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Your search keyword '"J Janne, Vehreschild"' showing total 3 results
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3 results on '"J Janne, Vehreschild"'

1. Ethical and coordinative challenges in setting up a national cohort study during the COVID-19 pandemic in Germany

Author

Katharina Tilch, Sina M. Hopff, Katharina Appel, Monika Kraus, Bettina Lorenz-Depiereux, Lisa Pilgram, Gabi Anton, Sarah Berger, Ramsia Geisler, Kirsten Haas, Thomas Illig, Dagmar Krefting, Roberto Lorbeer, Lazar Mitrov, Maximilian Muenchhoff, Matthias Nauck, Christina Pley, Jens-Peter Reese, Siegbert Rieg, Margarete Scherer, Melanie Stecher, Christoph Stellbrink, Heike Valentin, Christof Winter, Martin Witzenrath, and J. Janne Vehreschild

Subjects
Pandemic preparedness, Ethical approval, COVID-19, Multicenter study, Study initiation, Ethics committee, Medical philosophy. Medical ethics, R723-726
Abstract

Abstract With the outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), global researchers were confronted with major challenges. The German National Pandemic Cohort Network (NAPKON) was launched in fall 2020 to effectively leverage resources and bundle research activities in the fight against the coronavirus disease 2019 (COVID-19) pandemic. We analyzed the setup phase of NAPKON as an example for multicenter studies in Germany, highlighting challenges and optimization potential in connecting 59 university and nonuniversity study sites. We examined the ethics application process of 121 ethics submissions considering durations, annotations, and outcomes. Study site activation and recruitment processes were investigated and related to the incidence of SARS-CoV-2 infections. For all initial ethics applications, the median time to a positive ethics vote was less than two weeks and 30 of these study sites (65%) joined NAPKON within less than three weeks each. Electronic instead of postal ethics submission (9.5 days (Q1: 5.75, Q3: 17) vs. 14 days (Q1: 11, Q3: 26), p value = 0.01) and adoption of the primary ethics vote significantly accelerated the ethics application process. Each study center enrolled a median of 37 patients during the 14-month observation period, with large differences depending on the health sector. We found a positive correlation between recruitment performance and COVID-19 incidence as well as hospitalization incidence. Our analysis highlighted the challenges and opportunities of the federated system in Germany. Digital ethics application tools, adoption of a primary ethics vote and standardized formal requirements lead to harmonized and thus faster study initiation processes during a pandemic.

Published
2023
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2. Use and effectiveness of remdesivir for the treatment of patients with covid-19 using data from the Lean European Open Survey on SARS-CoV-2 infected patients (LEOSS): a multicentre cohort study

Author

Lisa Pilgram, Katharina S. Appel, Maria M. Ruethrich, Carolin E. M. Koll, Maria J. G. T. Vehreschild, Susana M. Nunes de Miranda, Martin Hower, Kerstin Hellwig, Frank Hanses, Kai Wille, Martina Haselberger, Christoph D. Spinner, Juergen Vom Dahl, Bernd Hertenstein, Timm Westhoff, J. Janne Vehreschild, Björn-Erik Ole Jensen, and Melanie Stecher

Subjects
Microbiology (medical), Infectious Diseases, General Medicine
Abstract

Objectives The use of remdesivir (RDV) as the first drug approved for coronavirus disease 2019 (COVID-19) remains controversial. Based on the Lean European Open Survey on severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infected patients (LEOSS), we aim to contribute timing-focused complementary real-world insights to its evaluation. Methods SARS-CoV-2 infected patients between January 2020 and December 2021 treated with RDV were matched 1:1 to controls considering sociodemographics, comorbidities and clinical status. Multiple imputations were used to account for missing data. Effects on fatal outcome were estimated using uni- and multivariable Cox regression models. Results We included 9,687 patients. For those starting RDV administration in the complicated phase, Cox regression for fatal outcome showed an adjusted hazard ratio (aHR) of 0.59 (95%CI 0.41–0.83). Positive trends could be obtained for further scenarios: an aHR of 0.51 (95%CI 0.16–1.68) when RDV was initiated in uncomplicated and of 0.76 (95% CI 0.55–1.04) in a critical phase of disease. Patients receiving RDV with concomitant steroids exhibited a further reduction in aHR in both, the complicated (aHR 0.50, 95%CI 0.29–0.88) and critical phase (aHR 0.63, 95%CI 0.39–1.02). Conclusion Our study results elucidate that RDV use, in particular when initiated in the complicated phase and accompanied by steroids is associated with improved mortality. However, given the limitations of non-randomized trials in estimating the magnitude of the benefit of an intervention, further randomized trials focusing on the timing of therapy initiation seem warranted.

Published
2023
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3. FungiScope

Author

Danila, Seidel, Luisa A, Durán Graeff, Maria J G T, Vehreschild, Hilmar, Wisplinghoff, Maren, Ziegler, J Janne, Vehreschild, Blasius, Liss, Axel, Hamprecht, Philipp, Köhler, Zdenek, Racil, Nikolay, Klimko, Donald C, Sheppard, Raoul, Herbrecht, Anuradha, Chowdhary, Oliver A, Cornely, and FungiScope Group

Subjects
Quality Control, Immunocompromised Host, Rare Diseases, Mycoses, Humans, Registries, Global Health, Communicable Diseases, Emerging, Invasive Fungal Infections
Abstract

Rare invasive fungal diseases (IFD) are challenging for the treating physicians because of their unspecific clinical presentation, as well as the lack of standardised diagnostic and effective treatment strategies. Late onset of treatment and inappropriate medication is associated with high mortality, thus, urging the need for a better understanding of these diseases. The purpose of FungiScope

Published
2017

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