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Your search keyword '"Sturkenboom, Miriam C.J.M."' showing total 239 results
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239 results on '"Sturkenboom, Miriam C.J.M."'

2. An ethics framework for the transition to an operational learning healthcare system

Author

Medical Humanities Onderzoek Team 1, Bioethics & Health Humanities, Child Health, Circulatory Health, JC onderzoeksprogramma Methodology, Data Science & Biostatistiek, Infection & Immunity, Regenerative Medicine and Stem Cells, Hollestelle, Marieke J., van der Graaf, Rieke, Sturkenboom, Miriam C.J.M., van Delden, Johannes J.M., Medical Humanities Onderzoek Team 1, Bioethics & Health Humanities, Child Health, Circulatory Health, JC onderzoeksprogramma Methodology, Data Science & Biostatistiek, Infection & Immunity, Regenerative Medicine and Stem Cells, Hollestelle, Marieke J., van der Graaf, Rieke, Sturkenboom, Miriam C.J.M., and van Delden, Johannes J.M.

Published
2024

3. Respiratory syncytial virus vaccination during pregnancy for improving infant outcomes

Author

Infectieziekten onderzoek2 (Wildenbeest), MS Verloskunde, Infection & Immunity, Infectieziekten patientenzorg, Child Health, CTI Bont, Infectieziekten onderzoek1 (Bont), Epidemiology & Health Economics, Data Science & Biostatistiek, RWE/Causal inference, Geboortecentrum voorzitterschap, Phijffer, Emily, de Bruin, Odette, Wildenbeest, Joanne G., Bont, Louis J., Sturkenboom, Miriam C.J.M., Van der Maas, Nicoline A.T., Ahmadizar, Fariba, Bloemenkamp, Kitty W.M., Infectieziekten onderzoek2 (Wildenbeest), MS Verloskunde, Infection & Immunity, Infectieziekten patientenzorg, Child Health, CTI Bont, Infectieziekten onderzoek1 (Bont), Epidemiology & Health Economics, Data Science & Biostatistiek, RWE/Causal inference, Geboortecentrum voorzitterschap, Phijffer, Emily, de Bruin, Odette, Wildenbeest, Joanne G., Bont, Louis J., Sturkenboom, Miriam C.J.M., Van der Maas, Nicoline A.T., Ahmadizar, Fariba, and Bloemenkamp, Kitty W.M.

Published
2024

7. Variations across Europe in hospitalization and management of pregnant women with SARS-CoV-2 during the initial phase of the pandemic:Multi-national population-based cohort study using the International Network of Obstetric Survey Systems (INOSS)

Author

de Bruin, Odette, Engjom, Hilde, Vousden, Nicola, Ramakrishnan, Rema, Aabakke, Anna J.M., Äyräs, Outi, Donati, Serena, Jónasdóttir, Eva, Knight, Marian, Overtoom, Evelien M., Salvatore, Michele A., Sturkenboom, Miriam C.J.M., Svanvik, Teresia, Varpula, Reetta, Vercoutere, An, Bloemenkamp, Kitty W.M., de Bruin, Odette, Engjom, Hilde, Vousden, Nicola, Ramakrishnan, Rema, Aabakke, Anna J.M., Äyräs, Outi, Donati, Serena, Jónasdóttir, Eva, Knight, Marian, Overtoom, Evelien M., Salvatore, Michele A., Sturkenboom, Miriam C.J.M., Svanvik, Teresia, Varpula, Reetta, Vercoutere, An, and Bloemenkamp, Kitty W.M.

Abstract

Introduction: The majority of data on COVID-19 in pregnancy are not from sound population-based active surveillance systems. Material and methods: We conducted a multi-national study of population-based national or regional prospective cohorts using standardized definitions within the International Network of Obstetric Survey systems (INOSS). From a source population of women giving birth between March 1 and August 31, 2020, we included pregnant women admitted to hospital with a positive SARS-CoV-2 PCR test ≤7 days prior to or during admission and up to 2 days after birth. The admissions were further categorized as COVID-19-related or non-COVID-19-related. The primary outcome of interest was incidence of COVID-19-related hospital admission. Secondary outcomes included severe maternal disease (ICU admission and mechanical ventilation) and COVID-19-directed medical treatment. Results: In a source population of 816 628 maternities, a total of 2338 pregnant women were admitted with SARS-CoV-2; among them 940 (40%) were COVID-19-related admissions. The pooled incidence estimate for COVID-19-related admission was 0.59 (95% confidence interval 0.27–1.02) per 1000 maternities, with notable heterogeneity across countries (I2 = 97.3%, P = 0.00). In the COVID-19 admission group, between 8% and 17% of the women were admitted to intensive care, and 5%–13% needed mechanical ventilation. Thromboprophylaxis was the most frequent treatment given during COVID-19-related admission (range 14%–55%). Among 908 infants born to women in the COVID-19-related admission group, 5 (0.6%) stillbirths were reported. Conclusions: During the initial months of the pandemic, we found substantial variations in incidence of COVID-19-related admissions in nine European countries. Few pregnant women received COVID-19-directed medical treatment. Several barriers to rapid surveillance were identified. Investment in robust surveillance should be prioritized to prepare for future pandemics.

Published
2023

9. Validation study in four health-care databases: upper gastrointestinal bleeding misclassification affects precision but not magnitude of drug-related upper gastrointestinal bleeding risk

Author

Valkhoff, Vera E., Coloma, Preciosa M., Masclee, Gwen M.C., Gini, Rosa, Innocenti, Francesco, Lapi, Francesco, Molokhia, Mariam, Mosseveld, Mees, Nielsson, Malene Schou, Schuemie, Martijn, Thiessard, Frantz, van der Lei, Johan, Sturkenboom, Miriam C.J.M., and Trifirò, Gianluca

Published
2014
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12. Use of azithromycin and risk of ventricular arrhythmia

Author

Trifiro, Gianluca, de Ridder, Maria, Sultana, Janet, Oteri, Alessandro, Rijnbeek, Peter, Pecchioli, Serena, Mazzaglia, Giampiero, Bezemer, Irene, Garbe, Edeltraut, Schink, Tania, Poluzzi, Elisabetta, Froslev, Trine, Molokhia, Mariam, Diemberger, Igor, and Sturkenboom, Miriam C.J.M.

Subjects
Novartis AG, Azithromycin -- Usage -- Research, Arrhythmia -- Research, Databases -- Usage, Amoxicillin -- Usage -- Research, Information management, Pharmaceutical industry, Information accessibility, CD-ROM catalog, Database, CD-ROM database, Health
Abstract

BACKGROUND: There are conflicting findings from observational studies of the arrhythrogenic potential of azithromycin. Our aim was to quantify the association between azithromycin use and the risk of ventricular arrhythmia. METHODS: We conducted a nested case-control study within a cohort of new antibiotic users identified from a network of 7 population-based health care databases in Denmark, Germany, Italy, the Netherlands and the United Kingdom for the period 1997-2010. Up to 100 controls per case were selected and matched by age, sex and database. Recency of antibiotic use and type of drug (azithromycin was the exposure of interest) at the index date (occurrence of ventricular arrhythmia) were identified. We estimated the odds of ventricular arrhythmia associated with current azithromycin use relative to current amoxicillin use or nonuse of antibiotics ([greater than or equal to] 365 d without antibiotic exposure) using conditional logistic regression, adjusting for confounders. RESULTS: We identified 14040688 new antibiotic users who met the inclusion criteria. Ventricular arrhythmia developed in 12874, of whom 30 were current azithromycin users. The mean age of the cases and controls was 63 years, and two-thirds were male. In the pooled data analyses across databases, azithromycin use was associated with an increased risk of ventricular arrhythmia relative to nonuse of antibiotics (adjusted odds ratio [OR] 1.97, 95% confidence interval [CI] 1.35-2.86). This increased risk disappeared when current amoxicillin use was the comparator (adjusted OR 0.90, 95% CI 0.48-1.71). Database-specific estimates and meta-analysis confirmed results from the pooled data analysis. INTERPRETATION: Current azithromycin use was associated with an increased risk of ventricular arrhythmia when compared with nonuse of antibiotics, but not when compared with current amoxicillin use. The decreased risk with an active comparator suggests significant confounding by indication., Azithromycin is a widely prescribed broad-spectrum macrolide used mainly for the treatment of respiratory and urinary tract bacterial infections. Concerns have been raised recently regarding its arrhythmogenic potential, a risk [...]

Published
2017

14. Myocarditis and pericarditis associated with SARS-CoV-2 vaccines: A population-based descriptive cohort and a nested self-controlled risk interval study using electronic health care data from four European countries

Author

RWE/Causal inference, Epi Infectieziekten Team 2, Data Science & Biostatistiek, Biostatistiek Onderzoek, Global Health, JC onderzoeksprogramma Methodologie, Circulatory Health, Child Health, Bots, Sophie H., Riera-Arnau, Judit, Belitser, Svetlana V., Messina, Davide, Aragón, Maria, Alsina, Ema, Douglas, Ian J., Durán, Carlos E., García-Poza, Patricia, Gini, Rosa, Herings, Ron M.C., Huerta, Consuelo, Sisay, Malede Mequanent, Martín-Pérez, Mar, Martin, Ivonne, Overbeek, Jetty A., Paoletti, Olga, Pallejà-Millán, Meritxell, Schultze, Anna, Souverein, Patrick, Swart, Karin M.A., Villalobos, Felipe, Klungel, Olaf H., Sturkenboom, Miriam C.J.M., RWE/Causal inference, Epi Infectieziekten Team 2, Data Science & Biostatistiek, Biostatistiek Onderzoek, Global Health, JC onderzoeksprogramma Methodologie, Circulatory Health, Child Health, Bots, Sophie H., Riera-Arnau, Judit, Belitser, Svetlana V., Messina, Davide, Aragón, Maria, Alsina, Ema, Douglas, Ian J., Durán, Carlos E., García-Poza, Patricia, Gini, Rosa, Herings, Ron M.C., Huerta, Consuelo, Sisay, Malede Mequanent, Martín-Pérez, Mar, Martin, Ivonne, Overbeek, Jetty A., Paoletti, Olga, Pallejà-Millán, Meritxell, Schultze, Anna, Souverein, Patrick, Swart, Karin M.A., Villalobos, Felipe, Klungel, Olaf H., and Sturkenboom, Miriam C.J.M.

Published
2022

26. Challenges Associated with the Safety Signal Detection Process for Medical Devices

Author

Pane, Josep, Verhamme, Katia M.C., Villegas, Dorian, Gamez, Laura, Rebollo, Irene, Sturkenboom, Miriam C.J.M., Pane, Josep, Verhamme, Katia M.C., Villegas, Dorian, Gamez, Laura, Rebollo, Irene, and Sturkenboom, Miriam C.J.M.

Abstract

Background: Previous safety issues involving medical devices have stressed the need for better safety signal detection. Various European Union (EU) national competent authorities have started to focus on strengthening the analysis of vigilance data. Consequently, article 90 of the new EU regulation states that the European Commission shall put in place systems and processes to actively monitor medical device safety signals. Methods: A systematic literature review was conducted to synthesize the current state of knowledge and investigate the present tools used for medical device safety signal detection. An electronic literature search was performed in Embase, Medline, Cochrane, Web of science, and Google scholar from inception until January 2017. Articles that included terms related to medical devices and terms associated with safety were selected. A further selection was based on the abstract review. A full review of the remaining articles was conducted to decide on which articles finally to consider relevant for this review. Completeness was assessed based on the content of the articles. Results: Our search resulted in a total of 20,819 articles, of which 24 met the inclusion criteria and were subject to data extraction and completeness scoring. A wide range of data sources, especially spontaneous reporting systems and registries, used for the detection and assessment of product problems and patient harms associated with the use of medical devices, were studied. Coding is remarkably heterogeneous, no agreement on the preferred methods for signal detection exists, and no gold standard for signal detection has been established thus far. Conclusion: Data source harmonization, the development of gold standard signal detection methodologies and the standardization of coding dictionaries are amongst the recommendations to support the implementation of a new proactive approach to signal detection. The new safety surveillance system will be able to use real-wor

Published
2021

27. Challenges Associated with the Safety Signal Detection Process for Medical Devices

Author

Data Science & Biostatistiek, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Global Health, Pane, Josep, Verhamme, Katia M.C., Villegas, Dorian, Gamez, Laura, Rebollo, Irene, Sturkenboom, Miriam C.J.M., Data Science & Biostatistiek, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Global Health, Pane, Josep, Verhamme, Katia M.C., Villegas, Dorian, Gamez, Laura, Rebollo, Irene, and Sturkenboom, Miriam C.J.M.

Published
2021

33. Descriptive analysis of postmarket surveillance data for hip implants

Author

Pane, Josep, Verhamme, Katia M.C., Rebollo, Irene, Sturkenboom, Miriam C.J.M., Pane, Josep, Verhamme, Katia M.C., Rebollo, Irene, and Sturkenboom, Miriam C.J.M.

Abstract

Purpose: Recent safety issues involving medical devices have highlighted the need for better postmarket surveillance (PMS) evaluation. This article aims to describe and to assess the quality of the PMS data for a medical device and, finally, to provide recommendations to improve the data gathering process. Methods: A descriptive analysis of medical device reports (MDRs) on the use of MRA, a specific type of hip implant replacement submitted to the Food and Drug Administration Manufacturer and User Facility Device Experience database from 1 January 2008 to 31 December 2017. The number of reports was described as the number of MDRs per unique MDR number and stratified by different variables. The quality was assessed by the level of completeness of the collected PMS data. Results: The total number of reports related to MRA was 2377, and the number of MDRs per year ranged between 84 in 2009 and 452 in 2017. Most of the reports were reported by manufacturer Depuy Johnson & Johnson and were reported by a physician. In 44.9% of the reports, the device problem was reported as “Unknown.” When the device problem was known, in the majority of cases, it was related to an implant fracture. The quality of the collected data was assessed as low due to missing information. Conclusion: The underlying data should meet high quality standards to generate more evidence and to ensure a timely signal generation. This case study shows that the completeness and quality of the MDRs can be improved. The authors propose the development of tools to ensure a more dynamic complaint data collection to contribute to this enhancement.

Published
2020

34. Blockchain technology applications to postmarket surveillance of medical devices

Author

Pane, Josep, Verhamme, Katia M.C., Shrum, Lacey, Rebollo, Irene, Sturkenboom, Miriam C.J.M., Pane, Josep, Verhamme, Katia M.C., Shrum, Lacey, Rebollo, Irene, and Sturkenboom, Miriam C.J.M.

Abstract

Introduction: The amount of mandatory data that needs to be analyzed as part of a medical device postmarket surveillance (PMS) system has grown exponentially in recent times. This is a consequence of increasingly demanding and complex regulatory requirements from Health Authorities, aimed at a better understanding of the medical device safety evaluation. Proactive approaches to PMS processes are becoming more necessary as regulators increase the scrutiny of device safety. New technologies have been explored to address some of the challenges associated with this changing regulatory environment. Areas covered: This paper focuses on the different technical aspects of blockchain and how this new technology has the potential to support the ongoing efforts to improve the PMS system for medical devices. Expert opinion: To address these challenges, we suggest to generate a private PMS data permissioned blockchain with a proof-of-authority consensus mechanism, to which only a restricted number of designated and audited participants have authorization to validate transactions and add them to the PMS data blockchain ledger. Blockchain has the potential to support a more efficient approach, which could offer many advantages to the different stakeholders involved in the PMS process, such as supporting with new regulatory initiatives.

Published
2020

37. Determinants for the adoption of angiotensin II receptor blockers by general practitioners

Author

Greving, Jacoba P., Denig, Petra, van der Veen, Willem Jan, Beltman, Frank W., Sturkenboom, Miriam C.J.M., and Haaijer-Ruskamp, Flora M.

Subjects
Physicians (General practice) -- Surveys, Angiotensin II receptor blockers -- Usage, Angiotensin II receptor blockers -- Surveys, Health, Social sciences
Abstract

Results of studies conducted 10-20 years ago show the prominence of commercial information sources in the adoption process of new drugs. Over the past decade, there has been a growing emphasis on practicing evidence-based medicine in drug prescribing. This raises the question whether professional information sources currently counterbalance the influence of commercial information sources in the adoption process. The aim of this study was to identify determinants influencing the adoption of a new drug class, the angiotensin II receptor blockers (ARBs), by general practitioners (GPs) in The Netherlands. A retrospective study was conducted to assess prevalent ARB prescribing for hypertensive patients using the Integrated Primary Care Information (IPCI) database. We conducted a survey among all GPs who participated in the IPCI project in 2003 to assess their exposure to commercial and professional information sources, perceived benefits and risks of ARBs, perceived influences of the professional network, and general characteristics. Multilevel logistic regression was applied to identify determinants of ARB adoption while adjusting for patient characteristics. Data were obtained from 70 GPs and 9470 treated hypertensive patients. A total of 1093 patients received ARBs (12%). GPs who reported frequent use of commercial information sources were more likely to prescribe ARBs routinely in preference to other antihypertensives, whereas GPs who used a prescribing decision support system and those who were involved in pharmacotherapy education were less likely to prescribe ARBs. Other factors that were associated with higher levels of ARB adoption included a more positive perception of ARBs regarding their effectiveness in lowering blood pressure, and working in single-handed practices or in rural areas. Aside from determinants related to the patient population, adoption of a new drug class among Dutch GPs is still determined more by their reliance on promotional information than by their use of professional information sources. Keywords: The Netherlands; Angiotensin II receptor blockers; Antihypertensive treatment; Decision making; Drug utilization; Primary care

Published
2006

40. Risk of community-acquired pneumonia and use of gastric acid-suppressive drugs

Author

Laheij, Robert J.F., Sturkenboom, Miriam C.J.M., Hassing, Robert-Jan, Stricker, Bruno H.C., and Jansen, Jan B.M.J.

Subjects
Bacterial pneumonia -- Research, Gastric acid -- Usage, Gastric acid -- Research, LSD (Drug) -- Usage, LSD (Drug) -- Research, Pneumonia -- Research
Abstract

The association between the use of acid-suppressive drugs and occurrence of community-acquired pneumonia is examined. The result indicates that the use of gastric acid-suppressive therapy was associated with an increase risk of community-acquired pneumonia.

Published
2004

41. Risk of Rupture of Small Anterior Communicating Artery Aneurysms Is Similar to Posterior Circulation Aneurysms

Author

Bijlenga, Philippe, Ebeling, Christian, Jaegersberg, Max, Summers, Paul, Rogers, Alister, Waterworth, Alan, Iavindrasana, Jimison, Macho, Juan, Pereira, Vitor Mendes, Bukovics, Peter, Vivas, Elio, Sturkenboom, Miriam C.J.M., Wright, Jessica, Friedrich, Christoph M., Frangi, Alejandro, Byrne, James, Schaller, Karl, Rufenacht, Daniel, Narata, Ana Paula, Clarke, Alison, Yarnold, Julia, Kover, Ferenc, Schatlo, Bawarjan, Hudak, Stephan, Teta, Patrick, Blasco, Jordi, Gonzalez, Ana Marcos, Lovblad, Karl-Olof, Coley, Stuart, Dòczi, Tamas, Risselada, Roelof, Sola, Theresa, Lawford, Patricia, Patel, Umang, Singh, Pankaj, Wickins, Jeremy, Elger, Bernice, Beyleveld, Derick, Wood, Steven, Hasselmeyer, Peer, Arbona, Antonio, Meyer, Rodolphe, Hose, Rod, Lonsdale, Guy, Hofmann-Apitius, Martin, Frangi, Alejandro, Bijlenga, Philippe, Hofmann-Apitius, Martin, Hose, Rod, Lonsdale, Guy, Arbona, Antonio, Hasselmeyer, Peer, Rüfenacht, Daniel, Bijlenga, Philippe, Summers, Paul, Jägersberg, Max, Rogers, Alister, Schaller, Karl, Byrne, James, Wright, Jessica, Wilkins, Jeremy, Beyleveld, Derick, Elger, Bernice, Waterworth, Alan, Wood, Steven, Iavindrasana, Jimison, Meyer, Rodolphe, Friedrich, Christoph, Ebeling, Christian, Ebeling, Christian, Bijlenga, Philippe, Risselada, Roelof, Friedrich, Christoph, Sturkenboom, Miriam CJM, Bijlenga, Philippe, Jägersberg, Max, Rogers, Alister, Schatlo, Bawarjan, Teta, Patrick, Schaller, Karl, Mendes-Pereira, Vitor, Gonzalez, Ana Marcos, Narata, Ana Paula, Lovblad, Karl O, Rüfenacht, Daniel A., Yarnold, Julia, Summers, Paul, Clarke, Alison, Zilani, Gulam, Byrne, James, Macho, Juan, Blasco, Jordi, Bukovics, Peter, Kover, Ferenc, Hudak, Istvan, Doczi, Tamas, Risselada, Roelof, Sturkenboom, Miriam CJM, Singh, Pankaj, Waterworth, Alan, Patel, Umang, Coley, Stuart, Lawford, Patricia, Sola, Teresa, and Vivas, Elio

Published
2013
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47. Vaccinations and multiple sclerosis

Author

Begaud, Bernard, Alperovitch, Annick, Hanslik, Thomas, Viboud, Cecile, Flahault, Antoine, Gout, Olivier, Sturkenboom, Miriam C.J.M., Fourrier, Annie, Buttinelli, Carla, Salvetti, Marco, Ristori, Giovanni, Hostetler, Larry, Ascherio, Alberto, Zhang, Shumin M., Walker, Alexander M., Confavreux, Christian, Suissa, Samy, and Saddier, Patricia

Subjects
Hepatitis B vaccine -- Adverse and side effects, Multiple sclerosis -- Risk factors
Published
2001

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