CORONA (COre ultRasOund of covid in iNtensive care and Acute medicine) study: National service evaluation of lung and heart ultrasound in intensive care patients with suspected or proven COVID-19.

Background: Combined Lung Ultrasound (LUS) and Focused UltraSound for Intensive Care heart (FUSIC Heart - formerly Focused Intensive Care Echocardiography, FICE) can aid diagnosis, risk stratification and management in COVID-19. However, data on its application and results are limited to small studies in varying countries and hospitals. This United Kingdom (UK) national service evaluation study assessed how combined LUS and FUSIC Heart were used in COVID-19 Intensive Care Unit (ICU) patients during the first wave of the pandemic. Method: Twelve trusts across the UK registered for this prospective study. LUS and FUSIC Heart data were obtained, using a standardised data set including scoring of abnormalities, between 1st February 2020 to 30th July 2020. The scans were performed by intensivists with FUSIC Lung and Heart competency as a minimum standard. Data was anonymised locally prior to transfer to a central database. Results: 372 studies were performed on 265 patients. There was a small but significant relationship between LUS score >8 and 30-day mortality (OR 1.8). Progression of score was associated with an increase in 30-day mortality (OR 1.2). 30-day mortality was increased in patients with right ventricular (RV) dysfunction (49.4% vs 29.2%). Severity of LUS score correlated with RV dysfunction (p < 0.05). Change in management occurred in 65% of patients following a combined scan. Conclusions: In COVID-19 patients, there is an association between lung ultrasound score severity, RV dysfunction and mortality identifiable by combined LUS and FUSIC Heart. The use of 12-point LUS scanning resulted in similar risk score to 6-point imaging in the majority of cases. Our findings suggest that serial combined LUS and FUSIC Heart on COVID-19 ICU patients may aid in clinical decision making and prognostication.

Organizational resilience in healthcare: a review and descriptive narrative synthesis of approaches to resilience measurement and assessment in empirical studies.

BACKGROUND: The coronavirus pandemic has had a profound impact on organization and delivery of care. The challenges faced by healthcare organizations in dealing with the pandemic have intensified interest in the concept of resilience. While effort has gone into conceptualising resilience, there has been relatively little work on how to evaluate organizational resilience. This paper reports on an extensive review of approaches to resilience measurement and assessment in empirical healthcare studies, and examines their usefulness for researchers, policymakers and healthcare managers. METHODS: Various databases (MEDLINE, EMBASE, PsycINFO, CINAHL (EBSCO host), Cochrane CENTRAL (Wiley), CDSR, Science Citation Index, and Social Science Citation Index) were searched from January 2000 to September 2021. We included quantitative, qualitative and modelling studies that focused on measuring or qualitatively assessing organizational resilience in a healthcare context. All studies were screened based on titles, abstracts and full text. For each approach, information on the format of measurement or assessment, method of data collection and analysis, and other relevant information were extracted. We classified the approaches to organizational resilience into five thematic areas of contrast: (1) type of shock; (2) stage of resilience; (3) included characteristics or indicators; (4) nature of output; and (5) purpose. The approaches were summarised narratively within these thematic areas. RESULTS: Thirty-five studies met the inclusion criteria. We identified a lack of consensus on how to evaluate organizational resilience in healthcare, what should be measured or assessed and when, and using what resilience characteristic and indicators. The measurement and assessment approaches varied in scope, format, content and purpose. Approaches varied in terms of whether they were prospective (resilience pre-shock) or retrospective (during or post-shock), and the extent to which they addressed a pre-defined and shock-specific set of characteristics and indicators. CONCLUSION: A range of approaches with differing characteristics and indicators has been developed to evaluate organizational resilience in healthcare, and may be of value to researchers, policymakers and healthcare managers. The choice of an approach to use in practice should be determined by the type of shock, the purpose of the evaluation, the intended use of results, and the availability of data and resources.

Hospital at home: A systematic review of how medication management is conceptualised, described and implemented in practice-A study protocol.

INTRODUCTION: Hospital at Home (H@H) is a method of healthcare delivery, where hospital level interventions are conducted in the patient's usual place of residence, offering an alternative to hospital admission. This often includes the ability to perform point of care diagnostics and treat conditions using a range of treatments traditionally associated with hospital admission, including intravenous medicines and oxygen. H@H services have been established worldwide but there is a wide variation in definition and delivery models and currently no documented evidence supporting the delivery of medicines and medicines management within the H@H model. Therefore, this study aims to 1) describe how medication management in H@H is conceptulised, 2) describe and identify key components of medication management in H@H and 3) describe and identify variability in the implementation of medication management services within H@H models. METHODS AND ANALYSIS: We will search a range of databases (PubMed, Medline, Embase, CINAHL), publicly accessible documents and expert recommendations. Studies, reports and policy documents published between 1st January 2000 and 31st January 2022 will be included. Two independent reviewers will 1) screen and select studies based on a priori inclusion/exclusion, 2) conduct quality assessment using the Mixed Methods Appraisal Tool on included studies and 3) extract data. Inductive thematic analysis (objectives 1 and 2), the SEIPS 2.0 model (objective 2) and the Consolidated Framework for Implementation Research (objective 3) will be used to synthesise data. ETHICS AND DISSEMINATION: This systematic review will use secondary data sources from published documents, and as such research ethical approval was not required. We will disseminate the findings of this study in a peer-reviewed journal and national/international conference(s). TRIAL REGISTRATION: PROSPERO registration number: CRD42022300691. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022300691.

Hospital at home for acute medical illness: The 21st century acute medical unit for a changing population.

Recent trends across Europe show a year-on-year increase in the number of patients with acute medical illnesses presenting to hospitals, yet there are no plans for a substantial expansion in acute hospital infrastructure or staffing to address demand. Strategies to meet increasing demand need to consider the fact that there is limited capacity in acute hospitals and focus on new care models in both hospital and community settings. Increasing the efficiency of acute hospital provision by reducing the length of stay entails supporting acute ambulatory care, where patients receive daily acute care interventions but do not stay overnight in the hospitals. This approach may entail daily transfer between home and an acute setting for ongoing treatment, which is unsuitable for some patients living with frailty. Acute hospital at home (HaH) is a care model which, thanks to advances in point of care diagnostic capability, can provide a credible model of acute medical assessment and treatment without the need for hospital transfer. Investment and training to support scaling up of HaH are key strategic aims for integrated healthcare systems.

Examining the effect of evaluation sample size on the sensitivity and specificity of COVID-19 diagnostic tests in practice: a simulation study.

BACKGROUND: In response to the global COVID-19 pandemic, many in vitro diagnostic (IVD) tests for SARS-CoV-2 have been developed. Given the urgent clinical demand, researchers must balance the desire for precise estimates of sensitivity and specificity against the need for rapid implementation. To complement estimates of precision used for sample size calculations, we aimed to estimate the probability that an IVD will fail to perform to expected standards after implementation, following clinical studies with varying sample sizes. METHODS: We assumed that clinical validation study estimates met the 'desirable' performance (sensitivity 97%, specificity 99%) in the target product profile (TPP) published by the Medicines and Healthcare products Regulatory Agency (MHRA). To estimate the real-world impact of imprecision imposed by sample size we used Bayesian posterior calculations along with Monte Carlo simulations with 10,000 independent iterations of 5,000 participants. We varied the prevalence between 1 and 15% and the sample size between 30 and 2,000. For each sample size, we estimated the probability that diagnostic accuracy would fail to meet the TPP criteria after implementation. RESULTS: For a validation study that demonstrates 'desirable' sensitivity within a sample of 30 participants who test positive for COVID-19 using the reference standard, the probability that real-world performance will fail to meet the 'desirable' criteria is 10.7-13.5%, depending on prevalence. Theoretically, demonstrating the 'desirable' performance in 90 positive participants would reduce that probability to below 5%. A marked reduction in the probability of failure to hit 'desirable' specificity occurred between samples of 100 (19.1-21.5%) and 160 (4.3-4.8%) negative participants. There was little further improvement above sample sizes of 160 negative participants. CONCLUSION: Based on imprecision alone, small evaluation studies can lead to the acceptance of diagnostic tests which are likely to fail to meet performance targets when deployed. There is diminished return on uncertainty surrounding an accuracy estimate above a total sample size of 250 (90 positive and 160 negative).

Impact of the COVID-19 pandemic on emergency department attendances and acute medical admissions.

BACKGROUND: To better understand the impact of the COVID-19 pandemic on hospital healthcare, we studied activity in the emergency department (ED) and acute medicine department of a major UK hospital. METHODS: Electronic patient records for all adult patients attending ED (n = 243,667) or acute medicine (n = 82,899) during the pandemic (2020-2021) and prior year (2019) were analysed and compared. We studied parameters including severity, primary diagnoses, co-morbidity, admission rate, length of stay, bed occupancy, and mortality, with a focus on non-COVID-19 diseases. RESULTS: During the first wave of the pandemic, daily ED attendance fell by 37%, medical admissions by 30% and medical bed occupancy by 27%, but all returned to normal within a year. ED attendances and medical admissions fell across all age ranges; the greatest reductions were seen for younger adults in ED attendances, but in older adults for medical admissions. Compared to non-COVID-19 pandemic admissions, COVID-19 admissions were enriched for minority ethnic groups, for dementia, obesity and diabetes, but had lower rates of malignancy. Compared to the pre-pandemic period, non-COVID-19 pandemic admissions had more hypertension, cerebrovascular disease, liver disease, and obesity. There were fewer low severity ED attendances during the pandemic and fewer medical admissions across all severity categories. There were fewer ED attendances with common non-respiratory illnesses including cardiac diagnoses, but no change in cardiac arrests. COVID-19 was the commonest diagnosis amongst medical admissions during the first wave and there were fewer diagnoses of pneumonia, myocardial infarction, heart failure, cellulitis, chronic obstructive pulmonary disease, urinary tract infection and other sepsis, but not stroke. Levels had rebounded by a year later with a trend to higher levels of stroke than before the pandemic. During the pandemic first wave, 7-day mortality was increased for ED attendances, but not for non-COVID-19 medical admissions. CONCLUSIONS: Reduced ED attendances in the first wave of the pandemic suggest opportunities for reducing low severity presentations to ED in the future, but also raise the possibility of harm from delayed or missed care. Reassuringly, recent rises in attendance and admissions indicate that any deterrent effect of the pandemic on attendance is diminishing.

Improving the early identification of COVID-19 pneumonia: a narrative review.

Delayed presentation of COVID-19 pneumonia increases the risk of mortality and need for high-intensity healthcare. Conversely, early identification of COVID-19 pneumonia grants an opportunity to intervene early and thus prevent more complicated, protracted and less successful hospital admissions. To improve the earlier detection of COVID-19 pneumonia in the community we provide a narrative review of current evidence examining the clinical parameters associated with early disease progression. Through an evolving literature review, we examined: the symptoms that may suggest COVID-19 progression; the timing of deterioration; the utility of basic observations, clinical examination and chest X-ray; the value of postexertion oxygen saturations; and the use of CRP to monitor disease progression. We go on to discuss the challenges in monitoring the COVID-19 patient in the community and discuss thresholds for further assessment. Confusion, persistent fever and shortness of breath were identified as worrying symptoms suggestive of COVID-19 disease progression necessitating urgent clinical contact. Importantly, a significant proportion of COVID-19 pneumonia patients appear not to suffer dyspnoea despite severe disease. Patients with this asymptomatic hypoxia seem to have a poorer prognosis. Such patients may present with other signs of hypoxia: severe fatigue, exertional fatigue and/or altered mental status. We found duration of symptoms to be largely unhelpful in determining risk, with evidence of deterioration at any point in the disease. Basic clinical parameters (pulse, respiratory rate, blood pressure, temperature and oxygen saturations (SpO2)) are likely of high value in detecting the deteriorating community COVID-19 patient and/or COVID-19 mimickers/complications (eg, sepsis, bacterial pneumonia and pulmonary embolism). Of these, SpO2 carried the greatest utility in detecting COVID-19 progression. CRP is an early biochemical parameter predictive of disease progression and used appropriately is likely to contribute to the early identification of COVID-19 pneumonia. Identifying progressive COVID-19 in the community is feasible using basic clinical questions and measurements. As such, if we are to limit the mortality, morbidity and the need for complicated, protracted admissions, monitoring community COVID-19 cases for signs of deterioration to facilitate early intervention is a viable strategy.

NEWS2 to assess suspected COVID-19 in the community: a service evaluation of a primary care assessment centre.

BACKGROUND: Primary care has played a central role in the community response to the coronavirus disease-19 (COVID-19) pandemic. The use of the National Early Warning Score 2 (NEWS2) has been advocated as a tool to guide escalation decisions in the community. The performance of this tool applied in this context is unclear. AIM: To evaluate the process of escalation of care to the hospital within a primary care assessment centre (PCAC) designed to assess patients with suspected COVID-19 in the community. DESIGN AND SETTING: A retrospective service evaluation of all adult patients assessed between 30 March and 22 April 2020 within a COVID-19 primary care assessment centre within Sandwell West Birmingham CCG. METHOD: A database of patient demographics, healthcare interactions and physiological observations was constructed. NEWS2 and CRB65 scores were calculated retrospectively. The proportion of patients escalated was within risk groups defined by NHSE guidelines in place during the evaluation period was determined. RESULTS: A total of 150 patients were identified. Following assessment 13.3% (n = 20) patients were deemed to require escalation. The proportion of patients escalated with a NEWS2 greater than or equal to 3 was 46.9% (95% CI 30.8-63.6%). The proportion of patients escalated to secondary care using NHSE defined risk thresholds was 0% in the green group, 22% (n = 4) in the amber group, and 81.3% (n = 13) in the red group. CONCLUSION: Clinical decisions to escalate care to the hospital did not follow initial guidance written for the COVID-19 outbreak but were demonstrated to be safe.

In most cases, coronavirus disease-19 (COVID-19) is a mild illness that resolves on its own. Some patients develop severe disease requiring hospital treatment. Identifying which patients are likely to need hospital treatment is a challenge. Many GP practices have developed specific services designed to assess patients with suspected COVID-19 and establish whether hospital treatment is necessary. We evaluated a service providing this function in Birmingham. We examined the care pathway of 150 patients assessed within the service to established factors associated with the need for hospital assessment. We found a national decision tool designed to aid the process was a poor descriptor of what happened in practice.

Azithromycin versus standard care in patients with mild-to-moderate COVID-19 (ATOMIC2): an open-label, randomised trial.

BACKGROUND: The antibacterial, anti-inflammatory, and antiviral properties of azithromycin suggest therapeutic potential against COVID-19. Randomised data in mild-to-moderate disease are not available. We assessed whether azithromycin is effective in reducing hospital admission in patients with mild-to-moderate COVID-19. METHODS: This prospective, open-label, randomised superiority trial was done at 19 hospitals in the UK. We enrolled adults aged at least 18 years presenting to hospitals with clinically diagnosed, highly probable or confirmed COVID-19 infection, with fewer than 14 days of symptoms, who were considered suitable for initial ambulatory management. Patients were randomly assigned (1:1) to azithromycin (500 mg once daily orally for 14 days) plus standard care or to standard care alone. The primary outcome was death or hospital admission from any cause over the 28 days from randomisation. The primary and safety outcomes were assessed according to the intention-to-treat principle. This trial is registered at ClinicalTrials.gov (NCT04381962) and recruitment is closed. FINDINGS: 298 participants were enrolled from June 3, 2020, to Jan 29, 2021. Three participants withdrew consent and requested removal of all data, and three further participants withdrew consent after randomisation, thus, the primary outcome was assessed in 292 participants (145 in the azithromycin group and 147 in the standard care group). The mean age of the participants was 45·9 years (SD 14·9). 15 (10%) participants in the azithromycin group and 17 (12%) in the standard care group were admitted to hospital or died during the study (adjusted OR 0·91 [95% CI 0·43-1·92], p=0·80). No serious adverse events were reported. INTERPRETATION: In patients with mild-to-moderate COVID-19 managed without hospital admission, adding azithromycin to standard care treatment did not reduce the risk of subsequent hospital admission or death. Our findings do not support the use of azithromycin in patients with mild-to-moderate COVID-19. FUNDING: National Institute for Health Research Oxford Biomedical Research Centre, University of Oxford and Pfizer.

Protocol for a scoping review exploring the use of patient-reported outcomes in adult social care.

INTRODUCTION: Patient-reported outcomes (PROs) are measures of a person's own views of their health, functioning and quality of life. They are typically assessed using validated, self-completed questionnaires known as patient-reported outcome measures (PROMs). PROMs are used in healthcare settings to support care planning, clinical decision-making, patient-practitioner communication and quality improvement. PROMs have a potential role in the delivery of social care where people often have multiple and complex long-term health conditions. However, the use of PROMs in this context is currently unclear. The objective of this scoping review is to explore the evidence relating to the use of PROMs in adult social care. METHODS AND ANALYSES: The electronic databases Medline (Ovid), PsychInfo (Ovid), ASSIA (ProQuest), Social Care Online (SCIE), Web of Science and EMBASE (Ovid) were searched on 29 September 2020 to identify eligible studies and other publically available documents published since 2010. A grey literature search and hand searching of citations and reference lists of the included studies will also be undertaken. No restrictions on study design or language of publication will be applied. Screening and data extraction will be completed independently by two reviewers. Quality appraisal of the included documents will use the Critical Appraisal Skills Programme and AACODS (Authority, Accuracy, Coverage, Objectivity, Date, Significance) checklists. A customised data charting table will be used for data extraction, with analysis of qualitative data using the framework method. The review findings will be presented as tables and in a narrative summary. ETHICS AND DISSEMINATION: Ethical review is not required as scoping reviews are a form of secondary data analysis that synthesise data from publically available sources. Review findings will be shared with service users and other relevant stakeholders and disseminated through a peer-reviewed publication and conference presentations. This protocol is registered on the Open Science Framework (www.osf.io).

Measuring geographical disparities in England at the time of COVID-19: results using a composite indicator of population vulnerability.

OBJECTIVES: The growth of COVID-19 infections in England raises questions about system vulnerability. Several factors that vary across geographies, such as age, existing disease prevalence, medical resource availability and deprivation, can trigger adverse effects on the National Health System during a pandemic. In this paper, we present data on these factors and combine them to create an index to show which areas are more exposed. This technique can help policy makers to moderate the impact of similar pandemics. DESIGN: We combine several sources of data, which describe specific risk factors linked with the outbreak of a respiratory pathogen, that could leave local areas vulnerable to the harmful consequences of large-scale outbreaks of contagious diseases. We combine these measures to generate an index of community-level vulnerability. SETTING: 91 Clinical Commissioning Groups (CCGs) in England. MAIN OUTCOME MEASURES: We merge 15 measures spatially to generate an index of community-level vulnerability. These measures cover prevalence rates of high-risk diseases; proxies for the at-risk population density; availability of staff and quality of healthcare facilities. RESULTS: We find that 80% of CCGs that score in the highest quartile of vulnerability are located in the North of England (24 out of 30). Here, vulnerability stems from a faster rate of population ageing and from the widespread presence of underlying at-risk diseases. These same areas, especially the North-East Coast areas of Lancashire, also appear vulnerable to adverse shocks to healthcare supply due to tighter labour markets for healthcare personnel. Importantly, our index correlates with a measure of social deprivation, indicating that these communities suffer from long-standing lack of economic opportunities and are characterised by low public and private resource endowments. CONCLUSIONS: Evidence-based policy is crucial to mitigate the health impact of pandemics such as COVID-19. While current attention focuses on curbing rates of contagion, we introduce a vulnerability index combining data that can help policy makers identify the most vulnerable communities. We find that this index is positively correlated with COVID-19 deaths and it can thus be used to guide targeted capacity building. These results suggest that a stronger focus on deprived and vulnerable communities is needed to tackle future threats from emerging and re-emerging infectious disease.

A multi-centre open-label two-arm randomised superiority clinical trial of azithromycin versus usual care in ambulatory COVID-19: study protocol for the ATOMIC2 trial.

BACKGROUND: Azithromycin is an orally active synthetic macrolide antibiotic with a wide range of anti-bacterial, anti-inflammatory and antiviral properties. It is a safe, inexpensive, generic licenced drug available worldwide and manufactured to scale and is a potential candidate therapy for pandemic coronavirus disease 2019 (COVID-19). Azithromycin was widely used to treat severe SARS-CoV and MERS-CoV, but to date, no randomised data are available in any coronavirus infections. Other ongoing trials are exploring short courses of azithromycin either in early disease, within the first 7 days of symptoms, when azithromycin's antiviral properties may be important, or late in disease when anti-bacterial properties may reduce the risk of secondary bacterial infection. However, the molecule's anti-inflammatory properties, including suppression of pulmonary macrophage-derived pro-inflammatory cytokines such as interleukins-1ß, -6, -8, and -18 and cytokines G-CSF and GM-CSF may provide a distinct therapeutic benefit if given in as a prolonged course during the period of progression from moderate to severe disease. METHODS: ATOMIC2 is a phase II/III, multi-centre, prospective, open-label, two-arm randomised superiority clinical trial of azithromycin versus standard care for adults presenting to hospital with COVID-19 symptoms who are not admitted at initial presentation. We will enrol adults, ≥ 18 years of age assessed in acute hospitals in the UK with clinical diagnosis of COVID-19 infection where management on an ambulatory care pathway is deemed appropriate. Participants will be randomised in a 1:1 ratio to usual care or to azithromycin 500 mg orally daily for 14 days with telephone follow-up at days 14 and 28. The primary objective is to compare the proportion with either death or respiratory failure requiring invasive or non-invasive mechanical ventilation over 28 days from randomisation. Secondary objectives include mortality/respiratory failure in those with a PCR-confirmed diagnosis; all-cause mortality; progression to pneumonia; progression to severe pneumonia; peak severity of illness and mechanistic analysis of blood and nasal biomarkers. DISCUSSION: This trial will determine the clinical utility of azithromycin in patients with moderately severe, clinically diagnosed COVID-19 and could be rapidly applicable worldwide. TRIAL REGISTRATION: ClinicalTrials.gov NCT04381962 . Registered on 11 May 2020. EudraCT identifier 2020-001740-26 . Opened for accrual on 29 May 2020.