pH1N1 virus circulation) and Sweden (following vaccination). Simulations showed that the individual-level relative risk of narcolepsy was underestimated using ecological methods comparing post- vs. pre-vaccination periods; this effect was attenuated with higher vaccine coverage and a shorter interval from disease onset to diagnosis. Ecological methods can be useful for vaccine safety assessment but the results are influ

Published
2018

45. Enhancing global vaccine pharmacovigilance: Proof-of-concept study on aseptic meningitis and immune thrombocytopenic purpura following measles-mumps containing vaccination

Author

Perez-Vilar, Silvia, Weibel, Daniel, Sturkenboom, Miriam, Black, Steven, Maure, Christine, Castro, Jose Luis, Bravo-Alcántara, Pamela, Dodd, Caitlin N., Romio, Silvana A., Ridder, Maria de, Nakato, Swabra, Molina-León, Helvert Felipe, Elango, Varalakshmi, Zuber, Patrick L.F., Perez-Vilar, Silvia, Weibel, Daniel, Sturkenboom, Miriam, Black, Steven, Maure, Christine, Castro, Jose Luis, Bravo-Alcántara, Pamela, Dodd, Caitlin N., Romio, Silvana A., Ridder, Maria de, Nakato, Swabra, Molina-León, Helvert Felipe, Elango, Varalakshmi, and Zuber, Patrick L.F.

Abstract

New vaccines designed to prevent diseases endemic in low and middle-income countries (LMICs) are now being introduced without prior record of utilization in countries with robust pharmacovigilance systems. To address this deficit, our objective was to demonstrate feasibility of an international hospital-based network for the assessment of potential epidemiological associations between serious and rare adverse events and vaccines in any setting. This was done through a proof-of-concept evaluation of the risk of immune thrombocytopenic purpura (ITP) and aseptic meningitis (AM) following administration of the first dose of measles-mumps-containing vaccines using the self-controlled risk interval method in the primary analysis. The World Health Organization (WHO) selected 26 sentinel sites (49 hospitals) distributed in 16 countries of the six WHO regions. Incidence rate ratios (IRR) of 5.0 (95% CI: 2.5–9.7) for ITP following first dose of measles-containing vaccinations, and of 10.9 (95% CI: 4.2–27.8) for AM following mumps-containing vaccinations were found. The strain-specific analyses showed significantly elevated ITP risk for measles vaccines containing Schwarz (IRR: 20.7; 95% CI: 2.7–157.6), Edmonston-Zagreb (IRR: 11.1; 95% CI: 1.4–90.3), and Enders’Edmonston (IRR: 8.5; 95% CI: 1.9–38.1) strains. A significantly elevated AM risk for vaccines containing the Leningrad-Zagreb mumps strain (IRR: 10.8; 95% CI: 1.3–87.4) was also found. This proof-of-concept study has shown, for the first time, that an international hospital-based network for the investigation of rare vaccine adverse events, using common standardized procedures and with high participation of LMICs, is feasible, can produce reliable results, and has the potential to characterize differences in risk between vaccine strains. The completion of this network by adding large reference hospitals, particularly from tropical countries, and the systematic WHO-led implementation of this approach, should permit the r

Published
2018

46. Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study

Author

Global Health, Epi Infectieziekten Team 2, Dodd, Caitlin N, de Ridder, Maria, Huang, Wan-Ting, Weibel, Daniel, Giner-Soriano, Maria, Perez-Vilar, Silvia, Diez-Domingo, Javier, Svenson, Lawrence W, Mahmud, Salahddin M, Carleton, Bruce, Naus, Monika, Kwong, Jeffrey C, Murray, Brian J, Arnheim-Dahlstrom, Lisen, Pedersen, Lars, Morros, Rosa, Puertas, Francisco Javier, Black, Steven, Sturkenboom, Miriam, Global Health, Epi Infectieziekten Team 2, Dodd, Caitlin N, de Ridder, Maria, Huang, Wan-Ting, Weibel, Daniel, Giner-Soriano, Maria, Perez-Vilar, Silvia, Diez-Domingo, Javier, Svenson, Lawrence W, Mahmud, Salahddin M, Carleton, Bruce, Naus, Monika, Kwong, Jeffrey C, Murray, Brian J, Arnheim-Dahlstrom, Lisen, Pedersen, Lars, Morros, Rosa, Puertas, Francisco Javier, Black, Steven, and Sturkenboom, Miriam

Published
2018

47. Masking by vaccines in pediatric drug safety signal detection in the EudraVigilance database

Author

Epi Infectieziekten Team 2, Global Health, Dodd, Caitlin, Pacurariu, Alexandra, Osokogu, Osemeke U., Weibel, Daniel, Ferrajolo, Carmen, Vo, Dang H., Becker, Benedikt, Kors, Jan A., Sturkenboom, Miriam, Epi Infectieziekten Team 2, Global Health, Dodd, Caitlin, Pacurariu, Alexandra, Osokogu, Osemeke U., Weibel, Daniel, Ferrajolo, Carmen, Vo, Dang H., Becker, Benedikt, Kors, Jan A., and Sturkenboom, Miriam

Published
2018

48. Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines - Multi-country assessment

Author

Global Health, Epi Infectieziekten Team 2, Weibel, Daniel, Sturkenboom, Miriam, Black, Steven, de Ridder, Maria, Dodd, Caitlin, Bonhoeffer, Jan, Vanrolleghem, Ann, van der Maas, Nicoline, Lammers, Gert Jan, Overeem, Sebastiaan, Gentile, Angela, Giglio, Norberto, Castellano, Vanesa, Kwong, Jeffrey C., Murray, Brian J., Cauch-Dudek, Karen, Juhasz, Diana, Campitelli, Michael, Datta, Alexandre N., Kallweit, Ulf, Huang, Wan Ting, Huang, Yu Shu, Hsu, Chung Yao, Chen, Hsi Chung, Giner-Soriano, Maria, Morros, Rosa, Gaig, Carles, Tió, Ester, Perez-Vilar, Silvia, Diez-Domingo, Javier, Puertas, Francisco Javier, Svenson, Lawrence W., Mahmud, Salaheddin M., Carleton, Bruce, Naus, Monika, Arnheim-Dahlström, Lisen, Pedersen, Lars, DeStefano, Frank, Shimabukuro, Tom T., Global Health, Epi Infectieziekten Team 2, Weibel, Daniel, Sturkenboom, Miriam, Black, Steven, de Ridder, Maria, Dodd, Caitlin, Bonhoeffer, Jan, Vanrolleghem, Ann, van der Maas, Nicoline, Lammers, Gert Jan, Overeem, Sebastiaan, Gentile, Angela, Giglio, Norberto, Castellano, Vanesa, Kwong, Jeffrey C., Murray, Brian J., Cauch-Dudek, Karen, Juhasz, Diana, Campitelli, Michael, Datta, Alexandre N., Kallweit, Ulf, Huang, Wan Ting, Huang, Yu Shu, Hsu, Chung Yao, Chen, Hsi Chung, Giner-Soriano, Maria, Morros, Rosa, Gaig, Carles, Tió, Ester, Perez-Vilar, Silvia, Diez-Domingo, Javier, Puertas, Francisco Javier, Svenson, Lawrence W., Mahmud, Salaheddin M., Carleton, Bruce, Naus, Monika, Arnheim-Dahlström, Lisen, Pedersen, Lars, DeStefano, Frank, and Shimabukuro, Tom T.

Published
2018

50. Operational lessons learned in conducting a multi-country collaboration for vaccine safety signal verification and hypothesis testing: The global vaccine safety multi country collaboration initiative

Author

Global Health, Guillard-Maure, Christine, Elango, Varalakshmi, Black, Steven, Perez-Vilar, Silvia, Castro, Jose Luis, Bravo-Alcántara, Pamela, Molina-León, Helvert Felipe, Weibel, Daniel, Sturkenboom, Miriam, Zuber, Patrick L.F., WHO Global Vaccine Safety-Multi Country Collaboration, Global Health, Guillard-Maure, Christine, Elango, Varalakshmi, Black, Steven, Perez-Vilar, Silvia, Castro, Jose Luis, Bravo-Alcántara, Pamela, Molina-León, Helvert Felipe, Weibel, Daniel, Sturkenboom, Miriam, Zuber, Patrick L.F., and WHO Global Vaccine Safety-Multi Country Collaboration

Published
2018

Catalog

Books, media, physical & digital resources
See catalog results