scholarly journals DrugWAS: Leveraging drug-wide association studies to facilitate drug repurposing for COVID-19

2021 ◽  
Author(s):  
Cosmin A. Bejan ◽  
Katherine N. Cahill ◽  
Patrick J. Staso ◽  
Leena Choi ◽  
Josh F. Peterson ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Streptococcus Pneumoniae ◽  
Dietary Supplements ◽  
Primary Outcome ◽  
Drug Exposure ◽  
Randomized Clinical Trials ◽  
Association Studies ◽  
Drug Study ◽  
Risk Of Death ◽  
Electronic Health

AbstractImportanceThere is an unprecedented need to rapidly identify safe and effective treatments for the novel coronavirus disease 2019 (COVID-19).ObjectiveTo systematically investigate if any of the available drugs in Electronic Health Record (EHR), including prescription drugs and dietary supplements, can be repurposed as potential treatment for COVID-19.Design, Setting, and ParticipantsBased on a retrospective cohort analysis of EHR data, drug-wide association studies (DrugWAS) were performed on COVID-19 patients at Vanderbilt University Medical Center (VUMC). For each drug study, multivariable logistic regression with overlap weighting using propensity score was applied to estimate the effect of drug exposure on COVID-19 disease outcomes.ExposuresPatient exposure to a drug during 1-year prior to the pandemic and COVID-19 diagnosis was chosen as exposure of interest. Natural language processing was employed to extract drug information from clinical notes, in addition to the prescription drug data available in structured format.Main Outcomes and MeasuresAll-cause of death was selected as primary outcome. Hospitalization, admission to the intensive care unit (ICU), and need for mechanical ventilation were identified as secondary outcomes.ResultsThe study included 7,768 COVID-19 patients, of which 509 (6.55%) were hospitalized, 82 (1.06%) were admitted to ICU, 64 (0.82%) received mechanical ventilation, and 90 (1.16%) died. Overall, 15 drugs were significantly associated with decreased COVID-19 severity. Previous exposure to either Streptococcus pneumoniae vaccines (adjusted odds ratio [OR], 0.38; 95% CI, 0.14-0.98), diphtheria toxoid vaccine (OR, 0.39; 95% CI, 0.15-0.98), and tetanus toxoid vaccine (OR, 0.39; 95% CI, 0.15-0.98) were significantly associated with a decreased risk of death (primary outcome). Secondary analyses identified several other significant associations showing lower risk for COVID-19 outcomes: 2 vaccines (acellular pertussis, Streptococcus pneumoniae), 3 dietary supplements (turmeric extract, flaxseed extract, omega-3 fatty acids), methylprednisolone acetate, pseudoephedrine, ethinyl estradiol, estradiol, ibuprofen, and fluticasone.Conclusions and RelevanceThis cohort study leveraged EHR data to identify a list of drugs that could be repurposed to improve COVID-19 outcomes. Further randomized clinical trials are needed to investigate the efficacy of the proposed drugs.Key PointsQuestionCan Electronic Health Records (EHRs) be used to search for drug candidates that could be repurposed to treat the coronavirus disease 2019 (COVID-19)?FindingsDrug-wide association studies (DrugWAS) of COVID-19 severity outcomes were conducted on a cohort of 7,768 COVID-19 patients. The study found 15 drug ingredients that are significantly associated with a decreased risk of death and other severe COVID-19 outcomes.MeaningThe list of drugs proposed by this study could provide additional insights into developing new candidates for COVID-19 treatment.

scholarly journals In-Hospital Mortality in Patients with Idiopathic Pulmonary Fibrosis: A US Cohort Study

Lung ◽  
2019 ◽  
Vol 197 (6) ◽  
pp. 699-707 ◽  
Author(s):  
Michael T. Durheim ◽  
Jennifer Judy ◽  
Shaun Bender ◽  
Dorothy Baumer ◽  
Joseph Lucas ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Intensive Care ◽  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Hospital Mortality ◽  
Lung Transplant ◽  
Primary Outcome ◽  
Chronic Obstructive ◽  
Index Visit ◽  
Risk Of Death

Abstract Purpose In patients with idiopathic pulmonary fibrosis (IPF), hospitalizations are associated with high mortality. We sought to determine in-hospital mortality rates and factors associated with in-hospital mortality in patients with IPF. Methods Patients with IPF were identified from the Premier Healthcare Database, a representative administrative dataset that includes > 20% of hospital discharges in the US, using an algorithm based on diagnostic codes and billing data. We used logistic regression to analyze associations between patient-, hospital-, and treatment-related characteristics and a composite primary outcome of death during the index visit, lung transplant during the index visit and > 1 day after admission, or death during a readmission within 90 days. Results The cohort comprised 6665 patients with IPF hospitalized between October 2011 and October 2014. A total of 963 (14.4%) met the primary outcome. Factors significantly associated with a higher risk of the primary outcome included mechanical ventilation [odds ratio 4.65 (95% CI 3.73, 5.80)], admission to the intensive care unit [1.83 (1.52, 2.21)], treatment with opioids (3.06 [2.57, 3.65]), and a diagnosis of pneumonia [1.44 (1.21, 1.71)]. Factors significantly associated with a lower risk included concurrent chronic obstructive pulmonary disease [0.65 (0.55, 0.77)] and female sex [0.67 (0.57, 0.79)]. Conclusions Patients with IPF, particularly those receiving mechanical ventilation or intensive care, are at substantial risk of death or lung transplant during hospitalization or death during a readmission within 90 days.

scholarly journals Cross-sectional observational study of epidemiology of COVID-19 and clinical outcomes of hospitalised patients in North West London during March and April 2020

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e044384
Author(s):  
Guduru Gopal Rao ◽  
Alexander Allen ◽  
Padmasayee Papineni ◽  
Liyang Wang ◽  
Charlotte Anderson ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Clinical Outcomes ◽  
Severe Infection ◽  
Older Age ◽  
Cross Sectional ◽  
North West ◽  
Icu Admission ◽  
Risk Of Death ◽  
Hospitalised Patients ◽  
Increased Risk

ObjectiveThe aim of this paper is to describe evolution, epidemiology and clinical outcomes of COVID-19 in subjects tested at or admitted to hospitals in North West London.DesignObservational cohort study.SettingLondon North West Healthcare NHS Trust (LNWH).ParticipantsPatients tested and/or admitted for COVID-19 at LNWH during March and April 2020Main outcome measuresDescriptive and analytical epidemiology of demographic and clinical outcomes (intensive care unit (ICU) admission, mechanical ventilation and mortality) of those who tested positive for COVID-19.ResultsThe outbreak began in the first week of March 2020 and reached a peak by the end of March and first week of April. In the study period, 6183 tests were performed in on 4981 people. Of the 2086 laboratory confirmed COVID-19 cases, 1901 were admitted to hospital. Older age group, men and those of black or Asian minority ethnic (BAME) group were predominantly affected (p<0.05). These groups also had more severe infection resulting in ICU admission and need for mechanical ventilation (p<0.05). However, in a multivariate analysis, only increasing age was independently associated with increased risk of death (p<0.05). Mortality rate was 26.9% in hospitalised patients.ConclusionThe findings confirm that men, BAME and older population were most commonly and severely affected groups. Only older age was independently associated with mortality.

scholarly journals LB0001 MAVRILIMUMAB IMPROVES OUTCOMES IN PHASE 2 TRIAL IN NON-MECHANICALLY-VENTILATED PATIENTS WITH SEVERE COVID-19 PNEUMONIA AND SYSTEMIC HYPERINFLAMMATION

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 198.2-199
Author(s):  
L. Pupim ◽  
T. S. Wang ◽  
K. Hudock ◽  
J. Denson ◽  
N. Fourie ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Oxygen Therapy ◽  
Supplemental Oxygen ◽  
Ordinal Scale ◽  
Phase 2 ◽  
Double Blind ◽  
Gm Csf ◽  
Risk Of Death ◽  
Percentage Points ◽  
Supplemental Oxygen Therapy

Background:Granulocyte/macrophage-colony stimulating factor (GM-CSF) is a cytokine both vital to lung homeostasis and important in regulating inflammation and autoimmunity1,2,3 that has been implicated in the pathogenesis of respiratory failure and death in patients with severe COVID-19 pneumonia and systemic hyperinflammation.4-6 Mavrilimumab is a human anti GM-CSF receptor α monoclonal antibody capable of blocking GM-CSF signaling and downregulating the inflammatory process.Objectives:To evaluate the effect of mavrilimumab on clinical outcomes in patients hospitalized with severe COVID-19 pneumonia and systemic hyperinflammation.Methods:This on-going, global, randomized, double-blind, placebo-controlled seamless transition Phase 2/3 trial was designed to evaluate the efficacy and safety of mavrilimumab in adults hospitalized with severe COVID-19 pneumonia and hyperinflammation. The Phase 2 portion comprised two groups: Cohort 1 patients requiring supplemental oxygen therapy without mechanical ventilation (to maintain SpO2 ≥92%) and Cohort 2 patients requiring mechanical ventilation, initiated ≤48 hours before randomization. Here, we report results for Phase 2, Cohort 1: 116 patients with severe COVID- 19 pneumonia and hyperinflammation from USA, Brazil, Chile, Peru, and South Africa; randomized 1:1:1 to receive a single intravenous administration of mavrilimumab (10 or 6 mg/kg) or placebo. The primary efficacy endpoint was proportion of patients alive and free of mechanical ventilation at Day 29. Secondary endpoints included [1] time to 2-point clinical improvement (National Institute of Allergy and Infectious Diseases COVID-19 ordinal scale), [2] time to return to room air, and [3] mortality, all measured through Day 29. The prespecified evidentiary standard was a 2-sided α of 0.2 (not adjusted for multiplicity).Results:Baseline demographics were balanced among the intervention groups; patients were racially diverse (43% non-white), had a mean age of 57 years, and 49% were obese (BMI ≥ 30). All patients received the local standard of care: 96% received corticosteroids (including dexamethasone) and 29% received remdesivir. No differences in outcomes were observed between the 10 mg/kg and 6 mg/kg mavrilimumab arms. Results for these groups are presented together. Mavrilimumab recipients had a reduced requirement for mechanical ventilation and improved survival: at day 29, the proportion of patients alive and free of mechanical ventilation was 12.3 percentage points higher with mavrilimumab (86.7% of patients) than placebo (74.4% of patients) (Primary endpoint; p=0.1224). Mavrilimumab recipients experienced a 65% reduction in the risk of mechanical ventilation or death through Day 29 (Hazard Ratio (HR) = 0.35; p=0.0175). Day 29 mortality was 12.5 percentage points lower in mavrilimumab recipients (8%) compared to placebo (20.5%) (p=0.0718). Mavrilimumab recipients had a 61% reduction in the risk of death through Day 29 (HR= 0.39; p=0.0726). Adverse events occurred less frequently in mavrilimumab recipients compared to placebo, including secondary infections and thrombotic events (known complications of COVID-19). Thrombotic events occurred only in the placebo arm (5/40 [12.5%]).Conclusion:In a global, diverse population of patients with severe COVID-19 pneumonia and hyperinflammation receiving supplemental oxygen therapy, corticosteroids, and remdesivir, a single infusion of mavrilimumab reduced progression to mechanical ventilation and improved survival. Results indicate mavrilimumab, a potent inhibitor of GM-CSF signaling, may have added clinical benefit on top of the current standard therapy for COVID-19. Of potential importance is that this treatment strategy is mechanistically independent of the specific virus or viral variant.References:[1]Trapnell, Nat Rev Dis Pri, 2019[2]Wicks, Nat Rev Immunology, 2015[3]Hamilton, Exp Rev Clin Immunol, 2015[4]De Luca, Lancet Rheumatol, 2020[5]Cremer, Lancet Rheumatol, 2021[6]Zhou, Nature, 2020Disclosure of Interests:Lara Pupim Employee of: Kiniksa, Shareholder of: Kiniksa, Tisha S. Wang Consultant of: Partner Therapeutics; steering committee for Kinevant BREATHE clinical trial, Kristin Hudock: None declared, Joshua Denson: None declared, Nyda Fourie: None declared, Luis Hercilla Vasquez: None declared, Kleber Luz: None declared, Mohammad Madjid Grant/research support from: Kiniksa, Kirsten McHarry: None declared, José Francisco Saraiva: None declared, Eduardo Tobar: None declared, Teresa Zhou Employee of: Kiniksa, Shareholder of: Kiniksa, Manoj Samant Employee of: Kiniksa, Shareholder of: Kiniksa, Joseph Pirrello Employee of: Kiniksa, Shareholder of: Kiniksa, Fang Fang Employee of: Kiniksa, Shareholder of: Kiniksa, John F. Paolini Employee of: Kiniksa, Shareholder of: Kiniksa, Arian Pano Employee of: Kiniksa, Shareholder of: Kiniksa, Bruce C. Trapnell: None declared

Nasal High-Frequency Oscillatory Ventilation in Preterm Infants with Moderate Respiratory Distress Syndrome: A Multicenter Randomized Clinical Trial

Neonatology ◽  
2021 ◽  
pp. 1-7
Author(s):  
Xingwang Zhu ◽  
Zhichun Feng ◽  
Chengjun Liu ◽  
Liping Shi ◽  
Yuan Shi ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Respiratory Distress Syndrome ◽  
Preterm Infants ◽  
High Frequency ◽  
Primary Outcome ◽  
Distress Syndrome ◽  
Invasive Mechanical Ventilation ◽  
Risk Difference ◽  
High Frequency Oscillatory Ventilation ◽  
High Frequency Oscillatory

<b><i>Objective:</i></b> To determine whether nasal high-frequency oscillatory ventilation (NHFOV) as a primary mode of respiratory support as compared with nasal continuous airway pressure (NCPAP) will reduce the need for invasive mechanical ventilation in preterm infants (26<sup>0/7</sup>–33<sup>6/7</sup> weeks of gestational age [GA]) with respiratory distress syndrome (RDS). <b><i>Methods:</i></b> This multicenter randomized controlled trial was conducted in 18 tertiary neonatal intensive care units in China. A total of 302 preterm infants born at a GA of 26<sup>0/7</sup>–33<sup>6/7</sup> weeks with a diagnosis of RDS were randomly assigned to either the NCPAP (<i>n</i> = 150) or the NHFOV (<i>n</i> = 152) group. The primary outcome was the need for invasive mechanical ventilation during the first 7 days after birth. <b><i>Results:</i></b> Treatment failure occurred in 15 of 152 infants (9.9%) in the ­NHFOV group and in 26 of 150 infants (17.3%) in the NCPAP group (95% CI of risk difference: −15.2 to 0.4, <i>p =</i> 0.06). In the subgroup analysis, NHFOV resulted in a significantly lower rate of treatment failure than did NCPAP in the strata of 26<sup>+0/7</sup>–29<sup>+6/7</sup>weeks of GA (11.9 vs. 32.4%, 95% CI of risk difference: −39.3 to −1.7, <i>p =</i> 0.03) and birth weight &#x3c;1,500 g (10.4 vs. 29.6%, 95% CI of risk difference: −33.8 to −4.6, <i>p =</i> 0.01). The rate of thick secretions causing an airway obstruction was higher in the NHFOV group than in the NCPAP group (13.8 vs. 5.3%, 95% CI of risk difference: 1.9–15.1, <i>p =</i> 0.01). No significant differences in other secondary outcomes were found between the NHFOV and NCPAP groups. <b><i>Conclusions:</i></b> NHFOV was not superior to NCPAP with regard to the primary outcome when applied as the primary respiratory support for RDS in infants between 26<sup>+0/7</sup> and 33<sup>+6/7</sup> weeks of GA. In the subgroup analysis, NHFOV seemed to improve effectiveness than NCPAP in preterm infants &#x3c;30 weeks of GA.

scholarly journals Clinical characteristics and outcomes of people living with HIV hospitalized with COVID-19: a nationwide experience

2021 ◽  
Vol 32 (5) ◽  
pp. 435-443
Author(s):  
Maria Elena Ceballos ◽  
Patricio Ross ◽  
Martin Lasso ◽  
Isabel Dominguez ◽  
Marcela Puente ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Intensive Care ◽  
General Population ◽  
Clinical Characteristics ◽  
Cd4 Count ◽  
People Living With Hiv ◽  
Hiv Diagnosis ◽  
Hiv Viral Load ◽  
Risk Of Death ◽  
Living With Hiv

In this prospective, multicentric, observational study, we describe the clinical characteristics and outcomes of people living with HIV (PLHIV) requiring hospitalization due to COVID-19 in Chile and compare them with Chilean general population admitted with SARS-CoV-2. Consecutive PLHIV admitted with COVID-19 in 23 hospitals, between 16 April and 23 June 2020, were included. Data of a temporally matched-hospitalized general population were used to compare demography, comorbidities, COVID-19 symptoms, and major outcomes. In total, 36 PLHIV subjects were enrolled; 92% were male and mean age was 44 years. Most patients (83%) were on antiretroviral therapy; mean CD4 count was 557 cells/mm3. Suppressed HIV viremia was found in 68% and 56% had, at least, one comorbidity. Severe COVID-19 occurred in 44.4%, intensive care was required in 22.2%, and five patients died (13.9%). No differences were seen between recovered and deceased patients in CD4 count, HIV viral load, or time since HIV diagnosis. Hypertension and cardiovascular disease were associated with a higher risk of death ( p = 0.02 and 0.006, respectively). Compared with general population, the HIV cohort had significantly more men (OR 0.15; IC 95% 0.07–0.31) and younger age (OR 8.68; IC 95% 2.66–28.31). In PLHIV, we found more intensive care unit admission (OR 2.31; IC 95% 1.05–5.07) but no differences in the need for mechanical ventilation or death. In this cohort of PLHIV hospitalized with COVID-19, hypertension and cardiovascular comorbidities, but not current HIV viro-immunologic status, were the most important risk factors for mortality. No differences were found between PLHIV and general population in the need for mechanical ventilation and death.

scholarly journals Tranexamic acid for acute intracerebral haemorrhage growth based on imaging assessment (TRAIGE): a multicentre, randomised, placebo-controlled trial

2021 ◽  
pp. svn-2021-000942
Author(s):  
Jingyi Liu ◽  
Ximing Nie ◽  
Hongqiu Gu ◽  
Qi Zhou ◽  
Haixin Sun ◽  
...  
Keyword(s):  
Placebo Group ◽  
Tranexamic Acid ◽  
Intracerebral Haemorrhage ◽  
Intracranial Haemorrhage ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intracerebral Haematoma ◽  
Spot Sign ◽  
Double Blind ◽  
Risk Of Death

BackgroundStudies show tranexamic acid can reduce the risk of death and early neurological deterioration after intracranial haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in intracerebral haemorrhage patients susceptible to haemorrhage expansion.MethodsWe did a prospective, double-blind, randomised, placebo-controlled trial at 10 stroke centres in China. Acute supratentorial intracerebral haemorrhage patients were eligible if they had indication of haemorrhage expansion on admission imaging (eg, spot sign, black hole sign or blend sign), and were treatable within 8 hours of symptom onset. Patients were randomly assigned (1:1) to receive either tranexamic acid or a matching placebo. The primary outcome was intracerebral haematoma growth (>33% relative or >6 mL absolute) at 24 hours. Clinical outcomes were assessed at 90 days.ResultsOf the 171 included patients, 124 (72.5%) were male, and the mean age was 55.9±11.6 years. 89 patients received tranexamic acid and 82 received placebo. The primary outcome did not differ significantly between the groups: 36 (40.4%) patients in the tranexamic acid group and 34 (41.5%) patients in the placebo group had intracranial haemorrhage growth (OR 0.96, 95% CI 0.52 to 1.77, p=0.89). The proportion of death was lower in the tranexamic acid treatment group than placebo group (8.1% vs 10.0%), but there were no significant differences in secondary outcomes including absolute intracranial haemorrhage growth, death and dependency.ConclusionsAmong patients susceptible to haemorrhage expansion treated within 8 hours of stroke onset, tranexamic acid did not significantly prevent intracerebral haemorrhage growth. Larger studies are needed to assess safety and efficacy of tranexamic acid in intracerebral haemorrhage patients.

scholarly journals 562. Tocilizumab for the Treatment of Severe COVID-19: A Retrospective, Multi-Center, Case-Matched Series

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S346-S346
Author(s):  
Sarah Norman ◽  
Sara Jones ◽  
David Reeves ◽  
Christian Cheatham
Keyword(s):  
Mechanical Ventilation ◽  
Length Of Stay ◽  
Hospital Mortality ◽  
Primary Outcome ◽  
Fungal Infections ◽  
Hospital Length ◽  
Hospitalized Patients ◽  
Hospital Length Of Stay ◽  
Matched Design ◽  
Median Hospital

Abstract Background At the time of this writing, there is no FDA approved medication for the treatment of COVID-19. One medication currently under investigation for COVID-19 treatment is tocilizumab, an interleukin-6 (IL-6) inhibitor. It has been shown there are increased levels of cytokines including IL-6 in severe COVID-19 hospitalized patients attributed to cytokine release syndrome (CRS). Therefore, inhibition of IL-6 receptors may lead to a reduction in cytokines and prevent progression of CRS. The purpose of this retrospective study is to utilize a case-matched design to investigate clinical outcomes associated with the use of tocilizumab in severe COVID-19 hospitalized patients. Methods This was a retrospective, multi-center, case-matched series matched 1:1 on age, BMI, and days since symptom onset. Inclusion criteria included ≥ 18 years of age, laboratory confirmed positive SARS-CoV-2 result, admitted to a community hospital from March 1st – May 8th, 2020, and received tocilizumab while admitted. The primary outcome was in-hospital mortality. Secondary outcomes included hospital length of stay, total mechanical ventilation days, mechanical ventilation mortality, and incidence of secondary bacterial or fungal infections. Results The following results are presented as tocilizumab vs control respectively. The primary outcome of in-hospital mortality for tocilizumab (n=26) vs control (n=26) was 10 (38%) vs 11 (42%) patients, p=0.777. The median hospital length of stay for tocilizumab vs control was 14 vs 11 days, p=0.275. The median days of mechanical ventilation for tocilizumab (n=21) vs control (n=15) was 8 vs 7 days, p=0.139, and the mechanical ventilation mortality was 10 (48%) vs 9 (60%) patients, p=0.463. In the tocilizumab group, for those expired (n=10) vs alive (n=16), 10 (100%) vs 7 (50%) patients respectively had a peak ferritin &gt; 600 ng/mL, and 6 (60%) vs 8 (50%) patients had a peak D-dimer &gt; 2,000 ng/mL. The incidence of secondary bacterial or fungal infections within 7 days of tocilizumab administration occurred in 5 (19%) patients. Conclusion These findings suggest that tocilizumab may be a beneficial treatment modality for severe COVID-19 patients. Larger, prospective, placebo-controlled trials are needed to further validate results. Disclosures Christian Cheatham, PharmD, BCIDP, Antimicrobial Resistance Solutions (Shareholder)

Novel oral anticoagulats for the treatment of left ventricle thrombosis: a systematic review and meta-analysis

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
M Serenelli ◽  
F Vitali ◽  
R Pavasini ◽  
E Tonet ◽  
G Pompei ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Random Effect ◽  
Random Effect Model ◽  
Left Ventricular ◽  
Left Ventricular Thrombus ◽  
Cochrane Library ◽  
Secondary Outcome ◽  
Ventricular Thrombus

Abstract Funding Acknowledgements Type of funding sources: None. Background novel oral anticoagulants (NOACs) are not guideline-recommanded treatment for left ventricular thrombus.  Purpose: the aim of this meta-analysis is to compare NOACs versus vitamin-K atagonsits (VKAs) efficacy in treating left ventricular thrombus (LVT). Methods: we systematically searched MEDLINE, Cochrane Library, Biomed Central, and Web of Science for trials comparing NOACs versus VKAs in the setting of LVT. Five studies, out of the 74 initially selected after first screening, were included in the meta-analysis. For the development of this meta-analysis, the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines were followed. The shortlisted studies were retrieved as full articles and appraised independently by two unblinded reviewers. The Mantel-Haensel method with a random effect model was used for the pooled analysis. The primary outcome was the occurrence of stroke and systemic embolism. Secondary outcome was occurrence of left ventricular thrombosis resolution during treatment.  Results: 707 patients were included in the analysis for the primary outcome. Of these, 230 were treated with NOACs and 477 with VKAs. The pooled OR for the primary outcome was 0.71 (95% CI 0.18-2.86, I2 67%), thus showing similar effect in term of ischaemic protection. A total of 698 patients, 228 on NOACs and 470 on VKAs were included in the analysis of the secondary outcome. The pooled OR for the secondary outcome pooled OR 0.97, 95% CI 0.56-1.68, I2 46%. Conclusions and Relevance: NOACs seem to have a similar efficacy profile compare to VKAs and so they should be considered as an alternative treatment for left ventricular thrombosis. Large prospective randomized clinical trials are needed to confirm this exploratory finding. Abstract Figure 1

scholarly journals Use of albumin as a risk factor for hospital mortality among burn patients in Brazil: non-concurrent cohort study

2010 ◽  
Vol 128 (5) ◽  
pp. 289-295 ◽  
Author(s):  
Gilson Caleman ◽  
José Fausto de Morais ◽  
Maria Eduarda dos Santos Puga ◽  
Rachel Riera ◽  
Álvaro Nagib Atallah
Keyword(s):  
Cohort Study ◽  
Hospital Mortality ◽  
Primary Outcome ◽  
Statistical Significance ◽  
Burn Patients ◽  
Burnt Area ◽  
Historical Cohort ◽  
Risk Of Death ◽  
Crystalloid Solutions ◽  
De Medicina

CONTEXT AND OBJECTIVE: Among burn patients, it is common to use colloidal substances under the justification that it is necessary to correct the oncotic pressure of the plasma, thereby reducing the edema in the burnt area and the hypotension. The aim here was to assess the risk of hospital mortality, comparing the use of albumin and crystalloid solutions for these patients. DESIGN AND SETTING: Non-concurrent historical cohort study at Faculdade de Medicina de Marília; within the Postgraduate program on Internal and Therapeutic Medicine, Universidade Federal de São Paulo; and at the Brazilian Cochrane Center. METHODS: Burn patients hospitalized between 2000 and 2001, with registration in the Hospital Information System, who received albumin, were compared with those who received other types of volume replacement. The primary outcome was the hospital mortality rate. The data were collected from files within the Datasus software. RESULTS: 39,684 patients were included: 24,116 patients with moderate burns and 15,566 patients with major burns. Among the men treated with albumin, the odds ratio for the risk of death was 20.58 (95% confidence interval, CI: 11.28-37.54) for moderate burns and 6.24 (CI 5.22-7.45) for major burns. Among the women, this risk was 40.97 for moderate burns (CI 21.71-77.30) and 7.35 for major burns (CI 5.99-9.01). The strength of the association between the use of albumin and the risk of death was maintained for the other characteristics studied, with statistical significance. CONCLUSION: The use of albumin among patients with moderate and major burns was associated with considerably increased mortality.

scholarly journals Clinical Research Informatics: Contributions from 2017

2018 ◽  
Vol 27 (01) ◽  
pp. 177-183 ◽  
Author(s):  
Christel Daniel ◽  
Dipak Kalra ◽  
Keyword(s):  
Electronic Health Records ◽  
Clinical Research ◽  
Association Studies ◽  
Bias Reduction ◽  
Lessons Learned ◽  
Editorial Team ◽  
Private Industry ◽  
Health Records ◽  
Clinical Research Informatics ◽  
Electronic Health

Objectives: To summarize key contributions to current research in the field of Clinical Research Informatics (CRI) and to select best papers published in 2017. Method: A bibliographic search using a combination of MeSH descriptors and free terms on CRI was performed using PubMed, followed by a double-blind review in order to select a list of candidate best papers to be then peer-reviewed by external reviewers. A consensus meeting between the two section editors and the editorial team was organized to finally conclude on the selection of best papers. Results: Among the 741 returned papers published in 2017 in the various areas of CRI, the full review process selected five best papers. The first best paper reports on the implementation of consent management considering patient preferences for the use of de-identified data of electronic health records for research. The second best paper describes an approach using natural language processing to extract symptoms of severe mental illness from clinical text. The authors of the third best paper describe the challenges and lessons learned when leveraging the EHR4CR platform to support patient inclusion in academic studies in the context of an important collaboration between private industry and public health institutions. The fourth best paper describes a method and an interactive tool for case-crossover analyses of electronic medical records for patient safety. The last best paper proposes a new method for bias reduction in association studies using electronic health records data. Conclusions: Research in the CRI field continues to accelerate and to mature, leading to tools and platforms deployed at national or international scales with encouraging results. Beyond securing these new platforms for exploiting large-scale health data, another major challenge is the limitation of biases related to the use of “real-world” data. Controlling these biases is a prerequisite for the development of learning health systems.

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