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  1. Article ; Online: Pedagogical foundations to online lectures in health professions education.

    Seymour-Walsh, Amy E / Weber, Anthony / Bell, Andy

    Rural and remote health

    2020  Volume 20, Issue 2, Page(s) 6038

    Abstract: Professional and tertiary health professions education (HPE) has been markedly challenged by the current novel coronavirus (COVID-19). Mandates for training organisations to reduce social contact during the global pandemic, and make learning available ... ...

    Abstract Professional and tertiary health professions education (HPE) has been markedly challenged by the current novel coronavirus (COVID-19). Mandates for training organisations to reduce social contact during the global pandemic, and make learning available online, provide an opportunity for regional, rural and remote clinicians and students to more easily access learning and professional development opportunities. Online lectures, while posing an opportunity for regional, rural and remote HPE, entail potential risks. Educators who are familiar with face-to-face pedagogies may find a transition to remote, digital interaction unfamiliar, disarming, and therefore they may not design maximally engaging lectures. The strategies used in a face-to-face lecture cannot be directly transferred into the online environment. This article proposes strategies to ensure the ongoing effectiveness, efficiency and engagement of lectures transitioning from face-to-face to online delivery. Cognitive learning theory, strategies to promote learner engagement and minimise distraction, and examples of software affordances to support active learning during the lecture are proposed. This enables lecturers to navigate the challenges of lecturing in an online environment and plan fruitful online lectures during this disruptive time. These suggestions will therefore enable HPE to better meet the existing and future needs of regional, rural and remote learners who may not be able to easily access face-to-face learning upon the relaxation of social distancing measures. Strategies to provide equitable HPE to learners who cannot access plentiful, fast internet are also discussed.
    MeSH term(s) Betacoronavirus ; COVID-19 ; Clinical Competence ; Coronavirus Infections ; Curriculum/trends ; Education, Distance/organization & administration ; Education, Medical, Continuing/organization & administration ; Humans ; Pandemics ; Pneumonia, Viral ; Problem-Based Learning/organization & administration ; Rural Health Services/organization & administration ; SARS-CoV-2
    Keywords covid19
    Language English
    Publishing date 2020-05-29
    Publishing country Australia
    Document type Journal Article
    ZDB-ID 2105620-1
    ISSN 1445-6354 ; 1445-6354
    ISSN (online) 1445-6354
    ISSN 1445-6354
    DOI 10.22605/RRH6038
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Practical approaches to pedagogically rich online tutorials in health professions education.

    Seymour-Walsh, Amy E / Weber, Anthony / Bell, Andy

    Rural and remote health

    2020  Volume 20, Issue 2, Page(s) 6045

    Abstract: Health professions education in tertiary, industrial and other contexts often entails face-to-face small group learning through tutorials. The current novel coronavirus, COVID-19, has reduced face-to-face contact, and this has challenged how health ... ...

    Abstract Health professions education in tertiary, industrial and other contexts often entails face-to-face small group learning through tutorials. The current novel coronavirus, COVID-19, has reduced face-to-face contact, and this has challenged how health professionals and clinical students can access training, accreditation and development. Online and other remote mechanisms are available to tutors and course designers; however, they might not feel comfortable with such affordances, in light of expectations to so rapidly change familiar teaching and delivery styles. This may result in the loss of interaction and disruption of peer learning, which are hallmarks of the small group tutorial. Collaborative learning is essential to develop and refine an emerging sense of belonging to a professional community through formal studies, and interactive learning is a requirement for some registered health professions to satisfy ongoing professional accreditation. Online media has been used to promote social learning in regional, rural and remote communities for some time. Strategies for learning activity design and tutor training are proposed to equip course designers and educators to support health professions education remotely, through the synchronous, online small group. This may herald a new era of increased access to training and professional development for non-urban learners, beyond COVID-19.
    MeSH term(s) Betacoronavirus ; COVID-19 ; Coronavirus Infections ; Curriculum/standards ; Diffusion of Innovation ; Education, Distance/methods ; Health Occupations/education ; Humans ; Pandemics ; Pneumonia, Viral ; Problem-Based Learning/methods ; Professional Competence/standards ; SARS-CoV-2
    Keywords covid19
    Language English
    Publishing date 2020-05-30
    Publishing country Australia
    Document type Journal Article
    ZDB-ID 2105620-1
    ISSN 1445-6354 ; 1445-6354
    ISSN (online) 1445-6354
    ISSN 1445-6354
    DOI 10.22605/RRH6045
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Adapting to a new reality: COVID-19 coronavirus and online education in the health professions.

    Seymour-Walsh, Amy E / Bell, Andy / Weber, Anthony / Smith, Tony

    Rural and remote health

    2020  Volume 20, Issue 2, Page(s) 6000

    Abstract: The current novel coronavirus, COVID-19, has effected a significant change in the way industry-based and tertiary health professions education (HPE) can occur. Advice for strict, widespread social distancing has catalysed the transformation of course ... ...

    Abstract The current novel coronavirus, COVID-19, has effected a significant change in the way industry-based and tertiary health professions education (HPE) can occur. Advice for strict, widespread social distancing has catalysed the transformation of course delivery into fully online design across nations. This is problematic for HPE, which has traditionally relied on face-to-face learner interaction, in the form of skills laboratories, simulation training and industry-based clinical placements. The transition to online-only course delivery has brought with it a need to address particular issues regarding the construction and delivery of quality curricula and education activities. It is in this context that regional, rural and remote health professionals and academics can provide invaluable insights into the use of technology to overcome the tyranny of distance, promote high-quality online HPE and enable the ongoing development of communities of practice. This article is the first in a series addressing the risks and opportunities in the current transition to online HPE, providing practical solutions for educators who are now unable to embrace more traditional face-to-face HPE delivery methods and activities.
    MeSH term(s) Betacoronavirus ; COVID-19 ; Coronavirus Infections/epidemiology ; Education, Distance/methods ; Health Personnel/education ; Humans ; Internet ; Knowledge ; Learning ; Pandemics ; Pneumonia, Viral/epidemiology ; Professional Role ; SARS-CoV-2 ; Teaching/standards
    Keywords covid19
    Language English
    Publishing date 2020-05-26
    Publishing country Australia
    Document type Journal Article
    ZDB-ID 2105620-1
    ISSN 1445-6354 ; 1445-6354
    ISSN (online) 1445-6354
    ISSN 1445-6354
    DOI 10.22605/RRH6000
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Teaching psychomotor skills online: exploring the implications of novel coronavirus on health professions education.

    Seymour-Walsh, Amy E / Weber, Anthony / Bell, Andy / Smith, Tony

    Rural and remote health

    2020  Volume 20, Issue 4, Page(s) 6132

    Abstract: Context: The safe and effective application of psychomotor skills in the clinical environment is a central pillar of the health professions. The current global coronavirus pandemic has significantly impacted health professions education (HPE) and has ... ...

    Abstract Context: The safe and effective application of psychomotor skills in the clinical environment is a central pillar of the health professions. The current global coronavirus pandemic has significantly impacted health professions education (HPE) and has been of particular consequence for routine face-to-face (F2F) skill education for health professionals and clinical students worldwide. What is being experienced on an unprecedented scale parallels a problem familiar to regional, rural and remote health professionals and students: the learners are willing, and the educational expertise exists, but the two are separated by the tyranny of distance. This article considers how the problem of physical distance might be overcome, so that quality skill education might continue.
    Issues: Psychomotor skills are undeniably easier to teach and learn F2F, and training schedules in tertiary, in-service and accredited professional courses reflect this. This aspect of HPE is therefore at significant risk in the context of social distancing and physical isolation. Psychomotor skills are much more complex than the physical motor outputs alone might suggest, and an F2F skill session is only one way to build the complementary aspects of new skill performance. This article argues that educators and course designers can progress with psychomotor skill education from a physical distance.
    Lessons learned: Videos can be used to either passively present content to learners or actively engage them. It is the design of the educational activity, rather than the resource medium itself, that enables active engagement. Furthermore, while many training schedules have been adapted to accommodate intensive F2F skill training once it is safe to do so, distributed practice and the need for reflection during the acquisition and development of new skills may challenge the pedagogical effectiveness of this approach. Skill development can be fostered in the absence of F2F teaching, and in the absence of a shared physical space. Embracing the creative licence to do so will improve equitable access to regional, rural and remote clinicians and students well beyond the resolution of the current pandemic.
    MeSH term(s) COVID-19/epidemiology ; Clinical Competence ; Computer-Assisted Instruction/methods ; Education, Distance/methods ; Health Personnel/education ; Humans ; Psychomotor Performance ; Rural Health Services/organization & administration ; Rural Population/statistics & numerical data
    Keywords covid19
    Language English
    Publishing date 2020-11-06
    Publishing country Australia
    Document type Journal Article
    ZDB-ID 2105620-1
    ISSN 1445-6354 ; 1445-6354
    ISSN (online) 1445-6354
    ISSN 1445-6354
    DOI 10.22605/RRH6132
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  5. Article: Pedagogical foundations to online lectures in health professions education

    Seymour-Walsh, Amy E / Weber, Anthony / Bell, Andy

    Rural Remote Health

    Abstract: Professional and tertiary health professions education (HPE) has been markedly challenged by the current novel coronavirus (COVID-19). Mandates for training organisations to reduce social contact during the global pandemic, and make learning available ... ...

    Abstract Professional and tertiary health professions education (HPE) has been markedly challenged by the current novel coronavirus (COVID-19). Mandates for training organisations to reduce social contact during the global pandemic, and make learning available online, provide an opportunity for regional, rural and remote clinicians and students to more easily access learning and professional development opportunities. Online lectures, while posing an opportunity for regional, rural and remote HPE, entail potential risks. Educators who are familiar with face-to-face pedagogies may find a transition to remote, digital interaction unfamiliar, disarming, and therefore they may not design maximally engaging lectures. The strategies used in a face-to-face lecture cannot be directly transferred into the online environment. This article proposes strategies to ensure the ongoing effectiveness, efficiency and engagement of lectures transitioning from face-to-face to online delivery. Cognitive learning theory, strategies to promote learner engagement and minimise distraction, and examples of software affordances to support active learning during the lecture are proposed. This enables lecturers to navigate the challenges of lecturing in an online environment and plan fruitful online lectures during this disruptive time. These suggestions will therefore enable HPE to better meet the existing and future needs of regional, rural and remote learners who may not be able to easily access face-to-face learning upon the relaxation of social distancing measures. Strategies to provide equitable HPE to learners who cannot access plentiful, fast internet are also discussed.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #32466654
    Database COVID19

    Kategorien

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

  6. Article: Practical approaches to pedagogically rich online tutorials in health professions education

    Seymour-Walsh, Amy E / Weber, Anthony / Bell, Andy

    Rural Remote Health

    Abstract: Health professions education in tertiary, industrial and other contexts often entails face-to-face small group learning through tutorials. The current novel coronavirus, COVID-19, has reduced face-to-face contact, and this has challenged how health ... ...

    Abstract Health professions education in tertiary, industrial and other contexts often entails face-to-face small group learning through tutorials. The current novel coronavirus, COVID-19, has reduced face-to-face contact, and this has challenged how health professionals and clinical students can access training, accreditation and development. Online and other remote mechanisms are available to tutors and course designers; however, they might not feel comfortable with such affordances, in light of expectations to so rapidly change familiar teaching and delivery styles. This may result in the loss of interaction and disruption of peer learning, which are hallmarks of the small group tutorial. Collaborative learning is essential to develop and refine an emerging sense of belonging to a professional community through formal studies, and interactive learning is a requirement for some registered health professions to satisfy ongoing professional accreditation. Online media has been used to promote social learning in regional, rural and remote communities for some time. Strategies for learning activity design and tutor training are proposed to equip course designers and educators to support health professions education remotely, through the synchronous, online small group. This may herald a new era of increased access to training and professional development for non-urban learners, beyond COVID-19.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #32471311
    Database COVID19

    Kategorien

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

  7. Article: Adapting to a new reality: COVID-19 coronavirus and online education in the health professions

    Seymour-Walsh, Amy E / Bell, Andy / Weber, Anthony / Smith, Tony

    Rural Remote Health

    Abstract: The current novel coronavirus, COVID-19, has effected a significant change in the way industry-based and tertiary health professions education (HPE) can occur. Advice for strict, widespread social distancing has catalysed the transformation of course ... ...

    Abstract The current novel coronavirus, COVID-19, has effected a significant change in the way industry-based and tertiary health professions education (HPE) can occur. Advice for strict, widespread social distancing has catalysed the transformation of course delivery into fully online design across nations. This is problematic for HPE, which has traditionally relied on face-to-face learner interaction, in the form of skills laboratories, simulation training and industry-based clinical placements. The transition to online-only course delivery has brought with it a need to address particular issues regarding the construction and delivery of quality curricula and education activities. It is in this context that regional, rural and remote health professionals and academics can provide invaluable insights into the use of technology to overcome the tyranny of distance, promote high-quality online HPE and enable the ongoing development of communities of practice. This article is the first in a series addressing the risks and opportunities in the current transition to online HPE, providing practical solutions for educators who are now unable to embrace more traditional face-to-face HPE delivery methods and activities.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #32456441
    Database COVID19

    Kategorien

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

  8. Article: Teaching psychomotor skills online: exploring the implications of novel coronavirus on health professions education

    Seymour-Walsh, Amy E / Weber, Anthony / Bell, Andy / Smith, Tony

    Rural Remote Health

    Abstract: CONTEXT: The safe and effective application of psychomotor skills in the clinical environment is a central pillar of the health professions. The current global coronavirus pandemic has significantly impacted health professions education (HPE) and has ... ...

    Abstract CONTEXT: The safe and effective application of psychomotor skills in the clinical environment is a central pillar of the health professions. The current global coronavirus pandemic has significantly impacted health professions education (HPE) and has been of particular consequence for routine face-to-face (F2F) skill education for health professionals and clinical students worldwide. What is being experienced on an unprecedented scale parallels a problem familiar to regional, rural and remote health professionals and students: the learners are willing, and the educational expertise exists, but the two are separated by the tyranny of distance. This article considers how the problem of physical distance might be overcome, so that quality skill education might continue. ISSUES: Psychomotor skills are undeniably easier to teach and learn F2F, and training schedules in tertiary, in-service and accredited professional courses reflect this. This aspect of HPE is therefore at significant risk in the context of social distancing and physical isolation. Psychomotor skills are much more complex than the physical motor outputs alone might suggest, and an F2F skill session is only one way to build the complementary aspects of new skill performance. This article argues that educators and course designers can progress with psychomotor skill education from a physical distance. LESSONS LEARNED: Videos can be used to either passively present content to learners or actively engage them. It is the design of the educational activity, rather than the resource medium itself, that enables active engagement. Furthermore, while many training schedules have been adapted to accommodate intensive F2F skill training once it is safe to do so, distributed practice and the need for reflection during the acquisition and development of new skills may challenge the pedagogical effectiveness of this approach. Skill development can be fostered in the absence of F2F teaching, and in the absence of a shared physical space. Embracing the creative licence to do so will improve equitable access to regional, rural and remote clinicians and students well beyond the resolution of the current pandemic.
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #916612
    Database COVID19

    Kategorien

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

  9. Article ; Online: Effect of Convalescent Plasma on Organ Support-Free Days in Critically Ill Patients With COVID-19: A Randomized Clinical Trial.

    Estcourt, Lise J / Turgeon, Alexis F / McQuilten, Zoe K / McVerry, Bryan J / Al-Beidh, Farah / Annane, Djillali / Arabi, Yaseen M / Arnold, Donald M / Beane, Abigail / Bégin, Philippe / van Bentum-Puijk, Wilma / Berry, Lindsay R / Bhimani, Zahra / Birchall, Janet E / Bonten, Marc J M / Bradbury, Charlotte A / Brunkhorst, Frank M / Buxton, Meredith / Callum, Jeannie L /
    Chassé, Michaël / Cheng, Allen C / Cove, Matthew E / Daly, James / Derde, Lennie / Detry, Michelle A / De Jong, Menno / Evans, Amy / Fergusson, Dean A / Fish, Matthew / Fitzgerald, Mark / Foley, Claire / Goossens, Herman / Gordon, Anthony C / Gosbell, Iain B / Green, Cameron / Haniffa, Rashan / Harvala, Heli / Higgins, Alisa M / Hills, Thomas E / Hoad, Veronica C / Horvat, Christopher / Huang, David T / Hudson, Cara L / Ichihara, Nao / Laing, Emma / Lamikanra, Abigail A / Lamontagne, François / Lawler, Patrick R / Linstrum, Kelsey / Litton, Edward / Lorenzi, Elizabeth / MacLennan, Sheila / Marshall, John / McAuley, Daniel F / McDyer, John F / McGlothlin, Anna / McGuinness, Shay / Miflin, Gail / Montgomery, Stephanie / Mouncey, Paul R / Murthy, Srinivas / Nichol, Alistair / Parke, Rachael / Parker, Jane C / Priddee, Nicole / Purcell, Damian F J / Reyes, Luis F / Richardson, Peter / Robitaille, Nancy / Rowan, Kathryn M / Rynne, Jennifer / Saito, Hiroki / Santos, Marlene / Saunders, Christina T / Serpa Neto, Ary / Seymour, Christopher W / Silversides, Jon A / Tinmouth, Alan A / Triulzi, Darrell J / Turner, Anne M / van de Veerdonk, Frank / Walsh, Timothy S / Wood, Erica M / Berry, Scott / Lewis, Roger J / Menon, David K / McArthur, Colin / Zarychanski, Ryan / Angus, Derek C / Webb, Steve A / Roberts, David J / Shankar-Hari, Manu

    JAMA

    2021  Volume 326, Issue 17, Page(s) 1690–1702

    Abstract: Importance: The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive.: Objective: To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19.: Design, ... ...

    Abstract Importance: The evidence for benefit of convalescent plasma for critically ill patients with COVID-19 is inconclusive.
    Objective: To determine whether convalescent plasma would improve outcomes for critically ill adults with COVID-19.
    Design, setting, and participants: The ongoing Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) enrolled and randomized 4763 adults with suspected or confirmed COVID-19 between March 9, 2020, and January 18, 2021, within at least 1 domain; 2011 critically ill adults were randomized to open-label interventions in the immunoglobulin domain at 129 sites in 4 countries. Follow-up ended on April 19, 2021.
    Interventions: The immunoglobulin domain randomized participants to receive 2 units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization (n = 1084) or no convalescent plasma (n = 916).
    Main outcomes and measures: The primary ordinal end point was organ support-free days (days alive and free of intensive care unit-based organ support) up to day 21 (range, -1 to 21 days; patients who died were assigned -1 day). The primary analysis was an adjusted bayesian cumulative logistic model. Superiority was defined as the posterior probability of an odds ratio (OR) greater than 1 (threshold for trial conclusion of superiority >99%). Futility was defined as the posterior probability of an OR less than 1.2 (threshold for trial conclusion of futility >95%). An OR greater than 1 represented improved survival, more organ support-free days, or both. The prespecified secondary outcomes included in-hospital survival; 28-day survival; 90-day survival; respiratory support-free days; cardiovascular support-free days; progression to invasive mechanical ventilation, extracorporeal mechanical oxygenation, or death; intensive care unit length of stay; hospital length of stay; World Health Organization ordinal scale score at day 14; venous thromboembolic events at 90 days; and serious adverse events.
    Results: Among the 2011 participants who were randomized (median age, 61 [IQR, 52 to 70] years and 645/1998 [32.3%] women), 1990 (99%) completed the trial. The convalescent plasma intervention was stopped after the prespecified criterion for futility was met. The median number of organ support-free days was 0 (IQR, -1 to 16) in the convalescent plasma group and 3 (IQR, -1 to 16) in the no convalescent plasma group. The in-hospital mortality rate was 37.3% (401/1075) for the convalescent plasma group and 38.4% (347/904) for the no convalescent plasma group and the median number of days alive and free of organ support was 14 (IQR, 3 to 18) and 14 (IQR, 7 to 18), respectively. The median-adjusted OR was 0.97 (95% credible interval, 0.83 to 1.15) and the posterior probability of futility (OR <1.2) was 99.4% for the convalescent plasma group compared with the no convalescent plasma group. The treatment effects were consistent across the primary outcome and the 11 secondary outcomes. Serious adverse events were reported in 3.0% (32/1075) of participants in the convalescent plasma group and in 1.3% (12/905) of participants in the no convalescent plasma group.
    Conclusions and relevance: Among critically ill adults with confirmed COVID-19, treatment with 2 units of high-titer, ABO-compatible convalescent plasma had a low likelihood of providing improvement in the number of organ support-free days.
    Trial registration: ClinicalTrials.gov Identifier: NCT02735707.
    MeSH term(s) ABO Blood-Group System ; Adult ; Aged ; COVID-19/therapy ; Critical Illness/therapy ; Female ; Hospital Mortality ; Humans ; Immunization, Passive ; Length of Stay ; Logistic Models ; Male ; Middle Aged ; Respiration, Artificial/statistics & numerical data ; Treatment Failure ; Vasoconstrictor Agents/therapeutic use ; COVID-19 Serotherapy
    Chemical Substances ABO Blood-Group System ; Vasoconstrictor Agents
    Language English
    Publishing date 2021-10-19
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial
    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.2021.18178
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. 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 / 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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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