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indy 发表于 2023-1-9 09:10
(PART I)
SummaryBackgroundDexamethasone was the first intervention proven to reduce mortality in ...
(PART II)
DiscussionWe observed a rapid and significant increase in the administration of corticosteroids since publication of the RECOVERY trial results on June 16, 2020. However, not all patients who fulfilled the criteria of oxygen therapy and additional severity criteria received corticosteroids. Ages of 70 years or older were associated with consistently lower rates of corticosteroid administration. Patients with dementia, chronic neurological disease, chronic cardiac disease, moderate or severe liver disease, and pregnant patients were also less likely to receive corticosteroids, regardless of severity of illness.
Considering the knowing–doing gap between evidence and implementation, which gets averaged at 17 years,21
the implementation of this programme has been rapid. This fast implementation could have been facilitated by the timing of the evidence, communication, the simplicity of the intervention, and the global focus on the COVID-19 pandemic. In June, 2020, in-hospital mortality from COVID-19 was around 20–25% overall, and up to 38% among patients receiving invasive mechanical ventilation,22
with no proven treatments to reduce mortality. For clinicians, corticosteroids are widely used across hospitals and specialties, and their administration is simple, and the widespread coverage of the trial results in the UK media might have helped to make corticosteroids acceptable among patients. This perceived high benefit-to-risk ratio, familiarity, and simplicity might have aided the achievement of the accepted 80–90% target reliability.23
However, this target was not achieved universally. Age of 70 years or older, clinical frailty, and the aforementioned comorbidities were associated with lower rates of corticosteroid administration. There were also regional differences in corticosteroid uptake. In December, 2020, there seemed to be a reduction in corticosteroid prescribing, which could reflect the increase in hospital burden of patients with COVID-19. These discrepancies highlight the importance of process mapping and exploring potential barriers in addition to quantifying rate of change, to better understand the implementation process.24
Clinicians might have been hesitant to prescribe corticosteroids in patients with advanced age or multiple comorbidities, especially if care was primarily palliative. We found a significant reduction in corticosteroid administration among patients who were 70 years or older, independent of patient demographics, illness severity, and comorbidities, which persisted when adjusting for frailty in the smaller cohort of patients for whom frailty was recorded. However, we did not find that treatment escalation plans affected the administration of corticosteroids or that patients who died in the first 2 days of hospital admission, or who were potentially on a palliative pathway, had lower rates of corticosteroids prescribed.
Other reasons for lower rates of corticosteroid prescribing in patients aged 70 years or older could include concerns of cognitive adverse effects and initial limited evidence in the RECOVERY trial subgroup analysis,3
although the REACT meta-analysis showed benefit in patients older than 60 years.6
The known corticosteroid-induced effects on cognition, delirium, and agitation, might have led clinicians to be cautious when prescribing them for patients with pre-existing cognitive decline or delirium.25
As the prevalence of delirium increases with age,26
clinicians might perceive patients older than 70 years to be at higher risk of such adverse effects. Although delirium was not recorded in this dataset, a Glasgow coma score of less than 15 was associated with lower rates of corticosteroid administration in patients with moderate or severe COVID-19 and in the subgroup of patients aged 80 years or older with moderate or severe COVID-19. This strong independent association of older age and lower rates of corticosteroid administration should be further explored.
Concerns over safety and scarce evidence could also disadvantage patients with diabetes27
and pregnant patients. Although we did not see significant differences in corticosteroid administration associated with diabetes, the uptake in pregnant patients was considerably lower than in non-pregnant women of reproductive age. This result could be explained by the limited and changing COVID-19 guidance for the use of corticosteroids in pregnancy.5
, 28
Although the most recent guidance from the Royal College of Obstetricians and Gynaecologists recommends use of corticosteroids in pregnant patients with COVID-19 requiring oxygen supplementation or ventilation,29
the initial concern of harm and controversies around the ideal corticosteroid30
might have compromised effective implementation. Although there might be a lower threshold to admit pregnant patients resulting in a less unwell cohort overall, the persistent poor uptake in pregnant patients with markers of high illness severity warrants further exploration.
Pre-admission immunosuppressants were associated with higher rates of corticosteroid administration, potentially reflecting indications for pre-existing conditions or lower thresholds to start corticosteroids. Some pre-existing comorbidities for which corticosteroids are occasionally indicated, such as malignancy or rheumatological conditions, were associated with lower rates of corticosteroid administration, which could reflect proven or potential concern about associated immunosuppression. Immunosuppression might present a relative contraindication to corticosteroids; therefore, the risk of secondary infection with corticosteroids should be explored further to ensure safe and appropriate prescribing.31
Alternatively, clinicians might perceive there to be less benefit from corticosteroids because of a potential effect of existing immunosuppression.
Corticosteroids are also indicated in exacerbations of asthma and other chronic pulmonary diseases. However, patients with moderate or severe COVID-19 and non-asthmatic chronic pulmonary disease received fewer corticosteroids, which persisted after adjusting for age and comorbidities. This finding could reflect lower baseline SpO2 and higher respiratory rates resulting in misclassification of some patients into artificially higher severity groups.
The rates of corticosteroid administration increased with markers of severity, such as high respiratory rate, low SpO2, and high CRP, and increasing level of care, but corticosteroids were also administered to patients not recorded to have received supplementary oxygen or without markers of severe COVID-19. Despite the WHO severity criteria,7
the initial clinical guidelines and the principal message from the RECOVERY trial recommended corticosteroids to anyone needing supplementary oxygen,5
and this message might have persisted as a simple decision aid. Contrarily, both the RECOVERY and the Metcovid trials reported a potential signal to harm among patients not receiving oxygen,3
, 32
which might have persuaded clinicians to err to the side of caution among patients with less severe COVID-19. Despite this signal to harm among patients receiving no oxygen, the rate of corticosteroid administration in the non-oxygen cohort observed here did not change after RECOVERY trial publication. To account for the less clear indication for patients with milder disease, we focused on patients with moderate or severe COVID-19 when identifying the discussed factors independently associated with lower corticosteroid administration.
The comprehensive clinical data collected allowed detailed analysis of subgroups to explore administration of corticosteroids. However, there are some limitations. There were more missing data than would be expected for a prospective cohort study, due to the nature of the pandemic, but this issue was handled using appropriate methods. Although the ISARIC WHO CCP-UK study captured a third of the patients admitted to hospital with COVID-19 in the UK after June 16, 2020, and therefore offers a generalisable estimate of the national uptake of corticosteroids, selection bias might still exist. Fewer hospital admissions before June 16 could be partly contributing to the slight premature increase in corticosteroid administration. We cannot comment on the duration of corticosteroid treatment or supplementary oxygen, or the time to prescription. We were also unable to determine the type of non-critical care ward, which could contribute to differences in rates of corticosteroid prescribing due to a range of skills, preparedness, or knowledge in treating patients with COVID-19. As the indication for the corticosteroid therapy was not recorded, a proportion of patients might have received corticosteroids for other indications; therefore, our corticosteroid administration rates for patients with COVID-19 are probably overestimates of the true administration rate for COVID-19. Similarly, cautions with corticosteroids, such as peptic ulcer disease or risk of gastrointestinal bleeding,33
were not collected. Although the severity criteria were robust, derived from commonly used clinical markers on admission, and reflected the current clinical guidelines, they could not capture all criteria for severe or critical COVID-19,2
such as clinical trend. Finally, there might be unmeasured confounders that we were either unaware of or unable to measure.
Rates of corticosteroid administration in COVID-19 have increased substantially since the publication of the RECOVERY trial results and updated clinical guidelines, with the greatest rates seen among patients with higher severity of illness. However, this study highlighted a marked difference in corticosteroid uptake based on age, with patients aged 70 years or older much less likely to receive corticosteroids, even after accounting for illness severity, comorbidities, and clinical frailty. The presence of chronic cardiac disease, chronic neurological disease, dementia, or pregnancy was also associated with lower rates of corticosteroid administration. A decision not to administer a cheap, simple, and potentially life-saving therapy such as low-dose corticosteroids in COVID-19 might benefit from a consensus approach, whereby any decision not to adhere to a guideline requires discussion and sense checking with another clinical colleague. This approach might provide reassurance to patients of equitable access and support clinicians in potentially challenging decision making. Future qualitative research should evaluate whether there were systematic barriers or enablers to implementation, overall or in specific subgroups of patients, across a range of institutions, settings, and practitioners. Such work should aim to understand to what extent the results presented here represent appropriate clinical judgement or potentially modifiable barriers to receiving life-saving treatments.
ISARIC Coronavirus Clinical Characterisation Consortium (ISARIC4C)
J Kenneth Baillie, Malcolm G Semple, Peter JM Openshaw, Gail Carson, Beatrice Alex, Benjamin Bach, Wendy S Barclay, Debby Bogaert, Meera Chand, Graham S Cooke, Annemarie B Docherty, Jake Dunning, Ana da Silva Filipe, Tom Fletcher, Christopher A Green, Julian A Hiscox, Antonia Ying Wai Ho, Peter W Horby, Samreen Ijaz, Saye Khoo, Paul Klenerman, Andrew Law, Wei Shen Lim, Alexander J Mentzer, Laura Merson, Alison M Meynert, Mahdad Noursadeghi, Shona C Moore, Massimo Palmarini, William A Paxton, Georgios Pollakis, Nicholas Price, Andrew Rambaut, David L Robertson, Clark D Russell, Vanessa Sancho-Shimizu, Janet T Scott, Tom Solomon, Shiranee Sriskandan, David Stuart, Charlotte Summers, Richard S Tedder, Emma C Thomson, Ryan S Thwaites, Lance C W Turtle, Maria Zambon, Hayley E Hardwick, Chloe Donohue, Jane Ewins, Wilna Oosthuyzen, Fiona Griffiths, Lisa Norman, Riinu Pius, Tom M Drake, Cameron J Fairfield, Stephen Knight, Kenneth A Mclean, Derek Murphy, Catherine A Shaw, Jo Dalton, Michelle Girvan, Egle Saviciute, Stephanie Roberts, Janet Harrison, Laura Marsh, Marie Connor, Gary Leeming, Andrew Law, Ross Hendry, William Greenhalf, Victoria Shaw, Sarah McDonald, Kayode Adeniji, Daniel Agranoff, Ken Agwuh, Dhiraj Ail, Ana Alegria, Brian Angus, Abdul Ashish, Dougal Atkinson, Shahedal Bari, Gavin Barlow, Stella Barnass, Nicholas Barrett, Christopher Bassford, David Baxter, Michael Beadsworth, Jolanta Bernatoniene, John Berridge, Nicola Best, Pieter Bothma, David Brealey, Robin Brittain-Long, Naomi Bulteel, Tom Burden, Andrew Burtenshaw, Vikki Caruth, David Chadwick, Duncan Chambler, Nigel Chee, Jenny Child, Srikanth Chukkambotla, Tom Clark, Paul Collini, Graham Cooke, Catherine Cosgrove, Jason Cupitt, Maria-Teresa Cutino-Moguel, Paul Dark, Chris Dawson, Samir Dervisevic, Phil Donnison, Sam Douthwaite, Ingrid DuRand, Ahilanadan Dushianthan, Tristan Dyer, Cariad Evans, Chi Eziefula, Chrisopher Fegan, Adam Finn, Duncan Fullerton, Sanjeev Garg, Sanjeev Garg, Atul Garg, Effrossyni Gkrania-Klotsas, Jo Godden, Arthur Goldsmith, Clive Graham, Elaine Hardy, Stuart Hartshorn, Daniel Harvey, Peter Havalda, Daniel B Hawcutt, Antonia Ho, Maria Hobrok, Luke Hodgson, Anita Holme, Anil Hormis, Michael Jacobs, Susan Jain, Paul Jennings, Agilan Kaliappan, Vidya Kasipandian, Stephen Kegg, Michael Kelsey, Jason Kendall, Caroline Kerrison, Ian Kerslake, Oliver Koch, Gouri Koduri, George Koshy, Shondipon Laha, Susan Larkin, Tamas Leiner, Patrick Lillie, James Limb, Vanessa Linnett, Jeff Little, Michael MacMahon, Emily MacNaughton, Ravish Mankregod, Huw Masson, Elijah Matovu, Katherine McCullough, Ruth McEwen, Manjula Meda, Gary Mills, Jane Minton, Mariyam Mirfenderesky, Kavya Mohandas, James Moon, Elinoor Moore, Patrick Morgan, Craig Morris, Katherine Mortimore, Samuel Moses, Mbiye Mpenge, Rohinton Mulla, Michael Murphy, Megan Nagel, Thapas Nagarajan, Mark Nelson, Igor Otahal, Mark Pais, Selva Panchatsharam, Hassan Paraiso, Brij Patel, Justin Pepperell, Mark Peters, Mandeep Phull, Stefania Pintus, Jagtur Singh Pooni, Frank Post, David Price, Rachel Prout, Nikolas Rae, Henrik Reschreiter, Tim Reynolds, Neil Richardson, Mark Roberts, Devender Roberts, Alistair Rose, Guy Rousseau, Brendan Ryan, Taranprit Saluja, Aarti Shah, Prad Shanmuga, Anil Sharma, Anna Shawcross, Jeremy Sizer, Richard Smith, Catherine Snelson, Nick Spittle, Nikki Staines, Tom Stambach, Richard Stewart, Pradeep Subudhi, Tamas Szakmany, Kate Tatham, Jo Thomas, Chris Thompson, Robert Thompson, Ascanio Tridente, Darell Tupper-Carey, Mary Twagira, Andrew Ustianowski, Nick Vallotton, Lisa Vincent-Smith, Shico Visuvanathan, Alan Vuylsteke, Sam Waddy, Rachel Wake, Andrew Walden, Tony Whitehouse, Paul Whittaker, Ashley Whittington, Meme Wijesinghe, Martin Williams, Lawrence Wilson, Sarah Wilson, Stephen Winchester, Martin Wiselka, Adam Wolverson, Daniel G Wooton, Andrew Workman, Bryan Yates, Peter Young.
Contributors
JKB, JD, JSN-V-T, PJMO, and MGS contributed to conceptualisation of the study. FN, EMH, MGS, and ABD did the formal analysis. FN, SRM, SDS, EMH, MGS, and ABD wrote the original draft. FN, SRM, SDS, TMD, RHM, JD, CJF, AH, JSN-V-T, RP, CDR, CAS, LT, PJMO, JKB, EMH, MGS, and ABD contributed to review and editing of the report. CD, HEH, AH, MG, GL, and RGS were responsible for project administration. JKB, PJMO, and MGS were responsible for funding acquisition. FN, EMH, and ABD verified all the data. All authors had full access to all data, and have seen and approved of the final text. EMH, MGS, and ABD had final responsibility for the decision to submit for publication.
Data sharingData, protocols, and all documentation around this analysis will be made available to academic researchers after authorisation from the ISARIC independent data management and access committee.
Declaration of interestsABD reports grants from the UK Department of Health and Social Care (DHSC) during the conduct of the study, and grants from the Wellcome Trust outside the submitted work. JSN-V-T reports grants from the DHSC during the conduct of the study, and is seconded to the DHSC. PJMO reports personal fees from consultancies and from the European Respiratory Society; grants from the UK Medical Research Council (MRC), the MRC Global Challenge Research Fund, the EU, the NIHR Biomedical Research Centre, MRC–GSK, the Wellcome Trust, and the NIHR (Health Protection Research Unit in Respiratory Infections at Imperial College London); and is an NIHR senior investigator outside the submitted work; his role as President of the British Society for Immunology was unpaid but travel and accommodation at some meetings was provided by the society. JKB reports grants from the MRC. MGS reports grants from DHSC, NIHR UK, MRC UK, HPRU in Emerging and Zoonotic Infections, and University of Liverpool, during the conduct of the study; and is chair of the Infectious Diseases Science Advisory Board and minority shareholder of Integrum Scientific, Greensboro NC, and Independent external and non-remunerated member of Pfizer's External Data Monitoring Committee for their mRNA vaccine program(s) outside the submitted work. All other authors declare no competing interests.
Acknowledgments
This study is supported by grants from the NIHR (award CO-CIN-01), the MRC (grant MC_PC_19059), the NIHR Imperial Biomedical Research Centre (grants P45058 and IS-BRC-1215-20013), the NIHR HPRU in Respiratory Infections at Imperial College London and NIHR HPRU in Emerging and Zoonotic Infections at the University of Liverpool, both in partnership with Public Health England (NIHR award 200907), the Wellcome Trust and the UK Department for International Development (215091/Z/18/Z), the Bill & Melinda Gates Foundation (OPP1209135), the Liverpool Experimental Cancer Medicine Centre (grant reference C18616/A25153), and the EU Platform for European Preparedness Against (Re-)emerging Epidemics 1 (FP7 project 602525). The NIHR Clinical Research Network provided infrastructure support for this research. This research was funded, in part, by the Wellcome Trust. RHM reports grants from BREATHE, the health data research hub for respiratory health (MC_PC_19004). BREATHE is funded through the UK Research and Innovation Industrial Strategy Challenge Fund and is delivered by Health Data Research UK. ABD acknowledges funding from the Wellcome Trust (216606/Z/19/Z0). LT is supported by a Wellcome Trust fellowship (205228/Z/16/Z). PJMO is supported by a NIHR Senior Investigator Award (award 201385). The views expressed are those of the authors and not necessarily those of the DHSC, the Department for International Development, the NIHR, the MRC, the Wellcome Trust, or Public Health England. Investigators were independent from funders. ISARIC4C CCP-UK data are provided by patients and collected by the UK National Health Service as part of their care. Although there was no direct involvement from patients or the public, quality improvement is paramount in ensuring the reliability of the health-care system that aims to maximise benefit and minimise harm to patients. This research was conducted as part of an urgent public health study in response to an emergency, meaning there was insufficient time for public involvement before data collection commenced. We are extremely grateful to the 2648 front-line NHS clinical and research staff and volunteer medical students who collected these data under challenging circumstances, and the generosity of the participants and their families for their individual contributions in these difficult times. We also acknowledge the support of Jeremy J Farrar (Wellcome Trust, London, UK) and Nahoko Shindo (WHO, Geneva, Switzerland).
Supplementary Material
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Article InfoPublication HistoryPublished: April 2022
IdentificationCopyright© 2022 The Authors. Published by Elsevier Ltd.
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ScienceDirectAccess this article on ScienceDirectFigures![]()
[size=0.938][size=0.938]Figure 1Trial profile
![]()
[size=0.938][size=0.938]Figure 2Corticosteroid administration in patients between the June 8, 2020, and April 14, 2021, stratified by supplementary oxygen, level of care, and COVID-19 severity at hospital admission
![]()
[size=0.938][size=0.938]Figure 3Fitted lines of the linear regression model for corticosteroid administration to patients who required oxygen, admitted to hospital between March 16, 2020, and April 18, 2021
![]()
[size=0.938][size=0.938]Figure 4Multivariable multilevel regression model of any corticosteroid administration among 30 670 patients with moderate or severe COVID-19 receiving supplementary oxygen and admitted to hospital between June 16, 2020, and April 14, 2021
Tables- Table 1Baseline characteristics of patients admitted between June 17, 2020, and April 14, 2021, who received supplementary oxygen at any point in their admission, stratified by corticosteroid administration
- Table 2Patients who received oxygen at any point in their admission and classified as having moderate or severe COVID-19 between June 17, 2020, and April 14, 2021, stratified by corticosteroid administration
- Table 3Subgroup analysis of patients aged 80 years or older with moderate or severe COVID-19, admitted to hospital between June 17, 2020, and April 14, 2021
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