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1. WCN24-1204 MULTIDIMENSIONAL BURDEN OF CHRONIC KIDNEY DISEASE IN EIGHT COUNTRIES: INSIGHTS FROM THE IMPACT CKD STUDY

Author

Moura, Ana Flavia, primary, Wheeler, David, additional, Brotons-Munto, Francisco, additional, Brown, Stephen, additional, Grima, Daniel, additional, Priest, Stacey, additional, Rao, Naveen, additional, Kocks, Janwillem W.H., additional, Ming-Hui, Zhao, additional, Obolensky, Kyra, additional, Chen, Jieling, additional, and Chadban, Stephen, additional

Published
2024
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3. A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products

Author

Ruth Boetzel, Joerg Schlingemann, Sebastian Hickert, Christian Korn, Grace Kocks, Bert Luck, Giorgio Blom, Mark Harrison, Marc François, Leonardo Allain, Yongmei Wu, and Youssi Bousraf

Subjects
Pharmaceutical Science
Abstract

N-Nitrosamine risk assessment and control have become an integral part of pharmaceutical drug product development and quality evaluation. Initial reports of nitrosamine contamination were linked with the drug substance and its manufacturing process. Subsequently, the drug product and aspects of the formulation process have shown to be relevant. Regarding specific formulation contributions to nitrosamine content in a product, one risk lies in possible interactions between nitrosating agents, derived from nitrite in excipients, and vulnerable amines, either present as moieties of the active molecule or as impurities / degradants. However, the limited validated information on nitrite levels in excipients available until now, has been an obstacle for scientists to assess the risk of nitrosamine formation in pharmaceutical products. This has driven the creation of a database to store and share such validated information. The database, maintained by Lhasa Limited, constitutes a central platform to hold the data donated by the pharmaceutical company members on the nitrite concentrations in common excipients measured with validated analytical procedures. The goal of this data sharing initiative is to provide a common framework to contextualize and estimate the risk posed by presence of nitrites to contribute to the formation of nitrosamines in drug products. The major findings from the database analyses are: (1) average nitrite content and batch to batch variance differ among excipients, (2) for solid dosage forms, the nitrite contribution is dominated by the highest formula % excipients, e.g., the fillers (diluents), which are typically used in larger proportion, and are characterized by low nitrite levels and low variability, leading to an average value of 1 µg/g nitrite in a typical formulation, (3) substantial differences in average nitrite content in batches from different excipient vendors potentially reflecting differences in source materials or processing methods for excipient manufacturing. That final point suggests that future selection of raw materials or processing by excipient manufacturers may help reduce nitrite levels in finished drug product formulations, and thus the overall risk of nitrosamine formation in cases where the product contains vulnerable amines.

Published
2023
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4. PROVIDING EVIDENCE-BASED ANSWERS TO FIRST-HAND COVID-19 AND RESPIRATORY QUESTIONS FROM THE IPCRG SENTINEL NETWORK OF PRACTICING PRIMARY CARE CLINICIANS: A NOVEL SERVICE

Author

KAPLAN, ALAN G, primary, FITCH, NEIL, additional, MOSGROVE, FIONA, additional, KOCKS, JANWILLEM, additional, CORREIA DE SOUSA, JAIME, additional, MING KHOO, EE, additional, LISSPERS, KARIN, additional, MARICOTO, TIAGO, additional, TSILIGIANNI, IOANNA, additional, LONERGAN, TRACEY, additional, and WILLIAMS, SIÂN, additional

Published
2023
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7. Urinary single-cell sequencing captures kidney injury and repair processes in human acute kidney injury

Author

Jan Klocke, Seung Joon Kim, Christopher M. Skopnik, Christian Hinze, Anastasiya Boltengagen, Diana Metzke, Emil Grothgar, Luka Prskalo, Leonie Wagner, Paul Freund, Nina Görlich, Frédéric Muench, Kai M. Schmidt-Ott, Mir-Farzin Mashreghi, Christine Kocks, Kai-Uwe Eckardt, Nikolaus Rajewsky, and Philipp Enghard

Subjects
Mice, Oxidative Stress, Cardiovascular and Metabolic Diseases, Nephrology, Humans, Animals, Epithelial Cells, Acute Kidney Injury, Kidney, Biomarkers
Abstract

Acute kidney injury (AKI) is a major health issue, the outcome of which depends primarily on damage and reparative processes of tubular epithelial cells. Mechanisms underlying AKI remain incompletely understood, specific therapies are lacking and monitoring the course of AKI in clinical routine is confined to measuring urine output and plasma levels of filtration markers. Here we demonstrate feasibility and potential of a novel approach to assess the cellular and molecular dynamics of AKI by establishing a robust urine-to-single cell RNA sequencing (scRNAseq) pipeline for excreted kidney cells via flow cytometry sorting. We analyzed 42,608 single cell transcriptomes of 40 urine samples from 32 patients with AKI and compared our data with reference material from human AKI post-mortem biopsies and published mouse data. We demonstrate that tubular epithelial cells transcriptomes mirror kidney pathology and reflect distinct injury and repair processes, including oxidative stress, inflammation, and tissue rearrangement. We also describe an AKI-specific abundant urinary excretion of adaptive progenitor-like cells. Thus, single cell transcriptomics of kidney cells excreted in urine provides noninvasive, unprecedented insight into cellular processes underlying AKI, thereby opening novel opportunities for target identification, AKI sub-categorization, and monitoring of natural disease course and interventions.

Published
2022
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9. Electronic monitoring with a digital smart spacer to support personalized inhaler use education in patients with asthma: The randomized controlled OUTERSPACE trial

Author

Dierick, Boudewijn J.H., primary, Achterbosch, Maria, additional, Eikholt, Amber A., additional, Been-Buck, Sandra, additional, Klemmeier-Boekhout, Titia, additional, van de Hei, Susanne J., additional, Hagedoorn, Paul, additional, Kerstjens, Huib A.M., additional, Kocks, Janwillem W.H., additional, and van Boven, Job F.M., additional

Published
2023
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10. ICH Q3D Drug Product Elemental Risk Assessment: The Use of An Elemental Impurities Excipients Database

Author

Christopher Day, Fiona King, Diego Zulkiewicz Gomes, Richard E. Jones, Laurence James Harris, Nancy Lewen, Andrew Teasdale, Enid Gatimu, Grace Kocks, Ruth Boetzel, and Susana Torres

Subjects
Databases, Factual, Database, Pharmaceutical Science, Excipient, computer.software_genre, Risk Assessment, Excipients, Pharmaceutical Preparations, medicine, Environmental science, Drug product, Analytical Testing, Elemental impurities, Drug Contamination, Risk assessment, computer, medicine.drug
Abstract

The purpose of this publication is to show how an elemental impurities excipient database can be used in assisting the execution of a drug product elemental impurities risk assessment as required by the ICH Q3D guidelines. As a result of this exercise, we have demonstrated that the database, used in conjugation with other sources of information, is a credible source of elemental impurity levels in excipients therefore, a valuable source of information in completion of drug product risk assessments. This useful collection of data helps to reduce the burden of analytical testing for elemental impurities in excipients.

Published
2022
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13. Diagnostic performance of a machine-learning algorithm (Asthma/COPD Differentiation Classification; AC/DC) tool versus primary care physicians and pulmonologists in asthma, COPD and ACO

Author

Kocks, Janwillem W.H., primary, Cao, Hui, additional, Holzhauer, Björn, additional, Kaplan, Alan, additional, FitzGerald, J. Mark, additional, Kostikas, Konstantinos, additional, Price, David, additional, Reddel, Helen K., additional, Tsiligianni, Ioanna, additional, Vogelmeier, Claus F., additional, Bostel, Sebastien, additional, and Mastoridis, Paul, additional

Published
2023
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14. Urinary single-cell sequencing captures kidney injury and repair processes in human acute kidney injury

Author

Klocke, Jan, primary, Kim, Seung Joon, additional, Skopnik, Christopher M., additional, Hinze, Christian, additional, Boltengagen, Anastasiya, additional, Metzke, Diana, additional, Grothgar, Emil, additional, Prskalo, Luka, additional, Wagner, Leonie, additional, Freund, Paul, additional, Görlich, Nina, additional, Muench, Frédéric, additional, Schmidt-Ott, Kai M., additional, Mashreghi, Mir-Farzin, additional, Kocks, Christine, additional, Eckardt, Kai-Uwe, additional, Rajewsky, Nikolaus, additional, and Enghard, Philipp, additional

Published
2022
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15. Personalized Medication Adherence Management in Asthma and Chronic Obstructive Pulmonary Disease: A Review of Effective Interventions and Development of a Practical Adherence Toolkit

Author

Janwillem W. H. Kocks, Joyce E P Aarts, Susanne J. van de Hei, Job F M van Boven, and Boudewijn J H Dierick

Subjects
Adult, Decision support system, medicine.medical_specialty, Psychological intervention, Medication Adherence, law.invention, Pulmonary Disease, Chronic Obstructive, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, medicine, Humans, Immunology and Allergy, 030212 general & internal medicine, Asthma, COPD, business.industry, Nebulizers and Vaporizers, System usability scale, Usability, medicine.disease, humanities, 030228 respiratory system, Physical therapy, Personalized medicine, business, human activities
Abstract

The management of medication nonadherence of patients with asthma or chronic obstructive pulmonary disease (COPD) remains challenging. Given the multitude of underlying causes, a personalized approach is required. The Test of Adherence to Inhalers (TAI) can identify reasons for nonadherence, but it does not provide guidance regarding how to act effectively after results.To develop a practical, evidence-based decision support toolkit for health care professionals managing adult patients with asthma and/or COPD, by matching TAI-identified adherence barriers to proven effective adherence-enhancing interventions.We performed a literature review in PubMed and Embase identifying interventions that enhanced medication adherence in adult patients with asthma and/or COPD. Randomized controlled trials published in English with full texts available were included. Effective interventions assessed by the Cochrane risk of bias tool were categorized, matched with specific TAI responses, and developed into a practical TAI Toolkit. The Toolkit was assessed for content and usability (System Usability Scale) by a multidisciplinary group of health care professionals.In total, 40 randomized controlled trials were included in the review. Seven effective interventions categories were identified, informing the TAI Toolkit: reminders, educational interventions, motivational strategies, feedback on medication use, shared decision-making, simplifying the medication regimen, and multiple component interventions. Health care professionals rated the TAI Toolkit with a mean System Usability Scale score of 71.4 (range, 57.5-80.0).Adherence can be improved using the different interventions that the TAI Toolkit helps select. The TAI Toolkit was well-received by health care professionals. Further research is required to test its validity, practicality, and effectiveness in practice.

Published
2021
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16. Einbindung von Pflegefachpersonen mit Hochschulabschlüssen an deutschen Universitätskliniken: ein Follow-up-Survey

Author

Manuela Bergjan, Johanna Feuchtinger, Antje Tannen, Uli Fischer, Jennifer Luboeinski, Tobias Mai, Andreas Kocks, and Julian Bauer

Subjects
Gynecology, medicine.medical_specialty, 030503 health policy & services, Health Policy, Medicine (miscellaneous), University hospital, Master s degree, Education, 03 medical and health sciences, 0302 clinical medicine, Political science, medicine, 030212 general & internal medicine, 0305 other medical science, Follow up survey
Abstract

Zusammenfassung Einleitung Eine sinnvolle Einbindung von Pflegefachpersonen mit Hochschulabschluss in die Versorgungsablaufe wird international haufig mit besseren Behandlungsergebnissen bei den Patient*innen assoziiert. In Deutschland fehlt es derzeit noch an verlasslichen Zahlen uber Absolvent*innen und deren Aufgabenfeldern. Ziel dieser Erhebung war daher, durch Wiederholung einer fruheren Erhebung erneut den Anteil von Pflegefachpersonen mit Bachelor- oder Masterabschlussen in der direkten Patient*innenversorgung zu ermitteln. Methode In einer Querschnittserhebung wurden die Pflegedirektor*innen der Universitatskliniken und Medizinischen Hochschulen (UK) Deutschlands mittels einer standardisierten Befragung nach der Anzahl der Pflegefachpersonen mit Hochschulabschlussen (Bachelor, Master und Doktor) gefragt. Weitere Fragen betrafen deren Aufgabengebiete und Integrationsmasnahmen. Die Daten wurden mittels deskriptiver Statistik ausgewertet. Ergebnisse Insgesamt konnten n = 29 gultige Fragebogen aus 35 UK in die Analyse eingeschlossen werden, daraus ergibt sich eine Rucklaufquote von 82,85%. Fur insgesamt 18 UK konnte eine Steigerung der hochschulisch qualifizierten Pflegefachpersonen um n = 786, von 2015 (n = 593) auf 2018 (n = 1379) erreicht werden. Der Anteil an Pflegefachpersonen mit Hochschulabschluss in den teilnehmenden UK liegt bei 3,16% (SD = 1,66; Min - Max = 1,09 - 6,69; Q1 - Q3 = 1,49 - 4,04; 95% KI = 2,30 – 3,95). In der direkten Versorgung betragt der Anteil 2,11% (SD = 1,40; Min – Max = 0,47 - 5,42; Q1 – Q3 = 0,87 – 3,16; 95% KI 1,36 - 2,76). Die Aufgabenschwerpunkte liegen im Bereich der Regelversorgung und Patient*innenedukation (Bachelorabsolvent*innen), der evidenzbasierten Pflegepraxisentwicklung (Masterabsolvent*innen) und Forschung (promovierte Absolvent*innen). Diskussion Im Vergleich zu 2015 ist der Anteil hochschulisch qualifizierter Pflegefachpersonen zwar angestiegen, doch er liegt immer noch auf einem sehr niedrigen Niveau. Die Hochschulabsolvent*innen nehmen versorgungs- und entwicklungsrelevante Aufgaben wahr, doch besteht hinsichtlich ihrer Aufgabengebiete Bedarf an kompetenzorientierter Differenzierung.

Published
2021
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17. Short-Acting Beta-2-Agonist Exposure and Severe Asthma Exacerbations: SABINA Findings From Europe and North America

Author

Quint, Jennifer K., primary, Arnetorp, Sofie, additional, Kocks, Janwillem W.H., additional, Kupczyk, Maciej, additional, Nuevo, Javier, additional, Plaza, Vicente, additional, Cabrera, Claudia, additional, Raherison-Semjen, Chantal, additional, Walker, Brandie, additional, Penz, Erika, additional, Gilbert, Ileen, additional, Lugogo, Njira Lucia, additional, van der Valk, Ralf J.P., additional, Fong, Andrew, additional, Qian, Christina, additional, Fabry-Vendrand, Caroline, additional, Touboul, Chantal, additional, Brzostek, Dorota, additional, Maslova, Ekaterina, additional, Surmont, Filip, additional, Goike, Helena, additional, Gandhi, Hitesh, additional, Korevaar, J.C., additional, Tkacz, Joseph, additional, Johnston, Karissa, additional, Peres da Costa, Keith, additional, van Dijk, L., additional, Vervloet, M., additional, Pollack, Michael, additional, Hernandez, Paul, additional, Boarino, Silvia, additional, Noorduyn, Stephen G., additional, Beekman-Hendricks, Wendy, additional, and Weesie, Y.M., additional

Published
2022
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18. Digital spacer data driven COPD inhaler adherence education: The OUTERSPACE proof-of-concept study

Author

Dierick, Boudewijn J.H., primary, Been-Buck, Sandra, additional, Klemmeier, Titia, additional, Hagedoorn, Paul, additional, van de Hei, Susanne J., additional, Kerstjens, Huib A.M., additional, Kocks, Janwillem W.H., additional, Zijp, Tanja R., additional, Wessels, A. Mireille A., additional, Touw, Daan J., additional, and van Boven, Job F.M., additional

Published
2022
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19. Perceptions on Home-Administration of Biologics in the Context of Severe Asthma: An International Qualitative Study

Author

Flokstra-de Blok, Bertine, primary, Kocks, Janwillem, additional, Wouters, Hans, additional, Arling, Chantal, additional, Chatelier, Josh, additional, Douglass, Jo, additional, Heaney, Liam G., additional, Holmes, Joshua, additional, Humbert, Marc, additional, Kolanowski, Mary, additional, Landsman, Jeanet J.A., additional, Lugogo, Njira, additional, Malpass, Alice, additional, Meijer, Jiska, additional, Metz, Boyd, additional, de Mul, Bibicha, additional, Postma, Frank, additional, and Leving, Marika, additional

Published
2022
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22. Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma

Author

Porsbjerg, Celeste M., primary, Menzies-Gow, Andrew N., additional, Tran, Trung N., additional, Murray, Ruth B., additional, Unni, Bindhu, additional, Audrey Ang, Shi Ling, additional, Alacqua, Marianna, additional, Al-Ahmad, Mona, additional, Al-Lehebi, Riyad, additional, Altraja, Alan, additional, Belevskiy, Andrey S., additional, Björnsdóttir, Unnur S., additional, Bourdin, Arnaud, additional, Busby, John, additional, Canonica, G. Walter, additional, Christoff, George C., additional, Cosio, Borja G., additional, Costello, Richard W., additional, FitzGerald, J. Mark, additional, Fonseca, João A., additional, Hansen, Susanne, additional, Heaney, Liam G., additional, Heffler, Enrico, additional, Hew, Mark, additional, Iwanaga, Takashi, additional, Jackson, David J., additional, Kocks, Janwillem W.H., additional, Kallieri, Maria, additional, Bruce Ko, Hsin-Kuo, additional, Koh, Mariko Siyue, additional, Larenas-Linnemann, Désirée, additional, Lehtimäki, Lauri A., additional, Loukides, Stelios, additional, Lugogo, Njira, additional, Maspero, Jorge, additional, Papaioannou, Andriana I., additional, Perez-de-Llano, Luis, additional, Pitrez, Paulo Márcio, additional, Popov, Todor A., additional, Rasmussen, Linda M., additional, Rhee, Chin Kook, additional, Sadatsafavi, Mohsen, additional, Schmid, Johannes, additional, Siddiqui, Salman, additional, Taillé, Camille, additional, Taube, Christian, additional, Torres-Duque, Carlos A., additional, Ulrik, Charlotte, additional, Upham, John W., additional, Wang, Eileen, additional, Wechsler, Michael E., additional, Bulathsinhala, Lakmini, additional, Carter, Victoria, additional, Chaudhry, Isha, additional, Eleangovan, Neva, additional, Hosseini, Naeimeh, additional, Rowlands, Mari-Anne, additional, Price, David B., additional, and van Boven, Job F.M., additional

Published
2022
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24. Is inhaler technique adequately assessed and reported in clinical trials of asthma and COPD therapy? A systematic review and suggested best practice checklist.

Author

Dekhuijzen, P.N. Richard, primary, Levy, Mark L., additional, Corrigan, Chris J., additional, Hadfield, Ruth M., additional, Roche, Nicolas, additional, Usmani, Omar S., additional, Barnes, Peter J., additional, Scullion, Jane E., additional, Lavorini, Federico, additional, Corbetta, Lorenzo, additional, Kocks, Janwillem W.H., additional, Cosio, Borja G., additional, Buhl, Roland, additional, and Pedersen, Søren E., additional

Published
2022
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25. Short-acting β2-agonist exposure and severe asthma exacerbations: SABINA findings from Europe and North America

Author

Jennifer K. Quint, Sofie Arnetorp, Janwillem W.H. Kocks, Maciej Kupczyk, Javier Nuevo, Vicente Plaza, Claudia Cabrera, Chantal Raherison-Semjen, Brandie Walker, Erika Penz, Ileen Gilbert, Njira Lucia Lugogo, Ralf J.P. van der Valk, Andrew Fong, Christina Qian, Caroline Fabry-Vendrand, Chantal Touboul, Dorota Brzostek, Ekaterina Maslova, Filip Surmont, Helena Goike, Hitesh Gandhi, J.C. Korevaar, Joseph Tkacz, Karissa Johnston, Keith Peres da Costa, L. van Dijk, M. Vervloet, Michael Pollack, Paul Hernandez, Silvia Boarino, Stephen G. Noorduyn, Wendy Beekman-Hendricks, Y.M. Weesie, AstraZeneca UK Limited, Groningen Research Institute for Asthma and COPD (GRIAC), PharmacoTherapy, -Epidemiology and -Economics, and Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET)

Subjects
Asthma management, National Health Programs, Inhaled corticosteroids, Severe exacerbations, Asthma, Bronchodilator Agents, Adrenal Cortex Hormones, Administration, Inhalation, SABINA North American and European Study contributors, Immunology and Allergy, Budesonide, Formoterol Fumarate Drug Combination, Humans, Anti-Asthmatic Agents, Short-acting beta-2 agonists, Aged
Abstract

Background: Expert national/global asthma management recommendations raise the issue whether a safe threshold of short-acting beta-2 agonist (SABA) use without concomitant inhaled corticosteroids (ICS) exists.Objective: To examine SABA and maintenance therapy associations with severe asthma exacerbations across North America and Europe.Methods: Observational analyses of 10 SABa use IN Asthma (SABINA) datasets involving 1,033,564 patients (≥12 y) from Canada, France, the Netherlands, Poland, Spain, the United Kingdom, and the United States. Negative binomial models (incidence rate ratio [IRR] [95% CI adjusted for prespecified-covariates]) evaluated associations between SABA and exacerbations.Results: Across severities, 40.2% of patients were prescribed/possessed 3 or more SABA canisters/y. Per the Global Initiative for Asthma (GINA) 2018 definitions, steps 3 to 5–treated patients prescribed/possessing 3 or more versus 1 or 2 SABAs experienced more severe exacerbations (IRR 1.08 [95% CI 1.04‒1.13], U.S. Medicare; IRR 2.11 [95% CI 1.96‒2.27], Poland). This association was not observed in all step 1 or 2–treated patients (the Netherlands, IRR 1.25 [95% CI 0.91‒1.71]; U.S. commercial, IRR 0.92 [95% CI 0.91‒0.93]; U.S. Medicare, IRR 0.74 [95% CI 0.71‒0.76]). We hypothesize that this inverse association between SABA and severe exacerbations in the U.S. datasets was attributable to the large patient population possessing fewer than 3 SABA and no maintenance therapy and receiving oral corticosteroid bursts without face-to-face health care provider encounters. In U.S. SABA monotherapy–treated patients, 3 or more SABAs were associated with more emergency/outpatient visits and hospitalizations (IRR 1.31 [95% CI 1.29‒1.34]). Most GINA 2 to 5–treated study patients (60.6%) did not have maintenance therapy for up to 50% of the time; however, the association of 3 or more SABAs and severe exacerbations persisted (IRR 1.32 [95% CI 1.18‒1.49]) after excluding these patients and the independent effect was further confirmed when U.K. SABA data were analyzed as a continuous variable in patients with up to 100% annual coverage for ICS-containing medications.Conclusions: Increasing SABA exposure is associated with severe exacerbation risk, independent of maintenance therapy. As addressed by GINA, based on studies across asthma severities where as-needed fast-acting bronchodilators with concomitant ICS decrease severe exacerbations compared with SABA, our findings highlight the importance of avoiding a rescue/reliever paradigm utilizing SABA monotherapy.

Published
2022

26. Digital spacer data driven COPD inhaler adherence education: The OUTERSPACE proof-of-concept study

Author

Boudewijn J.H. Dierick, Sandra Been-Buck, Titia Klemmeier, Paul Hagedoorn, Susanne J. van de Hei, Huib A.M. Kerstjens, Janwillem W.H. Kocks, Tanja R. Zijp, A. Mireille A. Wessels, Daan J. Touw, Job F.M. van Boven, Pharmaceutical Technology and Biopharmacy, Groningen Research Institute for Asthma and COPD (GRIAC), Pharmaceutical Analysis, Critical care, Anesthesiology, Peri-operative and Emergency medicine (CAPE), Biopharmaceuticals, Discovery, Design and Delivery (BDDD), Medicinal Chemistry and Bioanalysis (MCB), Value, Affordability and Sustainability (VALUE), and Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET)

Subjects
Pulmonary and Respiratory Medicine, Pulmonary Disease, Chronic Obstructive, Formoterol Fumarate, Nebulizers and Vaporizers, Administration, Inhalation, Humans, Metered Dose Inhalers, Bronchodilator Agents
Abstract

Pressurized metered dose inhalers are recommended to be used in combination with spacers, yet inhaler technique and adherence are poor. A novel digital "smart" spacer can record spacer use and technique errors and could facilitate personalized education. In this proof-of-concept study, we assessed the usability of the digital spacer and explored its effects on inhaler technique, adherence, long-term systemic drug exposure and clinical outcomes in COPD. Usability was deemed high. One month after personalized digital spacer inhaler education, the mean number of errors per patient per day decreased with 36%, from 6.40 errors/day to 4.07 errors/day (p = 0.038). Drug exposure was confirmed by bioanalytical scalp hair analysis of formoterol. No significant change in clinical outcomes was observed. This study demonstrates the digital spacer's potential value in inhaler education, but larger, longer-term studies are required.

Published
2022
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29. Letter to the editor of Heliyon re: determination of dimethylamine and nitrite in pharmaceuticals by ion chromatography to assess the likelihood of nitrosamine formation Heliyon. 2021; 77: e06179

Author

Joerg Schlingemann, Sebastian Hickert, Giorgio Blom, Grace Kocks, and Leonardo Allain

Subjects
Multidisciplinary
Abstract

Our letter to the editor of Heliyon outlines queries on the methodology and sample preparation used in article e06179, published in 2021. The nitrite measurements reported are higher than those observed in our experience. In the interest of reporting nitrite levels that are fully accurate, we would like to discuss the findings with the article authors.

Published
2022
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31. Artificial Intelligence/Machine Learning in Respiratory Medicine and Potential Role in Asthma and COPD Diagnosis

Author

Kaplan, Alan, primary, Cao, Hui, additional, FitzGerald, J. Mark, additional, Iannotti, Nick, additional, Yang, Eric, additional, Kocks, Janwillem W.H., additional, Kostikas, Konstantinos, additional, Price, David, additional, Reddel, Helen K., additional, Tsiligianni, Ioanna, additional, Vogelmeier, Claus F., additional, Pfister, Pascal, additional, and Mastoridis, Paul, additional

Published
2021
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33. INTREPID : efficacité clinique de Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) en inhalateur unique versus triples thérapies en inhalateurs multiples en pratique clinique quotidienne

Author

Halpin, D.M., primary, Worsley, S., additional, Ismaila, A.S., additional, Astrom, J., additional, Beeh, K.M., additional, Brintziki, D., additional, Di Boscio, V., additional, Kocks, J., additional, Marin, J.M., additional, Tabberer, M., additional, Snowise, N.G., additional, Compton, C., additional, and Saïl, L., additional

Published
2021
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34. Benefits of eculizumab in AQP4+ neuromyelitis optica spectrum disorder: Subgroup analyses of the randomized controlled phase 3 PREVENT trial

Author

Palace, Jacqueline, primary, Wingerchuk, Dean M., additional, Fujihara, Kazuo, additional, Berthele, Achim, additional, Oreja-Guevara, Celia, additional, Kim, Ho Jin, additional, Nakashima, Ichiro, additional, Levy, Michael, additional, Terzi, Murat, additional, Totolyan, Natalia, additional, Viswanathan, Shanthi, additional, Wang, Kai-Chen, additional, Pace, Amy, additional, Yountz, Marcus, additional, Miller, Larisa, additional, Armstrong, Róisín, additional, Pittock, Sean, additional, Muñoz, Daniel Julio, additional, Amor, Jorge David, additional, Bocchiardo, Carolina, additional, Danielle, Julieta Iourno, additional, Laffue, Alfredo, additional, Obregon, Carolina Daniela Diaz, additional, Paez, Maria Fernanda, additional, Perez, Roberto Martin, additional, Rocchi, Viviana Ana Maria, additional, Teijeiro, Loreley Deborah, additional, Gómez, Jesica, additional, Villa, Andres Maria, additional, Aguirre, Florencia, additional, Fernández, Victoria Carla, additional, Goicoechea, Ramon F., additional, Melamud, Luciana, additional, Stillman, Ana, additional, de Virgiliis, Mariana, additional, Cassara, Fatima Pagani, additional, Cordoba, Marta, additional, Gutierrez, Maria Teresa, additional, Ingolotti, Mariana, additional, Larripa, Natalia, additional, Lupinacci, Anahi, additional, Arroyo, Josefina, additional, Romano, Alejandra, additional, Torres, Mariana Foa, additional, Ballario, Carlos Héctor, additional, Chiesa, Ana Elisa, additional, Gómez, Hernán Gustavo, additional, Lattini, Hernán Gabriel, additional, Mainella, Carolina Natalia, additional, Bolner, Gisel Edith, additional, Eschoyez, María Soledad, additional, Broadley, Simon Andrew, additional, Heshmat, Saman, additional, Sabet, Arman, additional, Swayne, Andrew, additional, Freeman, Susan, additional, Sanchez, Sofia Jimenez, additional, Shuey, Neil, additional, Dalic, Linda, additional, French, Ann, additional, Kuma, Guru, additional, Laing, Joshua, additional, Law, Lai Yin, additional, MacIntyre, Jennifer, additional, Neal, Andrew, additional, Plummer, Christopher, additional, Ramachandran, Prashanth, additional, Sedal, Leslie, additional, Wilson, Ian, additional, Winkel, Antony, additional, Zhang, Wenwen, additional, Chen, Tina, additional, Watts, Rani, additional, Barnett, Michael, additional, Barton, Joshua, additional, Beadnall, Heidi, additional, Garber, Justin, additional, Hardy, Todd Andrew, additional, Trewin, Benjamin, additional, Taha, Marinda, additional, Walters, Deleni, additional, Sieger, Federico Arturo Silva, additional, Alfonso, Nhora Patricia Ruiz, additional, Camacho, Anna Maria Pinzon, additional, Moreno, Alexander Pabón, additional, Prad, Jorge Armando Castellanos, additional, Rueda, Adriana Paola Duarte, additional, Castillo, Tatiana, additional, Gonzalez, Karol Melissa Castillo, additional, Pico, Martha Yolanda Moreno, additional, Castill, Judith, additional, Habek, Mario, additional, Adamec, Ivan, additional, Barun, Barbara, additional, Crnosija, Luka, additional, Gabelic, Tereza, additional, Nytrova, Petra, additional, Krasulova, Eva, additional, Pavlickova, Jana, additional, Tyblova, Michaela, additional, Zubkova, Jana, additional, Petersen, Thor, additional, Dale, Gro Helen, additional, Rasmussen, Peter Vestergaard, additional, Stilund, Morten, additional, Svendsen, Kristina Bacher, additional, Brandt, Vivi, additional, Collongues, Nicolas, additional, Fleury, Marie-Celine, additional, Kremer, Laurent, additional, Bendele, Sandrine, additional, Neff, Valérie, additional, Diem, Ricarda, additional, Platten, Michael, additional, Berberich, Anne, additional, Jansen, Jonabelle, additional, Jaschoneck, Hannah, additional, Wildemann, Brigitte, additional, Aures, Ursula, additional, Brandenburger, Tanja, additional, Haut, Tanja, additional, Fernández, Maria-Lourdes Treceno, additional, Aly, Lilian, additional, Brinkhoff, Kirsten, additional, Buck, Dorothea, additional, Golkowski, Daniel, additional, Hermisson, Mirjam, additional, Hoshi, Muna-Miriam, additional, Kaminski, Miriam, additional, Kowarik, Markus Christian, additional, Kronsbein, Helena, additional, Lehmann-Horn, Klaus, additional, Pongratz, Viola Maria, additional, Schweiker, Andreas, additional, Leddy, Lisa-Ann, additional, Mueller, Silvia, additional, Obergfell, Kim, additional, Wanka, Marion, additional, Zettl, Uwe Klaus, additional, Klinke, Jan, additional, Loebermann, Micha, additional, Meister, Stefanie, additional, Rimmele, Florian, additional, Winkelmann, Alexander, additional, Schroeder, Ina, additional, Lau, Alexander Yuk-Lun, additional, Au, Lisa Wing-Chi, additional, Fan, Florence Sin-Ying, additional, Ip, Vincent Hing-Lung, additional, Ma, Karen Ka-Yan, additional, Ma, Sze-Ho, additional, Mok, Vincent Chung-Tong, additional, Au, Cheryl Chung-Kwan, additional, Kwan, Pauline Wing-Lam, additional, Patti, Francesco, additional, Caramma, Andrea Salvatore, additional, Chisari, Clara Grazia, additional, Fermo, Salvatore Lo, additional, Messina, Silvia, additional, Projetto, Maria, additional, Caserta, Cinzia, additional, Filla, Alessandro, additional, Costabile, Teresa, additional, Pane, Chiara, additional, Sacca, Francesco, additional, Marsili, Angela, additional, Puorro, Giorgia, additional, Bergamaschi, Roberto, additional, Berra, Eliana, additional, Mallucci, Giulia, additional, Fattore, Cinzia, additional, Gasperini, Claudio, additional, Galgani, Simonetta, additional, Haggiag, Shalom, additional, Ruggieri, Serena, additional, Vento, Claudio, additional, Quartuccio, Esmeralda Maria, additional, Pozzilli, Carlo, additional, Barletta, Valeria Teresa, additional, Borriello, Giovanna, additional, De Giglio, Laura, additional, Marinelli, Fabiana, additional, Tasillo, Miriam, additional, Amadori, Alessandra, additional, Fischetti, Mariano, additional, Gurreri, Flavia, additional, Mori, Masahiro, additional, Masuda, Hiroki, additional, Ohtani, Ryohei, additional, Sekiguchi, Yukari, additional, Uchida, Tomohiko, additional, Uzawa, Akiyuki, additional, Ito, Hiromi, additional, Kabasawa, Emi, additional, Kaneko, Yoko, additional, Matsushita, Takuya, additional, Matsuse, Dai, additional, Murai, Hiroyuki, additional, Hayashi, Shintaro, additional, Masak, Katsuhisa, additional, Ogata, Hidenori, additional, Shinoda, Koji, additional, Uehara, Taira, additional, Watanabe, Mitsuru, additional, Yamaguchi, Hiroo, additional, Yamasaki, Ryo, additional, Yonekawa, Tomomi, additional, Jingu, Maki, additional, Nagano, Makiko, additional, Nakamura, Yumiko, additional, Sano, Yoshiko, additional, Araki, Manabu, additional, Lin, Youwei, additional, Mori, Madoka, additional, Mukai, Yohei, additional, Sano, Terunori, additional, Sato, Wakiro, additional, Gogun, Naoya, additional, Maeda, Yuriko, additional, Nishimoto, Asami, additional, Tsukamoto, Sachiko, additional, Yanagi, Ritsuko, additional, Saida, Takahiko, additional, Nakamura, Shinichi, additional, Nasu, Tetsuya, additional, Saida, Kyoko, additional, Shikata, Yuko, additional, Kodani, Yoshimi, additional, Saeki, Megumi, additional, Sawada, Yukako, additional, Yoshikawa, Hiroo, additional, Kimura, Takashi, additional, Nishi, Masamitsu, additional, Sakamoto, Shun, additional, Ukon, Shinichiro, additional, Watanabe, Shohei, additional, Ebisuya, Saori, additional, Kimura, Nami, additional, Matsuura, Manami, additional, Morisaki, Yukie, additional, Muroi, Yoshiko, additional, Onishi, Kuniko, additional, Oshima, Ikuko, additional, Washino, Yuki, additional, Yamashita, Tomomi, additional, Misu, Tatsuro, additional, Kaneko, Kimihiko, additional, Kato, Masaaki, additional, Kuroda, Hiroshi, additional, Kurosawa, Kazuhiro, additional, Nishiyama, Shuhei, additional, Ono, Hirohiko, additional, Takai, Yoshiki, additional, Abe, Keiko, additional, Hoshi, Hitomi, additional, Jinushi, Mari, additional, Oyama, Azusa, additional, Sakuma, Motonari, additional, Sawada, Yuko, additional, Ishibashi, Satoru, additional, Yokota, Takanori, additional, Nishida, Yoichiro, additional, Ozaki, Kokoro, additional, Sanjo, Nobuo, additional, Sato, Nozomu, additional, Denno, Fuki, additional, Hiraki, Haruko, additional, Matsubara, Yumi, additional, Kanda, Takashi, additional, Abe, Masaaki, additional, Honda, Masaya, additional, Kawai, Motoharu, additional, Koga, Michiaki, additional, Maeda, Toshihiko, additional, Ogasawara, Junichi, additional, Omoto, Masatoshi, additional, Sano, Yasuteru, additional, Sato, Ryota, additional, Shimizu, Fumitaka, additional, Arima, Hideki, additional, Fukui, Sachie, additional, Ishikawa, Yoshiko, additional, Koyama, Tomoko, additional, Shimose, Shigemi, additional, Shinozaki, Hirokazu, additional, Watanabe, Masanori, additional, Yasuda, Sachi, additional, Yoshiwaka, Chieko, additional, Adenan, Suffian, additional, Aris, Mohd Azman M, additional, Mawardi, Ahmad Shahir bin, additional, Adnan, Muhammad Al Hafiz, additional, Munusamy, Nanthini, additional, Razali, Siti Nur Omaira, additional, Somasundram, Punitha, additional, Hyun, Jae Won, additional, Jeong, In Hye, additional, Kim, Su-Hyun, additional, Shin, Hyun-June, additional, Yoo, Ji Sung, additional, Jang, HyunMin, additional, Joung, AeRan, additional, Kim, Byung-Jo, additional, Baek, Seol-Hee, additional, Kim, Jung Bin, additional, Kim, Yoo Hwan, additional, Koo, Yong Seo, additional, Lee, Chan Nyoung, additional, Seok, Hung Youl, additional, Hwang, Jinhee, additional, Kim, Sung Min, additional, Ahn, So Hyun, additional, Choi, Kyomin, additional, Choi, Seok-Jin, additional, Kim, Jun-Soon, additional, Kwon, Young Nam, additional, Shin, Je-Young, additional, Kwon, Hyeonju, additional, Kim, Byoung Joon, additional, Cho, Eun Bin, additional, Cho, Hye-Jin, additional, Choi, Misong, additional, Kim, DongSun, additional, Kim, Ju Hyeon, additional, Ki, SeungJu, additional, Lee, Hye Lim, additional, Lee, Kwang-Ho, additional, Min, Ju-Hong, additional, Park, Ji-Hyung, additional, Seok, Jinmyoung, additional, Choi, Eunhwa, additional, Park, Sang Ae, additional, Kim, Seung Min, additional, Jeong, Ha-Neul, additional, Jeongbin, Bong, additional, Jung, Jin Woo, additional, Kim, Seung Woo, additional, Kim, Yool-hee, additional, Lee, Hyung Seok, additional, Shin, Ha Young, additional, Jung, Yeon, additional, Kim, Min Jung, additional, Lee, Nou Ri, additional, Shin, MiJu, additional, Khabirov, Farit A, additional, Averyanova, Lyudmila, additional, Babicheva, Natalya, additional, Granatov, Eugenii, additional, Kazarov, Sergey, additional, Khaybullin, Timur, additional, Rogozhin, Alexander, additional, Pokhabov, Dmitry V, additional, Abramov, Vladislav, additional, Amelina, Anastasia, additional, Nesteroca, Yulia, additional, Bozhenkina, Tatyana, additional, Boyko, Aleksey N, additional, Demyan, Elena G, additional, Khoroshilova, Inessa, additional, Melnikov, Mikhail, additional, Popova, Ekaterina V, additional, Sharanova, Svetlana N, additional, Shchur, Sergey G, additional, Sazonov, Denis V, additional, Babenko, Larisa, additional, Bayandina, Elena, additional, Yarmoschuk, Asya, additional, Baliazin, Victor A, additional, Baliazina, Elena, additional, Budaeva, Elena, additional, Chernikova, Irina, additional, Goncharova, Zoya, additional, Krasnov, Vladimir, additional, Myatleva, Marina, additional, Rodionova, Olga V., additional, Samulyzhko, Iuliana, additional, Timofeeva, Alla A., additional, Duran, Sabas Boyero, additional, Bilbao, Maria Mar Mendibe, additional, Cuervo, Irene Diaz, additional, Domingo, Jose Maria Losada, additional, Eizaguirre, Amaia Gonzalez, additional, Llona, Jose Eulalio Barcena, additional, Moyano, Roberto Valverde, additional, Bahamonde, Carmen, additional, Lopez, Fernando Sanchez, additional, Morales, Raquel Pinar, additional, Morales, Eduardo Agüera, additional, Roman, Carmen Bahamonde, additional, Sepulveda, Juan Jose Ochoa, additional, Valero, Maria del Carmen Blanco, additional, Viña, Nazaret Pelaez, additional, Gavilan, Cristina Conde, additional, Sanchez, Ana Maria Jover, additional, Bedmar, Sara Vila, additional, Garcia, Nuria Gonzalez, additional, Garcia, Aida Orviz, additional, Gonzalez-Suarez, Ines, additional, Guillamon, Elena Miñano, additional, Kawiorski, Miguel, additional, Schulz, Elena Guerra, additional, Alonso, Alba Garcia, additional, Perez, Francisco Jesus Lopez, additional, Sarmiento, Marta Palacios, additional, Ayuso, Guillermo Izquierdo, additional, Mascarell, Guillermo Navarro, additional, Camino, Cristina Paramo, additional, Garcia, Asuncion Varas, additional, Mendoza, Yaiza Montserrat, additional, Muñoz, Veronica Ines Vargas, additional, Tonda, Patricia Torres, additional, Tsai, Ching-Piao, additional, Yin, Jiu-Haw, additional, Chen, Mei-Jung, additional, Li, Shan-Ni, additional, Wang, Fei-Ti, additional, Srisuwannanukorn, Suwat, additional, Boonmongkol, Thanatat, additional, Borisutbuathip, Duangporn, additional, Singwicha, Duangkamol, additional, Siritanan, Krittika, additional, Thearapati, Chidchanoke, additional, Sornda, Kwanmuang, additional, Apiwattanakul, Metha, additional, Aungsumart, Saharat, additional, Suanprasert, Narupat, additional, Suksuchano, Kaona, additional, Parkinsee, Nittaya, additional, Kulkantrakorn, Kongkiat, additional, Lolekha, Praween, additional, Potigumjon, Artit, additional, Sukphulloprat, Puchit, additional, Suksasunee, Dararat, additional, Komaratat, Chankawee, additional, Luangtong, Sunattana, additional, Arayawichanont, Arkhom, additional, Konpan, Phanpaphon, additional, Riablershirun, Nathapol, additional, Wiroteurairuang, Thaddao, additional, Jantaweesirirat, Panadda, additional, Kurne, Aslı, additional, Erkent, Irem, additional, Kurt, Ebru Bekircan, additional, Saylam, Ezgi, additional, Caliskan, Yagmur, additional, Orsel, Gulsah, additional, Celik, Yahya, additional, Celebi, Canan, additional, Tekatas, Aslan, additional, Banbal, Tugce, additional, Demir, Gulsen Akman, additional, Altunrende, Burcu, additional, Matur, Zeliha, additional, Topcular, Baris, additional, Elmas, Tules, additional, Gulo, Aysenur, additional, Ozdemir, Selin, additional, Ozkoklesen, Cansu, additional, Ozturk, Mahinur, additional, Yanik, Mertkan, additional, Yildirim, Elif, additional, Tutuncu, Melih, additional, Altintas, Ayse, additional, Cam, Abdulsamet, additional, Elmali, Ayse Deniz, additional, Saip, Sabahattin, additional, Siva, Aksel, additional, Tanrıverdi, Uygur, additional, Uygunoglu, Ugur, additional, Caliskan, Sinem, additional, Gulo, Pinar, additional, Kozig, Esra, additional, Sakiz, Sakine, additional, Sengun, Ihsan Sukru, additional, Idiman, Egemen, additional, Ala, Rahmi Tumay, additional, Arslan, Duygu, additional, Bulut, Utku, additional, Karakaptan, Yasemin, additional, Kaya, Derya, additional, Mehdiyev, Zaur, additional, Balkan, Bengu, additional, Kuku, Berfu, additional, Ozhun, Mujgan, additional, Tuga, Celal, additional, Ugur, Muzeyyen, additional, Efendi, Husnu, additional, Bunul, Sena Destan, additional, Cavus, Hakan, additional, Gorke, Yunus Emre, additional, Kutlu, Ayse, additional, Ozturk, Seda, additional, Sarikaya, Cansu Egilmez, additional, Becerikli, Gulsah, additional, Semiz, Cansu, additional, Tun, Ozlem, additional, Ayer, Sehriban, additional, Onar, Musa Kazim, additional, Ozberk, Mehlika Berra, additional, Sen, Sedat, additional, Cavdar, Tugce Kirbas, additional, Veske, Adife, additional, Boz, Cavit, additional, Altiparmak, Didem, additional, Aydin, Cigdem Ozen, additional, Gazioglu, Sibel, additional, Bekircan, Duygu, additional, Jacob, Anu, additional, Arndt, Heike, additional, Elsone, Liene, additional, Hamid, Shahd Hassan Mahmoud, additional, Whittam, Daniel Hugh, additional, Wilson, Martin, additional, O'Brien, Imelda, additional, Leite, Maria Isabel da Silva, additional, Cruz, Pedro Maria Rodriguez, additional, Jenkins, Damian Robert, additional, Tackley, George, additional, Cavey, Ana, additional, Everett, Rosie, additional, Hodder, Joy, additional, Koelewyn, Abigail, additional, Mowry, Ellen, additional, Royal, Walter, additional, Shin, Robert, additional, Bever, Christopher, additional, Harrison, Daniel, additional, Rus, Horea, additional, Zheng, Wei, additional, Callison, Karen, additional, Naunton, Kerry, additional, Frishberg, Benjamin M, additional, Blumenfeld, Andrew M, additional, Inocelda, Andrew, additional, Korabathina, Kalyani, additional, Lobatz, Michael, additional, Mortin, Melissa M, additional, Oh, Irene J, additional, Rosenberg, Jay H, additional, Sadoff, Mark, additional, Sahagian, Gregory A, additional, Wang, Anchi, additional, Camberos, Yasmin, additional, Sanchez, Guadalupe, additional, Soto, Estela, additional, Nicholas, Jacqueline A, additional, Boster, Aaron, additional, Eubank, Geoffrey, additional, Groezinger, Katy, additional, Lauf, Meghan, additional, Okai, Annette F, additional, Hasan, Rashedul, additional, Khoury, Chaouki, additional, Stokes, Victoria, additional, Clardy, Stacey, additional, Cortez, Melissa, additional, Greenlee, John, additional, Rose, John, additional, Soldan, Mateo Paz, additional, Emett, Amanda, additional, Esquibel, Lawanda, additional, Fagatele, Lilly, additional, Wong, Ka-Ho, additional, Stevens, James C, additional, Banas, Thomas M, additional, Bultemeyer, Marlene C, additional, Haller, Andrea, additional, Manalo, Natalie, additional, Aeschliman, Keri, additional, Kocks, Debi, additional, Racke, Michael, additional, Boster, Aaron Lee, additional, Bowman, Michelle, additional, Imitola, Jaime, additional, Kisanuki, Yasushi, additional, Green, Misty, additional, Scarberry, Stephanie, additional, Lynch, Sharon G, additional, Anderson, Heather S, additional, Gronseth, Gary S, additional, Hammond, Nancy E, additional, Jassam, Yasir N, additional, Mittal, Manoj K, additional, Nashatizadeh, Muhammed M, additional, Levine, Nicholas, additional, Schmidt, Lisa, additional, Sibley, Jill, additional, Whitley, Vonda, additional, Winkley, James, additional, Coleman, Timothy, additional, Cooper, Gregory, additional, Sheffield, Stephanie, additional, Turner, Keri, additional, Galloway, Dana, additional, Tillett, Robert S, additional, Ganesh, Geeta A, additional, Plato, Brian M, additional, Seifert, Tad D, additional, Godwin, Diana, additional, Lockridge, Deborah, additional, Rammohan, Kottil W, additional, Sheremata, William A, additional, Delgado, Silvia, additional, Gonzalez, Jose, additional, Lizarraga, Alexis, additional, Maldonado, Janice, additional, Ortega, Melissa, additional, Tornes, Leticia, additional, Babcock, Yanet, additional, Cailam, Osmara, additional, Campos, Yesica, additional, Couvertier, Irlisse, additional, Daneri, Bettina, additional, Deni, Jeremy, additional, Hernandez, Jeffrey, additional, Jaramillo, Tatiana, additional, Morris, Tenita, additional, Nobel, Daniel, additional, Oliveira, Anjelis, additional, Richardson, Reshma, additional, Rodriguez, Gloria, additional, Romero, Ana, additional, Sandova, Carlos, additional, Sawant, Ruta, additional, Tueros, Lissett, additional, Zetka, Eric S, additional, Zheng, Chao, additional, Jacobs, Daniel H, additional, Easterling, Constance, additional, Fairbank, Jennifer, additional, Iyengar, Revathi, additional, Klafter, Mark, additional, Lindquist, Justin, additional, Sadek, Ahmed H, additional, Toro, Elizabeth Carmona, additional, Verma, Navin, additional, Castro, Brigith Patino, additional, Sukhraj-Singh, Nadia, additional, Berger, Joseph, additional, Williamson, Eric, additional, Chahin, Salim, additional, Jacobs, Dina, additional, Markowitz, Clyde, additional, Dobbins, Jessica, additional, Mace, Lauren, additional, Martin, Maria, additional, Pinckney, Ashley, additional, Roberts, Amber, additional, Zaydan, Islam, additional, Mitchell, Galen W, additional, Heyman, Rock A, additional, Orie, Ryan L, additional, Suski, Valerie R, additional, Oddis, Kerry, additional, Punjack, Darlene, additional, Flanagan, Eoin, additional, Gadoth, Avi, additional, McKeon, Andrew, additional, Tobin, W Oliver, additional, Zekeridou, Anastasia, additional, Dunlay, Katie, additional, Sagen, Jessica, additional, Carter, Jonathan L, additional, Estephan, Bachir, additional, Goodman, Brent P, additional, Snyder, Charlene R Hoffman, additional, Francone, Andrea, additional, Galasky, Irene, additional, Thomas, Martha, additional, Repovic, Pavle, additional, Bowen, James, additional, Mayadev, Angeli, additional, Qian, Peiqing, additional, Courtney, Yuriko, additional, Lennox, Lauren, additional, Naismith, Robert Thomas, additional, Cross, Anne Haney, additional, Evans, Emily, additional, Longbrake, Erin E, additional, Orchard, Megan E, additional, Wu, Gregory F, additional, Heinrich, Linda, additional, Sommers, Susan, additional, Amjad, Faria, additional, Mitchell, Erika, additional, Mora, Carlos, additional, Schreiber, Bethany, additional, Tornatore, Carlo, additional, Carlson, Alexis, additional, McCarthy, Sacha, additional, and Oliver, Alexandria, additional

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2021
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39. L’optimisation du parcours des soins, le rôle de l’allergologue et la réduction du retentissement sur la qualité de la vie de l’urticaire pour les patients et la société : revue systématique

Author

Clark, E., primary, Cardoso, B., additional, Kocks, J., additional, van der Velde, J.L., additional, Flokstra, B., additional, Angier, E., additional, Gawlik, R., additional, Demoly, P., additional, Ryan, D., additional, and Tanno, L., additional

Published
2020
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42. An expert consensus framework for asthma remission as a treatment goal

Author

Menzies-Gow, Andrew, primary, Bafadhel, Mona, additional, Busse, William W., additional, Casale, Thomas B., additional, Kocks, Janwillem W.H., additional, Pavord, Ian D., additional, Szefler, Stanley J., additional, Woodruff, Prescott G., additional, de Giorgio-Miller, Alexander, additional, Trudo, Frank, additional, Fageras, Malin, additional, and Ambrose, Christopher S., additional

Published
2020
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44. INTREPID : efficacité clinique de Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) en inhalateur unique versus triples thérapies en inhalateurs multiples en pratique clinique quotidienne

Author

Jose M. Marin, Sally Worsley, Neil G Snowise, Afisi S. Ismaila, David M.G. Halpin, D. Brintziki, Kai-Michael Beeh, Maggie Tabberer, J. Astrom, Janwillem W. H. Kocks, L. Sail, V. Di Boscio, and Chris Compton

Subjects
Pulmonary and Respiratory Medicine
Abstract

Introduction Chez les patients BPCO, l’usage de plusieurs inhalateurs est lie a plus d’erreurs et a une moindre observance comparee aux inhalateurs uniques. Des donnees d’efficacite en vie reelle des TRT avec inhalateur unique vs multiples sur l’etat de sante dans la BPCO manquent. Nous avons evalue l’impact de la triple therapie inhalateur unique FF/UMEC/VI vs triples therapies inhalateurs multiples (TTIM ; associations CSI + LAMA + LABA) sur l’etat de sante, mesure par le COPD Assessment Test (CAT), sur 24 sem en soins cliniques (SC) habituels dans 5 pays EU. Methodes INTREPID est une etude d’efficacite de phase IV, randomisee, en ouvert, avec patients BPCO sous TRT de fond continu non-ELLIPTA (TTIM, ou bitherapie avec indication clinique documentee de passer a la triple therapie) pendant ≥ 16 sem avant randomisation, score CAT ≥ 10, et ≥ 1 exacerbation moderee/severe dans les 3 annees precedentes. Les patients ont ete randomises FF/UMEC/VI 100/62,5/25 μg via ELLIPTA (cohorte FF/UMEC/VI) ou choix de leur clinicien de toute association CSI + LAMA + LABA non-ELLIPTA (cohorte TTIM) pendant 24 sem. Seules 2 visites obligatoires pour reduire les interventions et refleter les SC habituels. Le critere d’evaluation principal etait la proportion de repondeurs CAT (diminution ≥ 2 unites score CAT par rapport a l’inclusion) a la S24. Les criteres d’evaluation secondaires etaient la variation par rapport a l’inclusion du VEMS et la proportion de patients avec ≥ 1 erreur critique dans la technique d’inhalation a la S24. La tolerance a ete evaluee de facon descriptive. Resultats La population ITT comptait 3092 patients (FF/UMEC/VI n = 1545 ; TTIM n = 1547). La probabilite d’etre repondeur au CAT a la S24 etait significativement plus elevee avec FF/UMEC/VI qu’avec TTIM (OR 1,31 ; p Tableau 1 ). A la S24, FF/UMEC/VI a ameliore le VEMS par rapport a l’inclusion, difference de 50 mL de plus que les TTIM (p Tableau 1 ). Au total, 38/653 patients traites par FF/UMEC/VI (6 %) et 7/230 patients traites par TTIM (3 %) ont fait ≥ 1 erreur critique dans la technique d’inhalation a la S24 (p = 0,103 ; Tableau 1). Les profils de tolerance etaient similaires entre cohortes, sans nouveaux signaux. Des EIGs de pneumonies sont survenus chez 26 (2 %) et 30 (2 %) patients des cohortes FF/UMEC/VI et TTIM. Conclusion En SC quotidiens, le TRT inhalateur unique FF/UMEC/VI compte un nombre significativement plus eleve de patients avec une amelioration de l’etat de sante et un meilleur benefice de la fonction pulmonaire, vs TTIM avec profils de tolerance similaires.

Published
2021
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45. Automated measurement of pH-dependent solid-liquid equilibria of itaconic acid and protocatechuic acid

Author

Andreas Jupke, Arne Holtz, Mark Junker, Christian Kocks, and Jonas Görtz

Subjects
Chromatography, 010405 organic chemistry, Chemistry, General Chemical Engineering, Sodium, General Physics and Astronomy, chemistry.chemical_element, 02 engineering and technology, Electrolyte, 01 natural sciences, Protocatechuic acid, 0104 chemical sciences, law.invention, chemistry.chemical_compound, 020401 chemical engineering, law, Molecule, Fermentation, Itaconic acid, 0204 chemical engineering, Physical and Theoretical Chemistry, Crystallization, Solubility
Abstract

Crystallization is a highly selective unit operation capable of separating target molecules from complex media. Its design requires precise solid-liquid equilibrium (SLE) data. The SLE of platform chemicals like carboxylic acids in complex aqueous media depends on temperature, pH value as well as on present side components, but predominantly, only the solubility for different temperatures is reported. This work presents a novel automated method for the determination of the pH- and temperature-dependent SLE in complex media using readily available laboratory equipment. Taking the example of itaconic acid, the pH-dependent solubility for different temperatures is measured and validated with results obtained from the classic excess solid method along with literature data. Using the automated setup, the influence of different loadings of sodium chloride on the SLE of itaconic acid is investigated and a correlation between solubility and concentration of the electrolyte is derived. The SLE data acquired for protocatechuic acid in fermentation medium demonstrates the applicability of the method for the determination of comprehensive SLE in multicomponent mixtures without the requirement of specific analytical methods for the target compound. The resulting SLE data can be used for a more precise design and techno-economic evaluation of crystallization processes in biotechnological production routes.

Published
2021
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46. Survey zur Einbindung von Pflegefachpersonen mit Hochschulabschlüssen an deutschen Universitätskliniken - Stand 2015

Author

Johanna Feuchtinger, Antje Tannen, Andreas Kocks, and Barbara Strohbücker

Subjects
Gynecology, medicine.medical_specialty, Nursing staff, 030504 nursing, Health Policy, Advanced practice nursing, Medicine (miscellaneous), University hospital, Education, 03 medical and health sciences, 0302 clinical medicine, Political science, medicine, 030212 general & internal medicine, 0305 other medical science
Abstract

Zusammenfassung Einleitung Um dem Anforderungswandel in der komplexer werdenden Patientenversorgung zukunftig gerecht werden zu konnen, wird eine starkere Differenzierung der Pflegepersonalstruktur, insbesondere die Einbindung hochschulisch qualifizierter Pflegefachpersonen empfohlen. Dies ist internationaler Standard und wird vom deutschen Wissenschaftsrat empfohlen. Unklar ist der aktuelle Umsetzungsgrad der Empfehlungen in deutschen Universitatskliniken. Die Untersuchung ermittelt den Anteil hochschulisch qualifizierter Pflegefachpersonen und deren Tatigkeitsprofil an deutschen Universitatskliniken. Methode Standardisierte schriftliche Befragung der Pflegedirektionen aller 32 Universitatskliniken und medizinischen Hochschulen in Deutschland im Jahr 2015. Ergebnisse Bei einer Rucklaufquote von 75% ergab sich eine Quote von hochschulisch qualifizierten Pflegefachpersonen von 1,7% insgesamt und 1,0% in der direkten Patientenversorgung. Die Tatigkeiten der Pflegefachpersonen mit Hochschulabschluss entsprechen dem Profil einer erweiterten Pflegepraxis, darunter konzeptionelle Entwicklung (76%), Qualitatssicherung und Forderung einer evidenzbasierten Versorgung (72%), Praxisprojekte (64%) und Patientenberatung (56%). Es gab bundesweit deutliche Schwankungen zwischen einzelnen Kliniken hinsichtlich der Entgeltstufen bei gleichzeitigem Fehlen von verlasslichen Tarifstrukturen. Diskussion Dieses Survey ist eine erste nationale Untersuchung, welche den Anteil hochschulisch qualifizierter Pflegender in der direkten Versorgung untersucht. Die Quote von 1% liegt weit unter den offiziellen Empfehlungen des Wissenschaftsrats (10-20%) und weist auf einen erheblichen Reformbedarf hin. Eine Folgeerhebung ist 2017 geplant.

Published
2017
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47. Two-Dimensional CFD based compartment modeling for dynamic simulation of semi-batch crystallization processes in stirred tank reactors

Author

Leonhard Parakenings, Christian Kocks, Benedikt Weber, Tim Massmann, and Andreas Jupke

Subjects
Supersaturation, education.field_of_study, Work (thermodynamics), Materials science, business.industry, 020209 energy, General Chemical Engineering, Population, Flow (psychology), 02 engineering and technology, Mechanics, Computational fluid dynamics, Computer Science Applications, law.invention, Volumetric flow rate, Dynamic simulation, 020401 chemical engineering, law, 0202 electrical engineering, electronic engineering, information engineering, 0204 chemical engineering, Crystallization, education, business
Abstract

Crystallization processes whose characteristic is dosing of one or multiple feeds are often dominated by local phenomena at the feeding positions. This work applies a computational fluid dynamics (CFD) based compartment model (CM) to pH-shift crystallization of itaconic acid with two feeds to account for inhomogeneities. Population balancing in each compartment is solved by time-driven n-Monte-Carlo modeling. Compartmentation and model validation is performed according to literature. The influence of the feed volume flow and CM is neglected for CFD simulation, no feedback loop from CM to CFD is applied. This work shows the application for strongly changing filling levels (up to 63%) and thereby flow regimes. Local relative supersaturations of compartments are necessary for the interpretation of obtained experimental data by ( Eggert et al., 2019 ). Local resolution has to be considered for change rates of the relative supersaturation with respect to mean seed surface area over 168 h−1 m−2.

Published
2020
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48. L’Hypersensibilité médicamenteuse (HSM) en soins primaires : revue systématique afin de soutenir la qualité de la gestion et l’optimisation des parcours de soins de santé

Author

Elisabeth Angier, Dermot Ryan, Radosław Gawlik, Pascal Demoly, Janwillem W. H. Kocks, L. Kase Tanno, Myriam Mamodaly, Clara Gaudin, T. Velde, and B. Flokstra De Bok

Subjects
Immunology and Allergy
Abstract

Introduction L’HSM represente une cause de deces evitable importante. Les medecins de soins primaires (SP) constituent souvent le premier contact pour les patients presentant une HSM. Cette revue systematique vise a fournir des preuves afin de faciliter le developpement d’outils d’aide a la decision aux medecins generalistes (MG). Methodes Une revue de la litterature a ete effectuee a partir de cinq plateformes bibliographiques internationales afin d’identifier les articles abordant le sujet de l’HSM en SP. Les documents ont ete examines par deux evaluateurs independants et le degre d’accord sur les articles eligibles a ete evalue par kappa de Cohen. Les desaccords ont ete resolus par discussion et analyse qualitative avec un troisieme relecteur. Resultats Nous avons selectionne 40 articles, comprenant 17 articles originaux, 7 guides, 2 revues, 9 etudes epidemiologiques et 5 questionnaires. Parmi eux 32,5 % ont ete publies dans un journal de MG et 25 % traitaient d’une etiologique specifique : dont 90 % des Beta- lactamines et 10 % des AINS. La concordance entre evaluateurs a ete satisfaisante (kappa : 0,68). Nous avons observe la necessite de differencier les reactions d’HSM des autres effets secondaires des medicaments (62,5 %). Les principaux signes d’alerte d’une reaction etaient l’atteinte systemique, des symptomes cutanes atypiques et l’atteinte muqueuse, exigeant une orientation immediate vers un service d’urgences. Les donnees soulignent encore les difficultes a reconnaitre les manifestations ainsi que la necessite d’aide a la decision pour soutenir la gestion des reactions d’HSM par les MG (51 %). L’histoire clinique structuree et l’examen clinique sont des outils cles du diagnostic. Les principaux motifs pour referer un patient a un specialiste, d’apres la litterature, sont : enqueter sur l’etiologie, subir une procedure specifique (desensibilisation) et identifier des medicaments alternatifs surs. Conclusion Les donnees presentees soutiennent la construction d’un algorithme afin d’aider nos collegues a identifier et a bien adresser les patients souffrant d’HSM, optimiser la duree de traitement des patients tout au long des parcours de soins et prevenir des deces evitables.

Published
2020
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49. Recovery of succinic acid by integrated multi-phase electrochemical pH-shift extraction and crystallization

Author

Tim Maßmann, Armin Eggert, Christian Kocks, Andreas Jupke, Marcel Gausmann, and Moritz Doeker

Subjects
Aqueous solution, Chemistry, Extraction (chemistry), Filtration and Separation, 02 engineering and technology, 021001 nanoscience & nanotechnology, Analytical Chemistry, Electrochemical cell, law.invention, chemistry.chemical_compound, 020401 chemical engineering, Chemical engineering, Succinic acid, law, Fermentation, Succinic acid fermentation, 0204 chemical engineering, Crystallization, 0210 nano-technology, Faraday efficiency
Abstract

This work presents a novel approach for the recovery of succinic acid from aqueous solutions by electrochemically induced extraction and crystallization. The suggested process allows purification by electrical energy via pH-shift downstream operations. Experimental results show that direct electrochemical extraction can recover succinic acid from aqueous solution containing approximately 50 g/L succinic acid at bulk pH of 5–7 without prior acidification by strong inorganic acid. Simultaneously, an alkaline solution was obtained from the cathode reaction, which can potentially reduce the base consumption for pH maintenance in succinic acid fermentation. Replacing salt waste generating base and acid addition by electrochemically operated pH-shift unit operations can provide more environmentally benign separation strategies for the production of bio-based succinic acid. Experimental examples for electrochemical extraction, back-extraction and crystallization are given. For extraction and back-extraction, a faradaic efficiency of 22–36% was recorded. Crystal size distribution of succinic acid from electrochemical crystallization was found to be comparable to commercially available succinic acid. Based on the experimental results we suggest a concept for the recovery of solid succinic acid from aqueous solution and pH-control in fermentation by a series of four electrochemical downstream operations, which can be coupled into two electrochemical cells. This process layout enables operating fermentation at optimal pH for maximal space-time-yield and independent pH-shift separation in the downstream, while product losses can be minimized by closed recycle streams. In the long-term perspective, electrochemical unit operations provide a way to utilize electricity for the purification of carboxylic acids.

Published
2020
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50. L’optimisation du parcours des soins, le rôle de l’allergologue et la réduction du retentissement sur la qualité de la vie de l’urticaire pour les patients et la société : revue systématique

Author

Pascal Demoly, B. Flokstra, Elisabeth Angier, E. Clark, Dermot Ryan, B. Cardoso, Radosław Gawlik, J. L. van der Velde, Janwillem W. H. Kocks, and Luciana Kase Tanno

Subjects
Immunology and Allergy
Abstract

Introduction L’urticaire est une dermatose frequente, la majorite des cas sont d’abord vus par les medecins generalistes (MG) ou les urgences, et eventuellement par des allergologues sur orientation du MG. Cette revue systematique vise a creer un algorithme simple pour les soins primaires optimisant la prise en charge et l’orientation des patients. Methodes Les recherches ont debute en novembre 2018 avec le recueil de donnees bibliographiques sur l’urticaire et les soins primaires, a partir de cinq bases de recherche PUBMED, Cochrane, Lilacs, Scielo et Science direct. Nous avons etudie et extrait ces donnees en double lecture en aveugle (calcul coefficient Kappa), puis nous nous sommes interesses a la prise en charge primaire, a l’aiguillage du patient, au fardeau de cette maladie et aux couts en resultant. Resultats Nous avons trouve un total de 45 articles (30 articles originaux, 11 revues et 4 guides), avec un excellent coefficient Kappa (0,93). Plus de vingt publications concernaient exclusivement l’urticaire chronique (UC). Plusieurs articles insistaient sur la non necessite de realisation d’un bilan complementaire lors de la prise en charge initiale de l’UC. Le MG doit orienter ses patients en presence de signes atypiques ou de non efficacite therapeutique apres augmentation de la posologie des antihistaminiques. Le fardeau de l’UC est important, et est compare a celui des patients atteints de maladies cardiaques ischemiques severes. Une frustration intense peut egalement naitre de l’incertitude de la cause de leur maladie. Du fait d’une mauvaise connaissance de la maladie, le traitement est souvent inadapte (corticoides) participant, par leurs effets secondaires, a l’augmentation des couts medicaux, similaires a ceux des maladies cardiovasculaires et diabetiques. Conclusion Ces donnees nous permettent la creation d’un arbre decisionnel pour les soins primaires, en vue de l’amelioration du diagnostic et de la prise en charge de l’UC. Il permettra d’affiner les parcours des soins jusqu’aux consultations specialisees, d’optimiser la qualite de vie et de reduire les couts evitables. Cet outil sera valide et diffuse en soins primaires via une plateforme informatique.

Published
2020
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