Publications by authors named "Dinah Parums"

37 Publications

Editorial: Cardiovascular Complications at One Year After SARS-CoV-2 Infection are Independent of Underlying Cardiovascular Risk Factors or Severity of COVID-19.

Authors:
Dinah V Parums

Med Sci Monit 2022 May 1;28:e937048. Epub 2022 May 1.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

The consequences of SARS-CoV-2 infection include short-term, long-term, mild, and severe clinical symptoms. The cardiovascular system, including endothelial cells, vascular smooth muscle cells, and cardiac myocytes, are important targets for SARS-CoV-2. In February 2022, the findings from a large US cohort of individuals diagnosed with COVID-19 and two sets of control cohorts evaluated the risk and 12-month cardiovascular disease burden. Individuals who had COVID-19 had a 72% increased risk of heart failure, a 63% increased risk of myocardial infarction, and a 52% increased risk of ischemic stroke compared with controls. These results were independent of gender, race, age, and other cardiovascular risk factors, including diabetes, obesity, hypertension, hyperlipidemia, and chronic kidney disease. As of 25 April 2022, the World Health Organization (WHO) reported that more than 80 million people in the US, more than 22 million people in the UK, and more than 505 million people worldwide were infected with SARS-CoV-2. This Editorial aims to present what is currently known about the cardiovascular outcomes at one year following SARS-CoV-2 infection and highlights that primary care physicians should be mindful of the COVID-19 infection status of their patients when evaluating cardiovascular health.
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http://dx.doi.org/10.12659/MSM.937048DOI Listing
May 2022

Editorial: First Approval of the Protein-Based Adjuvanted Nuvaxovid (NVX-CoV2373) Novavax Vaccine for SARS-CoV-2 Could Increase Vaccine Uptake and Provide Immune Protection from Viral Variants.

Authors:
Dinah V Parums

Med Sci Monit 2022 Mar 1;28:e936523. Epub 2022 Mar 1.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

The Nuvaxovid™ (NVX-CoV2373) Novavax vaccine is a recombinant spike (S) protein nanoparticle vaccine combined with the Matrix-M adjuvant. On December 20, 2021, the European Commission of the European Union (EU) granted conditional marketing authorization for the Nuvaxovid™ (NVX-CoV2373) Novavax vaccine, following recommendations from the European Medicines Agency (EMA). On February 3, 2022, this vaccine was granted conditional marketing authorization (CMA) in Great Britain by the Medicines and Healthcare Products Regulatory Agency (MHRA) for use in individuals ≥18 years. The two vaccine components elicit both B-lymphocyte and T-lymphocyte immune responses to the S protein of SARS-CoV-2. The full-length S protein in this vaccine has common epitopes that could protect against all the SARS-CoV-2 viral variants. Also, the vaccine is stable and has a shelf life of 9 months when stored at standard refrigerated temperatures of between 2-8°C. This Editorial aims to present an update on the first approval of a protein-based adjuvanted vaccine for SARS-CoV-2, Nuvaxovid (NVX-CoV2373) from Novavax, and why it is such a significant development at this time.
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http://dx.doi.org/10.12659/MSM.936523DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8897963PMC
March 2022

Editorial: The 2022 World Health Organization (WHO) Priority Recommendations and Response to the Omicron Variant (B.1.1.529) of SARS-CoV-2.

Authors:
Dinah V Parums

Med Sci Monit 2022 Feb 1;28:e936199. Epub 2022 Feb 1.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

The omicron variant of SARS-CoV-2, B.1.1.529, was included in the World Health Organization (WHO) list of variants of concerns (VOC) on 26 November 2021. Within only three months, omicron has spread rapidly to become the dominant variant in many countries. Studies have begun to evaluate the virulence, transmissibility, and degree of immune protection from current SARS-CoV-2 vaccines or previous of infection with the omicron variant. On 21 January 2022, the WHO published its seventh technical update and recommendations for priority actions in response to the omicron SARS-CoV-2 variant and cautioned that the overall risk from omicron remains high. At the start of this third year of the global COVID-19 pandemic, this editorial aims to summarize the evidence that supports the current priority recommendations and response from the WHO regarding the omicron variant of SARS-CoV-2, B.1.1.529.
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http://dx.doi.org/10.12659/MSM.936199DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8817616PMC
February 2022

Editorial: Current Status of Oral Antiviral Drug Treatments for SARS-CoV-2 Infection in Non-Hospitalized Patients.

Authors:
Dinah V Parums

Med Sci Monit 2022 Jan 1;28:e935952. Epub 2022 Jan 1.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

On 4th November 2021, the first oral antiviral drug for COVID-19, molnupiravir (Lagevrio®), received full regulatory approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. Molnupiravir is an orally bioavailable antiviral drug for use at home when a SARS-CoV-2 test is positive. On 22nd December 2022, the FDA granted emergency use authorization (EUA) for the oral antiviral drug, nirmatrelvir/ritonavir (Paxlovid®) for adults and children with mild and moderate COVID-19 at increased risk of progression to severe COVID-19. These regulatory drug approvals come at a crucial time when new variants of concern of the SARS-CoV-2 virus are spreading rapidly. Although the FDA approved remdesivir (Veklury®) on 22nd October 2020 for use in adults and children for the treatment of COVID-19 requiring hospitalization, its use has been limited by the requirement for intravenous administration in a healthcare facility. The four FDA-approved therapeutic neutralizing monoclonal antibodies, imdevimab, bamlanivimab, etesevimab, and casirivimab are costly and also require medically-supervised intravenous administration. The availability of effective, low-cost oral antiviral drugs available in a community setting that can be used at an early stage of SARS-CoV-2 infection is now a priority in controlling COVID-19. An increasing number of repurposed antiviral drugs are currently under investigation or in the early stages of regulatory approval. This Editorial aims to present an update on the current status of orally bioavailable antiviral drug treatments for SARS-CoV-2 infection.
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http://dx.doi.org/10.12659/MSM.935952DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8729033PMC
January 2022

Editorial: SARS-CoV-2 Vaccine Responses and Breakthrough COVID-19.

Authors:
Dinah V Parums

Med Sci Monit 2021 Dec 1;27:e935624. Epub 2021 Dec 1.

Scientific Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

In 2021, data from global disease monitoring and infection surveillance programs have shown that vaccination programs have reduced the incidence of SARS-CoV-2 infection and hospitalization and mortality rates. Currently, the US Centers for Disease Control and Prevention (CDC) identifies a fully vaccinated individual as being ≥14 days after the completion of all the recommended doses of a COVID-19 vaccine that has been authorized by the US Food and Drug Administration (FDA). A partially vaccinated individual is <14 days following primary vaccination or has not completed the vaccination program. Clinical studies and data on the vaccine status of populations have identified breakthrough COVID-19 cases in fully vaccinated individuals at 14 or more days after completing the recommended dose of an authorized SARS-CoV-2 vaccine. This Editorial presents an update on what has been learned in the past year on SARS-CoV-2 vaccine responses and breakthrough COVID-19.
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http://dx.doi.org/10.12659/MSM.935624DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8647456PMC
December 2021

Editorial: What Can be Learned from National and International Vaccine Adverse Event Reporting Systems During the COVID-19 Pandemic?

Authors:
Dinah V Parums

Med Sci Monit 2021 11 1;27:e935299. Epub 2021 Nov 1.

Scientific Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

Healthcare professionals have an ethical, medico-legal, and professional responsibility to report all suspected adverse events following immunization to relevant national reporting agencies as part of the process of post-marketing drug safety monitoring. In the US, the Vaccine Adverse Event Reporting System (VAERS) is co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). Data from VAERS and other national and global reporting systems show very low rates of adverse events related to currently approved SARS-CoV-2 vaccines. Populations studies have supported the findings from adverse event reporting systems. The presentation, monitoring, and reporting of adverse events related to SARS-CoV-2 vaccines may have future applications in vaccine monitoring for several other potential pandemic zoonotic infections. This editorial aims to summarize the current understanding of adverse events from current COVID-19 vaccines from global adverse event reporting systems, rather than individual case reports or anecdotal reporting in the media.
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http://dx.doi.org/10.12659/MSM.935299DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8570045PMC
November 2021

Editorial: The 2021 European Society of Cardiology (ESC) Guidelines on the Real-World Prevention of Atherosclerotic Cardiovascular Disease (ASCVD).

Authors:
Dinah V Parums

Med Sci Monit 2021 Oct 25;27:e935172. Epub 2021 Oct 25.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

Some of the most challenging guidelines for clinical practice include recommendations for disease prevention, which often involve lifestyle modifications, which may vary between populations. On August 30, 2021, the European Society of Cardiology (ESC) published new guidelines for primary and secondary prevention of atherosclerotic cardiovascular disease (ASCVD), endorsed by 12 European professional societies. Important features of the 2021 ESC guidelines include recommendations for disease prevention in individuals in clinical practice, including in older adults, with and without ASCVD, with diabetes, familial hypercholesterolemia, and chronic kidney disease (CKD). Importantly, and for the first time, the updated 2021 ESC guidelines also address the impact of environmental factors, including water, air, and soil pollution, on the risk of ASCVD. This Editorial aims to present and discuss how the latest 2021 ESC guidelines on the prevention of ASCVD have practical real-world applications in clinical practice.
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http://dx.doi.org/10.12659/MSM.935172DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8555443PMC
October 2021

Editorial: Global Initiatives Support the Use and Regulation of Digital Health Technology During the COVID-19 Pandemic.

Authors:
Dinah V Parums

Med Sci Monit 2021 Oct 18;27:e935123. Epub 2021 Oct 18.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

The development and use of digital health technology have increased during the global COVID-19 pandemic. Artificial intelligence (AI)-powered digital tools have been increasingly used to diagnose and screen for SARS-CoV-2 infection. Digital technology, in the form of mobile phone applications (apps), has been adopted by several countries to track infected individuals as infection prevention and surveillance measures. Global best practice guidelines, technology approvals, and patient care models have only recently begun to catch up with the developments in digital technology. In 2021, the WHO published a global strategy on digital health (eHealth) and mobile health (mHealth) for 2020 to 2025. The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) now evaluates software as a medical device (SaMD) and software that is in a medical device (SiMD) through the International Medical Device Regulators Forum (IMDRF). This Editorial aims to discuss how the COVID-19 pandemic has driven global initiatives to support the use and regulation of digital health technology and the requirements for digital health evidence frameworks and new approaches to regulatory approvals.
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http://dx.doi.org/10.12659/MSM.935123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8532519PMC
October 2021

Editorial: Multisystem Inflammatory Syndrome in Adults (MIS-A) and the Spectrum of COVID-19.

Authors:
Dinah V Parums

Med Sci Monit 2021 Oct 11;27:e935005. Epub 2021 Oct 11.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

Recent studies on the pathogenesis and clinical spectrum of human disease following infection with the new human pathogen, SARS-CoV-2, have identified the varied presentations and sequelae of COVID-19. Acute 'cytokine storm' in severe COVID-19 results in multiorgan damage due to vascular hyperpermeability, edema, and hypercoagulation. The long-term consequences of infection from SARS-CoV-2 include long COVID. or post-COVID syndrome, and multisystem inflammatory syndrome in children (MIS-C). Several case reports of multisystem inflammatory syndrome in adults (MIS-A) have shown the presentation at more than four weeks after initial infection with SARS-CoV-2 in adults more than 21 years of age. In September 2021, a published systematic review of the literature identified 221 patients with MIS-A, representing the most comprehensive clinical study to date. MIS-A occurs in the post-acute COVID-19 period. The pathogenesis may involve a dysregulated antibody-mediated immune response, similar to MIS-C. Therefore, patients with MIS-A may respond to supportive therapies that control hyperinflammation. This Editorial aims to describe MIS-A and discuss COVID-19 as a spectrum of hyperinflammatory disease in terms of severity, extent, duration, and patient age.
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http://dx.doi.org/10.12659/MSM.935005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518511PMC
October 2021

Editorial: A Decline in Influenza During the COVID-19 Pandemic and the Emergence of Potential Epidemic and Pandemic Influenza Viruses.

Authors:
Dinah V Parums

Med Sci Monit 2021 Oct 4;27:e934949. Epub 2021 Oct 4.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

There have been five viral pandemics in the past century, four were due to influenza, and the ongoing COVID-19 pandemic is due to SARS-CoV-2 infection. During the COVID-19 pandemic, there has been a 99% global reduction in the diagnosis of influenza. Also, from 2020, global mortality rates from influenza fell to record levels during the influenza seasons in the southern and northern hemispheres. However, as social restrictions become lifted and the winter season begins in the northern hemisphere, it is expected that influenza will re-emerge. The World Health Organization (WHO) FluNet surveillance platform provides global surveillance data on influenza, and the US Centers for Disease Control and Prevention (CDC) records national weekly infection rates. Both surveillance programs have identified zoonotic avian and swine influenza variants in humans. The WHO Pandemic Influenza Preparedness (PIP) Framework requires WHO Member States to share data on cases of emerging influenza viruses with pandemic potential in a regular and timely way. The WHO PIP Framework organizes the Global Influenza Surveillance and Response System (GISRS), a global network of public health laboratories developing candidate virus vaccines. This Editorial aims to present the reasons for concern regarding the emergence of pandemic influenza viruses driven by the social and public health responses to the COVID-19 pandemic and highlights the importance of global influenza surveillance at this time.
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http://dx.doi.org/10.12659/MSM.934949DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8499673PMC
October 2021

Editorial: Global Regulatory Initiatives Deliver Accelerated Approval of the First Bispecific Therapeutic Monoclonal Antibody for Advanced Non-Small Cell Lung Cancer (NSCLC).

Authors:
Dinah V Parums

Med Sci Monit 2021 Sep 27;27:e934854. Epub 2021 Sep 27.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

The coronavirus disease 2019 (COVID-19) pandemic has affected the number of completed clinical trials, particularly in oncology. Between 80-85% of all lung cancers are non-small cell lung cancer (NSCLC), and of these, between 2-3% have an EGFR exon 20 insertion, which is associated with increased cell proliferation, metastasis, and a lack of response to chemotherapy and epidermal growth factor receptor (EGFR) inhibitors. Until this year, there were no available targeted therapies for advanced NSCLC with this genetic subtype. However, in May 2021, the US Food and Drug Administration (FDA) granted accelerated approval for amivantamab-vmjw (Rybrevant®), a bispecific monoclonal antibody, targeting activating and resistant EGFR and MET mutations and amplifications. This FDA approval was for adult patients with locally advanced metastatic NSCLC, with disease progression on or following platinum-based chemotherapy. The FDA also approved the Guardant360® companion diagnostic, a next-generation sequencing platform for circulating tumor DNA (ctDNA), which is a liquid biopsy assay. In 2019, Project Orbis was launched by the FDA Oncology Center of Excellence as a global collaborative review program to facilitate rapid global access for patients to innovative cancer therapies. This Editorial aims to highlight how global regulatory initiatives from the FDA have delivered accelerated approval of the first bispecific therapeutic monoclonal antibody, amivantamab-vmjw (Rybrevant®), and a companion diagnostic for patients with advanced NSCLC with an EGFR exon 20 insertion.
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http://dx.doi.org/10.12659/MSM.934854DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8482802PMC
September 2021

Editorial: Autoantibodies to Components of the Immune System, Including Type 1 Interferons, and the Risk of Severe COVID-19.

Authors:
Dinah V Parums

Med Sci Monit 2021 Sep 20;27:e934766. Epub 2021 Sep 20.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

During the past two years, clinical studies have attempted to identify risk factors to predict clinical outcomes following infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In July 2021, a study using a high-throughput technique detected autoantibodies to chemokines, cytokines, and complement components in patients with symptomatic coronavirus disease 2019 (COVID-19). In August 2021, a study identified pre-existing autoantibodies to type 1 interferons (IFNs) in 10% of patients with severe COVID-19 but not asymptomatic individuals. Autoantibodies may be the long-awaited markers of clinical risk for severe COVID-19 in patients with SARS-CoV-2 infection. This Editorial aims to present some recent findings of autoantibodies to components of the immune system, including type 1 IFNs, and the risk of severe COVID-19.
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http://dx.doi.org/10.12659/MSM.934766DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8462125PMC
September 2021

Editorial: The First Monoclonal Antibody Vaccine to Prevent Malaria Heralds a New Era of Malaria Vaccines to the Plasmodium falciparum Circumsporozoite Protein (PfCSP).

Authors:
Dinah V Parums

Med Sci Monit 2021 Sep 13;27:e934676. Epub 2021 Sep 13.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

Malaria affects more than 3 billion people in 95 countries, with an estimated mortality rate of 400,000 per year. The female Anopheles spp mosquito most commonly transmits malaria, and the main burden of disease is due to Plasmodium falciparum. The most abundant antigen on the sporozoite surface is the Plasmodium falciparum circumsporozoite protein (PfCSP). PfCSP is required for parasite development and attachment to host hepatocytes. The first potential protein vaccine, RTS,S/ASO1, consists of a recombinant fusion antigen based on PfCSP. Initial findings from a phase 3 trial of RTS,S/ASO1 were promising but resulted in recommendations for further evaluation in large-scale trials. R21, a circumsporozoite protein-based vaccine, combined with an adjuvant, Matrix-M (MM), was recently evaluated in a phase 2 investigational study in children between 5-17 months of age in Burkina Faso. The R21/MM candidate vaccine resulted in high titers of malaria-specific antibodies. On August 26, 2021, the findings from a phase 1 trial on a new monoclonal antibody to PfCSP, CIS43LS, showed that a single dose of the CIS43LS monoclonal antibody resulted in protection against malaria. These new findings have implications for the seasonal control of malaria in endemic regions and a possible future role in public health strategies to eliminate malaria. This Editorial aims to provide the background to developing and evaluating the new malaria vaccines that target PfCSP, including the first monoclonal antibody vaccine to malaria.
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http://dx.doi.org/10.12659/MSM.934676DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8447852PMC
September 2021

Editorial: First Full Regulatory Approval of a COVID-19 Vaccine, the BNT162b2 Pfizer-BioNTech Vaccine, and the Real-World Implications for Public Health Policy.

Authors:
Dinah V Parums

Med Sci Monit 2021 Sep 6;27:e934625. Epub 2021 Sep 6.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

In the past 18 months, accelerated vaccine development to prevent or reduce the severity of coronavirus disease 2019 (COVID-19) has resulted in rapid global emergency regulatory approvals, including the US Food and Drug Administration (FDA) emergency use authorization (EUA) approvals. On August 23, 2021, the US FDA gave the first full regulatory approval for a COVID-19 vaccine and approved the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) for individuals 16 years and older. In the US, there is a continued EUA for individuals aged 12-15 years of age. Also, the EUA includes the administration of a third or booster dose in immunocompromised individuals at increased risk for severe COVID-19. This Editorial aims to present an update on the first COVID-19 vaccine to receive full regulatory approval, the Pfizer-BioNTech vaccine, and the implications for real-world public health during the global COVID-19 pandemic and increasing concerns for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern.
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http://dx.doi.org/10.12659/MSM.934625DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8434768PMC
September 2021

Editorial: Reporting Clinical Trials with Important Modifications Due to Extenuating Circumstances, Including the COVID-19 Pandemic: CONSERVE 2021.

Authors:
Dinah V Parums

Med Sci Monit 2021 Aug 30;27:e934514. Epub 2021 Aug 30.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

During 2020 and 2021, the COVID-19 pandemic has resulted in interruptions and cancellations of clinical trials and has delayed drug development in all areas except SARS-CoV-2 vaccine development. A further concern is the need to rapidly share anonymized datasets and improve opportunities to conduct randomized clinical trials (RCTs) in low-resource developing countries, particularly for oncology trials and for other infectious diseases. The Consolidated Standards of Reporting Trials (CONSORT) 2010 and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 currently guide the reporting of trial protocols and completed RCTs, respectively. Extenuating circumstances or unavoidable situations may occur that are beyond the control of study sponsors and investigators. On June 21, 2021, the CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstance (CONSERVE) was published. The scope of CONSERVE 2021 includes modifications that have substantive implications for the feasibility, ethical conduct, scientific content, and study analysis. This Editorial aims to provide the background to CONSERVE 2021 and show how these guidelines may reduce the number of clinical trials currently being paused or discontinued due to the COVID-19 pandemic, particularly in poorly resourced and developing countries.
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http://dx.doi.org/10.12659/MSM.934514DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8415037PMC
August 2021

Editorial: Review Articles, Systematic Reviews, Meta-Analysis, and the Updated Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 Guidelines.

Authors:
Dinah V Parums

Med Sci Monit 2021 Aug 23;27:e934475. Epub 2021 Aug 23.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

Subjective narrative review articles have an educational and informative role in medical and scientific journals. Systematic review of the literature requires an objective and complete review of all available publications on an identified topic. Systematic review that undergoes meta-analysis aims to provide a complete and objective evaluation of all the published data. Data from systematic review and meta-analysis publications support evidence-based medical practice and are prepared as original research articles. These studies require a clear aim and detailed planning with registration and approval of the study protocol before the study commences. Systematic review and meta-analysis studies are designed, conducted, and reported according to mandatory guidelines. The number of these publications has continued to rise during the past decade. However, concerns with the quality of the studies have resulted in more stringent study guidelines. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement, guidelines, reporting checklist, and study flow diagram from 2009 were updated and published in March 2021 as PRISMA 2020. The Editorial aims to present the roles and requirements of subjective narrative review articles, systematic review of the literature, and systematic review and meta-analysis, and introduces the revisions and aims of the PRISMA 2020 guidelines.
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http://dx.doi.org/10.12659/MSM.934475DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8394590PMC
August 2021

Editorial: Post-Exposure Prophylactic Neutralizing Monoclonal Antibodies to SARS-CoV-2 for Individuals at High Risk for COVID-19.

Authors:
Dinah V Parums

Med Sci Monit 2021 Aug 16;27:e934393. Epub 2021 Aug 16.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

Regulatory authorities, including the US Food and Drug Administration (FDA), have accelerated diagnostic and therapeutic approvals during the coronavirus disease 2019 (COVID-19) pandemic. Accelerated clinical development and approvals have resulted in vaccine programs for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, some individuals remain at high risk for the progression of COVID-19. In the US, the FDA has given Emergency Use Authorization (EUA) for two neutralizing therapeutic monoclonal antibody 'cocktails,' casirivimab and imdevimab (REGEN-COV), bamlanivimab and etesevimab, and one monotherapy, bamlanivimab, for prophylactic post-exposure therapy in individuals at high risk of progressing to severe COVID-19. Preclinical and clinical studies showed consistent effectiveness of REGEN-COV against current variants of SARS-CoV-2. On 21st November 2020, the FDA approved an initial EUA for REGEN-COV to treat mild to moderate COVID-19 in adults and in children 12 years or older with exposure to SARS-CoV-2 at high risk for progression to severe COVID-19. On 30th July 2021, the FDA updated its EUA for REGEN-COV for emergency use as post-exposure prophylactic to prevent COVID-19 progression in adults and children aged 12 years or older. This Editorial aims to provide an update on accelerated regulatory authorization for post-exposure prophylactic neutralizing monoclonal antibodies to SARS-CoV-2 for individuals at high risk for COVID-19.
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http://dx.doi.org/10.12659/MSM.934393DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8378223PMC
August 2021

Editorial: Updates from the World Health Organization (WHO) on Global Treatment Recommendations for Drug-Susceptible and Multidrug-Resistant Tuberculosis.

Authors:
Dinah V Parums

Med Sci Monit 2021 Aug 9;27:e934292. Epub 2021 Aug 9.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

The World Health Organization (WHO) estimated that in 2019, 10.0 million people worldwide developed tuberculosis (TB), with 1.4 million deaths from TB in that year. Infection with Mycobacterium tuberculosis that is resistant to at least isoniazid and rifampin and an additional chemotherapeutic agent is known as multidrug-resistant TB (MDR TB). Until recently, the prevalence of drug resistance in patients with TB has been poorly understood due to a lack of infection surveillance and molecular testing. Countries with the highest prevalence of TB, including MDR TB, are also those most affected by the COVID-19 pandemic. The identification of MDR TB requires careful monitoring and resources for molecular testing. Previous treatment regimens have required intravenous treatments of long duration and high cost. The 2020 and 2021 recommendations from the WHO for the management of drug-susceptible TB and MDR TB have included oral treatment regimens and reduced treatment duration. This Editorial aims to present the rationale for the 2020 and 2021 recommendations from the WHO for the management of drug-susceptible TB and MDR TB.
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http://dx.doi.org/10.12659/MSM.934292DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8362336PMC
August 2021

Retracted: Editorial: mRNA Vaccines and Immunotherapy in Oncology: A New Era for Personalized Medicine.

Authors:
Dinah V Parums

Med Sci Monit 2021 Jul 27;27:e934129. Epub 2021 Jul 27.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

This manuscript has been retracted at the author's request due to possible conflict of interest.Reference:Dinah V. Parums. Editorial: mRNA Vaccines and Immunotherapy in Oncology: A New Era for Personalized Medicine. Med Sci Monit 2021;27:e933088. DOI: 10.12659/MSM.933088.
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http://dx.doi.org/10.12659/MSM.934129DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8325390PMC
July 2021

Editorial: The National COVID Cohort Collaborative Consortium Combines Population Data with Machine Learning to Evaluate and Predict Risk Factors for the Severity of COVID-19.

Authors:
Dinah V Parums

Med Sci Monit 2021 Aug 2;27:e934171. Epub 2021 Aug 2.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes coronavirus disease 2019 (COVID-19) commonly presents with pneumonia. However, COVID-19 is now recognized to involve multiple organ systems with varying severity and duration. In July 2021, the findings from a retrospective population study from the National COVID Cohort Collaborative (N3C) Consortium were published that included analysis by machine learning methods of 174,568 adults with SARS-CoV-2 infection from 34 medical centers in the US. The study stratified patients for COVID-19 according to the World Health Organization (WHO) Clinical Progression Scale (CPS). Severe clinical outcomes were identified as the requirement for invasive ventilatory support, or extracorporeal membrane oxygenation (ECMO), and patient mortality. Machine learning analysis showed that the factor most strongly associated with severity of clinical course in patients with COVID-19 was pH. A separate multivariable logistic regression model showed that independent factors associated with more severe clinical outcomes included age, dementia, male gender, liver disease, and obesity. This Editorial aims to present the rationale and findings of the largest population cohort of adult patients with COVID-19 to date and highlights the importance of using large population studies with sophisticated analytical methods, including machine learning.
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http://dx.doi.org/10.12659/MSM.934171DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8343537PMC
August 2021

Editorial: Targets for Disease-Modifying Therapies in Alzheimer's Disease, Including Amyloid β and Tau Protein.

Authors:
Dinah V Parums

Med Sci Monit 2021 Jul 26;27:e934077. Epub 2021 Jul 26.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Mellville, NY, USA.

Current treatments for patients with Alzheimer's disease aim to improve behavioral, cognitive, and non-cognitive symptoms. There have been no new drug approvals for preventing or treating Alzheimer's disease for more than two decades. Drug development in Alzheimer's disease aims to identify disease-modifying therapies that will delay or slow the clinical course of this disease. More than 50% of the current Alzheimer's disease drug pipeline now involves immunotherapies or oral small molecule agents. The most promising disease-modifying drug targets are amyloid ß and tau protein. In June 2021, aducanumab, a humanized recombinant monoclonal antibody to amyloid ß, was the first potential disease-modifying therapy approved by the US Food and Drug Administration (FDA) to treat Alzheimer's disease and mild cognitive impairment. Accelerated approval of aducanumab was based on the results of only one of two phase 3 clinical trials. Several clinical trials of targeted disease-modifying immunotherapies to the tau protein and amyloid ß that commenced before the current COVID-19 pandemic have been delayed. This Editorial aims to provide an update on past, present, and future disease-modifying therapies in Alzheimer's disease, including targeted therapies for amyloid ß and tau protein.
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http://dx.doi.org/10.12659/MSM.934077DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8323472PMC
July 2021

Editorial: Tocilizumab, a Humanized Therapeutic IL-6 Receptor (IL-6R) Monoclonal Antibody, and Future Combination Therapies for Severe COVID-19.

Authors:
Dinah V Parums

Med Sci Monit 2021 Jul 19;27:e933973. Epub 2021 Jul 19.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Mellville, NY, USA.

Vaccinated, non-vaccinated, and immunosuppressed individuals will continue to be infected with SARS-CoV-2. Therefore, there is a priority to develop treatments that reduce the severity of COVID-19 in patients who require hospital admission. Interleukin-6 (IL-6) is a proinflammatory cytokine. In 2011, a humanized monoclonal antibody to the IL-6 receptor (IL-6R), tocilizumab, was approved by the US Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, giant cell arteritis, and Castleman's disease. In 2017, tocilizumab was approved to treat chimeric antigen receptor (CAR) T-cell therapy-induced cytokine release syndrome (CRS). In 2021, the results of the REMAP-CAP clinical trial (NCT02735707) and the COVID-19 Therapy (RECOVERY) clinical trial (NCT04381936) supported FDA Emergency Use Authorization (EUA) for tocilizumab to treat hospitalized patients with moderate and severe COVID-19. Monoclonal antibodies are currently in clinical development or undergoing clinical trials to treat COVID-19. Further clinical trials will provide safety and efficacy data on targeting IL-6 and IL-6R and provide rationales for more personalized combination treatments to control the systemic effects of SARS-CoV-2 infection in hospitalized patients with moderate and severe COVID-19. This Editorial aims to present the background to the recent authorization of tocilizumab, a humanized therapeutic monoclonal antibody to the IL-6 receptor (IL-6R), for hospitalized patients with moderate and severe COVID-19 and future combination therapies.
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http://dx.doi.org/10.12659/MSM.933973DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8299871PMC
July 2021

Editorial: Maternal SARS-CoV-2 Infection and Pregnancy Outcomes from Current Global Study Data.

Authors:
Dinah V Parums

Med Sci Monit 2021 Jul 5;27:e933831. Epub 2021 Jul 5.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Mellville, NY, USA.

During the global COVID-19 pandemic, data from clinical studies, systematic review, and population registry data have shown that when compared with non-pregnant women, SARS-CoV-2 infection in pregnancy is associated with a small increase in risk to the mother. Large cohort studies and registry data collected from 2020 have included the US Surveillance for Emerging Threats to Mothers and Babies Network (SET-NET), COVI-PREG, the UK and Global Pregnancy and Neonatal Outcomes in COVID-19 (PAN-COVID) study, the American Academy of Pediatrics (AAP) Section on Neonatal-Perinatal Medicine (SONPM) National Perinatal COVID-19 Registry, the Swedish Pregnancy Register, and the Canadian Surveillance of COVID-19 in Pregnancy (CANCOVID-Preg) registry. Recently published data have shown that most maternal infections with SARS-CoV-2 occur during the third trimester and result in a small increase in hospital admission, admission to the intensive care unit (ICU), mechanical ventilation, preterm birth, and increased cesarean sections in mothers infected with SARS-CoV-2. However, currently approved vaccines given in pregnancy result in an immune response to current SARS-CoV-2 variants. Transplacental transmission of SARS-CoV-2 to the fetus can occur, but the immediate and long-term effects on the newborn infant remain unclear. Therefore, women who are pregnant or planning a pregnancy should be managed according to current clinical guidelines with timely vaccination to prevent infection with SARS-CoV-2. This Editorial summarizes what is currently known about maternal SARS-CoV-2 infection and pregnancy outcomes from multinational studies.
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http://dx.doi.org/10.12659/MSM.933831DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8268975PMC
July 2021

Editorial: Artificial Intelligence (AI) in Clinical Medicine and the 2020 CONSORT-AI Study Guidelines.

Authors:
Dinah V Parums

Med Sci Monit 2021 Jun 28;27:e933675. Epub 2021 Jun 28.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Mellville, NY, USA.

Artificial intelligence (AI) in clinical medicine includes physical robotics and devices and virtual AI and machine learning. Concerns have been raised regarding ethical issues for the use of AI in surgery, including guidance for surgical decisions, patient confidentiality, and the need for support from controlled clinical trials to use these methods so that clinical guidelines can be developed. The most common applications for virtual AI include disease diagnosis, health monitoring and digital patient consultations, clinical training, patient data management, drug development, and personalized medicine. In September 2020, the CONSORT-A1 extension was developed with 14 additional items that should be reported for AI studies that include clear descriptions of the AI intervention, skills required, study setting, inputs and outputs of the AI intervention, analysis of errors, and the human and AI interactions. This Editorial aims to present current applications and challenges of AI in clinical medicine and the importance of the new 2020 CONSORT-AI study guidelines.
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http://dx.doi.org/10.12659/MSM.933675DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8252890PMC
June 2021

Editorial: Registries and Population Databases in Clinical Research and Practice.

Authors:
Dinah V Parums

Med Sci Monit 2021 Jun 14;27:e933554. Epub 2021 Jun 14.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

Patient registries include data on patient diagnosis, demographics, treatment, and outcomes and are now fundamental to the provision of successful global health systems. Patient registries include mainly local, regional, and national patient data on general or specific patient groups. Global registries currently exist mainly for rare diseases. Some of the most studied registries include the national Surveillance, Epidemiology, and End Results (SEER) program and the hospital-based Medical Information Mart for Intensive Care (MIMIC-III) dataset. The limitations of registry databases have included lack of feedback from clinical studies to the clinical center, the lack of patient involvement, and limited findings on patient-reported outcomes (PROs). In September 2020, the European Medicines Agency (EMA) published its draft guidelines on registry-based clinical studies. Guidelines for the development and analysis of registry data will improve the quality and registry-based studies and increase the role of registry data to support clinical trials. This Editorial aims to present the current status of registries and population databases in clinical research and practice.
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http://dx.doi.org/10.12659/MSM.933554DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8212698PMC
June 2021

Editorial: Revised World Health Organization (WHO) Terminology for Variants of Concern and Variants of Interest of SARS-CoV-2.

Authors:
Dinah Parums

Med Sci Monit 2021 06 21;27:e933622. Epub 2021 Jun 21.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Mellville, USA

The global pandemic of coronavirus disease 2019 (COVID-19) has identified thousands of genome sequences of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On 31st May 2021, the Virus Evolution Working Group of the World Health Organization (WHO) announced its recommendations for revised naming of SARS-CoV-2 variants of concern (VOCs) and variants of interest (VOIs). This new nomenclature system may improve infection monitoring, infection control, and sharing of research data on viral genomics and epidemiology. This Editorial aims to present an update on the current revised WHO terminology for the genomic VOCs and VOIs of SARS-CoV-2.
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http://dx.doi.org/10.12659/MSM.933622DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8230247PMC
June 2021

Editorial: Long COVID, or Post-COVID Syndrome, and the Global Impact on Health Care.

Authors:
Dinah V Parums

Med Sci Monit 2021 Jun 7;27:e933446. Epub 2021 Jun 7.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

During 2020, increasing numbers of case reports, case series, and small observational studies reported long-term complications of coronavirus disease 2019 (COVID-19) in patients who had recovered from acute infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Long COVID has a prevalence of between 10-30% in patients with a recent history of SARS-CoV-2 infection. Pulmonary, hematologic, cardiovascular, neuropsychiatric, renal, endocrine, gastrointestinal and hepatobiliary, and dermatologic involvement, and chronic multisystem inflammatory syndrome in children (MIS-C) highlights the requirement for a multidisciplinary approach to the management of patients with long COVID. This Editorial aims to present the current status of long COVID, or post-COVID syndrome, and its global impact on health and the provision of health care.
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http://dx.doi.org/10.12659/MSM.933446DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8194290PMC
June 2021

Editorial: COVID-19 and Multisystem Inflammatory Syndrome in Children (MIS-C).

Authors:
Dinah V Parums

Med Sci Monit 2021 May 31;27:e933369. Epub 2021 May 31.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

In early 2020, at the beginning of the coronavirus disease 2019 (COVID-19) pandemic due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), rare cases were reported in children and adolescents of multisystem inflammatory syndrome in children (MIS-C). MIS-C is characterized by fever, systemic inflammation, and multiorgan dysfunction and usually presents late in SARS-CoV-2 infection. Since May 2020, the Centers for Disease Control and Prevention (CDC) has recorded all reported cases of COVID-19 and MIS-C in children and adolescents in the USA. In April 2021, the American College of Rheumatology (ACR) revised its clinical guidelines for diagnosing and managing hyperinflammation and MIS-C. There are several challenges ahead for preventing, diagnosing, and managing MIS-C, particularly following the rapid emergence of new strains of SARS-CoV-2. This Editorial aims to present an update on the current status of the clinical presentation, diagnosis, and management of MIS-C and includes some updates from population studies and clinical guidelines.
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http://dx.doi.org/10.12659/MSM.933369DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8176784PMC
May 2021

Editorial: 2021 European Society for Medical Oncology (ESMO) Recommendations on Laboratory Diagnostics for RET Gene Fusions and Mutations: A New Era in Targeted Therapy for RET-Altered Solid Tumors.

Authors:
Dinah V Parums

Med Sci Monit 2021 May 24;27:e933206. Epub 2021 May 24.

Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.

During the past four decades, the identification of phenotypic changes in malignant tumor cells has been refined by the standardization of immunohistochemistry methods. Regulatory-approved companion diagnostics were initially developed for immunohistochemistry and to support early tumor tissue-based clinical trials. In the last decade, molecular profiling and gene sequencing data have identified specific molecular targets that have resulted in increasing drug development programs and regulatory approvals. As an example, RET-altered cancers include RET gene mutations and RET gene fusions. In January 2021, the European Society for Medical Oncology (ESMO) published new guidelines for routine clinical laboratory detection of targetable RET gene rearrangements and mutations. FDA approval has now been given for selpercatinib for RET fusion-positive NSCLC and papillary thyroid cancer, and RET mutation-positive thyroid cancer. This Editorial aims to present a brief overview of the evolution of personalized medicine in oncology and how the 2021 ESMO guidelines have anticipated the need to detect targetable RET-altered tumors using technology currently available in accredited clinical diagnostic laboratories.
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http://dx.doi.org/10.12659/MSM.933206DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8162049PMC
May 2021

Editorial: mRNA Vaccines and Immunotherapy in Oncology: A New Era for Personalized Medicine.

Authors:
Dinah V Parums

Med Sci Monit 2021 05 17;27:e933088. Epub 2021 May 17.

Science Editor, International Scientific Information, Inc., Melville, NY, USA.

Synthetic mRNA and the expression of therapeutic proteins have accelerated vaccine development to prevent infection and heralds a new era in targeted immunotherapy in oncology. Therapeutic mRNA vaccines rely on available tumor tissue for gene sequencing analysis to compare the patient's normal cellular DNA sequences and those of the tumor. Carrier-based mRNA vaccines for cancer immunotherapy are now in development that use delivery systems based on peptides, lipids, polymers, and cationic nano-emulsions. There have also been recent developments in dendritic cell-based mRNA vaccines. For patients with available tumor tissue samples, it is possible to develop mRNA vaccines that result in the expression of tumor antigens by antigen-presenting cells (APCs), resulting in innate and adaptive immune responses. Ongoing developments in mRNA immunotherapy include modifications in the route of administration and combined delivery of multiple mRNA vaccines with checkpoint inhibitors. This Editorial aims to present a brief overview of how mRNA immunotherapy may change the therapeutic landscape of personalized medicine for patients with solid malignant tumors.
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http://dx.doi.org/10.12659/MSM.933088DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8139131PMC
May 2021
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