MedicalResearch.com Interview with:
Dr.Stacy Loeb, MD, MSc
Department of Urology, Population Health,
and Laura and Isaac Perlmutter Cancer Center
New York University, New YorkMedical Research: What is the background for this study?
Dr. Loeb: A paper published last year suggested a relationship between use of (Viagra) and melanoma. That study had only 142 cases of melanoma, and of these men 14 had used sildenafil. This study got a lot of publicity leading numerous patients to express concern over whether erectile dysfunction drugs could cause melanoma.
Our goal was to look more closely at this issue in a larger population from Sweden (including 4065 melanoma cases of whom 435 used any type of erectile dysfunction drug- Viagra, as well as Levitra and Cialis). Sweden has a national health system so we were able to access prescription records for men across the entire country, which we linked to the national registries for melanoma and basal cell skin cancer. (more…)
MedicalResearch.com Interview with:
Sean D. Pokorney, MD, MBA
Division of Cardiology, Duke University Medical Center
Duke Clinical Research Institute, Durham, North Carolina
Medical Research: What is the background for this study?
Dr. Pokorney: About 350,000 people die of sudden cardiac death in the US each year. Patients who have weakened heart function, particularly those with heart muscle damage as a result of a heart attack, are more likely to experience sudden cardiac death. Defibrillators have been around since the 1980s, and have prolonged countless lives. A previous study showed that 87% of patients who had a cardiac arrest were eligible for an implantable-cardioverter defibrillator (ICD) beforehand but did not get an ICD implanted prior to their arrest. The timing of ICD implantation is critical, as studies have not found a benefit to ICD implantation early after myocardial infarction (MI). Guidelines recommend primary prevention ICD implantation in patients with an EF ≤ 35% despite being treated with optimal medical therapy for at least 40 days after an MI. Given the need to wait for at least 40 days after an MI, ICD consideration is susceptible to errors of omission during the transition of post-MI care between inpatient and outpatient care teams. Also, the benefit of ICDs remains controversial among older patients, as these patients were underrepresented in clinical trials.
Medical Research: What are the main findings?Dr. Pokorney: We looked at Medicare patients discharged from US hospitals after a heart attack between 2007 and 2010. We focused on those patients who had weak heart function, and this left us with a little over 10,300 patients from 441 hospitals for our study. This was an older patient population with a median age of 78 years. We looked to see how many of these patients got an ICD within the first year after MI, and how many patients survived to 2 years after their heart attack. Only 8% of patients received an ICD within 1 year of their heart attack. ICD implantation was associated with a third lower risk of death within 2 years after a heart attack, and this was consistent with the benefit that were seen in the randomized clinical trials. Importantly, 44% of the patients in our study were over 80 years old, and we found that the relationship between ICD use and mortality was the same for patients over and under age 80 years. Increased patient contact with the health care system through early cardiology follow-up or re-hospitalization for heart failure or MI was associated with higher likelihood of ICD implantation. Rates of ICD implantation remained around 1 in 10 patients within 1 year of MI even among patients with the largest heart attacks and the weakest hearts (lowest ejection fractions), who were least likely to have improvement in their heart function over time. Similarly, even after excluding patients at highest risk for non-arrhythmic death (prior cancer, prior stroke, and end stage renal disease), ICD implantation rates remained around 1 in 10 patients.
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MedicalResearch.com Interview with:
Dan Dongeun Huh, Ph.D.
Wilf Family Term Chair & Assistant Professor
Department of Bioengineering
University of Pennsylvania
Philadelphia, PA 19104
Medical Research: What is the background for this study? What are the main findings?
Response: The placenta is a temporary organ central to pregnancy and serves as a major interface that tightly regulates transport of various endogenous and exogenous materials between mother and fetus. The placental barrier consisting of the closely apposed trophoblast epithelium and fetal capillary endothelium is responsible for maintaining this critical physiological function, and its dysfunction leads to adverse pregnancy outcomes. Despite its importance, barrier function of the placenta has been extremely challenging to study due to a lack of surrogate models that faithfully recapitulate the key features of the placental barrier in humans. Our study aims to directly address this long-standing technical challenge by providing a microengineered in vitro system that replicates architecture, microenvironment, and physiological function of the human placenta barrier. This “placenta-on-a-chip” device consists of microfabricated upper and lower cell culture chambers separated by a thin semipermeable membrane, and the placental barrier is generated by culturing human trophoblasts and fetal endothelial cells on either side of the membrane with steady flows of culture media in both chambers. This microfluidic cell culture condition allowed the cells to form confluent monolayers on the membrane surface and to create a bi-layer tissue that resembled the placental barrier in vivo. Moreover, the microengineered barrier enabled transport of glucose from the maternal chamber to the fetal compartment at physiological rates.
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MedicalResearch.com Interview with:Satoru Kishi, MD
Division of Cardiology
Johns Hopkins University
Baltimore, Maryland
MedicalResearch: What is the background for this study? What are the main findings?Dr. Kishi: Blood pressure (BP) at the higher end of the population distribution may represent a chronic exposure that produces chronic injury to the cardiovascular system. Cumulative BP exposure from young adulthood to middle age may adversely influence myocardial function and predispose individuals to heart failure (HF) and other cardiovascular disease (CVD) later in life. The 2005 guidelines for the diagnosis and treatment of HF from the American College of Cardiology and American Heart Association highlight the importance of early recognition of subclinical cardiac disease and the importance of non-invasive tests in the clinical evaluation of heart failure.
Our main objective was to investigate how cumulative exposure to high blood pressure from young to middle adulthood influence LV function. In the Coronary Artery Risk Development in Young Adults (CARDIA) study, multiple repeated measures of BP and other cardiovascular risk factors was recorded over a 25 year time span, starting during early adulthood (ages 18-30). (more…)
MedicalResearch.com Interview with:
Lois K. Lee, MD, MPH
Division of Emergency Medicine
Boston Children's Hospital
Boston, MA 02115
Medical Research: What is the background for this study? What are the main findings?Response: Motor vehicle crashes remain a leading cause of death for children and adults in the U.S. Seat belts are the single most effective protective device to decreased death and mitigate injuries in the event of a motor vehicle crash. Our study found that states with primary seat belt laws, where a motorist can be ticketed only for not wearing a seat belt, demonstrated a 17% decreased fatality rate, compared to states with secondary seat belt laws, where a motorist must be cited for another violation first before also getting ticketed for not wearing a seat belt. We found this difference was robust even after controlling for other motor vehicle safety legislation and state demographic factors. We found that although seatbelts prevent deaths, they don't completely stop injury so if you have been in an accident that wasn't your fault then you might want to look for a place like the Parnall Law Firm to see if they can help you get compensation for your injuries. (more…)
MedicalResearch.com Interview with:
Dr. Alexander Golberg Ph.D.
Center for Engineering in Medicine
Department of Surgery, Massachusetts General Hospital
Harvard Medical School, and Shriners Burns Hospital
Boston, MA, 02114
Porter School of Environmental Studies
Tel Aviv University, Israel
MedicalResearch: What is the background for this study? What are the main findings?Dr. Golberg: Well, the population grows and becomes older. Degenerative skin diseases affect one third of individuals over the age of sixty. Current therapies use various physical and chemical methods to rejuvenate skin; but since the therapies affect many tissue components including cells and extracellular matrix, they may also induce significant side effects, such as scarring.
We report on a new, non-invasive, non-thermal technique to rejuvenate skin with pulsed electric fields. The fields destroy cells while simultaneously completely preserving the extracellular matrix architecture and releasing multiple growth factors locally that induce new cells and tissue growth. We have identified the specific pulsed electric field parameters in rats that lead to prominent proliferation of the epidermis, formation of microvasculature, and secretion of new collagen at treated areas without scarring. Our results suggest that pulsed electric fields can improve skin function and thus can potentially serve as a novel non-invasive skin therapy for multiple degenerative skin diseases.
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MedicalResearch.com Interview with:
Brooke Bozick
Ph.D. Candidate
Population Biology, Ecology, & Evolution Program
Emory University
MedicalResearch: What is the background for this study? Response: Previous research at the global scale has shown that air travel is important for the spread of disease. For example, much work has focused on the recent Ebola epidemic in Africa, identifying where this disease emerged and then using air travel networks to predict the path of spread from there.
At a more local scale, other modes of transportation may be more important to structuring pathogen populations. We were interested in investigating seasonal influenza in the United States. Previous research has shown that once the winter influenza epidemic starts, it spreads very rapidly across the continental states, suggesting that the US may act as one large, well-mixed population. Previous work using genetic data to look for spatial structure at this scale didn’t identify any patterns. However, these studies used geographic proximity to define the distance between states; we wanted to see whether similar patterns existed at this spatial scale if we instead used movement data as a proxy for the distance between locations. Commuter movements have previously been shown to correlate with influenza timing and spread based on influenza-like-illness and mortality data.
MedicalResearch: What are the main findings?Response: We found that spatial structure is detectable within the US. We used data on the genetic distance between sequences collected from different states and compared that to different measures of ‘distance’ between states—geographic proximity, the daily number of people flying between states and the daily number of commuters traveling between states using ground transportation—to see whether any correlations were present. Further, we did this for two different subtypes of seasonal influenza: A/H3N2 and A/H1N1. These subtypes have different epidemiological properties, so there was reason to believe that the observed patterns might differ depending on subtype.
We found that some correlations were present for all the distance metrics studied, but that they were observed a greater proportion of the time when looking at commuter movements, and when looking at the A/H1N1 subtype. Since A/H1N1 is generally milder and spreads more slowly throughout the US compared to A/H3N2, we interpret this to mean that spatial structure is likely more easily detected in this subtype. If A/H3N2 spreads rapidly from coast to coast, any signature of spatial structure is likely obscured before we have a chance to observe it.
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MedicalResearch.com Interview with:Vinay Prasad, MD, MPH
Medical Oncology Service, National Cancer Institute
National Institutes of Health
Bethesda, Maryland MedicalResearch: What is the background for this study? What are the main findings?Dr. Prasad: In medicine, there are two types of endpoints: clinical endpoints and surrogate endpoints. Clinical endpoints, such as survival or quality of life, measure how a patient, feels, functions or lives. In contrast, a surrogate endpoint is not a measure of patient benefit. Instead, it is merely hoped to correlate with one. LDL levels are a surrogate for cardiovascular risk, for instance.
Oncologists use and trust surrogate endpoints, such as response rate, progression free survival and disease free survival. The majority of drug approvals and many guideline recommendations are based on improvements in surrogates. Surrogates are assumed to correlate with overall survival, but we wanted to know if this was true, and under what circumstances.
We reviewed all well done studies of surrogate-survival association. We found that the majority--especially in the setting of metastatic disease--found a poor correlation between a surrogate and survival. In fact, correlations were strong in only a handful of settings, such as adjuvant colorectal cancer. Moreover, we found that correlations were always based on a subset of potentially informative literature, even when authors surveyed unpublished trials. Missing data in these association studies raises the concern that correlations would be different if all data had been considered.
Our overall conclusion was that most surrogate-survival correlations in oncology are based on weak evidence and are poor.
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MedicalResearch.com Interview with:
Leslee L. Subak, MD
University of California, San Francisco
Professor, Departments of Obstetrics, Gynecology & Reproductive Sciences, Urology and Epidemiology & Biostatistics
Chief of Gynecology, SF Veterans Affairs Medical Center
UCSF Women's Health Clinical Research Center
MedicalResearch: What is the background for this study? What are the main findings?Dr. Subak: Urinary incontinence is very common, affecting an estimated 30 million adults in the U.S., and may account for as much as $60 billion in annual medical costs. Incontinence can cause significant distress, limitations in daily functioning, and reduced quality of life. Obesity is an important risk factor, with each 5-unit increase in body mass index – a ratio of someone’s weight divided by the square of their height – above normal weight associated with far higher rates of incontinence. The prevalence of incontinence has been reported to be as high as 70 percent among severely obese women, and 24 percent among severely obese men (BMI greater than 40, or more than about 100 pounds greater than ideal body weight).
Since obesity is a risk factor for incontinence, several studies have examined whether weight loss is a treatment for incontinence among obese people with the condition. Clinical trials have shown the low calorie diets, behavioral weight reduction, and bariatric surgery are associated with improvement in incontinence in obese women and men through one year, but evidence on the durability of this effect is lacking.
We performed this study to examine changes in urinary incontinence and identify factors associated with improvement among women and men in the first 3 years following bariatric surgery.
This study included 1987women and men in the Longitudinal Assessment of Bariatric Surgery-2 (LABS-2) study performed at 10 hospitals at 6 clinical centers in the U.S. who underwent bariatric surgery between 2005 and 2009. The study participants ranged in age from 18 to 78 years old – the median age was 47. The analysis controlled for factors such as age, race, smoking status and recent pregnancy. Nearly 79 percent of the participants in the study were women with 49% reporting at least weekly incontinence, compared with 2% of men reporting incontinence.
Following surgery and large weight loss of 29% for women and 26% for men, substantial improvements in incontinence were observed, with a majority of women and men achieving remission at 3 years post-surgery. The more weight lost, the higher the chances of improvement. While the risk of relapse rose with each gain of about 10 pounds, overall there was substantial improvement for both women and men. People who were older, had severe walking limitations or were recently pregnant showed less improvement.
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MedicalResearch.com Interview with:
Isabelle Bedrosian, M.D., F.A.C.S.
Associate Professor, Department of Surgical Oncology, Division of Surgery,
Medical Director, Nellie B. Connelly Breast Center
The University of Texas MD Anderson Cancer Center, Houston, TX
Medical Research: What is the background for this study? What are the main findings?Dr. Bedrosian: There have been a number of reports on the rates of Breast Conserving Therapy (BCT) and mastectomy among women with early stage breast cancer. These reports have been discordant, with some suggesting that index mastectomy rates have increased and others suggestion Breast Conserving Therapy rates have actually increased. We hypothesized that these differences in reporting may be due to data source (ie tertiary referral centers vs population based studies) and turned to the NCDB, which captures 70% of cancer cases in the US and as such provides us with the most comprehensive overview on patient treatment patterns.
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MedicalResearch.com Interview with:Mr. Angus Turnbull
Imperial College School of Medicine,
London UK
Medical Research: What is the background for this study? What are the main findings?
Mr. Turnbull: Autopsy has been used to advance medical knowledge and understanding of pathological processes for millennia but increasing evidence indicates its decline in the UK and elsewhere. This study not only confirms that but suggests autopsy for learning purposes has almost disappeared.
In the United Kingdom autopsy is divided into medico-legal autopsy (that required by law under the jurisdiction of HM Coroner) and consented autopsy (performed with the consent of the bereaved or their family). Over the past half-century, small single site studies have noted a marked decline in consented autopsy rates, however there has been no study for over 20 years to determine the extent of the decline nationwide.
This study examined all acute NHS Trusts within England, NHS Boards in Scotland and Wales and Social Care Trusts in Northern Ireland. We found that the average autopsy rate (the percentage of adult inpatient deaths which under go consented autopsy) in the United Kingdom in 2013 was only 0.7%. The study showed that in nearly a quarter (23%) of all NHS Trusts in the United Kingdom, consented autopsy is now extinct.
These findings may have implications for training, for research and for learning from mortality – a key aspect of patient safety. (more…)
MedicalResearch.com Interview with:
Stella Yi, PhD, MPH
New York University Langone School of Medicine,
Department of Population Health
New York, NY 10016
MedicalResearch: What is the background for this study? What are the main findings?Dr. Yi: Sedentary behaviors, such as sitting time, are an emerging risk factor in the field of physical activity epidemiology. Recent studies have demonstrated the negative health consequences associated with extended sitting time, including metabolic disturbances and decreased life expectancy independent of the effects of regular exercise.
We also assessed mean values of self-reported sitting time to characterize these behaviors in a diverse, urban sample of adults. The average New York City resident sits more than seven hours a day—greatly exceeding the three hours or more per day that is associated with decreased life expectancy.
Among the findings:
At the lower economic end, individuals spent 6.3 hours per day sitting, while those with higher incomes spent 8.2 hours per day sitting
College graduates spent 8.2 hours per day sitting, compared with 5.5 hours per day for those with less than a high school education
Whites spent on average 7.8 hours per day sitting, African Americans spent 7.4 hours sitting, Hispanics spent 5.4 hours sitting, and Asian Americans spent 7.9 hours per day sitting
Sitting time was highest in Manhattan, compared to other boroughs.
In the current analysis, we also assessed the validity of a two-question survey method of sitting time during waking hours using accelerometers to measure sedentary time in a subsample of our study participants. The correlation between sitting time reported in the survey and accelerometer-measured sedentary time was modest (r=0.32, p<0.01) with wide limits of agreement. We interpreted this to mean that while self-reported sitting might be useful at the population-level to provide rankings and subgroups, it may be limited in assessing an individual’s actual behavior.
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MedicalResearch.com Interview with:
Dr. Ken Uchino, MD
Cleveland Clinic Main Campus
Cleveland, OH 44195
Medical Research: What is the background for this study? What are the main findings?
Dr. Uchino: Stroke center designation started in 2003 and more hospitals have been certified as primary stroke centers over time. We asked the question how many are certified now? What are the characteristics of the hospitals that are certified?
In 2013, nearly a third (23%) of acute short-term adult general hospitals with emergency departments were certified as stroke centers. 74% of the stroke centers were certified by the Joint Commission, a non-profit organization that certifies health care facilities and programs. 20% were certified by state health departments. States varied in percentages of hospitals that were certified, ranging from 4% in Wyoming to 100% in Delaware.
Not unexpectedly larger hospitals and hospitals in urban locations were more likely to be certified as stroke centers.
But a hospital being located in a state with so-called “stroke legislation” more than tripled the chance of being a certified stroke centers, even accounting for other factors. These states passed legislation to promote stroke centers and mandated stroke patients to be preferentially transported to qualified hospitals.
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MedicalResearch.com Interview with:
Daniel E. Freedberg, MD, MS
Assistant Professor of Medicine
Division of Digestive and Liver Diseases
Columbia University, New York
Medical Research: What is the background for this study?
Dr. Freedberg: Acid suppression medications are increasingly prescribed to relatively healthy children without clear indications, but the side effects of these medications are uncertain.
Medical Research: What are the main findings?
Dr. Freedberg: Acid suppression with (proton pump inhibitors ) PPIs or (histamine-2 receptor antagonists) H2RAs was associated with increased risk for C. diff infection in both infants and older children.
Medical Research: What should clinicians and patients take away from your report?Dr. Freedberg: Increased risk for C. diff should be factored into the decision to use acid suppression medications in children. Our findings imply that acid suppression medications alter the bacterial composition of the lower gastrointestinal tract.
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MedicalResearch.com Interview with:
Deborah S. Hasin, Ph.D.
Professor of Epidemiology
Columbia University
New York, New York 10032
MedicalResearch: What is the background for this study? What are the main findings?Dr. Hasin: The background for the study was the need to identify the causes of the marked increase in marijuana use among U.S. adolescents over the last several years, given that early adolescent marijuana use leads to a number of adverse health and psychosocial consequences, including cognitive decline, into adulthood.
We had two main findings from the study:
A comparison of the rates of adolescent marijuana use between states that ever passed a medical marijuana law and those that did not revealed that states with such laws had higher rates of teen marijuana use, regardless of when they passed the law; and
When we compared the rates of teen marijuana use in these states before and after passage of the laws, we did not find a post-passage increase in the rates of teen marijuana use. This suggests that some common factor may be causing both the laws to be passed and the teens to be more likely to smoke marijuana in the states that passed these laws.
MedicalResearch.com Interview with:
William S. Yancy, Jr., MD, MHSc
Research Associate
Center for Health Services Research in Primary Care
Durham, NC 27705
Associate Professor Department of Medicine
Duke University Medical Center
Medical Research: What is the background for this study? What are the main findings?
Dr. Yancy: A number of studies have compared different diet approaches for weight management with many of these finding that several different diets can result in significant weight loss. This has led many experts to advise that we should offer a choice among these diet options to our patients who are seeking to lose weight. We know that adherence is the best predictor of weight loss during dietary interventions, so the thought is that patients will adhere better to a diet that they prefer, resulting in more successful weight loss. In addition, allowing choice enhances patient autonomy, which is patient-centered and has been shown to increase treatment adherence. However, the previous studies of various diet approaches did not let people choose a diet, so we don’t actually know if letting them choose will lead to better weight loss. Our study specifically tested this assumption. We randomized participants to a condition where they were allowed to choose between 2 common weight loss diets or to a condition where they were randomly assigned to one of the diets. The 2 diets we used were a low-carbohydrate diet without calorie restriction and a low-fat diet combined with calorie restriction. Participants received counseling about the diets, and about behavioral strategies and physical activity, in 19 group sessions over the span of 12 months. They also received 6 phone calls with motivational counseling in the latter half of the program.
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MedicalResearch.com Interview with:
Eric Jonasch, MDAssociate Professor Department of Genitourinary Medical Oncology
University of Texas MD Anderson Cancer Center
Houston, TX
and
Dr. Thai H. Ho, MD Ph.D.
Department of Oncology
Mayo Clinic Scottsdale Arizona
Medical Research: What is the background for this study? What are the main findings?
Response: The blueprints of a cell are encoded in DNA strands (its genome) which are highly compressed in order to fit into a tiny cell. The reading (called the epigenome) of these DNA ‘blueprints’ determines whether that cell will develop into a kidney cell or another type of cell. However, in cancer, errors occur either in the blueprints themselves or the cell makes mistakes in reading the blueprints. Cancers of the kidney affect more than 61,000 patients annually and over 13,000 patients die annually, making it one of the top 10 leading causes of cancer deaths. Studies have revealed that mutations occur in genes that regulate how our DNA ‘blueprints’ are compacted in greater than >50% of kidney cancers, making these genes as a group the most frequently mutated. In our study, we identified that these errors that initially arise in an early kidney cancer lead to propagation of these same errors in metastases, a phenomenon in which the cancer has spread to another organ and is a major cause of death. Furthermore, we generated a detailed map of these epigenomic changes in patient-derived tumors.
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MedicalResearch.com Interview with:
Ron Postuma, MD, MSc
Associate Professor
Department of Neurology
Montreal General Hospital
Montreal, Quebec
Medical Research: What is the background for this study? What are the main findings?Dr. Postuma: The background is that we often think about Parkinson’s Disease as a single disease. However, every clinician knows that there is a great deal of variability from patient to patient. If we can understand the main aspects that separate patients into groups, we can target therapy better.
The analysis used a semi-automated means to divide Parkinson’s patients into groups, using extensive information about motor and non-motor aspects of disease. We found that the non-motor symptoms, especially cognition, sleep disorders, and blood pressure changes were the most powerful predictors of which group a patient would be in. Based on these non-motor (and some motor aspects), the most accurate way to divide patients was into three groups - diffuse (many non-motor symptoms), pure motor, and intermediate (halfway between the other). We then followed patients over time. The diffuse group had, by far, the worse prognosis. This was not only for the non-motor aspects, but the motor as well. (more…)
MedicalResearch.com Interview with:Susan Schwab, PhD
Assistant professor at NYU Langone
Skirball Institute of Biomolecular Medicine
Medical Research: What is the background for this study? What are the main findings?Dr. Schwab: T cell acute lymphoblastic leukemia (T-ALL) remains a devastating pediatric disease. Roughly 20% of children do not respond to current therapies. Furthermore, metastasis to the central nervous system is common in T-ALL, and intrathecal chemotherapy, even when successful at eradicating the cancer, causes serious long-term cognitive side-effects.
Here we report that the chemokine receptor CXCR4 is essential for T cell acute lymphoblastic leukemia progression in both mouse and human xenograft models of disease. Consistent with sustained disease remission in the absence of CXCR4, loss of CXCR4 signaling results in decreased levels of c-Myc, which is required for leukemia initiating cell activity. T-ALL cells reside near cells generating the CXCR4 ligand CXCL12 in the bone marrow, and our data suggest that vascular endothelial cells may be an important part of the T-ALL niche.
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MedicalResearch.com Interview with:
Eric T. Roberts and Darrell Gaskin
Johns Hopkins University Bloomberg School of Public Health
Baltimore, MDMedical Research: What is the background for this study? What are the main findings?
Response: This study looked at the implications of the Affordable Care Act’s expansion of Medicaid on the need for additional physicians working in primary care. Since 2014, 11 million low-income adults have signed up for Medicaid, and this figure will likely increase as more states participate in the expansion. Many new Medicaid enrollees lacked comprehensive health insurance before, and will be in need of primary and preventive care when their Medicaid coverage begins. In light of these questions, in this study, we projected the number of primary care providers that are needed to provide care for newly-enrolled adults.
We forecast that, if all states expand Medicaid, newly-enrolled adults will make 6.1 million additional provider visits per year. This translates into a need for 2,100 additional full time-equivalent primary care providers. We conclude that this need for additional providers is manageable, particularly if Congress fully funds key primary care workforce training programs, such as the National Health Service Corps. (more…)
MedicalResearch.com Interview with:Raghavan Murugan MD, MS, FRCP, FCCP
Associate Professor of Critical Care Medicine and Clinical and Translational Science
Core Faculty, Center for Critical Care Nephrology, CRISMA Center,
John Kellum, MD
Professor and Vice Chair for Research
Director, Bioengineering and Organ Support Program, CRISMA Center
Director, Center for Assistance in Research using eRecord (CARe)
Department of Critical Care Medicine
University of Pittsburgh Pittsburgh, PA
Medical Research: What is the background for this study? What are the main findings?Response: In our prior studies, we found that nearly one-half of critically ill patients in the intensive care unit who receive dialysis die by 2 months after acute illness and more than one-third of surviving patients are dialysis dependent. We sought to examine whether simple patient characteristics and inflammatory biomarkers predicted death and non-recovery of kidney function after severe acute kidney injury.
We found that a combination of four simple and readily available patient characteristics including older age, lower mean arterial pressure, need for mechanical ventilation, and higher serum bilirubin levels predicted death and dialysis dependence. Higher plasma concentration of interleukin (IL)-8 in combination with the clinical characteristics also increased risk prediction. To our knowledge, this study is the first large study to examine risk prediction for outcomes after severe acute kidney injury using a panel of biomarkers in a large cohort of critically ill patients receiving dialysis.
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MedicalResearch.com Interview with:
Wei Zheng, MD, PhD, Professor of Medicine
Anne Potter Wilson Chair in Medicine
Director, Vanderbilt Epidemiology Center and
Danxia Yu, PhD Research Fellow
Vanderbilt Epidemiology Center
Vanderbilt University School of Medicine
Nashville, TN, 37203
Medical Research: What is the background for this study? What are the main findings?Response: The Dietary Guidelines for Americans (DGA) provide the most authoritative advice in the US about healthy eating. Higher adherence to the DGA, reflected by a higher Healthy Eating Index (HEI) score, has been found to be associated with lower risk of developing or dying from chronic diseases (e.g. diabetes, cardiovascular disease, and certain cancers) in several US studies. However, these studies recruited mostly non-Hispanic white individuals and middle to high income Americans. It has been reported that racial/ethnical background and socioeconomic status may influence food choices and diet quality. However, no previous study has adequately evaluated the association between adherence to the DGA and risk of death due to diseases in racial/ethnical minorities and low-income Americans. Therefore, it is uncertain whether the health benefits of adherence to the current DGA can be generalized to these underserved populations.
We analyzed diet and mortality data from the Southern Community Cohort Study (SCCS), a large, prospective cohort study including approximately 85,000 American adults, 40-79 years old, enrolled from 12 southeastern states between 2002 and 2009. Two-thirds of the SCCS participants were African-American and more than half reported an annual household income <$15,000.
During a mean follow-up of 6.2 years, we identified 6,906 deaths in the SCCS, including 2,244 from cardiovascular disease, 1,794 from cancer, and 2,550 from other diseases. Using multivariate analysis methods, we found that participants in the top 20% of the HEI score (highest adherence to the DGA) had only about 80% of the risk of death due to any diseases compared with those in the bottom 20% of the HEI score. This protective association was found regardless of sex, race and income levels.
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MedicalResearch.com Interview with:Neetika Garg, MD
Fellow in Nephrology
Beth Israel Deaconess Medical Center
Division of Nephrology, Department of Medicine
Boston, MA 02215
MedicalResearch: What is the background for this study? What are the main findings?Dr. Garg: One in every three Americans suffers from hypertension. Since high blood pressure (BP) frequently does not cause any symptoms, self-blood pressure monitoring at home and patient education are critical components of patient management. With more than 58% of the US adults owning a smartphone, mobile-based health technologies (most commonly in the form of applications or “apps”) can serve as useful adjuncts in diagnosis and management of hypertension. At the same time, several smartphone-based applications are advertised as having blood pressure measurement functionality, which have not been validated against a gold standard. In this cross-sectional study, we analyzed the top 107 hypertension related apps available on the most popular smartphone platforms (Google Android and Apple iPhone) to analyze the functional characteristics and consumer interaction metrics of various hypertension related apps.
Nearly three-quarters of the apps record and track blood pressure, heart rate, salt intake, caloric intake and weight/body mass index. These app features can facilitate patient participation in hypertension management, medication adherence and patient-physician communication. However, it was concerning to find that 6.5% of the apps analyzed could transform the smartphone into a cuffless BP measuring device. None of these had any documentations of validation against a gold standard. Furthermore, number of downloads and favorable user ratings were significantly higher for these apps compared to apps without blood pressure measurement function. This highlights the need for greater oversight and regulation in medical device development.
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MedicalResearch.com Interview with:
Frank C. Brosius, MD
Professor, Internal Medicine and Physiology
Chief, Division of Nephrology
University of Michigan Ann Arbor, MI
Dr. Matthias Kretzler MD
Professor, Internal Medicine
Research Professor, Computational Medicine and Biology
University of Michigan Ann Arbor, MI
Katherine R. Tuttle MD
Clinical Professor of Medicine, Division of Nephrology
Medical & Scientific Director, Providence Medical Research Center/Sacred Heart Center
Professor of Basic Medical Sciences, WWAMI Program
Washington State University
Medical Research: What is the background for this study?
Response: Our University of Michigan team had found that JAK-STAT gene expression was increased in kidneys in patients with diabetic kidney disease and that these changes correlated with progression of kidney disease. We subsequently substantiated these changes in other studies and have found that by increasing expression of just one of these genes, JAK2, in a single kidney cell type (podocytes) in mice that we can make their diabetic kidney disease much worse.
At around the same time, investigators at Eli Lilly and Co. had FDA approval to test a JAK1-2 inhibitor, baricitinib, in patients with rheumatoid arthritis. The Lilly scientists saw our human results and thought about using baricitinib in patients with diabetic kidney disease. After initial discussions with Dr. Kretzler and myself they concluded that there was good reason to move ahead with this study and just 14 months after the initial meeting the phase 2 clinical trial of baricitinib in the treatment of patients with diabetic kidney disease was initiated.
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MedicalResearch.com Interview with:
Dr. Ahmad Haidar Ph.D
Division of Experimental Medicine, Department of Medicine
McGill University, Montreal, QC, Canada
Medical Research: What is the background for this study? What are the main findings?
Dr. Haidar: This is the first head-to-head-to-head comparison in outpatient setting of dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional pump therapy in children and adolescents with type 1 diabetes.
The main finding is that the dual-hormone artificial pancreas seems to outperform the other two systems in reducing nocturnal hypoglycemia in camp settings when the patients are very physically active during the day.
Medical Research: What should clinicians and patients take away from your report?Dr. Haidar: Glucagon has the potential to reduce nocturnal hypoglycemia if added to the artificial pancreas. However, this needs to be confirmed in larger and longer studies as the single-hormone artificial pancreas might be sufficient in home settings (this study was conducted at a camp, which is an environment different that home).
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MedicalResearch.com Interview with:
Aileen Gariepy, MD, MPH
Assistant Professor Section of Family Planning
Department of Obstetrics, Gynecology, and Reproductive Sciences
Yale School of Medicine
New Haven, CT
Medical Research: What is the background for this study? What are the main findings?
Dr.Gariepy: Women who have just given birth are often highly motivated to prevent a rapid, repeat pregnancy. For women who desire the contraceptive implant, a highly effective reversible form of contraception that is placed in the arm and can last for 3 years, new research shows that it is more cost-effective to place the implant while women are still in the hospital after giving birth, compared to delaying insertion to the postpartum visit 6-8 weeks later which is currently the most common practice.
When the costs associated with the implant insertion and the costs of unintended pregnancy are compared in women who receive immediate contraceptive implant insertion (while still in the hospital after giving birth) to women who are asked to come back in 6-8 weeks for the implant insertion (delayed insertion), immediate insertion is expected to save $1,263 per patient. Based on these estimates, for every 1,000 women using postpartum implant, immediate placement is expected to avert 191 unintended pregnancies and save $1,263,000 compared with delayed insertion in the first year. Cost savings would continue to increase for the second and third year after insertion.
In fact, over half of U.S. pregnancies are unintended. Maternal and infant care costs for unintended pregnancies amount to $11.1 billion annually for public insurance programs alone. The immediate postpartum period (after delivery but before discharge home) provides an ideal opportunity for initiating contraceptives as patients are motivated and timing is convenient.
However, the majority of insurance company policies do not provide coverage for insertion of the contraceptive implant when the new mother is still in the hospital. This lack of reimbursement is the most significant barrier to providing this highly effective contraceptive method for women who have just delivered a baby. Surprisingly, the reason most insurance companies do not offer reimbursement for immediate insertion is due to an outdated insurance protocol, “the global obstetric fee” which precludes separate reimbursement of individual procedures (like inserting the implant).
The main reason that immediate insertion results in cost savings is because more women will get the implant compared to a strategy of delayed insertion. Women can get pregnant again within 4 weeks of delivering a baby. Starting contraception as soon as possible after giving birth is important because most women will resume sexual activity before their postpartum office visit and therefore will be at risk of pregnancy. And approximately 35% of women do not return for a postpartum visit.
Even for women who want another pregnancy soon, the implant has benefits. When women conceive and deliver a baby within 2 years of last giving birth, there is a significantly higher risk of poor maternal and neonatal outcomes, including preterm birth, low birth weight, and even early neonatal and maternal death. Birth spacing is better for moms and babies.
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MedicalResearch.com Interview with:
Joseph A. Ladapo, MD, PhD
Assistant Professor of Medicine
Section on Value and Effectiveness
Department of Population Health
NYU Langone School of Medicine
Medical Research: What is the background for this study? What are the main findings?
Dr. Ladapo: Routine tests before elective surgery are largely considered to be of low value, and they may also increase costs. In an attempt to discourage their use, two professional societies released guidance on use of routine preoperative testing in 2002. We sought to examine the long-term national effect of these guidelines from the American College of Cardiology/American Heart Association and the American Society of Anesthesiologists on physicians' use of routine preoperative testing. While we found that overall rates of routine testing declined across several categories over the 14-year study period, these changes were not significant after accounting for overall changes in physicians’ ordering practices. Our findings suggest that professional guidance aimed at improving quality and reducing waste has had little effect on physician or hospital practice.
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MedicalResearch.com Interview with:
Kristina H. Lewis, MD, MPH, SM
Kaiser Permanente Georgia, Center for Clinical and Outcomes Research, Atlanta
Department of Population Medicine
Harvard Medical School/Harvard...
MedicalResearch.com Interview with:
Nicholas Tatonetti, PhD
Department of Biomedical Informatics
Department of Systems Biology, Department of Medicine
Columbia University
New York, NY
Medical Research: What is the background for this study? What are the main findings?
Dr. Tatonetti: For decades, researchers have studied the link between disease incidence and the seasons. We’ve known, for example, that those born when the dust mite population is highest (summer) will have an increased chance of developing asthma. Traditionally, diseases have been studied one at a time to identify these seasonal trends. Because of the rapid adoption of electronic health records, it is now possible to study thousands of diseases, simultaneously. That is what we did in this study. We evaluated over 1,600 diseases and discovered 55 that showed this seasonal trend. Many of these had been studied previously, but several are new discoveries — most prominently, we found that the lifetime risk of developing cardiovascular disease is highest for those born in the spring.
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MedicalResearch.com Interview with:
Jordan M. Cloyd, MD
Department of Surgery
Stanford University
Stanford, California
Medical Research: What is the background for this study? What are the main findings?
Dr. Cloyd: The motivation for the study was that, anecdotally, we had noticed that several of our patients who had been discharged on a weekend required readmission for potentially preventable reasons. We wanted to investigate whether the data supported the idea that weekend discharge was associated with a higher risk of hospital readmission.
(more…)
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MedicalResearch.com Interview with:
Dr. Stacy Loeb, MD, MSc
Department of Urology, Population Health,
and Laura and Isaac Perlmutter Cancer Center
New York University, New York
Medical Research: What is the background for this study?
Dr. Loeb: A paper published last year suggested a relationship between use of (Viagra) and melanoma. That study had only 142 cases of melanoma, and of these men 14 had used sildenafil. This study got a lot of publicity leading numerous patients to express concern over whether erectile dysfunction drugs could cause melanoma.
Our goal was to look more closely at this issue in a larger population from Sweden (including 4065 melanoma cases of whom 435 used any type of erectile dysfunction drug- Viagra, as well as Levitra and Cialis). Sweden has a national health system so we were able to access prescription records for men across the entire country, which we linked to the national registries for melanoma and basal cell skin cancer. (more…)
