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INTRODUCTION: Previous studies suggest that delayed initiation of extracorporeal membrane oxygenation (ECMO) is associated with higher patient mortality. Hence, we hypothesized that prolonged invasive mechanical ventilation (IMV) prior to ECMO was associated with higher mortality in patients with COVID-19. METHOD(S): The COVID-19 Critical Care Consortium, a prospective international multicenter registry, was queried for all patients with COVID-19 infection who received IMV and ECMO. Patients who were intubated prior to transfer to a study site were excluded. The primary variable was number of days on IMV prior to ECMO initiation and study endpoint was death or discharge from the study site. Cox proportional hazards model for the time between ECMO initiation and death was built using covariates including age, gender, selected comorbidities, and time intervals from ICU admission to IMV and IMV to ECMO initiation. RESULT(S): Between 1/1/2020 and 6/6/2022, A total of 593 patients from 107 study sites and 25 countries were included in the analysis. In this cohort, the median age was 50 (Interquartile range [IQR]: 40-58) years. Obesity and hypertension were prevalent among 220 (38.4%) and 223 (38.8%) of the patients, respectively. Twenty-four (4.2%) patients had chronic pulmonary disease. Prior to ECMO initiation, patients spent a median of 3.68 (IQR: 1.36-8.07) days in the ICU and a median of 2.49 (IQR: 0.88-5.65) days on IMV. Overall mortality was 47.2% with 3.9% patients' status not finalized or unknown. According to the final survival model, the number of days on IMV prior to ECMO initiation was not associated with mortality. The hazard ratios for 0, 3, 7, and 14 days of pre-ECMO IMV were 0.94 (95% confidence interval [CI]: 0.83 to 1.07), 1.02 (95% CI: 0.97 to 1.08), 1.09 (95% CI: 0.92 to 1.3) and 1.09 (95% CI: 0.83 to 1.42), respectively. Other noticeable contributory factors in the model included age and gender. CONCLUSION(S): Among patients with COVID-19 who received ECMO, the length of pre-ECMO IMV was not associated with hospital mortality. Further studies evaluating the ventilator settings before and after ECMO initiation are needed.
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Digital health has accelerated, in part, due to the recent COVID-19 pandemic in terms of both implementation and acceptability. However, while digitalization in healthcare brings an opportunity to improve the quality of care, this creates a need for sustainability through funding of these technologies by healthcare payers. Traditional innovations such as pharmaceuticals are rigorously evaluated by health technology assessment (HTA) bodies in many countries to advise payers on how scarce funds can be efficiently distributed. The aim of this study was to review the HTA evidence frameworks being applied by HTA bodies or payers for the evaluation of digital health interventions. We reviewed recent literature and the websites of the leading payer and HTA bodies to understand the frameworks which have been used for the evaluation of digital health innovations. We found that 6 frameworks directly addressed digital health technologies for the purposes of pricing and reimbursement. Building on previous work, we reviewed the context and evidence domains of each framework. The evidence requirements of the included frameworks were diverse, and their domains extended the European Network for Health Technology Assessment (EUnetHTA) Core HTA Model. Our research concluded that while some frameworks exist, they require additional refinement to ensure that the level of evidence is commensurate with the technology being assessed and that relevant stakeholders are included to more holistically assess the outcomes produced. Developers of digital health technologies need to be aware of the evidence requirements by payers or HTA bodies, which differ from HTA requirements for traditional health technologies and may represent additional hurdle before entering publicly financed healthcare markets. © 2022, Budapest Tech Polytechnical Institution. All rights reserved.
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Objectives: the COVID pandemic has accelerated the uptake of digital health interventions (DHIs) in healthcare systems. The aim of this rapid review is to provide an overview about the evidence frameworks required by payers when assessing DHIs. Methods: we reviewed recent literature and the websites of the leading payer and HTA bodies (Australia, Canada, Western Europe) for evidence frameworks which have been developed for the evaluation of DHIs. We sought whether and how the following evidence framework domains were covered: health problem and comparator, safety, clinical effectiveness as well as patient and social, economic, legal, ethical, organizational and technical / stability aspects, usability, data security and interoperability. Results: as of September 2021, we identified 6 evidence frameworks specific to reimbursement decisions concerning DHIs from Australia (Medical Services Advisory Committee, MSAC), Belgium (National Institute for Health and Disability Insurance, RIZIV), Germany (Federal Institute for Drugs and Medical Devices / Directory of Reimbursable Digital Health Applications, BfARM / DiGa), Finland (Finnish Coordination Centre for Health Technology Assessment, FinCCHTA), France (French National Authority for Health,HAS) and the United Kingdom (National Institute for Health and Care Excellence, NICE). All frameworks specified requirements concerning the health problem and comparator, safety, clinical effectiveness as well as patient and social aspects. Four-four frameworks covered legal and ethical aspects (Australia, Belgium, Germany, United Kingdom) as well as organizational aspects, data security and interoperability (Australia, Belgium, Germany, Finland) and technical aspects / stability (Australia, Germany, Finland, France). Usability was covered by only three frameworks (Australia, Germany, Finland). Conclusions: The evidence frameworks for DHIs require a wider perspective than is often applied to pharmaceuticals. However, they require additional refinement to ensure that the level of evidence is commensurate with the technology being assessed and that relevant stakeholders are included to assess more holistically produced outcomes.
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Objectives: To evaluate the epidemiology of rapid response team (RRT) reviews that led to intensive care unit (ICU) admissions, and to evaluate the frequency of in-hospital cardiac arrests (IHCAs) among ICU patients with confirmed coronavirus disease 2019 (COVID-19) in Australia. Design: Multicentre, retrospective cohort study. Setting: 48 public and private ICUs in Australia. Participants: All adults (aged ≥ 16 years) with confirmed COVID-19 admitted to participating ICUs between 25 January and 31 October 2020, as part of SPRINT-SARI (Short PeRiod IncideNce sTudy of Severe Acute Respiratory Infection) Australia, which were linked with ICUs contributing to the Australian and New Zealand Intensive Care Society Adult Patient Database (ANZICS APD). Main outcome measures and results: Of the 413 critically ill patients with COVID-19 who were analysed, 48.2% (199/413) were admitted from the ward and 30.5% (126/413) were admitted to the ICU following an RRT review. Patients admitted following an RRT review had higher Acute Physiology and Chronic Health Evaluation (APACHE) scores, fewer days from symptom onset to hospitalisation (median, 5.4 [interquartile range (IQR), 3.2–7.6] v 7.1 days [IQR, 4.1–9.8];P < 0.001) and longer hospitalisations (median, 18 [IQR, 11–33] v 13 days [IQR, 7–24];P < 0.001) compared with those not admitted via an RRT review. Admissions following RRT review comprised 60.3% (120/199) of all ward-based admissions. Overall, IHCA occurred in 1.9% (8/413) of ICU patients with COVID-19, and most IHCAs (6/8, 75%) occurred during ICU admission. There were no differences in IHCA rates or in ICU or hospital mortality rates based on whether a patient had a prior RRT review or not. Conclusions: This study found that RRT reviews were a common way for deteriorating ward patients with COVID-19 to be admitted to the ICU, and that IHCA was rare among ICU patients with COVID-19. © 2022, College of Intensive Care Medicine. All rights reserved.
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Objective: To compare the characteristics, treatments and 6-month functional outcomes of patients with coronavirus disease 2019 (COVID-19) versus non-COVID-19 viral pneumonitis supported by venovenous extracorporeal membrane oxygenation (VV-ECMO). Design: Prospective, observational cohort study in seven intensive care units (ICUs) across Australia. Participants: Patients admitted to participating ICUs with laboratory-confirmed COVID-19 or viral pneumonitis requiring VV-ECMO. Results: From 30 March 2019 to 31 December 2020, 13 patients were initiated on VV-ECMO for COVID-19 and 23 were initiated for non-COVID-19 viral pneumonitis. Patients with COVID-19 were older and had a longer duration from intubation to ECMO initiation, but had similar illness severity and APACHE IV scores at the time of initiation. Overall disability, health-related quality of life, and mortality were similar, but ICU and hospital length of stay were significantly longer in patients with COVID-19. Conclusions: Six-month functional outcomes and mortality were similar between COVID-19 and viral pneumonitis patients treated with VV-ECMO. However, length of stay was longer in COVID-19 patients, which may have resource implications.
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Objective: To assess the performance of the UK International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC) Coronavirus Clinical Characterisation Consortium (4C) Mortality Score for predicting mortality in Australian patients with coronavirus disease 2019 (COVID-19) requiring intensive care unit (ICU) admission. Design: Multicentre, prospective, observational cohort study. Setting: 78 Australian ICUs participating in the SPRINT-SARI (Short Period Incidence Study of Severe Acute Respiratory Infection) Australia study of COVID-19. Participants: Patients aged 16 years or older admitted to participating Australian ICUs with polymerase chain reaction (PCR)confirmed COVID-19 between 27 February and 10 October 2020. Main outcome measures: ISARIC-4C Mortality Score, calculated at the time of ICU admission. The primary outcome was observed versus predicted in-hospital mortality (by 4C Mortality and APACHE II). Results: 461 patients admitted to a participating ICU were included. 149 (32%) had complete data to calculate a 4C Mortality Score without imputation. Overall, 61/461 patients (13.2%) died, 16.9% lower than the comparable ISARIC-4C cohort in the United Kingdom. In patients with complete data, the median (interquartile range [IQR]) 4C Mortality Score was 10.0 (IQR, 8.0-13.0) and the observed mortality was 16.1% (24/149) versus 22.9% median predicted risk of death. The 4C Mortality Score discriminatory performance measured by the area under the receiver operating characteristic curve (AUROC) was 0.79 (95% CI, 0.68-0.90), similar to its performance in the original ISARIC-4C UK cohort (0.77) and not superior to APACHE II (AUROC, 0.81;95% CI, 0.75-0.87). Conclusions: When calculated at the time of ICU admission, the 4C Mortality Score consistently overestimated the risk of death for Australian ICU patients with COVID-19. The 4C Mortality Score may need to be individually recalibrated for use outside the UK and in different hospital settings. Crit Care Resusc 2021;23 (4): 403-13
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Objective: To report longitudinal differences in baseline characteristics, treatment, and outcomes in patients with coronavirus disease 2019 (COVID-19) admitted to intensive care units (ICUs) between the first and second waves of COVID-19 in Australia. Design, setting and participants: SPRINT-SARI Australia is a multicentre, inception cohort study enrolling adult patients with COVID-19 admitted to participating ICUs. The first wave of COVID-19 was from 27 February to 30 June 2020, and the second wave was from 1 July to 22 October 2020. Results: A total of 461 patients were recruited in 53 ICUs across Australia;a higher number were admitted to the ICU during the second wave compared with the first: 255 (55.3%) versus 206 (44.7%). Patients admitted to the ICU in the second wave were younger (58.0 v 64.0 years;P = 0.001) and less commonly male (68.9% v 60.0%;P = 0.045), although Acute Physiology and Chronic Health Evaluation (APACHE) II scores were similar (14 v 14;P = 0.998). High flow oxygen use (75.2% v 43.4%;P < 0.001) and non-invasive ventilation (16.5% v 7.1%;P = 0.002) were more common in the second wave, as was steroid use (95.0% v 30.3%;P < 0.001). ICU length of stay was shorter (6.0 v 8.4 days;P = 0.003). In-hospital mortality was similar (12.2% v 14.6%;P = 0.452), but observed mortality decreased over time and patients were more likely to be discharged alive earlier in their ICU admission (hazard ratio, 1.43;95% CI, 1.13–1.79;P = 0.002). Conclusion: During the second wave of COVID-19 in Australia, ICU length of stay and observed mortality decreased over time. Multiple factors were associated with this, including changes in clinical management, the adoption of new evidence-based treatments, and changes in patient demographic characteristics but not illness severity. © 2021, College of Intensive Care Medicine. All rights reserved.
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Introduction: The AFTERCOR study was developed by the COVID-19 Critical Care Consortium (>7000 intensive care unit [ICU] and >400 extracorporeal membrane oxygenation [ECMO] patients currently) to enhance understanding of occurrence and progression of long-term dysfunction post-COVID-19. Design: Prospective longitudinal (24 months) study of ICU survivors of COVID-19 to describe recovery of the following aspects: a) health-related quality of life b) dynamics of organ dysfunction and recovery and c) pulmonary function. Countries involved Italy, Spain, Ireland, Austria, South Africa, Australia, USA, Argentina, Brazil, Colombia. Protocol specifics available at https://www.aftercorstudy.com. Inclusion Criteria: 1) COVID-19 infection requiring ICU admission;2) informed consent;3) age ≥18 years. Exclusion Criteria: 1) pregnancy;2) pre-COVID paralysis;3) history of pulmonary resection;4) prior lung transplant;5) inability to perform 6-min walk test or participate in interview. Methods: Goal enrollment is 1000 patients. Follow-up visits are at 3, 6, 12, 18 and 24-month post-ICU discharge. Assessments include: 1) Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36);2) Montreal Cognitive Assessment;3) any subsequent admission 4) St. George's Respiratory Questionnaire;5) Pulmonary function testing;6) chest radiography;7) 6-minute-walk test;8) Patient Health Questionnaire 9 (PHQ-9) and 9) full blood count and biochemistry. CT chest at 6 months and repeat ECHO at 3, 12 and 24 months if performed during COVID-19 hospitalization. If results are normal, subsequent testing will not be performed. Summary: The AFTERCOR study represents a comprehensive evaluation for long-term effects from COVID-19. Interested centers are sought and invited to participate.
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Background: Funerals are a fundamental component of cultural and religious mourning systems that facilitate the offering of support to the bereaved. Those who are bereaved during the COVID-19 pandemic are subject to restrictions on funeral sizes and practices. It is possible that being unable to participate in funerals, rituals, and ceremonies will have a detrimental effect on the bereaved, affecting their mental health and ability to cope with or process their grief. Aim: To synthesize evidence on the impact of funeral practices on bereaved friends and relatives' mental health and experience of bereavement, and consider implications for the COVID-19 pandemic. Methods: We conducted a rapid systematic review according to PRISMA guidelines, synthesising the quantitative and qualitative evidence regarding the effect of funeral practices on bereaved relatives' mental health and bereavement outcomes. Searches of MEDLINE, PsycINFO, KSR Evidence, and COVID-related resources were conducted on 24/4/2020. Results: 805 records were screened;17 studies of variable quality were included. Current evidence regarding the effect of funeral practices on bereaved relatives' mental health and bereavement outcomes is inconclusive. Five observational studies found benefits from funeral participation while six did not. However, qualitative research provides additional insight: the benefit of after-death rituals including funerals depends on the ability of the bereaved to shape those rituals and say goodbye in a way which is meaningful for them, and on whether the funeral demonstrates social support for the bereaved. Discussion: Our findings suggest that restrictions to funeral practices do not necessarily entail poor outcomes or experiences for bereaved people. As well as access to bereavement support and sign-posting to specialist services, palliative care and bereavement teams should provide locally-relevant information regarding the creation of meaningful, culturally appropriate funerals.
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Rationale Heterogeneous respiratory system static compliance (CRS) values and levels of hypoxemia in patients with novel coronavirus disease (COVID-19) requiring mechanical ventilation have been reported in previous smallcase series or studies conducted at a national level.Methods We designed a retrospective observational cohort study with rapid data gathering from the international COVID-19 Critical Care Consortium study to comprehensively describe the impact of CRS on the ventilatory management and outcomes of COVID-19 patients on mechanical ventilation (MV), admitted to intensive care units (ICU) worldwide.Results We enrolled 318 COVID-19 patients enrolled into the study from January 14th through September 31th, 2020 in 19 countries and stratified into two CRS groups. CRS was calculated as: tidal volume/[airway plateau pressure-positive endexpiratory pressure (PEEP)] and available within 48h from commencement of MV in 318 patients. Patients were mean±SD of 58.0±12.2, predominantly from Europe (54%) and males (68%). Median CRS (IQR) was 34.1 mL/cmH2O (26.5-45.5) and PaO2/FiO2 was 119 mmHg (87.1-164) and was not correlated with CRS. Female sex presented lower CRS than in males (95% CI:-13.8 to-8.5 P<0.001) and higher body mass index (34.7±10.9 vs 29.1±6.0, p<0.001). Median (IQR) PEEP was 12 cmH2O (10-15), throughout the range of CRS, while median (IQR) driving pressure was 12.3 (10-15) cmH2O and significantly decreased as CRS improved (p<0.001). No differences were found in comorbidities and clinical management between CRS strata. In addition, 28-day ICU mortality and hospital mortality did not differ between CRSgroups.Conclusions This multicentre report provides a comprehensive account of CRS in COVID-19 patients on MV-predominantly males or overweight females, in their late 50s-admitted to ICU during the first international outbreaks. Phenotypes associated with different CRS upon commencement of MV could not be identified.
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Rationale: Patients with COVID-19 commonly develop severe hypoxemic respiratory failure and require invasive mechanical ventilation (MV). The disease burden and predictors of mortality in this population remain uncertain. Methods: Prospective observational cohort study from 139 intensive care units of the international COVID-19 Critical Care Consortium. Patients enrolled from January 14th through November 31st 2020 were included in the analysis. Patient's characteristics and clinical data were assessed. Multivariable Cox proportional hazards analysis was conducted to identify indipendent predictors of mortality within 28 days from commencement of MV. Results: 1578 patients on MV were included into the analysis. Mean±SD age was 59 years±13 and patients were predominantly males (66%). 542 Patients (34.4%) died within 28 days from commencement of MV. Nonsurvivors were slightly older (mean age±SD 62±13 vs. 59±13) and presented more frequently hypertension, chronic cardiac disease and diabetes. Median (IQR) PaO2/FiO2 upon commencement of MV was 96 (68-135) and 111 (81-173) in patients who did not survive vs. survivors, respectively (p=0.04). ECMO (13% vs 25%, p<0.01), inhaled nitric oxide (11% vs 15%, p=0.02) and recruitment manoeauvres (26% vs 31%, p<0.01) were used less frequently in patients who did not survive. Independent risk factors associated with 28-day mortality included age older than 70 years (hazard ratio [HR], 2.83;95% CI, 1.32-6.07), higher creatinine levels upon ICU admission (HR, 1.20;95% CI, 1.03-1.40), and lower pH within 24h from commencement of MV (HR, 0.12;95% CI, 0.02-0.62), while a shorter period (day) from early symptoms to hospitalisation reduced mortality risks (HR, 0.96;95% CI, 0.93-0.99). Conclusions: Our findings from a large international cohort of critically-ill COVID-19 patients on mechanical ventilation emphasises that elderly patients, not promptly admitted to the hospital, and who present higher creatinine levels and acidosis are at higher risk of mortality.
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Objectives: COVID-19 has accelerated the use of digital health, however, there is no universally accepted definition. The objective of this scoping review was to provide an overview of definitions in the literature including the context in which it exists e.g. public health organization, supplier organization, etc. to derive those which are aligned with the ISPOR mission of outcomes research. Methods: A literature search was undertaken for the past 5 years (2015-2020) on the major specific terms used in digital health (n=38) where these exist with synonyms of definition as a key term. Databases searched included Embase, PubMed/Medline, Cochrane Library and EconLit. A team of 2 volunteers independently reviewed each abstract to identify those which were likely to contain a definition or taxonomy and then reconciled any misalignment between the authors or referred the abstract to a third-party reviewer. Independent review by 2 volunteers was also employed to extract the relevant parameters in a recording spreadsheet from the full paper review. Results: From 2966 hits in the four different databases (Embase: n=2263;PubMed: n=657, Cochrane n=35, EconLit: n=11), the scoping review identified 2,610 original abstracts. Fifteen teams of two independent volunteers undertook the review of the abstracts. The agreement between the initial assessments of rater pairs was between 97.1% and 36.2%. Cohen’s kappa ranged from 0.91 to 0.11. A third reviewer reconciled disagreement in 73 (2.8%) citations. The number of abstracts taken through to the full paper review was 545 (20.9%). Conclusions: This timely work indicates that definitions included in the literature cover several terms which can be grouped under different applications of digital health. An overview of the different terms and their context to identify options which align with the ISPOR Mission will be presented.