Even After Rebates, Use of PCSK9 Inhibitor Would Still Cost Over $5 Million To Prevent One Stroke

MedicalResearch.com Interview with:

Inmaculada Hernandez, PharmD, PhD Assistant Professor of Pharmacy and Therapeutics University of Pittsburgh School of Pharmacy Pittsburgh, PA 1526

Dr. Hernandez

Inmaculada Hernandez, PharmD, PhD
Assistant Professor of Pharmacy and Therapeutics
University of Pittsburgh School of Pharmacy
Pittsburgh, PA 1526

MedicalResearch.com: What is the background for this study?

Response: A few months ago, the results of the FOURIER trial were published. This trial was the first one to evaluate the efficacy of PCSK9 inhibitors in the prevention of cardiovascular events, since the approval of these agents was based on trials that evaluated their efficacy in reducing levels of LDL-C. The results of the FOURIER trial did not meet the expectations generated by prior studies that had simulated how much the risk of cardiovascular events should decrease based on the observed reduction in LDL-C levels. A few hours after the publication of the results of the FOURIER trial, Amgen (evolocumab´s manufacturer) announced that it would be willing to engage in contracts where the cost of evolocumab would be refunded for those patients who suffer a heart attack or a stroke while using the drug.

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Cardiovascular Fat in Women at Midlife Varies By Race and Body Shape

MedicalResearch.com Interview with:

Samar R. El Khoudary, PhD, MPH, BPharm, FAHA Associate Professor, Epidemiology PITT Public Health Epidemiology Data Center University of Pittsburgh Pittsburgh, PA 15260 

Dr. El Khoudary

Samar REl KhoudaryPhDMPH, BPharm, FAHA
Associate Professor, Epidemiology
PITT Public Health
Epidemiology Data Center
University of Pittsburgh
Pittsburgh, PA 15260  

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Heart fat is associated with greater coronary heart disease risk. Postmenopausal women have greater heart fat volumes than premenopausal women, and the association between specific heart fat depots and calcification in the coronary arteries is more pronounced after menopause. Race, central adiposity, and visceral adiposity are important factors that could impact heart fat volumes.

We evaluated whether racial differences in heart fat volumes and in their associations with central (abdominal visceral fat) and general adiposity (as measured by body mass index [BMI]) exist in midlife women. Our study included 524 women from the Study of Women’s Health Across the Nation (SWAN) (mean age: 51 years; 62% White and 38% Black) who had data on heart fat volumes, abdominal visceral fat and BMI.

After accounting for the potential health effects of lifestyle and socioeconomic factors we found that midlife Black women had less heart fat volumes than white women and not surprisingly, the more fat a women carries overall, the higher her risk for a fatty heart. However, white women with higher BMI had significantly more heart fat, as measured by a CT scan, than black women with the same BMI. For black women, the levels of heart fat were greater if they carried more fat in their midsection, as measured by a cross-sectional CT scan, compared with white women with the same volume of fat in their midsection. The results echo the findings we have reported previously in midlife men and published at the International Journal of Obesity (2015) 39, 488–494.
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Physician Assistants and Nurse Practitioners Are Increasingly Providing Specialty Care

MedicalResearch.com Interview with:

Kristin Ray, MD, MS</strong> Assistant Professor Health Policy Institute University of Pittsburgh School of Medicine

Dr. Ray

Kristin Ray, MD, MS
Assistant Professor
Health Policy Institute
University of Pittsburgh School of Medicine

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We were interested in understanding how nurse practitioners and physician assistants are working with specialist physicians to provide specialty care. Much has been described and studied about nurse practitioners and physician assistants providing primary care, but the literature about their role in specialty care is more sparse. There have been many concerns over time about the supply of specialist physicians, heightening our interest in the role of nurse practitioners and physician assistants in working with specialist physicians.

We focused on examining whether care to physician specialist’s patients by nurse practitioners and physician assistants has increased over time as well as examining characteristics of patients seen by nurse practitioners and physician assistants.

We found that visits with NPs and PAs for specialty care have increased over time, but remains a small fraction of specialty care overall.

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Rory’s Regulations: Faster Is Better When It Comes To Sepsis Care

MedicalResearch.com Interview with:

Christopher W. Seymour, M.D., M.Sc. Assistant professor of Critical Care Medicine and Emergency Medicine, and member of Clinical Research Investigation and Systems Modeling of Acute Illness University of Pittsburgh

Dr. Seymour

Christopher W. Seymour, M.D., M.Sc.
Assistant professor of Critical Care Medicine and Emergency Medicine, and member of Clinical Research Investigation and Systems Modeling of Acute Illness
University of Pittsburgh

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Following the tragic and widely publicized death of Rory Staunton, 12, from undiagnosed sepsis in 2012, New York became the first state to require that hospitals follow a protocol to quickly identify and treat the condition. The mandate led to widespread controversy in the medical community as to whether such steps would have saved Rory or anyone else’s life.

Rory’s Regulations require hospitals to follow protocols for early identification and treatment of sepsis, and submit data on compliance and outcomes. The hospitals can tailor how they implement the protocols, but must include a blood culture to test for infection, measurement of blood lactate (a sign of tissue stress) and administration of antibiotics within three hours of diagnosis—collectively known as the “three-hour bundle.”

We analyzed data from nearly 50,000 patients from 149 New York hospitals to scientifically determine if  Rory’s Regulations worked. We found that they did – 83 percent of the hospitals completed the bundle within the required three hours, overall averaging 1.3 hours for completion. For every hour that it took clinicians to complete the bundle, the odds of the patient dying increased by 4 percent.

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Paracardial Fat Linked To Postmenopausal Coronary Artery Calcification

MedicalResearch.com Interview with:

Samar R. El Khoudary, Ph.D., M.P.H. Assistant professor Department of Epidemiology University of Pittsburgh Graduate School of Public Health

Dr. El Khoudary,

Samar R. El Khoudary, Ph.D., M.P.H.
Assistant professor
Department of Epidemiology
University of Pittsburgh Graduate School of Public Health

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Our study revealed a previously unknown, menopause-specific indicator of heart disease risk. For the first time, we’ve pinpointed the type of heart fat, linked it to a risk factor for heart disease and shown that menopausal status and estrogen levels are critical modifying factors of its associated risk in women.

My team evaluated clinical data, including blood samples and heart CT scans, on 478 women from Pittsburgh and Chicago enrolled in the Study of Women’s Health Across the Nation (SWAN). The women were in varying stages of menopause, averaged 51 years old and were not on hormone replacement therapy.

In a previous study, we showed that a greater volume of paracardial fat, but not epicardial fat, after menopause is associated with a decline in the sex hormone estradiol—the most potent estrogen—in women. The higher volume of epicardial fat was tied to other risk factors, such as obesity.

In the new study, we built on those findings to discover that not only is a greater paracardial fat volume specific to menopause, but—in postmenopausal women and women with lower levels of estradiol—it’s also associated with a greater risk of coronary artery calcification, an early sign of heart disease that is measured with a heart CT scan.

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Poor Kids More Likely To Have More Than One Chronic Health Condition

MedicalResearch.com Interview with:

Christian D. Pulcini, MD, MEd, MPH Pediatric Resident, Children's Hospital of Pittsburgh of UPMC Chair, Section on Pediatric Trainees (SOPT) American Academy of Pediatrics

Dr. Christian Pulcini

Christian D. Pulcini, MD, MEd, MPH
Pediatric Resident
Children’s Hospital of Pittsburgh of UPMC
Chair, Section on Pediatric Trainees (SOPT)
American Academy of Pediatrics

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Poverty influences the well-being of children and adolescents in a negative way. Poor children are often exposed to toxic health stressors, including violence, environmental toxins, and inadequate nutrition. Children in poverty with chronic health conditions also are more likely to have higher rates of secondary disorders and worse outcomes. We studied children with asthma, attention-deficit/hyperactivity disorder (ADHD), and autism spectrum disorder (ASD), to describe the how much disease and if the children had multiple (comorbid) conditons and how these vary by poverty status.

Parents reported through the National Survey of Children’s Health that asthma and ADHD rose 18% and 44% from 2003-2011/2012, respectively, whereas the lifetime prevalence of ASD rose 32% from 2007-2011/2012 in all income levels. For asthma, the rise was most among the poor at 25.8%. For ADHD, the percent change among the poor was similar, however the rise in autism spectrum disorder was associated with being non-poor. Publicly insured children with asthma, ADHD, and ASD also had a significant higher chance (1.9×, 1.6×, 3.0×, respectively) of having higher more than one chronic condition. In addition, kids who were poor with asthma and ADHD.
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Majority of Neurologists Report Symptoms of Burnout

MedicalResearch.com Interview with:

Neil A. Busis, M.D. University of Pittsburgh Physicians Department of Neurology Chief of Neurology, UPMC Shadyside Director of Community Neurology

Dr. Neil A. Busis

Neil A. Busis, M.D.
University of Pittsburgh Physicians
Department of Neurology
Chief of Neurology, UPMC Shadyside
Director of Community Neurology

MedicalResearch.com: What is the background for this study?

Response: Previous studies showed that neurologists have both one of the highest rates of burnout and the lowest rates of satisfaction with work-life balance, compared to other physicians.

The mission of the American Academy of Neurology (AAN) is to promote the highest quality patient-centered neurologic care and enhance member career satisfaction. This is why AAN President Dr. Terrence Cascino initiated this research, to better define the issue. Our findings can guide current and future programs to prevent and mitigate neurologist burnout, promote neurologist career satisfaction and well-being, and direct efforts to advocate on behalf of neurologists and their patients.

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Sepsis Linked To High Rate of Hospital Readmissions

MedicalResearch.com Interview with:

Sachin Yende, M.D., M.S., Associate professor University of Pittsburgh School of Medicine’s departments of Critical Care Medicine and Clinical and Translational and Vice president of Critical Care at the VA Pittsburgh.

Dr. Yende

Sachin Yende, M.D., M.S., Associate professor
University of Pittsburgh School of Medicine’s departments of
Critical Care Medicine and Clinical and Translational and
Vice president of Critical Care at the VA Pittsburgh.

Florian B. Mayr, M.D., M.P.H. Faculty member in University of Pittsburgh Department of Critical Care Medicine and the Center for Health Equity Research and Promotion

Dr. Mayr

Florian B. Mayr, M.D., M.P.H.
Faculty member in University of Pittsburgh
Department of Critical Care Medicine and the
Center for Health Equity Research and Promotion

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The Centers for Medicare and Medicaid Services and the Veteran Health Administration currently track readmission rates for pneumonia, acute heart attacks, heart failure and chronic obstructive lung disease for quality purposes and pay for performance. In our study, we were able to demonstrate that unplanned readmissions after sepsis (defined as life threatening organ failure due to the body’s response to an overwhelming infection) are more common than readmission for these other conditions stated above and associated with significant excess costs.

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How Do Tattoo Artists Handle Moles?

MedicalResearch.com Interview with:

Westley Mori, fourth-year medical student (MSIV) University of Pittsburgh Medical School

Westley Mori

Westley Mori, fourth-year medical student (MSIV)
University of Pittsburgh Medical School

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Tattooed skin represents an important diagnostic challenge for the dermatologist performing a skin cancer screening. Several case reports have described melanoma being hidden in tattoos.

To our knowledge, our study is the first of its kind investigating the approach of the tattoo artist to skin with melanocytic nevi (moles) or other skin lesions. We found that the approach to tattooing skin spots is highly variable, with some artists tattooing around moles and others simply tattooing over them.

The final cosmetic outcome—not the potential for skin cancer—is often the paramount concern for artists. Those artists with a personal or family history of skin cancer were more likely to refuse inking over a skin spot and recommend the client see a dermatologist.

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Access To Two Different Health Care Systems Can Lead To Dangerous Presciption Combinations

MedicalResearch.com Interview with:

Dr-Joshua-M-Thorpe.jpg

Dr. Joshua Thorpe

Joshua M. Thorpe, PhD, MPH
From the Center for Health Equity Research and Promotion
Veterans Affairs Pittsburgh Healthcare System
Pittsburgh Pennsylvania, and
Center for Health Services Research in Primary Care
Department of Pharmacy and Therapeutics
University of Pittsburgh School of Pharmacy

MedicalResearch.com: What is the background for this study?

Response: Care coordination for persons with dementia is challenging for health care systems under the best of circumstances. These coordination challenges are exacerbated in Medicare-eligible veterans who receive care through both Medicare and the Department of Veterans Affairs (VA). Recent Medicare and VA policy changes (e.g., Medicare Part D, Veteran’s Choice Act) expand veterans’ access to providers outside the VA. While access to care may be improved, seeking care across multiple health systems may disrupt care coordination and increase the risk of unsafe prescribing – particularly in veterans with dementia. To see how expanded access to care outside the VA might influence medication safety for veterans with dementia, we studied prescribing safety in Veterans who qualified for prescriptions through the VA as well as through the Medicare Part D drug benefit.

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Frailty Screening Can Predict Postoperative Survival

MedicalResearch.com Interview with:

Daniel E. Hall, MD, MDiv, MHSc, FACS Associate Professor of Surgery University of Pittsburgh Staff Surgeon VA Pittsburgh Healthcare System Core Investigator VA Center for Health Equity Research and Promotion. PIttsburgh, PA

Dr. Daniel E. Hall

Daniel E. Hall, MD, MDiv, MHSc, FACS
Associate Professor of Surgery
University of Pittsburgh Staff Surgeon
VA Pittsburgh Healthcare System Core Investigator
VA Center for Health Equity Research and Promotion.
PIttsburgh, PA

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: A growing body of research demonstrates that frailty is a more powerful predictor of postoperative outcomes than risk-prediction models based on age or comorbidity alone. However, it has not been clear if surgeons could intervene on frailty to improve outcomes.

This study reports what we believe to be the first ever demonstration that it is not only feasible to screen an entire health system for frailty, but that it is possible to act on that information to improve outcomes. Every patient evaluated for elective surgery was screened for frailty with a brief tool that takes 1-2 minutes to complete. Those identified as potentially frail and thus at greater risk for poor surgical outcomes received an ad-hoc administrative review aimed at optimizing perioperative care. After implementing the frailty screening initiative, we observed a 3-fold increase in long-term survival at 6 and 12 months—even after controlling for age, frailty, and predicted mortality.

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Palliative Care Linked To Fewer Symptoms and Better Quality of Life

MedicalResearch.com Interview with:

Dr. Dio Kavalieratos, PhD Assistant Professor of Medicine Section of Palliative Care and Medical Ethics Division of General Medicine Institute of Clinical Research University of Pittsburgh

Dr. Dio Kavalieratos

Dr. Dio Kavalieratos, PhD
Assistant Professor of Medicine
Section of Palliative Care and Medical Ethics
Division of General Medicine
Institute of Clinical Research
University of Pittsburgh

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The field of palliative care has seen a dramatic surge in research and clinical implementation over the past decade. The last systematic review of palliative care trials was published in 2008. In that review, the authors reported very weak evidence for palliative care, as well as major methodological limitations in the trials that had been done to date. Since then, several landmark trials have been published, some with very compelling findings such increased survival. Therefore, an up-to-date review was in order.

There also had not previously been enough trials to perform a meta-analysis. A meta-analysis is the statistical process of combining the results of multiple trials, which gives you an overall effect for an intervention, in this case, palliative care. We were able to conduct the first meta-analysis of the effect of palliative care with three important outcomes: patient quality of life, patient symptom burden, and patient survival.

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Genotyping and 3D Imaging Help Identify Genes That Influence Facial Appearance

MedicalResearch.com Interview with:

Seth M. Weinberg, PhD

Dr. Seth Weinberg

Seth M. Weinberg, PhD
Assistant Professor, Department of Oral Biology
Assistant Professor, Department of Anthropology
Director, CCDG Imaging and Morphometrics Lab

MedicalResearch.com: What is the background for this study?

Response: Scientists have long recognized that aspects of facial appearance have a genetic basis. This is most obvious when we look at the faces of people in the same family.  It is also well known that mutations in certain genes can result in syndromes where the face is affected.  However, very little is known about how specific genes influence the size and shape of normal human facial features.  To date, only a handful of studies have looked at this question, and while these studies have reported several interesting results, only a small number of genes have so far been linked to normal variation in facial features.  The primary goal of our study was to test for evidence of association between detailed facial measures derived from 3D images and common genetic variants spread across the entire genome.  We also attempted to independently replicate some of the findings from previous studies.

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Menopausal Hot Flashes Can Start Younger and Last For Years

MedicalResearch.com Interview with:

Rebecca Thurston, Ph.D. Professor in the University of Pittsburgh Department of Psychiatry and Epidemiologist at the University of Pittsburgh Graduate School of Public Health.

Dr. Rebecca Clark-Thurston

Rebecca Thurston, Ph.D.
Professor, University of Pittsburgh Department of Psychiatry and
Epidemiologist, University of Pittsburgh
Graduate School of Public Health

MedicalResearch.com: What is the background for this study?

Response: Vasomotor symptoms – or hot flashes and night sweats – are the “classic” symptom of the menopause transition. Most women will get vasomotor symptoms, yet there have been striking gaps in our knowledge about them, including what their natural history is. The traditional thinking has been that vasomotor symptoms last a few years around the final menstrual period for most women. However, in this and several other papers we have debunked this myth.

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Physical Activity Linked To Significant Decrease in Diabetes Incidence

MedicalResearch.com Interview with:

Dr-Andrea-M-KriskaDr. Andrea M. Kriska PhD MS
Professor, Department of Epidemiology
Graduate School of Public Health
Pittsburgh, PA 15261

MedicalResearch.com: What is the background for this study?

Dr. Kriska:  The Diabetes Prevention Program (DPP) was a well administered national research study primarily supported by the National Institutes of Health (NIDDK) that demonstrated that lifestyle intervention with weight loss and physical activity goals can prevent type 2 diabetes in diverse, high risk US adults. The importance of physical activity in preventing diabetes development in the DPP until now was thought to be due to its role in achieving weight loss and weight maintenance but activity was not considered a strong key factor alone.

The lifestyle group had a significantly greater increase in physical activity and decrease in weight than the other two groups. They also had a 58% decrease in diabetes incidence compared to the control group. The successful decrease in T2D held across all age, sex, baseline BMI and ethnicity/race subgroups.

Despite the fact that the lifestyle intervention was then offered to all participants, in the follow-up years, the lifestyle participants still maintained a lower cumulative diabetes incidence that could not be explained by differences in weight loss.

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‘Epi-Chip’ Aims To Reconstruct Entire Infection Exposure History From Drop of Blood

MedicalResearch.com Interview with:

Donald S. Burke, M.D. Dean of the University of Pittsburgh Graduate School of Public Health Director of the University of Pittsburgh Center for Vaccine Research

Dr. Donald Burke

Donald S. Burke, M.D.
Dean of the University of Pittsburgh Graduate School of Public Health
Director of the University of Pittsburgh Center for Vaccine Research

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Burke: At the University of Pittsburgh we developed a unique method for detecting antibodies in the blood of patients in a proof-of-principle study that opens the door to development of simple diagnostic tests for diseases for which no microbial cause is known, including auto-immune diseases, cancers and other conditions.

We used a technique pioneered by co-author Thomas Kodadek, Ph.D., of the Scripps Research Institute, that synthesizes random molecular shapes called “peptoids” hooked onto microscopic plastic beads. The technique can produce millions of molecular shapes. The peptoids are not organic, but if they match to the corresponding shape on an antibody, that antibody will connect to them, allowing the scientist to pull out that bead and examine that peptoid and its corresponding antibody.

My team chemically generated a huge library of random molecular shapes. Then, using blood from HIV-infected patients and from non-infected people, we screened a million of these random molecular shapes to find the ones that bound only to antibodies present in the blood of HIV-infected patients, but not the healthy controls. No HIV proteins or structures were used to construct or select the peptoids, but the approach, nonetheless, successfully led to selection of the best molecular shapes to use in screening for HIV antibodies.

We then resynthesized that HIV-antibody-targeting peptoid in mass and tested it by screening hundreds of samples from the Multicenter AIDS Cohort Study (MACS), a confidential research study of the natural history of treated and untreated HIV/AIDS in men who have sex with men (supported by the National Institutes of Health). Study co-author Charles Rinaldo, Ph.D., chair of Pitt Public Health’s Department of Infectious Diseases and Microbiology and director of the Pittsburgh arm of the MACS, selected the samples, but blinded the testers to which samples were HIV-positive or -negative. The test distinguished between the samples of HIV-positive blood and HIV-negative blood with a high degree of accuracy.

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Nivolumab Extended Life in Subset of Head and Neck Cancer Patients

MedicalResearch.com Interview with:

Robert L. Ferris, M.D., Ph.D. UPMC Endowed Professor and Vice-Chair Chief, Division of Head and Neck Surgery University of Pittsburgh

Dr. Robert Ferris

Robert L. Ferris, M.D., Ph.D.
Robert L. Ferris, M.D., Ph.D.
UPMC Endowed Professor and Vice-Chair
Associate Director for Translational Research
Co-Leader, Cancer Immunology Program

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Ferris: Investigators at the University of Pittsburgh Cancer Institute<http://upci.upmc.edu/> (UPCI) co-led CheckMate-141<https://clinicaltrials.gov/ct2/show/NCT02105636> a large, randomized international phase III clinical trial that enrolled 361 patients with recurrent or metastatic head and neck squamous cell carcinoma who had not responded to platinum-based chemotherapy, a rapidly progressing form of the disease with an especially poor prognosis. Patients were randomized to receive either nivolumab or a single type of standard chemotherapy until tumor progression was observed.

Nivolumab, which belongs to a class of drugs known as immunotherapeutics, enables the body’s immune system to destroy cancer cells. It currently is approved to treat certain types of cancers, including melanoma and lung cancer. The nivolumab group achieved better outcomes than the standard chemotherapy group by all accounts. After 12 months, 36 percent of the nivolumab group was alive, compared to just 17 percent of the standard chemotherapy group.

Nivolumab treatment also doubled the number of patients whose tumors shrunk, and the number whose disease had not progressed after six months of treatment. Importantly, these benefits were achieved with just one-third the rate of serious adverse events reported in the standard chemotherapy group. In addition, on average, patients receiving nivolumab reported that their quality of life remained stable or improved throughout the study, while those in the chemotherapy group reported a decline. The new trial was considered so successful that it was stopped early to allow patients in the comparison group to receive the new drug.

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Primary Care Screening Detects Melanoma at Earlier Stage

Laura Ferris, M.D., Ph.D. Associate professor, Department of Dermatology University of Pittsburgh School of Medicine and Member of the Melanoma Program University of Pittsburgh Cancer Institute

Dr. Laura Ferris

MedicalResearch.com Interview with:
Laura Ferris, M.D., Ph.D.
Associate professor, Department of Dermatology
University of Pittsburgh School of Medicine and
Member of the Melanoma Program
University of Pittsburgh Cancer Institute

MedicalResearch.com: What is the background for this study?

Dr. Ferris: Rates of melanoma, the most dangerous form of skin cancer, are on the rise, and skin cancer screenings are one of the most important steps for early detection and treatment. Typically, patients receive skin checks by setting up an appointment with a dermatologist. UPMC instituted a new screening initiative, which was modeled after a promising German program, the goal being to improve the detection of melanomas by making it easier for patients to get screened during routine office visits with their primary care physicians (PCPs). PCPs completed training on how to recognize melanomas and were asked to offer annual screening during office visits to all patients aged 35 and older. In 2014, during the first year of the program, 15 percent of the 333,788 eligible UPMC patients were screened in this fashion.

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Increased Drug Overdoses and Deaths Not Limited To High Intensity Drug Trafficking Areas

MedicalResearch.com Interview with:

Jeanine Buchanich, Ph.D. Deputy director of the Graduate School of Public Health’s Center for Occupational Biostatistics and Epidemiology Research assistant professor in Pitt Public Health’s Department of Biostatistics University of Pittsburgh

Dr. Jeanine Buchanich

Jeanine Buchanich, Ph.D.
Deputy director of the Graduate School of Public Health’s Center for Occupational Biostatistics and Epidemiology
Research assistant professor in Pitt Public Health’s Department of Biostatistics
University of Pittsburgh

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Buchanich: Using the Mortality and Population Data System, a unique repository and retrieval system for detailed death data from the National Center for Health Statistics, housed at the University of Pittsburgh Graduate School of Public Health, my team examined overdose deaths in the U.S. from 1979 to 2014. We started with 1979 because changes in reporting cause of death make it impossible to make comparisons with previous years. 2014 is the most recent year for which data are available.

The counties with the largest increases in overdose death rates were clustered in southern Michigan; eastern Ohio and western Pennsylvania; eastern Pennsylvania, New Jersey and much of southeastern New York; and coastal New England. Counties in the Midwest, California and Texas have seen little to no increase in overdose death rates.

We cross-referenced the mortality data with counties in the High Intensity Drug Trafficking Areas program, which was created by Congress in 1988 to provide 31 high drug-trafficking areas of the U.S. with coordinated law enforcement resources dedicated to reducing trafficking and production. High Intensity Drug Trafficking Areas with high overdose death rates were mostly concentrated in Appalachia and the Southwest U.S., whereas such areas with lower death rates were near the borders in California, Texas and southern Florida.

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Joint Pain and Physical Function Commonly Improve after Bariatric Surgery

MedicalResearch.com Interview with:

Wendy King, PhD Associate Professor of Epidemiology Epidemiology Data Center, Room 105 University of Pittsburgh Pittsburgh, PA 15213

Dr. Wendy King

Wendy King, PhD
Associate Professor of Epidemiology
Epidemiology Data Center, Room 105
University of Pittsburgh
Pittsburgh, PA 15213

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. King: Severe obesity is associated with significant joint pain and impaired physical function, such as difficulty bending, lifting carrying and walking. Excess weight can lead to joint damage and accompanying pain, resulting in activity restriction and walking limitations. Obesity can also contribute to pain and physical limitations through factors such as impaired cardiorespiratory function, systematic inflammation, reduced flexibility, low strength per body mass, and depression.  Previous studies have reported significant improvements in mean values of bodily and joint specific pain, physical function, and walking capacity in the first 3-12 months following RYGB or LAGB. However, very few studies have examined the variability in response to surgery or reported on longer-term follow-up of these procedures.

My colleagues and I followed 2,221 patients participating in the Longitudinal Assessment of Bariatric Surgery-2, a large NIH-funded prospective study of adults with severe obesity undergoing weight-loss surgery at one of 10 hospitals across the U.S. Through three years of follow-up, approximately 50 to 70 % of patients who underwent bariatric surgery reported clinically important improvements in bodily pain, physical function and usual walking speed. About three-quarters of the participants with symptoms indicative of osteoarthritis before surgery experienced improvements in knee and hip pain and function. In addition, over half of participants who had a mobility deficit prior to surgery did not post-surgery. Several baseline characteristics such as younger age, male sex, higher household income, lower body mass index, fewer depressive symptoms and no history of diabetes or venous edema with ulcerations, were associated with a higher chance of improvement in pain and physical function following surgery. In addition, pre- to post-surgery reductions in weight and depressive symptoms, and remission of diabetes and venous edema with ulcerations were associated with pre- to post-surgery improvements. Thus, our findings reinforce results from shorter-term studies by addressing the durability or response and expand our understanding of the variability in response, and what factors are related to chance of improvement.

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Many Academic Medical Professors Serve on Health Care Company Boards

Timothy Anderson, M.D. Chief medical resident University of Pittsburgh’s Department of Internal MedicineMedicalResearch.com Interview with:
Timothy Anderson, M.D.
Chief medical resident
Department of Internal Medicine
University of Pittsburgh

Medical Research: What is the background for this study? What are the main findings?

Dr. Anderson: My coauthors and I analyzed the public disclosures of all publicly traded U.S. health care companies listed on the NASDAQ exchange and New York Stock Exchange in January 2014 that specialized in pharmaceuticals, biotechnology, medical equipment and providing health care services.  Of the 442 companies with publicly accessible disclosures on boards of directors, 180 – or 41 percent – had one or more academically affiliated directors in 2013. These individuals included chief executive officers, vice presidents, presidents, provosts, chancellors, medical school deans, professors and trustees from 85 non-profit academic research and health care institutions. These individuals received compensation and stock shares from companies which far exceeds payment for other relationships such as consulting. In some cases compensation approaches or exceeds average professor and physician salaries.

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Believing In Yourself Important For Weight Loss Maintenance

MedicalResearch.com Interview with:
Linda J Ewing PhD RN
Department of Psychiatry and
Lora E Burke PhD, MPH, RN, FAAN
Department of Health and Community Systems
University of Pittsburgh School of Nursing
Pittsburgh, Pennsylvania

Medical Research: What is the background for this study? What are the main findings?

Response: This study was the product both of work done in Dr. Burke’s lab as well as cumulative findings of other investigators demonstrating that improved self-efficacy is related to positive changes in health behaviors (e.g., physical activity, increased Intake of healthier foods, such as fruits and vegetables).  Given that, we designed a behavioral weight loss study that included an intentional focus on enhancing participant self-efficacy for healthy behaviors related to weight loss maintenance.  No previous study had self-efficacy enhancement as a focus of intervention with the long-term goal of increasing weight loss maintenance.  Thus our study focused on mastery performance of weight loss related behaviors.  Findings supported our hypothesis; participants in both arms of the study (standard behavioral weight loss (SBT) and SBT with self-efficacy enhancement (SBT+SE) achieved clinically significant weight loss.  Participants in the SBT+SE group had greater weight loss maintenance while those in the SBT group had clinically significant weight regain.
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“Breakthrough” FDA Labeling of New Drugs Can Lead To Unwarranted Expectations

Dr. Tamar Krishnamurti PhD Department of Engineering & Public Policy Carnegie Mellon University Pittsburgh, PA 15213MedicalResearch.com Interview with:
Dr. Tamar Krishnamurti PhD
Department of Engineering & Public Policy
Carnegie Mellon University
Pittsburgh, PA 15213 

Medical Research: What is the background for this study? What are the main findings?

Dr. Krishnamurti: In 2012, the Food and Drug Administration Safety and Innovation Act became law. As part of this law, FDA can assign drugs the “breakthrough” designation. Breakthrough drugs are drugs that are intended to treat a serious or life threatening condition and have shown preliminary evidence of a substantial improvement over existing therapies on at least one one clinically significant endpoint. These clinical endpoints can be surrogate outcomes and don’t have to be a direct outcome of the disease. All FDA press releases announcing approval of breakthrough-designated drugs use the term “breakthrough” and about half use the term “promising” when describing the drugs. Our study randomly assigned participants to read 1 of 5 short descriptions of a recently approved drug. These vignettes differed by the term assigned to the drug (e.g. “breakthrough” or “promising”) or by whether the basis for the designation was clearly and succinctly explained in the description. We found that using the terms “breakthrough” and “promising” to describe these drugs resulted in people having unwarranted confidence about the effectiveness of breakthrough drugs, which could prevent them from making a fully informed decision about whether to take the drug or not. The influence of these terms on peoples’ judgments was mitigated by explaining the regulatory meaning of the drug’s approval (which is required in the drug’s professional label, but not in public discourse about the drug).

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Adolscents Who Try E-Cigs More Likely To Become Smokers

Brian A. Primack, MD, PhD Associate Professor of Medicine, Pediatrics, and Clinical and Translational Science Director, Center for Research on Media, Technology, and Health Assistant Vice Chancellor for Research on Health and Society University of Pittsburgh School of Medicine Pittsburgh, PA 15213MedicalResearch.com Interview with:
Brian A. Primack, MD, PhD

Associate Professor of Medicine, Pediatrics, and Clinical and Translational Science
Director, Center for Research on Media, Technology, and Health
Assistant Vice Chancellor for Research on Health and Society
University of Pittsburgh School of Medicine
Pittsburgh, PA 15213

Medical Research: What is the background for this study?

Dr. Primack: Adolescents and young adults who have never smoked traditional cigarettes are now using e-cigarettes. It is unclear whether these people are at risk for progression to traditional cigarette smoking. Therefore, we followed 694 non-smokers ages 16-26 who did not intend on taking up smoking for 1 year.

Medical Research: What are the main findings?

Dr. Primack: At baseline, only 16 of the 694 participants had used e-cigarettes. However, those individuals were significantly more likely to start smoking traditional cigarettes by the 1-year follow-up. In fully adjusted models, baseline e-cigarette use was independently associated with both progression to smoking (AOR = 8.3, 95% CI  = 1.2-58.6) and to susceptibility (AOR = 8.5, 95% CI = 1.3-57.2).

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Menopausal Women Accumulate Fat…..Around Their Hearts

Samar R. El Khoudary, Ph.D., M.P.H. Assistant professor Graduate School of Public Health Department of Epidemiology University of Pittsburgh MedicalResearch.com Interview with:
Samar R. El Khoudary, Ph.D., M.P.H.

Assistant professor
Graduate School of Public Health Department of Epidemiology
University of Pittsburgh

Medical Research: What is the background for this study?

Dr. El Khoudary: Cardiovascular disease is the leading cause of death in women, and it increases after age 50 – the average age when a woman is going through menopause. Weight gain in women during and after menopause has long been attributed to aging, rather than menopause itself. However, recent research identified changes in body fat composition and distribution due to menopause-related hormonal fluctuations.

No previous study had evaluated whether those changes in fat distribution during menopause affect cardiovascular fat. Increased and excess fat around the heart and vasculature can be more detrimental than abdominal fat, causing local inflammation and leading to heart disease. Doubling certain types of cardiovascular fat can lead to a more than 50 percent increase in coronary events. My team and I investigated whether there may be a link between menopause and cardiovascular fat using data from 456 women from Pittsburgh and Chicago enrolled in the Study of Women’s Health Across the Nation (SWAN). The women averaged about 51 years of age and were not on hormone replacement therapy.

Medical Research: What are the main findings?

Dr. El Khoudary: Our study is the first to find that  late- and post-menopausal women have significantly greater volumes of fat around their hearts than their pre-menopausal counterparts. As concentrations of the sex hormone estradiol – the most potent estrogen – declined during menopause, greater volumes of cardiovascular fat were found. The finding held even after my colleagues and I took into account the effects of age, race, obesity, physical activity, smoking, alcohol consumption, medication use and chronic diseases. Continue reading