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2.
Lancet Respir Med ; 10(7): 715-724, 2022 07.
Article in English | MEDLINE | ID: covidwho-1886188

ABSTRACT

Health consequences that persist beyond the acute infection phase of COVID-19, termed post-COVID-19 condition (also commonly known as long COVID), vary widely and represent a growing global health challenge. Research on post-COVID-19 condition is expanding but, at present, no agreement exists on the health outcomes that should be measured in people living with the condition. To address this gap, we conducted an international consensus study, which included a comprehensive literature review and classification of outcomes for post-COVID-19 condition that informed a two-round online modified Delphi process followed by an online consensus meeting to finalise the core outcome set (COS). 1535 participants from 71 countries were involved, with 1148 individuals participating in both Delphi rounds. Eleven outcomes achieved consensus for inclusion in the final COS: fatigue; pain; post-exertion symptoms; work or occupational and study changes; survival; and functioning, symptoms, and conditions for each of cardiovascular, respiratory, nervous system, cognitive, mental health, and physical outcomes. Recovery was included a priori because it was a relevant outcome that was part of a previously published COS on COVID-19. The next step in this COS development exercise will be to establish the instruments that are most appropriate to measure these core outcomes. This international consensus-based COS should provide a framework for standardised assessment of adults with post-COVID-19 condition, aimed at facilitating clinical care and research worldwide.


Subject(s)
COVID-19 , Adult , COVID-19/complications , Delphi Technique , Humans , Outcome Assessment, Health Care , Research Design , Treatment Outcome
3.
EuropePMC; 2022.
Preprint in English | EuropePMC | ID: ppcovidwho-329850

ABSTRACT

Objective Previous studies have reported conflicting findings regarding aldosterone levels in patients hospitalised with COVID-19. We therefore used the gold-standard technique of liquid chromatography tandem mass-spectrometry (LCMSMS) to address this uncertainty. Design All patients admitted to Cambridge University Hospitals with COVID-19 between March 10, 2020 and May 13, 2021, and in whom a stored blood sample was available for analysis, were eligible for inclusion. Methods Aldosterone was measured by LCMSMS and by immunoassay;cortisol and renin were determined by immunoassay. Results Using LCMSMS, aldosterone was below the limit of detection (<70 pmol/L) in 74 (58.7%) patients. Importantly, this finding was discordant with results obtained using a commonly employed clinical immunoassay (Liaison Diasorin®), which over-estimated aldosterone compared to the LCMSMS assay (intercept 14.1 [95% CI -34.4 to 54.1] + slope 3.16 [95% CI 2.09 to 4.15] pmol/L). The magnitude of this discrepancy did not clearly correlate with markers of kidney or liver function. Solvent extraction prior to immunoassay improved the agreement between methods (intercept -14.9 [95% CI -31.9 to -4.3] and slope 1.0 [95% CI 0.89 to 1.02] pmol/L) suggesting the presence of a water-soluble metabolite causing interference in the direct immunoassay. We also replicated a previous finding that blood cortisol concentrations were often increased, with increased mortality in the group with serum cortisol levels >744 nmol/L (p=0.005). Conclusion When measured by LCMSMS, aldosterone was found to be profoundly low in a significant proportion of patients with COVID-19 at the time of hospital admission. This has likely not been detected previously due to high levels of interference with immunoassays in patients with COVID-19, and this merits further prospective investigation.

4.
BMC Med ; 20(1): 50, 2022 02 04.
Article in English | MEDLINE | ID: covidwho-1690914

ABSTRACT

BACKGROUND: A substantial portion of people with COVID-19 subsequently experience lasting symptoms including fatigue, shortness of breath, and neurological complaints such as cognitive dysfunction many months after acute infection. Emerging evidence suggests that this condition, commonly referred to as long COVID but also known as post-acute sequelae of SARS-CoV-2 infection (PASC) or post-COVID-19 condition, could become a significant global health burden. MAIN TEXT: While the number of studies investigating the post-COVID-19 condition is increasing, there is no agreement on how this new disease should be defined and diagnosed in clinical practice and what relevant outcomes to measure. There is an urgent need to optimise and standardise outcome measures for this important patient group both for clinical services and for research and to allow comparing and pooling of data. CONCLUSIONS: A Core Outcome Set for post-COVID-19 condition should be developed in the shortest time frame possible, for improvement in data quality, harmonisation, and comparability between different geographical locations. We call for a global initiative, involving all relevant partners, including, but not limited to, healthcare professionals, researchers, methodologists, patients, and caregivers. We urge coordinated actions aiming to develop a Core Outcome Set (COS) for post-COVID-19 condition in both the adult and paediatric populations.


Subject(s)
COVID-19 , Adult , COVID-19/complications , Child , Disease Progression , Humans , Outcome Assessment, Health Care , SARS-CoV-2
5.
SSRN;
Preprint in English | SSRN | ID: ppcovidwho-326233

ABSTRACT

Abstract Background: Recent data suggest that many people experience Post COVID-19 Condition (Long COVID) following the acute phase of the SaRS CoV-2 infection. At present there is no agreement on what patient health outcomes should be measured in Post COVID-19 Condition. We aimed to identify core outcomes for Post COVID-19 Condition that stakeholders considered critical to assess in all research studies and clinical practice. Methods: We conducted a multi-step study: (1) review of outcomes reported in studies of Post COVID-19 Condition to develop a list of potential core outcomes;(2) outcomes were then grouped, using the COMET taxonomy, to present in a consensus process;(3) a two-round online international modified Delphi consensus process, including 3 stakeholder groups (‘people with Post COVID-19 Condition and their carers’, ‘healthcare professionals and researchers’ and ‘healthcare professionals and researchers with Post COVID-19 Condition) to prioritise outcomes;and (4) an international online consensus meeting to finalize the core outcome set. Consensus ‘in’ was defined, a priori, as 80% or more of each stakeholder group rating an outcome as critical (‘7-9’ on a 9-point scale). Patient engagement and global outreach activities were undertaken at all stages of the project. Findings: 1535 participants from 71 countries, representing six continents, were involved in the online modified Delphi process, with 1148 participating in both rounds (75% completion rate). Eleven of 24 outcomes met consensus ‘in’ criteria after the two Delphi rounds and consensus meeting: fatigue or exhaustion;pain;post-exertion symptoms;work/occupational and study changes;survival;and “functioning, symptoms and conditions” for each of the following outcomes: cardiovascular, respiratory, nervous system, cognition, mental and physical. ‘Recovery’ outcome was added ‘a-priori’ as a part of previously published COS on COVID-19. Interpretation: This international study resulted in the development of a COS for Post COVID-19 Condition using a rigorous methodology. The generated consensus-based list of core outcomes should be assessed in clinical research and practice settings. The next step for the development of this COS will be to determine which measurement instruments best measure these outcomes. Funding Information: Funding by the National Institute for Health Research (NIHR) (Grant COV-LT2-0072) supporting the second stage of the process. Declaration of Interests: None to declare.

6.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-323979

ABSTRACT

Background: While numerous point-of-admission disease severity models for COVID-19 have been proposed, disease stratification that accounts for changes in a patient’s condition while in hospital is urgently needed to facilitate patient management and resource allocation.Methods: We developed a prognostic model for 48-hour in-hospital mortality using 473 consecutive patients with COVID-19 presenting to a UK hospital between March 1 and September 12, 2020;and temporally validated using data on 405 patients presenting between September 13, 2020 and January 3, 2021.The primary outcome was all-cause in-hospital mortality. We additionally considered the competing risks of discharge from hospital and transfer to a tertiary Intensive Care Unit for extracorporeal membrane oxygenation. We adopted a landmarking approach to dynamic prediction that accounts for competing risks and informative missingness, and selected predictors using penalised regression. The model estimates, at any point during a hospital visit, the probability of in-hospital mortality during the next 48 hours.Results: Our final model includes age, Clinical Frailty Scale score, heart rate, respiratory rate, SpO2/FiO2 ratio, white cell count, presence of acidosis (pH < 7.35) and Interleukin-6. Internal validation achieved an AUROC of 0.90 (95% CI 0.87–0.93) and temporal validation gave an AUROC of 0.91 (95% CI 0.88-0.95). Interpretation: Our model uniquely incorporates both static risk factors (e.g. age) and evolving clinical and laboratory data, to provide a dynamic risk prediction model that adapts to both sudden and gradual changes in an individual patient’s clinical condition. External validation outside the study hospital will be required before adoption.Funding: NIHR Cambridge Biomedical Research Centre, UKRI Medical Research CouncilDeclaration of Interest: None to declare. Ethical Approval: The study was approved by a UK Health Research Authority ethics committee (20/WM/0125). Patient consent was waived because the de-identified data presented here were collected during routine clinical practice;there was no requirement for informed consent.

7.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-318443

ABSTRACT

Introduction: We describe the clinical features and inpatient trajectories of older adults hospitalized with COVID-19, and explore relationships with frailty. Methods: This retrospective observational study included older adults admitted as an emergency to a University Hospital who were diagnosed with COVID-19. Patient characteristics and hospital outcomes, primarily inpatient death or death within 14 days of discharge, were described for the whole cohort and by frailty status. Associations with mortality were further evaluated using Cox Proportional Hazards Regression (Hazard Ratio [HR], 95% Confidence Interval). Results: 214 patients (94 women) were included of whom 142 (66.4%) were frail with a median Clinical Frailty Scale (CFS) score of 6. Frail compared to non-frail patients were more likely to present with atypical symptoms including new or worsening confusion (45.1% vs 20.8%, p<0.001) and were more likely to die (66% vs 16%, p=0.001). Older age, being male, presenting with high illness acuity and high frailty were independent predictors of death and a dose-response association between frailty and mortality was observed (CFS 1-4: reference;CFS 5-6: HR 1.78, 95% CI 0.90, 3.53;CFS 7-8: HR 2.57, 95% CI 1.26, 5.24). Conclusions: Clinicians should have a low threshold for testing for COVID-19 in older and frail patients during periods of community viral transmission and diagnosis should prompt early advanced care planning.

8.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-318442

ABSTRACT

Background: A comprehensive description of the clinical characteristics, inpatient trajectory and relationship with frailty of older inpatients admitted with COVID-19 is essential in the management of older adults during the COVID-19 pandemic. The aim of this study was to describe the clinical features and inpatient trajectory of older inpatients with confirmed COVID -19. Methods: This was a retrospective observational study of hospitalised older adults. Subjects include unscheduled medical admissions of older inpatients to a University Hospital with laboratory and clinically confirmed COVID-19. The primary outcome was death during the inpatient stay or within 14 days of discharge after a maximum follow up time of 45 days. The characteristics of the cohort were described in detail as a whole and by frailty status. Results: 214 patients were included in this study with a mean length of stay of 11 days (Range 6 to 18 days), of whom 140 (65.4%) patients were discharged and 74 (34.6%) patients died in hospital. 142 (66.4%) patients were frail with median Clinical Frailty Scale (CFS) score of 6. Frail patients were more likely to present with atypical symptoms including new or worsening confusion compared to non-frail patients (20.8% vs 45.1%, p<0.001) and were more likely to die in hospital or within 14 days of discharge (66% vs 16%, p=0.001). Older age, being male, presenting with high illness acuity and high frailty were all independently associated with higher risk of death and a dose response association between higher frailty and higher mortality was observed. Conclusions: Older adult inpatients with COVID-19 infection are likely to present with atypical symptoms, experience delirium and have a high mortality, especially if they are also living with frailty. Clinicians should have a low threshold for testing for COVID-19 in older and frail patients presenting to hospital as an emergency during periods when there is community transmission of COVID-19 and, when diagnosed, this should prompt early advanced care planning with the patient and family.

10.
BMJ ; 372: n526, 2021 03 01.
Article in English | MEDLINE | ID: covidwho-1112324

ABSTRACT

CLINICAL QUESTION: What is the role of drugs in preventing covid-19? WHY DOES THIS MATTER?: There is widespread interest in whether drug interventions can be used for the prevention of covid-19, but there is uncertainty about which drugs, if any, are effective. The first version of this living guideline focuses on the evidence for hydroxychloroquine. Subsequent updates will cover other drugs being investigated for their role in the prevention of covid-19. RECOMMENDATION: The guideline development panel made a strong recommendation against the use of hydroxychloroquine for individuals who do not have covid-19 (high certainty). HOW THIS GUIDELINE WAS CREATED: This living guideline is from the World Health Organization (WHO) and provides up to date covid-19 guidance to inform policy and practice worldwide. Magic Evidence Ecosystem Foundation (MAGIC) provided methodological support. A living systematic review with network analysis informed the recommendations. An international guideline development panel of content experts, clinicians, patients, an ethicist and methodologists produced recommendations following standards for trustworthy guideline development using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. UNDERSTANDING THE NEW RECOMMENDATION: The linked systematic review and network meta-analysis (6 trials and 6059 participants) found that hydroxychloroquine had a small or no effect on mortality and admission to hospital (high certainty evidence). There was a small or no effect on laboratory confirmed SARS-CoV-2 infection (moderate certainty evidence) but probably increased adverse events leading to discontinuation (moderate certainty evidence). The panel judged that almost all people would not consider this drug worthwhile. In addition, the panel decided that contextual factors such as resources, feasibility, acceptability, and equity for countries and healthcare systems were unlikely to alter the recommendation. The panel considers that this drug is no longer a research priority and that resources should rather be oriented to evaluate other more promising drugs to prevent covid-19. UPDATES: This is a living guideline. New recommendations will be published in this article and signposted by update notices to this guideline. READERS NOTE: This is the first version of the living guideline for drugs to prevent covid-19. It complements the WHO living guideline on drugs to treat covid-19. When citing this article, please consider adding the update number and date of access for clarity.


Subject(s)
COVID-19/prevention & control , Chemoprevention , Hydroxychloroquine/pharmacology , Risk Assessment , COVID-19/epidemiology , Chemoprevention/methods , Chemoprevention/standards , Clinical Decision-Making/methods , Humans , Immunologic Factors/pharmacology , SARS-CoV-2/drug effects , Uncertainty , World Health Organization
11.
Geriatrics (Basel) ; 6(1)2021 Feb 01.
Article in English | MEDLINE | ID: covidwho-1060010

ABSTRACT

INTRODUCTION: We describe the clinical features and inpatient trajectories of older adults hospitalized with COVID-19 and explore relationships with frailty. METHODS: This retrospective observational study included older adults admitted as an emergency to a University Hospital who were diagnosed with COVID-19. Patient characteristics and hospital outcomes, primarily inpatient death or death within 14 days of discharge, were described for the whole cohort and by frailty status. Associations with mortality were further evaluated using Cox Proportional Hazards Regression (Hazard Ratio (HR), 95% Confidence Interval). RESULTS: 214 patients (94 women) were included of whom 142 (66.4%) were frail with a median Clinical Frailty Scale (CFS) score of 6. Frail compared to nonfrail patients were more likely to present with atypical symptoms including new or worsening confusion (45.1% vs. 20.8%, p < 0.001) and were more likely to die (66% vs. 16%, p = 0.001). Older age, being male, presenting with high illness acuity and high frailty were independent predictors of death and a dose-response association between frailty and mortality was observed (CFS 1-4: reference; CFS 5-6: HR 1.78, 95% CI 0.90, 3.53; CFS 7-8: HR 2.57, 95% CI 1.26, 5.24). CONCLUSIONS: Clinicians should have a low threshold for testing for COVID-19 in older and frail patients during periods of community viral transmission, and diagnosis should prompt early advanced care planning.

12.
BMJ ; 370: m3379, 2020 09 04.
Article in English | MEDLINE | ID: covidwho-744846

ABSTRACT

UPDATES: This is the tenth version (ninth update) of the living guideline, replacing earlier versions, available as data supplements. New recommendations will be published as updates to this guideline. CLINICAL QUESTION: What is the role of drugs in the treatment of patients with covid-19? CONTEXT: The evidence base for therapeutics for covid-19 is evolving with numerous recently completed randomised controlled trials (RCTs). In this update the Guideline Development Group (GDG) developed new recommendations for patients with non-severe covid-19, concerning the use of nirmatrelvir/ritonavir (2 RCTs, 3100 participants) and remdesivir (5 RCTs, 2710 participants). We have also revised the structure of the guideline to accommodate for an increasing number of effective treatment options to choose between. NEW RECOMMENDATION: • Nirmatrelvir/ritonavir: a strong recommendation for its use in patients at highest risk of hospitalisation; and a conditional recommendation against its use in patients at low risk of hospitalisation. In the absence of trial data, no recommendation on nirmatrelvir/ritonavir was made in patients with severe or critical illness. • Remdesivir: a conditional recommendation for its use in patients at highest risk of hospitalisation. UNDERSTANDING THE NEW RECOMMENDATIONS: In patients with non-severe illness at highest risk of hospitalisation, the recommendations for treatment with nirmatrelvir/ritonavir and remdesivir reflect what the GDG considered to be important reductions in admission to hospital (moderate certainty) with little or no impact on mortality, mechanical ventilation, time to symptom resolution (low to very low certainty), and adverse effects leading to drug discontinuation (high certainty for nirmatrelvir/ritonavir, moderate certainty for remdesivir), though diarrhoea and altered taste were noted more often with nirmatrelvir/ritonavir. Several treatment alternatives are now available for patients with non-severe covid-19 at highest risk of hospitalisation. In the absence of direct comparisons in trials, indirect comparisons from the living network meta-analysis have been used to inform the use of one drug over another with a related mechanism of action. Choices will depend on availability of the drugs, routes of administration (only intravenous for remdesivir), duration of treatment, and time from onset of symptoms to starting treatment in the trials. The strong recommendation for nirmatrelvir/ritonavir reflects what the GDG considered to represent a superior choice over other treatment options for those with non-severe illness at highest risk; it may prevent more hospitalisations than the alternatives, has fewer harms than molnupiravir, and is easier to administer than intravenous options such as remdesivir and the monoclonal antibodies. For monoclonal antibodies, efficacy may depend on the given SARS-CoV-2 variant, with a less certain benefit seen with the omicron BA1-2 variant which is dominating in many regions. There are no clinical data on combination treatment, and currently the GDG advises against combining antivirals in the absence of supporting evidence. UPDATES TO PRIOR RECOMMENDATIONS: The conditional (weak) recommendation for remdesivir in patients with non-severe illness at highest risk of hospitalisation replaces a previous conditional recommendation against treatment with remdesivir in all patients with covid-19 regardless of disease severity. The recommendation for patients with severe or critical illness is being updated using new evidence. PRIOR RECOMMENDATIONS: • Recommended for patients with severe or critical covid-19­a strong recommendation for systemic corticosteroids; a strong recommendation for IL-6 receptor blockers (tocilizumab or sarilumab), in combination with corticosteroids; a strong recommendation for baricitinib as an alternative to IL-6 receptor blockers, in combination with corticosteroids; and a conditional recommendation for casirivimab-imdevimab, for those with seronegative status, (where rapid viral genotyping is available to confirm infection with a susceptible SARS-CoV-2 variant). • Recommended for patients with non-severe covid-19­conditional recommendations for those at highest risk of hospitalisation for molnupiravir; sotrovimab; and for casirivimab-imdevimab (where rapid viral genotyping is available to confirm infection with a susceptible SARS-CoV-2 variant). • Not recommended for patients with non-severe covid-19­a conditional recommendation against systemic corticosteroids; and a strong recommendation against convalescent plasma. • Not recommended for patients with severe or critical covid-19­a recommendation against convalescent plasma, except in the context of a clinical trial; and a conditional recommendation against ruxolitinib and tofacitinib. • Not recommended, regardless of covid-19 disease severity­a strong recommendation against hydroxychloroquine; a strong recommendation against lopinavir/ritonavir; and a recommendation against ivermectin, except in the context of a clinical trial. ABOUT THIS GUIDELINE: This living guideline from the World Health Organization (WHO) incorporates new recommendations on two drugs for covid-19 and updates existing recommendations. The GDG typically evaluates a therapy when WHO judges sufficient evidence is available to make a recommendation. While the GDG takes an individual patient perspective in making recommendations, it also considers resource implications, acceptability, feasibility, equity, and human rights. This guideline was developed according to standards and methods for trustworthy guidelines making use of an innovative process to achieve efficiency in dynamic updating of recommendations. The methods are aligned with the WHO Handbook for Guideline Development and according to a pre-approved protocol (planning proposal) by the Guideline Review Committee (GRC). A box at the end of the article outlines key methodological aspects of the guideline process. MAGIC Evidence Ecosystem Foundation provides methodological support, including the coordination of living systematic reviews with network meta-analyses to inform the recommendations. The full version of the guideline is available online in MAGICapp and in PDF, with a summary version here in The BMJ.


Subject(s)
Adrenal Cortex Hormones/therapeutic use , Betacoronavirus , Coronavirus Infections/drug therapy , Pneumonia, Viral/drug therapy , COVID-19 , Humans , Pandemics , SARS-CoV-2 , World Health Organization
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