MedicalResearch.com Interview with:
Sripal Bangalore, MD, MHA, FACC, FAHA, FSCAI
Director of Research, Cardiac Catheterization Laboratory,
Director, Cardiovascular Outcomes Group,
Associate Professor of Medicine,
New York University School of Medicine,
New York, NY 10016
Medical Research: What is the background for this study? What are the main findings?
Dr. Bangalore: Prior studies have shown a mortality benefit of bypass surgery over stenting. But these studies compared bypass surgery with older generation stents which are no longer used. We used data from the New York state registry of patients who underwent stenting or bypass surgery for 2 or more blockages of coronary arteries. With data from over 18,000 patients we found that there was no difference between stenting and bypass surgery for long term mortality. In addition we found that both procedures have trade offs. Bypass surgery has upfront risk of death and stroke whereas PCI has long term risk of needing a repeat procedure. In addition, in patients who underwent incomplete revascularization, there was increase in myocardial infarction with PCI.
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MedicalResearch.com Interview with:
Jonathan L. Halperin, M.D.
The Robert and Harriet Heilbrunn Professor of Medicine
Mount Sinai School of Medicine
Dr. Halperin is a member of the Steering Committee for the GLORIA-AF program and a consultant to Boehringer Ingelheim, which sponsored this research.Medical Research: What is the background for this study? What are the main findings?
Dr. Halperin: The two analyses come from the GLORIA-AF Registry Program, a global, prospective, observational study supported by Boehringer Ingelheim, which is designed to characterize the population of newly diagnosed patients with non-valvular atrial fibrillation (NVAF) at risk for stroke, and to study patterns, predictors and outcomes of different treatment regimens for stroke risk reduction in non-valvular atrial fibrillation patients. The data is based on treatment trends in 3,415 patients who entered the registry from November 2011 to February 2014 in North America. All patients had a recent diagnosis of NVAF, and 86.2 percent had a CHA2DS2-VASc score of 2 or higher.
Results from the first analysis demonstrated that patients with the paroxysmal (occasional) form of non-valvular atrial fibrillation and at a high risk for stroke (CHA2DS2-VASc score of 2 or higher) were given an anticoagulant medication less often than those with persistent or permanent forms of NVAF, and a CHA2DS2-VASc score of 2 or higher. This pattern runs counter to NVAF guidelines calling for patients to receive oral anticoagulant therapy based on their risk of stroke, rather than the type of atrial fibrillation.
In the second analysis, researchers found that despite high stroke risk, a considerable number of patients receive only aspirin or no medication.
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MedicalResearch.com Interview with:
Arnold Bakker, Ph.D. Assistant Professor
Division of Psychiatric Neuroimaging
Department of Psychiatry and Behavioral Sciences
The Johns Hopkins University School of Medicine
Baltimore, MD 21287Medical Research: What is the background for this study? What are the main findings?
Dr. Bakker: Patients who are at increased risk for developing dementia due to Alzheimer’s disease show hyperactivity in an area of the brain called the hippocampus, which is critically important for memory function. This study investigated the functional significance of this hyperactivity and determined if, similar to animal studies, treatment with low dose levetiracetam would reduce this increased activation and improve memory function in these patients. Results showed that this overactivity is a dysfunctional condition that contributes to the memory impairment such that treatment with very low doses of levetiracetam both reduces this overactivity and improves memory function in these patients.(more…)
MedicalResearch.com Interview with:
Jeff Coller, PhD Associate professor
Division of General Medical Science
Associate director, The Center for RNA Molecular Biology,
Case Western Reserve University School of Medicine
MedicalResearch: What is the background of this study?
Dr. Coller: There are a diverse number of half-lives for any individual messenger RNA (mRNA). The range of those half-lives is from seconds to hours. What the field has wanted to know for 30 years is how those rates are regulated, and there has been considerable anecdotal and real evidence that sequences in untranslated regions (UTRs) could regulate decay, but it doesn’t explain all of the half-lives that are observed for all messages. In addition, we have known mRNAs that are translated better are more stable than mRNAs that are translated poorly, so those pieces together led to the discovery.
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MedicalResearch.com Interview with:
Russel E. Kaufman, MD President Emeritus
Professor, Molecular and Cellular Oncogenesis Program
Molecular and Cellular Oncogenesis Program
The Wistar Institute
Medical Research: What is the background for this study? What are the main findings?
Response: Targeted therapies in cancer were hailed as a “magic bullet” because of their ability to act upon the mutations responsible for cancer while leaving nearby healthy cells alone. Using an approach like this, it would make sense that therapies designed to target mutations of BRAFV600E/K could be effective for melanoma, since that gene is mutated in about half of all cases of the disease.
However, we’ve learned over time that these targeted therapies simply aren’t as effective as we had hoped they would be. In the case of these BRAF inhibitors, while patients do live slightly longer, they eventually relapse within months of treatment. We wanted to know why this was happening.
We decided to look at macrophages, which are the most abundant inflammatory cells in melanoma. The more macrophages present in a patient with melanoma, the worse his or her outcome will be. They’ve been linked to cancer progression, but before this study, no one had really looked at the role they may play in the resistance to treatment with BRAF inhibitors.
We found that BRAF inhibitors activate the mitogen-activated protein kinase (MAPK) pathway in macrophages. When this pathway is activated, it leads to the production of vascular endothelial growth factor (VEGF), a signaling protein closely associated with angiogenesis. The VEGF produced in the macrophages is able to activate the MAPK pathway in melanoma cells, thereby stimulating the growth of cancer cells.
Taking these findings one step further, we discovered that when we blocked the MAPK pathway or VEGF signaling, we appeared to reverse macrophage-mediated resistance. When we targeted macrophages, we were able to increase the antitumor activity of BRAF inhibitors in mouse and human models.
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MedicalResearch.com Interview with:Donald M Lloyd-Jones, MD/ScM
Senior Associate Dean for Clinical and Translational Research, Chair, Department of Preventive Medicine
Director, Northwestern University Clinical and Translational Sciences Institute (NUCATS) Eileen M. Foell Professor
Professor in Preventive Medicine-Epidemiology and Medicine-Cardiology
Northwestern University Feinberg School of MedicineMedicalResearch: What is the background for this study? What are the main findings?Dr. Lloyd-Jones: Previous studies have examined the associations of cardiovascular health, as defined by the American Heart Association, with outcomes in younger and middle-aged adults. Prior studies have also examined the status (i.e., prevalence) of cardiovascular health in adults across the age spectrum, and in adolescents ages 12-19 years. However, no study to date has examined the status of cardiovascular health in children under 12 years of age, so we sought to define it in detail using nationally-representative data.
Overall, although we have inadequate surveillance systems to monitor cardiovascular health optimally in our youngest children, this study shows that there are concerning signals that they are losing the intrinsic cardiovascular health they are born with, even well before age 12 years. The implications for loss of cardiovascular health before adulthood have been well established, with earlier onset of cardiovascular diseases, cancer and other diseases, earlier mortality, lower quality of life and many other adverse consequences.
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MedicalResearch.com Interview with:
Donovan Maust, MD, MS
Assistant Professor of Psychiatry
University of Michigan
Research Scientist, Center for Clinical Management Research
VA Ann Arbor Healthcare System
Medical Research: What is the background for this study? What are the main findings?
Dr.Maust: From a recent government report, we known that about 1/3 of older adults with dementia in nursing homes and about 14% of those in the community have been prescribed an antipsychotic. While providers focus on what benefit the treatment they offer, it is important to also be aware of the potential harms, particularly when it is death. Prior estimates came from relatively short studies and showed a 1% increase. This paper finds that, over 180 days, the increased mortality comparing antipsychotic users to matched non-users is about 2 to 5 times higher.
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MedicalResearch.com Interview with:
Dr. Adil Haider, MD, MPH
Kessler Director of the Center for Surgery and Public Health (CSPH)
at Brigham and Women’s Hospital
Medical Research: What is the background for this study? Response: Disparities in the quality of care received by minority and low-income patients have been reported for years across multiple medical conditions, types of care, and institutions.
To determine whether clinicians’ unconscious race and/or social class biases correlated with a lower quality of care for minority patients and those of lower socioeconomic status, my colleagues and I conducted a web-based survey among 215 physicians at an academic, level one trauma center. Participants were asked to review eight clinical vignettes, and then respond to three questions about management of care after each. Following their response, a test known as an Implicit Association Test (IAT Test) was used to assess any unconscious preferences.
Medical Research: What are the main findings?Response: We found that race and class biases, as measured by response time to a standardized Implicit Association Test, had no relationship to the way that patients were clinically treated.
Whether the lack of association found between implicit bias and decision making in this study represents a true lack of association or the failure of clinical vignettes to capture the nuances of how implicit biases translate into management decisions remains unclear. Existing biases might influence the quality of care received by minority patients and those of lower socioeconomic status in real-life clinical encounters. (more…)
MedicalResearch.com Interview with:
Lona Mody, MBBS, MSc
Associate Division Chief, Clinical and Translational Research
Associate Director, Clinical Programs, VA GRECC
Associate Professor, Internal Medicine
Research Associate Professor, Institute of Gerontology
University of Michigan Geriatrics Ann Arbor, MI
Medical Research: What is the background for this study? What are the main findings?
Response: Over 1.5 million residents live in 15,600 Nursing Homes in the US. The acuity of illness in this population has increased substantially in the last decade, as has the risk of acquiring new infections. Multi-drug resistant organisms, also known as MDROs, are endemic in this setting with prevalence estimates upwards of 35% and surpassing those in the hospitals. Nursing homes historically have had few infection prevention resources, which contributes to these high rates. Patients with indwelling devices such as urinary catheters and feeding tubes present an attractive habitat for these ‘superbugs’ and thus carry the added burden of device-related infections.
The authors examined the effect of a targeted infection program, or TIP, to reduce the prevalence of Multi-drug resistant organisms and new catheter or feeding tube infections among patients with indwelling devices. The TIP intervention was three-fold:
Surveillance for infections and Multi-drug resistant organism colonization with regular feedback to facilities;
Extensive and interactive staff education using adult learning theory about key infection prevention practices and hand hygiene; and
Use of gowns and gown when providing assistance to patients for high-risk activities such as bathing and grooming.
Staff education emphasized precautionary measures against the spread of infection and included mock game shows, songs and dances. Hands were cultured for bacteria before and after hand washing. Outcomes were measured by results of the cultures taken for each patient and monitoring infection rates.
A team of researchers from the University of Michigan and the Veterans Affairs Ann Arbor Health System has demonstrated that simple measures might be all it takes to push back at the spread of Multi-drug resistant organisms or ‘superbugs’ in nursing homes as well as reduce infections. In their study of patients with indwelling devices, MDROs were reduced by 23 percent among 418 residents in six southeast Michigan nursing homes who participated over the course of the three-year study. The numbers of catheter-associated urinary tract infections and MRSA acquisitions also decreased, 46 percent and 22 percent respectively.
The trial examined the relationship between acquisition of antimicrobial resistance among nursing home and assisted living facility residents with the use of devices by adapting new methodological approaches and study designs to study infection prevention interventions including the use of cluster-randomized study design for infection prevention interventions, adopting adult learning practices to engage frontline healthcare personnel and using multi-anatomic site sampling to demonstrate effectiveness of the program.
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MedicalResearch.com Interview with:
Stephen W. Waldo, MD
Research Fellow in MedicineMassachusetts General Hospital
MedicalResearch: What is the background for this study? What are the main findings?Dr. Waldo: Public reporting is intended to improve outcomes for our patients. Proponents of public reporting applaud the increased transparency that it offers, allowing both patients and physicians to objectively evaluate health care outcomes for a given institution or individual provider. Previous research has demonstrated, however, that public reporting of procedural outcomes may create disincentives to provide percutaneous coronary intervention for critically ill patients. The present study sought to evaluate the association between public reporting of outcomes with procedural management and clinical outcomes among patients with acute myocardial infarction. As the data demonstrate, public reporting of outcomes is associated with a lower rate of percutaneous revascularization and increased overall in-hospital mortality among patients with an acute myocardial infarction, particularly among those that do not receive percutaneous intervention. This may reflect risk aversion among physicians in states that participate in public reporting, an unintended consequence of this policy.
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MedicalResearch.com Interview with:
Raffaele Bugiardini, M.D.
Professor of Cardiology
University of Bologna
Medical Research: What is the background for this study? What are the main findings?
Dr. Bugiardini: Our analysis differs from previous reports of outcomes following STEMI because prior studies have not looked at sex differences in outcomes adjusted for time from symptom onset to hospital presentation and subsequent utilization of cardiac revascularization procedures, and rates of revascularization are typically significantly lower in women compared with men
Our study is the first to look at the relationship between delays and outcomes. (more…)
MedicalResearch.com Interview with:
Jagpreet Chhatwal Ph.D.
Assistant Professor, Department of Health Services Research
Division of Cancer Prevention and Population Sciences
The University of Texas MD Anderson Center
Houston, TX
Medical Research: What is the background for this study? What are the main findings?
Dr. Chhatwal: More than two million people in the U.S. are infected with Hepatitis C (HCV), a virus found in the liver. In 2012, the Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force both recommended a one-time hepatitis C screening for baby boomers – people born between the years 1946 and 1964. Last year, the Food and Drug Administration approved the medications sofosbuvir and ledipasvir for Hepatitis C treatment. The newly approved oral regimen comes at a staggering price to payers – as much as $1,125 per day. As a result, several payers have questioned if the price is justified.
The study results show that using new therapies is cost-effective in the majority of patients. However, the budget required to treat all eligible patients would be $136 billion over the next five years. Compared with the old drugs, new therapies would cost an additional $65 billion, whereas the cost offsets would be only $16 billion.
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MedicalResearch.com Interview with: Pam R. Taub, MD, FACC
Assistant Professor of Medicine
UC San Diego Health System
Division of Cardiology Encinitas, CA 92024
Medical Research: What is the background for this study?Dr. Taub: Epidemiological studies indicate that the consumption of modest amounts of dark chocolate (DC), which contains the natural cacao flavanol (-)-epicatechin (Epi,) is associated with reductions in the incidence of cardiovascular diseases (CVD). The health benefits of dark chocolate have been attributed to Epi. Clinical studies using cocoa and/or DC in normal volunteers or subjects with CVD have reported improvements in peripheral and coronary vascular endothelial function, blood pressure, lipids, insulin resistance, and inflammatory markers. The mechanism underlying these improvements is thought to be due to increased nitric oxide levels and improved endothelial function. We have also shown that capacity of Epi to favorable impact mitochondria under normal and disease states.
We previously conducted pilot study in five patients with heart failure and type II diabetes, and showed that in skeletal muscle (SkM) biopsies there is a severe reduction in mitochondrial volume and cristae, as well as, in structural/functional proteins. After treatment with Epi rich dark chocolate , there was a significant recovery of SkM mitochondrial cristae, structural/functional proteins (e.g. mitofilin), as well as in regulators of mitochondrial biogenesis. However, no studies have examined the capacity of Epi rich dark chocolate to enhance exercise capacity in normal subjects and assess its impact on mitochondrial and oxidative control systems.
Medical Research: What are the main findings?Dr. Taub: Seventeen subjects were randomized to placebo (n=8) or DC groups (n=9) and consumed 2 squares of chocolate (20 g, provided by Hershey) for 3 months.
We showed in the chocolate group subjects had improved levels of HDL cholesterol and enhanced exercise capacity that is linked to the stimulation of SkM metabolic control endpoints which enhance mitochondrial function.
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MedicalResearch.com Interview with: Jaspreet Ahuja, Nutritionist
USDA, Agricultural Research Service
Nutrient Data Laboratory
Beltsville, MD 20705
MedicalResearch: What is the background for this study? What are the main findings? Response: Most sodium in the U.S. diet comes from commercially processed and restaurant foods. Sodium reduction in these foods is key to several recent public health efforts. In this paper, we provide an overview of a program led by Nutrient Data Laboratory, USDA, in partnership with CDC and FDA to monitor sodium contents in commercially processed and restaurant foods in United States.
We track about 125 highly consumed, sodium-contributing foods, termed “Sentinel Foods” annually using information from food manufacturers and periodically by nationwide sampling and laboratory analyses. In addition, we monitor over 1,100 other commercially processed and restaurant food items, termed “Priority-2 Foods,” biennially using information from food manufacturers. These foods serve as indicators for assessing changes in the sodium content of commercially processed and restaurant foods in the U.S. In addition to sodium, we are monitoring related nutrients (potassium, total dietary fiber, total and saturated fat, total sugar) because their levels may change when manufacturers and restaurants reformulate their products to reduce their sodium content.
We sampled all Sentinel Foods nationwide and reviewed all Priority-2 Foods in 2010–2013 to determine baseline sodium concentrations. The results of sodium reduction efforts, based on re-sampling of the Sentinel Foods or re-review of P2Fs, will become available in 2015 on our website. The updated data are also released in USDA food composition databases, National Nutrient Database for Standard Reference and Food and Nutrient Database for Dietary Studies.
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Prof Samir R Kapadia MD Director, Sones Cardiac Catheterization Laboratories
Cleveland Clinic Cleveland, OH
For patients with severe symptomatic aortic stenosis (AS) who are not candidates for surgical valve replacement, transcatheter aortic valve replacement (TAVR) offers superior benefit to standard therapy, as measured by all-cause mortality, cardiovascular mortality, repeat hospital admission and functional status. PARTNER 1B 5 year data were published simultaneously with PARTNER 1A 5 year data in 2 separate manuscripts in the Lancet (March 15 2105).
In this landmark trial, TAVR produced a 22 percent survival benefit and a 28 percent reduced risk of cardiovascular mortality, compared with standard treatment.
According to Cleveland Clinic interventional cardiologist Samir Kapadia, MD, lead author of PARTNER 1B, these findings have changed the treatment paradigm for severe Aortic Stenosis patients who can’t undergo surgical Aortic Valve Replacement.
“This trial is the first—and will probably be the only—randomized AS trial that includes a standard treatment group, since these results will make it unethical to treat severe AS patients with medical therapy alone without aortic valve replacement. ” he says.
Superior survival benefit with TAVR
PARTNER 1B is the only rigorous randomized trial of extreme-risk aortic stenosis patients that has prospectively reported the outcomes of TAVR versus standard treatment in patients for whom the estimated probability of death or serious irreversible morbidity after surgical aortic valve replacement was 50 percent or greater.
The trial enrolled 358 patients between May 11, 2007 and March 16, 2009; 179 patients were assigned to TAVR with the first-generation Sapien valve and 179 to standard therapy which includes medical therapy and balloon aortic valvuloplasty. TAVR was performed under general anesthesia with common femoral artery access. Guidance was provided by transesophagel echocardiography and fluoroscopy. The mean age of participants was 83.
The primary endpoint was all-cause survival. Secondary endpoints included cardiovascular mortality, stroke, vascular complications, major bleeding and functional status.
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MedicalResearch.com Interview with:
Stella Yi, Ph.D., MPH, Assistant Professor
Department of Population Health
New York University School of Medicine
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Yi: Self-blood pressure monitoring has been shown to be an effective tool for improving blood pressure control, however most studies have only included white race participants. We were interested in assessing whether distribution of self-blood pressure monitors (intervention) would improve blood pressure and hypertension control over usual care (control) in a 9-month period in a predominantly Hispanic, uninsured population. Systolic blood pressure improved over time in both the intervention (n=409) and the control (n=419) arms by 14.7 mm Hg and 14.1 mm Hg, respectively, as did hypertension control; 39% of study participants overall achieved control at the end of follow-up. However there were no statistical differences between the outcomes in the intervention and usual care groups. (more…)
MedicalResearch.com Interview with:
Elizabeth Burns, MPH
Rollins School of Public Health
Emory University
MedicalResearch: What is the background for this study? What are the main findings?Response: Epidemiologic studies suggest that prenatal stress is associated with preterm birth, low birth weight and peripartum anxiety and depressive symptoms. The most recent population-based study on the prevalence of stress among pregnant women, which used data from 1990-1995, reported that 64% of women experience stressful life events (SLEs) in the year before their infant’s birth. More recent estimates of prevalence and trends of prenatal stressful life events are useful for clinicians in order to understand the risk profile of their patients.
The Pregnancy Risk Assessment Monitoring System (PRAMS) collects self-reported information on maternal experiences and behaviors before, during, and after pregnancy among women who delivered a live infant. PRAMS includes 13 questions about maternal SLEs experienced in the year preceding the birth of the child. Based on previous research, SLEs were grouped into four dichotomous constructs:
1) emotional stressors (family member was ill and hospitalized or someone very close died);
2) financial stressors (moved to a new address, lost job, partner lost job, or unable to pay bills);
3) partner-associated stressors (separated/divorced, argued more than usual with partner/husband, or husband/partner said he did not want pregnancy); and
4) traumatic stressors (homeless, involved in a physical fight, partner or self-went to jail, or someone very close had a problem with drinking or drugs).
The prevalence of self-reported stressful life events decreased modestly but significantly during 2000–2010. Despite this, 70.2% of women reported ≥1 SLEs in 2010. Prevalence of stressful life events vary by state and maternal demographic characteristics and are especially prevalent among younger women, women with ≤12 years of education (75.6%), unmarried women (79.6%), and women that were covered by Medicaid for prenatal care or delivery of their child (78.7%).
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MedicalResearch.com Interview with:
Miia Kivipelto MD, PhD, Professor
Deputy Head, Senior Geriatrician
Aging Research Center and Alzheimer Disease Research Center
Karolinska Institutet Clinical Trials Unit, Memory Clinic
Karolinska University Hospital Stockholm, Sweden
Medical Research: What is the background for this study? What are the main findings?
Dr. Kivipelto: Epidemiological studies have linked several modifiable risk factors to cognitive impairment and dementia but evidence from randomized controlled trials (RCT) has been lacking showing the efficacy of the interventions. Because cognitive impairment, dementia and Alzheimer’s disease are complex, multi-factorial disorders, multidomain interventions targeting several risk factors and disease mechanisms simultaneously could be needed for optimum preventive effect. The FINGER study is the first large, long-term RCT indicating that multi-domain intervention can improve and maintain cognitive functioning in at risk elderly people from the general population. We observed a significant intervention effects on the primary outcome (overall cognition), main secondary outcomes (executive functioning and processing speed) as well as on complex memory tasks and risk of cognitive decline. The multidomain lifestyle intervention was feasible and safe.
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MedicalResearch.com Interview with:
Danil Makarov, MD Lead Investigator
Assistant Professor, Departments of Urology, Population Health and Health Policy
Member, Laura and Isaac Perlmutter Cancer Center
NYU Langone Medical Center, New York, NY
Medical Research: What is the background for this study?
Dr. Makarov: The background for this study is that regional variation in patterns of care and healthcare spending is widely known. The drivers of this regional variation, though, are poorly understood. Certain policy groups like the IOM have suggested that policy efforts be focused on individual providers and patients. Programs such as Choosing Wisely, which encourage a dialogue between physicians and patients, are a great example of such efforts. However, some of our prior research suggests that regional variation is not random and that there might be are regional-level factors which drive variation.
To test out our hypothesis, we wanted to see whether inappropriate imaging for two unrelated cancers was associated at a regional level (it should not be).
Medical Research: What are the main findings?
Dr. Makarov: We found that, at a regional level, inappropriate breast cancer imaging was associated with inappropriate prostate cancer imaging.
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MedicalResearch.com Interview with:
Elizabeth M. Widen, PhD, RD
Postdoctoral Fellow in the Institute of Human Nutrition & Department of Epidemiology
Columbia University
Mailman School...
MedicalResearch.com Interview with:
James Scheiman, M.D.
Professor of Gastroenterology
University of Michigan Medical School
Medical Research: What is the background for this study? What...
MedicalResearch.com Interview with:
Prof. Moshe Szyf Ph.D.
James McGill Professor of Pharmacology and Therapeutics
McGill University
Medical Research: What is the background for this study? What are the main findings?Dr. Szyf: Humans exhibit a marked variation in traits both physical and behavioral and different susceptibilities for developing disease. What causes this inter-individual variation? The prevailing dogma has been that changes in the sequences of genes or heritable genetic differences are responsible for these differences. We tested here an alternative hypothesis that perhaps some of the reason for this natural variation in traits is not caused by differences in inherited genes but by “epigenetic” changes that alter the way genes work without changing the genes. The main difference between genetic and epigenetic changes is that epigenetic changes could be introduced by experience and exposure to environment. The experiences that can cause epigenetic changes include physical as well as social environments. Although we had known that epigenetic differences occur in humans and animals we didn’t have evidence that these changes are behind the natural variation in traits that is observed in humans and animals. Ants are an exciting biological paradigm that exhibits quantitative variations in size and therefore provided a unique opportunity to test this hypothesis.
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MedicalResearch.com Interview with: Leslie Curry PhD, MPH
Senior Research Scientist in and Lecturer in Public Health (Health Policy)
Co-Director, Robert Wood Johnson Clinical Scholars Program
Yale School of Public Health
Medical Research: What is the background for this study? What are the main findings?
Dr. Curry: Quality of care for patients with acute myocardial infarction (AMI) has improved substantially in recent years due to important investments by clinicians and policymakers; however, survival rates across U.S. Hospitals still differ greatly. Evidence suggests links between hospital organizational culture and hospital performance in care of patients with AMI. Yet few studies have attempted to shift organizational culture in order to improve performance, fewer have focused on patient outcomes, and none have addressed mortality for patients with acute myocardial infarction. We sought to address this gap through a novel longitudinal intervention study, Leadership Saves Lives (LSL). We have a large team of people with backgrounds in nursing, medicine, health care administration and research working in 10 very diverse hospitals across the country in 10 states. All hospitals are members of the Mayo Clinic Care Network and are fully committed to saving lives of patients with heart attacks. Teams of 10-12 clinicians and administrators are devoting substantial energy, expertise and good will to this project.
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MedicalResearch.com Interview with:Marc Ellsworth, M.D
Neonatology fellow at the
Mayo Clinic Children’s Center
MedicalResearch: What is the background for this study? Dr. Ellsworth: Inhaled Nitric Oxide (iNO) is a drug that has FDA approval for use in neonates >34 weeks gestational age. It is used for severe respiratory failure secondary to pulmonary hypertension. However, it has been previously shown that neonatologists have been using this medication off-label and especially in the most premature neonates. Over the last 10 years there have been multiple large studies trying to determine a clinical use (ie long term benefit) for iNO in preterm neonates (patients where there is no FDA approval for iNO use currently). Despite evidence of short term benefit (improved clinical stability) use of this drug has not been shown to improve long-term outcomes (death and chronic lung disease) in premature neonates. As a result of these findings the National Institute of Child Health and Human Development (NICHD) released a consensus guideline in 2011 indicated that available evidence did not support the routine use of iNO in preterm neonates and discouraged this use of this expensive therapy in preterm neonates. Similarly, in 2014 the American Academy of Pediatrics issued a similar statement with similar recommendations.
In 2014 a group of NICUs (collectively called the Neonatal Research Network) associated with the NICHD published a report showing that the use of Inhaled Nitric Oxide in preterm infants (ie off-label) decreased following the report in 2011.
However, I did not feel that these NICUs were representative of the United States alone as the Neonatal Research Network consists of only a handful of NICUs (~15) and is directly associated with the NICHD. As a result I wanted to get a better idea of Inhaled Nitric Oxide use in a population based study to see if the trends were similar (ie use of iNO has been decreasing) on a much larger, more representative scale. (Editorial comment: My anecdotal experience was that rates of iNO use off-label have not decreased in preterm neonates since the 2011 report).
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MedicalResearch.com Interview with:
Hallie Prescott, MD, MSc
Clinical Lecturer, Internal Medicine
Division of Pulmonary & Critical Care Medicine
University of Michigan Health System
Ann Arbor, MI 48109-2800
Medical Research: What is the background for this study? What are the main findings?
Dr. Prescott: The post-hospital period has been widely recognized as a vulnerable time for patients. In particular, patients who survive sepsis are frequently readmitted to the hospital in the following three months.
In this study, we examined data from 2,600 survivors of sepsis, a severe infection that leads to organ failure. About 42% of the sepsis patients were readmitted in the next 90 days, similar to the rate seen for patients hospitalized for other acute conditions.
However, the reasons for hospital readmission after sepsis are different. A greater number of patients are re-hospitalized for “ambulatory-care sensitive conditions”, which are conditions that could potentially be prevented or treated early in the outpatient setting to avoid a hospital stay.
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MedicalResearch.com Interview with:
Professor Jane A. Mitchell
Head of Vascular Biology Section
Head of Cardiothoracic Pharmacology
National Heart and Lung Institute,
Institute of Cardiovascular Medicine & Science,
Imperial College, London
Medical Research: What is the background for this study? What are the main findings?Response: In 2006 a drug called TGN1412 was given to 6 healthy male volunteers as a final test for safety. The drug had passed all of the preclinical tests and showed no problem when it was given to laboratory animals. However when it was given to people it caused a catastrophic side effect known as a ‘cytokine storm response’. All 6 volunteers became sick very quickly and needed immediate hospital treatment, they nearly died and remain at risk of immune problems still. We found a way to mimic the effects of TGN1412 in the laboratory using stem cell technology to engineer two different types of cells from the same donor to be grown and mixed together in a dish. Our test is better than the current tests used because it mimics better the human body and uses cells from one individual donor.
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MedicalResearch.com Interview with:
Michael L. Eisenberg, M.D.
Director, Male Reproductive Medicine and Surgery
Assistant Professor
Department of Urology
Stanford University School of Medicine
Medical Research: What is the background for this study? What are the main findings?
Dr. Eisenberg: There has been growing data that a man's overall health may impact his fertility. As such, we wanted to explore this link using the NICHD LIFE Study which has the unique ability to account for both health and work exposure in men with both normal and abnormal fertility. We found that certain aspects of a man's work and health can impact his semen parameters.
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MedicalResearch.com Interview with:
Dr. Pina Violano, RN, PhD
Trauma Department, Yale-New Haven Hospital,
Injury Free Coalition for Kids of New Haven
Yale-New Haven Children’s Hospital
New Haven 06510, CT
MedicalResearch: What is the background for this study? Dr. Violano: In July of 2012, Connecticut became one of the first states to enact legislation to ensure the safety and appropriate evaluation and management of sports-related concussions (SRC) among High School students. SRCs are a common occurrence in high school sports with their diagnosis increasing over the last decade. While the exact reasons are not known, public health campaign efforts and education may have facilitated improvement in the evaluation and detection of sports-related concussions and may have contributed to increase awareness and treatment.
MedicalResearch: What are the main findings?Dr. Violano: Evaluation of two emergency department records revealed a marked increase in the frequency of high school student athletes being treated for sports-related concussions after the implementation of Connecticut’s SRC law. This suggests that Connecticut’s legislation is effective in improving the evaluation and detection of sports-related concussions in high school students.
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Medicalresearch.com Interview with:
Dr. Clarice R. Weinberg Ph.D
Biostatistics and Computational Biology Branch
National Institute of Environmental Health Sciences
Research Triangle Park, NC 27709
MedicalResearch: What is the background for this study?Dr. Weinberg: Hormone therapy (HT) was commonly prescribed in the U.S. late in the 20th century to help women through the challenges of menopause. Several decades ago, therapy with estrogen alone was shown to cause endometrial cancer, and the combined use of both estrogen and progesterone replaced treatment with estrogen alone. But research published around 2002 had far reaching effects on gynecologic practice. Both the randomized trial component of the US Women’s Health Initiative and the observational European Million Women’s Study reported that postmenopausal women who were older than 50 and were taking the combination HT had an increased risk of breast cancer. Physicians and patients responded quickly, and Hormone therapy use plummeted.
However, it remained unclear whether there were risks of Hormone therapy use in women under age 50. Some factors, for example obesity, have opposite effects on the risk of breast cancer in pre- and post-menopausal women, so one cannot assume risk findings from older women necessarily apply to younger women. We carried out a sibling-based study of 1,419 women with breast cancer diagnosed under the age of 50 (http://sisterstudy.niehs.nih.gov/English/2sis.htm). Each case had a sister (also studied) who had never been diagnosed with breast cancer, who could serve as her control. The study was funded by Susan G. Komen for the Cure, and the National Institutes of Health.
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MedicalResearch.com Interview with:
Dr. Jennifer Adibi, MPH ScD
University of Pittsburgh, Public HealthAssistant Professor, Epidemiology
Assistant Professor, Department of Obstetrics/Gynecology and Reproductive Sciences
Affiliate, Dept. of ObGYN and Reproductive Sciences
University of California, San Francisco
Medical Research: What is the background for this study?
Dr. Adibi: Prenatal exposure to phthalates in rodents can cause defects in male sexual development including a shorter distance between the anus and the genitalia (anogenital distance or AGD). Human studies have shown a correlation between higher prenatal phthalate urinary concentrations in the mother and shorter AGD in males. AGD in males is related to fertility and reproductive health over the lifetime. In females, AGD was associated with numbers of ovarian follicles. The role of the placenta has not been considered in these studies. A placental hormone called human chorionic gonadotropin (hCG) is essential for normal male development. Our previous research has shown that hCG expression by human placental cells is disrupted by phthalate concentrations equal to what we measured in maternal urine. The placenta secretes molecules early in pregnancy that might provide an opportunity to detect these effects in humans.
Medical Research: What are the main findings?Dr. Adibi: In 350 pregnancies, we measured a significant association of maternal urinary concentrations of mono-n-butyl phthalate (MnBP) and monobenzyl phthalate (MBzP) with hCG in maternal blood in the first trimester. Higher phthalate concentrations were associated with higher hCG if the mother was carrying a female fetus, and lower concentrations if she was carrying a male fetus. In a high/low MnBP comparison, hCG was 15-fold higher in the higher exposed female fetuses. We also observed a relationship between maternal levels of hCG in the first trimester and anogenital distance in the newborns. The correlation was positive in female newborns, and inverse in male newborns. Similar to the parent study, we observed associations of higher first trimester MnBP and mono-2-ethyl hexyl phthalate (MEHP) with lower male anogenital distance. If we combined these findings into a mediation analysis, we estimated that approximately 20-30% of the phthalate-induced effect on anogenital distance was due to the phthalate disruption of hCG.
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MedicalResearch.com Interview with:
Sripal Bangalore, MD, MHA, FACC, FAHA, FSCAI
Director of Research, Cardiac Catheterization Laboratory,
Director, Cardiovascular Outcomes Group,
Associate Professor of Medicine,
New York University School of Medicine,
New York, NY 10016
Medical Research: What is the background for this study? What are the main findings?
Dr. Bangalore: Prior studies have shown a mortality benefit of bypass surgery over stenting. But these studies compared bypass surgery with older generation stents which are no longer used. We used data from the New York state registry of patients who underwent stenting or bypass surgery for 2 or more blockages of coronary arteries. With data from over 18,000 patients we found that there was no difference between stenting and bypass surgery for long term mortality. In addition we found that both procedures have trade offs. Bypass surgery has upfront risk of death and stroke whereas PCI has long term risk of needing a repeat procedure. In addition, in patients who underwent incomplete revascularization, there was increase in myocardial infarction with PCI.
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