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Article: Contralaterally EMG-triggered functional electrical stimulation during serious gaming for upper limb stroke rehabilitation: a feasibility study.

Höhler, Chiara / Wild, Laura / de Crignis, Alexandra / Jahn, Klaus / Krewer, Carmen

2023 Volume 17, Page(s) 1168322

Abstract: Introduction: Virtual Reality/serious games (SG) and functional electrical stimulation (FES) therapies are used in upper limb stroke rehabilitation. A combination of both approaches seems to be beneficial for therapy success. The feasibility of a ... ...

Abstract	Introduction: Virtual Reality/serious games (SG) and functional electrical stimulation (FES) therapies are used in upper limb stroke rehabilitation. A combination of both approaches seems to be beneficial for therapy success. The feasibility of a combination of SG and contralaterally EMG-triggered FES (SG+FES) was investigated as well as the characteristics of responders to such a therapy. Materials and methods: In a randomized crossover trial, patients performed two gaming conditions: SG alone and SG+FES. Feasibility of the therapy system was assessed using the Intrinsic Motivation Inventory (IMI), the Nasa Task Load Index, and the System Usability Scale (SUS). Gaming parameters, fatigue level and a technical documentation was implemented for further information. Results: In total, 18 patients after stroke (62.1 ± 14.1 years) with a unilateral paresis of the upper limb (MRC ≤4) were analyzed in this study. Both conditions were perceived as feasible. Comparing the IMI scores between conditions, perceived competence was significantly increased ( Discussion: The combination of SG with ccFES is feasible and well-accepted among patients after stroke. It seems that the additional use of ccFES may be more beneficial for severely impaired patients as it enables the execution of the serious game. These findings provide valuable implications for the development of rehabilitation systems by combining different therapeutic interventions to increase patients' benefit and proposes system modifications for home use. Clinical trial registration: https://drks.de/search/en, DRKS00025761.
Language	English
Publishing date	2023-05-25
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2453002-5
ISSN	1662-5218
ISSN	1662-5218
DOI	10.3389/fnbot.2023.1168322
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Zur Neurobiologie der Psychopathie

Wild, Laura M. / Poeppl, Timm B.

Forensische Psychiatrie, Psychologie, Kriminologie

2022 Volume 16, Issue 3, Page(s) 259–264

Abstract: Die Erforschung der neurobiologischen Grundlagen der Psychopathie hat in den letzten Jahren an Bedeutung gewonnen. In diesem Artikel soll eine kurze Übersicht des aktuellen Stands der Forschung gegeben werden. In Bildgebungsmetaanalysen finden sich ... ...

Title translation	On the neurobiology of psychopathy
Abstract	Die Erforschung der neurobiologischen Grundlagen der Psychopathie hat in den letzten Jahren an Bedeutung gewonnen. In diesem Artikel soll eine kurze Übersicht des aktuellen Stands der Forschung gegeben werden. In Bildgebungsmetaanalysen finden sich Hinweise auf eine Volumenminderung grauer Substanz im linken dorsolateralen präfrontalen Kortex und im medialen Orbitofrontalkortex bei Psychopathen. Des Weiteren zeigt eine groß angelegte Metaanalyse robuste Evidenz für veränderte Hirnaktivität im frontoinsulären Kortex, im lateralen präfrontalen Kortex, im dorsomedialen präfrontalen Kortex und in der rechten Amygdala. Aus der Kombination von Neurobildgebung und Datenbankanalysen ist zudem bekannt, dass es eine Beziehung zwischen den beschriebenen Hirnveränderungen und typischen Psychopathiesymptomen gibt. Der Vergleich von Hirnveränderungen mit Neurotransmitterkarten und Genexpressionskarten gibt Hinweise auf mögliche zugrunde liegende molekulare Mechanismen, insbesondere eine Dysregulation im serotonergen System. In der Zusammenschau weisen diese Befunde klar auf fassbare neurobiologische Veränderungen bei hochgradig psychopathischen Personen hin. Zwar können sie keinen Aufschluss darüber geben, ob es sich bei den Veränderungen um Ursache oder Folge der Störung handelt, doch können sie Ansatzpunkte für spezifischere, biologische Therapieverfahren bieten.
Keywords	Amygdala ; Brain ; Brain Size ; Cerebral Cortex ; Gehirn ; Gehirngröße ; Gene Expression ; Genexpression ; Graue Substanz (Gehirn) ; Gray Matter ; Großhirnrinde ; Neurobiologie ; Neurobiology ; Neurotransmitter ; Neurotransmitters ; Prefrontal Cortex ; Präfrontaler Kortex ; Psychopathie ; Psychopathy
Language	German
Document type	Article
ZDB-ID	2262947-6
ISSN	1862-7080 ; 1862-7072
ISSN (online)	1862-7080
ISSN	1862-7072
DOI	10.1007/s11757-022-00720-0
Database	PSYNDEX

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Article ; Online: County-Level Social Vulnerability Is Positively Associated with Cardiometabolic Disease in Colorado.

Wild, Laura E / Walters, McKailey / Powell, Alaina / James, Katherine A / Corlin, Laura / Alderete, Tanya L

International journal of environmental research and public health

2022 Volume 19, Issue 4

Abstract: Cardiometabolic diseases are a group of interrelated diseases that pose greater burden among socially vulnerable communities. The social vulnerability index (SVI) identifies communities vulnerable to emergencies and may also help determine communities at ...

Abstract	Cardiometabolic diseases are a group of interrelated diseases that pose greater burden among socially vulnerable communities. The social vulnerability index (SVI) identifies communities vulnerable to emergencies and may also help determine communities at risk of adverse chronic health outcomes. However, no studies have examined the relationship between the SVI and cardiometabolic health outcomes in Colorado or focused on rural settings. The aim of this ecological study was to determine whether the county-level SVI is associated with county-level cardiometabolic health indicators with a particular focus on rurality and racial/ethnic diversity. We obtained 2014 SVI scores from the Centers for Disease Control and Prevention (scored 0-1; higher = more vulnerable) and 2013-2015 cardiometabolic health estimates from the Colorado Department of Public Health and Environment. The distribution of social determinants of health was spatially evaluated. Bivariate relationships between the SVI and cardiometabolic indicators were estimated using simple linear regression models. The highest SVI scores were observed in rural areas, including the San Luis Valley (mean: 0.78, median: 0.91), Southeast (mean: 0.72, median: 0.73), and Northeast (mean: 0.66, median: 0.76) regions. Across Colorado, the SVI accounted for 41% of the variability in overweight and obesity prevalence (
MeSH term(s)	Cardiovascular Diseases/epidemiology ; Colorado/epidemiology ; Ethnicity ; Humans ; Racial Groups ; Social Vulnerability
Language	English
Publishing date	2022-02-15
Publishing country	Switzerland
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2175195-X
ISSN	1660-4601 ; 1661-7827
ISSN (online)	1660-4601
ISSN	1661-7827
DOI	10.3390/ijerph19042202
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Article ; Online: Exposure to air pollutants and the gut microbiota: a potential link between exposure, obesity, and type 2 diabetes.

Bailey, Maximillian J / Naik, Noopur N / Wild, Laura E / Patterson, William B / Alderete, Tanya L

Gut microbes

2020 Volume 11, Issue 5, Page(s) 1188–1202

Abstract: Work has shown that increased exposure to air pollutants independently contributes to obesity and type 2 diabetes risk, yet the exact mechanisms underlying these associations have not been fully characterized. The current review summarizes recent ... ...

Abstract	Work has shown that increased exposure to air pollutants independently contributes to obesity and type 2 diabetes risk, yet the exact mechanisms underlying these associations have not been fully characterized. The current review summarizes recent findings regarding the impact of inhaled and ingested air pollutants on the gut microbiota. Animal and human studies provide evidence that air pollutants, such as particulate matter, nitrogen oxides, and ozone, have the potential to alter the gut microbiota. Further, studies suggest that such exposure-induced alterations to the gut microbiota may contribute to increased risk for obesity and type 2 diabetes through inflammatory pathways. Future work is needed to fully understand the complex interactions between air pollution, the gut microbiome, and human health. Additionally, advanced sequencing methods for gut microbiome research present unique opportunities to study the underlying pathways that link increased air pollution exposure with obesity and type 2 diabetes risk.
MeSH term(s)	Air Pollutants/adverse effects ; Air Pollutants/analysis ; Air Pollution/adverse effects ; Animals ; Bacteria/classification ; Bacteria/metabolism ; Diabetes Mellitus, Type 2/etiology ; Diabetes Mellitus, Type 2/microbiology ; Gastrointestinal Microbiome ; Gastrointestinal Tract/metabolism ; Gastrointestinal Tract/microbiology ; Humans ; Inflammation ; Models, Animal ; Obesity/etiology ; Obesity/microbiology ; Particulate Matter/adverse effects ; Particulate Matter/analysis ; Risk Factors
Chemical Substances	Air Pollutants ; Particulate Matter
Language	English
Publishing date	2020-04-29
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Review
ISSN	1949-0984
ISSN (online)	1949-0984
DOI	10.1080/19490976.2020.1749754
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Article: Auf dem Weg zu einer EBN-fördernden Haltung. Erste Schritte zur Implementierung einer Evidence-basierten Pflegepraxis

Eberhardt, Doris / Wild, Laura

PADUA

2017 Volume 12, Issue 1, Page(s) 15

Language	German
Document type	Article
ZDB-ID	2227919-2
ISSN	1861-6186
Database	Current Contents Medicine

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Article: Specific amino acids but not total protein attenuate postpartum weight gain among Hispanic women from Southern California.

Wild, Laura E / Alderete, Tanya L / Naik, Noopur C / Patterson, William B / Berger, Paige K / Jones, Roshonda B / Plows, Jasmine F / Goran, Michael I

Food science & nutrition

2021 Volume 9, Issue 4, Page(s) 1842–1850

Abstract: There is a high prevalence of obesity and type 2 diabetes in the United States, particularly among Hispanic women, which may be partly explained by failure to lose gestational weight during the postpartum period. Previous work indicates that protein and ... ...

Abstract	There is a high prevalence of obesity and type 2 diabetes in the United States, particularly among Hispanic women, which may be partly explained by failure to lose gestational weight during the postpartum period. Previous work indicates that protein and amino acids may protect against weight gain; therefore, this study examined the impact of dietary protein and amino acid intake on changes in postpartum weight and the percent of women meeting the Estimated Average Requirement (EAR) for these dietary variables among Hispanic women from the Southern California Mother's Milk Study (
Language	English
Publishing date	2021-02-13
Publishing country	United States
Document type	Journal Article
ZDB-ID	2703010-6
ISSN	2048-7177
ISSN	2048-7177
DOI	10.1002/fsn3.2085
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Article: Risk of Micronutrient Inadequacy among Hispanic, Lactating Mothers: Preliminary Evidence from the Southern California Mother’s Milk Study

Wild, Laura E. / Patterson, William B. / Jones, Roshonda B. / Plows, Jasmine F. / Berger, Paige K. / Rios, Claudia / Fogel, Jennifer L. / Goran, Michael I. / Alderete, Tanya L.

Nutrients. 2021 Sept. 18, v. 13, no. 9

2021

Abstract: Micronutrients are dietary components important for health and physiological function, and inadequate intake of these nutrients can contribute to poor health outcomes. The risk of inadequate micronutrient intake has been shown to be greater among low- ... ...

Abstract	Micronutrients are dietary components important for health and physiological function, and inadequate intake of these nutrients can contribute to poor health outcomes. The risk of inadequate micronutrient intake has been shown to be greater among low-income Hispanics and postpartum and lactating women. Therefore, we aimed to determine the risk of nutrient inadequacies based on preliminary evidence among postpartum, Hispanic women. Risk of micronutrient inadequacy for Hispanic women (29–45 years of age) from the Southern California Mother’s Milk Study (n = 188) was assessed using 24 h dietary recalls at 1 and 6 months postpartum and the estimated average requirement (EAR) fixed cut-point approach. Women were considered at risk of inadequate intake for a nutrient if more than 50% of women were consuming below the EAR. The Chronic Disease Risk Reduction (CDRR) value was also used to assess sodium intake. These women were at risk of inadequate intake for folate and vitamins A, D, and E, with 87.0%, 93.4%, 43.8%, and 95% of women consuming less than the EAR for these nutrients, respectively. Lastly, 71.7% of women consumed excess sodium. Results from this preliminary analysis indicate that Hispanic women are at risk of inadequate intake of important micronutrients for maternal and child health.
Keywords	Estimated Average Requirement ; child health ; chronic diseases ; folic acid ; milk ; risk ; risk reduction ; sodium ; California
Language	English
Dates of publication	2021-0918
Publishing place	Multidisciplinary Digital Publishing Institute
Document type	Article
ZDB-ID	2518386-2
ISSN	2072-6643
ISSN	2072-6643
DOI	10.3390/nu13093252
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Risk of Micronutrient Inadequacy among Hispanic, Lactating Mothers: Preliminary Evidence from the Southern California Mother's Milk Study.

Wild, Laura E / Patterson, William B / Jones, Roshonda B / Plows, Jasmine F / Berger, Paige K / Rios, Claudia / Fogel, Jennifer L / Goran, Michael I / Alderete, Tanya L

Nutrients

2021 Volume 13, Issue 9

Abstract	Micronutrients are dietary components important for health and physiological function, and inadequate intake of these nutrients can contribute to poor health outcomes. The risk of inadequate micronutrient intake has been shown to be greater among low-income Hispanics and postpartum and lactating women. Therefore, we aimed to determine the risk of nutrient inadequacies based on preliminary evidence among postpartum, Hispanic women. Risk of micronutrient inadequacy for Hispanic women (29-45 years of age) from the Southern California Mother's Milk Study (
MeSH term(s)	Adult ; California/epidemiology ; Cohort Studies ; Diet ; Eating ; Female ; Hispanic or Latino/statistics & numerical data ; Humans ; Lactation/physiology ; Longitudinal Studies ; Micronutrients/deficiency ; Middle Aged ; Milk, Human ; Mothers/statistics & numerical data ; Postpartum Period/physiology ; Sodium, Dietary/administration & dosage
Chemical Substances	Micronutrients ; Sodium, Dietary
Language	English
Publishing date	2021-09-18
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2518386-2
ISSN	2072-6643 ; 2072-6643
ISSN (online)	2072-6643
ISSN	2072-6643
DOI	10.3390/nu13093252
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Article ; Online: Added sugar and sugar-sweetened beverages are associated with increased postpartum weight gain and soluble fiber intake is associated with postpartum weight loss in Hispanic women from Southern California.

Alderete, Tanya L / Wild, Laura E / Mierau, Savannah M / Bailey, Maximilian J / Patterson, William B / Berger, Paige K / Jones, Roshonda B / Plows, Jasmine F / Goran, Michael I

The American journal of clinical nutrition

2020 Volume 112, Issue 3, Page(s) 519–526

Abstract: Background: Obesity prevalence remains high in the United States, and there is an increased risk among women who do not lose their gestational weight gain during the postpartum period. Indicators of dietary carbohydrate quality including added sugar ... ...

Abstract	Background: Obesity prevalence remains high in the United States, and there is an increased risk among women who do not lose their gestational weight gain during the postpartum period. Indicators of dietary carbohydrate quality including added sugar consumption, glycemic load, and glycemic index have been linked with weight gain, whereas fiber may protect against obesity. However, these dietary factors have not been examined during the postpartum period. Objectives: The aim of this study was to determine whether dietary sugars and fiber intake were associated with changes in postpartum weight. Methods: We examined Hispanic women from the longitudinal Southern California Mother's Milk Study (n = 99) at 1 and 6 mo postpartum. Maternal assessments included height, weight, and dietary intake based on 24-h diet recalls. We used multivariable linear regression to examine the relation between maternal diet and change in postpartum weight after adjusting for maternal age, height, and energy intake. Results: Higher intake of added sugar was associated with postpartum weight gain (β: 0.05; 95% CI: 0.004, 0.10; P = 0.05). In addition, a half 8-ounce (8 fluid ounces = 236.6 mL) serving per day increase in soft drinks was associated with a 1.52-kg increase in weight (95% CI: 0.70, 2.34 kg; P < 0.001). A high glycemic index (β: 0.25; 95% CI: 0.07, 0.42; P = 0.006) and glycemic load (β: 0.04; 95% CI: 0.002, 0.08; P = 0.04) were associated with postpartum weight gain. Higher soluble fiber was associated with a decrease in postpartum weight (β: -0.82 kg; 95% CI: -1.35, -0.29 kg; P = 0.003) and the negative effects of added sugar, sugary beverages, and high-glycemic-index and -load diets were partially attenuated after adjusting for soluble fiber intake. Conclusions: Increased consumption of added sugar, sugar-sweetened beverages, and high-glycemic diets were associated with greater weight gain in the first 6 mo postpartum. In addition, increased consumption of soluble fiber was associated with postpartum weight loss, which may partially offset the obesogenic effects of some dietary sugars.
MeSH term(s)	Adult ; Body Weight/drug effects ; California ; Diet ; Dietary Fiber/administration & dosage ; Dietary Sugars/administration & dosage ; Energy Intake ; Female ; Hispanic or Latino ; Humans ; Nutrition Surveys ; Postpartum Period ; Sugar-Sweetened Beverages ; Young Adult
Chemical Substances	Dietary Fiber ; Dietary Sugars
Language	English
Publishing date	2020-06-24
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	280048-2
ISSN	1938-3207 ; 0002-9165
ISSN (online)	1938-3207
ISSN	0002-9165
DOI	10.1093/ajcn/nqaa156
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial.

Angus, Derek C / Derde, Lennie / Al-Beidh, Farah / Annane, Djillali / Arabi, Yaseen / Beane, Abigail / van Bentum-Puijk, Wilma / Berry, Lindsay / Bhimani, Zahra / Bonten, Marc / Bradbury, Charlotte / Brunkhorst, Frank / Buxton, Meredith / Buzgau, Adrian / Cheng, Allen C / de Jong, Menno / Detry, Michelle / Estcourt, Lise / Fitzgerald, Mark /

Goossens, Herman / Green, Cameron / Haniffa, Rashan / Higgins, Alisa M / Horvat, Christopher / Hullegie, Sebastiaan J / Kruger, Peter / Lamontagne, Francois / Lawler, Patrick R / Linstrum, Kelsey / Litton, Edward / Lorenzi, Elizabeth / Marshall, John / McAuley, Daniel / McGlothin, Anna / McGuinness, Shay / McVerry, Bryan / Montgomery, Stephanie / Mouncey, Paul / Murthy, Srinivas / Nichol, Alistair / Parke, Rachael / Parker, Jane / Rowan, Kathryn / Sanil, Ashish / Santos, Marlene / Saunders, Christina / Seymour, Christopher / Turner, Anne / van de Veerdonk, Frank / Venkatesh, Balasubramanian / Zarychanski, Ryan / Berry, Scott / Lewis, Roger J / McArthur, Colin / Webb, Steven A / Gordon, Anthony C / Angus, Derek / Cheng, Allen / De Jong, Menno / Gordon, Anthony / Lawler, Patrick / Webb, Steve / Campbell, Lewis / Forbes, Andrew / Gattas, David / Heritier, Stephane / Higgins, Lisa / Peake, Sandra / Presneill, Jeffrey / Seppelt, Ian / Trapani, Tony / Young, Paul / Bagshaw, Sean / Daneman, Nick / Ferguson, Niall / Misak, Cheryl / Hullegie, Sebastiaan / Pletz, Mathias / Rohde, Gernot / Rowan, Kathy / Alexander, Brian / Basile, Kim / Girard, Timothy / Huang, David / Vates, Jennifer / Beasley, Richard / Fowler, Robert / McGloughlin, Steve / Morpeth, Susan / Paterson, David / Venkatesh, Bala / Uyeki, Tim / Baillie, Kenneth / Duffy, Eamon / Fowler, Rob / Hills, Thomas / Orr, Katrina / Patanwala, Asad / Tong, Steve / Netea, Mihai / Bihari, Shilesh / Carrier, Marc / Fergusson, Dean / Goligher, Ewan / Haidar, Ghady / Hunt, Beverley / Kumar, Anand / Laffan, Mike / Lawless, Patrick / Lother, Sylvain / McCallum, Peter / Middeldopr, Saskia / McQuilten, Zoe / Neal, Matthew / Pasi, John / Schutgens, Roger / Stanworth, Simon / Turgeon, Alexis / Weissman, Alexandra / Adhikari, Neill / Anstey, Matthew / Brant, Emily / de Man, Angelique / Lamonagne, Francois / Masse, Marie-Helene / Udy, Andrew / Arnold, Donald / Begin, Phillipe / Charlewood, Richard / Chasse, Michael / Coyne, Mark / Cooper, Jamie / Daly, James / Gosbell, Iain / Harvala-Simmonds, Heli / Hills, Tom / MacLennan, Sheila / Menon, David / McDyer, John / Pridee, Nicole / Roberts, David / Shankar-Hari, Manu / Thomas, Helen / Tinmouth, Alan / Triulzi, Darrell / Walsh, Tim / Wood, Erica / Calfee, Carolyn / O’Kane, Cecilia / Shyamsundar, Murali / Sinha, Pratik / Thompson, Taylor / Young, Ian / Bihari, Shailesh / Hodgson, Carol / Laffey, John / McAuley, Danny / Orford, Neil / Neto, Ary / Lewis, Roger / McGlothlin, Anna / Miller, Eliza / Singh, Vanessa / Zammit, Claire / van Bentum Puijk, Wilma / Bouwman, Wietske / Mangindaan, Yara / Parker, Lorraine / Peters, Svenja / Rietveld, Ilse / Raymakers, Kik / Ganpat, Radhika / Brillinger, Nicole / Markgraf, Rene / Ainscough, Kate / Brickell, Kathy / Anjum, Aisha / Lane, Janis-Best / Richards-Belle, Alvin / Saull, Michelle / Wiley, Daisy / Bion, Julian / Connor, Jason / Gates, Simon / Manax, Victoria / van der Poll, Tom / Reynolds, John / van Beurden, Marloes / Effelaar, Evelien / Schotsman, Joost / Boyd, Craig / Harland, Cain / Shearer, Audrey / Wren, Jess / Clermont, Giles / Garrard, William / Kalchthaler, Kyle / King, Andrew / Ricketts, Daniel / Malakoutis, Salim / Marroquin, Oscar / Music, Edvin / Quinn, Kevin / Cate, Heidi / Pearson, Karen / Collins, Joanne / Hanson, Jane / Williams, Penny / Jackson, Shane / Asghar, Adeeba / Dyas, Sarah / Sutu, Mihaela / Murphy, Sheenagh / Williamson, Dawn / Mguni, Nhlanhla / Potter, Alison / Porter, David / Goodwin, Jayne / Rook, Clare / Harrison, Susie / Williams, Hannah / Campbell, Hilary / Lomme, Kaatje / Williamson, James / Sheffield, Jonathan / van’t Hoff, Willian / McCracken, Phobe / Young, Meredith / Board, Jasmin / Mart, Emma / Knott, Cameron / Smith, Julie / Boschert, Catherine / Affleck, Julia / Ramanan, Mahesh / D’Souza, Ramsy / Pateman, Kelsey / Shakih, Arif / Cheung, Winston / Kol, Mark / Wong, Helen / Shah, Asim / Wagh, Atul / Simpson, Joanne / Duke, Graeme / Chan, Peter / Cartner, Brittney / Hunter, Stephanie / Laver, Russell / Shrestha, Tapaswi / Regli, Adrian / Pellicano, Annamaria / McCullough, James / Tallott, Mandy / Kumar, Nikhil / Panwar, Rakshit / Brinkerhoff, Gail / Koppen, Cassandra / Cazzola, Federica / Brain, Matthew / Mineall, Sarah / Fischer, Roy / Biradar, Vishwanath / Soar, Natalie / White, Hayden / Estensen, Kristen / Morrison, Lynette / Smith, Joanne / Cooper, Melanie / Health, Monash / Shehabi, Yahya / Al-Bassam, Wisam / Hulley, Amanda / Whitehead, Christina / Lowrey, Julie / Gresha, Rebecca / Walsham, James / Meyer, Jason / Harward, Meg / Venz, Ellen / Williams, Patricia / Kurenda, Catherine / Smith, Kirsy / Smith, Margaret / Garcia, Rebecca / Barge, Deborah / Byrne, Deborah / Byrne, Kathleen / Driscoll, Alana / Fortune, Louise / Janin, Pierre / Yarad, Elizabeth / Hammond, Naomi / Bass, Frances / Ashelford, Angela / Waterson, Sharon / Wedd, Steve / McNamara, Robert / Buhr, Heidi / Coles, Jennifer / Schweikert, Sacha / Wibrow, Bradley / Rauniyar, Rashmi / Myers, Erina / Fysh, Ed / Dawda, Ashlish / Mevavala, Bhaumik / Litton, Ed / Ferrier, Janet / Nair, Priya / Buscher, Hergen / Reynolds, Claire / Santamaria, John / Barbazza, Leanne / Homes, Jennifer / Smith, Roger / Murray, Lauren / Brailsford, Jane / Forbes, Loretta / Maguire, Teena / Mariappa, Vasanth / Smith, Judith / Simpson, Scott / Maiden, Matthew / Bone, Allsion / Horton, Michelle / Salerno, Tania / Sterba, Martin / Geng, Wenli / Depuydt, Pieter / De Waele, Jan / De Bus, Liesbet / Fierens, Jan / Bracke, Stephanie / Reeve, Brenda / Dechert, William / Chassé, Michaël / Carrier, François Martin / Boumahni, Dounia / Benettaib, Fatna / Ghamraoui, Ali / Bellemare, David / Cloutier, Ève / Francoeur, Charles / Lamontagne, François / D’Aragon, Frédérick / Carbonneau, Elaine / Leblond, Julie / Vazquez-Grande, Gloria / Marten, Nicole / Wilson, Maggie / Albert, Martin / Serri, Karim / Cavayas, Alexandros / Duplaix, Mathilde / Williams, Virginie / Rochwerg, Bram / Karachi, Tim / Oczkowski, Simon / Centofanti, John / Millen, Tina / Duan, Erick / Tsang, Jennifer / Patterson, Lisa / English, Shane / Watpool, Irene / Porteous, Rebecca / Miezitis, Sydney / McIntyre, Lauralyn / Brochard, Laurent / Burns, Karen / Sandhu, Gyan / Khalid, Imrana / Binnie, Alexandra / Powell, Elizabeth / McMillan, Alexandra / Luk, Tracy / Aref, Noah / Andric, Zdravko / Cviljevic, Sabina / Đimoti, Renata / Zapalac, Marija / Mirković, Gordan / Baršić, Bruno / Kutleša, Marko / Kotarski, Viktor / Vujaklija Brajković, Ana / Babel, Jakša / Sever, Helena / Dragija, Lidija / Kušan, Ira / Vaara, Suvi / Pettilä, Leena / Heinonen, Jonna / Kuitunen, Anne / Karlsson, Sari / Vahtera, Annukka / Kiiski, Heikki / Ristimäki, Sanna / Azaiz, Amine / Charron, Cyril / Godement, Mathieu / Geri, Guillaume / Vieillard-Baron, Antoine / Pourcine, Franck / Monchi, Mehran / Luis, David / Mercier, Romain / Sagnier, Anne / Verrier, Nathalie / Caplin, Cecile / Siami, Shidasp / Aparicio, Christelle / Vautier, Sarah / Jeblaoui, Asma / Fartoukh, Muriel / Courtin, Laura / Labbe, Vincent / Leparco, Cécile / Muller, Grégoire / Nay, Mai-Anh / Kamel, Toufik / Benzekri, Dalila / Jacquier, Sophie / Mercier, Emmanuelle / Chartier, Delphine / Salmon, Charlotte / Dequin, PierreFrançois / Schneider, Francis / Morel, Guillaume / L’Hotellier, Sylvie / Badie, Julio / Berdaguer, Fernando Daniel / Malfroy, Sylvain / Mezher, Chaouki / Bourgoin, Charlotte / Megarbane, Bruno / Voicu, Sebastian / Deye, Nicolas / Malissin, Isabelle / Sutterlin, Laetitia / Guitton, Christophe / Darreau, Cédric / Landais, Mickaël / Chudeau, Nicolas / Robert, Alain / Moine, Pierre / Heming, Nicholas / Maxime, Virginie / Bossard, Isabelle / Nicholier, Tiphaine Barbarin / Colin, Gwenhael / Zinzoni, Vanessa / Maquigneau, Natacham / Finn, André / Kreß, Gabriele / Hoff, Uwe / Friedrich Hinrichs, Carl / Nee, Jens / Hagel, Stefan / Ankert, Juliane / Kolanos, Steffi / Bloos, Frank / Petros, Sirak / Pasieka, Bastian / Kunz, Kevin / Appelt, 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JAMA

2020 Volume 324, Issue 13, Page(s) 1317–1329

Abstract: Importance: Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited.: Objective: To determine whether hydrocortisone improves outcome for patients with severe COVID-19.: Design, setting, and participants: An ...

Abstract	Importance: Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited. Objective: To determine whether hydrocortisone improves outcome for patients with severe COVID-19. Design, setting, and participants: An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020. Interventions: The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108). Main outcomes and measures: The primary end point was organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned -1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%). Results: After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n = 137), shock-dependent (n = 146), and no (n = 101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis. The mean age for the 3 groups ranged between 59.5 and 60.4 years; most patients were male (range, 70.6%-71.5%); mean body mass index ranged between 29.7 and 30.9; and patients receiving mechanical ventilation ranged between 50.0% and 63.5%. For the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively, the median organ support-free days were 0 (IQR, -1 to 15), 0 (IQR, -1 to 13), and 0 (-1 to 11) days (composed of 30%, 26%, and 33% mortality rates and 11.5, 9.5, and 6 median organ support-free days among survivors). The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone. Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1%) patients in the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively. Conclusions and relevance: Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support-free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions. Trial registration: ClinicalTrials.gov Identifier: NCT02735707.
MeSH term(s)	Adrenal Cortex Hormones/therapeutic use ; Adult ; Anti-Inflammatory Agents/administration & dosage ; Anti-Inflammatory Agents/adverse effects ; Betacoronavirus ; COVID-19 ; Coronavirus Infections/drug therapy ; Coronavirus Infections/mortality ; Coronavirus Infections/therapy ; Early Termination of Clinical Trials ; Female ; Humans ; Hydrocortisone/administration & dosage ; Hydrocortisone/adverse effects ; Intensive Care Units ; Male ; Middle Aged ; Pandemics ; Pneumonia, Viral/drug therapy ; Pneumonia, Viral/mortality ; Pneumonia, Viral/therapy ; Respiration, Artificial/statistics & numerical data ; SARS-CoV-2 ; Shock/drug therapy ; Shock/etiology ; Treatment Outcome ; COVID-19 Drug Treatment
Chemical Substances	Adrenal Cortex Hormones ; Anti-Inflammatory Agents ; Hydrocortisone (WI4X0X7BPJ)
Keywords	covid19
Language	English
Publishing date	2020-12-08
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2958-0
ISSN	1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
ISSN (online)	1538-3598
ISSN	0254-9077 ; 0002-9955 ; 0098-7484
DOI	10.1001/jama.2020.17022
Database	MEDical Literature Analysis and Retrieval System OnLINE

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