Investigation Statistical Methods in Medical Engineering Fields: Coronavirus (COVID-19) as Model

Many epidemic diseases spread and infect humans, including Corona pandemic, which has spread throughout the world, including our country, Iraq, and to all provinces randomly and with different rates of infection. It is difficult to control this disease and determine the exact increase or decrease in the number of people infected with it. Predicting the numbers of people affected by this epidemic supports decision-makers in health institutions to make the right decisions regarding preparedness to face it in terms of providing the infrastructure and human resources of the crisis, and the more accurate the prediction, the more influential the decisions in containing this epidemic. A new framework was proposed by studying the spread of this epidemic, which depends on random spread, so Markov sequences were used, which do not rely mainly on past data to predict the future. The aim of this research is to predict the numbers of people infected with this disease through the use of statistical methods, especially the Markov chains method, which is characterized by its ability to predict the future of cases that are characterized by randomness in spread and not relying on past data only. The accuracy of the results of this research depends on the accuracy of the data taken from the Health Department of Baghdad Governorate / Al-Rusafa side, as well as on the factors affecting the spread of this disease that were taken from the research centers concerned with this epidemic. © 2022 American Institute of Physics Inc.. All rights reserved.

COVID-19 Vaccine Safety Surveillance and Causality Assessment of Adverse Events Following Immunisation: Lessons from South Africa

Introduction: The South African Health Products Regulatory Authority (SAHPRA) utilises various AEFI reporting tools to monitor vaccine safety in the country. In 2020, SAHPRA in collaboration with the National Department of Health's (NDoH) Expanded Programme on Immunisation (EPI), joined the African Union Smart Safety Surveillance programme, as one of four pilot countries, to introduce an electronic adverse event following immunisation (AEFI) reporting system (Med Safety App) for healthcare professionals and consumers [1]. On 17/05/2021, the NDoH introduced its national COVID-19 vaccination programme. SAHPRA launched a microsite during 2021, to provide feedback to the public on AEFI with the COVID-19 vaccines. Objective(s): To provide an overview of COVID-19 vaccine safety surveillance and describe causality assessment outcomes for serious AEFI reported during the first year of COVID-19 vaccine administration. Method(s): All severe and/or serious AEFI are investigated by provincial EPI surveillance teams, followed by causality assessment conducted by the National Immunisation Safety Expert Committee (NISEC), using the World Health Organization (WHO) methodology [2]. Causality assessment outcomes are classified based on the final diagnoses determined during the assessment by NISEC according to WHO categories, seriousness, Medical Dictionary for Regulatory Activities (MedDRA) system organ class and patient demographics. Data were collected retrospectively from the SAHPRA COVID-19 AEFI microsite and the EPI national AEFI database. Result(s): By 01/04/2022, 33,063,221 COVID-19 vaccine doses had been administered, with 5 815 spontaneous AEFI reports (0.0173%) submitted. Of these, 2,571 (0.008%) were reported as serious. Spontaneous reporting of AEFI increased significantly compared to pre-COVID-19 vaccine introduction. The most frequently reported AEFIs were side effects already listed in the product information. No safety concerns were raised based on causality assessment outcomes for 273 serious cases analysed by 01/04/2022. Over two thirds of these cases were classified as coincidental (70.7%) as cardiac-, respiratory- or vascular disorders (MedDRA system organ class), with 12.1% classified as vaccine product related (see table below). The presentation will include all causality assessments conducted up to 31/08/2022, and more detailed information about causality assessed cases will be available in the public domain at the time of the conference and will be included in the presentation. Conclusion(s): Vaccine safety surveillance and monitoring trends of reported AEFI are vital measures to ensure that the benefits of immunisation are maintained in the interest of public health and efficient vaccination programmes. Transparent communication with the public is important to maintain public confidence in vaccines and prevent all AEFI being misinterpreted as caused by the vaccine.

COVID-19 Vaccine Safety Surveillance and Causality Assessment of Adverse Events Following Immunisation: Lessons from South Africa: An International Journal of Medical Toxicology and Drug Experience

Introduction: The South African Health Products Regulatory Authority (SAHPRA) utilises various AEFI reporting tools to monitor vaccine safety in the country. In 2020, SAHPRA in collaboration with the National Department of Health's (NDoH) Expanded Programme on Immunisation (EPI), joined the African Union Smart Safety Surveillance programme, as one of four pilot countries, to introduce an electronic adverse event following immunisation (AEFI) reporting system (Med Safety App) for healthcare professionals and consumers [1]. On 17/05/2021, the NDoH introduced its national COVID-19 vaccination programme. SAHPRA launched a microsite during 2021, to provide feedback to the public on AEFI with the COVID-19 vaccines. Objective: To provide an overview of COVID-19 vaccine safety surveillance and describe causality assessment outcomes for serious AEFI reported during the first year of COVID-19 vaccine administration. Methods: All severe and/or serious AEFI are investigated by provincial EPI surveillance teams, followed by causality assessment conducted by the National Immunisation Safety Expert Committee (NISEC), using the World Health Organization (WHO) methodology [2]. Causality assessment outcomes are classified based on the final diagnoses determined during the assessment by NISEC according to WHO categories, seriousness, Medical Dictionary for Regulatory Activities (MedDRA) system organ class and patient demographics. Data were collected retrospectively from the SAHPRA COVID-19 AEFI microsite and the EPI national AEFI database. Results: By 01/04/2022, 33,063,221 COVID-19 vaccine doses had been administered, with 5 815 spontaneous AEFI reports (0.0173%) submitted. Of these, 2,571 (0.008%) were reported as serious. Spontaneous reporting of AEFI increased significantly compared to pre-COVID-19 vaccine introduction. The most frequently reported AEFIs were side effects already listed in the product information. No safety concerns were raised based on causality assessment outcomes for 273 serious cases analysed by 01/04/2022. Over two thirds of these cases were classified as coincidental (70.7%) as cardiac-, respiratory- or vascular disorders (MedDRA system organ class), with 12.1% classified as vaccine product related (see table below). The presentation will include all causality assessments conducted up to 31/08/2022, and more detailed information about causality assessed cases will be available in the public domain at the time of the conference and will be included in the presentation. Conclusion: Vaccine safety surveillance and monitoring trends of reported AEFI are vital measures to ensure that the benefits of immunisation are maintained in the interest of public health and efficient vaccination programmes. Transparent communication with the public is important to maintain public confidence in vaccines and prevent all AEFI being misinterpreted as caused by the vaccine.

Primary endpoint analysis of a randomized phase II of darolutamide or capecitabine in patients with triple-negative androgen receptor-positive advanced breast cancer (UCBG3-06 START trial)

Background: A subgroup of triple negative breast cancer (TNBC) expresses the androgen receptor (AR). In this trial we evaluated the efficacy and tolerability of the AR inhibitor darolutamide (D) or capecitabine (C) in patients (pts) with advanced AR-positive TNBC (NCT03383679). Methods: Pts with centrally reviewed AR-positive (≥ 10% by immunohistochemistry) TNBC treated with up to one line of chemotherapy for advanced disease were eligible. They were randomized in a 2:1 ratio to receive D 600 mg twice daily or C 1000 mg/m2 twice daily 2-weeks on/ 1-week off, until progression or unacceptable toxicity. Primary endpoint was clinical benefit rate (CBR) at 16 weeks and was assessed in the eligible population and in the sensitivity analysis population (pts with delayed tumour assessment performed in the context of COVID pandemic). Main secondary endpoints included objective response rate, overall survival, progression-free survival (PFS) and safety. Results: A total of 254 pts from 45 centres were screened;94 pts were randomized (61 in D arm, 33 in C arm) from April 2018 to July 2021. A clinical benefit was observed in D arm in 13 of 53 evaluable pts (CBR at 16 weeks 24.5%;95% CI: 12.9%-36.1%) including 2 PR and 1 CR and in C arm in 11 of 23 evaluable pts (CBR at 16 weeks 47.8%;95% CI: 27.4%-68.2%). In the sensitivity analysis, a clinical benefit was observed in D arm in 17 of 58 evaluable patients (CBR ≥ 16 weeks 29.3%;95% CI: 17.6%-41.0%) and in C arm in 19 of 32 evaluable patients (CBR ≥ 16 weeks 59.4%;95% CI: 42.3%-76.4%). 7 pts presented with drug-related serious adverse events: 3 in D arm and 4 in C arm. In D arm, asthenia (26.7%), nausea (25%) and ASAT increase (21.7%) were the most common adverse events, the majority being grade 1 or 2, similar to previous safety data. Median PFS were 1.8 months (CI 95% 1.7-3.1) and 3.6 months (1.8-9.1) in D arm and C arm respectively. Other secondary endpoints will be presented at the meeting. Conclusions: Despite not reaching the pre-specified CBR, darulotamide demonstrated clinical activity with significant benefit for a group of patients. A research program to identify predictive biomarkers of sensitivity is ongoing. Clinical trial identification: EudraCT: 2017-002284-18 NCT03383679. Legal entity responsible for the study: UNICANCER. Funding: BAYER. Disclosure: All authors have declared no conflicts of interest.

Detection of Aspergillus spp. and Candida albicans antigenemia in a sample of Iraqi patients with severe COVID-19

Introduction: Since December 2019, coronavirus disease 2019 (COVID-19), which is caused by SARSCoV- 2, has spread locally in Wuhan, China, and later on, a worldwide outbreak occurred. Invasive fungal infections can cause complications in critically ill immunocompromised patients of COVID-19, especially those admitted to intensive care units and who required mechanical ventilation. Candida albicans have been the most common pathogenic species, followed by other Candida spp. Mannan is a major component of the Candida cell wall and can be detected by the enzyme-linked immunosorbent assay (ELISA) in blood and other fluids. Invasive pulmonary aspergillosis is considered a lifethreatening infection, especially among immunocompromised patients. COVID-19-associated pulmonary aspergillosis has emerged as an important complication among patients in the intensive care units. Galactomannan (GM) is a major cell-wall component of Aspergillus spp. and can be found in body fluids. Blood GM can be detected by the enzyme immunoassay. The aim of the current study is to assess the frequency of aspergillosis and candidiasis among COVID-19 patients in some hospitals in Baghdad by using GM and mannan biomarkers. Methods: During the period from February 2020 to May 2021, 175 COVID-19 blood samples of patients were collected and a sandwich ELISA test was performed to detect GM Ag of Aspergillus spp. and mannan Ag of Candida spp. Results: Regarding C-reactive protein (CRP), significant differences were seen among Aspergillus/- COVID-19 patients ( p 0.029). Regarding sex and age group, the results indicated that of a total of 175 adult patients with positive COVID-19, more than half of the patients were males. Regarding the distribution of mannan Ag and GM Ag in COVID-19 patients, it was seen that out of the 175 patients, 167 (95.43%) Candida mannan Ag were negative and only 8 (4.57%) were positive, and 170 (79.14%) Aspergillus GM Ag were negative and only 5 (2.86%) were positive. It was also seen that 2 patients (1.14%) who had both Candida mannan and Aspergillus GM were positive and 173 (98.6%) were negative. No statistically significant difference was seen in candidiasis and aspergillosis among patients with COVID-19 regarding age group, sex, underlying chronic diseases (hypertension and diabetes mellitus), and biochemical tests. Conclusion: COVID-19 infections increased with age and were seen more in males than in females. The percentage of infection with C. albicans and Aspergillus spp. among COVID-19 patients was not significant, and this may come from the random collection of samples from patients with different stages of illness. A significant correlation was found between Aspergillus GM Ag in COVID-19 patients and the CRP test.

A GLOBAL VIEW ON COMPLEX PARENTING DYNAMICS FOR BETTER PRACTICES AND SOCIAL POLICY TO OVERCOME 21ST CENTURY CRISES

Human cooperation and compassion are fundamental moral values of the human condition to nurture healthy parent-child relationships. Around the world and across generations crises associated with socio-cultural changes and technological advancements test these moral values. By providing a synthesis of the literature on parenting styles across cultures and using a global developmental framework, the evolution of parenting strategies show that there is an adjustment when families face manmade (anthropogenic) and natural disasters. According to the Bioecological Model of Human Development (Bronfenbrenner & Morris, 2006), individuals develop in complex layers of nested systems (micro, meso, exo, macro), which directly and indirectly influence child development. As a result, individual (idiographic) developmental pathways evolve across the lifespan. The current chapter discusses the high influx of mass migration, a natural response to societal dilemmas of the 21st century and explains how this type of relocation has forced a change in the global perspective of social policy. © 2021 by Nova Science Publishers, Inc.

Measuring the impact of COVID-19 surveillance variables over the international oil market

Coronavirus (COVID-19) has turned to be an alarm for the whole world both in terms of health and economics. It is striking the global economy and increasing the unpredictability of the financial market in several ways. Significantly, the pandemic spread stimulated the social distancing which led to the lockdown of the countries’ businesses, financial markets, and daily life events. International oil markets have accommodated the crude oil prices during the early COVID-19 period. However, after the first 50 days, Saudi Arabia has surged the market with oil, which caused a certain decrease in crude oil prices, internationally. Saudi Arabia is one of the biggest oil reserves in the world. International trade is based on oil reservoirs which in turn, have been significantly dislodged by the pandemic. Therefore, it is crucial to study the impact of COVID-19 on the international oil market. The purpose of this study is to investigate the short-term and long-term impact of COVID-19 on the international oil market. The daily crude oil price data is used to analyze the impact of daily price fluctuation over COVID-19 surveillance variables. The correlation between surveillance variables and international crude oil prices is calculated and analyzed. Consequently, the project will help in stabilizing the expected world economic crises and particularly will provide the implications for the policymakers in the oil market. © 2021 The Authors. Published by IASE.

A position statement and practical guide to the use of particulate filtering facepiece respirators (N95, FFP2, or equivalent) for South African health workers exposed to respiratory pathogens including Mycobacterium tuberculosis and SARS-CoV-2.

SUMMARY: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is transmitted mainly by aerosol in particles <10 µm that can remain suspended for hours before being inhaled. Because particulate filtering facepiece respirators ('respirators'; e.g. N95 masks) are more effective than surgical masks against bio-aerosols, many international organisations now recommend that health workers (HWs) wear a respirator when caring for individuals who may have COVID-19. In South Africa (SA), however, surgical masks are still recommended for the routine care of individuals with possible or confirmed COVID-19, with respirators reserved for so-called aerosol-generating procedures. In contrast, SA guidelines do recommend respirators for routine care of individuals with possible or confirmed tuberculosis (TB), which is also transmitted via aerosol. In health facilities in SA, distinguishing between TB and COVID-19 is challenging without examination and investigation, both of which may expose HWs to potentially infectious individuals. Symptom-based triage has limited utility in defining risk. Indeed, significant proportions of individuals with COVID-19 and/or pulmonary TB may not have symptoms and/or test negative. The prevalence of undiagnosed respiratory disease is therefore likely significant in many general clinical areas (e.g. waiting areas). Moreover, a proportion of HWs are HIV-positive and are at increased risk of severe COVID-19 and death. RECOMMENDATIONS: Sustained improvements in infection prevention and control (IPC) require reorganisation of systems to prioritise HW and patient safety. While this will take time, it is unacceptable to leave HWs exposed until such changes are made. We propose that the SA health system adopts a target of 'zero harm', aiming to eliminate transmission of respiratory pathogens to all individuals in every healthcare setting. Accordingly, we recommend: the use of respirators by all staff (clinical and non-clinical) during activities that involve contact or sharing air in indoor spaces with individuals who: (i) have not yet been clinically evaluated; or (ii) are thought or known to have TB and/or COVID-19 or other potentially harmful respiratory infections;the use of respirators that meet national and international manufacturing standards;evaluation of all respirators, at the least, by qualitative fit testing; andthe use of respirators as part of a 'package of care' in line with international IPC recommendations. We recognise that this will be challenging, not least due to global and national shortages of personal protective equipment (PPE). SA national policy around respiratory protective equipment enables a robust framework for manufacture and quality control and has been supported by local manufacturers and the Department of Trade, Industry and Competition. Respirator manufacturers should explore adaptations to improve comfort and reduce barriers to communication. Structural changes are needed urgently to improve the safety of health facilities: persistent advocacy and research around potential systems change remain essential.

Meta-analytic magic, ivermectin, and socially responsible reporting.

Some clinicians prescribe ivermectin for COVID-19 despite a lack of support from any credible South African professional body. They argue that when faced by clinical urgency, weak signals of efficacy should trigger action if harm is unlikely. Several recent reviews found an apparent mortality benefit by including studies at high risk of bias and with active rather than placebo controls. If these studies are discounted, the pooled mortality effect is no longer statistically significant, and evidence of benefit is very weak. Relying on this evidence could cause clinical harm if used to justify vaccine hesitancy. Clinicians remain responsible for ensuring that guidance they follow is both legitimate and reliable. In the ivermectin debate, evidence-based medicine (EBM) principles have largely been ignored under the guise thatin a pandemic the 'rules are different', probably to the detriment of vulnerable patients and certainly to the detriment of the profession's image. Medical schools and professional interest groups are responsible for transforming EBM from a taught but seldom-used tool into a process of lifelong learning, promoting a consistent call for evidence-based and unconflicted debate integral to clinical practice.

COVID-19 outbreak in Jordan: Epidemiological features, clinical characteristics, and laboratory findings.

BACKGROUND: In March 2020, an outbreak of coronavirus 19 (COVID-19) was detected in the North of Jordan. This retrospective study is the first from Jordan to report the epidemiologic, clinical, laboratory, and radiologic characteristics of COVID-19 infected patients. METHODS: All patients with laboratory-confirmed COVID-19 infection by RT-PCR in the North of Jordan admitted between March 15 and April 2, 2020 were included. The clinical features, radiological, and laboratory findings were reviewed. RESULTS: Of 81 patients affected, 79 (97.5%) shared a common exposure to four recent travelers from endemic areas. The mean age was 40 years. Although about half (44 [54.3%]) were females, symptomatic patients were mostly females (75%). The most common presenting symptoms were nasal congestion, sore throat and dry cough. Less than one-third (31%) had chronic diseases. Although 84% of patients reported receiving Bacille Calmette-Guérin (BCG) vaccination, more asymptomatic patients had BCG than symptomatic (p = 0.017). Almost all patients (97.5%) had an elevated D-dimer level. Erythrocyte sedimentation rate (ESR) and c-reactive protein were elevated in 50% and 42.7% of patients, respectively. High ESR found to be the predictor of abnormal chest radiograph observed in 13 (16%) patients with OR of 14.26 (95% CI 1.37-147.97, p = 0.026). CONCLUSIONS: An outbreak of COVID-19 infection in northern Jordan affected more females and relatively young individuals and caused mainly mild illnesses. The strict outbreak response measures applied at early stages probably contributed to the lenient nature of this outbreak, but the contribution of other factors to such variability in COVID-19 presentation is yet to be explained.