ABSTRACT
In the summer of 2020, there were multiple efforts to establish safe and effective vaccines that would combat the spread of COVID-19. Efforts to eradicate the virus in the United States included Operation Warp Speed (OWS) which was a partnership between the Departments of Health and Human Services (HHS) and Defense (DOD), and the private sector, that aimed to help accelerate control of the COVID-19 pandemic by advancing development, manufacturing, and distribution of vaccines, therapeutics, and diagnostics. As the nation's largest integrated healthcare system, the US Department of Veterans Affairs (VA) was identified as a potential collaborator in several large-scale OWS Phase III clinical trial efforts designed to evaluate the safety and efficacy of various vaccines in development. Given the national (and global) importance of these trials, it was recognized that there would be a need for a coordinated, centralized effort within VA to ensure that its medical centers (sites) would be ready and able to efficiently initiate, recruit, and enroll into these OWS COVID-19 vaccine trials. To accomplish this mission, two groups within the VA Office of Research and Development (ORD) partnered to manage and provide support to these sites and facilitate their execution of these trials. The Partnered Research Program (PRP) is a division of VA ORD that is dedicated to developing partnerships that enhance Veterans' access to high-quality, multi-site clinical trials. PRP has an overall goal of establishing long-term relationships with external organizations that are committed to Veterans' health and VA's clinical research mission. The VA Cooperative Studies Program (CSP) is a clinical research infrastructure embedded within the VA healthcare system. CSP is also a division of the VA ORD and was established to provide coordination for, and enable cooperation on, multi-site clinical trials and epidemiological studies that fall within the purview of VA. Its infrastructure comprises a number of Coordinating Centers that are responsible for the planning and conduct of large multi-site clinical trials in the VA healthcare system. CSP also established a consortium of 10 VA medical centers (VAMCs) called the Network of Dedicated Enrollment Sites (NODES) that have teams (nodes) to provide site-level expertise and innovative approaches in addressing challenges to clinical trial execution. This (poster) outlines the partnership and activities undertaken by VA's PRP and CSP NODES groups to manage and support a large-scale OWS Phase III multi-site clinical trial. It focuses specifically on the determination to designate clinical trial facilitators to study sites, the important role that they played in getting this trial initiated at those sites in a timely fashion, and their work to ensure successful study enrollment.
ABSTRACT
Background and aims: In trials conducted in India, recombinant granulocyte colony stimulating factor (GCSF) improved survival in alcohol-associated hepatitis (AH). The aim of this trial was to determine the safety and efficacy of pegfilgrastim, a long-acting recombinant GCSF, in patients with AH in the United States. Method: This prospective, open label trial randomized patients with a clinical diagnosis of AH and a Maddrey discriminant function score ≥32 to standard of care (SOC) or SOC+pegfilgrastim (0.6 mg subcutaneously) on Day 1 and Day 8. SOC was 28 days of either pentoxifylline or prednisolone, as determined by the patient’s primary physician. The second injection of pegfilgrastim was not administered if the white blood cell count exceeded 30, 000/mm3 on Day 8. Primary outcomewas survival at Day 90. Secondary outcomes included the incidence of acute kidney injury (AKI), hepatorenal syndrome (HRS), hepatic encephalopathy, or infections. Results: The study was terminated early due to COVID19 pandemic. Eighteen patients were randomized to SOC and 16 to SOC+pegfilgrastim. All patients received prednisolone as SOC. Nine patients failed to receive a second dose of pegfilgrastin due to WBC>30, 000/ mm3 on Day 8. Survival at 90 days was similar in both groups (SOC: 0.83 [95% confidence interval {CI}: 0.57–0.94] vs. pegfilgrastim: 0.73 [95% CI: 0.44–0.89];p > 0.05). The incidences of AKI, HRS, hepatic encephalopathy, and infections were similar in both treatment arms and therewere no serious adverse events attributed to pegfilgrastim. Conclusion: This phase II trial found no survival benefit at 90 days among subjects with AH who received pegfilgrastim+prednisolone compared with subjects receiving prednisolone alone.
ABSTRACT
Objective: To assess the risk perception mental health impact and coping strategies during Covid-19 pandemic among health care workers. Study Design: Cross-sectional study. Place and Duration of Study: Department of Community Dentistry, Frontier Medical & Dental College, Abbottabad from 1st January 2021 to 31st December 2021. Methodology: Two hundred health care workers were given questionnaire for complete detailing their information regarding demographic, occupational, anxiety scoring and depression state. Results: The age of the health care workers was mostly within 26-40 years followed by greater than 18 years. It was observed that anxiety was presented at a mild score within doctors and other health care worker staff while it was seen to a moderate level within the nursing health care workers. Furthermore, the gender distribution of anxiety showed higher level of anxiety among females than males. Within genders a low risk perception was seen within males than females. Among the health care workers, the risk perception was highest in nurses followed by paramedic and other health care staff. Conclusion: Covid-19 has caused devastating effects on the psychological stability of the health care workers which needs to be properly assessed and addressed.
ABSTRACT
INTRODUCTION AND OBJECTIVE: Nephrectomy and venous thrombectomy is a challenging procedure with potential morbidity and mortality. Despite the increasing use of immune checkpoint inhibitors (ICI) in the management of advanced renal cell carcinoma (RCC), data regarding the outcomes of venous thrombectomy following ICI is limited. We evaluated the feasibility and perioperative outcomes of nephrectomy and venous thrombectomy following ICIs. METHODS: Patients with locally advanced or metastatic RCC with venous thrombus undergoing nephrectomy following ICI therapy were evaluated in four high-volume US academic centers between June 2017 and June 2021. Clinical data, perioperative outcomes, and 90-day complications were recorded. RESULTS: Out of 79 patients who received post-ICI nephrectomy, 27 had venous thrombus. Median (IQR) age was 64 (55-71) years. ICI regimens were Nivolumab ± Ipilimumab (n=19), and Pembrolizumab± Axitinib (n=8). Nephrectomy was indicated following either a good clinical response to ICI (n=24) or as a palliative surgery (n=3). Venous thrombi levels are shown in Table-1. Among all patients, 26 (96%) underwent radical and 1 (4%) partial nephrectomy;12 (44.5%) open, 12 (44.5%) robotic and 3 (11%) laparoscopic. One robotic case converted electively to open. Vascular procedures included renal vein thrombectomy (n=6), IVC thrombectomy and primary repair (n=19), IVC patch repair (n=1), and suprarenal cavectomy (n=1). No intraoperative complications were reported. Nine patients showed no viable tumor in the thrombus, of whom 2 had complete response in the primary tumor as well (ypT0N0). 90-day complication rate was 33% (n=9), with 8 patients (30%) requiring readmission (Table-2). One death was reported within 90 days due to COVID-19 infection. CONCLUSIONS: Nephrectomy and venous thrombectomy following systemic immune checkpoint inhibitor therapy is feasible. One third of patients show no viable tumor in the thrombus. Larger studies are needed to predict pathological response.
ABSTRACT
Objective: To detect people who may develop lung fibrosis early, allowing for the early administration of anti-fibrotic medications, which will not only benefit the infected patients with timely effective disease management, but will also ensure appropriate use of medical resources for this purpose. Study Design: Descriptive case series study Place and Duration of Study: This study was conducted at the Department of Radiology, Sharif Medical City Hospital, Lahore for one year from September 2020 to August 2021. Materials and Methods: This study was conducted after the approval of the ethical review board. Cases of Covid-19 were included as per inclusion criteria using non-probability, consecutive sampling. Results: Among the patients included in the study, 171 (45.6%) were male and 204 (54.4%) were females. Majority of the patients were of age group more than 50 years. The frequency of pulmonary fibrosis in our study population was 27.5% (103) with degree of pulmonary involvement: mild in 21 (20%), moderate in 39 patients (37.9%) and severe involvement in 43 of 103 patients (41.7%). Data was stratified for various effect modifiers including age (p=0.19), gender (p=0.01), socioeconomic status (p=0.002), BMI (p=0.11), history of chronic illness (p<0.00001), degree of pulmonary involvement (p=0.01) and history of steroid use (p<0.00001). Conclusion: The aim of this study was to detect people who may develop lung fibrosis early, allowing for the early administration of anti-fibrotic medications. Along with determination of disease severity using HRCT severity scoring, which will not only benefit the infected patients with timely effective disease management, but will also ensure appropriate use of medical resources for this purpose. Side by side our study will guide the medical and government authorities to take suitable steps for the local population depending upon the lethality of disease in the second wave. This study will also able to identify the population at risk of developing fibrosis. © 2022 Medical Forum Monthly. All rights reserved.
ABSTRACT
Objective: To comparison was made between standard (control group) nasopharyngeal sample collection technique for RT-PCR and modified technique and the outcome was compared in terms of the proportion of positive results of Rt-PCR tests. Study Design: Double blinded randomized clinical trial. Place and Duration of Study: Pakistan Naval Ship Shifa Hospital Karachi Pakistan, from June and July 2020. Methodology: This study was a newly developed modified technique for nasopharyngeal sampling for RT-PCR tests of COVID-19 suspects. Target population included all patients who developed COVID-19 related symptoms and/or also had history of recent travel or closed contact with Covid-19 patients. Total 1500 nasopharyngeal PCR tests were done by a team of trained technicians. Systemetic probability sampling technique was utilized. Subjects were divided into two groups by using even and odd serial numbers. Proportion of positive test results were compared between two groups by using chi square test. Results: Results were collected for 3000 nasopharyngeal swab sample for RT-PCR testing. Mean age was 31.68 ± 11.89 years. In study group with modified technique, 470 tests were found positive for a total of 1500 samples while only 297 out of 1500 samples were detected positive in control group with standard technique. Chi square test applied to assess the difference between this proportion and it proved that the difference was highly statistically significant (p-value <0.00). Conclusion: we interpret that modified samples collection technique is relatively safe for sample collector of Covid-19 PCR which has got potential benefits to get more genuine results of these samples. © 2021, Army Medical College. All rights reserved.
ABSTRACT
Work engagement is defined as a positive work-related state of mind that is characterized by vigor, dedication, and absorption. The engagement of staff has been associated with their performance and efficiency, productivity, safety, attendance and retention, customer service and satisfaction, and several other organizational success factors. The Coronavirus Disease 2019 (COVID-19) is an infectious disease caused by the most recently discovered coronavirus and is now a pandemic that is affecting many countries globally. The literature surrounding the employment of measures and strategies to increase work engagement amongst clinical research staff during pandemics is scarce, and to date, focuses primarily on health care and community health workers. The Cooperative Studies Program (CSP) Network of Dedicated Enrollment Sites (NODES) is a clinical research consortium of ten medical centers that are embedded within the Department of Veterans Affairs (VA) Health Care System. The consortium developed and implemented strategies during the pandemic that were intended to maintain work engagement amongst clinical research staff at each of the sites within the consortium. In this manuscript, we describe the development and deployment of these strategies to clinical research study teams in our clinical research consortium. It is our hope that the opportunities, successes, and challenges described here will serve as a useful resource for other clinical research consortia that are working to identify approaches to keep their staff members engaged during the current pandemic, as well as in other potential future situations in which their primary operations may be altered during other times of crises.
ABSTRACT
Work engagement is defined as a positive work-related state of mind that is characterized by vigor, dedication, and absorption. The engagement of staff has been associated with their performance and efficiency, productivity, safety, attendance and retention, customer service and satisfaction, and several other organizational success factors. The Coronavirus Disease 2019 (COVID- 19) is the infectious disease caused by the most recently discovered coronavirus and is now a pandemic that is affecting many countries globally. The literature surrounding the employment of measures and strategies to increase work engagement among clinical research staff during pandemics is scarce, and to date, focuses primarily on healthcare and community health workers. The Cooperative Studies Program Network of Dedicated Enrollment Sites is a clinical research consortium of 10 medical centers that are embedded within the Department of Veterans Affairs Health Care System. The consortium recently developed and implemented strategies that were intended to maintain work engagement among clinical research staff at each of the sites within the consortium. In this poster, we describe the development and deployment of these strategies to clinical research study teams in our clinical research consortium. It is our hope that the opportunities, successes, and challenges described here will serve as a useful resource for other clinical research consortia that are working to identify approaches to keep their staff members engaged during the current pandemic, as well as in other potential future situations in which their primary operations may be altered during other times of crises.
ABSTRACT
Aim: To determine the viral load in the patients admitted in Covid-19 isolation and its correlation with the inflammatory markers and the following clinical outcome. Methodology: A retrospective study was conducted in the Pathology Department of Doctors Hospital and Medical Centre in Lahore, Pakistan from November 2020 to January 2021. IRB approval was granted. A total of 86 patients met the inclusion criteria for the study. Data was analyzed using research tool SPSS 24. Results: Increased serum viral load in SARS-CoV-2 infection showed positive correlation with inflammatory markers IL-6 (P =0.04) and D-dimer (P =0.029). Inflammatory markers LDH, Ferritin, Procalcitonin, D-Dimers and viral load itself (CT) all correlated with higher mortality while IL-6 did not. Conclusion: Serum viral load in patients infected with SARS-CoV-2 correlates with higher mortality rates itself and also raises certain inflammatory markers (IL-6, D-Dimers), which are independently accountable for causing higher mortality as well. Hence, increased inflammatory markers resulted in poor prognosis regardless of high or low viral load. Their correlation with mortality can still serve as prognostic indicators.
ABSTRACT
Health literacy is an essential to respond proactively to pandemic situations like Covid-19. It helps the general public to reduce the spread of infectious diseases, prevent from over-reactions, reduce carelessness, adopt health protective behavior. The purpose of this research was to examine the impact of health literacy on fear of Covid-19, protective behavior, and conspiracy beliefs of university students in Pakistan. A cross-sectional survey using an online questionnaire was conducted at two public sector universities in Punjab with permission. A total of 271 received responses were analyzed by applying both descriptive and inferential statistics in SPSS. The results indicated students’ gender had a relationship with their health protective behavior indicating that female students were more likely to adopt health protective behavior as compared to male students. Besides, the students’ health literacy did not predict their fear of Covid-19 and conspiracy beliefs. However, the health literacy of university students predicted their health protective behavior which meant that the students with better health literacy likely to adopt health protective behavior related to Covid-19 infection. There was a need for promotion of health literacy related to Covid-19 to fight not only the current pandemic situation but also an infodemic associated with it. These results are useful for policymakers, health professionals, university and library administration for promoting health and creating awareness related to Covid-19 pandemic. It would also be helpful in developing useful directions for health literacy programs promoting health education and protective behavior to avoid and management Covid-19 infection. This research would make a worthy addition to existing research on health literacy as limited empirical studies have been conducted so far. © 2021
ABSTRACT
COVID-19 infection has emerged as a pandemic. This infection is new to the world, and the management strategy is evolving daily. As per the current guidelines, the patients of COVID-19 infection requiring mechanical ventilation should be treated on the lines of management of Acute Respiratory Distress Syndrome (ARDS). However, it seems that the management of ventilation in the case of COVID-19 needs to be modified. With growing experience, many hospitals have turned to Non-invasive Ventilation (NIV) to ward-off severe respiratory failure and in keeping with the inadequate resources. The controversy in using NIV is whether the benefits of using such interventions are more than the potential risks of aerosolisation of the virus. There is a hope that helmet-based ventilation may help reduce the risk of nosocomial infection. Autopsy findings demonstrated that besides ARDS, the alveolar capillaries were clearly thickened, with fibrin thrombi within the capillaries and small vessels and surrounding oedema present in COVID-19 affected lungs. This virus attacks the beta chain of haemoglobin, dissociates heme, removing iron converting it to porphyrin. The cause of desaturation is the failure of the blood to carry oxygen leading to multiorgan failure and mortality. The cause of lung damage seen on Computerised Tomography (CT) scans is the release of oxidative iron, which in turn overcomes the natural defenses against pulmonary oxidative stress and causes what is known as the Cytokine Storm. The question is whether mechanical ventilation is harming the patient by traumatising their lungs leading to increased mortality. Prone ventilation is the next preferred step for COVID-19 patients who fail to achieve adequate oxygenation with low tidal volume ventilation. Hyperbaric oxygen therapy can help the leftover functioning haemoglobin to carry more oxygen. Blood transfusion and plasmapheresis provide symptomatic relief. Thrombolytic therapy is also being tried with some benefits. These may be promising in treating patients with COVID-19 infection. Researches are required on the other probability and to test newly emerging treatment modalities.
ABSTRACT
Coronavirus disease 2019 (COVID-19) is associated with an increased risk of venous and arterial thrombosis in patients. Numerous studies have been conducted on COVID-19 and its association with thromboembolism is well known. We conducted a meta-analysis to find out the incidence of thromboembolism in hospitalised patients with COVID-19 to provide more generalized results. A systematic literature search was conducted in PubMed and SCOPUS to find observational studies reporting outcomes of interest. Amongst the studied thromboembolic events, the meta-analysis showed the prevalence of pulmonary embolism (PP: 12.4% [7.2%, 18.6%];12 = 97.23%) to be the highest. It was followed by deep vein thrombosis (PP: 8.6% [4.2%, 14.3%];12 = 97.52%), myocardial infarction (PP: 2.3% [0.2%, 11.2%];12 = 99.3%), and stroke (PP: 1.2% [0.8%, 1.6%];12 = 65.09%). The results of this analysis further warrant the timely and appropriate use of pharmacological thromboprophylaxis and identification of risk factors in hospitalized COVID-19 patients.