Author Interviews, COVID -19 Coronavirus, JAMA, NYU / 03.02.2022
COVID-19: Study Finds Narrow Window For Convalescent Plasma Effectiveness
MedicalResearch.com Interview with:
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Dr. Troxel[/caption]
Andrea B. Troxel, ScD (she/her/hers)
Professor and Director, Division of Biostatistics
Department of Population Health
NYU Grossman School of Medicine
NYU Langone Health
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This study represents an international collaboration across four continents and six countries, to pool information from studies in different patient populations to generate robust information about the possible benefits of convalescent plasma in treating COVID-19. Because the study was so large and the methods so rigorous, we were able to show that while CP doesn’t benefit all patients, it may have positive effects in certain subgroups.
Dr. Troxel[/caption]
Andrea B. Troxel, ScD (she/her/hers)
Professor and Director, Division of Biostatistics
Department of Population Health
NYU Grossman School of Medicine
NYU Langone Health
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This study represents an international collaboration across four continents and six countries, to pool information from studies in different patient populations to generate robust information about the possible benefits of convalescent plasma in treating COVID-19. Because the study was so large and the methods so rigorous, we were able to show that while CP doesn’t benefit all patients, it may have positive effects in certain subgroups.
Dr. Eberly[/caption]
Lauren A. Eberly, MD, MPH
Clinical Fellow, Cardiovascular Medicine
Perelman School of Medicine
Cardiovascular Division, Perelman School of Medicine
Center for Cardiovascular Outcomes, Quality, and Evaluative Research,
Cardiovascular Center for Health Equity and Social Justice,
Leonard Davis Institute of Health Economics
University of Pennsylvania, Philadelphia
MedicalResearch.com: What is the background for this study?
Response: Racial inequities are pervasive in our country, and cardiovascular therapeutics with proven benefit have been shown to be underutilized among Black and Latinx patients.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), a recommended treatment option for glycemic control in patients with diabetes, have recently emerged as a cardioprotective therapy as multiple large randomized clinical trials have shown they prevent cardiovascular events among patients with Type 2 Diabetes (T2D), particularly patients with established atherosclerotic cardiovascular disease (ASCVD). Given this, they are now recommended therapy for patients with diabetes and established or high risk of ASCVD.
Given the known inequitable utilization of other therapies, along with the known higher burden of diabetes and cardiovascular disease among Black patients, the aim of this study was to evaluate the uptake of GLP-1 RA as well as for inequities in utilization.
Dr. Mapara[/caption]
Markus Y Mapara, MD
Professor of Medicine
Director of the Blood and Marrow Transplantation
Columbia University Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Sickle cell disease is caused by a point mutation in the beta-globin gene of hemoglobin resulting in the production of abnormal hemoglobin which leads to formation of sickle-shaped RBC under conditions of low oxygen. Sickle cell disease affects about 100,000 patients in the US which are predominantly African American. The only curative approach is to perform an allogeneic bone marrow transplant which is however fraught with significant treatment-related risks if a matched sibling donor is not available.
The current study describes the successful application of a novel gene therapy to treat patients with sickle cell disease. The strategy is based on a gene-addition approach to introduce the genetic information for a Hemoglobin F-like molecule termed HgAT87Q into hematopoietic stem cells. The expression of this novel hemoglobin prevents polymerization of HgbS and has now been demonstrated to prevent the occurrence of vaso-occlusive pain crises in sickle cell disease patients.
Dr. Thakrar[/caption]
Ashish Thakrar, MD
Internal Medicine & Addiction Medicine
National Clinician Scholars Program
University of Pennsylvania
MedicalResearch.com: What is the background for this study?
Response: About 1.8 million Americans are currently incarcerated, more than any other country in the world per capita. Of those 1.8 million, about 1 in 7 suffers from opioid addiction, putting them at high risk of overdose and death, particularly in the weeks following release.
Opioid use disorder is a treatable condition, particularly with the medications buprenorphine or methadone, but historically, prisons and jails have not offered treatment. Over the past five years, a few states and municipalities have enacted policies to provide access for OUD treatment. We examined whether these policies were actually improving access to treatment.
Dr. Dickerman[/caption]
Dr. Barbra Dickerman, PhD
CAUSALab investigator and instructor
Department of Epidemiology
Harvard T.H. Chan School of Public Health
MedicalResearch.com: What is the background for this study?
Response: Early randomized trials showed that the BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccines were both remarkably effective at preventing symptomatic disease, when comparing each vaccine with no vaccine. However, head-to-head comparisons of these vaccines have been lacking, leaving open the question of which vaccine is more effective.
In this study, we analyzed the VA’s high-quality databases in a way that emulated the design of the hypothetical trial that would have answered this question. Specifically, we used the findings from the original trials to benchmark our methods and then extended them to provide novel evidence for the comparative effectiveness of these two vaccines in a real-world setting and across diverse subgroups and different time periods.
Dr. Woodruff[/caption]
Carina M. Woodruff, MD
Department of Dermatolog
University of California, San Francisco
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Rigorous hand hygiene has been an important component of the CDC's COVID-19 guidelines. With millions of Americans now using hand sanitizers regularly, we are seeing many more cases of hand dermatitis. Our study evaluated the key product features and most common allergens in the top-reviewed, commercial hand sanitizers sold by major US retailers.
We found that the most common potential allergens were tocopherol, fragrance, propylene glycol and phenoxyethanol. Our study also showed that nearly 1 in 5 marketing claims on these products was misleading. For example, 70% of sanitizers with the marketing claim "hypoallergenic" included at least one common allergen in its formulation.
Dr. Ashwin Nathan[/caption]
Ashwin Nathan, MD, MSHP
Assistant Professor, Medicine, Perelman School of Medicine
Interventional Cardiologist
Hospital of the University of Pennsylvania and at the
Corporal Michael C. Crescenz VA Medical Center in Philadelphia
Penn Cardiovascular Outcomes, Quality & Evaluative Research Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: We found that the rates of TAVR were lower in areas with higher proportions of Black, Hispanic and socioeconomically disadvantaged patients. Inequities in access in areas with higher proportions of Black and Hispanic patients existed despite adjusting for socioeconomic status.
Dr. Dan P. Ly[/caption]
Division of General Internal Medicine and Health Services Research
David Geffen School of Medicine at UCLA
Los Angeles, CA
MedicalResearch.com: What is the background for this study?
Response: Lyme disease presents first on the skin with the classic “bull’s-eye” rash. But such rashes in Black patients aren’t well-represented in medical textbooks. This may lead to physicians not recognizing such rashes in Black patients.
As a result, Black patients are more likely to present with later complications of Lyme disease when first diagnosed such as neurologic complications.
Dr. Singer[/caption]
Daniel E. Singer, MD
Professor of Medicine, Harvard Medical School
Professor in the Department of Epidemiology
Harvard T.H. Chan School of Public Health
Division of General Internal Medicine
Massachusetts General Hospital
Boston, MA, 02114
MedicalResearch.com: What is the background for this study?
Response: Atrial fibrillation (AF) raises the risk of ischemic stroke 4-5-fold and this risk is largely reversible by oral anticoagulants (OAC). These facts are part of the core knowledge of internal medicine and the basis of multiple guidelines. They are based on studies of patients with persistent or predominantly “heavy burden” paroxysmal AF completed in the 1990s.
More recent studies using cardiac implantable devices (CIEDs: implantable defibrillators, pacemakers, etc) which have the capacity to monitor heart rhythm continuously have found that many older patients have brief, often undiagnosed, episodes of AF. Several of these studies have found that strokes occur during periods of sinus rhythm temporally distant from a preceding episode of AF. This has led to a widespread suspicion that AF is not a direct causal risk factor but a risk “marker” indicating the presence of other truly causal features like a diseased left atrium (atrial myopathy). If the risk marker hypothesis is correct, then long-term anticoagulation is needed even for brief and rare episodes of AF (assuming the patient’ s CHA2DS2-VASc score is high enough). The key problem with prior prospective studies using CIEDs was that only a small number of strokes were observed leading to inadequate statistical power.
Our study addressed this power problem by linking the very large Optum electronic health record database which could identify ischemic strokes with the Medtronic CareLink database of long-term, continuous heart rhythm records of patients with CIEDs. We ended up studying 891 individuals who had an ischemic stroke and had 120 days of continuous heart monitoring prior to the stroke.