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1.
SSRN; 2022.
Preprint in English | SSRN | ID: ppcovidwho-332147

ABSTRACT

Background The neurological manifestations of COVID-19 have not been well characterized. Our goals were to determine the prevalence of neurological diagnoses among COVID-19 patients hospitalized in intensive care unit (ICU) and non-ICU settings and ascertain differences between adults and children. Methods We analysed the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) database, which collects data from 61 countries and 1507 sites. Analyses of neurological manifestations and neurological complications considered unadjusted prevalence estimates for predefined patient subgroups, and adjusted estimates as a function of patient age and time of hospitalisation using generalised linear models. Findings Overall, 161 239 patients (158 267 adults;2972 children) hospitalized with COVID-19 were included. In adults and children, the most frequent neurological manifestations at admission were fatigue (adults: 37·4%;children: 20·4%), altered consciousness (20·9%;6·8%), myalgia (16·9%;7·6%), dysgeusia (7·4%;1·9%), anosmia (6·0%;2·2%), and seizure (1·1%;5·2%). Among adults, rates were significantly higher in the ICU cohort than in the non-ICU cohort for myalgia (19·9% vs. 16·1%, p<0·001) and anosmia (6·3% vs. 5·9%, p=0·01) but lower in the ICU cohort for altered consciousness (10·8% vs. 24%, p<0·001) and seizure (0·8% vs. 1·2%, p<0·001). In children, rates were significantly higher in the ICU cohort than in the non-ICU cohort for fatigue (30·4% vs. 18·7%, p<0·001), myalgia (12·8% vs. 6·7%, p<0·001), and altered consciousness (12% vs. 5·7%, p<0·001). In adults, the most frequent in-hospital neurological complications were stroke (1·5%), seizure (1%), and central nervous system (CNS) infection (0·2%). Each occurred more frequently in ICU than in non-ICU patients. In children, seizure was the only neurological complication to occur more frequently in ICU than in non-ICU patients (7·1 vs. 2·3, p<0·001). Hypertension, chronic neurological disease, and the use of extracorporeal membrane oxygenation were associated with increased risk of stroke. Altered consciousness was associated with CNS infection, seizure, and stroke. All neurological complications reported during hospitalisation were associated with increased odds of death. Interpretation Adults and children have different neurological manifestations and in-hospital complications associated with COVID-19. Hypertension and previous neurological disease are risk factors for in-hospital neurological complications, which are associated with an increased probability of death in both adults and children.

2.
BMC Cardiovasc Disord ; 22(1): 123, 2022 03 23.
Article in English | MEDLINE | ID: covidwho-1759693

ABSTRACT

BACKGROUND: The influence of renin-angiotensin-aldosterone system (RAAS) inhibitors on the critically ill COVID-19 patients with pre-existing hypertension remains uncertain. This study examined the impact of previous use of angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) on the critically ill COVID-19 patients. METHODS: Data from an international, prospective, observational cohort study involving 354 hospitals spanning 54 countries were included. A cohort of 737 COVID-19 patients with pre-existing hypertension admitted to intensive care units (ICUs) in 2020 were targeted. Multi-state survival analysis was performed to evaluate in-hospital mortality and hospital length of stay up to 90 days following ICU admission. RESULTS: A total of 737 patients were included-538 (73%) with pre-existing hypertension had received ACEi/ARBs before ICU admission, while 199 (27%) had not. Cox proportional hazards model showed that previous ACEi/ARB use was associated with a decreased hazard of in-hospital death (HR, 0.74, 95% CI 0.58-0.94). Sensitivity analysis adjusted for propensity scores showed similar results for hazards of death. The average length of hospital stay was longer in ACEi/ARB group with 21.2 days (95% CI 19.7-22.8 days) in ICU and 6.7 days (5.9-7.6 days) in general ward compared to non-ACEi/ARB group with 16.2 days (14.1-18.6 days) and 6.4 days (5.1-7.9 days), respectively. When analysed separately, results for ACEi or ARB patient groups were similar for both death and discharge. CONCLUSIONS: In critically ill COVID-19 patients with comorbid hypertension, use of ACEi/ARBs prior to ICU admission was associated with a reduced risk of in-hospital mortality following adjustment for baseline characteristics although patients with ACEi/ARB showed longer length of hospital stay. Clinical trial registration The registration number: ACTRN12620000421932; The date of registration: 30, March 2020; The URL of the registration: https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12620000421932 .


Subject(s)
COVID-19 , Hypertension , Angiotensin Receptor Antagonists/adverse effects , Angiotensin-Converting Enzyme Inhibitors/adverse effects , Cohort Studies , Critical Illness , Hospital Mortality , Humans , Hypertension/diagnosis , Hypertension/drug therapy , Prospective Studies , Renin-Angiotensin System , Retrospective Studies
3.
PLoS One ; 17(3): e0264360, 2022.
Article in English | MEDLINE | ID: covidwho-1736508

ABSTRACT

Appropriate descriptions of statistical methods are essential for evaluating research quality and reproducibility. Despite continued efforts to improve reporting in publications, inadequate descriptions of statistical methods persist. At times, reading statistical methods sections can conjure feelings of dèjá vu, with content resembling cut-and-pasted or "boilerplate text" from already published work. Instances of boilerplate text suggest a mechanistic approach to statistical analysis, where the same default methods are being used and described using standardized text. To investigate the extent of this practice, we analyzed text extracted from published statistical methods sections from PLOS ONE and the Australian and New Zealand Clinical Trials Registry (ANZCTR). Topic modeling was applied to analyze data from 111,731 papers published in PLOS ONE and 9,523 studies registered with the ANZCTR. PLOS ONE topics emphasized definitions of statistical significance, software and descriptive statistics. One in three PLOS ONE papers contained at least 1 sentence that was a direct copy from another paper. 12,675 papers (11%) closely matched to the sentence "a p-value < 0.05 was considered statistically significant". Common topics across ANZCTR studies differentiated between study designs and analysis methods, with matching text found in approximately 3% of sections. Our findings quantify a serious problem affecting the reporting of statistical methods and shed light on perceptions about the communication of statistics as part of the scientific process. Results further emphasize the importance of rigorous statistical review to ensure that adequate descriptions of methods are prioritized over relatively minor details such as p-values and software when reporting research outcomes.

4.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-306446

ABSTRACT

Background: Risk factors associated with mortality in patients with coronavirus disease 2019 (COVID-19) on mechanical ventilation are still not fully elucidated. Thus, we aimed to identify patient-level factors, readily available at the bedside, associated with the risk of in-hospital mortality within 28 days from commencement of invasive mechanical ventilation (28-day IMV mortality) in patients with COVID-19. Methods: Prospective observational cohort study in 148 intensive care units in the global COVID-19 Critical Care Consortium . Patients with clinically suspected or laboratory confirmed COVID-19 infection admitted to the intensive care unit (ICU) from February 2 nd through December 29th, 2020, requiring IMV. No study-specific interventions were performed. Patient characteristics and clinical data were assessed upon ICU admission, the commencement of IMV and for 28 days thereafter. We primarily aimed to identify time-independent and time-dependent risk factors for 28-day IMV mortality. Results: : A total of 1713 patients were included in the survival analysis, 588 patients died in hospital within 28 days of commencing IMV (34.3%). Cox-regression analysis identified associations between the hazard of 28-day IMV mortality with age (HR 1.27 per 10-year increase in age, 95% CI 1.17 to 1.37, P<0.001), PEEP upon commencement of IMV (HR 0.78 per 5-cmH 2 O increase, 95% CI 0.66-0.93, P=0.005). Time-dependent parameters associated with 28-day IMV mortality were serum creatinine (HR 1.30 per doubling, 95% CI 1.19-1.42, P<0.001), lactate (HR 1.16 per doubling, 95% CI 1.06-1.27 P=0.001), PaCO 2 (HR 1.31 per doubling, 95% CI 1.05-1.64, P=0.015), pH (HR 0.82 per 0.1 increase, 95% CI 0.74-0.91, P<0.001), PaO 2 /FiO 2 (HR 0.56 per doubling, 95% CI 0.50-0.62, P<0.001) and mean arterial pressure (HR 0.92 per 10 mmHg increase, 95% CI 0.88-0.97, P=0.002). Conclusions: : This international study establishes that in mechanically ventilated patients with COVID-19, older age and clinically relevant variables monitored at the bedside are risk factors for 28-day IMV mortality. Further investigation is warranted to validate any causative roles these parameters might play in influencing clinical outcomes.

5.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-306445

ABSTRACT

Background: Heterogeneous respiratory system static compliance (C RS ) values and levels of hypoxemia in patients with novel coronavirus disease (COVID-19) requiring mechanical ventilation have been reported in previous small-case 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 C RS 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 C RS groups. C RS was calculated as: tidal volume/[airway plateau pressure-positive end-expiratory pressure (PEEP)] and available within 48 h from commencement of MV in 318 patients. Patients were mean ± SD of 58.0 ± 12.2, predominantly from Europe (54%) and males (68%). Median C RS (IQR) was 34.1 mL/cmH 2 O (26.5–45.5) and PaO 2 /FiO 2 was 119 mmHg (87.1–164) and was not correlated with C RS . Female sex presented lower C RS 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 cmH 2 O (10–15), throughout the range of C RS , while median (IQR) driving pressure was 12.3 (10–15) cmH 2 O and significantly decreased as C RS improved (p < 0.001). No differences were found in comorbidities and clinical management between C RS strata. In addition, 28-day ICU mortality and hospital mortality did not differ between C RS groups. Conclusions This multicentre report provides a comprehensive account of C RS in COVID-19 patients on MV – predominantly males or overweight females, in their late 50 s – admitted to ICU during the first international outbreaks. Phenotypes associated with different C RS upon commencement of MV could not be identified. Trial documentation: Available at https://www.covid-critical.com/study. Trial registration ACTRN12620000421932.

6.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-295915

ABSTRACT

Background: The influence of renin-angiotensin-aldosterone system (RAAS) inhibitors on the critically ill COVID-19 patients with pre-existing hypertension remains uncertain. This study examined the impact of previous use of angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) on the critically ill COVID-19 patients. Methods: Data from an international, prospective, observational cohort study involving 354 hospitals spanning 54 countries were included. A cohort of 746 COVID-19 patients with pre-existing hypertension admitted to intensive care units (ICUs) in 2020 were targeted. Multi-state survival analysis was performed to evaluate in-hospital mortality and hospital length of stay up to 90 days following ICU admission. Results: A total of 746 patients were included - 543 (73%) with pre-existing hypertension had received ACEi/ARBs before ICU admission, while 203 (27%) had not. Cox proportional hazards model showed that previous ACEi/ARB use was associated with a decreased hazard of in-hospital death (HR, 0.73, 95% CI, 0.58 to 0.93). Sensitivity analysis adjusted for propensity scores showed similar results for hazards of death. The average length of hospital stay was longer in ACEi/ARB group with 21.4 days (95% CI: 19.9 to 23.0 days) in ICU and 6.7 days (5.9 to 7.6 days) in general ward compared to non-ACEi/ARB group with 16.2 days (14.1 to 18.5 days) and 6.3 days (5.0 to 7.7 days), respectively. When analysed separately, there was insufficient evidence of differential effects between ACEi and ARB use on the hazards of death and discharge. Conclusions: In critically ill COVID-19 patients with comorbid hypertension, use of ACEi/ARBs prior to ICU admission was associated with a reduced risk of in-hospital mortality following adjustment for baseline characteristics although patients with ACEi/ARB showed longer length of hospital stay.

7.
Crit Care Explor ; 3(11): e0567, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1515112

ABSTRACT

Factors associated with mortality in coronavirus disease 2019 patients on invasive mechanical ventilation are still not fully elucidated. OBJECTIVES: To identify patient-level parameters, readily available at the bedside, associated with the risk of in-hospital mortality within 28 days from commencement of invasive mechanical ventilation or coronavirus disease 2019. DESIGN SETTING AND PARTICIPANTS: Prospective observational cohort study by the global Coronavirus Disease 2019 Critical Care Consortium. Patients with laboratory-confirmed coronavirus disease 2019 requiring invasive mechanical ventilation from February 2, 2020, to May 15, 2021. MAIN OUTCOMES AND MEASURES: Patient characteristics and clinical data were assessed upon ICU admission, the commencement of invasive mechanical ventilation and for 28 days thereafter. We primarily aimed to identify time-independent and time-dependent risk factors for 28-day invasive mechanical ventilation mortality. RESULTS: One-thousand five-hundred eighty-seven patients were included in the survival analysis; 588 patients died in hospital within 28 days of commencing invasive mechanical ventilation (37%). Cox-regression analysis identified associations between the hazard of 28-day invasive mechanical ventilation mortality with age (hazard ratio, 1.26 per 10-yr increase in age; 95% CI, 1.16-1.37; p < 0.001), positive end-expiratory pressure upon commencement of invasive mechanical ventilation (hazard ratio, 0.81 per 5 cm H2O increase; 95% CI, 0.67-0.97; p = 0.02). Time-dependent parameters associated with 28-day invasive mechanical ventilation mortality were serum creatinine (hazard ratio, 1.28 per doubling; 95% CI, 1.15-1.41; p < 0.001), lactate (hazard ratio, 1.22 per doubling; 95% CI, 1.11-1.34; p < 0.001), Paco2 (hazard ratio, 1.63 per doubling; 95% CI, 1.19-2.25; p < 0.001), pH (hazard ratio, 0.89 per 0.1 increase; 95% CI, 0.8-14; p = 0.041), Pao2/Fio2 (hazard ratio, 0.58 per doubling; 95% CI, 0.52-0.66; p < 0.001), and mean arterial pressure (hazard ratio, 0.92 per 10 mm Hg increase; 95% CI, 0.88-0.97; p = 0.003). CONCLUSIONS AND RELEVANCE: This international study suggests that in patients with coronavirus disease 2019 on invasive mechanical ventilation, older age and clinically relevant variables monitored at baseline or sequentially during the course of invasive mechanical ventilation are associated with 28-day invasive mechanical ventilation mortality hazard. Further investigation is warranted to validate any causative roles these parameters might play in influencing clinical outcomes.

8.
Crit Care ; 25(1): 199, 2021 06 09.
Article in English | MEDLINE | ID: covidwho-1262513

ABSTRACT

BACKGROUND: 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 small-case 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 CRS-calculated as: tidal volume/[airway plateau pressure-positive end-expiratory pressure (PEEP)]-and its association with ventilatory management and outcomes of COVID-19 patients on mechanical ventilation (MV), admitted to intensive care units (ICU) worldwide. RESULTS: We studied 745 patients from 22 countries, who required admission to the ICU and MV from January 14 to December 31, 2020, and presented at least one value of CRS within the first seven days of MV. Median (IQR) age was 62 (52-71), patients were predominantly males (68%) and from Europe/North and South America (88%). CRS, within 48 h from endotracheal intubation, was available in 649 patients and was neither associated with the duration from onset of symptoms to commencement of MV (p = 0.417) nor with PaO2/FiO2 (p = 0.100). Females presented lower CRS than males (95% CI of CRS difference between females-males: - 11.8 to - 7.4 mL/cmH2O p < 0.001), and although females presented higher body mass index (BMI), association of BMI with CRS was marginal (p = 0.139). Ventilatory management varied across CRS range, resulting in a significant association between CRS and driving pressure (estimated decrease - 0.31 cmH2O/L per mL/cmH20 of CRS, 95% CI - 0.48 to - 0.14, p < 0.001). Overall, 28-day ICU mortality, accounting for the competing risk of being discharged within the period, was 35.6% (SE 1.7). Cox proportional hazard analysis demonstrated that CRS (+ 10 mL/cm H2O) was only associated with being discharge from the ICU within 28 days (HR 1.14, 95% CI 1.02-1.28, p = 0.018). CONCLUSIONS: This multicentre report provides a comprehensive account of CRS in COVID-19 patients on MV. CRS measured within 48 h from commencement of MV has marginal predictive value for 28-day mortality, but was associated with being discharged from ICU within the same period. Trial documentation: Available at https://www.covid-critical.com/study . TRIAL REGISTRATION: ACTRN12620000421932.


Subject(s)
COVID-19/complications , COVID-19/therapy , Lung Compliance/physiology , Respiration, Artificial/methods , Respiratory Distress Syndrome/etiology , Respiratory Distress Syndrome/therapy , Adult , Cohort Studies , Critical Care/methods , Europe , Female , Humans , Intensive Care Units , Male , Middle Aged , Retrospective Studies , Severity of Illness Index
10.
Clin Epidemiol ; 12: 925-928, 2020.
Article in English | MEDLINE | ID: covidwho-781765

ABSTRACT

By definition, in-hospital patient data are restricted to the time between hospital admission and discharge (alive or dead). For hospitalised cases of COVID-19, a number of events during hospitalization are of interest regarding the influence of risk factors on the likelihood of experiencing these events. The same is true for predicting times from hospital admission of COVID-19 patients to intensive care or from start of ventilation (invasive or non-invasive) to extubation. This logical restriction of the data to the period of hospitalisation is associated with a substantial risk that inappropriate methods are used for analysis. Here, we briefly discuss the most common types of bias which can occur when analysing in-hospital COVID-19 data.

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