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2. 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)

Author

Appel, Katharina S., Nürnberger, Carolin, Bahmer, Thomas, Förster, Christian, Polidori, Maria Cristina, Kohls, Mirjam, Kraus, Tanja, Hettich-Damm, Nora, Petersen, Julia, Blaschke, Sabine, Bröhl, Isabel, Butzmann, Jana, Dashti, Hiwa, Deckert, Jürgen, Dreher, Michael, Fiedler, Karin, Finke, Carsten, Geisler, Ramsia, Hanses, Frank, Hopff, Sina M., Jensen, Björn-Erik O., Konik, Margarethe, Lehnert, Kristin, de Miranda, Susana M. Nunes, Mitrov, Lazar, Miljukov, Olga, Reese, Jens-Peter, Rohde, Gernot, Scherer, Margarete, Tausche, Kristin, Tebbe, Johannes J., Vehreschild, Jörg Janne, Voit, Florian, Wagner, Patricia, Weigl, Martin, and Lemhöfer, Christina

Published
2024
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3. Estimates of protection levels against SARS-CoV-2 infection and severe COVID-19 in Germany before the 2022/2023 winter season: the IMMUNEBRIDGE project

Author

Lange, Berit, Jaeger, Veronika K., Harries, Manuela, Rücker, Viktoria, Streeck, Hendrik, Blaschke, Sabine, Petersmann, Astrid, Toepfner, Nicole, Nauck, Matthias, Hassenstein, Max J., Dreier, Maren, von Holt, Isabell, Budde, Axel, Bartz, Antonia, Ortmann, Julia, Kurosinski, Marc-André, Berner, Reinhard, Borsche, Max, Brandhorst, Gunnar, Brinkmann, Melanie, Budde, Kathrin, Deckena, Marek, Engels, Geraldine, Fenzlaff, Marc, Härtel, Christoph, Hovardovska, Olga, Katalinic, Alexander, Kehl, Katja, Kohls, Mirjam, Krüger, Stefan, Lieb, Wolfgang, Meyer-Schlinkmann, Kristin M., Pischon, Tobias, Rosenkranz, Daniel, Rübsamen, Nicole, Rupp, Jan, Schäfer, Christian, Schattschneider, Mario, Schlegtendal, Anne, Schlinkert, Simon, Schmidbauer, Lena, Schulze-Wundling, Kai, Störk, Stefan, Tiemann, Carsten, Völzke, Henry, Winter, Theresa, Klein, Christine, Liese, Johannes, Brinkmann, Folke, Ottensmeyer, Patrick F., Reese, Jens-Peter, Heuschmann, Peter, and Karch, André

Published
2024
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4. Persistent symptoms and risk factors predicting prolonged time to symptom-free after SARS‑CoV‑2 infection: an analysis of the baseline examination of the German COVIDOM/NAPKON-POP cohort

Author

Shi, Yanyan, Strobl, Ralf, Apfelbacher, Christian, Bahmer, Thomas, Geisler, Ramsia, Heuschmann, Peter, Horn, Anna, Hoven, Hanno, Keil, Thomas, Krawczak, Michael, Krist, Lilian, Lemhöfer, Christina, Lieb, Wolfgang, Lorenz-Depiereux, Bettina, Mikolajczyk, Rafael, Montellano, Felipe A., Reese, Jens Peter, Schreiber, Stefan, Skoetz, Nicole, Störk, Stefan, Vehreschild, Jörg Janne, Witzenrath, Martin, and Grill, Eva

Published
2023
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5. Depression and fatigue six months post-COVID-19 disease are associated with overlapping symptom constellations: A prospective, multi-center, population-based cohort study

Author

Weiß, Martin, Gutzeit, Julian, Appel, Katharina S., Bahmer, Thomas, Beutel, Manfred, Deckert, Jürgen, Fricke, Julia, Hanß, Sabine, Hettich-Damm, Nora, Heuschmann, Peter U., Horn, Anna, Jauch-Chara, Kamila, Kohls, Mirjam, Krist, Lilian, Lorenz-Depiereux, Bettina, Otte, Christian, Pape, Daniel, Reese, Jens-Peter, Schreiber, Stefan, Störk, Stefan, Vehreschild, Jörg Janne, and Hein, Grit

Published
2024
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6. Ethical and coordinative challenges in setting up a national cohort study during the COVID-19 pandemic in Germany

Author

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

Published
2023
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7. Impact of Clinical Study Implementation on Data Quality Assessments – Using Contradictions within Interdependent Health Data Items as a Pilot Indicator

Author

Yusuf, Khalid O., primary, Chaplinskaya-Sobol, Irina, additional, Schoneberg, Anne, additional, Hanss, Sabine, additional, Valentin, Heike, additional, Lorenz-Depiereux, Bettina, additional, Hansch, Stefan, additional, Fiedler, Karin, additional, Scherer, Margarete, additional, Sikdar, Shimita, additional, Miljukov, Olga, additional, Reese, Jens-Peter, additional, Wagner, Patricia, additional, Bröhl, Isabel, additional, Geisler, Ramsia, additional, Vehreschild, Jörg J., additional, Blaschke, Sabine, additional, Bellinghausen, Carla, additional, Milovanovic, Milena, additional, and Krefting, Dagmar, additional

Published
2023
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8. The German National Pandemic Cohort Network (NAPKON): rationale, study design and baseline characteristics

Author

Schons, Maximilian, Pilgram, Lisa, Reese, Jens-Peter, Stecher, Melanie, Anton, Gabriele, Appel, Katharina S., Bahmer, Thomas, Bartschke, Alexander, Bellinghausen, Carla, Bernemann, Inga, Brechtel, Markus, Brinkmann, Folke, Brünn, Clara, Dhillon, Christine, Fiessler, Cornelia, Geisler, Ramsia, Hamelmann, Eckard, Hansch, Stefan, Hanses, Frank, Hanß, Sabine, Herold, Susanne, Heyder, Ralf, Hofmann, Anna-Lena, Hopff, Sina Marie, Horn, Anna, Jakob, Carolin, Jiru-Hillmann, Steffi, Keil, Thomas, Khodamoradi, Yascha, Kohls, Mirjam, Kraus, Monika, Krefting, Dagmar, Kunze, Sonja, Kurth, Florian, Lieb, Wolfgang, Lippert, Lena Johanna, Lorbeer, Roberto, Lorenz-Depiereux, Bettina, Maetzler, Corina, Miljukov, Olga, Nauck, Matthias, Pape, Daniel, Püntmann, Valentina, Reinke, Lennart, Römmele, Christoph, Rudolph, Stefanie, Sass, Julian, Schäfer, Christian, Schaller, Jens, Schattschneider, Mario, Scheer, Christian, Scherer, Margarete, Schmidt, Sein, Schmidt, Julia, Seibel, Kristina, Stahl, Dana, Steinbeis, Fridolin, Störk, Stefan, Tauchert, Maike, Tebbe, Johannes Josef, Thibeault, Charlotte, Toepfner, Nicole, Ungethüm, Kathrin, Vadasz, Istvan, Valentin, Heike, Wiedmann, Silke, Zoller, Thomas, Nagel, Eike, Krawczak, Michael, von Kalle, Christof, Illig, Thomas, Schreiber, Stefan, Witzenrath, Martin, Heuschmann, Peter, and Vehreschild, Jörg Janne

Published
2022
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9. Severity, predictors and clinical correlates of Post-COVID syndrome (PCS) in Germany: A prospective, multi-centre, population-based cohort study

Author

Bahmer, Thomas, Borzikowsky, Christoph, Lieb, Wolfgang, Horn, Anna, Krist, Lilian, Fricke, Julia, Scheibenbogen, Carmen, Rabe, Klaus F., Maetzler, Walter, Maetzler, Corina, Laudien, Martin, Frank, Derk, Ballhausen, Sabrina, Hermes, Anne, Miljukov, Olga, Haeusler, Karl Georg, Mokhtari, Nour Eddine El, Witzenrath, Martin, Vehreschild, Jörg Janne, Krefting, Dagmar, Pape, Daniel, Montellano, Felipe A., Kohls, Mirjam, Morbach, Caroline, Störk, Stefan, Reese, Jens-Peter, Keil, Thomas, Heuschmann, Peter, Krawczak, Michael, and Schreiber, Stefan

Published
2022
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10. Statistical biases due to anonymization evaluated in an open clinical dataset from COVID-19 patients

Author

Koll, Carolin E. M., Hopff, Sina M., Meurers, Thierry, Lee, Chin Huang, Kohls, Mirjam, Stellbrink, Christoph, Thibeault, Charlotte, Reinke, Lennart, Steinbrecher, Sarah, Schreiber, Stefan, Mitrov, Lazar, Frank, Sandra, Miljukov, Olga, Erber, Johanna, Hellmuth, Johannes C., Reese, Jens-Peter, Steinbeis, Fridolin, Bahmer, Thomas, Hagen, Marina, Meybohm, Patrick, Hansch, Stefan, Vadász, István, Krist, Lilian, Jiru-Hillmann, Steffi, Prasser, Fabian, and Vehreschild, Jörg Janne

Published
2022
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12. A precise performance-based reimbursement model for the multi-centre NAPKON cohorts – development and evaluation.

Author

Appel, Katharina S., Lee, Chin Huang, Nunes de Miranda, Susana M., Maier, Daniel, Reese, Jens-Peter, Anton, Gabriele, Bahmer, Thomas, Ballhausen, Sabrina, Balzuweit, Beate, Bellinghausen, Carla, Blumentritt, Arne, Brechtel, Markus, Chaplinskaya-Sobol, Irina, Erber, Johanna, Fiedler, Karin, Geisler, Ramsia, Heyder, Ralf, Illig, Thomas, Kohls, Mirjam, and Kollek, Jenny

Abstract

Fair allocation of funding in multi-centre clinical studies is challenging. Models commonly used in Germany - the case fees (“fixed-rate model”, FRM) and up-front staffing and consumables (“up-front allocation model”, UFAM) lack transparency and fail to suitably accommodate variations in centre performance. We developed a performance-based reimbursement model (PBRM) with automated calculation of conducted activities and applied it to the cohorts of the National Pandemic Cohort Network (NAPKON) within the Network of University Medicine (NUM). The study protocol activities, which were derived from data management systems, underwent validation through standardized quality checks by multiple stakeholders. The PBRM output (first funding period) was compared among centres and cohorts, and the cost-efficiency of the models was evaluated. Cases per centre varied from one to 164. The mean case reimbursement differed among the cohorts (1173.21€ [95% CI 645.68–1700.73] to 3863.43€ [95% CI 1468.89–6257.96]) and centres and mostly fell short of the expected amount. Model comparisons revealed higher cost-efficiency of the PBRM compared to FRM and UFAM, especially for low recruitment outliers. In conclusion, we have developed a reimbursement model that is transparent, accurate, and flexible. In multi-centre collaborations where heterogeneity between centres is expected, a PBRM could be used as a model to address performance discrepancies. Trial registration: ; ; . [ABSTRACT FROM AUTHOR]

Published
2024
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13. A multicenter, matched case–control analysis comparing burden of illness among patients with tuberous sclerosis complex related epilepsy, generalized idiopathic epilepsy, and focal epilepsy in Germany.

Author

Lappe, Lisa, Hertzberg, Christoph, Knake, Susanne, Knuf, Markus, von Podewils, Felix, Willems, Laurent M., Kovac, Stjepana, Zöllner, Johann Philipp, Sauter, Matthias, Kurlemann, Gerhard, Mayer, Thomas, Bertsche, Astrid, Marquard, Klaus, Meyer, Sascha, Schäfer, Hannah, Thiels, Charlotte, Zukunft, Bianca, Schubert-Bast, Susanne, Reese, Jens-Peter, and Rosenow, Felix

Subjects
TUBEROUS sclerosis, PARTIAL epilepsy, IDIOPATHIC diseases, REPORT cards, EPILEPSY
Abstract

Background: Depending on the underlying etiology and epilepsy type, the burden of disease for patients with seizures can vary significantly. This analysis aimed to compare direct and indirect costs and quality of life (QoL) among adults with tuberous sclerosis complex (TSC) related with epilepsy, idiopathic generalized epilepsy (IGE), and focal epilepsy (FE) in Germany. Methods: Questionnaire responses from 92 patients with TSC and epilepsy were matched by age and gender, with responses from 92 patients with IGE and 92 patients with FE collected in independent studies. Comparisons were made across the main QoL components, direct costs (patient visits, medication usage, medical equipment, diagnostic procedures, ancillary treatments, and transport costs), indirect costs (employment, reduced working hours, missed days), and care level costs. Results: Across all three cohorts, mean total direct costs (TSC: €7602 [median €2620]; IGE: €1919 [median €446], P < 0.001; FE: €2598 [median €892], P < 0.001) and mean total indirect costs due to lost productivity over 3 months (TSC: €7185 [median €11,925]; IGE: €3599 [median €0], P < 0.001; FE: €5082 [median €2981], P = 0.03) were highest among patients with TSC. The proportion of patients with TSC who were unemployed (60%) was significantly larger than the proportions of patients with IGE (23%, P < 0.001) or FE (34%, P = P < 0.001) who were unemployed. Index scores for the EuroQuol Scale with 5 dimensions and 3 levels were significantly lower for patients with TSC (time-trade-off [TTO]: 0.705, visual analog scale [VAS]: 0.577) than for patients with IGE (TTO: 0.897, VAS: 0.813; P < 0.001) or FE (TTO: 0.879, VAS: 0.769; P < 0.001). Revised Epilepsy Stigma Scale scores were also significantly higher for patients with TSC (3.97) than for patients with IGE (1.48, P < 0.001) or FE (2.45, P < 0.001). Overall Quality of Life in Epilepsy Inventory-31 items scores was significantly lower among patients with TSC (57.7) and FE (57.6) than among patients with IGE (66.6, P = 0.004 in both comparisons). Significant differences between patients with TSC and IGE were also determined for Neurological Disorder Depression Inventory for Epilepsy (TSC: 13.1; IGE: 11.2, P = 0.009) and Liverpool Adverse Events Profile scores (TSC: 42.7; IGE: 37.5, P = 0.017) with higher score and worse results for TSC patients in both questionnaires. Conclusions: This study is the first to compare patients with TSC, IGE, and FE in Germany and underlines the excessive QoL burden and both direct and indirect cost burdens experienced by patients with TSC. Key points: • This is the first analysis to compare QoL and direct/indirect cost burden among patients with TSC, IGE, and FE in Germany. • Generic QoL for patients with TSC was significantly lower than for patients with IGE and FE. • Care grade and disability cards were more frequently obtained by patients with TSC than by patients in the other cohorts. • Drug treatment costs were the highest direct cost component for patients with TSC. • More patients with TSC than with IGE or FE were unemployed, and the mean indirect productivity costs were highest for the TSC cohort. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Quality of life and its predictors in adults with tuberous sclerosis complex (TSC): a multicentre cohort study from Germany

Author

Zöllner, Johann Philipp, Conradi, Nadine, Sauter, Matthias, Knuf, Markus, Knake, Susanne, Kurlemann, Gerhard, Mayer, Thomas, Hertzberg, Christoph, Bertsche, Astrid, Immisch, Ilka, Klein, Karl Martin, Marquard, Klaus, Meyer, Sascha, Noda, Anna H., von Podewils, Felix, Schäfer, Hannah, Thiels, Charlotte, Zukunft, Bianca, Schubert-Bast, Susanne, Grau, Janina, Willems, Laurent M., Rosenow, Felix, Reese, Jens-Peter, and Strzelczyk, Adam

Published
2021
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15. Estimates of protection levels against SARS-CoV-2 infection and severe COVID-19 in Germany before the 2022/2023 winter season: the IMMUNEBRIDGE project

Author

Lange, Berit, primary, Jaeger, Veronika K., additional, Harries, Manuela, additional, Rücker, Viktoria, additional, Streeck, Hendrik, additional, Blaschke, Sabine, additional, Petersmann, Astrid, additional, Toepfner, Nicole, additional, Nauck, Matthias, additional, Hassenstein, Max J., additional, Dreier, Maren, additional, von Holt, Isabell, additional, Budde, Axel, additional, Bartz, Antonia, additional, Ortmann, Julia, additional, Kurosinski, Marc-André, additional, Berner, Reinhard, additional, Borsche, Max, additional, Brandhorst, Gunnar, additional, Brinkmann, Melanie, additional, Budde, Kathrin, additional, Deckena, Marek, additional, Engels, Geraldine, additional, Fenzlaff, Marc, additional, Härtel, Christoph, additional, Hovardovska, Olga, additional, Katalinic, Alexander, additional, Kehl, Katja, additional, Kohls, Mirjam, additional, Krüger, Stefan, additional, Lieb, Wolfgang, additional, Meyer-Schlinkmann, Kristin M., additional, Pischon, Tobias, additional, Rosenkranz, Daniel, additional, Rübsamen, Nicole, additional, Rupp, Jan, additional, Schäfer, Christian, additional, Schattschneider, Mario, additional, Schlegtendal, Anne, additional, Schlinkert, Simon, additional, Schmidbauer, Lena, additional, Schulze-Wundling, Kai, additional, Störk, Stefan, additional, Tiemann, Carsten, additional, Völzke, Henry, additional, Winter, Theresa, additional, Klein, Christine, additional, Liese, Johannes, additional, Brinkmann, Folke, additional, Ottensmeyer, Patrick F., additional, Reese, Jens-Peter, additional, Heuschmann, Peter, additional, and Karch, André, additional

Published
2023
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16. Immune correlates against SARS-CoV-2 infection – results of population and hospital-based studies in the IMMUNEBRIDGE project in Germany, 2022

Author

Manuela, HARRIE S, additional, Lange, Berit, additional, Dreier, Maren, additional, Jäger, Veronika, additional, Karch, André, additional, Rücker, Viktoria, additional, Streeck, Hendrik, additional, Blaschke, Sabine, additional, Pestersmann, Astrid, additional, Toepfner, Nicole, additional, Nauck, Matthias, additional, Vonholt, Isbell, additional, Budde, Axel, additional, Bartz, Antonia, additional, Kurosins, Marc, additional, Berner, Reinhard, additional, Borsche, Max, additional, Brandhorst, Gunnar, additional, Brinkmann, Melanie, additional, Budde, Kathrin, additional, Deckena, Marek, additional, Engels, Geraldine, additional, Flenzlaff, Marc, additional, Härtel, Christoph, additional, Hovardovska, Olga, additional, Katalinic, Alexander, additional, Kehl, Katja, additional, Kohls, Mirjam, additional, Krüger, Stefan, additional, Lieb, Wolfgang, additional, Pischon, Tobias, additional, Rosenkranz, Daniel, additional, Rübsamen, Nicole, additional, Rupp, Jan, additional, Schäfer, Christian, additional, Schattschneider, Mario, additional, Schlegtendal, Anne, additional, Schlinkert, Simone, additional, Schmidbauer, Lena, additional, Schulze-Wundling, Kai, additional, Störk, Stefan, additional, Tiemann, Carsten, additional, Völzke, Henry, additional, Winter, Theresa, additional, Klein, Christine, additional, Liese, Johannes, additional, Brinkmann, Folke, additional, Ottensmeyer, Patrick, additional, Reese, Jens-Peter, additional, and Heuschmann, Peter, additional

Published
2023
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17. Increased circulating fibronectin, depletion of natural IgM and heightened EBV, HSV-1 reactivation in ME/CFS and long COVID

Author

Liu, Zheng, primary, Hollmann, Claudia, additional, Kalanidhi, Sharada, additional, Grothey, Arnhild, additional, Keating, Sam, additional, Mena-Palomo, Irene, additional, Lamer, Stephanie, additional, Schlosser, Andreas, additional, Kaiping, Agnes, additional, Scheller, Carsten, additional, Sotzny, Franzeska, additional, Horn, Anna, additional, Nürnberger, Carolin, additional, Cejka, Vladimir, additional, Afshar, Boshra, additional, Bahmer, Thomas, additional, Schreiber, Stefan, additional, Vehreschild, Jörg Janne, additional, Miljukov, Olga, additional, Schäfer, Christian, additional, Kretzler, Luzie, additional, Keil, Thomas, additional, Reese, Jens-Peter, additional, Eichner, Felizitas A, additional, Schmidbauer, Lena, additional, Heuschmann, Peter U, additional, Störk, Stefan, additional, Morbach, Caroline, additional, Riemekasten, Gabriela, additional, Beyersdorf, Niklas, additional, Scheibenbogen, Carmen, additional, Naviaux, Robert K, additional, Williams, Marshall, additional, Ariza, Maria E, additional, and Prusty, Bhupesh K, additional

Published
2023
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18. Ethical and coordinative challenges setting up a national cohort study during the COVID-19 pandemic in Germany

Author

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

Published
2023
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19. Das Gesundheitsdatennutzungsgesetz – Potenzial für eine bessere Forschung und Gesundheitsversorgung

Author

Schmitt, Jochen, additional, Bierbaum, Thomas, additional, Geraedts, Max, additional, Gothe, Holger, additional, Härter, Martin, additional, Hoffmann, Falk, additional, Ihle, Peter, additional, Kramer, Ursula, additional, Klinkhammer-Schalke, Monika, additional, Kuske, Silke, additional, March, Stefanie, additional, Reese, Jens-Peter, additional, Schoffer, Olaf, additional, Swart, Enno, additional, Vollmar, Horst Christian, additional, Walther, Felix, additional, and Hoffmann, Wolfgang, additional

Published
2023
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20. Estimates of protection against SARS-CoV-2 infection and severe COVID-19 in Germany before the 2022/2023 winter season - the IMMUNEBRIDGE project

Author

Lange, Berit, primary, Jaeger, Veronika K, additional, Harries, Manuela, additional, Rücker, Viktoria, additional, Streeck, Hendrik, additional, Blaschke, Sabine, additional, Petersmann, Astrid, additional, Toepfner, Nicole, additional, Nauck, Matthias, additional, Hassenstein, Max J, additional, Dreier, Maren, additional, Von Holt, Isabell, additional, Budde, Axel, additional, Bartz, Antonia, additional, Ortmann, Julia, additional, Kurosinski, Marc-André, additional, Berner, Reinhard, additional, Borsche, Max, additional, Brandhorst, Gunnar, additional, Brinkmann, Melanie, additional, Budde, Kathrin, additional, Deckena, Marek, additional, Engels, Geraldine, additional, Fenzlaff, Marc, additional, Härtel, Christoph, additional, Hovardovska, Olga, additional, Katalinic, Alexander, additional, Kehl, Katja, additional, Kohls, Mirjam, additional, Krüger, Stefan, additional, Lieb, Wolfgang, additional, Meyer-Schlinkmann, Kristin M, additional, Pischon, Tobias, additional, Rosenkranz, Daniel, additional, Rübsamen, Nicole, additional, Rupp, Jan, additional, Schäfer, Christian, additional, Schattschneider, Mario, additional, Schlegtendal, Anne, additional, Schlinkert, Simon, additional, Schmidbauer, Lena, additional, Schulze-Wundling, Kai, additional, Störk, Stefan, additional, Tiemann, Carsten, additional, Völzke, Henry, additional, Winter, Theresa, additional, Klein, Christine, additional, Liese, Johannes, additional, Brinkmann, Folke, additional, Ottensmeyer, Patrick F, additional, Reese, Jens-Peter, additional, Heuschmann, Peter, additional, and Karch, André, additional

Published
2023
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21. Consistency as a Data Quality Measure for German Corona Consensus Items Mapped from National Pandemic Cohort Network Data Collections

Author

Yusuf, Khalid O., additional, Miljukov, Olga, additional, Schoneberg, Anne, additional, Hanß, Sabine, additional, Wiesenfeldt, Martin, additional, Stecher, Melanie, additional, Mitrov, Lazar, additional, Hopff, Sina Marie, additional, Steinbrecher, Sarah, additional, Kurth, Florian, additional, Bahmer, Thomas, additional, Schreiber, Stefan, additional, Pape, Daniel, additional, Hofmann, Anna-Lena, additional, Kohls, Mirjam, additional, Störk, Stefan, additional, Stubbe, Hans Christian, additional, Tebbe, Johannes J., additional, Hellmuth, Johannes C., additional, Erber, Johanna, additional, Krist, Lilian, additional, Rieg, Siegbert, additional, Pilgram, Lisa, additional, Vehreschild, Jörg J., additional, Reese, Jens-Peter, additional, and Krefting, Dagmar, additional

Published
2023
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22. Consistency as a Data Quality Measure for German Corona Consensus items mapped from National Pandemic Cohort Network data collections

Author

Yusuf, Khalid O., primary, Miljukov, Olga, additional, Schoneberg, Anne, additional, Hanß, Sabine, additional, Wiesenfeldt, Martin, additional, Stecher, Melanie, additional, Mitrov, Lazar, additional, Hopff, Sina Marie, additional, Steinbrecher, Sarah, additional, Kurth, Florian, additional, Bahmer, Thomas, additional, Schreiber, Stefan, additional, Pape, Daniel, additional, Hoffman, Anna-Lena, additional, Kohls, Mirjam, additional, Störk, Stefan, additional, Stubbe, Hans Christian, additional, Tebbe, Johannes J., additional, Hellmuth, Johannes C., additional, Erber, Johanna, additional, Krist, Lilian, additional, Rieg, Siegbert, additional, Pilgram, Lisa, additional, Vehreschild, Jörg J., additional, Reese, Jens-Peter, additional, and Krefting, Dagmar, additional

Published
2022
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23. 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)

Author

Appel, Katharina S, primary, Maier, Daniel, additional, Hopff, Sina M, additional, Mitrov, Lazar, additional, Stecher, Melanie, additional, Scherer, Margarete, additional, Geisler, Ramsia, additional, Hagen, Marina, additional, Haas, Kirsten, additional, Reese, Jens-Peter, additional, Jiru-Hillmann, Steffi, additional, Miljukov, Olga, additional, Jakob, Carolin E M, additional, Nunes de Miranda, Susana M, additional, Meybohm, Patrick, additional, Hanß, Sabine, additional, Erber, Johanna, additional, Winter, Christof, additional, Tebbe, Johannes J, additional, Stellbrink, Christoph, additional, Khodamoradi, Yascha, additional, Schmidt, Julia, additional, Hanses, Frank, additional, Scheer, Christian, additional, Blaschke, Sabine, additional, Göpel, Siri, additional, Kluge, Stefan, additional, Witzke, Oliver, additional, Römmele, Christoph, additional, Krawczyk, Marcin, additional, Teufel, Andreas, additional, Schmid, Jonas, additional, Pape, Daniel, additional, Schütte, Christian, additional, Tausche, Kristin, additional, Milovanovic, Milena, additional, Krug, Natalie, additional, Tepasse, Phil-Robin, additional, Verket, Marlo, additional, Hamprecht, Axel, additional, Tasci, Selcuk, additional, Hower, Martin, additional, Jensen, Björn-Erik O, additional, Sprinzl, Martin F, additional, Zimmermann, Tim, additional, and Vehreschild, Jörg J, additional

Published
2022
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24. Culturally adapted cognitive behavioural group therapy for mental disorders in refugees plus problem solving training (ReTreat): study protocol for a multicentre randomised controlled trial

Author

Kananian, Schahryar, primary, Kip, Ahlke, additional, Schumm, Hannah, additional, Giesebrecht, Julia, additional, Nicolai, Anica, additional, Schade-Brittinger, Carmen, additional, Reese, Jens-Peter, additional, Weise, Cornelia, additional, Mewes, Ricarda, additional, Morina, Nexhmedin, additional, Ehring, Thomas, additional, and Stangier, Ulrich, additional

Published
2022
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25. Das Gesundheitsdatennutzungsgesetz – Potenzial für eine bessere Forschung und Gesundheitsversorgung

Author

Schmitt, Jochen, Bierbaum, Thomas, Geraedts, Max, Gothe, Holger, Härter, Martin, Hoffmann, Falk, Ihle, Peter, Kramer, Ursula, Klinkhammer-Schalke, Monika, Kuske, Silke, March, Stefanie, Reese, Jens-Peter, Schoffer, Olaf, Swart, Enno, Vollmar, Horst Christian, Walther, Felix, and Hoffmann, Wolfgang

Subjects
360 Soziale Probleme, Sozialdienste, Versicherungen, 610 Medizin, Gesundheit, ddc:360, 330 Wirtschaft, Gesundheitswesen, Public Health, Environmental and Occupational Health, ddc:330, ddc:610, Gesundheitspolitik, Forschungsdaten
Abstract

Im Koalitionsvertrag der Ampel-Koalition wird für die laufende Legislaturperiode ein Gesundheitsdatennutzungsgesetz (GDNG) angekündigt. Dieses Gesetz soll „zu einer besseren wissenschaftlichen Nutzung in Einklang mit der DSGVO“ führen. Bekanntermaßen steht unser Gesundheitssystem vor großen Herausforderungen (Demografie, Digitalisierung, Fachkräftemangel, Klimakrise, regionale Unterschiede, etc.) und ist jetzt schon das teuerste in Europa bei mittelmäßiger Leistung. Diese Herausforderungen können effizienter und evidenzgeleitet bewältigt werden, wenn wie im geplanten GDNG angedacht, die Datenressourcen für die Evaluierung und Weiterentwicklung des Gesundheitssystems und der Gesundheitsversorgung optimal genutzt werden. In den folgenden Ausführungen werden aus Sicht von Versorgungsforscher*innen Voraussetzungen und Desiderata für eine optimale Ausgestaltung des Gesetzes formuliert. Das Papier wurde durch das Deutsche Netzwerk Versorgungsforschung (DNVF) und die Arbeitsgruppe Erhebung und Nutzung von Sekundärdaten (AGENS) der Deutschen Gesellschaft für Sozialmedizin und Prävention (DGSMP) und der Deutschen Gesellschaft für Epidemiologie (DGEpi) erstellt und wird von den unterzeichnenden Fachgesellschaften getragen. Das vorliegende Positionspapier und die hier aufgestellten Forderungen sind vor der Veröffentlichung und damit in Unkenntnis des Referentenentwurfs zum GDNG formuliert worden.

Published
2023

26. Olfactory dysfunction in Long-COVID

Author

Winkelmann, Sanja, additional, Korth, Alia, additional, Voss, Bettina, additional, Abou Nasr, Maher, additional, Behrend, Naomi, additional, Pudszuhn, Annett, additional, Hofmann, VeitMaria, additional, Schendzielorz, Philipp, additional, Witzenrath, Martin, additional, Krist, Lilian, additional, Fricke, Julia, additional, Bahmer, Thomas, additional, Schreiber, Stefan, additional, Keil, Thomas, additional, Lieb, Wolfgang, additional, Reese, Jens-Peter, additional, Heuschmann, Peter, additional, Hummel, Thomas, additional, Borzikowsky, Christoph, additional, and Laudien, Martin, additional

Published
2022
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27. Geschmacksstörungen bei long COVID

Author

Behrend, Naomi, additional, Winkelmann, Sanja, additional, Korth, Alia, additional, Voss, Bettina, additional, Abou, Nasr Maher, additional, Pudszuhn, Annett, additional, Hofmann, VeitMaria, additional, Schendzielorz, Philipp, additional, Witzenrath, Martin, additional, Krist, Lilian, additional, Fricke, Julia, additional, Bahmer, Thomas, additional, Schreiber, Stefan, additional, Keil, Thomas, additional, Lieb, Wolfgang, additional, Reese, Jens-Peter, additional, Heuschmann, Peter, additional, Hummel, Thomas, additional, Borzikowsky, Christoph, additional, and Laudien, Martin, additional

Published
2022
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28. Gustatory dysfunction in long COVID

Author

Behrend, Naomi, additional, Winkelmann, Sanja, additional, Korth, Alia, additional, Voss, Bettina, additional, Abou, Nasr Maher, additional, Pudszuhn, Annett, additional, Hofmann, Veit Maria, additional, Schendzielorz, Philipp, additional, Witzenrath, Martin, additional, Krist, Lilian, additional, Fricke, Julia, additional, Bahmer, Thomas, additional, Schreiber, Stefan, additional, Keil, Thomas, additional, Lieb, Wolfgang, additional, Reese, Jens-Peter, additional, Heuschmann, Peter, additional, Hummel, Thomas, additional, Borzikowsky, Christoph, additional, and Laudien, Martin, additional

Published
2022
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29. Geruchsstörungen bei Long-COVID

Author

Winkelmann, Sanja, additional, Korth, Alia, additional, Voss, Bettina, additional, Abou, Nasr Maher, additional, Behrend, Naomi, additional, Pudszuhn, Annett, additional, Hofmann, Veit Maria, additional, Schendzielorz, Philipp, additional, Witzenrath, Martin, additional, Krist, Lilian, additional, Fricke, Julia, additional, Bahmer, Thomas, additional, Schreiber, Stefan, additional, Keil, Thomas, additional, Lieb, Wolfgang, additional, Reese, Jens-Peter, additional, Heuschmann, Peter, additional, Hummel, Thomas, additional, Borzikowsky, Christoph, additional, and Laudien, Martin, additional

Published
2022
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30. The Structured Delegation of Medical Care Services for Patients With Inflammatory Rheumatic Diseases: Findings of a Randomized Controlled Trial (the StärkeR Project)

Author

Krause*, Dietmar, Mai*, Anna, Denz, Robin, Johow, Johannes, Reese, Jens-Peter, Westerhoff, Benjamin, Klaaßen-Mielke, Renate, Timmesfeld, Nina, Rittstieg, Annette, Saracbasi-Zender, Ertan, Günzel, Judith, Klink, Claudia, Schmitz, Elmar, Fendler, Claas, Raub, Wolf, Böddeker, Stephanie, Dybowski, Friedrich, Hübner, Georg, Menne, Hans-Jürgen, Lakomek, Heinz-Jürgen, Sarholz, Michael, Trampisch, Ulrike, J. Trampisch, Hans, and Braun, Jürgen

Subjects
Arthritis, Rheumatoid, Germany, Quality of Life, Humans, Original Article, Rheumatologists
Abstract

BACKGROUND: In some areas of Germany, there is a shortage of specialist physicians for patients with inflammatory rheumatic diseases. Delegating certain medical care services to qualified, specialized rheumatological assistants (SRAs) might be an effective way to supplement the available capacity for specialized medical care. METHODS: Patients under stable treatment for rheumatoid arthritis (RA) or psoriatic arthritis (PsA) were included in this trial, which was designed to demonstrate, in a first step, the non-inferiority of a form of care involving delegation of physicians’ tasks to SRAs (team-based care), in comparison to standard care, with respect to changes in disease activity at one year. “Non-inferiority,” in this context, means either superiority or else an irrelevant extent of inferiority. In a second step, in case non-inferiority could be shown, the superiority of team-based care with respect to changes in patients’ health-related quality of life would be tested as well. Disease activity was measured with the Disease Activity Score 28, and health-related quality of life with the EQ-5D-5L. This was a randomized, multicenter, rater-blinded trial with two treatment arms (team-based care and standard care). The statistical analysis was performed with mixed linear models (DRKS00015526). RESULTS: From September 2018 to June 2019, 601 patients from 14 rheumatological practices and 3 outpatient rheumatological clinics in the German states of North Rhine–Westphalia and Lower Saxony were randomized to either team-based or standard care. Team-based care was found to be non-inferior to standard care with respect to changes in disease activity (adjusted difference = -0.19; 95% confidence interval [-0.36; -0.02]; p

Published
2022

31. Trends in resource utilization and cost of illness in patients with active epilepsy in Germany from 2003 to 2020

Author

Willems, Laurent Maximilian, Hochbaum, Maja, Zöllner, Johann Philipp, Schulz, Juliane, Menzler, Katja, Langenbruch, Lisa Marie, Kovać, Stjepana, Knake, Susanne, Podewils, Felix von, Hamacher, Mario, Hamer, Hajo, Reese, Jens-Peter, Frey, Katharina, Rosenow, Felix, Strzelczyk, Adam, Willems, Laurent Maximilian, Hochbaum, Maja, Zöllner, Johann Philipp, Schulz, Juliane, Menzler, Katja, Langenbruch, Lisa Marie, Kovać, Stjepana, Knake, Susanne, Podewils, Felix von, Hamacher, Mario, Hamer, Hajo, Reese, Jens-Peter, Frey, Katharina, Rosenow, Felix, and Strzelczyk, Adam

Abstract

Objective: This study was undertaken to calculate epilepsy-related direct, indirect, and total costs in adult patients with active epilepsy (ongoing unprovoked seizures) in Germany and to analyze cost components and dynamics compared to previous studies from 2003, 2008, and 2013. This analysis was part of the Epi2020 study. Methods: Direct and indirect costs related to epilepsy were calculated with a multicenter survey using an established and validated questionnaire with a bottom-up design and human capital approach over a 3-month period in late 2020. Epilepsy-specific costs in the German health care sector from 2003, 2008, and 2013 were corrected for inflation to allow for a valid comparison. Results: Data on the disease-specific costs for 253 patients in 2020 were analyzed. The mean total costs were calculated at €5551 (±€5805, median = €2611, range = €274–€21 667) per 3 months, comprising mean direct costs of €1861 (±€1905, median = €1276, range = €327–€13 158) and mean indirect costs of €3690 (±€5298, median = €0, range = €0–€11 925). The main direct cost components were hospitalization (42.4%), antiseizure medication (42.2%), and outpatient care (6.2%). Productivity losses due to early retirement (53.6%), part-time work or unemployment (30.8%), and seizure-related off-days (15.6%) were the main reasons for indirect costs. However, compared to 2013, there was no significant increase of direct costs (−10.0%), and indirect costs significantly increased (p < .028, +35.1%), resulting in a significant increase in total epilepsy-related costs (p < .047, +20.2%). Compared to the 2013 study population, a significant increase of cost of illness could be observed (p = .047). Significance: The present study shows that disease-related costs in adult patients with active epilepsy increased from 2013 to 2020. As direct costs have remained constant, this increase is attributable to an increase in indirect costs. These findings highlight the impact of productivity loss caused

Published
2022

32. Multicenter, cross-sectional study of the costs of illness and cost-driving factors in adult patients with epilepsy

Author

Willems, Laurent M., Hochbaum, Maja, Frey, Katharina, Schulz, Juliane, Menzler, Katja, Langenbruch, Lisa Marie, Kovać, Stjepana, Immisch, Ilka, Podewils, Felix von, Hamacher, Mario, Siebenbrodt, Kai, Rosenow, Felix, Reese, Jens-Peter, Strzelczyk, Adam, Willems, Laurent M., Hochbaum, Maja, Frey, Katharina, Schulz, Juliane, Menzler, Katja, Langenbruch, Lisa Marie, Kovać, Stjepana, Immisch, Ilka, Podewils, Felix von, Hamacher, Mario, Siebenbrodt, Kai, Rosenow, Felix, Reese, Jens-Peter, and Strzelczyk, Adam

Abstract

Objective: This study was undertaken to quantify epilepsy-related costs of illness (COI) in Germany and identify cost-driving factors. Methods: COI were calculated among adults with epilepsy of different etiologies and severities. Multiple regression analysis was applied to determine any epilepsy-related and sociodemographic factors that serve as cost-driving factors. Results: In total, 486 patients were included, with a mean age of 40.5 ± 15.5 years (range = 18–83 years, 58.2% women). Mean 3-month COI were estimated at €4911, €2782, and €2598 for focal, genetic generalized, and unclassified epilepsy, respectively. The mean COI for patients with drug-refractory epilepsy (DRE; €7850) were higher than those for patients with non-DRE (€4720), patients with occasional seizures (€3596), or patients with seizures in remission for >1 year (€2409). Identified cost-driving factors for total COI included relevant disability (unstandardized regression coefficient b = €2218), poorer education (b = €2114), living alone (b = €2612), DRE (b = €1831), and frequent seizures (b = €2385). Younger age groups of 18–24 years (b = −€2945) and 25–34 years (b = −€1418) were found to have lower overall expenditures. A relevant disability (b = €441), DRE (b = €1253), frequent seizures (b = €735), and the need for specialized daycare (b = €749) were associated with higher direct COI, and poorer education (b = €1969), living alone (b = €2612), the presence of a relevant disability (b = €1809), DRE (b = €1831), and frequent seizures (b = €2385) were associated with higher indirect COI. Significance: This analysis provides up-to-date COI data for use in further health economics analyses, highlighting the high economic impacts associated with disease severity, disability, and disease-related loss of productivity among adult patients with epilepsy. The identified cost drivers could be used as therapeutic and socioeconomic targets for future cost-containment strategies.

Published
2022

33. Trends in resource utilization and cost of illness in patients with active epilepsy in Germany from 2003 to 2020

Author

Willems, Laurent M., primary, Hochbaum, Maja, additional, Zöllner, Johann Philipp, additional, Schulz, Juliane, additional, Menzler, Katja, additional, Langenbruch, Lisa, additional, Kovac, Stjepana, additional, Knake, Susanne, additional, von Podewils, Felix, additional, Hamacher, Mario, additional, Hamer, Hajo M., additional, Reese, Jens‐Peter, additional, Frey, Katharina, additional, Rosenow, Felix, additional, and Strzelczyk, Adam, additional

Published
2022
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34. The structured delegation of medical care services for patients with inflammatory rheumatic diseases

Author

Krause, Dietmar, primary, Mai, Anna, additional, Denz, Robin, additional, Johow, Johannes, additional, Reese, Jens-Peter, additional, Westerhoff, Benjamin, additional, Klaaßen-Mielke, Renate, additional, Timmesfeld, Nina, additional, Rittstieg, Annette, additional, Saracbasi-Zender, Ertan, additional, Günzel, Judith, additional, Klink, Claudia, additional, Schmitz, Elmar, additional, Fendler, Claas, additional, Raub, Wolf, additional, Böddeker, Stephanie, additional, Dybowski, Friedrich, additional, Hübner, Georg, additional, Menne, Hans-Jürgen, additional, Lakomek, Heinz-Jürgen, additional, Sarholz, Michael, additional, Trampisch, Ulrike, additional, Trampisch, Hans J., additional, and Braun, Jürgen, additional

Published
2022
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35. Multicenter, cross‐sectional study of the costs of illness and cost‐driving factors in adult patients with epilepsy

Author

Willems, Laurent M., primary, Hochbaum, Maja, additional, Frey, Katharina, additional, Schulz, Juliane, additional, Menzler, Katja, additional, Langenbruch, Lisa, additional, Kovac, Stjepana, additional, Immisch, Ilka, additional, von Podewils, Felix, additional, Hamacher, Mario, additional, Siebenbrodt, Kai, additional, Rosenow, Felix, additional, Reese, Jens‐Peter, additional, and Strzelczyk, Adam, additional

Published
2022
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36. Brief imagery rescripting vs. usual care and treatment advice in refugees with posttraumatic stress disorder: study protocol for a multi-center randomized-controlled trial

Author

Steil, Regina, Lechner-Meichsner, Franziska, Johow, Johannes, Krüger-Gottschalk, Antje, Mewes, Ricarda, Reese, Jens-Peter, Schumm, Hannah, Weise, Cornelia, Morina, Nexhmedin, and Ehring, Thomas

Subjects
随机对照试验, Adult, Male, ensayo controlado aleatorizado, Imagery, Psychotherapy, cognitive-behavioral therapy, RC435-571, randomized-controlled trial, 难民, Stress Disorders, Post-Traumatic, Study Protocol, ddc:150, Clinical Protocols, Germany, mental disorders, Outcome Assessment, Health Care, Humans, ddc:610, Psychiatry, Refugees, Cognitive Behavioral Therapy, imagery rescripting, Posttraumatic stress disorder, PTSD, Middle Aged, refugiados, Culturally Competent Care, trauma, 创伤后应激障碍, Psychotherapy, Brief, Trastorno de estrés postraumático, Female, reescritura de imágenes, 意向重构, Research Article
Abstract

Background: Many refugees have experienced multiple traumatic events in their country of origin and/or during flight. Trauma-related disorders such as posttraumatic stress disorder (PTSD) or complex PTSD (CPTSD) are prevalent in this population, which highlights the need for accessible and effective treatment. Imagery Rescripting (ImRs), an imagery-based treatment that does not use formal exposure and that has received growing interest as an innovative treatment for PTSD, appears to be a promising approach. Objective: This randomized-controlled trial aims to investigate the efficacy of ImRs for refugees compared to Usual Care and Treatment Advice (UC+TA) on (C)PTSD remission and reduction in other related symptoms. Method: Subjects are 90 refugees to Germany with a diagnosis of PTSD according to DSM-5. They will be randomly allocated to receive either UC+TA (n = 45) or 10 sessions of ImRs (n = 45). Assessments will be conducted at baseline, post-intervention, three-month follow-up, and 12-month follow-up. Primary outcome is the (C)PTSD remission rate. Secondary outcomes are severity of PTSD and CPTSD symptoms, psychiatric symptoms, dissociative symptoms, quality of sleep, and treatment satisfaction. Economic analyses will investigate health-related quality of life and costs. Additional measures will assess migration and stress-related factors, predictors of dropout, therapeutic alliance and session-by-session changes in trauma-related symptoms. Results and Conclusions: Emerging evidence suggests the suitability of ImRs in the treatment of refugees with PTSD. After positive evaluation, this short and culturally adaptable treatment can contribute to close the treatment gap for refugees in high-income countries such as Germany. Trial registration: German Clinical Trials Register under trial number DRKS00019876, registered prospectively on 28 April 2020., Highlights • Many refugees have experienced traumatic events. • This trial investigates the efficacy of imagery rescripting, a short and culturally adaptable treatment that can contribute to close the treatment gap for refugees with posttraumatic stress disorder in high-income countries.

Published
2022

37. POTENZIALE DES GESUNDHEITSDATEN- NUTZUNGSGESETZES.

Author

Schmitt, Jochen, Bierbaum, Thomas, Geraedts, Max, Gothe, Holger, Härter, Martin, Hoffmann, Falk, Ihle, Peter, Kramer, Ursula, Klinkhammer-Schalke, Monika, Kuske, Silke, March, Stefanie, Reese, Jens-Peter, Schoffer, Olaf, Swart, Enno, Vollmar, Horst Christian, Walther, Felix, and Hoffmann, Wolfgang

Published
2023

38. The German National Pandemic Cohort Network (NAPKON): rationale, study design and baseline characteristics.

Author

Schons, Maximilian Jakob, primary, Pilgram, Lisa, additional, Reese, Jens-Peter, additional, Stecher, Melanie, additional, Anton, Gabriele, additional, Appel, Katharina, additional, Bahmer, Thomas, additional, Bartschke, Alexander, additional, Bellinghausen, Carla, additional, Bernemann, Inga, additional, Brechtel, Markus, additional, Brinkmann, Folke, additional, Brünn, Clara, additional, Dhillon, Christine, additional, Fiessler, Cornelia, additional, Geisler, Ramsia, additional, Hansch, Stefan, additional, Hanses, Frank, additional, Hanß, Sabine, additional, Herold, Susanne, additional, Heyder, Ralf, additional, Hofmann, Anna-Lena, additional, Hopff, Sina Marie, additional, Horn, Anna, additional, Jakob, Carolin, additional, Jiru-Hillmann, Steffi, additional, Keil, Thomas, additional, Khodamoradi, Yascha, additional, Kohls, Mirjam, additional, Kraus, Monika, additional, Krefting, Dagmar, additional, Kunze, Sonja, additional, Kurth, Florian, additional, Lieb, Wolfgang, additional, Lippert, Lena Johanna, additional, Lorbeer, Roberto, additional, Lorenz-Depiereux, Bettina, additional, Maetzler, Corina, additional, Miljukov, Olga, additional, Nauck, Matthias, additional, Pape, Daniel, additional, Püntmann, Valentina, additional, Reinke, Lennart, additional, Römmele, Christoph, additional, Rudolph, Stefanie, additional, Sass, Julian, additional, Schäfer, Christian, additional, Schaller, Jens, additional, Schattschneider, Mario, additional, Scheer, Christian, additional, Scherer, Margarete, additional, Schmidt, Sein, additional, Schmidt, Julia, additional, Seibel, Kristina, additional, Stahl, Dana, additional, Steinbeis, Fridolin, additional, Störk, Stefan, additional, Tauchert, Maike, additional, Thibeault, Charlotte, additional, Toepfner, Nicole, additional, Ungethüm, Kathrin, additional, Vadasz, Istvan, additional, Valentin, Heike, additional, Wiedmann, Silke, additional, Zoller, Thomas, additional, Nagel, Eike, additional, Krawczak, Michael, additional, von Kalle, Christof, additional, Illig, Thomas, additional, Schreiber, Stefan, additional, Witzenrath, Martin, additional, Heuschmann, Peter, additional, and Vehreschild, Jörg Janne, additional

Published
2022
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39. Efficacy of a Low-threshold, Culturally-Sensitive Group Psychoeducation Programme for Asylum Seekers (LoPe): study protocol for a multicentre randomised controlled trial

Author

Weise, Cornelia, primary, Grupp, Freyja, additional, Reese, Jens-Peter, additional, Schade-Brittinger, Carmen, additional, Ehring, Thomas, additional, Morina, Nexhmedin, additional, Stangier, Ulrich, additional, Steil, Regina, additional, Johow, Johannes, additional, and Mewes, Ricarda, additional

Published
2021
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40. [Integration of Inventory Data from Cohort and Registry Studies into an Existing Research Network: National Pandemic Cohort Network (NAPKON)].

Author

Hofmann AL, Vehreschild JJ, Witzenrath M, Hoffmann W, Illig T, Schreiber S, Anton G, Hellmuth JC, Muenchhoff M, Scherer C, Pley C, Thibeault C, Kurth F, Berger S, Hummel M, Hopff SM, Stecher M, Appel K, Stahl D, Kraus M, Lorenz-Depiereux B, Hanß S, von Kielmansegg S, Schlünder I, Niemeyer A, Heuschmann P, Krawczak M, and Reese JP

Abstract

In the early phase of the COVID-19 pandemic, many local collections of clinical data on patients infected with SARS-CoV-2 were initiated in Germany. As part of the National Pandemic Cohort Network (NAPKON) of the University Medicine Network, the "Integration Core" was established to design the legal, technical and organisational requirements for the integration of inventory data into ongoing prospective data collections and to test the feasibility of the newly developed solutions using use cases (UCs). Detailed study documents of the data collections were obtained. After structured document analysis, a review board evaluated the integrability of the data in NAPKON according to defined criteria. Of 30 university hospitals contacted, 20 responded to the request. Patient information and consent showed a heterogeneous picture with regard to the pseudonymised transfer of data to third parties and re-contact. The majority of the data collections (n=13) met the criteria for integration into NAPKON; four studies would require adjustments to the regulatory documents. Three cohorts were not suitable for inclusion in NAPKON. The legal framework for retrospective data integration and consent-free data use via research clauses (§27 BDSG) was elaborated by a legal opinion by TMF - Technology, Methods and Infrastructure for Networked Medical Research, Berlin. Two UCs selected by the NAPKON steering committee (CORKUM, LMU Munich; Pa-COVID-19, Charité- Universitätsmedizin Berlin) were used to demonstrate the feasibility of data integration in NAPKON by the end of 2021. Quality assurance and performance-based reimbursement of the cases were carried out according to the specifications. Based on the results, recommendations can be formulated for various contexts in order to create technical-operational prerequisites such as interoperability, interfaces and data models for data integration and to fulfil regulatory requirements on ethics, data protection, medical confidentiality and data access when integrating existing cohort data. The possible integration of data into research networks and their secondary use should be taken into account as early as the planning phase of a study - particularly with regard to informed consent - in order to maximise the benefits of the data collected., Competing Interests: Prof. Heuschmann berichtet über Zuschüsse vom deutschen Bundesministerium für Forschung und Bildung, während der Durchführung der Studie; weiterhin erhielt er Forschungszuschüsse des Bundesministeriums für Forschung und Bildung, Europäischen Union, Charité-Universitätsmedizin Berlin, Ärztekammer Berlin Ärztekammer Berlin, Deutsche Parkinson Gesellschaft, Universitätsklinikum Würzburg, Robert-Koch-Institut, Deutsche Herzstiftung, Gemeinsamer Bundesausschuss Gemeinsamer Bundesausschuss (G-BA) im Innovationsfond, Deutsche Forschungsgemeinschaft Forschungsgemeinschaft, Bayerischer Staat (Ministerium für Wissenschaft und Kunst), Deutsche Krebshilfe, Charité-Universitätsmedizin Berlin (im Rahmen von Mondafis; unterstützt durch einen uneingeschränkten Forschungszuschuss von Bayer an die Charité), Universität Göttingen (im Rahmen von FIND-AF randomisiert; unterstützt durch eine Universität Göttingen von Boehringer-Ingelheim), Universitätsklinikum Heidelberg (im Rahmen von RASUNOAprime; unterstützt durch einen uneingeschränkten Forschungszuschuss an die Universität Universitätsklinikum Heidelberg von Bayer, BMS, Boehringer-Ingelheim, Daiichi Sankyo), außerhalb der eingereichten Arbeit. Dr. Scherer berichtet ein Referentenhonorar von AstraZeneca, unabhängig von dieser Arbeit. Prof. Jens-Peter Reese berichtet über Forschungszuschüsse des Bundesministeriums für Forschung und Bildung, des Bayerischen Staates (Ministerium für Wissenschaft und Kunst), des Gemeinsamen Bundesausschusses (G-BA) im Rahmen des Innovationsfonds, des Deutschen Zentrums für Lungenforschung; Honorar für Gutachten des Bundesministeriums für Gesundheit (BMG); Honorar für EBM-Fortbildungsvorlesung durch die Landesärztekammer Hessen, außerhalb der eingereichten Arbeit. Alle anderen Ko-Autor:innen geben an, keine Interessenskonflikte zu haben., (Thieme. All rights reserved.)

Published
2024
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41. Increased circulating fibronectin, depletion of natural IgM and heightened EBV, HSV-1 reactivation in ME/CFS and long COVID.

Author

Liu Z, Hollmann C, Kalanidhi S, Grothey A, Keating S, Mena-Palomo I, Lamer S, Schlosser A, Kaiping A, Scheller C, Sotzny F, Horn A, Nürnberger C, Cejka V, Afshar B, Bahmer T, Schreiber S, Vehreschild JJ, Miljukov O, Schäfer C, Kretzler L, Keil T, Reese JP, Eichner FA, Schmidbauer L, Heuschmann PU, Störk S, Morbach C, Riemekasten G, Beyersdorf N, Scheibenbogen C, Naviaux RK, Williams M, Ariza ME, and Prusty BK

Abstract

Myalgic Encephalomyelitis/ Chronic Fatigue syndrome (ME/CFS) is a complex, debilitating, long-term illness without a diagnostic biomarker. ME/CFS patients share overlapping symptoms with long COVID patients, an observation which has strengthened the infectious origin hypothesis of ME/CFS. However, the exact sequence of events leading to disease development is largely unknown for both clinical conditions. Here we show antibody response to herpesvirus dUTPases, particularly to that of Epstein-Barr virus (EBV) and HSV-1, increased circulating fibronectin (FN1) levels in serum and depletion of natural IgM against fibronectin ((n)IgM-FN1) are common factors for both severe ME/CFS and long COVID. We provide evidence for herpesvirus dUTPases-mediated alterations in host cell cytoskeleton, mitochondrial dysfunction and OXPHOS. Our data show altered active immune complexes, immunoglobulin-mediated mitochondrial fragmentation as well as adaptive IgM production in ME/CFS patients. Our findings provide mechanistic insight into both ME/CFS and long COVID development. Finding of increased circulating FN1 and depletion of (n)IgM-FN1 as a biomarker for the severity of both ME/CFS and long COVID has an immediate implication in diagnostics and development of treatment modalities., Competing Interests: Competing Interests: The authors declare that they have no competing interests.

Published
2023
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