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  • 1
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    1886. External Validation of the 4C Mortality Score and the qSOFA for Different Variants of Concerns of SARS-CoV-2 Using Data of the NAPKON Cross-Sectoral Cohort Platform (SUEP)
    Oxford University Press (OUP) ; 2022
    In:  Open Forum Infectious Diseases Vol. 9, No. Supplement_2 ( 2022-12-15)
    Details
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: Numerous predictive clinical scores with varying discriminatory performance have been developed in the context of the current coronavirus disease 2019 (COVID-19) pandemic. To support clinical application, we test the transferability of the frequently applied 4C mortality score (4C score) to the German prospective Cross-Sectoral Platform (SUEP) of the National Pandemic Cohort Network (NAPKON) compared to the non COVID-19 specific quick sequential organ failure assessment score (qSOFA). Our project aims to externally validate these two scores, stratified for the most prevalent variants of concerns (VOCs) of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) in Germany. Methods A total of 685 adults with polymerase chain reaction (PCR)-detected SARS-CoV-2 infection were included from NAPKON-SUEP. Patients were recruited from 11/2020 to 03/2022 at 34 university and non-university hospitals across Germany. Missing values were complemented using multiple imputation. Predictive performance for in-hospital mortality at day of baseline visit was determined by area under the curve (AUC) with 95%-confidence interval (CI) stratified by VOCs of SARS-CoV-2 (alpha, delta, omicron) (Figure 1). Figure 1:Study flow chart with inclusion criteria and methodological workflow. Results Preliminary results suggest a high predictive performance of the 4C score for in-hospital mortality (Table 1). This applies for the overall cohort (AUC 0.813 (95%CI 0.738-0.888)) as well as the VOC-strata (alpha: AUC 0.859 (95%CI 0.748-0.970); delta: AUC 0.769 (95%CI 0.657-0.882); omicron: AUC 0.866 (95%CI 0.724-1.000)). The overall mortality rates across the defined 4C score risk groups are 0.3% (low), 3.2% (intermediate), 11.6% (high), and 49.5% (very high). The 4C score performs significantly better than the qSOFA (Chi2-test: p=0.001) and the qSOFA does not seem to be a suitable tool in this context. Table 1:Discriminatory performance of the 4C Mortality Score and the qSOFA score within the validation cohort NAPKON-SUEP stratified by the Variant of Concerns of SARS-CoV-2. Conclusion Despite its development in the early phase of the pandemic and improved treatment, external validation of the 4C score in NAPKON-SUEP indicates a high predictive performance for in-hospital mortality across all VOCs. However, since the qSOFA was not specifically designed for this predictive issue, it shows low discriminatory performance, as in other validation studies. Any interpretations regarding the omicron stratum are limited due to the sample size. Disclosures Daniel Pape, Dr., Advanz Pharma Germany: Support for attending meetings and/or travel for ECCMID 2021 Martin Hower, n/a, MSD: Advisor/Consultant|Trogarzo: Advisor/Consultant|ViiV Healthcare: Advisor/Consultant Björn-Erik O. Jensen, Dr. med., GILEAD: Advisor/Consultant|GILEAD: Lectures, Travel|GSK: Lectures, Travel Jörg J. Vehreschild, Univ.-Prof. Dr. med., Ärztekammer Nordrhein: Honoraria|Academy for Infectious Medicine, University Manchester: Honoraria|Astellas Pharma: Grant/Research Support|Astellas Pharma: Honoraria|Back Bay Strategies: Honoraria|Basilea: Grant/Research Support|Basilea: Honoraria|Deutsches Zetrum für Luft- und Raumfahrt (DLR): Grant/Research Support|German Centre for Infection Research (DZIF): Grant/Research Support|German Centre for Infection Research (DZIF): Honoraria|German Federal Ministry of Education and Research (BMBF): Grant/Research Support|German Society for Infectious Diseases (DGI): Honoraria|German Society for Internal Medicine (DGIM): Honoraria|GILEAD: Advisor/Consultant|GILEAD: Grant/Research Support|GILEAD: Honoraria|Janssen: Honoraria|Merck / MSD: Grant/Research Support|Merck / MSD: Honoraria|Molecular Health: Honoraria|Netzwerk Universitätsmedizin: Honoraria|NordForsk: Honoraria|Pfizer: Advisor/Consultant|Pfizer: Grant/Research Support|Pfizer: Honoraria|Rigshospitalet Copenhagen: Grant/Research Support|Shionogi: Advisor/Consultant|Shionogi: Honoraria|University Hospital Aachen: Honoraria|University Hospital Freiburg/ Congress and Communication: Honoraria|University of Bristol: Grant/Research Support.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    URL: Article
    DOI: 10.1093/ofid/ofac492.1513
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 2
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    The German National Pandemic Cohort Network (NAPKON): rationale, study design and baseline characteristics
    Springer Science and Business Media LLC ; 2022
    In:  European Journal of Epidemiology Vol. 37, No. 8 ( 2022-08), p. 849-870
    Details
    In: European Journal of Epidemiology, Springer Science and Business Media LLC, Vol. 37, No. 8 ( 2022-08), p. 849-870
    Abstract: The German government initiated the Network University Medicine (NUM) in early 2020 to improve national research activities on the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic. To this end, 36 German Academic Medical Centers started to collaborate on 13 projects, with the largest being the National Pandemic Cohort Network (NAPKON). The NAPKON’s goal is creating the most comprehensive Coronavirus Disease 2019 (COVID-19) cohort in Germany. Within NAPKON, adult and pediatric patients are observed in three complementary cohort platforms (Cross-Sectoral, High-Resolution and Population-Based) from the initial infection until up to three years of follow-up. Study procedures comprise comprehensive clinical and imaging diagnostics, quality-of-life assessment, patient-reported outcomes and biosampling. The three cohort platforms build on four infrastructure core units (Interaction, Biosampling, Epidemiology, and Integration) and collaborations with NUM projects. Key components of the data capture, regulatory, and data privacy are based on the German Centre for Cardiovascular Research. By April 01, 2022, 34 university and 40 non-university hospitals have enrolled 5298 patients with local data quality reviews performed on 4727 (89%). 47% were female, the median age was 52 (IQR 36–62-) and 50 pediatric cases were included. 44% of patients were hospitalized, 15% admitted to an intensive care unit, and 12% of patients deceased while enrolled. 8845 visits with biosampling in 4349 patients were conducted by April 03, 2022. In this overview article, we summarize NAPKON’s design, relevant milestones including first study population characteristics, and outline the potential of NAPKON for German and international research activities. Trial registration https://clinicaltrials.gov/ct2/show/NCT04768998 . https://clinicaltrials.gov/ct2/show/NCT04747366 . https://clinicaltrials.gov/ct2/show/NCT04679584
    Type of Medium: Online Resource
    ISSN: 0393-2990 , 1573-7284
    URL: Article
    DOI: 10.1007/s10654-022-00896-z
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
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  • 3
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    Definition of the Post-COVID syndrome using a symptom-based Post-COVID score in a prospective, multi-center, cross-sectoral cohort of the German National Pandemic Cohort Network (NAPKON)
    Springer Science and Business Media LLC ; 2024
    In:  Infection
    Details
    In: Infection, Springer Science and Business Media LLC
    Abstract: The objective examination of the Post-COVID syndrome (PCS) remains difficult due to heterogeneous definitions and clinical phenotypes. The aim of the study was to verify the functionality and correlates of a recently developed PCS score. Methods The PCS score was applied to the prospective, multi-center cross-sectoral cohort (in- and outpatients with SARS-CoV-2 infection) of the "National Pandemic Cohort Network (NAPKON, Germany)". Symptom assessment and patient-reported outcome measure questionnaires were analyzed at 3 and 12 months (3/12MFU) after diagnosis. Scores indicative of PCS severity were compared and correlated to demographic and clinical characteristics as well as quality of life (QoL, EQ-5D-5L). Results Six hundred three patients (mean 54.0 years, 60.6% male, 82.0% hospitalized) were included. Among those, 35.7% (215) had no and 64.3% (388) had mild, moderate, or severe PCS. PCS severity groups differed considering sex and pre-existing respiratory diseases. 3MFU PCS worsened with clinical severity of acute infection ( p  = .011), and number of comorbidities ( p  = .004). PCS severity was associated with poor QoL at the 3MFU and 12MFU ( p   〈  .001). Conclusion The PCS score correlated with patients’ QoL and demonstrated to be instructive for clinical characterization and stratification across health care settings. Further studies should critically address the high prevalence, clinical relevance, and the role of comorbidities. Trail registration number The cohort is registered at www.clinicaltrials.gov under NCT04768998.
    Type of Medium: Online Resource
    ISSN: 0300-8126 , 1439-0973
    URL: Article
    DOI: 10.1007/s15010-024-02226-9
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2024
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  • 4
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    The German Network of University Medicine: technical and organizational approaches for research data platforms
    Springer Science and Business Media LLC ; 2023
    In:  Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz Vol. 66, No. 2 ( 2023-02), p. 114-125
    Details
    In: Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz, Springer Science and Business Media LLC, Vol. 66, No. 2 ( 2023-02), p. 114-125
    Abstract: The Network University Medicine (NUM) consists of 36 university clinics in Germany. It was set up to coordinate COVID-19 university medicine research activities on a national level. This required, among other things, common infrastructures for the collection, storage, and use of medical research data. These infrastructures were not available in the required form when the NUM started in April 2020. Medical research data are extremely heterogeneous and reach far beyond “real world data” from patient care. There was no “one size fits all” solution, so NUM built five infrastructures for different types of data, different ways of obtaining data, and different data origination settings. To prevent the creation of new data silos, all five infrastructures operate based on FAIR principles (findable, accessible, interoperable, reusable). In addition, NUM is implementing an overarching governance framework to manage the evolution of these five infrastructures. The article describes the current state of development and possible perspectives with a strong focus on technical and organizational aspects.
    Type of Medium: Online Resource
    ISSN: 1436-9990 , 1437-1588
    URL: Article
    DOI: 10.1007/s00103-022-03649-1
    Language: German
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
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    SSG: 8,1
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    The DZHK research platform: maximisation of scientific value by enabling access to health data and biological samples collected in cardiovascular clinical studies
    Springer Science and Business Media LLC ; 2023
    In:  Clinical Research in Cardiology Vol. 112, No. 7 ( 2023-07), p. 923-941
    Details
    In: Clinical Research in Cardiology, Springer Science and Business Media LLC, Vol. 112, No. 7 ( 2023-07), p. 923-941
    Abstract: The German Centre for Cardiovascular Research (DZHK) is one of the German Centres for Health Research and aims to conduct early and guideline-relevant studies to develop new therapies and diagnostics that impact the lives of people with cardiovascular disease. Therefore, DZHK members designed a collaboratively organised and integrated research platform connecting all sites and partners. The overarching objectives of the research platform are the standardisation of prospective data and biological sample collections among all studies and the development of a sustainable centrally standardised storage in compliance with general legal regulations and the FAIR principles. The main elements of the DZHK infrastructure are web-based and central units for data management, LIMS, IDMS, and transfer office, embedded in a framework consisting of the DZHK Use and Access Policy, and the Ethics and Data Protection Concept. This framework is characterised by a modular design allowing a high standardisation across all studies. For studies that require even tighter criteria additional quality levels are defined. In addition, the Public Open Data strategy is an important focus of DZHK. The DZHK operates as one legal entity holding all rights of data and biological sample usage, according to the DZHK Use and Access Policy. All DZHK studies collect a basic set of data and biosamples, accompanied by specific clinical and imaging data and biobanking. The DZHK infrastructure was constructed by scientists with the focus on the needs of scientists conducting clinical studies. Through this, the DZHK enables the interdisciplinary and multiple use of data and biological samples by scientists inside and outside the DZHK. So far, 27 DZHK studies recruited well over 11,200 participants suffering from major cardiovascular disorders such as myocardial infarction or heart failure. Currently, data and samples of five DZHK studies of the DZHK Heart Bank can be applied for.
    Type of Medium: Online Resource
    ISSN: 1861-0684 , 1861-0692
    URL: Article
    DOI: 10.1007/s00392-023-02177-5
    RVK:
    XA 37040
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
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    Consistency as a Data Quality Measure for German Corona Consensus Items Mapped from National Pandemic Cohort Network Data Collections
    Georg Thieme Verlag KG ; 2023
    In:  Methods of Information in Medicine Vol. 62, No. S 01 ( 2023-06), p. e47-e56
    Details
    In: Methods of Information in Medicine, Georg Thieme Verlag KG, Vol. 62, No. S 01 ( 2023-06), p. e47-e56
    Abstract: Background As a national effort to better understand the current pandemic, three cohorts collect sociodemographic and clinical data from coronavirus disease 2019 (COVID-19) patients from different target populations within the German National Pandemic Cohort Network (NAPKON). Furthermore, the German Corona Consensus Dataset (GECCO) was introduced as a harmonized basic information model for COVID-19 patients in clinical routine. To compare the cohort data with other GECCO-based studies, data items are mapped to GECCO. As mapping from one information model to another is complex, an additional consistency evaluation of the mapped items is recommended to detect possible mapping issues or source data inconsistencies. Objectives The goal of this work is to assure high consistency of research data mapped to the GECCO data model. In particular, it aims at identifying contradictions within interdependent GECCO data items of the German national COVID-19 cohorts to allow investigation of possible reasons for identified contradictions. We furthermore aim at enabling other researchers to easily perform data quality evaluation on GECCO-based datasets and adapt to similar data models. Methods All suitable data items from each of the three NAPKON cohorts are mapped to the GECCO items. A consistency assessment tool (dqGecco) is implemented, following the design of an existing quality assessment framework, retaining their-defined consistency taxonomies, including logical and empirical contradictions. Results of the assessment are verified independently on the primary data source. Results Our consistency assessment tool helped in correcting the mapping procedure and reveals remaining contradictory value combinations within COVID-19 symptoms, vital signs, and COVID-19 severity. Consistency rates differ between the different indicators and cohorts ranging from 95.84% up to 100%. Conclusion An efficient and portable tool capable of discovering inconsistencies in the COVID-19 domain has been developed and applied to three different cohorts. As the GECCO dataset is employed in different platforms and studies, the tool can be directly applied there or adapted to similar information models.
    Type of Medium: Online Resource
    ISSN: 0026-1270 , 2511-705X
    URL: Article
    DOI: 10.1055/a-2006-1086
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    Language: English
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2023
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    Therapie der intraoperativen Hypotonie mit Cafedrin/Theodrenalin vs. Ephedrin : Ergebnisse der HYPOTENS-Studie, einer prospektiven, nationalen, multizentrischen, nicht-interventionellen Untersuchung bei Patienten, die eine Vollnarkose erhalten
    Springer Science and Business Media LLC ; 2021
    In:  Der Anaesthesist Vol. 70, No. 4 ( 2021-04), p. 298-307
    Details
    In: Der Anaesthesist, Springer Science and Business Media LLC, Vol. 70, No. 4 ( 2021-04), p. 298-307
    Abstract: Die medikamentöse Therapie mit Sympathomimetika bildet einen Grundpfeiler der Behandlung relevanter Blutdruckabfälle, so auch der intraoperativen Hypotonie (IOH). Dieses häufige Problem ist mit Endorganschäden assoziiert, wobei Nierenversagen und eine erhöhte Rate kardiovaskulärer Komplikationen am besten dokumentiert sind. Die Datenlage verdeutlicht die Notwendigkeit, dass eine IOH schnell und konsequent therapiert werden muss. Obwohl Cafedrin/Theodrenalin (C/T) in Deutschland häufig in dieser Indikation eingesetzt wird, fehlte bislang ein Wirksamkeitsvergleich mit international verfügbaren Alternativen wie Ephedrin (E). Methoden HYPOTENS ist eine prospektive, nationale, multizentrische (53 Kliniken mit 66 operativen Abteilungen), offene, zweiarmige, nicht-interventionelle Studie zum Vergleich der Wirksamkeit von C/T und E bei der IOH-Therapie unter klinischen Routinebedingungen. Diese Studie beschreibt eine prospektiv definierte Kohorte von Patienten im Alter von ≥50 Jahren mit Komorbiditäten, deren Allgemeinanästhesie mit Propofol und Fentanyl (≥0,2 mg oder Äquivalent) eingeleitet wurde. Alle Patienten hatten intraoperativ eine therapiepflichtige IOH entwickelt und wurden nach dem jeweiligen lokalen Standard mit C/T oder E therapiert. Die primären Studienziele waren Präzision und Schnelligkeit des Blutdruckanstiegs auf einen vor der Behandlung individuell festgelegten Mindest-Zielblutdruck, ohne dabei einen relevanten Anstieg der Herzfrequenz zu verursachen. Die Therapiezufriedenheit der Anästhesisten und die Anzahl zusätzlicher Bolusinjektionen oder weiterer kreislaufstabilisierender Maßnahmen waren sekundäre Endpunkte. Ergebnisse Insgesamt 1496 Patienten wurden protokollgemäß behandelt und ausgewertet. Eine Kreislaufstabilisierung wurde mit beiden Therapieoptionen erreicht. Post-hoc-Analysen zeigen, dass der Blutdruckanstieg unter C/T ausgeprägter war und gleichzeitig weniger zusätzliche Boli der jeweiligen Substanz appliziert und zusätzliche kreislaufstabilisierende Interventionen durchgeführt werden mussten. Die Inzidenz von Tachykardien war in beiden Behandlungsgruppen vergleichbar. Unter E kam es jedoch zu einer dosisabhängigen Erhöhung der Herzfrequenz, während bei den mit C/T behandelten Patienten die Herzfrequenz stabil blieb. Die Therapiezufriedenheit der Anästhesisten war im C/T-Arm höher. Schlussfolgerung Hinsichtlich der Kreislaufstabilisierung war keine der beiden Therapieoptionen überlegen. Post-hoc-Analysen deuten darauf hin, dass C/T unter Routinebedingungen eine zielorientiertere und einfacher zu steuernde Kreislaufstabilisierung ermöglicht. Die seltener erforderlichen erweiterten Therapiemaßnahmen zur ergänzenden IOH-Korrektur stellen einen möglichen Grund für die höhere Anwenderzufriedenheit dar.
    Type of Medium: Online Resource
    ISSN: 0003-2417 , 1432-055X
    URL: Article
    DOI: 10.1007/s00101-020-00877-5
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    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
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    Depression and fatigue six months post-COVID-19 disease are associated with overlapping symptom constellations: A prospective, multi-center, population-based cohort study
    Elsevier BV ; 2024
    In:  Journal of Affective Disorders Vol. 352 ( 2024-05), p. 296-305
    Details
    In: Journal of Affective Disorders, Elsevier BV, Vol. 352 ( 2024-05), p. 296-305
    Type of Medium: Online Resource
    ISSN: 0165-0327
    URL: Article
    DOI: 10.1016/j.jad.2024.02.041
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    Language: English
    Publisher: Elsevier BV
    Publication Date: 2024
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    Analysis of acute COVID-19 including chronic morbidity: protocol for the deep phenotyping National Pandemic Cohort Network in Germany (NAPKON-HAP)
    Springer Science and Business Media LLC ; 2024
    In:  Infection Vol. 52, No. 1 ( 2024-02), p. 93-104
    Details
    In: Infection, Springer Science and Business Media LLC, Vol. 52, No. 1 ( 2024-02), p. 93-104
    Abstract: The severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) pandemic causes a high burden of acute and long-term morbidity and mortality worldwide despite global efforts in containment, prophylaxis, and therapy. With unprecedented speed, the global scientific community has generated pivotal insights into the pathogen and the host response evoked by the infection. However, deeper characterization of the pathophysiology and pathology remains a high priority to reduce morbidity and mortality of coronavirus disease 2019 (COVID-19). Methods NAPKON-HAP is a multi‐centered prospective observational study with a long‐term follow‐up phase of up to 36 months post-SARS-CoV-2 infection. It constitutes a central platform for harmonized data and biospecimen for interdisciplinary characterization of acute SARS-CoV-2 infection and long-term outcomes of diverging disease severities of hospitalized patients. Results Primary outcome measures include clinical scores and quality of life assessment captured during hospitalization and at outpatient follow-up visits to assess acute and chronic morbidity. Secondary measures include results of biomolecular and immunological investigations and assessment of organ-specific involvement during and post-COVID-19 infection. NAPKON-HAP constitutes a national platform to provide accessibility and usability of the comprehensive data and biospecimen collection to global research. Conclusion NAPKON-HAP establishes a platform with standardized high-resolution data and biospecimen collection of hospitalized COVID-19 patients of different disease severities in Germany. With this study, we will add significant scientific insights and provide high-quality data to aid researchers to investigate COVID-19 pathophysiology, pathology, and chronic morbidity.
    Type of Medium: Online Resource
    ISSN: 0300-8126 , 1439-0973
    URL: Article
    DOI: 10.1007/s15010-023-02057-0
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2024
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