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6. Developing a framework for evaluation: A theory of change for complex workplace mental health interventions

Author

Tsantila, F., Coppens, E., de Witte, H., Abdulla, K., Amann, B., Arensman, E., Aust, B., Cresswell-Smith, J., D'Alessandro, L., de Winter, L., Doukani, A., Fanaj, N., Greiner, B., Griffin, E., Leduc, C., Maxwell, M., O'Connor, C., Paterson, C., Purebl, G., Reich, H., Ross, V., van Weeghel, J., van Audenhove, C., Tsantila, F., Coppens, E., de Witte, H., Abdulla, K., Amann, B., Arensman, E., Aust, B., Cresswell-Smith, J., D'Alessandro, L., de Winter, L., Doukani, A., Fanaj, N., Greiner, B., Griffin, E., Leduc, C., Maxwell, M., O'Connor, C., Paterson, C., Purebl, G., Reich, H., Ross, V., van Weeghel, J., and van Audenhove, C.

Abstract

Background There is a gap between the necessity of effective mental health interventions in the workplace and the availability of evidence-based information on how to evaluate them. The available evidence outlines that mental health interventions should follow integrated approaches combining multiple components related to different levels of change. However, there is a lack of robust studies on how to evaluate multicomponent workplace interventions which target a variety of outcomes at different levels taking into account the influence of different implementation contexts. Method We use the MENTUPP project as a research context to develop a theory-driven approach to facilitate the evaluation of complex mental health interventions in occupational settings and to provide a comprehensive rationale of how these types of interventions are expected to achieve change. We used a participatory approach to develop a ToC involving a large number of the project team representing multiple academic backgrounds exploiting in tandem the knowledge from six systematic reviews and results from a survey among practitioners and academic experts in the field of mental health in SMEs. Results The ToC revealed four long-term outcomes that we assume MENTUPP can achieve in the workplace: 1) improved mental wellbeing and reduced burnout, 2) reduced mental illness, 3) reduced mental illness-related stigma, and 4) reduced productivity losses. They are assumed to be reached through six proximate and four intermediate outcomes according to a specific chronological order. The intervention consists of 23 components that were chosen based on specific rationales to achieve change on four levels (employee, team, leader, and organization). Conclusions The ToC map provides a theory of how MENTUPP is expected to achieve its anticipated long-term outcomes through intermediate and proximate outcomes assessing alongside contextual factors which will facilitate the

Published
2023

7. Outcome assessment of a complex mental health intervention in the workplace. Results from the MENTUPP pilot study

Author

Tsantila, F., Coppens, E., de Witte, H., Arensman, E., Amann, B., Cerga-Pashoja, A., Corcoran, P., Cresswell-Smith, J., Cully, G., Ditta Toth, M., Greiner, B., Griffin, E., Hegerl, U., Holland, C., Leduc, C., Leduc, M., Ni Dhalaigh, D., O'Brien, C., Paterson, C., Purebl, G., Reich, H., Ross, V., Rugulies, R., Sanches, S., Thompson, K., van Audenhove, C., MENTUPP Consortium Members, van Weeghel, J., Tsantila, F., Coppens, E., de Witte, H., Arensman, E., Amann, B., Cerga-Pashoja, A., Corcoran, P., Cresswell-Smith, J., Cully, G., Ditta Toth, M., Greiner, B., Griffin, E., Hegerl, U., Holland, C., Leduc, C., Leduc, M., Ni Dhalaigh, D., O'Brien, C., Paterson, C., Purebl, G., Reich, H., Ross, V., Rugulies, R., Sanches, S., Thompson, K., van Audenhove, C., MENTUPP Consortium Members, and van Weeghel, J.

Abstract

Objective Multicomponent interventions are recommendable to achieve the greatest mental health benefits, but are difficult to evaluate due to their complexity. Defining long-term outcomes, arising from a Theory of Change (ToC) and testing them in a pilot phase, is a useful approach to plan a comprehensive and meaningful evaluation later on. This article reports on the pilot results of an outcome evaluation of a complex mental health intervention and examines whether appropriate evaluation measures and indicators have been selected ahead of a clustered randomised control trial (cRCT). Methods The MENTUPP pilot is an evidence-based intervention for Small and Medium Enterprises (SMEs) active in three work sectors and nine countries. Based on our ToC, we selected the MENTUPP long-term outcomes, which are reported in this article, are measured with seven validated scales assessing mental wellbeing, burnout, depression, anxiety, stigma towards depression and anxiety, absenteeism and presenteeism. The pilot MENTUPP intervention assessment took place at baseline and at 6 months follow-up. Results In total, 25 SMEs were recruited in the MENTUPP pilot and 346 participants completed the validated scales at baseline and 96 at follow-up. Three long-term outcomes significantly improved at follow-up (p < 0.05): mental wellbeing, symptoms of anxiety, and personal stigmatising attitudes towards depression and anxiety. Conclusions The results of this outcome evaluation suggest that MENTUPP has the potential to strengthen employees’ wellbeing and decrease anxiety symptoms and stigmatising attitudes. Additionally, this study demonstrates the utility of conducting pilot workplace interventions to assess whether appropriate measures and indicators have been selected. Based on the results, the intervention and the evaluation strategy have been optimised.

Published
2023

8. Prevalence of clozapine-induced sialorrhea and its effect on quality of life

Author

Sanagustin, D., primary, Martin-Subero, M., additional, Hogg, B., additional, Fortea, L., additional, Gardoki, I., additional, Guinart, D., additional, Roldán, M., additional, Angelats, M., additional, Cerro, L., additional, Navas, D., additional, Jiménez, J. D., additional, Ortiz, L., additional, Ros, R., additional, Polo, X., additional, Ventura, Y., additional, Contreras, J., additional, Moreno-Alcázar, A., additional, Pérez-Sola, V., additional, Amann, B. L., additional, and Valiente-Gómez, A., additional

Published
2022
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18. Corrigendum to 'Spanish validation of the Barcelona TEMPS-A questionnaire in patients with bipolar disorder and general population' [J. Affect. Disord. 249 (2019) 199–207 (Apr 15)]

Author

Jiménez, E, Bonnín, C D M, Solé, B, Sánchez-Moreno, J, Reinares, M, Torrent, C, Torres, I, Salagre, E, Varo, C, Ruíz, V, Giménez, A, Benabarre, A, Gutiérrez-Rojas, L, Cervilla, J, Sáiz, P A, García-Portilla, M P, Bobes, J, Amann, B L, Martínez-Arán, A, and Vieta, E

Subjects
Psychiatry and Mental health, Clinical Psychology
Published
2022

23. Ethical questions in human clinical psychopharmacology: should the focus be on placebo administration?

Author

Kotzalidis, G.D., Pacchiarotti, I., Manfredi, G., Savoja, V., Torrent, C., Mazzarini, L., Tatarelli, C., Amann, B., Di Marzo, S., Sanchez-Moreno, J., Sani, G., Girardi, P., Colom, F., and Vieta, E.

Subjects
Suicidal behavior -- Research -- Risk factors -- Complications and side effects, Antidepressants -- Complications and side effects -- Research -- Standards -- Usage, Placebos -- Usage -- Research -- Complications and side effects, Psychopharmacology -- Research -- Usage, Research ethics -- Standards -- Usage -- Research, Antipsychotic drugs -- Research -- Complications and side effects, Pharmaceuticals and cosmetics industries, Psychology and mental health, Standards, Usage, Complications and side effects, Research, Risk factors
Abstract

Keywords: ethics; placebo; randomised clinical trials 590 CritiqueEthical questions in human clinical psychopharmacology: should the focus be on placebo administration? SAGE Publications, Inc.200810.1177/0269881108089576 GDKotzalidis Department of Psychiatry, Sant'Andrea Hospital, 'La [...]

Published
2008
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25. Persistent photoconductivity in ZnO nanowires: Influence of oxygen and argon ambient.

Author

Madel, M., Huber, F., Mueller, R., Amann, B., Dickel, M., Xie, Y., and Thonke, K.

Subjects
PHOTOCONDUCTIVITY, OPTICAL properties of zinc oxide, NANOWIRES, OXYGEN analysis, ARGON analysis
Abstract

ZnO nanowires typically show persistent photoconductivity (PPC), which depends in their temporal behaviour on the ambient. We investigate ZnO nanowires in oxygen and argon ambient and analyze the PPC both on the short and on the long time scale to sort out the underlying mechanisms. Wavelength dependent excitation shows the energy barrier for the PPC to be around 150 meV below the band gap of ZnO, independent of the ambient atmosphere. In photocurrent measurements at constant wavelength, a log-logistic dependence of the conductivity on the partial oxygen pressure is observed. The experimental results are compared to a model of Bonasewicz et al. [J. Electrochem. Soc. 133, 2270 (1986)] and can be explained by oxygen adsorption processes occurring on the surface of the ZnO nanowires. From temperature dependent measurements of the decay times in oxygen and argon ambient, the related activation energies for the fast and slow decay processes are determined. Comparing our results to theoretical calculations of energy levels of intrinsic defects [Janotti and Van de Walle, Phys. Status Solidi B 248, 799 (2011)], we find oxygen vacancies to be related to the fast decay processes, whereas adsorption and desorption processes of oxygen on the ZnO nanowire surface account for the slow part. [ABSTRACT FROM AUTHOR]

Published
2017
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35. Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients

Author

Legkonogov, O., Ramacciotti, E., Mikhailova, E., Koryk, V., Adzerikho, I., Schoenerr, H., Mathies, R., Konig, J., Huber, K., Rubinfeld, A., Finfer, S., Manenti, E., Bott, M., Blessing, E., Beyer-Westendorf, J., Coughlin, P., Baker, R., Poy, C., Dengler, T., Parody, M., Oliva, M., Macin, S., Jure, H., Ferrari, A. E., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Mitkovskaya, N., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Tiefenbacher, C., Weimar, C., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Berrouschot, J., Kirschner, R., Amann, B., Paposhvili, K., Pagava, Z., Kristof, P., Lakatos, F., Laszlo, Z., Freire, A., Lupkovics, G., Megreladze, I., Kobulia, B., Khintibidze, I., Khabeishvili, G., Datikashvili-David, I., Simoneau, G., Merkely, B., Andras, C. Nagy, Nemeth, L., Papp, A., Soltesz, P., Fiss, E., Schmidt, J., Roy, P-M., Quere, I., Proust, A., Pottier, P., Pernod, G., Payot, L., Bizzacchi, J. Annichino, Lienart, F., Paleiron, N., Montaclair, K., Mismetti, P., Messas, E., Lacroix, P., Grange, C., Falvo, N., El Kouri, D., Decoulx, E., Debourdeau, P., De Geeter, G., Brisot, D., Belhassane, A., Aquilanti, S., Agraou, B., Vikman, S., Tatlisumak, T., Saarinen, J., Kaaja, R., Honkaniemi, J., Airaksinen, J., Uuetoa, T., Lember, M., Urhammer, S., Tuxen, C., Storgaard, M., Lassen, M., Christensen, H., Vyhnanek, M., Vejvoda, J., Spacek, R., Reiterer, P., Podpera, I., Mikulova, J., Lang, P., Jajtner, P., Hubac, J., Horny, I., Holaj, R., Herold, M., Havelka, J., Francek, L., Dusek, J., Dunaj, M., Cizek, V., Chochola, J., Chlumsky, J., Cermak, O., Skerk, V., Vagic, J. Sikic, Marusic, S., Knezevic, A., Kalinic-Grgorinic, H., Jakopovic, M., Francetic, I., Ciglenecki, N., Car, S., Butkovic-Soldo, S., Cardenas, S. Potthoff, Lazcano, M. Opazo, Alarcon, M. Arias, Verreault, S., Provencher, S., Pearce, M., Le Gal, G., Douketis, J., Dhar, A., Tokmakova, M., Todorov, G., Syulemzova, S., Raymuno, S., Rocha, A., Dimov, B., Grigorov, M., Kalpachki, R., Kamenova, Z., Bello, F., Harrington, Robert A., Bandman, Olga, Kostadinova, M., Milanova, M., Dive, A., Pencheva, G., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Delforge, M., Vertes, A., Efrati, S., Elias, M., Gafter, A., Nazliel, BİJEN, Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, R., Runev, N., Lembo, G., Lodigiani, C., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Stoeva, N., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Gold, Alex, Visona, A., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Stoyanov, M., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Castillo Leon, R., Pimanov, S., Polonetsy, L., Pereyra, R. Cotrina, Karlo, L. Farjardo, Horna, M., Soroka, N., Salas, M., Yanez, L. Toche, Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Walasek, L., Blockmans, D., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Musetescu, R., Podoleanu, C., Popescu, M., Stamate, S., Stanciulescu, G., Vida-Simiti, L., Abashev, A., Andreev, D., Apartsin, K., Arkhipov, M., Averkov, O., Barbarash, O., Belskaya, G., Bogdanov, E., Boldueva, S., Chefranova, Z., Dovgalevskiy, Y., Ershova, O., Goloshchekin, B., Khachatryan, N., Klein, G., Kobalava, Z., Kosmacheva, E., Kostenko, V., Malygin, A., Martynenko, T., Martynenko, V., Maslova, N., Mordovin, V., Nikolaev, K., Nilk, R., Popov, D., Privalova, E., Reshetko, O., Shapovalova, Y., Shpagina, L., Shvarts, Y., Simanenkov, V., Solovyov, O., Vishneva, E., Vishnevskiy, A., Apostolovic, S., Celic, V., Ilic, S., Kovacevic-Kuzmanovic, A., Miloradovic, V., Bodikova, S., Cervenakova, A., Dvorak, M., Herman, O., Hrubon, A., Kokles, M., Krastev, G., Payer, J., Prokop, D., Spisakova, M., Adler, D., Basson, M., Breedt, J., Engelbrecht, J., Mitha, I., Van Dyk, C., Alvarez Sala, L. A., Barbagelata Lopez, C., Bisbe, J., Castro Guardiola, A., Cepeda, J. M., Cereto, F., Diaz Santos, E., Ferrer, R., Gomez Cerezo, J., Hernandez, Adrian F., Gonzales-Porras, J. R., Grandes, J., Cohen, Alexander T., Gibson, C. Michael, Chi, Gerald, Halaby, Rim, Korjian, Serge, Daaboul, Yazan, Jain, Purva, Arbetter, Douglas, Goldhaber, Samuel Z., Hull, Russel, Jimenez, D., Mellibovsky, L., Richart, C., Riera, A., Trujillo, J., Vargas Nunez, J. A., Villalta, J., Akgul, O., Guneri, S., Kilichesmez, K., Kirma, C., Kutluk, H., Okumus, G., Tigen, K., Topcuoglu, M., Tuncay, E., Abrahamovych, O., Batushkin, V., Brozhyk, J., Burmak, I., Godlevska, O., Goloborodko, A., Goloborodko, B., Goncharova, Y., Gryb, V., Karpenko, O., Kopytsya, M., Zakai, N., Yousef, K., Wichman, T., Whitman, B., Welker, J., Welch, M., Warner, A., Updegrove, J., Tuck, M., Stoltz, S., Sokol, S., Sharma, S., Shammas, N., Saba, F., Rodriguez, W., Rees, C., Rastogi, P., Rajan, R., Quintana, O., Pullman, J., Pratt, R., Pineda, L., Pearl, R., Parthiban, K., Overcash, J., Ortel, T., Ohaju, V., Nadar, V., Mittal, M., Milling, T., McLaren, G., Margolis, B., Mahal, S., Macchiavelli, A., Lopez, J., Lerner, R., Kung, M., Kouras, F., Kazimir, M., Kao, C-K., Kabler, H., Ioachimescu, O., Hazelrigg, M., Hamad, A., Haidar, A., Hahn, B., Goytia-Leos, D., Gaggin, H., Fulmer, J., Koshlia, V., Fraiz, J., Krakhmalova, O., Fermann, G., Farley, B., Doshi, A., Dhingra, R., Cornell, J., Concha, M., Clark, C., Chang, H., Carman, T., Bidair, M., Bercz, P., Bastani, A., Barney, J., Baker, S., Anderson, C., Amin, M., Almasri, E., Natarajan, I., McCollum, C., MacCallum, P., Davis, M., Body, R., Yagensky, A., Voronkov, L., Vishnivestsky, I., Vakaliuk, I., Ursol, G., Tseluyko, V., Kyrychenko, I., Svyshchenko, Y., Svyridova, I., Ryabichenko, T., Rudenko, L., Reshotko, D., Perepeliuk, M., Parkhomenko, O., Nikonov, V., Maslovaskyi, V., Malynovsky, Y., Sergeeva, E., and Kolman, P.

Subjects
Male, medicine.medical_specialty, Pyridines, Intracranial Hemorrhages, 030204 cardiovascular system & hematology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Medical illness, Physiology (medical), medicine, Humans, 030212 general & internal medicine, Enoxaparin, Intensive care medicine, Stroke, Aged, business.industry, Anticoagulants, Venous Thromboembolism, medicine.disease, Thrombosis, chemistry, Betrixaban, Benzamides, Emergency medicine, Female, Cardiology and Cardiovascular Medicine, business, Complication, Venous thromboembolism
Abstract

Background: Stroke is a morbid and potentially mortal complication among patients hospitalized with acute medical illness. The potential of extended-duration thromboprophylaxis with the factor Xa inhibitor betrixaban to reduce the risk of stroke compared with standard-dose enoxaparin in this population was assessed in this retrospective APEX trial substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban). Methods: Hospitalized acutely medically ill subjects (n=7513) were randomized in a double-dummy double-blind fashion to either extended-duration oral betrixaban (80 mg once daily for 35–42 days) or standard-dose subcutaneous enoxaparin (40 mg once daily for 10±4 days) for venous thromboprophylaxis. Stroke events were adjudicated by an independent, blinded event adjudication committee. Results: The mean age of study participants was 76 years; 45% were male; 13% had had a stroke; and 45% had congestive heart failure. There were fewer all-cause strokes (0.54% versus 0.97%; relative risk [RR]=0.56; 95% confidence interval, 0.32–0.96; P =0.032; adjusted RR=0.43%; number needed to treat=233) and ischemic strokes (0.48% versus 0.91%; RR=0.53; 95% confidence interval, 0.30–0.94; P =0.026; adjusted RR=0.43%; number needed to treat=233) among patients treated with betrixaban versus enoxaparin through 77 days of follow-up. Among high-risk subjects, those with congestive heart failure or ischemic stroke as their index event, betrixaban reduced the risk of all-cause stroke (0.72% versus 1.48%; RR=0.49; 95% confidence interval, 0.26–0.90; P =0.019; adjusted RR=0.76%; number needed to treat=132) and ischemic stroke (0.63% versus 1.38%; RR=0.45; 95% confidence interval, 0.24–0.87; P =0.014; adjusted RR=0.75%; number needed to treat=134) compared with enoxaparin. Conclusions: Among hospitalized medically ill patients, extended-duration betrixaban significantly reduced all-cause stroke and ischemic stroke through 77 days of follow-up Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01583218.

Published
2017

41. Editorial: Present and future of EMDR in clinical psychology and psychotherapy

Author

Castelnuovo, Gianluca, Fernandez, I., Amann, B. L., Castelnuovo G. (ORCID:0000-0003-2633-9822), Castelnuovo, Gianluca, Fernandez, I., Amann, B. L., and Castelnuovo G. (ORCID:0000-0003-2633-9822)

Abstract

EMDR research; EMDR therapy; PTSD; eye movement desensitization and reprocessing; mechanism of action; psychological trauma.

Published
2019

42. Comparison of PTSD prevalence between immigrants and locals with psychotic disorders.

Author

Trabsa Biskri, A., Mané, A., Rodríguez, R., Zabaleta, N., Martínez, L., Casanovas, F., Ezquiaga, I., Legido, T., Pérez, V., Amann, B., and Moreno, A.

Subjects
MENTAL health services, HOSPITAL wards, POST-traumatic stress, PSYCHOSES, POST-traumatic stress disorder
Abstract

Introduction: Due to the global humanitarian crisis, there has been a significant increase in global immigration.(1) The migration process typically involves multiple trauma exposures that are sustained over time(2), which may result in an impact on the mental health of these individuals(3), such as posttraumatic stress disorder(3). A recent meta-analysis estimated that 25% of migrants had PTSD(15), which is significantly higher than the 0.2% to 3.8 percent prevalence data found for the general population(4). In addition, a number of meta-analyses indicate an increased risk of psychosis among immigrants(5). Despite this rise, there is a gap in trauma research in non-refugee immigrants, particularly those with psychotic disorders. Objectives: To describe and compare PTSD diagnosis between immigrants and locals recruited from mental health services in Barcelona. Methods: Patients who have presented, according to DSM-V criteria, one or more non-affective psychotic episodes, were recruited in Acute and Chronic inpatients units at Hospital del Mar (Barcelona) from November 2019 to June 2021, leading to a total sample of 199 patients. Demographic characteristics of patients, clinical data and main pharmacological treatment were recorded through a questionnaire. Database information was completed with electronic medical records. Global Assessment of Posttraumatic Stress Questionnaire (EGEP-5) was used as an instrument to assess PTSD diagnosis, main trauma nature and PTSD symptoms. Comparative analysis was performed with IBM SPSS Statistics (Chicago INC) using Chi-Square Test for qualitative variables and t-Student test for continuous variables. Covariate adjustment with demographic and clinical variables was performed by ANOVA test. Study received local ethics committee approval "CEIC" (No. 2019/8398/I). Results: From the total sample of 199 individuals, 98 were immigrants and 98 locals. From the total sample 39 individuals (19.69%) presented PTSD. 32.3% of the immigrants with psychotic disorders presented PTSD compared to 7.1% of the locals with psychotic disorders (F1=19.9, p=0.00). Most traumatic events related to PTSD in immigrants were: "murder of relatives" (33.1%), Physical violence (21.9%) and Terrorism (15.6%) in locals were: "physical violence" (28.6%). Immigrants and locals with psychotic disorders showed similar averages of symptoms, except for avoidance symptoms where locals showed a mean of 5.1 compared to a mean of 3.5 in the immigrant group. Finally, immigrants showed one more functionality affected area by PTSD (5.1) when compared to locals (4) (F7=3.9, p=0.05). Conclusions: According to our results there are important differences in PTSD prevalence between immigrants and locals with psychotic disorders. These findings ought to be taken into consideration for programs that are both clinically and sociopolitically tailored to improve assessment and treatment for this population. Disclosure of Interest: None Declared [ABSTRACT FROM AUTHOR]

Published
2024
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45. Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely III Medical Patients: An APEX Trial Substudy

Author

Gibson, C. M., Korjian, S., Chi, G., Daaboul, Y., Jain, P., Arbetter, D., Goldhaber, S. Z., Hull, R., Hernandez, A. F., Lopes, R. D., Gold, A., Cohen, A. T., Harrington, R. A., Bello, F., Ferrari, A. E., Jure, H., Macin, S., Oliva, M., Parody, M., Poy, C., Baker, R., Colquhoun, D., Coughlin, P., Finfer, S., Hammerschlag, G., Rubinfeld, A., Huber, K., Konig, J., Mathies, R., Pilger, E., Schoenerr, H., Adzerikho, I., Koryk, V., Mikhailova, E., Mitkovskaya, N., Pimanov, S., Polonetsy, L., Soroka, N., Blockmans, D., Delforge, M., Dive, A., Lienart, F., Motte, S., Annichino Bizzacchi, J., Fiss, E., Freire, A., Manenti, E., Ramacciotti, E., Raymuno, S., Rocha, A., Saraiva, J. F., Dimov, B., Grigorov, M., Kalpachki, R., Kamenova, Z., Kostadinova, M., Milanova, M., Mincheva, V., Pencheva, G., Raev, D., Runev, N., Stoeva, N., Stoyanov, M., Syulemzova, S., Todorov, G., Tokmakova, M., Dhar, A., Douketis, J., Kahn, S., Le Gal, G., Pearce, M., Provencher, S., Verreault, S., Arias Alarcon, M., Olivares Canon, C., Opazo Lazcano, M., Potthoff Cardenas, S., Butkovic-Soldo, S., Car, S., Ciglenecki, N., Francetic, I., Jakopovic, M., Kalinic-Grgorinic, H., Knezevic, A., Malojcic, B., Marusic, S., Sikic Vagic, J., Skerk, V., Cermak, O., Cervinka, P., Chlumsky, J., Chochola, J., Cizek, V., Dunaj, M., Dusek, J., Francek, L., Havelka, J., Herold, M., Holaj, R., Horny, I., Hubac, J., Jajtner, P., Kolman, P., Lang, P., Mayer, O., Mikulova, J., Podpera, I., Reiterer, P., Spacek, R., Vejvoda, J., Vyhnanek, M., Christensen, H., Lassen, M., Storgaard, M., Tuxen, C., Urhammer, S., Lember, M., Marandi, T., Uuetoa, T., Airaksinen, J., Honkaniemi, J., Kaaja, R., Lassila, R., Saarinen, J., Tatlisumak, T., Vikman, S., Agraou, B., Aquilanti, S., Belhassane, A., Brisot, D., De Geeter, G., Debourdeau, P., Decoulx, E., El Kouri, D., Falvo, N., Grange, C., Lacroix, P., Messas, E., Mismetti, P., Montaclair, K., Mottier, D., Paleiron, N., Payot, L., Pernod, G., Pottier, P., Proust, A., Quere, I., Roy, P. -M., Schmidt, J., Simoneau, G., Datikashvili-David, I., Khabeishvili, G., Khintibidze, I., Kobulia, B., Megreladze, I., Pagava, Z., Paposhvili, K., Shaburishvili, T., Amann, B., Berrouschot, J., Beyer-Westendorf, J., Blessing, E., Bott, M., Dengler, T., Diehm, C., Dziewas, R., Genth-Zotz, S., Hamann, F., Horacek, T., Klimpe, S., Kroning, R., Lapp, H., Lawall, H., Licka, M., Rizos, T., Schellong, S., Schmidt-Lucke, J., Singer, C., Tiefenbacher, C., Veltkamp, R., Weimar, C., Zeymer, U., Alkonyi, B., Falukozy, J., Futo, L., Katona, A., Kirschner, R., Kristof, P., Lakatos, F., Laszlo, Z., Lupkovics, G., Merkely, B., Nagy Andras, C., Nemeth, L., Papp, A., Soltesz, P., Sudar, Z., Szabo, G., Szegedi, N., Timar, G., Valco, J., Vertes, A., Efrati, S., Elias, M., Gafter, A., Hayek, T., Hussein, O., Lishner, M., Lugassy, G., Zeltser, D., Ageno, W., Cerveri, I., D'Angelo, A., De Pellegrin, A., Imberti, D., Landolfi, R., Lembo, G., Lodigiani, C., Luisetti, M., Moia, M., Molteni, M., Mumoli, N., Novo, S., Orlandini, F., Parisi, R., Pizzini, A., Pomero, F., Salvi, A., Schenone, A., Visona, A., Krievins, D., Martinova, V., Pontaga, N., Rozitis, V., Stukena, I., Alekniene, B., Bagdonas, A., Basijokiene, V., Butkiene, Z., Griskeviciene, V., Naudziunas, A., Norvaisiene, R., Norviliene, R., Petrauskiene, R., Poskiene, R., Susinskiene, D., Valavicius, A., Castillo Leon, R., Cotrina Pereyra, R., Farjardo Karlo, L., Horna, M., Lema Osores, J., Salas, M., Toche Yanez, L., Fryze, W., Gaciong, Z., Gniot, J., Gorecka, D., Gruenpeter, P., Grzelakowski, P., Jastrzebski, D., Kucharski, L., Mirek-Bryniarska, E., Pulkowski, G., Sobkowicz, B., Sulik, P., Tomkowski, W., Walasek, L., Waldemar, K., Wrzesinski, K., Balogh, Z. E., Bojinca, M., Marin, I., Mot, S., Musetescu, R., Podoleanu, C., Popescu, M., Stamate, S., Stanciulescu, G., Vida-Simiti, L., Abashev, A., Andreev, D., Apartsin, K., Arkhipov, M., Averkov, O., Barbarash, O., Belskaya, G., Bogdanov, E., Boldueva, S., Chefranova, Z., Dovgalevskiy, Y., Ershova, O., Goloshchekin, B., Khachatryan, N., Khurs, E., Klein, G., Kobalava, Z., Kosmacheva, E., Kostenko, V., Malygin, A., Martynenko, T., Martynenko, V., Maslova, N., Mordovin, V., Nikolaev, K., Nilk, R., Panchenko, E., Popov, D., Privalova, E., Reshetko, O., Sergeeva, E., Shapovalova, Y., Shpagina, L., Shvarts, Y., Simanenkov, V., Solovyov, O., Vishneva, E., Vishnevskiy, A., Apostolovic, S., Celic, V., Ilic, S., Kovacevic-Kuzmanovic, A., Miloradovic, V., Tan, R. S., Bodikova, S., Cervenakova, A., Dvorak, M., Gaspar, L., Herman, O., Hrubon, A., Kokles, M., Krastev, G., Payer, J., Prokop, D., Spisakova, M., Adler, D., Basson, M., Breedt, J., Engelbrecht, J., Jacobson, B., Mitha, I., Van Dyk, C., Alvarez Sala, L. A., Barbagelata Lopez, C., Bisbe, J., Castro Guardiola, A., Cepeda, J. M., Cereto, F., Diaz Santos, E., Ferrer, R., Gomez Cerezo, J., Gonzales-Porras, J. R., Grandes, J., Jimenez, D., Martin Loeches, I., Mellibovsky, L., Richart, C., Riera, A., Trujillo, J., Vargas Nunez, J. A., Villalta, J., Akgul, O., Guneri, S., Kilichesmez, K., Kirma, C., Kutluk, H., Nazliel, B., Okumus, G., Ongen, G., Tigen, K., Topcuoglu, M., Tuncay, E., Abrahamovych, O., Batushkin, V., Brozhyk, J., Burmak, I., Godlevska, O., Goloborodko, A., Goloborodko, B., Goncharova, Y., Gryb, V., Karpenko, O., Kopytsya, M., Koshlia, V., Krakhmalova, O., Kyrychenko, I., Legkonogov, O., Malynovsky, Y., Maslovaskyi, V., Nikonov, V., Parkhomenko, O., Perepeliuk, M., Reshotko, D., Rudenko, L., Ryabichenko, T., Svyridova, I., Svyshchenko, Y., Tseluyko, V., Ursol, G., Vakaliuk, I., Vishnivestsky, I., Voronkov, L., Yagensky, A., Body, R., Chandra, D., Davis, M., Kesteven, P., Maccallum, P., Mccollum, C., Natarajan, I., Almasri, E., Amin, M., Anderson, C., Baker, S., Barney, J., Bastani, B. B. A., Bercz, P., Bidair, M., Carman, T., Chang, H., Clark, C., Concha, M., Cornell, J., Dhingra, R., Doshi, A., Ebrahimi, R., Farley, B., Fermann, G., Foster, G., Fraiz, J., Fulmer, J., Gaggin, H., Goytia-Leos, D., Hahn, B., Haidar, A., Hamad, A., Hazelrigg, M., Ioachimescu, O., Johnson, B., Kabler, H., Kao, C. -K., Kazimir, M., Kouras, F., Kung, M., Lerner, R., Lopez, J., Macchiavelli, A., Mahal, S., Margolis, B., Mclaren, G., Milling, T., Mittal, M., Nadar, V., Ohaju, V., Ortel, T., Overcash, J., Parthiban, K., Pearl, R., Pineda, L., Pratt, R., Pullman, J., Quintana, O., Rajan, R., Rastogi, P., Rees, C., Rodriguez, W., Saba, F., Shammas, N., Sharma, S., Sokol, S., Stoltz, S., Subich, D., Tuck, M., Updegrove, J., Warner, A., Welch, M., Welker, J., Whitman, B., Wichman, T., Yousef, K., Yusen, R., and Zakai, N.

Subjects
Male, pulmonary embolism, Time Factors, Pyridines, Intracranial hemorrhage, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Risk Factors, Clinical Studies, Medicine, 030212 general & internal medicine, Myocardial infarction, Original Research, Ischemic stroke, Hazard ratio, Absolute risk reduction, Venous Thromboembolism, Middle Aged, Interventional Cardiology, Pulmonary embolism, Death, myocardial infarction, Treatment Outcome, Cardiovascular Diseases, Anesthesia, Acute Disease, Benzamides, Number needed to treat, Female, Cardiology and Cardiovascular Medicine, Intracranial Hemorrhages, Adult, venous thromboembolism, Hemorrhage, 03 medical and health sciences, Double-Blind Method, death, ischemic stroke, Humans, Enoxaparin, Aged, Proportional Hazards Models, Inpatients, Venous thromboembolism, business.industry, Settore MED/09 - MEDICINA INTERNA, Anticoagulants, Thrombosis, medicine.disease, Clinical trial, chemistry, Betrixaban, business, Acute Coronary Syndromes, intracranial hemorrhage, Factor Xa Inhibitors
Abstract

Background Extended‐duration betrixaban showed a significant reduction in venous thromboembolism in the APEX trial (Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study). Given the variable clinical impact of different efficacy and safety events, one approach to assess net clinical outcomes is to include only those events that are either fatal or cause irreversible harm. Methods and Results This was a post hoc analysis of the APEX trial—a multicenter, double‐blind, randomized controlled trial comparing extended‐duration betrixaban versus standard‐of‐care enoxaparin. A composite of all fatal or irreversible safety (fatal bleeding or intracranial hemorrhage) and efficacy events (cardiopulmonary death, myocardial infarction, pulmonary embolism, and ischemic stroke) was evaluated in a time‐to‐first event analysis. In patients with positive D‐dimer results, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.80% versus 3.54%; hazard ratio, 0.73; absolute risk reduction, 1.26%; number needed to treat, 79 [ P =0.033]) and at study end at 77 days (6.27% versus 4.36%; hazard ratio, 0.70; absolute risk reduction, 1.91%; number needed to treat, 52 [ P =0.005]) versus enoxaparin. In all patients, betrixaban reduced fatal or irreversible events at 35 to 42 days (4.08% versus 2.90%; hazard ratio, 0.71; absolute risk reduction, 1.18%; number needed to treat, 86 [ P =0.006]) and 77 days (5.17% versus 3.64%; hazard ratio, 0.70; absolute risk reduction, 1.53%; number needed to treat, 65 [ P =0.002]). Conclusions Among hospitalized medically ill patients, extended‐duration betrixaban demonstrated an ≈30% reduction in fatal or irreversible ischemic or bleeding events compared with standard‐duration enoxaparin. A total of 65 patients would require treatment with betrixaban to prevent 1 fatal or irreversible event versus enoxaparin. Clinical Trial Registration URL : http://www.ClinicalTrials.gov . Unique identifier: NCT 01583218.

Published
2017

46. Guide to compilation of standard operating procedures.

Author

Amann, B., Appel, T., Carter, A., Diedrich, D., Fengler, T., Gerasch, T., Mann, K., van Waveren, A., and Zimmermann, U.

Subjects
*STANDARD operating procedure, *MEDICAL equipment, *WORK environment, *WORK, *QUALITY
Abstract

The article focuses on the use of standard operating procedure (SOPs) help to demonstrate compliance with all the hygienic and technical requirements legally specified for medical device reprocessing. Topics include SOPs describe the correct implementation of all relevant work steps in the respective workplace; and SOPs being compiled to complement a procedure for all relevant steps of the reprocessing process.

Published
2020

48. Implications of MDR for the operators of medical devices in healthcare institutions - update.

Author

Amann, B., Appel, T., Diedrich, D., Fengler, T., Forster, A., Gehrmann, K., Grabhoff, C., Hartwig, A., Jakel, C., Jones, A., Kirsme, G., Kruger, S., Metzing, J., Papadopoulos, A., van Waveren, A., and Zimmermann, U.

Subjects
*MEDICAL equipment laws, *MEDICAL laws, *MEDICAL equipment industry, *MANUFACTURING industries, *LAW
Abstract

The article examines the implications of the Medical Device Regulation (MDR) for operators of medical devices in healthcare institutions in the European Union (EU). Topics discussed include important changes introduced by the MDR for medical device operators and manufacturers, implications of changes to the classification system, and the Medical Device Law Implementing Act in Germany.

Published
2020

49. Auswirkungen der MDR auf den Betreiber - Update.

Author

Amann, B., Appel, T., Diedrich, D., Fengler, T., Forster, A., Gehrmann, K., Grabhoff, C., Hartwig, A., Jakel, C., Jones, A., Kirmse, G., Kruger, S., Metzing, J., Papadopoulos, A., van Waveren, A., and Zimmermann, U.

Published
2020

50. Transport between the site of use and reprocessing department.

Author

Alflen, M., Amann, B., Appel, T., Diedrich, D., Diekmann, C., Fengler, T., Gehrmann, K., Gerasch, T., Hartwig, A., Mann, K., Metzing, J., Otzmann, R., Papadopoulos, A., van Waveren, A., Wiese, K., and Zimmermann, U.

Subjects
*TRANSPORTATION, *STORAGE, *MEDICAL equipment, *CONTAMINATION equipment, *ECOLOGY
Abstract

The article presents the transport and storage not adversely affecting the medical device characteristics. Topics include sterilized medical devices (MDs) being protected against contamination when transported between the reprocessing department and the site of use; using MDs harbor potentially infectious contaminants against which the must be protected; and sterilized MDs must be transported separately from non-sterilized MDs in ruling out contamination.

Published
2020

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