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2. Somatic RIT1 delins in arteriovenous malformations hyperactivate RAS-MAPK signaling amenable to MEK inhibition

Author

Kapp, Friedrich G., Bazgir, Farhad, Mahammadzade, Nagi, Mehrabipour, Mehrnaz, Vassella, Erik, Bernhard, Sarah M., Döring, Yvonne, Holm, Annegret, Karow, Axel, Seebauer, Caroline, Platz Batista da Silva, Natascha, Wohlgemuth, Walter A., Oppenheimer, Aviv, Kröning, Pia, Niemeyer, Charlotte M., Schanze, Denny, Zenker, Martin, Eng, Whitney, Ahmadian, Mohammad R., Baumgartner, Iris, and Rössler, Jochen

Published
2024
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3. Dialectical behavior therapy (DBT) in an assertive community treatment structure (ACT): testing integrated care borderline (ICB) in a randomized controlled trial (RECOVER)

Author

Andreas Schindler, H. F. Warkentin, J. Bierbrodt, H. König, A. Konnopka, A. Pepic, J. Peth, M. Lambert, J. Gallinat, A. Karow, H.-H. König, M. Härter, H. Schulz, A. Rohenkohl, K. Krog, S. V. Biedermann, and I. Schäfer

Subjects
Integrated care borderline (ICB), Borderline personality disorder (BPD), Dialectical behavior therapy (DBT), Assertive community treatment (ACT), Psychiatry, RC435-571
Abstract

Abstract Background Though Dialectical Behavior Therapy (DBT) and other treatment models for individuals with Borderline Personality Disorder (BPD) have shown to be efficient in inpatient and outpatient settings, there is a general shortage of these treatments. In Germany, most resources are spent on inpatient treatments and unspecific crisis interventions, while it is difficult to implement the necessary team structures in an outpatient setting. This study is testing an alternative approach focussing on outpatient treatment: Integrated Care Borderline (ICB) provides DBT for persons with severe BPD within the structures of an Assertive Community Treatment (ACT). ICB is team-based, integrating psychiatric and social support as well as crisis interventions into a DBT-strategy. Methods ICB was compared to TAU in a prospective, randomized controlled trial. This study is part of RECOVER, a comprehensive stepped care approach in Germany, which enrolled a total of 891 participants. 146 persons were diagnosed with BPD as main diagnosis. Of these, 100 were allocated to the highest level of severe mental illness (SMI) and randomly assigned to either ICB (n = 50) or TAU (n = 50). Data were collected at baseline and 12 months later. The main outcomes were psychosocial functioning (GAF), severity of BPD (BSL-23) and other mental symptoms (BSI, PHQ-9, GAD-7, self-harm), employment status (VILI), as well as hospital days and associated costs. Results Data show a significant increase of psychosocial functioning and a significant decrease of BPD and other psychiatric symptoms in both groups (r = .28 – .64), without any significant differences between the groups. The proportion of self-harming persons decreased in both groups without statistical significance. Patients were significantly more likely to be employed after a year of treatment in ICB (p = .001), but not in the TAU group (p = .454). Analyses showed a significant difference between the groups (p = .032). Moreover, psychiatric hospital days were significantly reduced in ICB (-89%, p

Published
2024
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5. Longitudinal transcriptomic analysis reveals persistent enrichment of iron homeostasis and erythrocyte function pathways in severe COVID-19 ARDS

Author

Moemen Eltobgy, Finny Johns, Daniela Farkas, Laura Leuenberger, Sarah P. Cohen, Kevin Ho, Sarah Karow, Gabrielle Swoope, Sonal Pannu, Jeffrey C. Horowitz, Rama K. Mallampalli, Joshua A. Englert, and Joseph S. Bednash

Subjects
COVID - 19, ARDS (acute respiratory disease syndrome), RNA seq analysis, longitudinal analysis, SARS-CoV-2, Immunologic diseases. Allergy, RC581-607
Abstract

IntroductionThe acute respiratory distress syndrome (ARDS) is a common complication of severe COVID-19 and contributes to patient morbidity and mortality. ARDS is a heterogeneous syndrome caused by various insults, and results in acute hypoxemic respiratory failure. Patients with ARDS from COVID-19 may represent a subgroup of ARDS patients with distinct molecular profiles that drive disease outcomes. Here, we hypothesized that longitudinal transcriptomic analysis may identify distinct dynamic pathobiological pathways during COVID-19 ARDS.MethodsWe identified a patient cohort from an existing ICU biorepository and established three groups for comparison: 1) patients with COVID-19 ARDS that survived hospitalization (COVID survivors, n = 4), 2) patients with COVID-19 ARDS that did not survive hospitalization (COVID non-survivors, n = 5), and 3) patients with ARDS from other causes as a control group (ARDS controls, n = 4). RNA was isolated from peripheral blood mononuclear cells (PBMCs) at 4 time points (Days 1, 3, 7, and 10 following ICU admission) and analyzed by bulk RNA sequencing.ResultsWe first compared transcriptomes between groups at individual timepoints and observed significant heterogeneity in differentially expressed genes (DEGs). Next, we utilized the likelihood ratio test to identify genes that exhibit different patterns of change over time between the 3 groups and identified 341 DEGs across time, including hemoglobin subunit alpha 2 (HBA1, HBA2), hemoglobin subunit beta (HBB), von Willebrand factor C and EGF domains (VWCE), and carbonic anhydrase 1 (CA1), which all demonstrated persistent upregulation in the COVID non-survivors compared to COVID survivors. Of the 341 DEGs, 314 demonstrated a similar pattern of persistent increased gene expression in COVID non-survivors compared to survivors, associated with canonical pathways of iron homeostasis signaling, erythrocyte interaction with oxygen and carbon dioxide, erythropoietin signaling, heme biosynthesis, metabolism of porphyrins, and iron uptake and transport.DiscussionThese findings describe significant differences in gene regulation during patient ICU course between survivors and non-survivors of COVID-19 ARDS. We identified multiple pathways that suggest heme and red blood cell metabolism contribute to disease outcomes. This approach is generalizable to larger cohorts and supports an approach of longitudinal sampling in ARDS molecular profiling studies, which may identify novel targetable pathways of injury and resolution.

Published
2024
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6. Transitionspsychiatrische Behandlungsansätze in der Kinder- und Jugendpsychiatrie

Author

Karow, Anne, Möhler, Eva, Resch, Franz, Fegert, Jörg M., Section editor, Plener, Paul L., Section editor, Kaess, Michael, Section editor, Legenbauer, Tanja, Section editor, Döpfner, Manfred, Section editor, Fegert, Jörg M., editor, Resch, Franz, editor, Kaess, Michael, editor, Döpfner, Manfred, editor, Konrad, Kerstin, editor, Legenbauer, Tanja, editor, and Plener, Paul, editor

Published
2024
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7. Transitionsphasen in der Entwicklung von Kindern und Jugendlichen

Author

Fegert, Jörg M., Karow, Anne, Schulze, Ulrike, Resch, Franz, Section editor, Konrad, Kerstin, Section editor, Plener, Paul L., Section editor, Döpfner, Manfred, Section editor, Fegert, Jörg M., editor, Resch, Franz, editor, Kaess, Michael, editor, Döpfner, Manfred, editor, Konrad, Kerstin, editor, Legenbauer, Tanja, editor, and Plener, Paul, editor

Published
2024
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8. Predicting deamidation and isomerization sites in therapeutic antibodies using structure-based in silico approaches

Author

David Hoffmann, Joschka Bauer, Markus Kossner, Andrew Henry, Anne R. Karow-Zwick, and Giuseppe Licari

Subjects
Deamidation, developability, in silico methods, isomerization, quantitative structure-activity relationship, therapeutic antibody, Therapeutics. Pharmacology, RM1-950, Immunologic diseases. Allergy, RC581-607
Abstract

ABSTRACTAsparagine (Asn) deamidation and aspartic acid (Asp) isomerization are common degradation pathways that affect the stability of therapeutic antibodies. These modifications can pose a significant challenge in the development of biopharmaceuticals. As such, the early engineering and selection of chemically stable monoclonal antibodies (mAbs) can substantially mitigate the risk of subsequent failure. In this study, we introduce a novel in silico approach for predicting deamidation and isomerization sites in therapeutic antibodies by analyzing the structural environment surrounding asparagine and aspartate residues. The resulting quantitative structure-activity relationship (QSAR) model was trained using previously published forced degradation data from 57 clinical-stage mAbs. The predictive accuracy of the model was evaluated for four different states of the protein structure: (1) static homology models, (2) enhancing low-frequency vibrational modes during short molecular dynamics (MD) runs, (3) a combination of (2) with a protonation state reassignment, and (4) conventional full-atomistic MD simulations. The most effective QSAR model considered the accessible surface area (ASA) of the residue, the pKa value of the backbone amide, and the root mean square deviations of both the alpha carbon and the side chain. The accuracy was further enhanced by incorporating the QSAR model into a decision tree, which also includes empirical information about the sequential successor and the position in the protein. The resulting model has been implemented as a plugin named “Forecasting Reactivity of Isomerization and Deamidation in Antibodies” in MOE software, completed with a user-friendly graphical interface to facilitate its use.

Published
2024
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9. A Multicompartmental Diffusion Model for Improved Assessment of Whole-Body Diffusion-weighted Imaging Data and Evaluation of Prostate Cancer Bone Metastases.

Author

Conlin, Christopher C, Feng, Christine H, Digma, Leonardino A, Rodríguez-Soto, Ana E, Kuperman, Joshua M, Rakow-Penner, Rebecca, Karow, David S, White, Nathan S, Seibert, Tyler M, Hahn, Michael E, and Dale, Anders M

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Prostate Cancer, Biomedical Imaging, Cancer, Urologic Diseases, Aging, Male, Humans, Aged, Prospective Studies, Bayes Theorem, Diffusion Magnetic Resonance Imaging, Magnetic Resonance Imaging, Prostatic Neoplasms, Bone Neoplasms, Bone Metastases, Diffusion Signal Model, Diffusion-weighted Imaging, Restriction Spectrum Imaging, Whole-Body MRI
Abstract

Purpose To develop a multicompartmental signal model for whole-body diffusion-weighted imaging (DWI) and apply it to study the diffusion properties of normal tissue and metastatic prostate cancer bone lesions in vivo. Materials and Methods This prospective study (ClinicalTrials.gov: NCT03440554) included 139 men with prostate cancer (mean age, 70 years ± 9 [SD]). Multicompartmental models with two to four tissue compartments were fit to DWI data from whole-body scans to determine optimal compartmental diffusion coefficients. Bayesian information criterion (BIC) and model-fitting residuals were calculated to quantify model complexity and goodness of fit. Diffusion coefficients for the optimal model (having lowest BIC) were used to compute compartmental signal-contribution maps. The signal intensity ratio (SIR) of bone lesions to normal-appearing bone was measured on these signal-contribution maps and on conventional DWI scans and compared using paired t tests (α = .05). Two-sample t tests (α = .05) were used to compare compartmental signal fractions between lesions and normal-appearing bone. Results Lowest BIC was observed from the four-compartment model, with optimal compartmental diffusion coefficients of 0, 1.1 × 10-3, 2.8 × 10-3, and >3.0 ×10-2 mm2/sec. Fitting residuals from this model were significantly lower than from conventional apparent diffusion coefficient mapping (P < .001). Bone lesion SIR was significantly higher on signal-contribution maps of model compartments 1 and 2 than on conventional DWI scans (P < .008). The fraction of signal from compartments 2, 3, and 4 was also significantly different between metastatic bone lesions and normal-appearing bone tissue (P ≤ .02). Conclusion The four-compartment model best described whole-body diffusion properties. Compartmental signal contributions from this model can be used to examine prostate cancer bone involvement. Keywords: Whole-Body MRI, Diffusion-weighted Imaging, Restriction Spectrum Imaging, Diffusion Signal Model, Bone Metastases, Prostate Cancer Clinical trial registration no. NCT03440554 Supplemental material is available for this article. © RSNA, 2023 See also commentary by Margolis in this issue.

Published
2023

10. Stepped, evidence-based and integrated care service model vs. usual care for mental disorders: A randomized controlled trial (RECOVER)

Author

Lambert, Martin, König, Hannah, Karow, Anne, König, Hans-Helmut, Rohenkohl, Anja, Luedecke, Daniel, Schröter, Romy, Finter, Constanze, Tlach, Lisa, Schindler, Andreas, Peter, Helmut, Scherer, Martin, Mews, Claudia, Härter, Martin, Bindt, Carola, Löwe, Bernd, Briken, Peer, Peper, Heike, Schweiger, Michael, Mösko, Mike, Bock, Thomas, Deister, Arno, Correll, Christoph U., Ozga, Ann-Kathrin, Pepić, Amra, Zapf, Antonia, Gallinat, Jürgen, Peth, Judith, Konnopka, Alexander, and Schulz, Holger

Published
2024
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11. Research on Rare Diseases in Germany – The cancer predisposition syndrome registry

Author

Christina M. Dutzmann, Nathalie E. Palmaers, Lucas J. Müntnich, Farina J. Strüwe, Judith Penkert, Birte Sänger, Beatrice Hoffmann, Anja Karow, Christina Reimer, Tanja Gerasimov, Marena R. Niewisch, and Christian P. Kratz

Subjects
cancer predisposition, prevention, surveillance, li-fraumeni syndrome, rare diseases, children, Medicine
Abstract

Background: Cancer predisposition syndromes (CPS) are rare diseases that are associated with an increased risk of cancer due to genetic alterations. At least 8 % of all cases of childhood cancer are attributable to CPS [1, 2]. The CPS registry was launched in 2017 to learn more about CPS and to improve the care to those afflicted by these diseases. Methods: This is an internationally networked registry with associated accompanying studies that investigate cancer risks and spectra, the possibilities of cancer prevention, early detection and therapy. Results: For several of these syndromes, new insights into the cancer risks and cancer types as well as factors modifying cancer risk have been gained. In addition, experimental, psycho-oncological, preclinical and clinical studies were initiated. Conclusions: The CPS registry is an example of how progress can be made within a short period of time to the benefit of individuals with rare diseases through systematic data collection and research.

Published
2023
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12. Synergistic lethality in chronic myeloid leukemia – targeting oxidative phosphorylation and unfolded protein response effectively complements tyrosine kinase inhibitor treatment

Author

Lukas Häselbarth, Sara Gamali, Domenica Saul, Manuela Krumbholz, Romy Böttcher-Loschinski, Martin Böttcher, Deyu Zou, Markus Metzler, Axel Karow, and Dimitrios Mougiakakos

Subjects
CML, TKI, UPR, Oxidative phosphorylation, Oligomycin, Thapsigargin, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Chronic myeloid leukemia (CML) is effectively treated with tyrosine kinase inhibitors (TKIs), targeting the BCR::ABL1 oncoprotein. Still, resistance to therapy, relapse after treatment discontinuation, and side effects remain significant issues of long-term TKI treatment. Preliminary studies have shown that targeting oxidative phosphorylation (oxPhos) and the unfolded protein response (UPR) are promising therapeutic approaches to complement CML treatment. Here, we tested the efficacy of different TKIs, combined with the ATP synthase inhibitor oligomycin and the ER stress inducer thapsigargin in the CML cell lines K562, BV173, and KU812 and found a significant increase in cell death. Both, oligomycin and thapsigargin, triggered the upregulation of the UPR proteins ATF4 and CHOP, which was inhibited by imatinib. We observed comparable effects on cell death when combining TKIs with the ATP synthase inhibitor 8-chloroadenosine (8-Cl-Ado) as a potentially clinically applicable therapeutic agent. Stress-related apoptosis was triggered via a caspase cascade including the cleavage of caspase 3 and the inactivation of poly ADP ribose polymerase 1 (PARP1). The inhibition of PARP by olaparib also increased CML death in combination with TKIs. Our findings suggest a rationale for combining TKIs with 8-Cl-Ado or olaparib for future clinical studies in CML.

Published
2023
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13. Effectiveness of mRNA Vaccines Against COVID-19 Hospitalization by Age and Chronic Medical Conditions Burden Among Immunocompetent US Adults, March-August 2021

Author

Lewis, Nathaniel M, Naioti, Eric A, Self, Wesley H, Ginde, Adit A, Douin, David J, Talbot, H Keipp, Casey, Jonathan D, Mohr, Nicholas M, Zepeski, Anne, Gaglani, Manjusha, Ghamande, Shekhar A, McNeal, Tresa A, Shapiro, Nathan I, Gibbs, Kevin W, Files, D Clark, Hager, David N, Shehu, Arber, Prekker, Matthew E, Erickson, Heidi L, Gong, Michelle N, Mohamed, Amira, Henning, Daniel J, Steingrub, Jay S, Peltan, Ithan D, Brown, Samuel M, Martin, Emily T, Hubel, Kinsley, Hough, Catherine L, Busse, Laurence W, Lohuis, Caitlin C ten, Duggal, Abhijit, Wilson, Jennifer G, Gordon, Alexandra J, Qadir, Nida, Chang, Steven Y, Mallow, Christopher, Rivas, Carolina, Babcock, Hilary M, Kwon, Jennie H, Exline, Matthew C, Halasa, Natasha, Chappell, James D, Lauring, Adam S, Grijalva, Carlos G, Rice, Todd W, Rhoads, Jillian P, Stubblefield, William B, Baughman, Adrienne, Womack, Kelsey N, Lindsell, Christopher J, Hart, Kimberly W, Zhu, Yuwei, Schrag, Stephanie J, Kobayashi, Miwako, Verani, Jennifer R, Patel, Manish M, Tenforde, Mark W, Collaborators, IVY Network, McNeal, Tresa, Ghamande, Shekhar, Calhoun, Nicole, Murthy, Kempapura, Herrick, Judy, McKillop, Amanda, Hoffman, Eric, Zayed, Martha, Smith, Michael, Settele, Natalie, Ettlinger, Jason, Priest, Elisa, Thomas, Jennifer, Arroliga, Alejandro, Beeram, Madhava, Kindle, Ryan, Kozikowski, Lori-Ann, De Souza, Lesley, Ouellette, Scott, Thornton-Thompson, Sherell, Tyler, Patrick, Mehkri, Omar, Mitchell, Meg, Brennan, Connery, Ashok, Kiran, Poynter, Bryan, Stanley, Nicholas, Hendrickson, Audrey, Caspers, Sean, Scharber, Tyler, Jorgensen, Jeffrey, Bowers, Robert, King, Jennifer, Aston, Valerie, Armbruster, Brent, Rothman, Richard E, Nair, Rahul, Chen, Jen-Ting, Karow, Sarah, Robart, Emily, Maldonado, Paulo Nunes, and Khan, Maryiam

Subjects
Immunization, Aging, Vaccine Related, Good Health and Well Being, Adult, COVID-19, COVID-19 Vaccines, Chronic Disease, Hospitalization, Humans, Vaccines, Synthetic, mRNA Vaccines, chronic medical conditions, preexisting conditions, vaccine effectiveness, IVY Network Collaborators, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

Vaccine effectiveness (VE) against COVID-19 hospitalization was evaluated among immunocompetent adults (≥18 years) during March-August 2021 using a case-control design. Among 1669 hospitalized COVID-19 cases (11% fully vaccinated) and 1950 RT-PCR-negative controls (54% fully vaccinated), VE was 96% (95% confidence interval [CI], 93%-98%) among patients with no chronic medical conditions and 83% (95% CI, 76%-88%) among patients with ≥ 3 categories of conditions. VE was similar between those aged 18-64 years versus ≥65 years (P > .05). VE against severe COVID-19 was very high among adults without chronic conditions and lessened with increasing comorbidity burden.

Published
2022

16. Imatinib treatment and longitudinal growth in pediatric patients with chronic myeloid leukemia: Influence of demographic, pharmacological, and genetic factors in the German CML-PAED cohort

Author

Sophie Stiehler, Stephanie Sembill, Oliver Schleicher, Michaela Marx, Manfred Rauh, Manuela Krumbholz, Axel Karow, Meinolf Suttorp, Joachim Woelfle, Carlo Maj, and Markus Metzler

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

In children and adolescents, impaired growth due to tyrosine kinase inhibitor therapy remains an insufficiently studied adverse effect. This study examines demographic, pharmacological, and genetic factors associated with impaired longitudinal growth in a uniform pediatric cohort treated with imatinib. We analyzed 94 pediatric patients with chronic myeloid leukemia (CML) diagnosed in the chronic phase and treated with imatinib for >12 months who participated in the Germany-wide CML-PAEDII study between February 2006 and February 2021. During imatinib treatment, significant height reduction occurred, with medians of -0.35 standard deviation score (SDS) at 12 months and -0.76 SDS at 24 months. Cumulative height SDS change (Δheight SDS) showed a more pronounced effect in prepubertal patients during the first year but were similar between prepubertal and pubertal subgroups by the second year (-0.55 vs. -0.50). From months 12 to 18 on imatinib, only 18% patients achieved individually longitudinal growth adequate to the growth standard (Δheight SDS≥0). When patients were divided into two subgroups based on median Δheight SDS (classifier Δheight SDS > or ≤-0.37) after one year on imatinib therapy, cohort 1 (Δheight SDS extending -0.37) showed younger age at diagnosis, a higher proportion of prepubertal children, but also better treatment response and higher imatinib serum levels. Exploring the association of growth parameters with pharmacokinetically relevant single nucleotide polymorphisms, known for affecting imatinib response, showed no correlation. This retrospective study provides new insights into imatinib-related growth impairment. We emphasize the importance of optimizing treatment strategies for pediatric patients to realize their maximum growth potential.

Published
2024
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20. Effectiveness of a Third Dose of Pfizer-BioNTech and Moderna Vaccines in Preventing COVID-19 Hospitalization Among Immunocompetent and Immunocompromised Adults — United States, August–December 2021

Author

Tenforde, Mark W, Patel, Manish M, Gaglani, Manjusha, Ginde, Adit A, Douin, David J, Talbot, H Keipp, Casey, Jonathan D, Mohr, Nicholas M, Zepeski, Anne, McNeal, Tresa, Ghamande, Shekhar, Gibbs, Kevin W, Files, D Clark, Hager, David N, Shehu, Arber, Prekker, Matthew E, Erickson, Heidi L, Gong, Michelle N, Mohamed, Amira, Johnson, Nicholas J, Srinivasan, Vasisht, Steingrub, Jay S, Peltan, Ithan D, Brown, Samuel M, Martin, Emily T, Monto, Arnold S, Khan, Akram, Hough, Catherine L, Busse, Laurence W, Duggal, Abhijit, Wilson, Jennifer G, Qadir, Nida, Chang, Steven Y, Mallow, Christopher, Rivas, Carolina, Babcock, Hilary M, Kwon, Jennie H, Exline, Matthew C, Botros, Mena, Lauring, Adam S, Shapiro, Nathan I, Halasa, Natasha, Chappell, James D, Grijalva, Carlos G, Rice, Todd W, Jones, Ian D, Stubblefield, William B, Baughman, Adrienne, Womack, Kelsey N, Rhoads, Jillian P, Lindsell, Christopher J, Hart, Kimberly W, Zhu, Yuwei, Naioti, Eric A, Adams, Katherine, Lewis, Nathaniel M, Surie, Diya, McMorrow, Meredith L, Self, Wesley H, Calhoun, Nicole, Murthy, Kempapura, Herrick, Judy, McKillop, Amanda, Hoffman, Eric, Zayed, Martha, Smith, Michael, Kindle, Ryan, Kozikowski, Lori-Ann, De Souza, Lesley, Ouellette, Scott, Thornton-Thompson, Sherell, Mehkri, Omar, Ashok, Kiran, Gole, Susan, King, Alexander, Poynter, Bryan, ten Lohuis, Caitlin, Stanley, Nicholas, Hendrickson, Audrey, Caspers, Sean, Tordsen, Walker, Kaus, Olivia, Scharber, Tyler, Jorgensen, Jeffrey, Bowers, Robert, King, Jennifer, Aston, Valerie, Rothman, Richard E, Ali, Harith, Nair, Rahul, Karow, Sarah, Robart, Emily, Maldonado, Paulo Nunes, Khan, Maryiam, So, Preston, Krol, Olivia, Martinez, Jesus, Zouyed, Zachary, Acosta, Michael, and Bazyarboroujeni, Reihaneh

Subjects
Immunization, Infectious Diseases, Prevention, Vaccine Related, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, 2019-nCoV Vaccine mRNA-1273, Adult, Aged, BNT162 Vaccine, COVID-19, Female, Hospitalization, Humans, Immunization, Secondary, Immunocompetence, Immunocompromised Host, Male, Middle Aged, SARS-CoV-2, United States, Vaccine Efficacy, IVY Network, General & Internal Medicine
Abstract

COVID-19 mRNA vaccines (BNT162b2 [Pfizer-BioNTech] and mRNA-1273 [Moderna]) provide protection against infection with SARS-CoV-2, the virus that causes COVID-19, and are highly effective against COVID-19-associated hospitalization among eligible persons who receive 2 doses (1,2). However, vaccine effectiveness (VE) among persons with immunocompromising conditions* is lower than that among immunocompetent persons (2), and VE declines after several months among all persons (3). On August 12, 2021, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a third mRNA vaccine dose as part of a primary series ≥28 days after dose 2 for persons aged ≥12 years with immunocompromising conditions, and, on November 19, 2021, as a booster dose for all adults aged ≥18 years at least 6 months after dose 2, changed to ≥5 months after dose 2 on January 3, 2022 (4,5,6). Among 2,952 adults (including 1,385 COVID-19 case-patients and 1,567 COVID-19-negative controls) hospitalized at 21 U.S. hospitals during August 19-December 15, 2021, effectiveness of mRNA vaccines against COVID-19-associated hospitalization was compared between adults eligible for but who had not received a third vaccine dose (1,251) and vaccine-eligible adults who received a third dose ≥7 days before illness onset (312). Among 1,875 adults without immunocompromising conditions (including 1,065 [57%] unvaccinated, 679 [36%] 2-dose recipients, and 131 [7%] 3-dose [booster] recipients), VE against COVID-19 hospitalization was higher among those who received a booster dose (97%; 95% CI = 95%-99%) compared with that among 2-dose recipients (82%; 95% CI = 77%-86%) (p

Published
2022

21. Management of children and adolescents with chronic myeloid leukemia in blast phase: International pediatric CML expert panel recommendations

Author

Sembill, Stephanie, Ampatzidou, Maria, Chaudhury, Sonali, Dworzak, Michael, Kalwak, Krzysztof, Karow, Axel, Kiani, Alexander, Krumbholz, Manuela, Luesink, Maaike, Naumann-Bartsch, Nora, De Moerloose, Barbara, Osborn, Michael, Schultz, Kirk R., Sedlacek, Petr, Giona, Fiorina, Zwaan, Christian Michel, Shimada, Hiroyuki, Versluijs, Birgitta, Millot, Frederic, Hijiya, Nobuko, Suttorp, Meinolf, and Metzler, Markus

Published
2023
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22. Updating structured matrix pencils with no spillover effect on unmeasured spectral data and deflating pair

Author

Adhikari, Bibhas, Datta, Biswa Nath, Ganai, Tinku, and Karow, Michael

Subjects
Mathematics - Numerical Analysis, Mathematics - Optimization and Control, 15A22, 65F18, 93B55, 46E30, 47A75
Abstract

This paper is devoted to the study of perturbations of a matrix pencil, structured or unstructured, such that a perturbed pencil will reproduce a given deflating pair while maintaining the invariance of the complementary deflating pair. If the latter is unknown, it is referred to as no spillover updating. The specific structures considered in this paper include symmetric, Hermitian, $\star$-even, $\star$-odd and $\star$-skew-Hamiltonian/Hamiltonian pencils. This study is motivated by the well-known Finite Element Model Updating Problem in structural dynamics, where the given deflating pair represents a set of given eigenpairs and the complementary deflating pair represents the remaining larger set of eigenpairs. Analytical expressions of structure preserving no spillover updating are determined for deflating pairs of structured matrix pencils. Besides, parametric representations of all possible unstructured perturbations are obtained when the complementary deflating pair of a given unstructured pencil is known. In addition, parametric expressions are obtained for structured updating with certain desirable structures which relate to existing results on structure preservation of a symmetric positive definite or semi definite matrix pencil., Comment: 23 pages

Published
2020

23. VARIANT PROFILING IN PEDIATRIC CHRONIC MYELOID LEUKEMIA

Author

Yvonne Lisa Behrens, Gudrun Göhring, Laura Gaschler, Ronny Nienhold, Thea Reinkens, Elke Schirmer, Sabine Lukat, Sabine Knöß, Renate Strasser, Stephanie Sembill, Zofia Wotschofsky, Meinolf Suttorp, Manuela Krumbholz, Brigitte Schlegelberger, Markus Metzler, and Axel Karow

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Published
2023
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24. Remission with or without comorbid substance use disorders in early psychosis: long-term outcome in integrated care (ACCESS III study)

Author

Friederike Rühl, Martin Lambert, Anja Rohenkohl, Vivien Kraft, Anne Daubmann, Brooke C. Schneider, Daniel Luedecke, Anne Karow, Jürgen Gallinat, Gregor Leicht, and Daniel Schöttle

Subjects
first episode psychosis, substance use, integrated care, assertive community treatment, remission, recovery, Psychology, BF1-990
Abstract

IntroductionSchizophrenia-Spectrum-Disorders are associated with poor long-term outcome as well as disability and often severely affect the lives of patients and their families often from symptom onset. Up to 70% of first episode psychosis (FEP) patients suffer from comorbid substance use disorders (SUD). We aimed at studying the course of illness in FEP patients within evidence-based care, with and without comorbid SUD, to examine how decreased, remitted or persistent substance use impacted rates of a combined symptomatic and functional long-term recovery compared with patients without SUD.MethodsACCESS III is an integrated care model for FEP or patients in the early phase of non-affective and affective psychotic disorders. Treatment trajectories of patients, who had been in ACCESS care for 1 year, with and without SUD were compared with regard to the course of illness and quality of life using Mixed Model Repeated Measures (MMRM) and recovery rates were compared using binary logistic regression. Change in substance use was coded as either persistent, decreased/remitted or no use.ResultsACCESS III was a prospective 1-year study (N = 120) in patients aged 12–29 years. Of these, 74 (61.6%) had a comorbid SUD at admission. There were no group differences regarding the course of illness between patients with or without comorbid SUD or between patients with a substance abuse or substance dependence. The only outcome parameter that was affected by SUD was quality of life, with larger improvement found in the group without substance use (p = 0.05) compared to persistent and remitted users. Using LOCF, 44 patients (48.9%) fulfilled recovery criteria at the endpoint; recovery did not differ based on substance use status.DiscussionSUD and especially substance dependence are common in psychotic disorders even in FEP patients. Evidence-based integrated care led to long-term improvement in patients with comorbid SUD and rate of recovery did not differ for patients with substance use.

Published
2023
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25. Service users’ perceptions of relevant and helpful components of an integrated care concept (ACCESS) for psychosis

Author

Anja Christine Rohenkohl, Pia Sowada, Martin Lambert, Jürgen Gallinat, Anne Karow, Daniel Lüdecke, Friederike Rühl, and Daniel Schöttle

Subjects
assertive community treatment, integrated care, psychosis, schizophrenia, bipolar disorder, severe mental illness, Psychology, BF1-990
Abstract

IntroductionPsychotic disorders have a significant impact on patients’ lives and their families, and long-term treatment with individually tailored multimodal combinations of therapies is often required. Integrated care (IC) concepts such as the “Hamburg Model (ACCESS)” with a focus on psychotic disorders, includes different (therapeutic) components with pharmaco- and psychotherapy, family involvement, home treatment and the option of using a 24/7 crisis hotline. All components are offered by a therapeutically-oriented assertive community treatment (TACT) team in a need-adapted manner. So far, however, little is known about which specific components are regarded as especially relevant and helpful by the users of IC.MethodsPatients currently participating in IC completed a questionnaire as part of the continuous quality assurance study (ACCESS II) in which they were asked to rate the different components of treatment according to their relevance and helpfulness, considering the individual’s unique experiences with IC and needs in mental health care. Furthermore, they were asked to make suggestions regarding additional helpful components of treatment.ResultsFifty patients participated in this survey (23% of the patients currently participating in the IC concept). For participants, the most helpful and important factors were having the same therapist in the long-term and the 24/7 crisis telephone. Additional components suggested by patients included more addiction-specific therapies and increased focus on vocational rehabilitation and integration.ConclusionFrom the perspective of the users of IC, long-term care from a trusted therapist with whom there is a therapeutic relationship and the possibility to reach someone they already know from the TACT team 24/7 serves as the best basis for effective care, fostering trust, understanding, and open communication. In contrast, home treatment remains a relevant aspect of evidence-based care for people with severe mental illness, but perhaps surprisingly, is not viewed as the most important issue.

Published
2023
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26. XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4 monoclonal antibody, demonstrates tumor-growth inhibition and tumor-selective pharmacodynamics in mouse models of cancer

Author

Zhen Liu, Wilson Guzman, Parker Johnson, Megan McLaughlin, Caitlin O’Toole, Magali Pederzoli-Ribeil, Huawei Qiu, Margaret Karow, Tim Clackson, Jennifer O’Neil, Ugur Eskiocak, Miso Park, Benjamin Nicholson, John C Williams, Kurt A Jenkins, Deborah Moore-Lai, Veronica Flesch, Ronan C O’Hagan, and Ulrich Rodeck

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Introduction The clinical benefit of the anti-CTLA-4 monoclonal antibody (mAb) ipilimumab has been well established but limited by immune-related adverse events, especially when ipilimumab is used in combination with anti-PD-(L)1 mAb therapy. To overcome these limitations, we have developed XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4 mAb.Methods XTX101 consists of an anti-human CTLA-4 mAb covalently linked to masking peptides that block the complementarity-determining regions, thereby minimizing the mAb binding to CTLA-4. The masking peptides are designed to be released by proteases that are typically dysregulated within the tumor microenvironment (TME), resulting in activation of XTX101 intratumorally. Mutations within the Fc region of XTX101 were included to enhance affinity for FcγRIII, which is expected to enhance potency through antibody-dependent cellular cytotoxicity.Results Biophysical, biochemical, and cell-based assays demonstrate that the function of XTX101 depends on proteolytic activation. In human CTLA-4 transgenic mice, XTX101 monotherapy demonstrated significant tumor growth inhibition (TGI) including complete responses, increased intratumoral CD8+T cells, and regulatory T cell depletion within the TME while maintaining minimal pharmacodynamic effects in the periphery. XTX101 in combination with anti-PD-1 mAb treatment resulted in significant TGI and was well tolerated in mice. XTX101 was activated in primary human tumors across a range of tumor types including melanoma, renal cell carcinoma, colon cancer and lung cancer in an ex vivo assay system.Conclusions These data demonstrate that XTX101 retains the full potency of an Fc-enhanced CTLA-4 antagonist within the TME while minimizing the activity in non-tumor tissue, supporting the further evaluation of XTX101 in clinical studies.

Published
2023
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29. Temporal evolution and differential patterns of cellular reconstitution after therapy for childhood cancers

Author

Gina Hofmann, Jakob Zierk, Bettina Sobik, Zofia Wotschofsky, Stephanie Sembill, Manuela Krumbholz, Markus Metzler, and Axel Karow

Subjects
Medicine, Science
Abstract

Abstract The cellular reconstitution after childhood cancer therapy is associated with the risk of infection and efficacy of revaccination. Many studies have described the reconstitution after stem cell transplantation (SCT). The recovery after cancer treatment in children who have not undergone SCT has mainly been investigated in acute lymphoblastic leukemia (ALL), less for solid tumors. Here, we have examined the temporal evolution of total leukocyte, neutrophil and lymphocyte counts as surrogate parameters for the post-therapeutic immune recovery in a cohort of n = 52 patients with ALL in comparison to n = 58 patients with Hodgkin’s disease (HD) and n = 22 patients with Ewing sarcoma (ES). Patients with ALL showed an efficient increase in blood counts reaching the age-adjusted lower limits of normal between 4 and 5 months after the end of maintenance therapy. The two groups of patients with HD and ES exhibited a comparably delayed recovery of total leukocytes due to a protracted post-therapeutic lymphopenia which was most pronounced in patients with HD after irradiation. Overall, we observed a clearly more efficient resurgence of total lymphocyte counts in patients aged below 12 years compared to patients aged 12 to 18 years. Our results underline that the kinetics of cellular reconstitution after therapy for HD and ES differ significantly from ALL and depend on treatment regimens and modalities as well as on patient age. This suggests a need for disease, treatment, and age specific recommendations concerning the duration of infection prophylaxis and the timing of revaccination.

Published
2023
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30. Intravenous aviptadil and remdesivir for treatment of COVID-19-associated hypoxaemic respiratory failure in the USA (TESICO): a randomised, placebo-controlled trial

Author

Tierney, John, Vogel, Susan E., McNay, Laura A., Cahill, Kelly, Crew, Page, Sardana, Ratna, Segal Raim, Sharo, Shaw-Saliba, Katy, Atri, Negin, Miller, Mark, Vallee, David, Chung, Lucy, Delph, Yvette, Adam, Stacey J., Read, Sarah, Draghia-Akli, Ruxandra, Harrigan, Rachel, Carlsen, Amy, Carter, Anita, DuChene, Alain, Eckroth, Kate, Frase, Alex, Harrison, Merrie, Meger, Sue, Quan, Kien, Quan, Siu Fun, Reilly, Cavan, Thompson, Greg, Walski, Jamie, Moskowitz, Alan J., Bagiella, Emilia, Moquete, Ellen, O'Sullivan, Karen, Marks, Mary E., Accardi, Evan, Kinzel, Emily, Bedoya, Gabriela, Gupta, Lopa, Overbey, Jessica R., Padillia, Maria L., Santos, Milerva, Gillinov, Marc A., Miller, Marissa A., Taddei-Peters, Wendy C., Fenton, Kathleen, Smith, Peter K., Vekstein, Andrew M., Ko, Emily R., Al-Hegelan, Mashael S., McGowan, Lauren M., Motta, Mary, Howell, Shauna, Bent, Francine, Kalager, Rachel, Chan, Emmanuel, Aloor, Heather L., Griffin, S. Michelle, Covington, Anna, McLendon-Arvik, Beth, Bussadori, Barbara, Miller-Bell, Mary, Sampey, Cathy, Gaver, Vincent, Hollister, Beth A., Giangiacomo, Dana M., Pauley, Alena, Patel, Aashay, Classon, Chris, Frazier, Madison, Osborne, Robyn, Conlon, Debbi H., Joshi, Marybeth, Gottlieb, Robert L., Mack, Michael, Berhe, Mezgebe, Haley, Clinton, Dishner, Emma, Bettacchi, Christopher, Golden, Kevin, Duhaime, Erin, Ryan, Madison, Tallmadge, Catherine, Estrada, Lorie, Jones, Felecia, Villa, Samantha, Wang, Samantha, Robert, Raven, Coleman, Tanquinisha, Clariday, Laura, Baker, Rebecca, Hurutado-Rodriguez, Mariana, Iram, Nazia, Fresnedo, Michelle, Davis, Allyson, Leonard, Kiara, Ramierez, Noelia, Thammavong, Jon, Duque, Krizia, Turner, Emma, Fisher, Tammy, Robinson, Dianna, Ransom, Desirae, Maldonado, Nicholas, Lusk, Erica, Killian, Aaron, Palacios, Adriana, Solis, Edilia, Jerrow, Janet, Watts, Matthew, Whitacre, Heather, Cothran, Elizabeth, Bender, William, Miller, Jeffrey, Nugent, Katherine, Farrington, Woodrow, Baio, Kim T., McBride, Mary K., Fielding, Michele, Mathewson, Sonya, Porte, Kristina, Haley, Elizabeth, Rogers, Susan, Tyler, Derrick, Perin, Emerson, Costello, Briana, Postalian, Alexander, Sohail, Rizwan, Hinsu, Punit, Watson, Carolyn, Kappenman, Casey, Chen, James, Walker, Kim, Fink, Melyssa, Phillip, Gabrielle, Mahon, Kim, Sturgis, Lydia, Maher, Patrick, Rogers, Linda, Ng, Nicole, Marshall, Jason, Bassily-Marcus, Adel, Cohen, Ivy, Ramoo, Shamini, Malhotra, Aryan, Kessler, Jonathan, Goetz, Rebekah, Badhwar, Vinay, Hayanga, Jeremiah, Giblin Sutton, Lisa, Williams, Roger, Berry Bartolo, Elizabeth, Walker, Dmitry, Bunner, Robin, Glaze, Chad, Aucremanne, Tanja, Bishop, James, Kelley, Macey, Peterson, Autumn, Sauerborn, Erica, Reckart, Robin, Miller, Brittany, Mittel, Aaron, Darmanian, Anita, Rosen, Amanda, Madahar, Purnema, Schicchi, John, Gosek, Katarzyna, Dzierba, Amy, Wahab, Romina, Eng, Connie, Al-Saadi, Mukhtar, Zahiruddin, Faisal, Syed, Mohi, George, Michael, Patel, Varsha, Onwunyi, Chisom, Barroso da Costa, Rosa, North, Crystal, Ringwood, Nancy, Fitzgerald, Laura, Muzikansky, Ariela, Morse, Richard, Brower, Roy G., Reineck, Lora A., Bienstock, Karen, Hou, Peter, Steingrub, Jay S., Tidswell, Mark A., Kozikowski, Lori-Ann, Kardos, Cynthia, De Souza, Leslie, Talmor, Daniel, Shapiro, Nathan, Hibbert, Kathryn, Brait, Kelsey, Kone, Mamary, Hendey, Gregory, Kangelaris, Kirsten N., Ashktorab, Kimia, Gropper, Rachel, Agrawal, Anika, Timothy, Kelly, Zhou, Hanjing, Hughes, Alyssa, Garcia, Rebekah, Torres, Adrian, Hernandez-Almaraz, Maria Elena, Vojnik, Rosemary, Perez, Cynthia, McDowell, Jordan, Chang, Steven Y., Vargas, Julia, Moss, Marc, McKeehan, Jeffrey, Higgins, Carrie, Johnson, Emily, Slaughter, Suzanne, Wyles, David, Hiller, Terra, Oakes, Judy, Garcia, Ana, Gravitz, Stephanie, Lyle, Carolynn, Swanson, Diandra, Gong, Michelle Ng., Richardson, Lynnne D., Chen, Jen-Ting, Moskowitz, Ari, Mohamed, Amira, Lopez, Brenda, Amosu, Omowunmi, Tzehaie, Hiwet, Boujid, Sabah, Bixby, Billie, Lopez, Anitza A., Durley, JaVon, Gilson, Boris, Hite, R. Duncan, Wang, Henry, Wiedemann, Hebert P., Mehkri, Omar, Ashok, Kiran, King, Alexander, Brennan, Connery, Exline, Matthew C., Englert, Joshua A., Karow, Sarah, Schwartz, Elizabeth, So, Preston, So, Madison, Krol, Olivia F., Briceno Parra, Genesis I., Mills, Emmanuel Nii Lantei, Oh, Minn, Pena, Jose, Martínez, Jesús Alejandro, Jackman, Susan E., Bayoumi, Emad, Pascual, Ethan, Caudill, Antonina, Chen, Po-En, Richardson, Tabia, Clapham, Gregg J., Herrera, Lisa, Ojukwu, Cristabelle, Fine, Devin, Gomez, Millie J., Choi-Kuaea, Yunhee, Weissberg, Gwendolyn, Isip, Katherine, Mattison, Brittany, Tran, Dana, Emilov Dukov, Jennifer, Chung, Paul, Kang, Bo Ran, Escobar, Lauren, Tran, Trung, Baig, Saba, Wallick, Julie A., Duven, Alexandria M., Fletcher, Dakota D., Gundel, Stephanie, Fuentes, Megan, Newton, Maranda, Peterson, Emily, Jiang, Kelsey, Files, D. Clark, Miller, Chadwick, Lematty, Caitlin, Rasberry, April, Warden, Ashley, Bledsoe, Joseph, Knowlton, Kirk, Knox, Daniel B., Klippel, Carolyn, Armbruster, Brent P., Applegate, Darrin, Imel, Karah, Fergus, Melissa, Rahmati, Kasra, Jensen, Hannah, Aston, Valerie T., Jeppson, Joshua, Marshall, J. Hunter, Lumpkin, Jenna, Smith, Cassie, Burke, Tyler, Gray, Andrew, Paine, Robert, Callahan, Sean, Yamane, Misty, Waddoups, Lindsey, Rice, Todd W., Johnson, Jakea, Gray, Christopher, Hays, Margaret, Roth, Megan, Musick, Sarah, Miller, Karen, Semler, Matthew W., Popielski, Laura, Kambo, Amy, Viens, Kimberly, Turner, Melissa, Vjecha, Michael J., Denyer, Rachel, Khosla, Rahul, Rajendran, Bindu, Gonzales, Melissa, Moriarty, Theresa, Biswas, Kousick, Harrington, Cristin, Garcia, Amanda, Bremer, Tammy, Burke, Tara, Koker, Brittany, Pittman, David, Vasudeva, Shikha S., Anholm, James D., Specht, Lennard, Rodriguez, Aimee, Ngo, Han, Duong, Lien, Previte, Matthew, Raben, Dorthe, Nielsen, Charlotte B., Friis Larsen, Jakob, Peters, Lars, Matthews, Gail, Kelleher, Anthony, Polizzotto, Mark, Carey, Catherine, Chang, Christina, Dharan, Nila, Hough, Sally, Virachit, Sophie, Davidson, Sarah, Bice, Daniel J., Ognenovska, Katherine, Cabrera, Gesalit, Flynn, Ruth, Abdelghany, Mazin, Baseler, Beth, Teitelbaum, Marc, Holley, H. Preston, Jankelevich, Shirley, Adams, Amy, Becker, Nancy, Doleny, Suzanne, Hissey, Debbie, Simpson, Shelly, Kim, Mi Ha, Beeler, Joy, Harmon, Liam, Vanderpuye, Sharon, Yeon, Lindsey, Frye, Leanna, Rudzinski, Erin, Buehn, Molly, Eccard-Koons, Vanessa, Frary, Sadie, MacDonalad, Leah, Cash, Jennifer, Hoopengardner, Lisa, Linton, Jessica, Nelson, Michaela, Spinelli-Nadzam, Mary, Proffitt, Calvin, Lee, Christopher, Engel, Theresa, Fontaine, Laura, Osborne, CK, Hohn, Matt, Galcik, Michael, Thompson, DeeDee, Sandrus, Jen, Manchard, Jon, Giri, Jiwan, Kopka, Stacy, Chang, Weizhong, Sherman, Brad T., Rupert, Adam W., Highbarger, Helene, Baseler, Michael, Lallemand, Perrine, Rehman, Tauseef, Imamichi, Tom, Laverdure, Sylvain, Paudel, Sharada, Cook, Kyndal, Haupt, Kendra, Hazen, Allison, Badralmaa, Yunden, Highbarger, Jeroen, McCormack, Ashley, Gerry, Norman P., Smith, Kenneth, Patel, Bhakti, Domeraski, Nadia, Hoover, Marie L., DuChateau, Nadine, Flosi, Adam, Nelson, Rich, Stojanovic, Jelena, Wenner, Christine, Brown, Samuel M, Barkauskas, Christina E, Grund, Birgit, Sharma, Shweta, Phillips, Andrew N, Leither, Lindsay, Peltan, Ithan D, Lanspa, Michael, Gilstrap, Daniel L, Mourad, Ahmad, Lane, Kathleen, Beitler, Jeremy R, Serra, Alexis L, Garcia, Ivan, Almasri, Eyad, Fayed, Mohamed, Hubel, Kinsley, Harris, Estelle S, Middleton, Elizabeth A, Barrios, Macy A G, Mathews, Kusum S, Goel, Neha N, Acquah, Samuel, Mosier, Jarrod, Hypes, Cameron, Salvagio Campbell, Elizabeth, Khan, Akram, Hough, Catherine L, Wilson, Jennifer G, Levitt, Joseph E, Duggal, Abhijit, Dugar, Siddharth, Goodwin, Andrew J, Terry, Charles, Chen, Peter, Torbati, Sam, Iyer, Nithya, Sandkovsky, Uriel S, Johnson, Nicholas J, Robinson, Bryce R H, Matthay, Michael A, Aggarwal, Neil R, Douglas, Ivor S, Casey, Jonathan D, Hache-Marliere, Manuel, Georges Youssef, J, Nkemdirim, William, Leshnower, Brad, Awan, Omar, Pannu, Sonal, O'Mahony, Darragh Shane, Manian, Prasad, Awori Hayanga, J W, Wortmann, Glenn W, Tomazini, Bruno M, Miller, Robert F, Jensen, Jens-Ulrik, Murray, Daniel D, Bickell, Nina A, Zatakia, Jigna, Burris, Sarah, Higgs, Elizabeth S, Natarajan, Ven, Dewar, Robin L, Schechner, Adam, Kang, Nayon, Arenas-Pinto, Alejandro, Hudson, Fleur, Ginde, Adit A, Self, Wesley H, Rogers, Angela J, Oldmixon, Cathryn F, Morin, Haley, Sanchez, Adriana, Weintrob, Amy C, Cavalcanti, Alexandre Biasi, Davis-Karim, Anne, Engen, Nicole, Denning, Eileen, Taylor Thompson, B, Gelijns, Annetine C, Kan, Virginia, Davey, Victoria J, Lundgren, Jens D, Babiker, Abdel G, Neaton, James D, and Lane, H Clifford

Published
2023
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31. Sustained Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Associated Hospitalizations Among Adults — United States, March–July 2021

Author

Tenforde, Mark W, Self, Wesley H, Naioti, Eric A, Ginde, Adit A, Douin, David J, Olson, Samantha M, Talbot, H Keipp, Casey, Jonathan D, Mohr, Nicholas M, Zepeski, Anne, Gaglani, Manjusha, McNeal, Tresa, Ghamande, Shekhar, Shapiro, Nathan I, Gibbs, Kevin W, Files, D Clark, Hager, David N, Shehu, Arber, Prekker, Matthew E, Erickson, Heidi L, Gong, Michelle N, Mohamed, Amira, Henning, Daniel J, Steingrub, Jay S, Peltan, Ithan D, Brown, Samuel M, Martin, Emily T, Monto, Arnold S, Khan, Akram, Hough, Catherine L, Busse, Laurence W, ten Lohuis, Caitlin C, Duggal, Abhijit, Wilson, Jennifer G, Gordon, Alexandra June, Qadir, Nida, Chang, Steven Y, Mallow, Christopher, Rivas, Carolina, Babcock, Hilary M, Kwon, Jennie H, Exline, Matthew C, Halasa, Natasha, Chappell, James D, Lauring, Adam S, Grijalva, Carlos G, Rice, Todd W, Jones, Ian D, Stubblefield, William B, Baughman, Adrienne, Womack, Kelsey N, Lindsell, Christopher J, Hart, Kimberly W, Zhu, Yuwei, Stephenson, Meagan, Schrag, Stephanie J, Kobayashi, Miwako, Verani, Jennifer R, Patel, Manish M, Calhoun, Nicole, Murthy, Kempapura, Herrick, Judy, McKillop, Amanda, Hoffman, Eric, Zayed, Martha, Smith, Michael, Settele, Natalie, Ettlinger, Jason, Priest, Elisa, Thomas, Jennifer, Arroliga, Alejandro, Beeram, Madhava, Kindle, Ryan, Kozikowski, Lori-Ann, De Souza, Lesley, Ouellette, Scott, Thornton-Thompson, Sherell, Tyler, Patrick, Mehkri, Omar, Ashok, Kiran, Gole, Susan, King, Alexander, Poynter, Bryan, Stanley, Nicholas, Hendrickson, Audrey, Maruggi, Ellen, Scharber, Tyler, Jorgensen, Jeffrey, Bowers, Robert, King, Jennifer, Aston, Valerie, Armbruster, Brent, Rothman, Richard E, Nair, Rahul, Chen, Jen-Ting Tina, Karow, Sarah, Robart, Emily, Maldonado, Paulo Nunes, Khan, Maryiam, and So, Preston

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Immunization, Clinical Research, Biodefense, Vaccine Related, Prevention, 3.4 Vaccines, 6.1 Pharmaceuticals, Prevention of disease and conditions, and promotion of well-being, Evaluation of treatments and therapeutic interventions, Infection, Good Health and Well Being, Adolescent, Adult, Aged, COVID-19, COVID-19 Vaccines, Female, Hospitalization, Humans, Male, Middle Aged, Time Factors, United States, Vaccination, Vaccines, Synthetic, Young Adult, IVY Network Investigators, IVY Network, General & Internal Medicine
Abstract

Real-world evaluations have demonstrated high effectiveness of vaccines against COVID-19-associated hospitalizations (1-4) measured shortly after vaccination; longer follow-up is needed to assess durability of protection. In an evaluation at 21 hospitals in 18 states, the duration of mRNA vaccine (Pfizer-BioNTech or Moderna) effectiveness (VE) against COVID-19-associated hospitalizations was assessed among adults aged ≥18 years. Among 3,089 hospitalized adults (including 1,194 COVID-19 case-patients and 1,895 non-COVID-19 control-patients), the median age was 59 years, 48.7% were female, and 21.1% had an immunocompromising condition. Overall, 141 (11.8%) case-patients and 988 (52.1%) controls were fully vaccinated (defined as receipt of the second dose of Pfizer-BioNTech or Moderna mRNA COVID-19 vaccines ≥14 days before illness onset), with a median interval of 65 days (range = 14-166 days) after receipt of second dose. VE against COVID-19-associated hospitalization during the full surveillance period was 86% (95% confidence interval [CI] = 82%-88%) overall and 90% (95% CI = 87%-92%) among adults without immunocompromising conditions. VE against COVID-19- associated hospitalization was 86% (95% CI = 82%-90%) 2-12 weeks and 84% (95% CI = 77%-90%) 13-24 weeks from receipt of the second vaccine dose, with no significant change between these periods (p = 0.854). Whole genome sequencing of 454 case-patient specimens found that 242 (53.3%) belonged to the B.1.1.7 (Alpha) lineage and 74 (16.3%) to the B.1.617.2 (Delta) lineage. Effectiveness of mRNA vaccines against COVID-19-associated hospitalization was sustained over a 24-week period, including among groups at higher risk for severe COVID-19; ongoing monitoring is needed as new SARS-CoV-2 variants emerge. To reduce their risk for hospitalization, all eligible persons should be offered COVID-19 vaccination.

Published
2021

32. Effectiveness of Pfizer-BioNTech and Moderna Vaccines Against COVID-19 Among Hospitalized Adults Aged ≥65 Years — United States, January–March 2021

Author

Tenforde, Mark W, Olson, Samantha M, Self, Wesley H, Talbot, H Keipp, Lindsell, Christopher J, Steingrub, Jay S, Shapiro, Nathan I, Ginde, Adit A, Douin, David J, Prekker, Matthew E, Brown, Samuel M, Peltan, Ithan D, Gong, Michelle N, Mohamed, Amira, Khan, Akram, Exline, Matthew C, Files, D Clark, Gibbs, Kevin W, Stubblefield, William B, Casey, Jonathan D, Rice, Todd W, Grijalva, Carlos G, Hager, David N, Shehu, Arber, Qadir, Nida, Chang, Steven Y, Wilson, Jennifer G, Gaglani, Manjusha, Murthy, Kempapura, Calhoun, Nicole, Monto, Arnold S, Martin, Emily T, Malani, Anurag, Zimmerman, Richard K, Silveira, Fernanda P, Middleton, Donald B, Zhu, Yuwei, Wyatt, Dayna, Stephenson, Meagan, Baughman, Adrienne, Womack, Kelsey N, Hart, Kimberly W, Kobayashi, Miwako, Verani, Jennifer R, Patel, Manish M, Amosu, Omowunmi, Armbruster, Brent, Aston, Valerie, Bernardo, Marianne, Bowers, Robert, De Souza, Leslie, Friedel, Jennifer, Gardner, Kevin, Goff, Jennifer, Gordon, Alexandra June, Hendrickson, Audrey, Hicks, Madeline, Howell, Michelle, Johnson, Jakea, Jorgensen, Jeffrey, Karow, Sarah, Kozikowski, Lori, Krol, Olivia, Landreth, Leigha, LaRose, Mary, Lopez, Brenda, York, New, Luong, Andrea, McClellan, Bob, Maruggi, Ellen, Miller, Karen, Nair, Rahul, Parks, Lisa, Peers, Jennifer, Perez, Cynthia, Rivera, Adreanne, Roque, Jonasel, Santana, Andres, Scharber, Tyler, Silverman, Emma, Tozier, Michael, Tzehaie, Hiwet, Zouyed, Zachary, Arroliga, Alejandro, Bagiatis, Alicia, Balasubramani, GK, Cheng, Caroline K, Eng, Heather, Ghamande, Shekhar, Herrick, Judy, Hoffman, Eric, Hughes, Kailey, Lamerato, Lois E, Lauring, Adam S, McKillop, Amanda, McNeal, Tresa, McSpadden, EJ, Midturi, John, Mutnal, Manohar, and Nowalk, Mary Patricia

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Prevention, Immunization, Vaccine Related, 3.4 Vaccines, Prevention of disease and conditions, and promotion of well-being, Good Health and Well Being, Aged, COVID-19, COVID-19 Vaccines, Female, Hospitalization, Humans, Male, Risk Assessment, Treatment Outcome, United States, Vaccination Coverage, Vaccines, Synthetic, IVY Network, HAIVEN Investigators, General & Internal Medicine
Abstract

Adults aged ≥65 years are at increased risk for severe outcomes from COVID-19 and were identified as a priority group to receive the first COVID-19 vaccines approved for use under an Emergency Use Authorization (EUA) in the United States (1-3). In an evaluation at 24 hospitals in 14 states,* the effectiveness of partial or full vaccination† with Pfizer-BioNTech or Moderna vaccines against COVID-19-associated hospitalization was assessed among adults aged ≥65 years. Among 417 hospitalized adults aged ≥65 years (including 187 case-patients and 230 controls), the median age was 73 years, 48% were female, 73% were non-Hispanic White, 17% were non-Hispanic Black, 6% were Hispanic, and 4% lived in a long-term care facility. Adjusted vaccine effectiveness (VE) against COVID-19-associated hospitalization among adults aged ≥65 years was estimated to be 94% (95% confidence interval [CI] = 49%-99%) for full vaccination and 64% (95% CI = 28%-82%) for partial vaccination. These findings are consistent with efficacy determined from clinical trials in the subgroup of adults aged ≥65 years (4,5). This multisite U.S. evaluation under real-world conditions suggests that vaccination provided protection against COVID-19-associated hospitalization among adults aged ≥65 years. Vaccination is a critical tool for reducing severe COVID-19 in groups at high risk.

Published
2021

33. Comparative Effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) Vaccines in Preventing COVID-19 Hospitalizations Among Adults Without Immunocompromising Conditions — United States, March–August 2021

Author

Self, Wesley H, Tenforde, Mark W, Rhoads, Jillian P, Gaglani, Manjusha, Ginde, Adit A, Douin, David J, Olson, Samantha M, Talbot, H Keipp, Casey, Jonathan D, Mohr, Nicholas M, Zepeski, Anne, McNeal, Tresa, Ghamande, Shekhar, Gibbs, Kevin W, Files, D Clark, Hager, David N, Shehu, Arber, Prekker, Matthew E, Erickson, Heidi L, Gong, Michelle N, Mohamed, Amira, Henning, Daniel J, Steingrub, Jay S, Peltan, Ithan D, Brown, Samuel M, Martin, Emily T, Monto, Arnold S, Khan, Akram, Hough, Catherine L, Busse, Laurence W, ten Lohuis, Caitlin C, Duggal, Abhijit, Wilson, Jennifer G, Gordon, Alexandra June, Qadir, Nida, Chang, Steven Y, Mallow, Christopher, Rivas, Carolina, Babcock, Hilary M, Kwon, Jennie H, Exline, Matthew C, Halasa, Natasha, Chappell, James D, Lauring, Adam S, Grijalva, Carlos G, Rice, Todd W, Jones, Ian D, Stubblefield, William B, Baughman, Adrienne, Womack, Kelsey N, Lindsell, Christopher J, Hart, Kimberly W, Zhu, Yuwei, Mills, Lisa, Lester, Sandra N, Stumpf, Megan M, Naioti, Eric A, Kobayashi, Miwako, Verani, Jennifer R, Thornburg, Natalie J, Patel, Manish M, Calhoun, Nicole, Murthy, Kempapura, Herrick, Judy, McKillop, Amanda, Hoffman, Eric, Zayed, Martha, Smith, Michael, Seattle, Natalie, Ettlinger, Jason, Priest, Elisa, Thomas, Jennifer, Arroliga, Alejandro, Beeram, Madhava, Kindle, Ryan, Kozikowski, Lori-Ann, De Souza, Lesley, Ouellette, Scott, Thornton-Thompson, Sherell, Mehkri, Omar, Ashok, Kiran, Gole, Susan, King, Alexander, Poynter, Bryan, Stanley, Nicholas, Hendrickson, Audrey, Maruggi, Ellen, Scharber, Tyler, Jorgensen, Jeffrey, Bowers, Robert, King, Jennifer, Aston, Valerie, Armbruster, Brent, Rothman, Richard E, Nair, Rahul, Chen, Jen-Ting Tina, Karow, Sarah, Robart, Emily, Maldonado, Paulo Nunes, and Khan, Maryiam

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Prevention, Immunization, Vaccine Related, Prevention of disease and conditions, and promotion of well-being, 3.4 Vaccines, Infection, Good Health and Well Being, Adolescent, Adult, Aged, COVID-19, COVID-19 Vaccines, Female, Hospitalization, Humans, Immunocompromised Host, Male, Middle Aged, United States, Vaccines, Synthetic, Young Adult, IVY Network, General & Internal Medicine
Abstract

Three COVID-19 vaccines are authorized or approved for use among adults in the United States (1,2). Two 2-dose mRNA vaccines, mRNA-1273 from Moderna and BNT162b2 from Pfizer-BioNTech, received Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) in December 2020 for persons aged ≥18 years and aged ≥16 years, respectively. A 1-dose viral vector vaccine (Ad26.COV2 from Janssen [Johnson & Johnson]) received EUA in February 2021 for persons aged ≥18 years (3). The Pfizer-BioNTech vaccine received FDA approval for persons aged ≥16 years on August 23, 2021 (4). Current guidelines from FDA and CDC recommend vaccination of eligible persons with one of these three products, without preference for any specific vaccine (4,5). To assess vaccine effectiveness (VE) of these three products in preventing COVID-19 hospitalization, CDC and collaborators conducted a case-control analysis among 3,689 adults aged ≥18 years who were hospitalized at 21 U.S. hospitals across 18 states during March 11-August 15, 2021. An additional analysis compared serum antibody levels (anti-spike immunoglobulin G [IgG] and anti-receptor binding domain [RBD] IgG) to SARS-CoV-2, the virus that causes COVID-19, among 100 healthy volunteers enrolled at three hospitals 2-6 weeks after full vaccination with the Moderna, Pfizer-BioNTech, or Janssen COVID-19 vaccine. Patients with immunocompromising conditions were excluded. VE against COVID-19 hospitalizations was higher for the Moderna vaccine (93%; 95% confidence interval [CI] = 91%-95%) than for the Pfizer-BioNTech vaccine (88%; 95% CI = 85%-91%) (p = 0.011); VE for both mRNA vaccines was higher than that for the Janssen vaccine (71%; 95% CI = 56%-81%) (all p

Published
2021

35. Prediction for 2-Year Vision Outcomes Using Early Morphologic and Functional Responses in the Comparison of Age-related Macular Degeneration Treatments Trials

Author

Williams, David F., Beardsley, Sara, Bennett, Steven, Cantrill, Herbert, Chan-Tram, Carmen, Cheshier, Holly, Damato, Kathyrn, Davies, John, Dev, Sundeep, Enloe, Julianne, Follano, Gennaro, Gilbert, Peggy, Johnson, Jill, Jones, Tori, Mayleben, Lisa, Mittra, Robert, Moos, Martha, Neist, Ryan, Oestreich, Neal, Quiram, Polly, Ramsay, Robert, Ryan, Edwin, Schindeldecker, Stephanie, Snater, John, Steele, Trenise, Selders, Dwight, Tonsfeldt, Jessica, Valardi, Shelly, Fish, Gary Edd, Aguado, Hank A., Arceneaux, Sally, Arnwine, Jean, Bell, Kim, Bell, Tina, Boleman, Bob, Bradley, Patricia, Callanan, David, Coors, Lori, Creighton, Jodi, Crew, Timothy, Cummings, Kimberly, Dock, Christopher, Duignan, Karen, Fuller, Dwain, Gray, Keith, Hendrix, Betsy, Hesse, Nicholas, Jaramillo, Diana, Jost, Bradley, Lash, Sandy, Lonsdale, Laura, Mackens, Michael, Mutz, Karin, Potts, Michael, Sanchez, Brenda, Snyder, William, Solley, Wayne, Tarter, Carrie, Wang, Robert, Williams, Patrick, Perkins, Stephen L., Anderson, Nicholas, Arnold, Ann, Blais, Paul, Googe, Joseph, Higdon, Tina T., Hunt, Cecile, Johnson, Mary, Miller, James, Moore, Misty, Morris, Charity K., Morris, Christopher, Oelrich, Sarah, Oliver, Kristina, Seitz, Vicky, Whetstone, Jerry, Doft, Bernard H., Bedel, Jay, Bergren, Robert, Borthwick, Ann, Conrad, Paul, Fec, Amanda, Fulwylie, Christina, Ingram, Willia, Latham, Shawnique, Lester, Gina, Liu, Judy, Lobes, Louis, Lucko, Nicole M., Mechling, Holly, Merlotti, Lori, McBroom, Keith, Olsen, Karl, Puskas, Danielle, Rath, Pamela, Schmucker, Maria, Schueckler, Lynn, Schultz, Christina, Shultz, Heather, Steinberg, David, Vyas, Avni, Whale, Kim, Yeckel, Kimberly, Orth, David H., Arredondo, Linda S., Brown, Susan, Ciscato, Barbara J., Civantos, Joseph M., Figliulo, Celeste, Hasan, Sohail, Kosinski, Belinda, Muir, Dan, Nelson, Kiersten, Packo, Kirk, Pollack, John S., Rezaei, Kourous, Shelton, Gina, Townsend-Patrick, Shannya, Walsh, Marian, McDonald, H. Richard, Ansari, Nina, Bye, Amanda, Fu, Arthur D., Grout, Sean, Indermill, Chad, Johnson, Robert N., Jumper, J. Michael, Linares, Silvia, Lujan, Brandon J., Munden, Ames, Persons, Meredith, Rodriguez, Rosa, Rose, Jennifer M., Teske, Brandi, Urias, Yesmin, Young, Stephen, Dreyer, Richard F., Daniel, Howard, Connaughton, Michele, Handelman, Irvin, Hobbs, Stephen, Hoerner, Christine, Hudson, Dawn, Kopfer, Marcia, Lee, Michael, Lemley, Craig, Logan, Joe, Ma, Colin, Mallet, Christophe, Milliron, Amanda, Peters, Mark, Wohlsein, Harry, Pearlman, Joel A., Andrews, Margo, Bartlett, Melissa, Carlson, Nanette, Cox, Emily, Equi, Robert, Gonzalez, Marta, Griffin, Sophia, Hogue, Fran, Kennedy, Lance, Kryuchkov, Lana, Lopez, Carmen, Lopez, Danny, Luevano, Bertha, McKenna, Erin, Patel, Arun, Reed, Brian, Secor, Nyla, Sison, Iris R., Tsai, Tony, Varghis, Nina, Waller, Brooke, Wendel, Robert, Yebra, Reina, Roth, Daniel B., Deinzer, Jane, Fine, Howard, Green, Flory, Green, Stuart, Keyser, Bruce, Leff, Steven, Leviton, Amy, Martir, Amy, Mosenthine, Kristin, Muscle, Starr, Okoren, Linda, Parker, Sandy, Prenner, Jonathan, Price, Nancy, Rogers, Deana, Rosas, Linda, Schlosser, Alex, Studenko, Loretta, Tantum, Thea, Wheatley, Harold, Trese, Michael T., Aaberg, Thomas, Bezaire, Denis, Bridges, Craig, Bryant, Doug, Capone, Antonio, Coleman, Michelle, Consolo, Christina, Cook, Cindy, DuLong, Candice, Garretson, Bruce, Grooten, Tracy, Hammersley, Julie, Hassan, Tarek, Jessick, Heather, Jones, Nanette, Kinsman, Crystal, Krumlauf, Jennifer, Lewis, Sandy, Locke, Heather, Margherio, Alan, Markus, Debra, Marsh, Tanya, Neal, Serena, Noffke, Amy, Oh, Kean, Pence, Clarence, Preston, Lisa, Raphaelian, Paul, Regan, Virginia R., Roberts, Peter, Ruby, Alan, Sarrafizadeh, Ramin, Scherf, Marissa, Scott, Sarita, Sneed, Scott, Staples, Lisa, Terry, Brad, Trese, Matthew T., Videtich, Joan, Williams, George, Zajechowski, Mary, Joseph, Daniel P., Blinder, Kevin, Boyd, Lynda, Buckley, Sarah, Crow, Meaghan, Dinatale, Amanda, Engelbrecht, Nicholas, Forke, Bridget, Gabel, Dana, Grand, Gilbert, Grillion-Cerone, Jennifer, Holekamp, Nancy, Kelly, Charlotte, Nobel, Ginny, Pepple, Kelly, Raeber, Matt, Rao, P. Kumar, Ressel, Tammy, Schremp, Steven, Sgorlon, Merrilee, Shears, Shantia, Thomas, Matthew, Timma, Cathy, Vaughn, Annette, Walters, Carolyn, Weeks, Rhonda, Wehmeier, Jarrod, Wright, Tim, Berinstein, Daniel M., Ayyad, Aida, Barazi, Mohammed K., Bickhart, Erica, Brady, Tracey, Byank, Lisa, Cronise, Alysia, Denny, Vanessa, Dunn, Courtney, Flory, Michael, Frantz, Robert, Garfinkel, Richard A., Gilbert, William, Lai, Michael M., Melamud, Alexander, Newgen, Janine, Newton, Shamekia, Oliver, Debbie, Osman, Michael, Sanders, Reginald, von Fricken, Manfred, Dugel, Pravin, Arenas, Sandra, Balea, Gabe, Bartoli, Dayna, Bucci, John, Cornelius, Jennifer A., Dickens, Scheleen, Doherty, Don, Dunlap, Heather, Goldenberg, David, Jamal, Karim, Jimenez, Norma, Kavanagh, Nicole, Kunimoto, Derek, Martin, John, Miner, Jessica, Mobley, Sarah, Park, Donald, Quinlan, Edward, Sipperley, Jack, Slagle, Carol, Smith, Danielle, Yafchak, Miguelina, Yager, Rohana, Flaxel, Christina J., Bailey, Steven, Francis, Peter, Howell, Chris, Hwang, Thomas, Ira, Shirley, Klein, Michael, Lauer, Andreas, Liesegang, Teresa, Lundquist, Ann, Nolte, Sarah, Nolte, Susan K., Pickell, Scott, Pope, Susan, Rossi, Joseph, Schain, Mitchell, Steinkamp, Peter, Toomey, Maureen D., Vahrenwald, Debora, West, Kelly, Hubbard, Baker, Andelman, Stacey, Bergstrom, Chris, Brower, Judy, Cribbs, Blaine, Curtis, Linda, Dobbs, Jannah, DuBois, Lindreth, Gaultney, Jessica, Gibbs, Deborah, Jordan, Debora, Leef, Donna, Martin, Daniel F., Myles, Robert, Olsen, Timothy, Schwent, Bryan, Srivastava, Sunil, Waldron, Rhonda, Antoszyk, Andrew N., Balasubramaniam, Uma, Brooks, Danielle, Brown, Justin, Browning, David, Clark, Loraine, Ennis, Sarah, Held, Susannah, Helms, Jennifer V., Herby, Jenna, Karow, Angie, Leotaud, Pearl, Massimino, Caterina, McClain, Donna, McOwen, Michael, Mindel, Jennifer, Pereira, Candace, Pierce, Rachel, Powers, Michele, Price, Angela, Rohrer, Jason, Sanders, Jason, Avery, Robert L., Avery, Kelly, Basefsky, Jessica, Beckner, Liz, Castellarin, Alessandro, Couvillion, Stephen, Giust, Jack, Giust, Matthew, Nasir, Maan, Pieramici, Dante, Rabena, Melvin, Risard, Sarah, See, Robert, Smith, Jerry, Wan, Lisha, Bakri, Sophie J., Abu-Yaghi, Nakhleh, Barkmeier, Andrew, Berg, Karin, Burrington, Jean, Edwards, Albert, Goddard, Shannon, Howard, Shannon, Iezzi, Raymond, Lewison, Denise, Link, Thomas, McCannel, Colin A., Overend, Joan, Pach, John, Ruszczyk, Margaret, Shultz, Ryan, Stephan, Cindy, Vogen, Diane, Bradford, Reagan H., Jr., Bergman, Vanessa, Burris, Russ, Butt, Amanda, Daniels, Beth, Dwiggins, Connie, Fransen, Stephen, Guerrero, Tiffany, Haivala, Darin, Harris, Amy, Icks, Sonny, Kingsley, Ronald, Redden, Lena, Richmond, Rob, Ross, Brittany, White, Kammerin, Youngberg, Misty, Topping, Trexler M., Bennett, Steve, Chong, Sandy, Ciotti, Mary, Cleary, Tina, Corey, Emily, Donovan, Dennis, Frederick, Albert, Freese, Lesley, Graham, Margaret, Gud, Natalya, Howard, Taneika, Jones, Mike, Morley, Michael, Moses, Katie, Stone, Jen, Ty, Robin, Wiegand, Torsten, Williams, Lindsey, Winder, Beth, Awh, Carl C., Amonette, Michelle, Arrindell, Everton, Beck, Dena, Busbee, Brandon, Dilback, Amy, Downs, Sara, Guidry, Allison, Gutow, Gary, Hardin, Jackey, Hines, Sarah, Hutchins, Emily, LaCivita, Kim, Lester, Ashley, Malott, Larry, McCain, MaryAnn, Miracle, Jayme, Moffat, Kenneth, Palazzotta, Lacy, Robinson, Kelly, Sonkin, Peter, Travis, Alecia, Wallace, Roy Trent, Winters, Kelly J., Wray, Julia, Harris, April E., Bunnell, Mari, Crooks, Katrina, Fitzgerald, Rebecca, Javid, Cameron, Kew, Corin, Kill, Erica, Kline, Patricia, Kreienkamp, Janet, Martinez, Maricruz, Moore, Roy Ann, Saavedra, Egbert, Taylor, LuAnne, Walsh, Mark, Wilson, Larry, Ciulla, Thomas A., Coyle, Ellen, Harrington, Tonya, Harris, Charlotte, Hood, Cindi, Kerr, Ingrid, Maturi, Raj, Moore, Dawn, Morrow, Stephanie, Savage, Jennifer, Sink, Bethany, Steele, Tom, Thukral, Neelam, Wilburn, Janet, Walker, Joseph P., Banks, Jennifer, Ciampaglia, Debbie, Dyshanowitz, Danielle, Frederick, Jennifer, Ghuman, A. Tom, Grodin, Richard, Kiesel, Cheryl, Knips, Eileen, McCue, Jonathan, Ortiz, Maria, Peters, Crystal, Raskauskas, Paul, Schoeman, Etienne, Sharma, Ashish, Wing, Glenn, Youngblood, Rebecca, Chandra, Suresh R., Altaweel, Michael, Blodi, Barbara, Burke, Kathryn, Dietzman, Kristine A., Gottlieb, Justin, Knutson, Gene, Krolnik, Denise, Nork, T. Michael, Olson, Shelly, Peterson, John, Reed, Sandra, Soderling, Barbara, Somers, Guy, Stevens, Thomas, Wealti, Angela, Bearelly, Srilaxmi, Branchaud, Brenda, Bryant, Joyce W., Crowell, Sara, Fekrat, Sharon, Gammage, Merritt, Harrison, Cheala, Jones, Sarah, McClain, Noreen, McCuen, Brooks, Mruthyunjaya, Prithvi, Queen, Jeanne, Sarin, Neeru, Skalak, Cindy, Skelly, Marriner, Suner, Ivan, Tomany, Ronnie, Welch, Lauren, Park, Susanna S., Cassidy, Allison, Chandra, Karishma, Good, Idalew, Imson, Katrina, Sashi, Kaur, Metzler, Helen, Morse, Lawrence, Redenbo, Ellen, Salvador, Marisa, Telander, David, Thomas, Mark, Wallace, Cindy, Barr, Charles C., Battcher, Amanda, Bottorff, Michelle, Chasteen, Mary, Clark, Kelly, Denning, Diane, Schoen, Debra, Schultz, Amy, Tempel, Evie, Wheeler, Lisa, Whittington, Greg K., Stone, Thomas W., Blevins, Todd, Buck, Michelle, Cruz, Lynn, Heath, Wanda, Holcomb, Diana, Isernhagen, Rick, Kidd, Terri, Kitchens, John, Sears, Cathy, Slade, Ed, Van Arsdall, Jeanne, VanHoose, Brenda, Wolfe, Jenny, Wood, William, Zilis, John, Crooks, Carol, Disney, Larry, Liu, Mimi, Petty, Stephen, Sall, Sandra, Folk, James C., Aly, Tracy, Brotherton, Abby, Critser, Douglas, Hinz, Connie J., Karakas, Stefani, Kirschner, Valerie, Lester, Cheyanne, Montague, Cindy, Russell, Stephen, Stockman, Heather, Taylor, Barbara, Verdick, Randy, Walshire, Jean, Thompson, John T., Connell, Barbara, Constantine, Maryanth, Davis, John L., Jr., Gwen Holsapple, Hunter, Lisa, Lenane, C. Nicki, Mitchell, Robin, Russel, Leslie, Sjaarda, Raymond, Brown, David M., Benz, Matthew, Burns, Llewellyn, Carranza, JoLene G., Fish, Richard, Goates, Debra, Hay, Shayla, Jeffers, Theresa, Kegley, Eric, Kubecka, Dallas, McGilvra, Stacy, Richter, Beau, Sneed, Veronica, Stoever, Cary, Tellez, Isabell, Wong, Tien, Kim, Ivana, Andreoli, Christopher, Barresi, Leslie, Brett, Sarah, Callahan, Charlene, Capaccioli, Karen, Carli, William, Coppola, Matthew, Emmanuel, Nicholas, Evans, Claudia, Fagan, Anna, Grillo, Marcia, Head, John, Kieser, Troy, Lee, Elaine, Lord, Ursula, Miretsky, Edward, Palitsch, Kate, Petrin, Todd, Reader, Liz, Reznichenko, Svetlana, Robertson, Mary, Smith, Justin, Vavvas, Demetrios, Wells, John, Cahill, Cassie, Clark, W. Lloyd, Henry, Kayla, Johnson, David, Miller, Peggy, Oliver, LaDetrick, Spivey, Robbin, Swinford, Tiffany, Taylor, Mallie, Lambert, Michael, Chase, Kris, Fredrickson, Debbie, Khawly, Joseph, Lazarte, Valerie, Lowd, Donald, Miller, Pam, Willis, Arthur, Ferrone, Philip J., Almonte, Miguel, Arnott, Rachel, Aviles, Ingrid, Carbon, Sheri, Chitjian, Michael, DAmore, Kristen, Elliott, Christin, Fastenberg, David, Golub, Barry, Graham, Kenneth, Lavorna, AnnMarie, Murphy, Laura, Palomo, Amanda, Puglisi, Christina, Rhee, David, Romero, Juan, Rosenblatt, Brett, Salcedo, Glenda, Schlameuss, Marianne, Shakin, Eric, Sookhai, Vasanti, Kaiser, Richard, Affel, Elizabeth, Brown, Gary, Centinaro, Christina, Fine, Deborah, Fineman, Mitchell, Formoso, Michele, Garg, Sunir, Grande, Lisa, Herbert, Carolyn, Ho, Allen, Hsu, Jason, Jay, Maryann, Lavetsky, Lisa, Liebenbaum, Elaine, Maguire, Joseph, Monsonego, Julia, O’Connor, Lucia, Pierce, Lisa, Regillo, Carl, Rosario, Maria, Spirn, Marc, Vander, James, Walsh, Jennifer, Davidorf, Frederick H., Barnett, Amanda, Chang, Susie, Christoforidis, John, Elliott, Joy, Justice, Heather, Letson, Alan, McKinney, Kathryne, Perry, Jeri, Salerno, Jill A., Savage, Scott, Shelley, Stephen, Singerman, Lawrence J., Coney, Joseph, DuBois, John, DuBois, Kimberly, Greanoff, Gregg, Himmelman, Dianne, Ilc, Mary, McNamara, Elizabeth, Novak, Michael, Pendergast, Scott, Rath, Susan, Smith-Brewer, Sheila, Tanner, Vivian, Weiss, Diane E., Zegarra, Hernando, Halperin, Lawrence, Aramayo, Patricia, Dhalla, Mandeep, Fernandez, Brian, Fernandez, Cindy, Lopez, Jaclyn, Lopez, Monica, Mariano, Jamie, Murphy, Kellie, Sherley, Clifford, Veksler, Rita, Rahhal, Firas, Babikian, Razmig, Boyer, David, Hami, Sepideh, Kessinger, Jeff, Kurokouchi, Janet, Mukarram, Saba, Pachman, Sarah, Protacio, Eric, Sierra, Julio, Tabandeh, Homayoun, Zamboni, Adam, Elman, Michael, Belz, Jennifer, Butcher, Tammy, Cain, Theresa, Coffey, Teresa, Firestone, Dena, Gore, Nancy, Singletary, Pamela, Sotirakos, Peter, Starr, JoAnn, Meredith, Travis A., Barnhart, Cassandra J., Cantrell, Debra, Esquejo-Leon, RonaLyn, Houghton, Odette, Kaur, Harpreet, NDure, Fatoumatta, Glatzer, Ronald, Joffe, Leonard, Schindler, Reid, Xue, Katie, Hua, Peiying, Maguire, Maureen G., Daniel, Ebenezer, Jaffe, Glenn J., Grunwald, Juan E., and Ying, Gui-shuang

Published
2023
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37. Early Serial Echocardiographic and Ultrasonographic Findings in Critically Ill Patients With COVID-19

Author

Calhoun, Nicole, Herrick, Judy, Hoffman, Eric, McKillop, Amanda, Murthy, Kempapura, Smith, Michael, Zayed, Martha, De Souza, Lesley, Kindle, Ryan, Kozikowski, Lori-Ann, Ouellette, Scott, Thornton-Thompson, Sherell, Bolstad, Michael, Ciottone, Robert, Coviello, Brianna, Devilla, Arnaldo, Grafals, Ana, Higgins, Conor, Ottanelli, Carlo, Redman, Kimberly, Scaffidi, Douglas, Weingart, Alexander, Lewis, Nathaniel, Olson, Samantha, Ashok, Kiran, Brennan, Connery, Mehkri, Omar, Mitchell, Megan, Poynter, Bryan, Stanley, Nicholas, Lohuis, Caitlin ten, Caspers, Sean, Erikson, Heidi, Hendrickson, Audrey, Kaus, Olivia, Maruggi, Ellen, Scharber, Tyler, Tordsen, Walker, Aston, Valerie, Bowers, Robert, Jorgensen, Jeffrey, King, Jennifer, Ali, Harith, Rothman, Richard E., Nair, Rahul, Chen, Jen-Ting, Karow, Sarah, Robart, Emily, Maldonado, Paulo Nunes, Khan, Maryiam, So, Preston, Schwartz, Elizabeth, So, Madison, Weigand, Michael, Luong, Andrea, Martinez, Jesus, Huynh, Bao, Ibrahim, Habiba, Villanueva-Vargas, Cynthia, Jung, Haeun, Villanueva-Vargas, Juliana, Quadri, Suha, Gordon, Alexandra Jun, Levitt, Joe, Perez, Cynthia, Visweswaran, Anita, Roque, Jonasel, Rivera, Adreanne, Frankel, Trevor, Goff, Jennifer, Huynh, David, Jensen, Kelly, Driver, Conner, Chambers, Ian, Nassar, Paul, Stout, Lori, Sibenaller, Zita, Walter, Alicia, Mares, Jasmine, Olson, Logan, Clinansmith, Bradley, Gershengorn, Hayley, Rivas, Carolina, McSpadden, E.J., Truscon, Rachel, Kaniclides, Anne, Thomas, Lara, Bielak, Ramsay, Valvano, Weronika Damek, Fong, Rebecca, Fitzsimmons, William J., Blair, Christopher, Valesano, Andrew, Baker, Leigh, Gilbert, Julie, Crider, Christine D., Steinbock, Kyle A., Paulson, Thomas C., Anderson, Layla A., Kampe, Christy, Johnson, Jakea, Short, Laura L., Ezzell, Lauren J., Whitsett, Margaret E., McHenry, Rendie E., Hargrave, Samarian J., Blair, Marica, Luther, Jennifer L., Pulido, Claudia Guevara, Peterson, Bryan P.M., LaRose, Mary, Landreth, Leigha, Hicks, Madeline, Parks, Lisa, Bongu, Jahnavi, McDonald, David, Cass, Candice, Seiler, Sondra, Park, David, Hink, Tiffany, Wallace, Meghan, Burnham, Carey-Ann, Arter, Olivia G., Lanspa, Michael J., Dugar, Siddharth P., Prigmore, Heather L., Boyd, Jeremy S., Rupp, Jordan D., Lindsell, Chris J., Rice, Todd W., Qadir, Nida, Lim, George W., Shiloh, Ariel L., Dieiev, Vladyslav, Gong, Michelle N., Fox, Steven W., Hirshberg, Eliotte L., Khan, Akram, Kornfield, James, Schoeneck, Jacob H., Macklin, Nicholas, Files, D.Clark, Gibbs, Kevin W., Prekker, Matthew E., Parsons-Moss, Daniel, Bown, Mikaele, Olsen, Troy D., Knox, Daniel B., Cirulis, Meghan M., Duggal, Abhijit, Tenforde, Mark W., Patel, Manish M., Self, Wesley H., and Brown, Samuel M.

Published
2023
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38. Seroprevalence of SARS-CoV-2 Among Frontline Health Care Personnel in a Multistate Hospital Network — 13 Academic Medical Centers, April–June 2020

Author

Self, Wesley H, Tenforde, Mark W, Stubblefield, William B, Feldstein, Leora R, Steingrub, Jay S, Shapiro, Nathan I, Ginde, Adit A, Prekker, Matthew E, Brown, Samuel M, Peltan, Ithan D, Gong, Michelle N, Aboodi, Michael S, Khan, Akram, Exline, Matthew C, Files, D Clark, Gibbs, Kevin W, Lindsell, Christopher J, Rice, Todd W, Jones, Ian D, Halasa, Natasha, Talbot, H Keipp, Grijalva, Carlos G, Casey, Jonathan D, Hager, David N, Qadir, Nida, Henning, Daniel J, Coughlin, Melissa M, Schiffer, Jarad, Semenova, Vera, Li, Han, Thornburg, Natalie J, Patel, Manish M, Baughman, Adrienne, Hart, Kimberly W, McClellan, Robert, McHenry, Rendie, Johnson, Jakea, Fletcher, Andrea, Rich, Curtis, Cordero, Kemberlyne, Kozikowski, Lori, De Souza, Lesley, Romain, Sarah, Ouellette, Scott, Santana, Andres, Thornton-Thompson, Sherell, Howell, Michelle, Peers, Jennifer, Shelton, Shelby, Finck, Lani, Soules, Kirsten, Klausner, Michael, Calderon-Morales, Ximena, Erickson, Heidi L, Hendrickson, Audrey, Stang, Jamie, Maruggi, Ellen, Dunn, Alex, Stenehjem, Eddie, Healthcare, Intermountain, Aston, Valerie, Bown, Mikaele, Matheu, Michelle, Smith, Rilee, Krol, Olivia, Salar, Andrew, Health, Oregon, Kamel, Makrina, Nguyen, Kelly, Huynh, Peter, Karow, Sarah, Bright, Michelle, Bookless, Holly, Mullins, Sandy, Neidert, Kelly, McGowan, Dina, Cassandra, Elizabeth, Brown, Emily, Carlin, Claire, Wemlinger, Trina, Edwards, Breona, Flores, Lori, LaRose, Mary, Ferbas, Kathie J, Martin-Blais, Rachel, Aldrovandi, Grace M, Thompson, Olivia, Sehgal, Sakshi, Ata Ur Rasheed, Mohammed, Mills, Lisa, Lester, Sandra N, Freeman, Brandi, Alston, Bailey, Ategbole, Muyiwa, Browning, Peter, Cronin, Li, David, Ebenezer, Desai, Rita, and Epperson, Monica

Subjects
Health Services and Systems, Biomedical and Clinical Sciences, Clinical Sciences, Health Sciences, Emerging Infectious Diseases, Biodefense, Prevention, Vaccine Related, Infectious Diseases, Lung, Infection, Good Health and Well Being, Academic Medical Centers, Adult, Antibodies, Viral, Asymptomatic Diseases, Betacoronavirus, COVID-19, Coronavirus Infections, Cross Infection, Female, Humans, Infectious Disease Transmission, Professional-to-Patient, Male, Middle Aged, Pandemics, Personal Protective Equipment, Personnel, Hospital, Pneumonia, Viral, SARS-CoV-2, Seroepidemiologic Studies, United States, CDC COVID-19 Response Team, IVY Network, General & Internal Medicine
Abstract

Health care personnel (HCP) caring for patients with coronavirus disease 2019 (COVID-19) might be at high risk for contracting SARS-CoV-2, the virus that causes COVID-19. Understanding the prevalence of and factors associated with SARS-CoV-2 infection among frontline HCP who care for COVID-19 patients are important for protecting both HCP and their patients. During April 3-June 19, 2020, serum specimens were collected from a convenience sample of frontline HCP who worked with COVID-19 patients at 13 geographically diverse academic medical centers in the United States, and specimens were tested for antibodies to SARS-CoV-2. Participants were asked about potential symptoms of COVID-19 experienced since February 1, 2020, previous testing for acute SARS-CoV-2 infection, and their use of personal protective equipment (PPE) in the past week. Among 3,248 participants, 194 (6.0%) had positive test results for SARS-CoV-2 antibodies. Seroprevalence by hospital ranged from 0.8% to 31.2% (median = 3.6%). Among the 194 seropositive participants, 56 (29%) reported no symptoms since February 1, 2020, 86 (44%) did not believe that they previously had COVID-19, and 133 (69%) did not report a previous COVID-19 diagnosis. Seroprevalence was lower among personnel who reported always wearing a face covering (defined in this study as a surgical mask, N95 respirator, or powered air purifying respirator [PAPR]) while caring for patients (5.6%), compared with that among those who did not (9.0%) (p = 0.012). Consistent with persons in the general population with SARS-CoV-2 infection, many frontline HCP with SARS-CoV-2 infection might be asymptomatic or minimally symptomatic during infection, and infection might be unrecognized. Enhanced screening, including frequent testing of frontline HCP, and universal use of face coverings in hospitals are two strategies that could reduce SARS-CoV-2 transmission.

Published
2020

40. List of contributors

Author

Aabye, Joseph, primary, Abdo, Magid, additional, Adelman, John P., additional, Allampalli, Varsha, additional, Almoaswes, Hanna, additional, Angelette, Alexis L., additional, Anugwom, Charles, additional, Arocha, Marina, additional, Benkli, Barlas, additional, Bise, Claire A., additional, Borne, Grant, additional, Bourgeois, Cade, additional, Braun, LaToya Jones, additional, Bush, Natalie M., additional, Calderon, Bianca B., additional, Carona, Anthony, additional, Carroll Turpin, Michelle A., additional, Chatim, Ajay, additional, Chen, Grace, additional, Chou, Jeff, additional, Clapp, Peter, additional, Cogan, Peter S., additional, Comardelle, Nicholas J., additional, Cornett, Elyse M., additional, Davidov, Rachel, additional, Derouen, Alyssa G., additional, Domingue, Natalie M., additional, Doppalapudi, Prithvi, additional, Edinoff, Amber N., additional, Elnasseh, Abdelrhman, additional, Feltman, Christine, additional, Fontem, Ndeloh, additional, Fox, Charles J., additional, Ganju, Nakul, additional, Geara, Elie, additional, Gevirtz, Clifford, additional, Giepert, Stephen, additional, Gilani, Sayyed Omar, additional, Gonzalez, Brianna I., additional, Green, Keionne M., additional, Gudin, Maria Teresa, additional, Hirani, Salman, additional, Iqbal, Fatima, additional, Iskander, Geina, additional, James, Stephanie, additional, Kankaria, Aman, additional, Karow, Matthew, additional, Kawji, Lena, additional, Kawji, Yasmeen, additional, Kaye, Alan David, additional, Keller, Courtney M., additional, Kongchum, Thaksin, additional, Kuhlenberg, Madalyn, additional, Kunnumpurath, Aiswarya, additional, Kunnumpurath, Anamika, additional, Kunnumpurath, Sreekumar, additional, Kweon, Jaeyeon, additional, Lam, Kevin K., additional, Lane, Olabisi, additional, Lewis, Kevin, additional, Madhusoodanan, Vishnu, additional, Marambage, Kapila, additional, McCord, Elizabeth, additional, McDonald, Michael, additional, Minwalla, Hormazd D., additional, Miriyala, Sumitra, additional, Moore, Peyton W., additional, Moore, Warner, additional, Mott, Maggie, additional, Murnane, Kevin S., additional, Murphy, Adrienne M., additional, Pham, Carrie N., additional, Pike, Ashton, additional, Potthoff, Kailey L., additional, Provenzano, Daniel A., additional, Rando, Lauren, additional, Reed, Tanner D., additional, Rosa, Christina A., additional, Rowland, Kevin, additional, Sagrera, Caroline, additional, Samra, Navdeep, additional, Sardana, Nitish, additional, Scher, Corey, additional, Selvaraj, Bright Jebaraj, additional, Shankar, Nikash, additional, Shea, Leticia A., additional, Shekoohi, Sahar, additional, Shum, Alika Z., additional, Snyder, Sarah, additional, Spence, Allyson L., additional, Steib, Mattie, additional, Stratton, Joanna, additional, Stroup, Cassandra, additional, Tang, Yi-Lang, additional, Thomas, George, additional, Thomas, John, additional, Van Hale, Charlotte, additional, Wackernah, Robin C., additional, Wakhlu, Sidarth, additional, Walton, Robert A., additional, Wang, Shu-Ming, additional, Williams, Brooke C., additional, Wilson, Kennedi, additional, Zaheri, Spencer C., additional, and Zerr, Brianna K. Sanelli, additional

Published
2023
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43. Study protocol of a randomized controlled trial evaluating home treatment with peer support for acute mental health crises (HoPe)

Author

Britta Reinke, Candelaria Mahlke, Christina Botros, Alexa Kläring, Martin Lambert, Anne Karow, Jürgen Gallinat, Antonia Zapf, Ann-Kathrin Ozga, Alexandra Höller, Nadia Bustami, Jens Reimer, Jenny Lüdtke, Oliver Schaper, Martin Lison, Andreas Bechdolf, Johanna Baumgardt, Jennifer Spiegel, Olaf Hardt, Sandeep Rout, Sonja Memarzadeh, Sebastian von Peter, Julian Schwarz, Claudia Langer, Sabine Glotz, Karel Frasch, Nicolas Rüsch, Ulf Künstler, Thomas Bock, and Thomas Becker

Subjects
Home treatment, Peer support, Severe mental illness, Randomized controlled trial, Mental health care, Crisis resolution teams, Psychiatry, RC435-571
Abstract

Abstract Background Home treatment (HT) is a treatment modality for patients with severe mental illness (SMI) in acute mental crises. It is frequently considered equivalent to psychiatric inpatient treatment in terms of treatment outcome. Peer Support (PS) means that people with lived experience of a mental illness are trained to support others on their way towards recovery. While PS is growing in international importance and despite a growing number of studies supporting its benefits, it is still not comprehensively implemented into routine care. The HoPe (Home Treatment with Peer Support) study investigates a combination of both – HT and PS – to provide further evidence for a recovery-oriented treatment of psychiatric patients. Methods In our randomized controlled trial (RCT), HT with PS is compared with HT without PS within a network of eight psychiatric clinical centers from the North, South and East of Germany. We investigate the effects of a combination of both approaches with respect to the prevention of relapse/recurrence defined as first hospitalization after randomization (primary outcome), disease severity, general functioning, self-efficacy, psychosocial health, stigma resistance, recovery support, and service satisfaction (secondary outcomes). A sample of 286 patients will be assessed at baseline after admission to HT care (data point t0) and randomized into the intervention (HT + PS) and control arm (HT). Follow-Up assessments will be conducted 2, 6 and 12 months after admission (resulting in three further data points, t1 to t3) and will be analyzed via intention-to-treat approach. Discussion This study may determine the positive effects of PS added to HT, prove additional evidence for the efficacy of PS and thereby facilitate its further implementation into psychiatric settings. The aim is to improve quality of mental health care and patients’ recovery as well as to reduce the risk of relapses and hospitalizations for patients with SMI. Trial registration The trial is registered with ClinicalTrials.gov: NCT04336527 , April 7, 2020.

Published
2022
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44. Health-related quality of life in severe psychotic disorders during integrated care: 5-year course, prediction and treatment implications (ACCESS II)

Author

Anja Christine Rohenkohl, Anne Daubmann, Jürgen Gallinat, Anne Karow, Vivien Kraft, Friederike Rühl, Daniel Schöttle, Martin Lambert, and Romy Schröter

Subjects
Quality of life, Psychosis, Severe mental illness, Patient-reported outcome, Assertive community treatment, Integrated care, Computer applications to medicine. Medical informatics, R858-859.7
Abstract

Abstract Purpose Studies on outcomes mapping Quality of Life (QoL) as patient-reported outcome over a longer period in severe psychotic disorders are scarce. However, such data would be particularly important for structuring, implementing and operating effective and efficient care models and for promoting satisfaction with care, service engagement and adherence. Methods The ACCESS II study is a prospective long-term study of an integrated care model for people with severe psychotic disorders. The model includes Therapeutic Assertive Community Treatment within a cross-sectoral and interdisciplinary network. This publication analyses the course of QoL assessed with the Q-LES-Q-18 using a mixed model for repeated measures. Results Mapping the course of QoL in N = 329 participants, there is a significant increase in the first 6 weeks of treatment (early course). Comparison to a published norm show significant lower QoL for severe psychotic disorders. The variable having a traumatic event before the age of 18 was significantly negatively associated with QoL. A decrease in the severity of depressive as well as in positive symptomatology in the first six weeks after admission was associated with increase of QoL. Conclusion Results indicate that the overall symptom burden at time of inclusion is not decisive for the perceived QoL in the long-term course while the reduction in the severity of depressive and positive symptoms is important. This means focusing even more on the treatment of depressive symptoms and include traumatherapeutic aspects in the long-term treatment of severe psychotic disorders if needed. Trail registration ClinicalTrials.gov (identifier: NCT01888627).

Published
2022
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45. A note on approximating the nearest stable discrete-time descriptor system with fixed rank

Author

Gillis, Nicolas, Karow, Michael, and Sharma, Punit

Subjects
Mathematics - Optimization and Control, Mathematics - Numerical Analysis
Abstract

Consider a discrete-time linear time-invariant descriptor system $Ex(k+1)=Ax(k)$ for $k \in \mathbb Z_{+}$. In this paper, we tackle for the first time the problem of stabilizing such systems by computing a nearby regular index one stable system $\hat E x(k+1)= \hat A x(k)$ with $\text{rank}(\hat E)=r$. We reformulate this highly nonconvex problem into an equivalent optimization problem with a relatively simple feasible set onto which it is easy to project. This allows us to employ a block coordinate descent method to obtain a nearby regular index one stable system. We illustrate the effectiveness of the algorithm on several examples., Comment: 10 pages, 3 tables, 1 figure

Published
2018
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46. Approximating the nearest stable discrete-time system

Author

Gillis, Nicolas, Karow, Michael, and Sharma, Punit

Subjects
Mathematics - Optimization and Control, Mathematics - Numerical Analysis
Abstract

In this paper, we consider the problem of stabilizing discrete-time linear systems by computing a nearby stable matrix to an unstable one. To do so, we provide a new characterization for the set of stable matrices. We show that a matrix $A$ is stable if and only if it can be written as $A=S^{-1}UBS$, where $S$ is positive definite, $U$ is orthogonal, and $B$ is a positive semidefinite contraction (that is, the singular values of $B$ are less or equal to 1). This characterization results in an equivalent non-convex optimization problem with a feasible set on which it is easy to project. We propose a very efficient fast projected gradient method to tackle the problem in variables $(S,U,B)$ and generate locally optimal solutions. We show the effectiveness of the proposed method compared to other approaches., Comment: 15 pages, new title, accepted in LAA

Published
2018
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48. Utility of Restriction Spectrum Imaging Among Men Undergoing First-Time Biopsy for Suspected Prostate Cancer.

Author

Felker, Ely R, Raman, Steven S, Shakeri, Sepideh, Mirak, Sohrab A, Bajgiran, Amirhossein M, Kwan, Lorna, Khoshnoodi, Pooria, ElKhoury, Fuad F, Margolis, Daniel JA, Karow, David, Lu, David SK, White, Nate, and Marks, Leonard S

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Cancer, Biomedical Imaging, Aging, Prostate Cancer, Urologic Diseases, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, Aged, Aged, 80 and over, Contrast Media, Diffusion Magnetic Resonance Imaging, Humans, Image-Guided Biopsy, Male, Middle Aged, Multimodal Imaging, Prospective Studies, Prostatic Neoplasms, Retrospective Studies, Ultrasonography, biopsy, DWI, prostate cancer, Nuclear Medicine & Medical Imaging, Clinical sciences
Abstract

OBJECTIVE. The purpose of this article is to evaluate restriction spectrum imaging (RSI) in men undergoing MRI-ultrasound fusion biopsy for suspected prostate cancer (PCa) and to compare the performance of RSI with that of conventional DWI. MATERIALS AND METHODS. One hundred ninety-eight biopsy-naïve men enrolled in a concurrent prospective clinical trial evaluating MRI-targeted prostate biopsy underwent multiparametric MRI with RSI. Clinical and imaging features were compared between men with and without clinically significant (CS) PCa (MRI-ultrasound fusion biopsy Gleason score ≥ 3 + 4). RSI z score and apparent diffusion coefficient (ADC) were correlated, and their diagnostic performances were compared. RESULTS. CS PCa was detected in 109 of 198 men (55%). Using predefined thresholds of ADC less than or equal to 1000 μm2/s and RSI z score greater than or equal to 3, sensitivity and specificity for CS PCa were 86% and 38%, respectively, for ADC and 61% and 70%, respectively, for RSI. In the transition zone (n = 69), the sensitivity and specificity were 94% and 17%, respectively, for ADC and 59% and 69%, respectively, for RSI. Among lesions with CS PCa, RSI z score and ADC were significantly inversely correlated in the peripheral zone (ρ = -0.4852; p < 0.01) but not the transition zone (ρ = -0.2412; p = 0.17). Overall diagnostic accuracies of RSI and DWI were 0.70 and 0.68, respectively (p = 0.74). CONCLUSION. RSI and DWI achieved equivalent diagnostic performance for PCa detection in a large population of men undergoing first-time prostate biopsy for suspected PCa, but RSI had superior specificity for transition zone lesions.

Published
2019

49. Natural History of Drusenoid Pigment Epithelial Detachment Associated with Age-Related Macular Degeneration Age-Related Eye Disease Study 2 Report No. 17

Author

Yu, Jeannette J, Agrón, Elvira, Clemons, Traci E, Domalpally, Amitha, van Asten, Freekje, Keenan, Tiarnan D, Cukras, Catherine, Chew, Emily Y, Ferris, Frederick L, SanGiovanni, John Paul, Clemons, Traci, Lindblad, Anne, Lindblad, Robert, Shah, Nilay, Sperduto, Robert, McBee, Wendy, Gensler, Gary, Harrington, Molly, Henning, Alice, Jones, Katrina, Thotapally, Kumar, Tull, Diana, Watson, Valerie, Williams, Kayla, Gentry, Christina, Kaufman, Francine, Morrison, Chris, Saverino, Elizabeth, Schenning, Sherrie, Blodi, Barbara, Danis, Ronald P, Davis, Matthew, Glander, Kathy, Guilfoil, Gregory, Hubbard, Larry D, Johnson, Kristine, Klein, Ronald, Nardi, Barbara, Neider, Michael, Robinson, Nancy, Rosensteel, Eileen, Wabers, Hugh, Zhang, Grace, Ruby, Alan J, Capone, Antonio, Dass, Bawa, Drenser, Kimberly, Garretson, Bruce R, Hassan, Tarek S, Trese, Michael, Williams, George A, Wolfe, Jeremy, Bell, Tina, Zajechowski, Mary, Bezaire, Dennis, McIver, Fran, Medina, Anthony, Pagett, Jackie, Smith, Stephanie Hatch, Swartz, Lynn, Treuter, Tom, Antoszyk, Andrew, Brown, Justin, Browning, David J, Holland, Walter, Karow, Angella, Stalford, Kelly, Price, Angela, Ennis, Sarah, Fredenberg, Sherry, Herby, Jenna, Balasubramaniam, Uma, Clark, Loraine, McClain, Donna, McOwen, Michael, Watson, Lynn, Klein, Michael, Bailey, Steven T, Hwang, Thomas J, Lauer, Andreas, Stout, J Timothy, McCollum, Patty, Johnson, Milt, Rice, Patrick B, Kim, Ivana, Loewenstein, John, Miller, Joan, Sobrin, Lucia, Young, Lucy, Sullivan, Jacqueline, Houlihan, Patricia, Merry, Linda, Lane, Ann Marie, Bator, Ursula Lord, Evans, Claudia, Brett, Sarah, and Callahan, Charleen

Subjects
Prevention, Clinical Research, Neurodegenerative, Clinical Trials and Supportive Activities, Eye Disease and Disorders of Vision, Macular Degeneration, Aging, Genetics, Eye, Aged, Aged, 80 and over, Disease Progression, Female, Follow-Up Studies, Genetic Predisposition to Disease, Humans, Male, Middle Aged, Polymorphism, Single Nucleotide, Prospective Studies, Proteins, Retinal Detachment, Retinal Drusen, Retinal Pigment Epithelium, Retrospective Studies, Time Factors, Visual Acuity, Age-Related Eye Disease Study 2 Research Group, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Ophthalmology & Optometry
Abstract

PurposeTo investigate the natural history and genetic associations of drusenoid pigment epithelial detachment (DPED) associated with age-related macular degeneration (AMD).DesignRetrospective analysis of a prospective cohort study.ParticipantsOf the 4203 Age-Related Eye Disease Study 2 (AREDS2) participants, 391 eyes (325 participants) had DPED without late AMD at the time of DPED detection. Genetic analyses included 120 white AREDS2 participants and 145 Age-Related Eye Disease Study (AREDS) participants with DPED.MethodsBaseline and annual stereoscopic fundus photographs were graded centrally to detect DPED, a well-defined yellow elevated mound of confluent drusen ≥433 μm in diameter, and to evaluate progression rates to late AMD: geographic atrophy (GA) and neovascular (NV)-AMD. Five single nucleotide polymorphisms (CFH [rs10611670], C3 [rs2230199], CFI [rs10033900], C2/CFB [rs114254831], ARMS2 [rs10490924]) and genetic risk score (GRS) group were investigated for association with DPED development. Kaplan-Meier analyses and multivariable proportional hazard regressions were performed.Main outcome measuresProgression rates to late AMD and decrease of ≥3 lines in visual acuity (VA) from the time of DPED detection; association of rate of DPED development with genotype.ResultsMean (standard deviation [SD]) follow-up time from DPED detection was 4.7 (0.9) years. DPED was associated with increased risk of progression to late AMD (hazard ratio [HR], 2.36; 95% confidence interval [CI], 1.98-2.82; P < 0.001); 67% of eyes progressed to late AMD 5 years after DPED detection. Drusenoid pigment epithelial detachment was associated with increased risk of ≥3 lines of VA loss (HR, 3.08; CI, 2.41-3.93; P < 0.001) with 46% of eyes experiencing vision loss at 5 years (with or without progression to late AMD). ARMS2 risk alleles (1 vs. 0: HR, 2.72, CI, 1.58-4.70; 2 vs. 0: HR, 3.16, CI, 1.60-6.21, P < 0.001) and increasing GRS group (4 vs. 1) (HR, 12.17, CI, 3.66-40.45, P < 0.001) were significantly associated with DPED development in AREDS. There were no significant genetic results in AREDS2.ConclusionsThis study replicates the results of previous natural history studies of eyes with DPED including the high rates of progression to late AMD and vision loss (regardless of progression to late AMD). The genetic associations are consistent with genes associated with AMD progression.

Published
2019

50. Progression of Geographic Atrophy in Age-related Macular Degeneration AREDS2 Report Number 16

Author

Keenan, Tiarnan D, Agrón, Elvira, Domalpally, Amitha, Clemons, Traci E, van Asten, Freekje, Wong, Wai T, Danis, Ronald G, Sadda, SriniVas, Rosenfeld, Philip J, Klein, Michael L, Ratnapriya, Rinki, Swaroop, Anand, Ferris, Frederick L, Chew, Emily Y, SanGiovanni, John Paul, Clemons, Traci, Lindblad, Anne, Lindblad, Robert, Shah, Nilay, Sperduto, Robert, McBee, Wendy, Gensler, Gary, Harrington, Molly, Henning, Alice, Jones, Katrina, Thotapally, Kumar, Tull, Diana, Watson, Valerie, Williams, Kayla, Gentry, Christina, Kaufman, Francine, Morrison, Chris, Saverino, Elizabeth, Schenning, Sherrie, Blodi, Barbara, Danis, Ronald P, Davis, Matthew, Glander, Kathy, Guilfoil, Gregory, Hubbard, Larry D, Johnson, Kristine, Klein, Ronald, Nardi, Barbara, Neider, Michael, Robinson, Nancy, Rosensteel, Eileen, Wabers, Hugh, Zhang, Grace, Ruby, Alan J, Capone, Antonio, Dass, Bawa, Drenser, Kimberly, Garretson, Bruce R, Hassan, Tarek S, Trese, Michael, Williams, George A, Wolfe, Jeremy, Bell, Tina, Zajechowski, Mary, Bezaire, Dennis, McIver, Fran, Medina, Anthony, Pagett, Jackie, Smith, Stephanie Hatch, Swartz, Lynn, Treuter, Tom, Antoszyk, Andrew, Brown, Justin, Browning, David J, Holland, Walter, Karow, Angella, Stalford, Kelly, Price, Angela, Ennis, Sarah, Fredenberg, Sherry, Herby, Jenna, Balasubramaniam, Uma, Clark, Loraine, McClain, Donna, McOwen, Michael, Watson, Lynn, Klein, Michael, Bailey, Steven T, Hwang, Thomas J, Lauer, Andreas, Stout, J Timothy, McCollum, Patty, Johnson, Milt, Rice, Patrick B, Kim, Ivana, Loewenstein, John, Miller, Joan, Sobrin, Lucia, Young, Lucy, Sullivan, Jacqueline, and Houlihan, Patricia

Subjects
Prevention, Genetics, Neurodegenerative, Aging, Eye Disease and Disorders of Vision, Macular Degeneration, Eye, Aged, Aged, 80 and over, Disease Progression, Docosahexaenoic Acids, Drug Therapy, Combination, Eicosapentaenoic Acid, Female, Geographic Atrophy, Humans, Lutein, Male, Middle Aged, Photography, Prospective Studies, Visual Acuity, Zeaxanthins, AREDS2 Research Group, Clinical Sciences, Opthalmology and Optometry, Public Health and Health Services, Ophthalmology & Optometry
Abstract

PurposeTo analyze the prevalence, incidence, and clinical characteristics of eyes with geographic atrophy (GA) in age-related macular degeneration (AMD), including clinical and genetic factors affecting enlargement.DesignProspective cohort study within a controlled clinical trial.ParticipantsAge-Related Eye Disease Study 2 (AREDS2) participants, aged 50-85 years.MethodsBaseline and annual stereoscopic color fundus photographs were evaluated for GA presence and area. Analyses included GA prevalence and incidence rates, Kaplan-Meier rates, mixed-model regression, and multivariable analysis of the square root of GA, area adjusted for covariates, including clinical/imaging characteristics and genotype.Main outcome measures(1) Presence or development of GA; (2) change in the square root of GA area over time.ResultsAt baseline, 517 eyes (6.2%) of 411 participants (9.8%) had pre-existing GA (without neovascular AMD), with the following characteristics: 33% central, 67% noncentral; and the following configurations: 36% small, 26% solid/unifocal, 24% multifocal, 9% horseshoe/ring, and 6% indeterminate. Of the remaining 6530 eyes at risk, 1099 eyes (17.3%) of 883 participants developed incident GA without prior neovascular disease during mean follow-up of 4.4 years. The Kaplan-Meier rate of incident GA was 19% of eyes at 5 years. In eyes with incident GA, 4-year risk of subsequent neovascular AMD was 29%. In eyes with incident noncentral GA, 4-year risk of central involvement was 57%. GA enlargement rate (following square root transformation) was similar in eyes with pre-existing GA (0.29 mm/year; 95% confidence interval 0.27-0.30) and incident GA (0.28 mm/year; 0.27-0.30). In the combined group, GA enlargement was significantly faster with noncentrality, multifocality, intermediate baseline size, and bilateral GA (P < 0.0001 for interaction in each case) but not with AREDS2 treatment assignment (P = 0.33) or smoking status (P = 0.05). Enlargement was significantly faster with ARMS2 risk (P < 0.0001), C3 non-risk (P = 0.0002), and APOE non-risk (P = 0.001) genotypes.ConclusionsAnalyses of AREDS2 data on natural history of GA provide representative data on GA evolution and enlargement. GA enlargement, which was influenced by lesion features, was relentless, resulting in rapid central vision loss. The genetic variants associated with faster enlargement were partially distinct from those associated with risk of incident GA. These findings are relevant to further investigations of GA pathogenesis and clinical trial planning.

Published
2018

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