scholarly journals 531. Risk Factors and Therapeutic Interventions Associated with Mortality in Veterans Diagnosed With SARS-CoV-2 Infection (or COVID-19) Admitted to a Large Academic Medical Center

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S366-S367
Author(s):  
Elwyn Welch ◽  
Shazia Raheem ◽  
Andrew Hunter ◽  
Uma Ayyala ◽  
Venkata Bandi ◽  
...  

Abstract Background Patient and treatment-related factors have been used to stratify COVID-19 outcomes; however, studies in the general population and specifically veterans have yielded variable results. This study was designed to assess how baseline characteristics and interventions correlate with clinical outcomes in patients admitted with COVID-19 at a large academic Veterans Affairs hospital. Methods Retrospective chart review was conducted on veterans admitted to the hospital with COVID-19 between March 1 to December 31, 2020. Veterans without respiratory symptoms attributed to COVID-19 or enrolled in a COVID-19 clinical trial were excluded. Primary outcome was in-hospital mortality up to 28 days. Secondary outcomes were 90-day mortality, discharge to higher level of care or remained in the hospital within 28 days, and discharge with new oxygen requirement within 28 days. Patient characteristics and therapeutic interventions were assessed for correlation with primary and secondary outcomes. Results Of 497 hospitalized patients reviewed, 293 were included for analysis; 94% were male; average age was 68 years with 64.9% of veterans greater than 65 years of age; 43.7% were Black; 17.4% were Hispanic. In-hospital mortality at 28-days and 90-day mortality were 18.1% and 21.5%, respectively. At discharge, 34.1% had a new oxygen requirement and 17.5% went to a higher level of care. Patients that died in-hospital were more likely to be greater than 65 years of age (p< 0.001), Hispanic (p=0.007), have chronic kidney disease (CKD) (p=0.005), be admitted to ICU (p< 0.001); receive dexamethasone (p< 0.001), convalescent plasma (p< 0.001), or antibiotics (p< 0.001); require mechanical ventilation (p< 0.001); or have new onset atrial fibrillation (p< 0.001). Veterans also had higher levels of inflammatory markers within 48 hours of hospital admission (see Table 2) and longer length of hospital stay (< 0.001). There was a trend for patients that died in the hospital within 28-days to be less likely to be Black (p=0.06). Table 1. Primary and Secondary Outcomes of Study Population (n=293) Table 2. Patient Characteristics Stratified by Primary Outcome Table 3. Characteristics of the Patients that Survived to Discharge Stratified by Secondary Outcome Measures Conclusion Patients were more likely to die in-hospital within 28-days if they were greater than 65 years of age, Hispanic and had CKD. Veterans that died in-hospital within 28-days had higher inflammatory marker levels and were more likely to receive COVID-19 treatments. Disclosures All Authors: No reported disclosures

2021 ◽  
Vol 17 (6) ◽  
pp. 445-453
Author(s):  
Angelina Vascimini, PharmD ◽  
Kevin Duane, PharmD ◽  
Stacey Curtis, PharmD

Objective: The opioid epidemic is frequently discussed including the staggering numbers involved with coprescribing opioids and benzodiazepines associated with death. Community pharmacists, with the help of a system intervention, have a unique opportunity to help reduce the coprescribing of benzodiazepines and opioids and reduce the associated risk of death.Design: A single center retrospective chart review was conducted after a system intervention was placed, as a quality improvement project, from November 2019 to May 2020.Setting: Independent community pharmacy.Patients/participants: Data included demographics, dosing of each medication pre- and post-intervention, and naloxone status.Main outcome(s) measures: The primary outcome evaluated was reduction in dose/discontinuation of these prescriptions. The secondary outcome evaluated was the number of naloxone prescriptions ordered per protocol and picked up.Results: The primary outcome did not show statistical difference; however, the secondary outcomes showed statistical significance.Conclusion: In conclusion, community pharmacists, with the help of evolving technologies, can reduce harm associated with the coprescribing of benzodiazepines and opioids.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Sirui Zhang ◽  
Yupei Li ◽  
Guina Liu ◽  
Baihai Su

Abstract Background Anticoagulation in hospitalized COVID-19 patients has been associated with survival benefit; however, the optimal anticoagulant strategy has not yet been defined. The objective of this meta-analysis was to investigate the effect of intermediate-to-therapeutic versus prophylactic anticoagulation for thromboprophylaxis on the primary outcome of in-hospital mortality and other patient-centered secondary outcomes in COVID-19 patients. Methods MEDLINE, EMBASE, and Cochrane databases were searched from inception to August 10th 2021. Cohort studies and randomized clinical trials that assessed the efficacy and safety of intermediate-to-therapeutic versus prophylactic anticoagulation in hospitalized COVID-19 patients were included. Baseline characteristics and relevant data of each study were extracted in a pre-designed standardized data-collection form. The primary outcome was all-cause in-hospital mortality and the secondary outcomes were incidence of thrombotic events and incidence of any bleeding and major bleeding. Pooled analysis with random effects models yielded relative risk with 95 % CIs. Results This meta-analysis included 42 studies with 28,055 in-hospital COVID-19 patients totally. Our pooled analysis demonstrated that intermediate-to-therapeutic anticoagulation was not associated with lower in-hospital mortality (RR=1.12, 95 %CI 0.99-1.25, p=0.06, I2=77 %) and lower incidence of thrombotic events (RR=1.30, 95 %CI 0.79-2.15, p=0.30, I2=88 %), but increased the risk of any bleeding events (RR=2.16, 95 %CI 1.79-2.60, p<0.01, I2=31 %) and major bleeding events significantly (RR=2.10, 95 %CI 1.77-2.51, p<0.01, I2=11 %) versus prophylactic anticoagulation. Moreover, intermediate-to-therapeutic anticoagulation decreased the incidence of thrombotic events (RR=0.71, 95 %CI 0.56-0.89, p=0.003, I2=0 %) among critically ill COVID-19 patients admitted to intensive care units (ICU), with increased bleeding risk (RR=1.66, 95 %CI 1.37-2.00, p<0.01, I2=0 %) and unchanged in-hospital mortality (RR=0.94, 95 %CI 0.79-1.10, p=0.42, I2=30 %) in such patients. The Grading of Recommendation, Assessment, Development, and Evaluation certainty of evidence ranged from very low to moderate. Conclusions We recommend the use of prophylactic anticoagulation against intermediate-to-therapeutic anticoagulation among unselected hospitalized COVID-19 patients considering insignificant survival benefits but higher risk of bleeding in the escalated thromboprophylaxis strategy. For critically ill COVID-19 patients, the benefits of intermediate-to-therapeutic anticoagulation in reducing thrombotic events should be weighed cautiously because of its association with higher risk of bleeding. Trial registration The protocol was registered at PROSPERO on August 17th 2021 (CRD42021273780). Graphical abstract


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S363-S364
Author(s):  
Sana Mohayya ◽  
Navaneeth Narayanan ◽  
Daniel Cimilluca ◽  
Parth Vaidya ◽  
Alexander Malanowski ◽  
...  

Abstract Background In an effort to minimize complications associated with over-utilization of antibiotics, many antimicrobial stewardship programs have incorporated an antibiotic time out (ATO). Despite the increasing adoption of the ATO, limited data are available to support its effectiveness. This study was designed to assess the impact of an automated ATO integrated into the electronic medical record (EMR) on the rate of antibiotic modification in patients receiving broad-spectrum antibiotic(s) for Gram-negative bacteremia (GNB). Methods This was a single-center retrospective cohort study of inpatients from January 2017 to June 2018 conducted at a large academic medical center. ATO was implemented on October 31, 2017. Adult patients with GNB who received at least 72 hours of a systemic antibiotic were included. Patients with neutropenia or polymicrobial infections were excluded. The primary outcome was the proportion of patients who received a modification of therapy within 24 hours of final culture results. Secondary outcomes included modification at any point in therapy, time to modification of therapy, time to de-escalation, and days of therapy of broad-spectrum antibiotics. Results There was a total of 88 patients who met inclusion criteria, 37 patients pre-ATO and 51 patients post-ATO. The primary outcome of modification of therapy within 24 hours of final culture results was not significantly different for patients in the pre-ATO and post-ATO groups (19% vs. 20%, P = 0.94, respectively). The secondary outcome of modification of therapy at any point in therapy was not significantly different between the two groups (62% vs. 66%, P = 0.67). Of the 47 patients who received a modification of therapy, the mean time to modification was significantly shorter in the post-ATO group (52.8 hours vs. 45.26 hours, P < 0.05,). All other secondary outcomes were not significantly different between study groups. Conclusion The ATO alert was not associated with a higher rate of antibiotic modification within 24 hours of culture results in patients with GNB, although there was a significant reduction in the time to antibiotic modification. Further efforts are needed to improve the time to modification and optimize antibiotic prescribing practices. Disclosures All authors: No reported disclosures.


BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e025374 ◽  
Author(s):  
Ariel Dora Stern ◽  
William J Gordon ◽  
Adam B Landman ◽  
Daniel B Kramer

ObjectivesTo more clearly define the landscape of digital medical devices subject to US Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and cybersecurity features in regulated medical devices.DesignWe analysed data from publicly available FDA product summaries to understand the frequency and recent time trends of inclusion of software and cybersecurity content in publicly available product information.SettingThe full set of regulated medical devices, approved over the years 2002–2016 included in the FDA’s 510(k) and premarket approval databases.Primary and secondary outcome measuresThe primary outcome was the share of devices containing software that included cybersecurity content in their product summaries. Secondary outcomes were differences in these shares (a) over time and (b) across regulatory areas.ResultsAmong regulated devices, 13.79% were identified as including software. Among these products, only 2.13% had product summaries that included cybersecurity content over the period studied. The overall share of devices including cybersecurity content was higher in recent years, growing from an average of 1.4% in the first decade of our sample to 5.5% in 2015 and 2016, the most recent years included. The share of devices including cybersecurity content also varied across regulatory areas from a low of 0% to a high of 22.2%.ConclusionsTo ensure the safest possible healthcare delivery environment for patients and hospitals, regulators and manufacturers should work together to make the software and cybersecurity content of new medical devices more easily accessible.


2020 ◽  
Vol 41 (44) ◽  
pp. 4234-4242
Author(s):  
Sebastian E Beyer ◽  
Andrew B Dicks ◽  
Scott A Shainker ◽  
Loryn Feinberg ◽  
Marc L Schermerhorn ◽  
...  

Abstract Aims Pregnancy is a known risk factor for arterial dissection, which can result in significant morbidity and mortality in the peripartum period. However, little is known about the risk factors, timing, distribution, and outcomes of arterial dissections associated with pregnancy. Methods and results We included all women ≥12 years of age with hospitalizations associated with pregnancy and/or delivery in the Nationwide Readmissions Database between 2010 and 2015. The primary outcome was any dissection during pregnancy, delivery, or the postpartum period (42-days post-delivery). Secondary outcomes included timing of dissection, location of dissection, and in-hospital mortality. Among 18 151  897 pregnant patients, 993 (0.005%) patients were diagnosed with a pregnancy-related dissection. Risk factors included older age (32.8 vs. 28.0 years), multiple gestation (3.6% vs. 1.9%), gestational diabetes (14.3% vs. 0.2%), gestational hypertension (6.0% vs. 0.6%), and pre-eclampsia/eclampsia (2.7% vs. 0.4%), in addition to traditional cardiovascular risk factors. Of the 993 patients with dissection, 150 (15.1%) dissections occurred in the antepartum period, 232 (23.4%) were diagnosed during the admission for delivery, and 611 (61.5%) were diagnosed in the postpartum period. The most common locations for dissections were coronary (38.2%), vertebral (22.9%), aortic (19.8%), and carotid (19.5%). In-hospital mortality was 3.7% among pregnant patients with a dissection vs. &lt;0.001% in patients without a dissection. Deaths were isolated to patients with an aortic (8.6%), coronary (4.2%), or supra-aortic (&lt;2.5%) dissection. Conclusion Arterial dissections occurred in 5.5/100 000 hospitalized pregnant or postpartum women, most frequently in the postpartum period, and were associated with high mortality risk. The coronary arteries were most commonly involved. Pregnancy-related dissections were associated with traditional risk factors, as well as pregnancy-specific conditions.


2018 ◽  
Vol 49 (6) ◽  
pp. 1005-1014 ◽  
Author(s):  
Heidi Frølund Pedersen ◽  
Johanne L. Agger ◽  
Lisbeth Frostholm ◽  
Jens S. Jensen ◽  
Eva Ørnbøl ◽  
...  

AbstractBackgroundPsychological treatment for functional somatic syndromes (FSS) has been found moderately effective. Information on how much treatment is needed to obtain improvement is sparse. We assessed the efficacy of a brief and extended version of group-based Acceptance and Commitment Therapy (ACT) v. enhanced care (EC) for patients with multiple FSS operationalised as Bodily Distress Syndrome multi-organ type.MethodsIn a randomised controlled three-armed trial, consecutively referred patients aged 20–50 with multiple FSS were randomly assigned to either (1) EC; (2) Brief ACT: EC plus 1-day workshop and one individual consultation; or (3) Extended ACT: EC plus nine 3-h group-based sessions. Primary outcome was patient-rated overall health improvement on the five-point clinical global improvement scale 14 months after randomisation. A proportional odds model was used for the analyses.ResultsA total of 180 patients were randomised; 60 to EC, 61 to Brief ACT, and 59 to Extended ACT. Improvement on the primary outcome after Extended ACT was significantly greater than after EC with an unadjusted OR of 2.9 [95% CI (1.4–6.2), p = 0.006]. No significant differences were found between Brief ACT and EC. Of the 18 secondary outcomes, the only significant difference found was for physical functioning in the comparison of Extended ACT with EC.ConclusionsPatients rated their overall health status as more improved after Extensive ACT than after EC; however, clinically relevant secondary outcome measures did not support this finding. Discrepancies between primary and secondary outcomes in this trial are discussed.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Youfeng Zhu ◽  
Haiyan Yin ◽  
Rui Zhang ◽  
Xiaoling Ye ◽  
Jianrui Wei

Abstract Background The use of dobutamine in patients with sepsis is questionable currently. As the benefit of dobutamine in septic patients is unclear, we aimed to evaluate whether the use of dobutamine was associated with decreased hospital mortality in sepsis patients. Methods Based on the analysis of MIMIC III public database, we performed a big-data, real world study. According to the use of dobutamine or not, patients were categorized as the dobutamine group or non dobutamine group.We used propensity score matched (PSM) analysis to adjust for confoundings. The primary outcome was hospital mortality. Results In the present study, after screening 38,605 patients, 2826 patients with sepsis were included. 121 patients were in dobutamine group and 2165 patients were in non dobutamine group. Compared with patients in non-dobutamine group, patients in dobutamine group had a lower MAP, higher HR, higher RR, higher severity of illness scores. 72 of 121 patients (59.5%) in the dobutamine group and 754 of 2165 patients (34.8%) in the non-dobutamine group died in the hospital, which resulted in a significant between-group difference (OR 1.56, 95% CI 1.01–2.40; P = 0.000). For the secondary outcomes, patients in dobutamine group received more MV use, more renal replacement therapy use, had longer ICU stay durations and more cardiac arrhythmias than those in non-dobutamine group. After adjusting for confoundings between groups by PSM analysis, hospital mortality was consistently higher in dobutamine group than that in non-dobutamine group (60.2% vs. 49.4%, OR 1.55, 95% CI 1.01–2.37; P = 0.044). Conclusions Among patients with sepsis, our study showed that the use of dobutamine was not associated with decreased hospital mortality. Further large scale, randomized controlled studies are warrented to confirm our findings.


Author(s):  
Ana Sanader Vucemilovic ◽  
Livia Puljak

Aim: Psoriasis includes unpleasant symptoms such as pain. This study aimed to investigate whether clinical trials have domains related to pain in their study designs. Materials and methods: We analyzed all clinical trials about interventions for psoriasis treatment registered on ClinicalTrials.gov and the frequency of pain-related outcomes. Results: Our analysis included 1033 registered clinical trials. They had 1329 primary outcomes and 5457 secondary outcomes. The pain was used in six (0.6%) protocols as a primary outcome and 68 (6.5%) protocols as a secondary outcome. Conclusion: Pain as an outcome was used in few registered clinical trial protocols for the treatment of psoriatic conditions. Future studies should investigate why the trialists do not include pain among primary or secondary outcomes.


2021 ◽  
pp. 088506662110705
Author(s):  
Shan Wang ◽  
Christy Huynh ◽  
Shahidul Islam ◽  
Brian Malone ◽  
Naveed Masani ◽  
...  

Purpose Safety of remdesivir in patients with renal impairment is unknown. Incidence of liver injury secondary to remdesivir is also unknown. The objective of this study is to assess the incidence of acute kidney injury (AKI) and to trend the liver enzymes during remdesivir treatment and change in eGFR from baseline to end of treatment as well as 48 h post completion of remdesivir therapy. Methods This is a retrospective chart review study including adult patients admitted with COVID-19 receiving remdesivir with a baseline eGFR < 30 ml/min per 1.73 m^2 from December 2020 to May 2021. The primary outcome was to assess the incidence of AKI and hepatic injury. The secondary outcome was to assess the efficacy of remdesivir defined by change in oxygen requirement. Results Seventy-one patients were included in the study. Patients experienced an improvement in eGFR from baseline (T0) to end of remdesivir treatment (T1), as well as 48 h after the end of the treatment (T2) ( + 30.3% and + 30.6% respectively, P < .0001). Creatinine reduced from baseline (T0) to T1 and T2 (-20.9% and −20.5% respectively, P < .0001). Creatinine clearance improved from baseline to T1 and T2 ( + 26.6% and + 26.2% respectively, p < .0001). Elevation of aminotransferase (AST) was observed at T1 ( + 2.5%, P  =  .727), however, AST reduction was seen at T2 (-15.8%, P  =  .021). Elevation in alanine transaminase (ALT) was observed at T1 and T2 ( + 25% and + 12%, P  =  .004 and P  =  .137 respectively). Both direct and total bilirubin remained stable and were not significantly changed from baseline. Conclusion Our study showed that remdesivir use in renally-impaired patients with eGFR < 30 ml/min is safe. Remdesivir may be considered as a therapeutic option in this population with COVID-19 infection.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_4) ◽  
Author(s):  
Rebecca Mathew ◽  
Pietro Di Santo ◽  
Jeffrey Marbach ◽  
Jordan Hutson ◽  
Trevor Simard ◽  
...  

Introduction: Cardiogenic shock (CS) is associated with significant morbidity and mortality. Although inotropic support is a mainstay of medical therapy for CS, little evidence exists to guide the selection of inotropic agents in clinical practice. Methods: In this double blind randomized controlled trial, we assigned patients with SCAI class B to E shock to either milrinone or dobutamine for inotropic support. Therapy was titrated based on clinical, biochemical and hemodynamic response as evaluated by the treating physician. The primary outcome was a combined endpoint of in hospital mortality, non-fatal MI, stroke, new initiation of renal replacement therapy (RRT), need for MCS or cardiac transplant, or cardiac arrest with successful resuscitation. Secondary outcomes included individual components of the primary outcome. Results: Among 192 participants, there was no significant difference in the primary outcome, occurring in 49% (47 of 96) of patients in the milrinone arm and 54% (52 of 96) patients in the dobutamine group (RR 0.90, 95% CI of 0.69-1.19, p-value = 0.47). There were also no differences in important secondary outcomes between milrinone and dobutamine, including in-hospital mortality 37% (35 of 96) vs 43% (41 of 96) (RR 0.85, 95% CI 0.60-1.21, p-value = 0.38) or need for RRT 22% (21 of 96) vs 17% (16 of 96) (RR 1.31, 95% CI 0.73-2.36, p-value = 0.36). Conclusions: In this randomized clinical trial of milrinone and dobutamine in CS, there was no difference in the primary composite outcome or in important secondary outcomes. The selection of inotropic agent could reasonably be based on physician comfort, cost and individual response to therapy.


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