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1.
Stud Health Technol Inform ; 294: 127-128, 2022 May 25.
Article in English | MEDLINE | ID: covidwho-1865415

ABSTRACT

We propose a re-calibration method for Machine Learning models, based on computing confidence intervals for the predicted confidence scores. We show the effectiveness of the proposed method on a COVID-19 diagnosis benchmark.


Subject(s)
COVID-19 , COVID-19 Testing , Calibration , Confidence Intervals , Humans , Machine Learning
2.
Cochrane Database Syst Rev ; 8: CD014962, 2021 08 05.
Article in English | MEDLINE | ID: covidwho-1813444

ABSTRACT

BACKGROUND: Remdesivir is an antiviral medicine with properties to inhibit viral replication of SARS-CoV-2. Positive results from early studies attracted media attention and led to emergency use authorisation of remdesivir in COVID-19.  A thorough understanding of the current evidence regarding the effects of remdesivir as a treatment for SARS-CoV-2 infection based on randomised controlled trials (RCTs) is required. OBJECTIVES: To assess the effects of remdesivir compared to placebo or standard care alone on clinical outcomes in hospitalised patients with SARS-CoV-2 infection, and to maintain the currency of the evidence using a living systematic review approach. SEARCH METHODS: We searched the Cochrane COVID-19 Study Register (which comprises the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and medRxiv) as well as Web of Science (Science Citation Index Expanded and Emerging Sources Citation Index) and WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies without language restrictions. We conducted the searches on 16 April 2021. SELECTION CRITERIA: We followed standard Cochrane methodology. We included RCTs evaluating remdesivir for the treatment of SARS-CoV-2 infection in hospitalised adults compared to placebo or standard care alone irrespective of disease severity, gender, ethnicity, or setting.  We excluded studies that evaluated remdesivir for the treatment of other coronavirus diseases. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methodology. To assess risk of bias in included studies, we used the Cochrane RoB 2 tool for RCTs. We rated the certainty of evidence using the GRADE approach for outcomes that were reported according to our prioritised categories: all-cause mortality at up to day 28, duration to liberation from invasive mechanical ventilation, duration to liberation from supplemental oxygen, new need for mechanical ventilation (high-flow oxygen or non-invasive or invasive mechanical ventilation), new need for invasive mechanical ventilation, new need for non-invasive mechanical ventilation or high-flow oxygen, new need for oxygen by mask or nasal prongs, quality of life, adverse events (any grade), and serious adverse events. MAIN RESULTS: We included five RCTs with 7452 participants diagnosed with SARS-CoV-2 infection and a mean age of 59 years, of whom 3886 participants were randomised to receive remdesivir. Most participants required low-flow oxygen (n=4409) or mechanical ventilation (n=1025) at baseline. We identified two ongoing studies, one was suspended due to a lack of COVID-19 patients to recruit. Risk of bias was considered to be of some concerns or high risk for clinical status and safety outcomes because participants who had died did not contribute information to these outcomes. Without adjustment, this leads to an uncertain amount of missing values and the potential for bias due to missing data. Effects of remdesivir in hospitalised individuals  Remdesivir probably makes little or no difference to all-cause mortality at up to day 28 (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.81 to 1.06; risk difference (RD) 8 fewer per 1000, 95% CI 21 fewer to 7 more; 4 studies, 7142 participants; moderate-certainty evidence). Considering the initial severity of condition, only one study showed a beneficial effect of remdesivir in patients who received low-flow oxygen at baseline (RR 0.32, 95% CI 0.15 to 0.66, 435 participants), but conflicting results exists from another study, and we were unable to validly assess this observations due to limited availability of comparable data. Remdesivir may have little or no effect on the duration to liberation from invasive mechanical ventilation (2 studies, 1298 participants, data not pooled, low-certainty evidence). We are uncertain whether remdesivir increases or decreases the chance of clinical improvement in terms of duration to liberation from supplemental oxygen at up to day 28 (3 studies, 1691 participants, data not pooled, very low-certainty evidence).   We are very uncertain whether remdesivir decreases or increases the risk of clinical worsening in terms of new need for mechanical ventilation at up to day 28 (high-flow oxygen or non-invasive ventilation or invasive mechanical ventilation) (RR 0.78, 95% CI 0.48 to 1.24; RD 29 fewer per 1000, 95% CI 68 fewer to 32 more; 3 studies, 6696 participants; very low-certainty evidence); new need for non-invasive mechanical ventilation or high-flow oxygen (RR 0.70, 95% CI 0.51 to 0.98; RD 72 fewer per 1000, 95% CI 118 fewer to 5 fewer; 1 study, 573 participants; very low-certainty evidence); and new need for oxygen by mask or nasal prongs (RR 0.81, 95% CI 0.54 to 1.22; RD 84 fewer per 1000, 95% CI 204 fewer to 98 more; 1 study, 138 participants; very low-certainty evidence). The evidence suggests that remdesivir may decrease the risk of clinical worsening in terms of new need for invasive mechanical ventilation (67 fewer participants amongst 1000 participants; RR 0.56, 95% CI 0.41 to 0.77; 2 studies, 1159 participants; low-certainty evidence).  None of the included studies reported quality of life. Remdesivir probably decreases the serious adverse events rate at up to 28 days (RR 0.75, 95% CI 0.63 to 0.90; RD 63 fewer per 1000, 95% CI 94 fewer to 25 fewer; 3 studies, 1674 participants; moderate-certainty evidence). We are very uncertain whether remdesivir increases or decreases adverse events rate (any grade) (RR 1.05, 95% CI 0.86 to 1.27; RD 29 more per 1000, 95% CI 82 fewer to 158 more; 3 studies, 1674 participants; very low-certainty evidence). AUTHORS' CONCLUSIONS: Based on the currently available evidence, we are moderately certain that remdesivir probably has little or no effect on all-cause mortality at up to day 28 in hospitalised adults with SARS-CoV-2 infection. We are uncertain about the effects of remdesivir on clinical improvement and worsening. There were insufficient data available to validly examine the effect of remdesivir on mortality in subgroups depending on the extent of respiratory support at baseline.  Future studies should provide additional data on efficacy and safety of remdesivir for defined core outcomes in COVID-19 research, especially for different population subgroups. This could allow us to draw more reliable conclusions on the potential benefits and harms of remdesivir in future updates of this review. Due to the living approach of this work, we will update the review periodically.


Subject(s)
Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Antiviral Agents/therapeutic use , COVID-19/drug therapy , Adenosine Monophosphate/therapeutic use , Alanine/therapeutic use , Bias , COVID-19/mortality , Cause of Death , Confidence Intervals , Disease Progression , Humans , Middle Aged , Oxygen/administration & dosage , Randomized Controlled Trials as Topic , Respiration, Artificial , SARS-CoV-2 , Ventilator Weaning
3.
PLoS One ; 17(2): e0263354, 2022.
Article in English | MEDLINE | ID: covidwho-1700312

ABSTRACT

PURPOSE: The aim this study was to provide an epidemiological injury analysis of the National Basketball Association, detailing aspects such as frequency rate, characteristics and impact on performance (missed games), including COVID-19 related and non-related injuries. METHODS: A retrospective study was conducted from the 2017-18 to 2020-2021 season. Publicly available records from the official website of the National Basketball Association were collected, including player's profiling data, minutes played per game until the injury occurred, unique injuries and injury description [location (body area), diagnosis (or mechanism)], and missed games due to injury. RESULTS: A total of 625 players and 3543 unique injuries were registered during the period analyzed. There was an increased incidence of missed games and unique injuries ratios, from 2017-18 until 2020-21, even when excluding COVID-19 related cases. The main body areas of injuries corresponded to lower body injuries, specifically knee, ankle and foot. The tendon/ligament group, for both games missed and unique injuries, showed the higher ratios (1.16 and 0.21, respectively), followed by muscle (0.69 and 0.16, respectively) and bones (0.30 and 0.03, respectively). Irrespective of season, the higher percentage of unique injuries occurred in the group of players playing in the 26-35 minutes, followed by the 16-25 minutes played. Guards showed the highest injury ratios compared to other playing positions. Most injuries and missed games due to injury occurred from mid-season to the end of the regular season. The majority of both injuries and missed games were concentrated in the two central experience groups (from 6 to 15 years). CONCLUSIONS: Despite previous efforts to better understand injury risk factors, there has been an increase in unique injuries and missed games. The distribution by body area, type of injury, when they occurred, minutes played and outcomes by play position, age a or years of experience vary between season and franchises.


Subject(s)
Basketball/injuries , COVID-19/epidemiology , Adult , Confidence Intervals , Humans , Male , Seasons , Young Adult
4.
BMC Nephrol ; 23(1): 63, 2022 02 11.
Article in English | MEDLINE | ID: covidwho-1690946

ABSTRACT

BACKGROUND: Hospitalized patients with SARS-CoV2 develop acute kidney injury (AKI) frequently, yet gaps remain in understanding why adults seem to have higher rates compared to children. Our objectives were to evaluate the epidemiology of SARS-CoV2-related AKI across the age spectrum and determine if known risk factors such as illness severity contribute to its pattern. METHODS: Secondary analysis of ongoing prospective international cohort registry. AKI was defined by KDIGO-creatinine only criteria. Log-linear, logistic and generalized estimating equations assessed odds ratios (OR), risk differences (RD), and 95% confidence intervals (CIs) for AKI and mortality adjusting for sex, pre-existing comorbidities, race/ethnicity, illness severity, and clustering within centers. Sensitivity analyses assessed different baseline creatinine estimators. RESULTS: Overall, among 6874 hospitalized patients, 39.6% (n = 2719) developed AKI. There was a bimodal distribution of AKI by age with peaks in older age (≥60 years) and middle childhood (5-15 years), which persisted despite controlling for illness severity, pre-existing comorbidities, or different baseline creatinine estimators. For example, the adjusted OR of developing AKI among hospitalized patients with SARS-CoV2 was 2.74 (95% CI 1.66-4.56) for 10-15-year-olds compared to 30-35-year-olds and similarly was 2.31 (95% CI 1.71-3.12) for 70-75-year-olds, while adjusted OR dropped to 1.39 (95% CI 0.97-2.00) for 40-45-year-olds compared to 30-35-year-olds. CONCLUSIONS: SARS-CoV2-related AKI is common with a bimodal age distribution that is not fully explained by known risk factors or confounders. As the pandemic turns to disproportionately impacting younger individuals, this deserves further investigation as the presence of AKI and SARS-CoV2 infection increases hospital mortality risk.


Subject(s)
Acute Kidney Injury/epidemiology , COVID-19/complications , Inpatients/statistics & numerical data , SARS-CoV-2 , Acute Kidney Injury/etiology , Adolescent , Adult , Age Distribution , Age Factors , Aged , Aged, 80 and over , COVID-19/epidemiology , Child , Child, Preschool , Comorbidity , Confidence Intervals , Creatinine/blood , Global Health/statistics & numerical data , Hospital Mortality , Humans , Middle Aged , Odds Ratio , Registries/statistics & numerical data , Severity of Illness Index
5.
BMC Nephrol ; 23(1): 50, 2022 02 01.
Article in English | MEDLINE | ID: covidwho-1666634

ABSTRACT

BACKGROUND: Acute kidney injury (AKI) is a common complication in patients hospitalized with COVID-19 and may require renal replacement therapy (RRT). Dipstick urinalysis is frequently obtained, but data regarding the prognostic value of hematuria and proteinuria for kidney outcomes is scarce. METHODS: Patients with positive severe acute respiratory syndrome-coronavirus 2 (SARS-CoV2) PCR, who had a urinalysis obtained on admission to one of 20 hospitals, were included. Nested models with degree of hematuria and proteinuria were used to predict AKI and RRT during admission. Presence of Chronic Kidney Disease (CKD) and baseline serum creatinine were added to test improvement in model fit. RESULTS: Of 5,980 individuals, 829 (13.9%) developed an AKI during admission, and 149 (18.0%) of those with AKI received RRT. Proteinuria and hematuria degrees significantly increased with AKI severity (P < 0.001 for both). Any degree of proteinuria and hematuria was associated with an increased risk of AKI and RRT. In predictive models for AKI, presence of CKD improved the area under the curve (AUC) (95% confidence interval) to 0.73 (0.71, 0.75), P < 0.001, and adding baseline creatinine improved the AUC to 0.85 (0.83, 0.86), P < 0.001, when compared to the base model AUC using only proteinuria and hematuria, AUC = 0.64 (0.62, 0.67). In RRT models, CKD status improved the AUC to 0.78 (0.75, 0.82), P < 0.001, and baseline creatinine improved the AUC to 0.84 (0.80, 0.88), P < 0.001, compared to the base model, AUC = 0.72 (0.68, 0.76). There was no significant improvement in model discrimination when both CKD and baseline serum creatinine were included. CONCLUSIONS: Proteinuria and hematuria values on dipstick urinalysis can be utilized to predict AKI and RRT in hospitalized patients with COVID-19. We derived formulas using these two readily available values to help prognosticate kidney outcomes in these patients. Furthermore, the incorporation of CKD or baseline creatinine increases the accuracy of these formulas.


Subject(s)
Acute Kidney Injury/etiology , COVID-19/complications , Hematuria/diagnosis , Proteinuria/diagnosis , Urinalysis/methods , Acute Kidney Injury/ethnology , Acute Kidney Injury/therapy , Aged , Area Under Curve , COVID-19/ethnology , Confidence Intervals , Creatinine/blood , Female , Hospitalization , Humans , Longitudinal Studies , Male , Middle Aged , Predictive Value of Tests , Renal Insufficiency, Chronic/diagnosis , Renal Replacement Therapy/statistics & numerical data
7.
Comput Math Methods Med ; 2022: 3163854, 2022.
Article in English | MEDLINE | ID: covidwho-1625427

ABSTRACT

Currently, the global report of COVID-19 cases is around 110 million, and more than 2.43 million related death cases as of February 18, 2021. Viruses continuously change through mutation; hence, different virus of SARS-CoV-2 has been reported globally. The United Kingdom (UK), South Africa, Brazil, and Nigeria are the countries from which these emerged variants have been notified and now spreading globally. Therefore, these countries have been selected as a research sample for the present study. The datasets analyzed in this study spanned from March 1, 2020, to January 31, 2021, and were obtained from the World Health Organization website. The study used the Autoregressive Integrated Moving Average (ARIMA) model to forecast coronavirus incidence in the UK, South Africa, Brazil, and Nigeria. ARIMA models with minimum Akaike Information Criterion Correction (AICc) and statistically significant parameters were chosen as the best models in this research. Accordingly, for the new confirmed cases, ARIMA (3,1,14), ARIMA (0,1,11), ARIMA (1,0,10), and ARIMA (1,1,14) models were chosen for the UK, South Africa, Brazil, and Nigeria, respectively. Also, the model specification for the confirmed death cases was ARIMA (3,0,4), ARIMA (0,1,4), ARIMA (1,0,7), and ARIMA (Brown); models were selected for the UK, South Africa, Brazil, and Nigeria, respectively. The results of the ARIMA model forecasting showed that if the required measures are not taken by the respective governments and health practitioners in the days to come, the magnitude of the coronavirus pandemic is expected to increase in the study's selected countries.


Subject(s)
COVID-19/epidemiology , COVID-19/virology , Pandemics , SARS-CoV-2 , Brazil/epidemiology , Computational Biology , Confidence Intervals , Forecasting/methods , Humans , Incidence , Models, Statistical , Nigeria/epidemiology , Pandemics/statistics & numerical data , Regression Analysis , SARS-CoV-2/genetics , SARS-CoV-2/pathogenicity , Severity of Illness Index , South Africa/epidemiology , United Kingdom/epidemiology
8.
Am J Trop Med Hyg ; 106(2): 571-573, 2022 01 07.
Article in English | MEDLINE | ID: covidwho-1614118

ABSTRACT

Between April and July 2020, and, therefore, prior to the broad recommendation of corticosteroids for severe COVID-19, a total of 50 full autopsies were performed in Manaus. We confirmed two invasive cases of aspergillosis through histopathology and gene sequencing (4%) in our autopsy series. The confirmed invasive aspergillosis incidence seems much lower than expected based on the "probable and possible" definitions, and an individualized approach should be considered for each country scenario. Interestingly, a prolonged length of stay in the intensive care unit was not observed in any of the cases. Timely diagnosis and treatment of fungal infection can reduce mortality rates.


Subject(s)
COVID-19/complications , COVID-19/microbiology , Pulmonary Aspergillosis/epidemiology , Pulmonary Aspergillosis/etiology , SARS-CoV-2 , Adult , Aged , Autopsy , Brazil/epidemiology , Confidence Intervals , Humans , Incidence , Male
9.
N Engl J Med ; 385(1): 11-22, 2021 07 01.
Article in English | MEDLINE | ID: covidwho-1585668

ABSTRACT

BACKGROUND: Evidence is urgently needed to support treatment decisions for children with multisystem inflammatory syndrome (MIS-C) associated with severe acute respiratory syndrome coronavirus 2. METHODS: We performed an international observational cohort study of clinical and outcome data regarding suspected MIS-C that had been uploaded by physicians onto a Web-based database. We used inverse-probability weighting and generalized linear models to evaluate intravenous immune globulin (IVIG) as a reference, as compared with IVIG plus glucocorticoids and glucocorticoids alone. There were two primary outcomes: the first was a composite of inotropic support or mechanical ventilation by day 2 or later or death; the second was a reduction in disease severity on an ordinal scale by day 2. Secondary outcomes included treatment escalation and the time until a reduction in organ failure and inflammation. RESULTS: Data were available regarding the course of treatment for 614 children from 32 countries from June 2020 through February 2021; 490 met the World Health Organization criteria for MIS-C. Of the 614 children with suspected MIS-C, 246 received primary treatment with IVIG alone, 208 with IVIG plus glucocorticoids, and 99 with glucocorticoids alone; 22 children received other treatment combinations, including biologic agents, and 39 received no immunomodulatory therapy. Receipt of inotropic or ventilatory support or death occurred in 56 patients who received IVIG plus glucocorticoids (adjusted odds ratio for the comparison with IVIG alone, 0.77; 95% confidence interval [CI], 0.33 to 1.82) and in 17 patients who received glucocorticoids alone (adjusted odds ratio, 0.54; 95% CI, 0.22 to 1.33). The adjusted odds ratios for a reduction in disease severity were similar in the two groups, as compared with IVIG alone (0.90 for IVIG plus glucocorticoids and 0.93 for glucocorticoids alone). The time until a reduction in disease severity was similar in the three groups. CONCLUSIONS: We found no evidence that recovery from MIS-C differed after primary treatment with IVIG alone, IVIG plus glucocorticoids, or glucocorticoids alone, although significant differences may emerge as more data accrue. (Funded by the European Union's Horizon 2020 Program and others; BATS ISRCTN number, ISRCTN69546370.).


Subject(s)
COVID-19/drug therapy , Glucocorticoids/therapeutic use , Immunoglobulins, Intravenous/therapeutic use , Systemic Inflammatory Response Syndrome/drug therapy , Adolescent , Antibodies, Viral , COVID-19/immunology , COVID-19/mortality , COVID-19/therapy , Child , Child, Preschool , Cohort Studies , Confidence Intervals , Drug Therapy, Combination , Female , Hospitalization , Humans , Immunomodulation , Male , Propensity Score , Regression Analysis , Respiration, Artificial , SARS-CoV-2/immunology , Systemic Inflammatory Response Syndrome/immunology , Systemic Inflammatory Response Syndrome/mortality , Systemic Inflammatory Response Syndrome/therapy , Treatment Outcome
10.
PLoS One ; 16(11): e0259527, 2021.
Article in English | MEDLINE | ID: covidwho-1542179

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing coronavirus disease 2019 (COVID-19) is currently finally determined in laboratory settings by real-time reverse-transcription polymerase-chain-reaction (rt-PCR). However, simple testing with immediately available results are crucial to gain control over COVID-19. The aim was to evaluate such a point-of-care antigen rapid test (AG-rt) device in its performance compared to laboratory-based rt-PCR testing in COVID-19 suspected, symptomatic patients. METHODS: For this prospective study, two specimens each of 541 symptomatic female (54.7%) and male (45.3%) patients aged between 18 and 95 years tested at five emergency departments (ED, n = 296) and four primary healthcare centres (PHC, n = 245), were compared, using AG-rt (positive/negative/invalid) and rt-PCR (positive/negative and cycle threshold, Ct) to diagnose SARS-CoV-2. Diagnostic accuracy, sensitivity, specificity, positive predictive values (PPV), negative predictive value (NPV), and likelihood ratios (LR+/-) of the AG-rt were assessed. RESULTS: Differences between ED and PHC were detected regarding gender, age, symptoms, disease prevalence, and diagnostic performance. Overall, 174 (32.2%) were tested positive on AG-rt and 213 (39.4%) on rt-PCR. AG correctly classified 91.7% of all rt-PCR positive cases with a sensitivity of 80.3%, specificity of 99.1%, PPV of 98.3, NPV of 88.6%, LR(+) of 87.8, and LR(-) of 0.20. The highest sensitivities and specificities of AG-rt were detected in PHC (sensitivity: 84.4%, specificity: 100.0%), when using Ct of 30 as cut-off (sensitivity: 92.5%, specificity: 97.8%), and when symptom onset was within the first three days (sensitivity: 82.9%, specificity: 99.6%). CONCLUSIONS: The highest sensitivity was detected with a high viral load. Our findings suggest that AG-rt are comparable to rt-PCR to diagnose SARS-CoV-2 in COVID-19 suspected symptomatic patients presenting both at emergency departments and primary health care centres.


Subject(s)
Antigens, Viral/immunology , COVID-19 Serological Testing , COVID-19/diagnosis , COVID-19/immunology , SARS-CoV-2/physiology , Adult , Aged , Aged, 80 and over , Confidence Intervals , Emergency Service, Hospital , Female , Health Facilities , Humans , Male , Middle Aged , Sensitivity and Specificity , Young Adult
11.
PLoS One ; 16(11): e0259026, 2021.
Article in English | MEDLINE | ID: covidwho-1496522

ABSTRACT

Interleukin (IL)-33 and its unique receptor, ST2, play a pivotal role in the immune response to infection and stress. However, there have been conflicting reports of the role of IL-33 in cardiovascular disease (CVD) and the potential of this axis in differentiating CVD patients and controls and with CVD disease severity, remains unclear. AIMS: 1) To quantify differences in circulating IL-33 and/or sST2 levels between CVD patients versus controls. 2) Determine association of these biomarkers with mortality in CVD and community cohorts. METHODS AND RESULTS: Using Pubmed/MEDLINE, Web of Science, Prospero and Cochrane databases, systematic review of studies published on IL-33 and/or sST2 levels in patients with CVD (heart failure, acute coronary syndrome, atrial fibrillation, stroke, coronary artery disease and hypertension) vs controls, and in cohorts of each CVD subtype was performed. Pooled standardised mean difference (SMD) of biomarker levels between CVD-cases versus controls and hazard ratios (HRs) for risk of mortality during follow-up in CVD patients, were assessed by random effects meta-analyses. Heterogeneity was evaluated with random-effects meta-regressions. From 1071 studies screened, 77 were meta-analysed. IL-33 levels were lower in HF and CAD patients vs controls, however levels were higher in stroke patients compared controls [Meta-SMD 1.455, 95% CI 0.372-2.537; p = 0.008, I2 = 97.645]. Soluble ST2 had a stronger association with risk of all-cause mortality in ACS (Meta-multivariate HR 2.207, 95% CI 1.160-4.198; p = 0.016, I2 = 95.661) than risk of all-cause mortality in HF (Meta-multivariate HR 1.425, 95% CI 1.268-1.601; p<0.0001, I2 = 92.276). There were insufficient data to examine the association of IL-33 with clinical outcomes in CVD. CONCLUSIONS: IL-33 and sST2 levels differ between CVD patients and controls. Higher levels of sST2 are associated with increased mortality in individuals with CVD. Further study of IL-33/ST2 in cardiovascular studies is essential to progress diagnostic and therapeutic advances related to IL-33/ST2 signalling.


Subject(s)
Interleukin-1 Receptor-Like 1 Protein/metabolism , Interleukin-33/metabolism , Signal Transduction , Acute Coronary Syndrome/metabolism , Cardiovascular Diseases , Case-Control Studies , Cohort Studies , Confidence Intervals , Heart Failure/metabolism , Humans , Multivariate Analysis , Risk Factors , Treatment Outcome
15.
Eur Rev Med Pharmacol Sci ; 25(19): 6003-6012, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1478938

ABSTRACT

OBJECTIVE: The present study aims to identify potential safety signals of chloroquine (CQ) and hydroxychloroquine (HCQ), over the period preceding their repurpose as COVID-19 treatment options, through the analysis of safety data retrieved from the FDA Adverse Event Reporting System (FAERS) pharmacovigilance database. MATERIALS AND METHODS: We performed a disproportionality analysis of FAERS data between the first quarter of 2004 and December 2019 using the OpenVigil2.1-MedDRA software. Disproportionality was quantified using the reporting odds ratio (ROR) and its 95% confidence interval (CIs). The reported mortality of CQ and HCQ was also investigated. RESULTS: The dataset contained 6,635,356 reports. Comparison of the RORs revealed significant differences between CQ and HCQ for the following adverse events: cardiomyopathy, cardiac arrhythmias, retinal disorders, corneal disorders, hearing disorders, headache, hepatic disorders, severe cutaneous reactions, musculoskeletal disorders, and cytopenia. Only CQ was associated with psychotic disorders, suicide, self-injury, convulsions, peripheral neuropathy, and decreased appetite. In multivariable logistic regression, death was more frequently associated with CQ use, advanced age, male sex, co-reported suicide and self-injury, cardiomyopathy, cardiac arrhythmias, and decreased appetite. CONCLUSIONS: Our results confirm previously published evidence and suggest that HCQ has a safer clinical profile compared to CQ, and thus could serve as the drug of choice for future therapeutic purposes.


Subject(s)
Adverse Drug Reaction Reporting Systems , Chloroquine/adverse effects , Hydroxychloroquine/adverse effects , United States Food and Drug Administration , COVID-19/drug therapy , Confidence Intervals , Databases, Factual , Humans , Male , Middle Aged , Odds Ratio , Pharmacovigilance , Suicide , United States
17.
Dis Markers ; 2021: 2571912, 2021.
Article in English | MEDLINE | ID: covidwho-1463050

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) is highly contagious and continues to spread rapidly. However, there are no simple and timely laboratory techniques to determine the severity of COVID-19. In this meta-analysis, we assessed the potential of the neutrophil-lymphocyte ratio (NLR) as an indicator of severe versus nonsevere COVID-19 cases. METHODS: A search for studies on the NLR in severe and nonsevere COVID-19 cases published from January 1, 2020, to July 1, 2021, was conducted on the PubMed, EMBASE, and Cochrane Library databases. The pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, diagnostic odds ratio (DOR), and area under the curve (AUC) analyses were done on Stata 14.0 and Meta-disc 1.4 to assess the performance of the NLR. RESULTS: Thirty studies, including 5570 patients, were analyzed. Of these, 1603 and 3967 patients had severe and nonsevere COVID-19, respectively. The overall sensitivity and specificity were 0.82 (95% confidence interval (CI), 0.77-0.87) and 0.77 (95% CI, 0.70-0.83), respectively; positive and negative correlation ratios were 3.6 (95% CI, 2.7-4.7) and 0.23 (95% CI, 0.17-0.30), respectively; DOR was 16 (95% CI, 10-24), and the AUC was 0.87 (95% CI, 0.84-0.90). CONCLUSION: The NLR could accurately determine the severity of COVID-19 and can be used to identify patients with severe disease to guide clinical decision-making.


Subject(s)
COVID-19/immunology , Lymphocytes/immunology , Neutrophils/immunology , SARS-CoV-2 , Area Under Curve , Biomarkers/blood , COVID-19/blood , Confidence Intervals , Humans , Leukocyte Count , Likelihood Functions , Odds Ratio , Sensitivity and Specificity , Severity of Illness Index
18.
Cochrane Database Syst Rev ; 4: CD000479, 2021 04 23.
Article in English | MEDLINE | ID: covidwho-1453523

ABSTRACT

BACKGROUND: Varicoceles are associated with male subfertility; however, the mechanisms by which varicoceles affect fertility have yet to be satisfactorily explained. Several treatment options exist, including surgical or radiological treatment, however the safest and most efficient treatment remains unclear.  OBJECTIVES: To evaluate the effectiveness and safety of surgical and radiological treatment of varicoceles on live birth rate, adverse events, pregnancy rate, varicocele recurrence, and quality of life amongst couples where the adult male has a varicocele, and the female partner of childbearing age has no fertility problems. SEARCH METHODS: We searched the following databases on 4 April 2020: the Cochrane Gynaecology and Fertility Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, and CINAHL. We also searched the trial registries and reference lists of articles. SELECTION CRITERIA: We included randomised controlled trials (RCTs) if they were relevant to the clinical question posed and compared different forms of surgical ligation, different forms of radiological treatments, surgical treatment compared to radiological treatment, or one of these aforementioned treatment forms compared to non-surgical methods, delayed treatment, or no treatment. We extracted data if the studies reported on live birth, adverse events, pregnancy, varicocele recurrence, and quality of life. DATA COLLECTION AND ANALYSIS: Screening of abstracts and full-text publications, alongside data extraction and 'Risk of bias' assessment, were done dually using the Covidence software. When we had sufficient data, we calculated random-effects (Mantel-Haenszel) meta-analyses; otherwise, we reported results narratively. We used the I2 statistic to analyse statistical heterogeneity. We planned to use funnel plots to assess publication bias in meta-analyses with at least 10 included studies. We dually rated the risk of bias of studies using the Cochrane 'Risk of bias' tool, and the certainty of evidence for each outcome using the GRADE approach. MAIN RESULTS: We identified 1897 citations after de-duplicating the search results. We excluded 1773 during title and abstract screening. From the 113 new full texts assessed in addition to the 10 studies (11 references) included in the previous version of this review, we included 38 new studies, resulting in a total of 48 studies (59 references) in the review providing data for 5384 participants. Two studies (three references) are ongoing studies and two studies are awaiting classification. Treatment versus non-surgical, non-radiological, delayed, or no treatment Two studies comparing surgical or radiological treatment versus no treatment reported on live birth with differing directions of effect. As a result, we are uncertain whether surgical or radiological treatment improves live birth rates when compared to no treatment (risk ratio (RR) 2.27, 95% confidence interval (CI) 0.19 to 26.93; 2 RCTs, N = 204; I2 = 74%, very low-certainty evidence). Treatment may improve pregnancy rates compared to delayed or no treatment (RR 1.55, 95% CI 1.06 to 2.26; 13 RCTs, N = 1193; I2 = 65%, low-certainty evidence). This suggests that couples with no or delayed treatment have a 21% chance of pregnancy, whilst the pregnancy rate after surgical or radiological treatment is between 22% and 48%. We identified no evidence on adverse events, varicocele recurrence, or quality of life for this comparison. Surgical versus radiological treatment We are uncertain about the effect of surgical versus radiological treatment on live birth and on the following adverse events: hydrocele formation, pain, epididymitis, haematoma, and suture granuloma. We are uncertain about the effect of surgical versus radiological treatment on pregnancy rate (RR 1.13, 95% CI 0.75 to 1.70; 5 RCTs, N = 456, low-certainty evidence) and varicocele recurrence (RR 1.31, 95% CI 0.82 to 2.08; 3 RCTs, N = 380, low-certainty evidence). We identified no evidence on quality of life for this comparison. Surgery versus other surgical treatment We identified 19 studies comparing microscopic subinguinal surgical treatment to any other surgical treatment. Microscopic subinguinal surgical treatment probably improves pregnancy rates slightly compared to other surgical treatments (RR 1.18, 95% CI 1.02 to 1.36; 12 RCTs, N = 1473, moderate-certainty evidence). This suggests that couples with microscopic subinguinal surgical treatment have a 10% to 14% chance of pregnancy after treatment, whilst the pregnancy rate in couples after other surgical treatments is 10%. This procedure also probably reduces the risk of varicocele recurrence (RR 0.48, 95% CI 0.29, 0.79; 14 RCTs, N = 1565, moderate-certainty evidence). This suggests that 0.4% to 1.1% of men undergoing microscopic subinguinal surgical treatment experience recurrent varicocele, whilst 1.4% of men undergoing other surgical treatments do. Results for the following adverse events were inconclusive: hydrocele formation, haematoma, abdominal distension, testicular atrophy, wound infection, scrotal pain, and oedema. We identified no evidence on live birth or quality of life for this comparison. Nine studies compared open inguinal surgical treatment to retroperitoneal surgical treatment. Due to small sample sizes and methodological limitations, we identified neither treatment type as superior or inferior to the other regarding adverse events, pregnancy rates, or varicocele recurrence. We identified no evidence on live birth or quality of life for this comparison. Radiological versus other radiological treatment One study compared two types of radiological treatment (sclerotherapy versus embolisation) and reported 13% varicocele recurrence in both groups. Due to the broad confidence interval, no valid conclusion could be drawn (RR 1.00, 95% CI 0.16 to 6.20; 1 RCT, N = 30, very low-certainty evidence). We identified no evidence on live birth, adverse events, pregnancy, or quality of life for this comparison. AUTHORS' CONCLUSIONS: Based on the limited evidence, it remains uncertain whether any treatment (surgical or radiological) compared to no treatment in subfertile men may be of benefit on live birth rates; however, treatment may improve the chances for pregnancy. The evidence was also insufficient to determine whether surgical treatment was superior to radiological treatment. However, microscopic subinguinal surgical treatment probably improves pregnancy rates and reduces the risk of varicocele recurrence compared to other surgical treatments. High-quality, head-to-head comparative RCTs focusing on live birth rate and also assessing adverse events and quality of life are warranted.


Subject(s)
Embolization, Therapeutic , Infertility, Male/therapy , Sclerotherapy/methods , Varicocele/therapy , Bias , Confidence Intervals , Embolization, Therapeutic/adverse effects , Female , Humans , Infertility, Male/etiology , Infertility, Male/surgery , Live Birth , Male , Outcome Assessment, Health Care , Postoperative Complications/etiology , Pregnancy , Pregnancy Rate , Randomized Controlled Trials as Topic , Recurrence , Sclerotherapy/adverse effects , Sperm Count , Testicular Hydrocele/etiology , Varicocele/complications , Varicocele/surgery
19.
PLoS One ; 16(9): e0257613, 2021.
Article in English | MEDLINE | ID: covidwho-1430545

ABSTRACT

This paper analyses COVID-19 patients' dynamics during the first wave in the region of Castilla y León (Spain) with around 2.4 million inhabitants using multi-state competing risk survival models. From the date registered as the start of the clinical process, it is assumed that a patient can progress through three intermediate states until reaching an absorbing state of recovery or death. Demographic characteristics, epidemiological factors such as the time of infection and previous vaccinations, clinical history, complications during the course of the disease and drug therapy for hospitalised patients are considered as candidate predictors. Regarding risk factors associated with mortality and severity, consistent results with many other studies have been found, such as older age, being male, and chronic diseases. Specifically, the hospitalisation (death) rate for those over 69 is 27.2% (19.8%) versus 5.3% (0.7%) for those under 70, and for males is 14.5%(7%) versus 8.3%(4.6%)for females. Among patients with chronic diseases the highest rates of hospitalisation are 26.1% for diabetes and 26.3% for kidney disease, while the highest death rate is 21.9% for cerebrovascular disease. Moreover, specific predictors for different transitions are given, and estimates of the probability of recovery and death for each patient are provided by the model. Some interesting results obtained are that for patients infected at the end of the period the hazard of transition from hospitalisation to ICU is significatively lower (p < 0.001) and the hazard of transition from hospitalisation to recovery is higher (p < 0.001). For patients previously vaccinated against pneumococcus the hazard of transition to recovery is higher (p < 0.001). Finally, internal validation and calibration of the model are also performed.


Subject(s)
COVID-19/diagnosis , COVID-19/mortality , Disease Progression , Hospital Records , Hospitals , Primary Health Care , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/complications , COVID-19/drug therapy , Calibration , Child , Child, Preschool , Comorbidity , Confidence Intervals , Female , Humans , Infant , Infant, Newborn , Male , Middle Aged , Probability , Proportional Hazards Models , Reproducibility of Results , Spain/epidemiology , Young Adult
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