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1.
Circ Heart Fail ; 14(3): e007767, 2021 03.
Article in English | MEDLINE | ID: covidwho-2153215

ABSTRACT

BACKGROUND: The expense of clinical trials mandates new strategies to efficiently generate evidence and test novel therapies. In this context, we designed a decentralized, patient-centered randomized clinical trial leveraging mobile technologies, rather than in-person site visits, to test the efficacy of 12 weeks of canagliflozin for the treatment of heart failure, regardless of ejection fraction or diabetes status, on the reduction of heart failure symptoms. METHODS: One thousand nine hundred patients will be enrolled with a medical record-confirmed diagnosis of heart failure, stratified by reduced (≤40%) or preserved (>40%) ejection fraction and randomized 1:1 to 100 mg daily of canagliflozin or matching placebo. The primary outcome will be the 12-week change in the total symptom score of the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes will be daily step count and other scales of the Kansas City Cardiomyopathy Questionnaire. RESULTS: The trial is currently enrolling, even in the era of the coronavirus disease 2019 (COVID-19) pandemic. CONCLUSIONS: CHIEF-HF (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure) is deploying a novel model of conducting a decentralized, patient-centered, randomized clinical trial for a new indication for canagliflozin to improve the symptoms of patients with heart failure. It can model a new method for more cost-effectively testing the efficacy of treatments using mobile technologies with patient-reported outcomes as the primary clinical end point of the trial. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04252287.


Subject(s)
Canagliflozin/therapeutic use , Heart Failure/drug therapy , Sodium-Glucose Transporter 2 Inhibitors/therapeutic use , Telemedicine , Actigraphy/instrumentation , Canagliflozin/adverse effects , Double-Blind Method , Exercise Tolerance/drug effects , Fitness Trackers , Heart Failure/diagnosis , Heart Failure/physiopathology , Humans , Mobile Applications , Quality of Life , Randomized Controlled Trials as Topic , Recovery of Function , Sodium-Glucose Transporter 2 Inhibitors/adverse effects , Stroke Volume/drug effects , Telemedicine/instrumentation , Time Factors , Treatment Outcome , United States , Ventricular Function, Left/drug effects
2.
Hypertension ; 76(5): 1350-1367, 2020 11.
Article in English | MEDLINE | ID: covidwho-2153223

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic is associated with significant morbidity and mortality throughout the world, predominantly due to lung and cardiovascular injury. The virus responsible for COVID-19-severe acute respiratory syndrome coronavirus 2-gains entry into host cells via ACE2 (angiotensin-converting enzyme 2). ACE2 is a primary enzyme within the key counter-regulatory pathway of the renin-angiotensin system (RAS), which acts to oppose the actions of Ang (angiotensin) II by generating Ang-(1-7) to reduce inflammation and fibrosis and mitigate end organ damage. As COVID-19 spans multiple organ systems linked to the cardiovascular system, it is imperative to understand clearly how severe acute respiratory syndrome coronavirus 2 may affect the multifaceted RAS. In addition, recognition of the role of ACE2 and the RAS in COVID-19 has renewed interest in its role in the pathophysiology of cardiovascular disease in general. We provide researchers with a framework of best practices in basic and clinical research to interrogate the RAS using appropriate methodology, especially those who are relatively new to the field. This is crucial, as there are many limitations inherent in investigating the RAS in experimental models and in humans. We discuss sound methodological approaches to quantifying enzyme content and activity (ACE, ACE2), peptides (Ang II, Ang-[1-7]), and receptors (types 1 and 2 Ang II receptors, Mas receptor). Our goal is to ensure appropriate research methodology for investigations of the RAS in patients with severe acute respiratory syndrome coronavirus 2 and COVID-19 to ensure optimal rigor and reproducibility and appropriate interpretation of results from these investigations.


Subject(s)
Coronavirus Infections/epidemiology , Hypertension/epidemiology , Peptidyl-Dipeptidase A/metabolism , Pneumonia, Viral/epidemiology , Renin-Angiotensin System/physiology , Severe Acute Respiratory Syndrome/metabolism , Angiotensin-Converting Enzyme 2 , Blood Pressure Determination/methods , COVID-19 , China/epidemiology , Female , Humans , Hypertension/physiopathology , Incidence , Male , Pandemics/statistics & numerical data , Practice Guidelines as Topic , Prognosis , Research Design , Risk Assessment , Severe Acute Respiratory Syndrome/epidemiology
3.
Hypertension ; 76(5): 1368-1383, 2020 11.
Article in English | MEDLINE | ID: covidwho-2153222

ABSTRACT

Telemedicine allows the remote exchange of medical data between patients and healthcare professionals. It is used to increase patients' access to care and provide effective healthcare services at a distance. During the recent coronavirus disease 2019 (COVID-19) pandemic, telemedicine has thrived and emerged worldwide as an indispensable resource to improve the management of isolated patients due to lockdown or shielding, including those with hypertension. The best proposed healthcare model for telemedicine in hypertension management should include remote monitoring and transmission of vital signs (notably blood pressure) and medication adherence plus education on lifestyle and risk factors, with video consultation as an option. The use of mixed automated feedback services with supervision of a multidisciplinary clinical team (physician, nurse, or pharmacist) is the ideal approach. The indications include screening for suspected hypertension, management of older adults, medically underserved people, high-risk hypertensive patients, patients with multiple diseases, and those isolated due to pandemics or national emergencies.


Subject(s)
Coronavirus Infections/prevention & control , Cross Infection/prevention & control , Hypertension/drug therapy , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Telemedicine/statistics & numerical data , Blood Pressure Determination/methods , COVID-19 , Coronavirus Infections/epidemiology , Disease Management , Evidence-Based Medicine , Female , Humans , Hypertension/diagnosis , Italy , Male , Occupational Health , Pandemics/statistics & numerical data , Patient Safety , Pneumonia, Viral/epidemiology , Severity of Illness Index
4.
Ther Drug Monit ; 42(3): 360-368, 2020 06.
Article in English | MEDLINE | ID: covidwho-2152206

ABSTRACT

BACKGROUND: COVID-19 is a novel infectious disease caused by the severe acute respiratory distress (SARS)-coronavirus-2 (SARS-CoV-2). Several therapeutic options are currently emerging but none with universal consensus or proven efficacy. Solid organ transplant recipients are perceived to be at increased risk of severe COVID-19 because of their immunosuppressed conditions due to chronic use of immunosuppressive drugs (ISDs). It is therefore likely that solid organ transplant recipients will be treated with these experimental antivirals. METHODS: This article is not intended to provide a systematic literature review on investigational treatments tested against COVID-19; rather, the authors aim to provide recommendations for therapeutic drug monitoring of ISDs in transplant recipients infected with SARS-CoV-2 based on a review of existing data in the literature. RESULTS: Management of drug-drug interactions between investigational anti-SARS-CoV-2 drugs and immunosuppressants is a complex task for the clinician. Adequate immunosuppression is necessary to prevent graft rejection while, if critically ill, the patient may benefit from pharmacotherapeutic interventions directed at limiting SARS-CoV-2 viral replication. Maintaining ISD concentrations within the desired therapeutic range requires a highly individualized approach that is complicated by the pandemic context and lack of hindsight. CONCLUSIONS: With this article, the authors inform the clinician about the potential interactions of experimental COVID-19 treatments with ISDs used in transplantation. Recommendations regarding therapeutic drug monitoring and dose adjustments in the context of COVID-19 are provided.


Subject(s)
Antiviral Agents/adverse effects , Coronavirus Infections/drug therapy , Drug Monitoring , Immunosuppressive Agents/adverse effects , Pneumonia, Viral/drug therapy , Transplant Recipients , Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Antibodies, Monoclonal, Humanized , Antiviral Agents/therapeutic use , Betacoronavirus , COVID-19 , Drug Interactions , Glucocorticoids , Humans , Hydroxychloroquine , Immunosuppressive Agents/therapeutic use , Pandemics , Protease Inhibitors , SARS-CoV-2
5.
JMIR Public Health Surveill ; 7(4): e25500, 2021 04 07.
Article in English | MEDLINE | ID: covidwho-2141301

ABSTRACT

BACKGROUND: The COVID-19 pandemic, caused by a novel coronavirus termed SARS-CoV-2, has spread quickly worldwide. Convalescent plasma (CP) obtained from patients following recovery from COVID-19 infection and development of antibodies against the virus is an attractive option for either prophylactic or therapeutic treatment, since antibodies may have direct or indirect antiviral activities and immunotherapy has proven effective in principle and in many clinical reports. OBJECTIVE: We seek to characterize the latest advances and evidence in the use of CP for COVID-19 through a systematic review and quantitative analysis, identify knowledge gaps in this setting, and offer recommendations and directives for future research. METHODS: PubMed, Web of Science, and Embase were continuously searched for studies assessing the use of CP for COVID-19, including clinical studies, commentaries, reviews, guidelines or protocols, and in vitro testing of CP antibodies. The screening process and data extraction were performed according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Quality appraisal of all clinical studies was conducted using a universal tool independent of study designs. A meta-analysis of case-control and randomized controlled trials (RCTs) was conducted using a random-effects model. RESULTS: Substantial literature has been published covering various aspects of CP therapy for COVID-19. Of the references included in this review, a total of 243 eligible studies including 64 clinical studies, 79 commentary articles, 46 reviews, 19 guidance and protocols, and 35 in vitro testing of CP antibodies matched the criteria. Positive results have been mostly observed so far when using CP for the treatment of COVID-19. There were remarkable heterogeneities in the CP therapy with respect to patient demographics, donor antibody titers, and time and dose of CP administration. The studies assessing the safety of CP treatment reported low incidence of adverse events. Most clinical studies, in particular case reports and case series, had poor quality. Only 1 RCT was of high quality. Randomized and nonrandomized data were found in 2 and 11 studies, respectively, and were included for meta-analysis, suggesting that CP could reduce mortality and increase viral clearance. Despite promising pilot studies, the benefits of CP treatment can only be clearly established through carefully designed RCTs. CONCLUSIONS: There is developing support for CP therapy, particularly for patients who are critically ill or mechanically ventilated and resistant to antivirals and supportive care. These studies provide important lessons that should inform the planning of well-designed RCTs to generate more robust knowledge for the efficacy of CP in patients with COVID-19. Future research is necessary to fill the knowledge gap regarding prevention and treatment for patients with COVID-19 with CP while other therapeutics are being developed.


Subject(s)
COVID-19/therapy , Coronavirus Infections , Coronavirus Infections/prevention & control , Coronavirus Infections/therapy , Humans , Immunization, Passive
6.
Heart ; 108(4): 258-265, 2022 02.
Article in English | MEDLINE | ID: covidwho-2137872

ABSTRACT

Ramadan fasting is observed by most of the 1.8 billion Muslims around the world. It lasts for 1 month per the lunar calendar year and is the abstention from any food and drink from dawn to sunset. While recommendations on 'safe' fasting exist for patients with some chronic conditions, such as diabetes mellitus, guidance for patients with cardiovascular disease is lacking. We reviewed the literature to help healthcare professionals educate, discuss and manage patients with cardiovascular conditions, who are considering fasting. Studies on the safety of Ramadan fasting in patients with cardiac disease are sparse, observational, of small sample size and have short follow-up. Using expert consensus and a recognised framework, we risk stratified patients into 'low or moderate risk', for example, stable angina or non-severe heart failure; 'high risk', for example, poorly controlled arrhythmias or recent myocardial infarction; and 'very high risk', for example, advanced heart failure. The 'low-moderate risk' group may fast, provided their medications and clinical conditions allow. The 'high' or 'very high risk' groups should not fast and may consider safe alternatives such as non-consecutive fasts or fasting shorter days, for example, during winter. All patients who are fasting should be educated before Ramadan on their risk and management (including the risk of dehydration, fluid overload and terminating the fast if they become unwell) and reviewed after Ramadan to reassess their risk status and condition. Further studies to clarify the benefits and risks of fasting on the cardiovascular system in patients with different cardiovascular conditions should help refine these recommendations.


Subject(s)
Cardiovascular Diseases , Heart Failure , Cardiovascular Diseases/therapy , Fasting/adverse effects , Heart Failure/therapy , Humans , Islam
7.
Sao Paulo Med J ; 138(4): 305-309, 2020.
Article in English | MEDLINE | ID: covidwho-2140943

ABSTRACT

BACKGROUND: The COVID-19 pandemic is threatening healthcare systems and hospital operations on a global scale. Treatment algorithms have changed in general surgery clinics, as in other medical disciplines providing emergency services, with greater changes seen especially in pandemic hospitals. OBJECTIVES: To evaluate the follow-up of patients undergoing emergency surgery in our hospital during the COVID-19 pandemic. DESIGN AND SETTING: Cross-sectional study conducted in a tertiary-level public hospital. METHODS: The emergency surgeries carried out between March 11 and April 2, 2020, in the general surgery clinic of a tertiary-care hospital that has also taken on the functions of a pandemic hospital, were retrospectively examined. RESULTS: A total of 25 patients were included, among whom 20 were discharged without event, one remained in the surgical intensive care unit, two are under follow-up by the surgery service and two died. Upon developing postoperative fever and shortness of breath, two patients underwent thoracic computed tomography (CT), although no characteristics indicating COVID-19 were found. The discharged patients had no COVID-19 positivity at follow-up. CONCLUSION: The data that we obtained were not surgical results from patients with COVID-19 infection. They were the results from emergency surgeries on patients who were not infected with COVID-19 but were in a hospital largely dealing with the pandemic. Analysis on the cases in this study showed that both the patients with emergency surgery and the patients with COVID infection were successfully treated, without influencing each other, through appropriate isolation measures, although managed in the same hospital. In addition, these successful results were supported by 14-day follow-up after discharge.


Subject(s)
Coronavirus Infections , Emergency Medical Services , Pandemics , Pneumonia, Viral , Surgical Procedures, Operative , Betacoronavirus , COVID-19 , Cross-Sectional Studies , Hospitals, Public , Humans , Retrospective Studies , SARS-CoV-2 , Tertiary Care Centers , Turkey
8.
Ann Intern Med ; 173(7): 536-541, 2020 10 06.
Article in English | MEDLINE | ID: covidwho-2110869

ABSTRACT

BACKGROUND: The incidence and severity of coronavirus disease 2019 (COVID-19) among HIV-positive persons receiving antiretroviral therapy (ART) have not been characterized in large populations. OBJECTIVE: To describe the incidence and severity of COVID-19 by nucleos(t)ide reverse transcriptase inhibitor (NRTI) use among HIV-positive persons receiving ART. DESIGN: Cohort study. SETTING: HIV clinics in 60 Spanish hospitals between 1 February and 15 April 2020. PARTICIPANTS: 77 590 HIV-positive persons receiving ART. MEASUREMENTS: Estimated risks (cumulative incidences) per 10 000 persons and 95% CIs for polymerase chain reaction-confirmed COVID-19 diagnosis, hospitalization, intensive care unit (ICU) admission, and death. Risk and 95% CIs for COVID-19 diagnosis and hospital admission by use of the NRTIs tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC), tenofovir alafenamide (TAF)/FTC, abacavir (ABC)/lamivudine (3TC), and others were estimated through Poisson regression models. RESULTS: Of 77 590 HIV-positive persons receiving ART, 236 were diagnosed with COVID-19, 151 were hospitalized, 15 were admitted to the ICU, and 20 died. The risks for COVID-19 diagnosis and hospitalization were greater in men and persons older than 70 years. The risk for COVID-19 hospitalization was 20.3 (95% CI, 15.2 to 26.7) among patients receiving TAF/FTC, 10.5 (CI, 5.6 to 17.9) among those receiving TDF/FTC, 23.4 (CI, 17.2 to 31.1) among those receiving ABC/3TC, and 20.0 (CI, 14.2 to 27.3) for those receiving other regimens. The corresponding risks for COVID-19 diagnosis were 39.1 (CI, 31.8 to 47.6), 16.9 (CI, 10.5 to 25.9), 28.3 (CI, 21.5 to 36.7), and 29.7 (CI, 22.6 to 38.4), respectively. No patient receiving TDF/FTC was admitted to the ICU or died. LIMITATION: Residual confounding by comorbid conditions cannot be completely excluded. CONCLUSION: HIV-positive patients receiving TDF/FTC have a lower risk for COVID-19 and related hospitalization than those receiving other therapies. These findings warrant further investigation in HIV preexposure prophylaxis studies and randomized trials in persons without HIV. PRIMARY FUNDING SOURCE: Instituto de Salud Carlos III and National Institutes of Health.


Subject(s)
Antiretroviral Therapy, Highly Active , Coronavirus Infections/epidemiology , HIV Infections/drug therapy , Pneumonia, Viral/epidemiology , Adenine/analogs & derivatives , Adult , Aged , Betacoronavirus , COVID-19 , Coronavirus Infections/mortality , Dideoxynucleosides , Drug Combinations , Emtricitabine , Female , HIV Infections/mortality , Hospitalization/statistics & numerical data , Humans , Incidence , Intensive Care Units/statistics & numerical data , Lamivudine , Male , Middle Aged , Pandemics , Pneumonia, Viral/mortality , Reverse Transcriptase Polymerase Chain Reaction , SARS-CoV-2 , Severity of Illness Index , Spain/epidemiology , Tenofovir
9.
Ann Intern Med ; 173(3): 204-216, 2020 08 04.
Article in English | MEDLINE | ID: covidwho-2110840

ABSTRACT

BACKGROUND: Mechanical ventilation is used to treat respiratory failure in coronavirus disease 2019 (COVID-19). PURPOSE: To review multiple streams of evidence regarding the benefits and harms of ventilation techniques for coronavirus infections, including that causing COVID-19. DATA SOURCES: 21 standard, World Health Organization-specific and COVID-19-specific databases, without language restrictions, until 1 May 2020. STUDY SELECTION: Studies of any design and language comparing different oxygenation approaches in patients with coronavirus infections, including severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS), or with hypoxemic respiratory failure. Animal, mechanistic, laboratory, and preclinical evidence was gathered regarding aerosol dispersion of coronavirus. Studies evaluating risk for virus transmission to health care workers from aerosol-generating procedures (AGPs) were included. DATA EXTRACTION: Independent and duplicate screening, data abstraction, and risk-of-bias assessment (GRADE for certainty of evidence and AMSTAR 2 for included systematic reviews). DATA SYNTHESIS: 123 studies were eligible (45 on COVID-19, 70 on SARS, 8 on MERS), but only 5 studies (1 on COVID-19, 3 on SARS, 1 on MERS) adjusted for important confounders. A study in hospitalized patients with COVID-19 reported slightly higher mortality with noninvasive ventilation (NIV) than with invasive mechanical ventilation (IMV), but 2 opposing studies, 1 in patients with MERS and 1 in patients with SARS, suggest a reduction in mortality with NIV (very-low-certainty evidence). Two studies in patients with SARS report a reduction in mortality with NIV compared with no mechanical ventilation (low-certainty evidence). Two systematic reviews suggest a large reduction in mortality with NIV compared with conventional oxygen therapy. Other included studies suggest increased odds of transmission from AGPs. LIMITATION: Direct studies in COVID-19 are limited and poorly reported. CONCLUSION: Indirect and low-certainty evidence suggests that use of NIV, similar to IMV, probably reduces mortality but may increase the risk for transmission of COVID-19 to health care workers. PRIMARY FUNDING SOURCE: World Health Organization. (PROSPERO: CRD42020178187).


Subject(s)
Coronavirus Infections/transmission , Pneumonia, Viral/transmission , Respiration, Artificial/adverse effects , Respiration, Artificial/methods , Aerosols , Animals , Betacoronavirus , COVID-19 , Coronavirus Infections/mortality , Humans , Pandemics , Pneumonia, Viral/mortality , Randomized Controlled Trials as Topic , SARS-CoV-2 , Severe Acute Respiratory Syndrome/transmission , Systematic Reviews as Topic , World Health Organization
10.
Ann Intern Med ; 173(11): 870-878, 2020 12 01.
Article in English | MEDLINE | ID: covidwho-2110823

ABSTRACT

BACKGROUND: Low-dose glucocorticoids are frequently used for the management of rheumatoid arthritis (RA) and other chronic conditions, but the safety of long-term use remains uncertain. OBJECTIVE: To quantify the risk for hospitalized infection with long-term use of low-dose glucocorticoids in patients with RA receiving stable disease-modifying antirheumatic drug (DMARD) therapy. DESIGN: Retrospective cohort study. SETTING: Medicare claims data and Optum's deidentified Clinformatics Data Mart database from 2006 to 2015. PATIENTS: Adults with RA receiving a stable DMARD regimen for more than 6 months. MEASUREMENTS: Associations between glucocorticoid dose (none, ≤5 mg/d, >5 to 10 mg/d, and >10 mg/d) and hospitalized infection were evaluated using inverse probability-weighted analyses, with 1-year cumulative incidence predicted from weighted models. RESULTS: 247 297 observations were identified among 172 041 patients in Medicare and 58 279 observations among 44 118 patients in Optum. After 6 months of stable DMARD use, 47.1% of Medicare patients and 39.5% of Optum patients were receiving glucocorticoids. The 1-year cumulative incidence of hospitalized infection in Medicare patients not receiving glucocorticoids was 8.6% versus 11.0% (95% CI, 10.6% to 11.5%) for glucocorticoid dose of 5 mg or less per day, 14.4% (CI, 13.8% to 15.1%) for greater than 5 to 10 mg/d, and 17.7% (CI, 16.5% to 19.1%) for greater than 10 mg/d (all P < 0.001 vs. no glucocorticoids). The 1-year cumulative incidence of hospitalized infection in Optum patients not receiving glucocorticoids was 4.0% versus 5.2% (CI, 4.7% to 5.8%) for glucocorticoid dose of 5 mg or less per day, 8.1% (CI, 7.0% to 9.3%) for greater than 5 to 10 mg/d, and 10.6% (CI, 8.5% to 13.2%) for greater than 10 mg/d (all P < 0.001 vs. no glucocorticoids). LIMITATION: Potential for residual confounding and misclassification of glucocorticoid dose. CONCLUSION: In patients with RA receiving stable DMARD therapy, glucocorticoids were associated with a dose-dependent increase in the risk for serious infection, with small but significant risks even at doses of 5 mg or less per day. Clinicians should balance the benefits of low-dose glucocorticoids with this potential risk. PRIMARY FUNDING SOURCE: National Institute of Arthritis and Musculoskeletal and Skin Diseases.


Subject(s)
Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/drug therapy , Glucocorticoids/adverse effects , Infections/chemically induced , Aged , Antirheumatic Agents/administration & dosage , Antirheumatic Agents/therapeutic use , Female , Glucocorticoids/administration & dosage , Glucocorticoids/therapeutic use , Hospitalization/statistics & numerical data , Humans , Male , Retrospective Studies , Risk Factors
11.
Psychiatr Danub ; 32(3-4): 549-556, 2020.
Article in English | MEDLINE | ID: covidwho-2100777

ABSTRACT

BACKGROUND: Mental health of medical workers treating patients with COVID-19 is an issue of increasing concern worldwide. The available data on stress and anxiety symptoms among healthcare workers during the COVID-19 are relatively limited and have not been evaluated in Russia yet. SUBJECTS AND METHODS: The cross-sectional anonymous survey included 1,090 healthcare workers. Stress and anxiety symptoms were assessed using Stress and Anxiety to Viral Epidemics - 9 (SAVE-9) and Generalized Anxiety Disorder - 7 (GAD-7) scales. Logistic regression, Kaiser-Meyer-Olkin two component factor model, Cronbach's alpha and ROC-analysis were performed to determine the influence of different variables, internal structure and consistency, sensitivity and specificity of SAVE-9 compared with GAD-7. RESULTS: The median scores on the GAD-7 and SAVE-9 were 5 and 14, respectively. 535 (49.1%) respondents had moderate and 239 (21.9%) had severe anxiety according to SAVE-9. 134 participants (12.3%) had severe anxiety, 144 (13.2%) had moderate according to GAD-7. The component model revealed two-factor structure of SAVE-9: "anxiety and somatic concern" and "social stress". Female gender (OR - 0.98, p=0.04) and younger age (OR - 0.65, p=0.04) were associated with higher level of anxiety according to regression model. The total score of SAVE-9 with a high degree of confidence predicted the GAD-7 value in comparative ROC analysis. CONCLUSIONS: Healthcare workers in Russia reported high rates of stress and anxiety. The Russian version of the SAVE-9 displayed a good ratio of sensitivity to specificity compared with GAD-7 and can be recommended as a screening instrument for detection of stress and anxiety in healthcare workers.


Subject(s)
COVID-19 , Anxiety/epidemiology , Anxiety Disorders/epidemiology , Cross-Sectional Studies , Female , Health Personnel , Humans , Male , Pandemics , Russia/epidemiology , SARS-CoV-2
12.
Egypt Heart J ; 72(1): 73, 2020 Oct 27.
Article in English | MEDLINE | ID: covidwho-2098499

ABSTRACT

BACKGROUND: The COVID-19 pandemic poses a major burden to the healthcare system in Egypt, and in the face of a highly infective disease which can prove fatal, healthcare systems need to change their management protocols to meet these new challenges. MAIN BODY: This scientific statement, developed by the cardiology department at Cairo University, emphasized 6 different aspects that are intended to guide healthcare providers during cardiopulmonary resuscitation (CPR) in the era of the COVID-19 pandemic. It highlighted the importance of dealing with all cardiac arrest victims, during the pandemic, as potential COVID-19 cases, and the use of appropriate personal protective equipment (PPE) by health care providers during the procedure. It also stated that the CPR procedure should be done in a separate room with the door closed and that the number of providers present during the procedure should be limited to only those who are essential for patient resuscitation. It also stressed that family members and accompanying personnel of patients with possible COVID-19 should not be in the vicinity of CPR site. The statement also pointed out that CPR procedure should be done in the standard manner with precautions to minimize spread of infection to the staff and accompanying people. Early intubation was prioritized, and the use of rapid sequence intubation with appropriate PPE was recommended. For delivery of CPR for the prone ventilated patient, delivery of chest compressions by pressing the patient's back, while a team prepares to turn the patient supine, was recommended. During intra-hospital transport, it was emphasized that the receiving intensive care unit (ICU) should be notified about the possibility of the patient being COVID-19 positive, so that appropriate infection control precautions are taken. CONCLUSION: Cardiopulmonary resuscitation of cardiac arrest patients in the COVID-19 era poses a significant challenge, and all health care providers should deal with any cardiac arrest victim presenting to the emergency department as potential COVID-19 suspects and should use the appropriate PPE.

13.
Infect Control Hosp Epidemiol ; 42(1): 89-92, 2021 01.
Article in English | MEDLINE | ID: covidwho-2096391
14.
Open Forum Infect Dis ; 7(10): ofaa446, 2020 Oct.
Article in English | MEDLINE | ID: covidwho-2097427

ABSTRACT

BACKGROUND: Effective therapies to combat coronavirus 2019 (COVID-19) are urgently needed. Hydroxychloroquine (HCQ) has in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), but the clinical benefit of HCQ in treating COVID-19 is unclear. Randomized controlled trials are needed to determine the safety and efficacy of HCQ for the treatment of hospitalized patients with COVID-19. METHODS: We conducted a multicenter, double-blind randomized clinical trial of HCQ among patients hospitalized with laboratory-confirmed COVID-19. Subjects were randomized in a 1:1 ratio to HCQ or placebo for 5 days and followed for 30 days. The primary efficacy outcome was a severe disease progression composite end point (death, intensive care unit admission, mechanical ventilation, extracorporeal membrane oxygenation, and/or vasopressor use) at day 14. RESULTS: A total of 128 patients were included in the intention-to-treat analysis. Baseline demographic, clinical, and laboratory characteristics were similar between the HCQ (n = 67) and placebo (n = 61) arms. At day 14, 11 (16.4%) subjects assigned to HCQ and 6 (9.8%) subjects assigned to placebo met the severe disease progression end point, but this did not achieve statistical significance (P = .350). There were no significant differences in COVID-19 clinical scores, number of oxygen-free days, SARS-CoV-2 clearance, or adverse events between HCQ and placebo. HCQ was associated with a slight increase in mean corrected QT interval, an increased D-dimer, and a trend toward an increased length of stay. CONCLUSIONS: In hospitalized patients with COVID-19, our data suggest that HCQ does not prevent severe outcomes or improve clinical scores. However, our conclusions are limited by a relatively small sample size, and larger randomized controlled trials or pooled analyses are needed.

15.
Pharmacoecon Open ; 5(4): 613-623, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-2093286

ABSTRACT

BACKGROUND: Costs associated with extracorporeal membrane oxygenation (ECMO) are an important factor in establishing cost effectiveness. In this systematic review, we aimed to determine the total hospital costs of ECMO for adults. METHODS: The literature was retrieved from the PubMed/MEDLINE, EMBASE, and Web of Science databases from inception to 4 March 2020 using the search terms 'extracorporeal membrane oxygenation' combined with 'costs'; similar terms or phrases were then added to the search, i.e. 'Extracorporeal Life Support' or 'ECMO' or 'ECLS' combined with 'costs'. We included any type of study (e.g. randomized trial or observational cohort) evaluating hospital costs of ECMO in adults (age ≥18 years). RESULTS: A total of 1768 unique articles were retrieved during our search. We assessed 74 full-text articles for eligibility, of which 14 articles were selected for inclusion in this review; six papers were from the US, five were from Europe, and one each from Japan, Australia, and Taiwan. The sample sizes ranged from 16 to 18,684 patients. One paper exclusively used prospective cost data collection, while all other papers used retrospective data collection. Five papers reported charges instead of costs. There was large variation in hospital costs, ranging from US$22,305 to US$334,608 (2019 values), largely depending on the indication for ECMO support and location. The highest reported costs were for lung transplant recipients who were receiving ECMO support in the US, and the lowest reported costs were for extracorporeal cardiopulmonary resuscitation patients presenting with non-shockable rhythm in Japan. The additional costs of ECMO patients compared with non-ECMO patients varied between US$2518 and US$200,658. Personnel costs varied between 11 and 52% of the total amount. CONCLUSIONS: ECMO therapy is an advanced and expensive technology, although reported costs differ considerably depending on ECMO indication and whether charges or costs are measured. Combined with the ongoing gathering of outcome data, cost effectiveness per ECMO indication could be determined in the future.

16.
Surg Endosc ; 34(10): 4225-4232, 2020 10.
Article in English | MEDLINE | ID: covidwho-2094619

ABSTRACT

BACKGROUND: Healthcare systems and general surgeons are being challenged by the current pandemic. The European Association for Endoscopic Surgery (EAES) aimed to evaluate surgeons' experiences and perspectives, to identify gaps in knowledge, to record shortcomings in resources and to register research priorities. METHODS: An ad hoc web-based survey of EAES members and affiliates was developed by the EAES Research Committee. The questionnaire consisted of 69 items divided into the following sections: (Ι) demographics, (II) institutional burdens and management strategies, and (III) analysis of resource, knowledge, and evidence gaps. Descriptive statistics were summarized as frequencies, medians, ranges,, and interquartile ranges, as appropriate. RESULTS: The survey took place between March 25th and April 16th with a total of 550 surgeons from 79 countries. Eighty-one percent had to postpone elective cases or suspend their practice and 35% assumed roles not related to their primary expertise. One-fourth of respondents reported having encountered abdominal pathologies in COVID-19-positive patients, most frequently acute appendicitis (47% of respondents). The effect of protective measures in surgical or endoscopic procedures on infected patients, the effect of endoscopic surgery on infected patients, and the infectivity of positive patients undergoing laparoscopic surgery were prioritized as knowledge gaps and research priorities. CONCLUSIONS: Perspectives and priorities of EAES members in the era of the pandemic are hereto summarized. Research evidence is urgently needed to effectively respond to challenges arisen from the pandemic.


Subject(s)
Betacoronavirus , Biomedical Research , Coronavirus Infections , Endoscopy , Pandemics , Pneumonia, Viral , Biomedical Research/methods , Biomedical Research/organization & administration , COVID-19 , Coronavirus Infections/prevention & control , Coronavirus Infections/transmission , Europe , Health Care Rationing/methods , Health Care Rationing/statistics & numerical data , Humans , Infection Control/methods , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Pneumonia, Viral/transmission , Practice Patterns, Physicians'/trends , SARS-CoV-2 , Societies, Medical , Surgeons , Surveys and Questionnaires
17.
Clin Exp Rheumatol ; 39 Suppl 129(2): 149-154, 2021.
Article in English | MEDLINE | ID: covidwho-2091801

ABSTRACT

People with cryoglobulinaemic vasculitis (CV) have an increased risk of infections, attributed to different causes: impairment of the immune system due to the disease itself, comorbidities, and immunosuppressive therapy. Therefore, these patients may be at high risk for a more severe course of COVID-19, including hospitalisation and death. Concerns about efficacy, immunogenicity and safety of vaccines, as well as doubts, not yet fully clarified in patients with systemic autoimmune diseases, represent other important factors for a low vaccination rate in people with (CV). Indeed, providing an expert position on the issues related to SARS-CoV-2 vaccination in patients suffering from CV is of critical relevance in order to help both patients and clinicians who are treating them in making the best choice in each case. A multidisciplinary task force of the Italian Group for the Study of Cryoglobulinaemia (GISC) was convened, and through a Delphi technique produced provisional recommendations regarding SARS-CoV-2 vaccination in cryoglobulinaemic patients.


Subject(s)
COVID-19 , Cryoglobulinemia , Vasculitis , COVID-19 Vaccines , Humans , Italy , SARS-CoV-2 , Vaccination
18.
Curr Opin Rheumatol ; 32(6): 572-582, 2020 11.
Article in English | MEDLINE | ID: covidwho-2077899

ABSTRACT

PURPOSE OF REVIEW: The purpose of this review is highlighting the most recent evidence on the clinical efficacy and toxicity of antimalarials in systemic lupus erythematosus (SLE). RECENT FINDINGS: New data confirm the effects of antimalarials in preventing SLE activity, damage and infections and in decreasing mortality. An important reduction in use of health resources is related to continued antimalarial use. Hydroxychloroquine (HCQ) may prevent preeclampsia in pregnant women with SLE. HCQ ocular toxicity is infrequent and could be associated with blood levels. Gastrointestinal and skin toxicity are underrecognized and could influence adherence. Prolongation of QT interval is extremely unusual with HCQ. Doses of HCQ of 200 mg/day seem to offer a good efficacy/toxicity balance. HCQ protection against herpes zoster and Pneumocystis jirovecii infection has been shown. On the contrary, HCQ prescription by doctors and adherence by patients are both under recommended standards. The recent coronavirus disease 2019 pandemic has resulted in a significant shortage of HCQ in many countries with possible consequences in the correct treatment of lupus patients. SUMMARY: Recent evidence reinforces the central role of HCQ in SLE therapy. The reduction in activity, damage accrual and mortality is consistent across studies, countries and ethnical groups. On the contrary, and despite the well established beneficial effects of prolonged regular HCQ therapy, many SLE patients do never take this drug or it is eventually stopped in the setting of severe flares, pregnancy or presumed toxicity. Every effort must be made to assure the correct prescription of HCQ and not to withdraw the drug unless unequivocal signs of toxicity are present.


Subject(s)
Antimalarials/therapeutic use , Betacoronavirus , Coronavirus Infections/epidemiology , Lupus Erythematosus, Systemic/drug therapy , Pandemics , Pneumonia, Viral/epidemiology , COVID-19 , Comorbidity , Coronavirus Infections/drug therapy , Female , Humans , Lupus Erythematosus, Systemic/epidemiology , Pneumonia, Viral/drug therapy , SARS-CoV-2 , Treatment Outcome
19.
Minerva Urol Nephrol ; 2021 Mar 26.
Article in English | MEDLINE | ID: covidwho-2067527

ABSTRACT

BACKGROUND: A randomized, double-blind, non-inferiority clinical study was performed on the efficacy and tolerability of IncobotulinumtoxinA vs OnabotulinumtoxinA intradetrusor injections in patients with refractory neurogenic detrusor overactivity incontinence performing intermittent catheterization. METHODS: Sixty-four patients with Spinal Cord Injury or Multiple Sclerosis were randomized to receive 30 intradetrusor injections of IncobotulinumtoxinA or OnabotulinumtoxinA 200 U; 28 patients in IncobotulinumtoxinA group and 29 in OnabotulinumtoxinA group completed the study. Primary outcome measure was the noninferior variation from baseline in daily urinary incontinence episodes (week 12), with a non-inferiority margin of one episode/day. Secondary outcomes measures were changes in Incontinence- Quality of Life questionnaire, Visual Analog Scale score (bother of symptoms on Quality of Life), urodynamic parameters, occurrence of adverse effects and related costs (week 12). RESULTS: At week 12, mean value of difference in urinary incontinence episodes/day between the two groups was -0.2 (95% two-sided CI: -1; 0.7); the difference in incontinence episodes/day between the two groups was -0.4 with a higher limit of one-sided 95% CI of 0.2 episodes/day which was much lower than the non-inferiority margin of one episode/day. Total score and subscores of Incontinence- Quality of Life questionnaire, Visual Analog Scale Scores and urodynamics did not show differences between the two groups. Adverse effects were similar for both treatments, with urinary tract infection being the most frequent, localised effect. Minor costs were observed following IncobotulinumtoxinA. CONCLUSIONS: In patients with refractory neurogenic incontinence due to Spinal Cord Injury or Multiple Sclerosis, IncobotulinumtoxinA was not inferior to OnabotulinumtoxinA in improving clinical and urodynamic findings in the short-term follow-up, with comparable adverse effects but minor costs.

20.
J Clin Psychiatry ; 82(2)2021 Mar 16.
Article in English | MEDLINE | ID: covidwho-2066787

ABSTRACT

BACKGROUND: Most research evaluating telehealth psychiatric treatment has been conducted in outpatient settings. There is a great lack of research assessing the efficacy of telehealth treatment in more acute, intensive treatment settings such as a partial hospital. In the face of the COVID-19 pandemic, much of behavioral health treatment has transitioned to a virtual format. In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project, we examined the effectiveness of our partial hospital program (PHP). METHOD: The sample included 207 patients who were treated virtually from May 2020 to September 2020 and a comparison group of 207 patients who were treated in the in-person partial program a year earlier. Patients completed self-administered measures of patient satisfaction, symptoms, coping ability, functioning, and general well-being. RESULTS: For both the in-person and telehealth methods of delivering partial hospital level of care, patients were highly satisfied with treatment and reported a significant reduction in symptoms and suicidality from admission to discharge. On the modified Remission from Depression Questionnaire, the primary outcome measure, both groups reported a significant (P < .01) improvement in functioning, coping ability, positive mental health, and general well-being. A large effect size of treatment (Cohen d > 0.8) was found in both treatment groups. The only significant difference in outcome between the patients treated in the different formats was a greater length of stay (mean ± SD of 13.5 ± 8.1 vs 8.5 ± 5.0 days, t = 7.61, P < .001) and greater likelihood of staying in treatment until completion (72.9% vs 62.3%, χ2 = 5.34, P < .05) in the virtually treated patients. CONCLUSIONS: Telehealth partial hospital treatment was as effective as in-person treatment in terms of patient satisfaction, symptom reduction, suicidal ideation reduction, and improved functioning and well-being. The treatment completion rate was higher in the telehealth cohort, and several patients who were treated virtually commented that they never would have presented for in-person treatment even if there was no pandemic. Telehealth PHPs should be considered a viable treatment option even after the pandemic has resolved.


Subject(s)
Behavior Therapy , COVID-19 , Emergency Services, Psychiatric , Mental Disorders , Telemedicine , Adult , Behavior Therapy/methods , Behavior Therapy/trends , COVID-19/epidemiology , COVID-19/prevention & control , Emergency Service, Hospital/statistics & numerical data , Emergency Services, Psychiatric/methods , Emergency Services, Psychiatric/trends , Female , Hospitalization/statistics & numerical data , Humans , Infection Control/methods , Male , Mental Disorders/diagnosis , Mental Disorders/epidemiology , Mental Disorders/therapy , Mental Health/trends , Patient Safety , Patient Satisfaction , SARS-CoV-2 , Telemedicine/methods , Telemedicine/organization & administration , United States/epidemiology
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