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1. Can information on functional and cognitive status improve short-term mortality risk prediction among community-dwelling older people? A cohort study using a UK primary care database

Author

Sultana J, Fontana A, Giorgianni F, Basile G, Patorno E, Pilotto A, Molokhia M, Stewart R, Sturkenboom M, and Trifirò G

Subjects
elderly, frailty, database, mortality, Infectious and parasitic diseases, RC109-216
Abstract

Janet Sultana,1,2 Andrea Fontana,3 Francesco Giorgianni,1 Giorgio Basile,1 Elisabetta Patorno,4 Alberto Pilotto,5 Mariam Molokhia,6 Robert Stewart,7 Miriam Sturkenboom,2 Gianluca Trifirò1,2 1Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy; 2Department of Medical Informatics, Erasmus University Medical Centre, Rotterdam, the Netherlands; 3Unit of Biostatistics, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy; 4Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, USA; 5Geriatrics Unit, Department of Geriatric Care, Ortho Geriatrics and Rehabilitation, Frailty Area, E.O. Galliera Hospital, Genova, Italy; 6Department of Primary Care and Public Health Sciences, King’s College, London, UK; 7Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience King’s College London, UK Background: Functional and cognitive domains have rarely been evaluated for their prognostic value in general practice databases. The aim of this study was to identify functional and cognitive domains in The Health Improvement Network (THIN) and to evaluate their additional value for the prediction of 1-month and 1-year mortality in elderly people.Materials and methods: A cohort study was conducted using a UK nationwide general practitioner database. A total of 1,193,268 patients aged 65 years or older, of whom 15,300 had dementia, were identified from 2000 to 2012. Information on mobility, dressing and accommodation was recorded frequently enough to be analyzed further in THIN. Cognition data could not be used due to very poor recording of data in THIN. One-year and 1-month mortality was predicted using logistic models containing variables such as age, sex, disease score and functionality status.Results: A significant but moderate improvement in 1-year and 1-month mortality prediction in elderly people was observed by adding accommodation to the variables age, sex and disease score, as the c-statistic (95% confidence interval [CI]) increased from 0.71 (0.70–0.72) to 0.76 (0.75–0.77) and 0.73 (0.71–0.75) to 0.79 (0.77–0.80), respectively. A less notable improvement in the prediction of 1-year and 1-month mortality was observed in people with dementia.Conclusion: Functional domains moderately improved the accuracy of a model including age, sex and comorbidities in predicting 1-year and 1-month mortality risk among community-dwelling older people, but they were much less able to predict mortality in people with dementia. Cognition could not be explored as a predictor of mortality due to insufficient data being recorded. Keywords: elderly, frailty, database, mortality

Published
2017

2. Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials

Author

Ahmadizar F., Luxi N., Raethke M., Schmikli S., Riefolo F., Saraswati P. W., Bucsa C., Osman A., Liddiard M., Maques F. B., Petrelli G., Sonderlichova S., Thurin N. H., Villalobos F., Trifiro G., Sturkenboom M., Moretti U., Bellitto C., Ciccimarra F., Gonella L. A., Arzenton E., Chiamulera C., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Cutroneo P. M., Minore C., Costantino C., Vitale F., D'Alessandro G., Morreale I., Marsala L., Farinella D., Bavetta S., Fantini M. P., Reno C., Raschi E., Poluzzi E., Sapigni E., Potenza A. M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M. S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Gavioli B., Palazzi S., Tuccori M., Vannacci A., Bonaiuti R., Ravaldi C., Lombardi N., Crescioli G., Gori F., Tessari R., Zandona E., Zanoni G., Senna G., Crivellaro M. A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Capuano A., Rafaniello C., Ferrajolo C., Pagliaro C., Mercaldo M., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., de Sarro C., Verduci C., Papadopoli R., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., Mastropasqua D., Ahmadizar F., Luxi N., Raethke M., Schmikli S., Riefolo F., Saraswati P.W., Bucsa C., Osman A., Liddiard M., Maques F.B., Petrelli G., Sonderlichova S., Thurin N.H., Villalobos F., Trifiro G., Sturkenboom M., Moretti U., Bellitto C., Ciccimarra F., Gonella L.A., Arzenton E., Chiamulera C., Lora R., Bellantuono D., Sabaini A., Firenze A., Zodda D., Guidotti F., Zappone M., Alagna B., Cutroneo P.M., Minore C., Costantino C., Vitale F., D'Alessandro G., Morreale I., Marsala L., Farinella D., Bavetta S., Fantini M.P., Reno C., Raschi E., Poluzzi E., Sapigni E., Potenza A.M., Podetti D., Nikitina V., Ricciardelli R., Mogheiseh N., Croce S., Paltrinieri B., Castellani S., Sangiorgi E., Selleri M., Lucchesi S., Catucci G., Savini D., Sacripanti C., Faccioli M., Romio M.S., Rossi L., Radici S., Negri G., Fares L., Ajolfi C., Fadda A., Chiarello A., Pieraccini F., Gavioli B., Palazzi S., Tuccori M., Vannacci A., Bonaiuti R., Ravaldi C., Lombardi N., Crescioli G., Gori F., Tessari R., Zandona E., Zanoni G., Senna G., Crivellaro M.A., Cancian M., Venturini F., Ferri M., Leonardi L., Orzetti S., Caccin E., Baldo P., Capuano A., Rafaniello C., Ferrajolo C., Pagliaro C., Mercaldo M., di Giorgio A., Tari M., Manna S., Farina G., Di Mauro C., De Carlo I., Senesi I., Pileggi C., Palleria C., Gallelli L., De Sarro G., de Sarro C., Verduci C., Papadopoli R., Trabace L., Morgese M., Schiavone S., Tucci P., Bove M., Lapi F., Cricelli C., Racagni G., Tonolo S., Fava G., Giuffrida S., Amato V., Gambera M., Montresor V., and Mastropasqua D.

Subjects
COVID-19 Vaccines, safety, Surveillance Systems, Pivotal Clinical Trials
Abstract

Background and Objectives: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials. Methods: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed. Results: The CVM study enrolled 658 first-dose vaccinees (children aged 5–11 years; n = 250 and adolescents aged 12–17 years; n = 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000. Conclusions: The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.

Published
2023

3. Background rates of 41 adverse events of special interest for COVID-19 vaccines in 10 European healthcare databases - an ACCESS cohort study

Author

RWE/Causal inference, Epi Infectieziekten Team 2, Global Health, Circulatory Health, JC onderzoeksprogramma Methodologie, Data Science & Biostatistiek, Child Health, Willame, C., Dodd, C., Durán, C. E., Elbers, R.J.H.J., Gini, R., Bartolini, C., Paoletti, O., Wang, L., Ehrenstein, V., Kahlert, J., Haug, U., Schink, T., Diez-Domingo, J., Mira-Iglesias, A., Carreras, J. J., Vergara-Hernández, C., Giaquinto, C., Barbieri, E., Stona, L., Huerta, C., Martín-Pérez, M., García-Poza, P., de Burgos, A., Martínez-González, M., Bryant, V., Villalobos, F., Pallejà-Millán, M., Aragón, M., Souverein, P., Thurin, N. H., Weibel, D., Klungel, O. H., Sturkenboom, M. C.J.M., RWE/Causal inference, Epi Infectieziekten Team 2, Global Health, Circulatory Health, JC onderzoeksprogramma Methodologie, Data Science & Biostatistiek, Child Health, Willame, C., Dodd, C., Durán, C. E., Elbers, R.J.H.J., Gini, R., Bartolini, C., Paoletti, O., Wang, L., Ehrenstein, V., Kahlert, J., Haug, U., Schink, T., Diez-Domingo, J., Mira-Iglesias, A., Carreras, J. J., Vergara-Hernández, C., Giaquinto, C., Barbieri, E., Stona, L., Huerta, C., Martín-Pérez, M., García-Poza, P., de Burgos, A., Martínez-González, M., Bryant, V., Villalobos, F., Pallejà-Millán, M., Aragón, M., Souverein, P., Thurin, N. H., Weibel, D., Klungel, O. H., and Sturkenboom, M. C.J.M.

Published
2023

5. 'Use of antipsychotics in children and adolescents: A picture from the ARITMO population-based European cohort study'

Author

Kaguelidou, F, Holstiege, J, Schink, T, Bezemer, I, Poluzzi, E, Mazzaglia, G, Pedersen, L, Sturkenboom, M, Trifiro, G, Kaguelidou F., Holstiege J., Schink T., Bezemer I., Poluzzi E., Mazzaglia G., Pedersen L., Sturkenboom M., Trifiro G., Kaguelidou, F, Holstiege, J, Schink, T, Bezemer, I, Poluzzi, E, Mazzaglia, G, Pedersen, L, Sturkenboom, M, Trifiro, G, Kaguelidou F., Holstiege J., Schink T., Bezemer I., Poluzzi E., Mazzaglia G., Pedersen L., Sturkenboom M., and Trifiro G.

Abstract

AimsPrevalence of the use of antipsychotics (APs) in the paediatric population is globally increasing. The aim of this study was to describe multinational trends and patterns in AP use in children and adolescents in Europe.MethodsThis was a dynamic retrospective cohort study comprising all children and adolescents ( 1/218 years of age). Data were extracted from five population-based electronic healthcare databases in Europe (Denmark, Germany, Italy, the Netherlands and United Kingdom) from 2000 to 2010. Yearly prevalence and incidence of AP use was expressed per 1000 person-years (PYs).ResultsPrevalence increased from 1.44 to 3.41/1000 PYs (2008) in Denmark and from 2.07 to 4.35/1000 PYs in the NL (2009), moderately increased from 2.8 to 3.24/1000 in UK (2009) and from 1.53 to 1.74/1000 PYs in Germany (2008) and remained low from 0.61 to 0.34/1000 PYs in Italy (2010). Similarly, incidence rates increased from 0.69 to 1.52/1000 PYs in Denmark and from 0.86 to 1.49/1000 PYs in the NL, stabilised from 2.29 to 2.37/1000 PYs in the UK and from 0.79 to 0.80/1000 PYs in Germany and remained low from 0.32 to 0.2/1000 PYs in Italy. AP use was highest in 15-18 year olds and in boys compared to girls. Yet, the use observed in the 5-9 year olds was found to be comparatively high in the NL. Prescriptions of second generation APs, especially risperidone, were privileged but the first generation APs were still prescribed in the youngest.ConclusionsA steady increase in AP use in children and adolescents was observed essentially in the NL and Denmark. The use in Germany and Italy was lowest among countries. The use of APs under 9 years of age underlines their off-label use and should be carefully monitored as the risk/benefit ratio of these medications remains unclear in young children. AP use was altogether lower in Europe as compared to that reported in North America.

Published
2020

6. Clinical standards for drug-susceptible pulmonary TB

Author

Akkerman, O. W., Duarte, R., Tiberi, S., Schaaf, H. S., Lange, C., Alffenaar, J. W.C., Denholm, J., Carvalho, A. C.C., Bolhuis, M. S., Borisov, S., Bruchfeld, J., Cabibbe, A. M., Caminero, J. A., Carvalho, I., Chakaya, J., Centis, R., Dalcomo, M. P., D'Ambrosio, L., Dedicoat, M., Dheda, K., Dooley, K. E., Furin, J., Garcia-Garcia, J. M., van Hest, N. A.H., de Jong, B. C., Kurhasani, X., Martson, A. G., Mpagama, S., Munoz Torrico, M., Nunes, E., Ong, C. W.M., Palmero, D. J., Ruslami, R., Saktiawati, A. M.I., Semuto, C., Silva, D. R., Singla, R., Solovic, I., Srivastava, S., de Steenwinkel, J. E.M., Story, A., Sturkenboom, M. G.G., Tadolini, M., Udwadia, Z. F., Verhage, A. R., Zellweger, J. P., Migliori, G. B., Akkerman, O. W., Duarte, R., Tiberi, S., Schaaf, H. S., Lange, C., Alffenaar, J. W.C., Denholm, J., Carvalho, A. C.C., Bolhuis, M. S., Borisov, S., Bruchfeld, J., Cabibbe, A. M., Caminero, J. A., Carvalho, I., Chakaya, J., Centis, R., Dalcomo, M. P., D'Ambrosio, L., Dedicoat, M., Dheda, K., Dooley, K. E., Furin, J., Garcia-Garcia, J. M., van Hest, N. A.H., de Jong, B. C., Kurhasani, X., Martson, A. G., Mpagama, S., Munoz Torrico, M., Nunes, E., Ong, C. W.M., Palmero, D. J., Ruslami, R., Saktiawati, A. M.I., Semuto, C., Silva, D. R., Singla, R., Solovic, I., Srivastava, S., de Steenwinkel, J. E.M., Story, A., Sturkenboom, M. G.G., Tadolini, M., Udwadia, Z. F., Verhage, A. R., Zellweger, J. P., and Migliori, G. B.

Abstract

BACKGROUND: The aim of these clinical standards is to provide guidance on 'best practice' for diagnosis, treatment and management of drug-susceptible pulmonary TB (PTB). METHODS : A panel of 54 global experts in the field of TB care, public health, microbiology, and pharmacology were identified; 46 participated in a Delphi process. A 5- point Likert scale was used to score draft standards. The final document represents the broad consensus and was approved by all 46 participants. RESULTS : Seven clinical standards were defined: Standard 1, all patients (adult or child) who have symptoms and signs compatible with PTB should undergo investigations to reach a diagnosis; Standard 2, adequate bacteriological tests should be conducted to exclude drug-resistant TB; Standard 3, an appropriate regimen recommended by WHO and national guidelines for the treatment of PTB should be identified; Standard 4, health education and counselling should be provided for each patient starting treatment; Standard 5, treatment monitoring should be conducted to assess adherence, follow patient progress, identify and manage adverse events, and detect development of resistance; Standard 6, a recommended series of patient examinations should be performed at the end of treatment; Standard 7, necessary public health actions should be conducted for each patient. We also identified priorities for future research into PTB. CONCLUSION: These consensus-based clinical standards will help to improve patient care by guiding clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment for PTB.

Published
2022

8. ACCESS-Background rate of adverse events-definition -thrombocytopenia

Author

Sturkenboom, M, Willame, C, Duran, C, and Belchabir, L

Subjects
electronic health care databases, codes, AESI, vaccine
Abstract

This document contains the definition of Thrombocytopenia and the operationalization to extract this event from different electronic health care databases in the EU, to calculate background rates of AESI The document contains the key definition, procedures and treatments, the diagnosis codes based on Codemapper output with changes/additions by data access providers, and when available published validation studies and background rates, This study (ACCESS project) was funded by the European Medicines Agency

Published
2021
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10. Applicability of the GAIA Maternal and Neonatal Outcome Case Definitions for the Evaluation of Adverse Events Following Vaccination in Pregnancy in High-income Countries.

Author

Watson G., Dodd C., Munoz F.M., Eckert L.O., Jones C.E., Buttery J.P., Yildirim I.B., Kachikis A., Heath P.T., Schlaudecker E.P., Bond N.H., Santarcangelo P.L., Wilcox C.R., Bellamy K., Elmontser M., Sienas L., Simon R., Khalil A., Townsend R., Sturkenboom M., Black S., Watson G., Dodd C., Munoz F.M., Eckert L.O., Jones C.E., Buttery J.P., Yildirim I.B., Kachikis A., Heath P.T., Schlaudecker E.P., Bond N.H., Santarcangelo P.L., Wilcox C.R., Bellamy K., Elmontser M., Sienas L., Simon R., Khalil A., Townsend R., Sturkenboom M., and Black S.

Abstract

BACKGROUND: The Brighton Collaboration Global Alignment of Immunization Safety in Pregnancy (GAIA) project developed case definitions for the assessment of adverse events in mothers and infants following maternal immunization. This study evaluated the applicability of these definitions to data collected in routine clinical care and research trial records across 7 sites in high-resource settings. METHOD(S): Data collection forms were designed and used to retrospectively abstract the key elements of the GAIA definitions from records for 5 neonatal and 5 maternal outcomes, as well as gestational age. Level of diagnostic certainty was assessed by the data abstractor and an independent clinician, and then verified by Automated Brighton Case logic. The ability to assign a level of diagnostic certainty for each outcome and the positive predictive value (PPV) for their respective ICD-10 codes were evaluated. RESULT(S): Data from 1248 case records were abstracted: 624 neonatal and 622 maternal. Neonatal outcomes were most likely to be assessable and assigned by the level of diagnostic certainty. PPV for preterm birth, low birth weight, small for gestational age and respiratory distress were all above 75%. Maternal outcomes for preeclampsia and fetal growth restriction showed PPV over 80%. However, microcephaly (neonatal outcome) and dysfunctional labor (maternal outcome) were often nonassessable, with low PPVs. CONCLUSION(S): The applicability of GAIA case definitions to retrospectively ascertain and classify maternal and neonatal outcomes was variable among sites in high-resource settings. The implementation of the case definitions is largely dependent on the type and quality of documentation in clinical and research records in both high- and low-resource settings. While designed for use in the prospective evaluation of maternal vaccine safety, the GAIA case definitions would likely need to be specifically adapted for observational studies using alternative sources of data

Published
2021

12. 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

13. Dissemination of Direct Healthcare Professional Communications on Medication Errors for Medicinal Products in the EU: An Explorative Study on Relevant Factors

Author

Hoeve, Christel, de Vries, E, Mol, PGM, Sturkenboom, M, Straus, Sabine, Hoeve, Christel, de Vries, E, Mol, PGM, Sturkenboom, M, and Straus, Sabine

Abstract

Introduction: When serious medication errors (ME) are identified, communication to the field may be necessary. In the EU, communication of serious safety issues, such as medication errors associated with adverse drug reactions, is done through direct healthcare professional communications (DHPCs). We aimed to identify how often DHPCs about medication errors are distributed, and we explored factors associated with these ME DHPCs. Methods: We performed a descriptive study of all centrally authorised products (CAPs) approved before 1 May 2019 in the EU. All DHPCs issued between 1 January 2001 and 1 May 2019 were reviewed for ME content. Characteristics of CAPs were collected from the website of the European Medicines Agency. A Kaplan–Meier survival analysis was performed to estimate the 5- and 10-year probability of the occurrence of a first ME DHPC. A logistic regression was performed to explore risk factors for ME DHPCs. Results: A total of 678 CAPs were included, of which 35 required an ME DHPC during the study period. The 5-year probability for a CAP to have a first ME DHPC was 2.5% (95% CI 1.1–3.9) and the 10-year probability was 4.4% (95% CI 2.2–6.5). Among products with an ME DHPC, the 5-year probability of a second ME DHPC was 21.3% (95% CI 0.2–38.0). The risk of ME DHPCs was increased for products with multiple pharmaceutical formulations, enteral liquid or parenteral injection preparations, and products classified as nervous system agents or antineoplastic and immunomodulating agents. Conclusions: The absolute number of ME DHPCs for CAPs is low and does not give rise to immediate concern. We identified potential risk factors for ME DHPCs that should be taken into account during approval procedures or line extensions.

Published
2021

18. Prospective evaluation of improving fluoroquinolone exposure using centralised therapeutic drug monitoring (TDM) in patients with tuberculosis (PERFECT)

Author

Van Den Elsen S. H. J., Sturkenboom M. G. G., Akkerman O., Barkane L., Bruchfeld J., Eather G., Heysell S. K., Hurevich H., Kuksa L., Kunst H., Kuhlin J., Manika K., Moschos C., Mpagama S. G., Munoz Torrico M., Skrahina A., Sotgiu G., Tadolini M., Tiberi S., Volpato F., Van Der Werf T. S., Wilson M. R., Zuniga J., Touw D. J., Migliori G. B., Alffenaar J. -W., Microbes in Health and Disease (MHD), Biopharmaceuticals, Discovery, Design and Delivery (BDDD), Groningen Research Institute for Asthma and COPD (GRIAC), Critical care, Anesthesiology, Peri-operative and Emergency medicine (CAPE), Pharmaceutical Analysis, Medicinal Chemistry and Bioanalysis (MCB), Van Den Elsen S.H.J., Sturkenboom M.G.G., Akkerman O., Barkane L., Bruchfeld J., Eather G., Heysell S.K., Hurevich H., Kuksa L., Kunst H., Kuhlin J., Manika K., Moschos C., Mpagama S.G., Munoz Torrico M., Skrahina A., Sotgiu G., Tadolini M., Tiberi S., Volpato F., Van Der Werf T.S., Wilson M.R., Zuniga J., Touw D.J., Migliori G.B., and Alffenaar J.-W.

Subjects
medicine.medical_specialty, infectious disease, lcsh:Medicine, organisation of health service, organisation of health services, law.invention, Fluoroquinolone, Moxifloxacin, Informed consent, law, Anti-Bacterial Agent, Tuberculosis, Multidrug-Resistant, medicine, Humans, Multicenter Studies as Topic, tuberculosi, Dosing, Prospective Studies, Precision Medicine, Intensive care medicine, Prospective cohort study, Clinical pharmacology, medicine.diagnostic_test, business.industry, lcsh:R, Sputum, General Medicine, Anti-Bacterial Agents, Prospective Studie, Observational Studies as Topic, Infectious Diseases, tuberculosis, Therapeutic drug monitoring, Research Design, Observational study, clinical pharmacology, Drug Monitoring, business, Human, medicine.drug, Cohort study, Fluoroquinolones
Abstract

IntroductionGlobal multidrug-resistant tuberculosis (MDR-TB) treatment success rates remain suboptimal. Highly active WHO group A drugs moxifloxacin and levofloxacin show intraindividual and interindividual pharmacokinetic variability which can cause low drug exposure. Therefore, therapeutic drug monitoring (TDM) of fluoroquinolones is recommended to personalise the drug dosage, aiming to prevent the development of drug resistance and optimise treatment. However, TDM is considered laborious and expensive, and the clinical benefit in MDR-TB has not been extensively studied. This observational multicentre study aims to determine the feasibility of centralised TDM and to investigate the impact of fluoroquinolone TDM on sputum conversion rates in patients with MDR-TB compared with historical controls.Methods and analysisPatients aged 18 years or older with sputum smear and culture-positive pulmonary MDR-TB will be eligible for inclusion. Patients receiving TDM using a limited sampling strategy (t=0 and t=5 hours) will be matched to historical controls without TDM in a 1:2 ratio. Sample analysis and dosing advice will be performed in a centralised laboratory. Centralised TDM will be considered feasible if >80% of the dosing recommendations are returned within 7 days after sampling and 100% within 14 days. The number of patients who are sputum smear and culture-negative after 2 months of treatment will be determined in the prospective TDM group and will be compared with the control group without TDM to determine the impact of TDM.Ethics and disseminationEthical clearance was obtained by the ethical review committees of the 10 participating hospitals according to local procedures or is pending (online supplementary file 1). Patients will be included after obtaining written informed consent. We aim to publish the study results in a peer-reviewed journal.Trial registration numberClinicalTrials.gov Registry (NCT03409315).

Published
2020

19. How to design a study to evaluate therapeutic drug monitoring in infectious diseases?

Author

Martson, A-G, Sturkenboom, M. G. G., Stojanova, J., Cattaneo, D., Hope, W., Marriott, D., Patanwala, A. E., Peloquin, C. A., Wicha, S. G., van der Werf, T. S., Tängdén, Thomas, Roberts, J. A., Neely, M. N., Alffenaar, J-WC., Martson, A-G, Sturkenboom, M. G. G., Stojanova, J., Cattaneo, D., Hope, W., Marriott, D., Patanwala, A. E., Peloquin, C. A., Wicha, S. G., van der Werf, T. S., Tängdén, Thomas, Roberts, J. A., Neely, M. N., and Alffenaar, J-WC.

Abstract

Background: Therapeutic drug monitoring (TDM) is a tool to personalize and optimize dosing by measuring the drug concentration and subsequently adjusting the dose to reach a target concentration or exposure. The evidence to support TDM is however often ranked as expert opinion. Limitations in study design and sample size have hampered definitive conclusions of the potential added value of TDM. Objectives: We aim to give expert opinion and discuss the main points and limitations of available data from antibiotic TDM trials and emphasize key elements for consideration in design of future clinical studies to quantify the benefits of TDM. Sources: The sources were peer-reviewed publications, guidelines and expert opinions from the field of TDM. Content: This review focuses on key aspects of antimicrobial TDM study design: describing the rationale for a TDM study, assessing the exposure of a drug, assessing susceptibility of pathogens and selecting appropriate clinical endpoints. Moreover we provide guidance on appropriate study design.

Published
2020
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20. Impact of risk minimisation measures on the use of strontium ranelate in Europe : a multi-national cohort study in 5 EU countries by the EU-ADR Alliance

Author

Berencsi, K, Sami, A, Ali, M S, Marinier, K, Deltour, N, Perez-Guthann, S, Pedersen, L, Rijnbeek, P, Van der Lei, J, Lapi, F, Simonetti, M, Reyes, C, Sturkenboom, M C J M, Prieto-Alhambra, D, Berencsi, K, Sami, A, Ali, M S, Marinier, K, Deltour, N, Perez-Guthann, S, Pedersen, L, Rijnbeek, P, Van der Lei, J, Lapi, F, Simonetti, M, Reyes, C, Sturkenboom, M C J M, and Prieto-Alhambra, D

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. (Miriam), Braeye, T. (Toon), van der Aa, L. (Lieke), Danieli, G. (Giorgia), Dodd, C.N. (Caitlin), Duarte-Salles, T. (Talita), Emborg, H.-D. (Hanne- Dorthe), Gheorghe, M. (Marius), Kahlert, J. (Johnny), Gini, R. (Rosa), huerta, C. (Consuelo), Martín-merino, E. (Elisa), McGee, C. (Chris), Lusignan, S. (Simon) de, Picelli, G. (Gino), Roberto, G. (Giuseppe), Tramontan, L. (Lara), Villa, M. (Marco), Weibel, D.M. (Daniel), Titievsky, L. (Lina), Sturkenboom, M. (Miriam), Braeye, T. (Toon), van der Aa, L. (Lieke), Danieli, G. (Giorgia), Dodd, C.N. (Caitlin), Duarte-Salles, T. (Talita), Emborg, H.-D. (Hanne- Dorthe), Gheorghe, M. (Marius), Kahlert, J. (Johnny), Gini, R. (Rosa), huerta, C. (Consuelo), Martín-merino, E. (Elisa), McGee, C. (Chris), Lusignan, S. (Simon) de, Picelli, G. (Gino), Roberto, G. (Giuseppe), Tramontan, L. (Lara), Villa, M. (Marco), Weibel, D.M. (Daniel), and Titievsky, L. (Lina)

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 eve

Published
2020
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22. Impact of risk minimisation measures on the use of strontium ranelate in Europe: a multi-national cohort study in 5 EU countries by the EU-ADR Alliance

Author

Global Health, JC onderzoeksprogramma Infectieziekten, Berencsi, K, Sami, A, Ali, M S, Marinier, K, Deltour, N, Perez-Guthann, S, Pedersen, L, Rijnbeek, P, Van der Lei, J, Lapi, F, Simonetti, M, Reyes, C, Sturkenboom, M C J M, Prieto-Alhambra, D, Global Health, JC onderzoeksprogramma Infectieziekten, Berencsi, K, Sami, A, Ali, M S, Marinier, K, Deltour, N, Perez-Guthann, S, Pedersen, L, Rijnbeek, P, Van der Lei, J, Lapi, F, Simonetti, M, Reyes, C, Sturkenboom, M C J M, and Prieto-Alhambra, D

Published
2020

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

Author

Tin Tin Htar, M, de Ridder, Maria, Braeye, T, Correa, A, McGee, C, de Lusignan, S, Duarte-Salles, T, Huerta-Alvarez, C, Martín-Merino, E, Tramontan, L, Danieli, G, Picelli, G, van der Maas, N, Berencsi, K, Arnheim-Dahlström, L, Heininger, U, Emborg, HD, Weibel, Daniel, Bollaerts, K, Sturkenboom, M, Tin Tin Htar, M, de Ridder, Maria, Braeye, T, Correa, A, McGee, C, de Lusignan, S, Duarte-Salles, T, Huerta-Alvarez, C, Martín-Merino, E, Tramontan, L, Danieli, G, Picelli, G, van der Maas, N, Berencsi, K, Arnheim-Dahlström, L, Heininger, U, Emborg, HD, Weibel, Daniel, Bollaerts, K, and Sturkenboom, M

Published
2020

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

Author

Gini, R, Dodd, Caitlin, Bollaerts, K, Bartolini, C, Roberto, G, Huerta-Alvarez, C, Martín-Merino, E, Duarte-Salles, T, Picelli, G, Tramontan, L, Danieli, G, Correa, A, McGee, C, Becker, BFH, Switzer, C, Gandhi-Banga, S, Bauwens, J, Maas, NAT, Spiteri, G, Sdona, E, Weibel, Daniel, Sturkenboom, M, Gini, R, Dodd, Caitlin, Bollaerts, K, Bartolini, C, Roberto, G, Huerta-Alvarez, C, Martín-Merino, E, Duarte-Salles, T, Picelli, G, Tramontan, L, Danieli, G, Correa, A, McGee, C, Becker, BFH, Switzer, C, Gandhi-Banga, S, Bauwens, J, Maas, NAT, Spiteri, G, Sdona, E, Weibel, Daniel, and Sturkenboom, M

Published
2020

25. Incidence, risk factors and re-exacerbation rate of severe asthma exacerbations in a multinational, multidatabase pediatric cohort study

Author

Engelkes, Marjolein, Baan, Esmé, de Ridder, Maria, Svensson, E, Prieto-Alhambra, D, Lapi, F, Giaquinto, C, Picelli, G, Boudiaf, N, Albers, F, Evitt, LA, Cockle, S, Bradford, E, Van Dyke, MK, Suruki, R, Rijnbeek, Peter, Sturkenboom, M, Janssens, Hettie, Verhamme, Katia, Engelkes, Marjolein, Baan, Esmé, de Ridder, Maria, Svensson, E, Prieto-Alhambra, D, Lapi, F, Giaquinto, C, Picelli, G, Boudiaf, N, Albers, F, Evitt, LA, Cockle, S, Bradford, E, Van Dyke, MK, Suruki, R, Rijnbeek, Peter, Sturkenboom, M, Janssens, Hettie, and Verhamme, Katia

Published
2020

26. 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

27. Hair cortisol and inhaled corticosteroid use in asthmatic children

Author

Baan, Esmé, van den Akker, Erica, Engelkes, Marjolein, de Rijke, Yolanda, Jongste, Johan, Sturkenboom, M, Verhamme, Katia, Janssens, Hettie, Baan, Esmé, van den Akker, Erica, Engelkes, Marjolein, de Rijke, Yolanda, Jongste, Johan, Sturkenboom, M, Verhamme, Katia, and Janssens, Hettie

Published
2020

29. 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

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

Author

Emborg, HD, Kahlert, J, Braeye, T, Bauwens, J, Bollaerts, K, Danieli, G, Duarte-Salles, T, Glismann, S, Huerta-Alvarez, C, de Lusignan, S, Martín-Merino, E, McGee, C, Correa, A, Tramontan, L, Weibel, Daniel, Sturkenboom, M, Emborg, HD, Kahlert, J, Braeye, T, Bauwens, J, Bollaerts, K, Danieli, G, Duarte-Salles, T, Glismann, S, Huerta-Alvarez, C, de Lusignan, S, Martín-Merino, E, McGee, C, Correa, A, Tramontan, L, Weibel, Daniel, and Sturkenboom, M

Published
2020

31. Correction to:: Impact of risk minimisation measures on the use of strontium ranelate in Europe: a multi-national cohort study in 5 EU countries by the EU-ADR Alliance (Osteoporosis International, (2019), 10.1007/s00198-019-05181-6)

Author

Epi Methoden Team 2, Global Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Berencsi, K, Sami, A, Ali, M S, Marinier, K, Deltour, N, Perez-Gutthann, S, Pedersen, L, Rijnbeek, P, Van der Lei, J, Lapi, F, Simonetti, M, Reyes, C, Sturkenboom, M C J M, Prieto-Alhambra, D, Epi Methoden Team 2, Global Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Berencsi, K, Sami, A, Ali, M S, Marinier, K, Deltour, N, Perez-Gutthann, S, Pedersen, L, Rijnbeek, P, Van der Lei, J, Lapi, F, Simonetti, M, Reyes, C, Sturkenboom, M C J M, and Prieto-Alhambra, D

Published
2020

37. Sudden cardiac and sudden unexpected death related to antipsychotics: A meta-analysis of observational studies

Author

Salvo, F., Pariente, A., Shakir, S., Robinson, P., Arnaud, M., Thomas, S. H. L., RASCHI, EMANUEL, Fourrier Reglat, A., Moore, N., Sturkenboom, M., Hazell, L., Salvo, F., Pariente, A., Shakir, S., Robinson, P., Arnaud, M., Thomas, S.H.L., Raschi, E., Fourrier-Reglat, A., Moore, N., Sturkenboom, M., Hazell, L., and Medical Informatics

Subjects
Olanzapine, ERG1 Potassium Channel, medicine.medical_specialty, hERG, Sudden cardiac death, Inhibitory Concentration 50, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Clozapine, Pharmacology, Risperidone, biology, business.industry, Ether-A-Go-Go Potassium Channel, Odds ratio, medicine.disease, Ether-A-Go-Go Potassium Channels, Confidence interval, 3. Good health, Observational Studies as Topic, Antipsychotic Agent, Death, Sudden, Cardiac, Anesthesia, biology.protein, Quetiapine, business, 030217 neurology & neurosurgery, Antipsychotic Agents, Human, medicine.drug
Abstract

To estimate the risk of sudden cardiac death (SCD) or sudden unexpected death (SUD) related to individual antipsychotics, a meta-analysis of observational studies was performed. Adjusted odds ratio (OR) of SCD/SUD with 95% confidence intervals (CI) were extracted and pooled; heterogeneity was studied using Q statistic and I(2) index, and its potential causes (e.g., hERG blockade potency) explored using meta-regression. Two cohort (740,306 person-years) and four case-control (2,557 cases; 17,670 controls) studies, investigating nine antipsychotics, were included. Compared with nonusers, the risk was increased for quetiapine (OR = 1.72, 95% CI: 1.33-2.23), olanzapine (OR = 2.04, 1.52-2.74), risperidone (OR = 3.04, 2.39-3.86), haloperidol (OR = 2.97, 1.59-5.54), clozapine (OR = 3.67, 1.94-6.94), and thioridazine (OR = 4.58, 2.09-10.05). Heterogeneity was found (Q = 20.0, P = 0.01; I(2) = 60.0%), and the increasing mean hERG blockade potency (P = 0.01) accounted for 43% of this. The SCD/SUD risk differed between individual antipsychotics, and mean hERG blockade potency could be an explanatory factor. This should be considered when initiating antipsychotic treatment.

Published
2015

41. Combining evidence from multiple electronic health care databases: performances of one-stage and two-stage meta-analysis in matched case-control studies

Author

La Gamba, F, Corrao, G, Romio, S, Sturkenboom, M, Trifiro, G, Schink, T, de Ridder, M, La Gamba F., Corrao G., Romio S., Sturkenboom M., Trifiro G., Schink T., de Ridder M., La Gamba, F, Corrao, G, Romio, S, Sturkenboom, M, Trifiro, G, Schink, T, de Ridder, M, La Gamba F., Corrao G., Romio S., Sturkenboom M., Trifiro G., Schink T., and de Ridder M.

Abstract

Purpose: Clustering of patients in databases is usually ignored in one-stage meta-analysis of multi-database studies using matched case-control data. The aim of this study was to compare bias and efficiency of such a one-stage meta-analysis with a two-stage meta-analysis. Methods: First, we compared the approaches by generating matched case-control data under 5 simulated scenarios, built by varying: (1) the exposure-outcome association; (2) its variability among databases; (3) the confounding strength of one covariate on this association; (4) its variability; and (5) the (heterogeneous) confounding strength of two covariates. Second, we made the same comparison using empirical data from the ARITMO project, a multiple database study investigating the risk of ventricular arrhythmia following the use of medications with arrhythmogenic potential. In our study, we specifically investigated the effect of current use of promethazine. Results: Bias increased for one-stage meta-analysis with increasing (1) between-database variance of exposure effect and (2) heterogeneous confounding generated by two covariates. The efficiency of one-stage meta-analysis was slightly lower than that of two-stage meta-analysis for the majority of investigated scenarios. Based on ARITMO data, there were no evident differences between one-stage (OR = 1.50, CI = [1.08; 2.08]) and two-stage (OR = 1.55, CI = [1.12; 2.16]) approaches. Conclusions: When the effect of interest is heterogeneous, a one-stage meta-analysis ignoring clustering gives biased estimates. Two-stage meta-analysis generates estimates at least as accurate and precise as one-stage meta-analysis. However, in a study using small databases and rare exposures and/or outcomes, a correct one-stage meta-analysis becomes essential.

Published
2017

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

Author

Emborg, H.-D. (Hanne-Dorthe), Kahlert, J. (Johnny), Braeye, T. (Toon), Bauwens, J. (Jorgen), Bollaerts, K. (Kaatje), Danieli, G. (Giorgia), Duarte-Salles, T. (Talita), Glismann, S. (Steffen), Huerta, C. (Consuelo), Lusignan, S. (Simon) de, Martin, E. (Elisa), McGee, C. (Chris), Correa, A. (Ana), Tramontan, L. (Lara), Weibel, D.M. (Daniel), Sturkenboom, M. (Miriam), Emborg, H.-D. (Hanne-Dorthe), Kahlert, J. (Johnny), Braeye, T. (Toon), Bauwens, J. (Jorgen), Bollaerts, K. (Kaatje), Danieli, G. (Giorgia), Duarte-Salles, T. (Talita), Glismann, S. (Steffen), Huerta, C. (Consuelo), Lusignan, S. (Simon) de, Martin, E. (Elisa), McGee, C. (Chris), Correa, A. (Ana), Tramontan, L. (Lara), Weibel, D.M. (Daniel), and Sturkenboom, M. (Miriam)

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 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

Published
2019
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50. ADVANCE system testing: Can safety studies be conducted using electronic healthcare data? An example using pertussis vaccination

Author

Weibel, D.M. (Daniel), Dodd, C.N. (Caitlin), Mahaux, O. (Olivia), Haguinet, F. (Francois), De Smedt, T. (Tom), Duarte-Salles, T. (Talita), Picelli, G. (Gino), Tramontan, L. (Lara), Danieli, G. (Giorgia), Correa, A. (Ana), McGee, C. (C.), Martín-Merino, E. (E.), Huerta, C. (Consuelo), Berencsi, K. (K.), Emborg, H.-D. (Hanne-Dorthe), Bollaerts, K. (Kaatje), Bauchau, V. (Vincent), Titievsky, L. (Lina), Sturkenboom, M. (Miriam), Weibel, D.M. (Daniel), Dodd, C.N. (Caitlin), Mahaux, O. (Olivia), Haguinet, F. (Francois), De Smedt, T. (Tom), Duarte-Salles, T. (Talita), Picelli, G. (Gino), Tramontan, L. (Lara), Danieli, G. (Giorgia), Correa, A. (Ana), McGee, C. (C.), Martín-Merino, E. (E.), Huerta, C. (Consuelo), Berencsi, K. (K.), Emborg, H.-D. (Hanne-Dorthe), Bollaerts, K. (Kaatje), Bauchau, V. (Vincent), Titievsky, L. (Lina), and Sturkenboom, M. (Miriam)

Abstract

Introduction: The Accelerated Development of Vaccine benefit-risk Collaboration in Europe (ADVANCE) public-private collaboration, aimed to develop and test a system for rapid benefit-risk monitoring of vaccines using healthcare databases in Europe. The objective of this proof-of-concept (POC) study was to test the feasibility of the ADVANCE system to generate incidence rates (IRs) per 1000 person-years and incidence rate ratios (IRRs) for risks associated with whole cell- (wP) and acellular- (aP) pertussis vaccines, occurring in event-specific risk windows in children prior to their pre-school-entry booster. Methods: The study population comprised almost 5.1 million children aged 1 month to <6 years vaccinated with wP or aP vaccines during the study period from 1 January 1990 to 31 December 2015. Data from two Danish hospital (H) databases (AUH and SSI) and five primary care (PC) databases from, UK (THIN and RCGP RSC), Spain (SIDIAP and BIFAP) and Italy (Pedianet) were analysed. Database-specific IRRs between risk vs. non-risk periods were estimated in a self-controlled case series study and pooled using random-effects meta-analyses. Results: The overall IRs were: fever, 58.2 (95% CI: 58.1; 58.3), 96.9 (96.7; 97.1) for PC DBs and 8.56 (8.5; 8.6) for H DBs; convulsions, 7.6 (95% CI: 7.6; 7.7), 3.55 (3.5; 3.6) for PC and 12.87 (12.8; 13) for H; persistent crying, 3.9 (95% CI: 3.8; 3.9) for PC, injection-site reactions, 2.2 (95% CI 2.1; 2.2) for PC, hypotonic hypo-responsive episode (HHE), 0.4 (95% CI: 0.4; 0.4), 0.6 (0.6; 0.6) for PC and 0.2 (0.2; 0.3) for H; and somnolence: 0.3 (95% CI: 0.3; 0.3) for PC. The pooled IRRs for persistent crying, fever, and ISR, adjusted for age and healthy vaccinee period were higher after wP vs. aP vaccination, and lower for convulsions, for all doses. The IRR for HHE was slightly lower for wP than aP, while wP was associated with somnolence only for dose 1 and dose 3 compared with aP. Conclusions: The estimated IRs and IRRs were compa

Published
2019
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