Medicaid Patients Who Overdose Likely To Get More Opioids

MedicalResearch.com Interview with:

Julie M. Donohue, Ph.D. Associate professor in Pitt Public Health’s Department of Health Policy and  Management and Director of the Medicaid Research Center Pitt’s Health Policy Institute University of Pittsburgh

Dr. Donohue

Julie M. Donohue, Ph.D.
Associate professor in Pitt Public Health’s Department of Health Policy and
Management and Director of the Medicaid Research Center
Pitt’s Health Policy Institute
University of Pittsburgh 

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

Response: Medicaid enrollees have three times higher risk of opioid overdose than non-enrollees, and for every fatal opioid overdose, there are about 30 nonfatal overdoses, according to the U.S. Centers for Disease Control and Prevention (CDC). My colleagues and I analyzed claims data from 2008 to 2013 for all Pennsylvania Medicaid enrollees aged 12 to 64 years with a medical record of a heroin or prescription opioid overdose and who had six months of continuous enrollment in Medicaid before and after the overdose claim. The 6,013 patients identified were divided into two groups—3,945 who overdosed on prescription opioids and 2,068 who overdosed on heroin, all of whom received treatment for overdose in a hospital or emergency department setting.

We found that Pennsylvania Medicaid recipients who suffer an opioid or heroin overdose continue to be prescribed opioids at high rates, with little change in their use of medication-assisted treatment programs after the overdose. Opioid prescriptions were filled after overdose by 39.7 percent of the patients who overdosed on heroin, a decrease of 3.5 percentage points from before the overdose; and by 59.6 percent of the patients who overdosed on prescription opioids, a decrease of 6.5 percentage points.

Medication-assisted treatment includes coupling prescriptions for buprenorphine, methadone or naltrexone—medications that can reduce opioid cravings—with behavioral therapy in an effort to treat the opioid use disorder. Our team found that such treatment increased modestly among the patients using heroin by 3.6 percentage points to 33 percent after the overdose, and by 1.6 percentage points to 15.1 percent for the prescription opioid overdose patients.

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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

Bariatric Surgery Bests Lifestyle Interventions For Diabetes Remission In Obesity

Anita P. Courcoulas M.D., M.P.H., F.A.C.S Professor of Surgery Director, Minimally Invasive Bariatric & General Surgery University of Pittsburgh Medical CenterMedicalResearch.com Interview with:
Anita P. Courcoulas M.D., M.P.H., F.A.C.S

Professor of Surgery
Director, Minimally Invasive Bariatric & General Surgery
University of Pittsburgh Medical Center

Medical Research: What is the background for this study?

Dr. Courcoulas: This study is a randomized clinical trial that was originally funded through the American Recovery and Reinvestment Act of 2009 (ARRA) as a high priority comparative effectiveness topic; the goal of which was to better understand the role of surgical versus non-surgical treatments for Type 2 diabetes mellitus (T2DM) in people with lower Body Mass Index (BMI) between 30 and 40 kg/m2. This report highlights longer-term outcomes at 3 years following random assignment to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) followed by low-level lifestyle intervention in years 2 and 3.

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Simple and readily available patient characteristics predicts death and dialysis dependence in critically ill patients with severe acute kidney injury

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, 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)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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First X-Chromosome Related Cause of Male Infertility Identified

Alexander N Yatsenko, MD, PhD Assistant Professor, Department of OBGYN and Reproductive Science, Magee-Womens Research Institute, University of Pittsburgh, PA  Pittsburgh, PA 15213MedicalResearch.com Interview with:
Alexander N Yatsenko, MD, PhD
Assistant Professor,
Department of OBGYN and Reproductive Science,
Magee-Womens Research Institute,
University of Pittsburgh, PA
Pittsburgh, PA 15213

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

Dr. Yatsenko: The known causes of male infertility not due to physical obstruction are usually because of sex-chromosome defects, such as deletions of the Y chromosome or duplication of the entire X chromosome in Klinefelter syndrome. Eight times out of 10, conventional genetic testing doesn’t reveal a chromosomal problem and infertility is considered idiopathic. We wanted to try to find other genetic reasons for the problem.

We found a deletion in part of the DNA coding of the testis-expressed gene 11 (TEX11) on the X-chromosome, which men inherit from their mothers. The alteration caused meiotic arrest, meaning the precursor cells could not properly undergo meiosis. We also found similar TEX11 gene mutations and meiotic arrest in two out of 49 men diagnosed with idiopathic azoospermia in Pittsburgh or at a Poland infertility clinic, and in five out of 240 infertile men assessed at a collaborating Andrology clinic in Muenster, Germany. These genetic findings were confirmed on protein level using patients’ testis biopsies. Continue reading

ACA Enrollees More Likely To Use Medicines For Hepatitis and HIV

Julie M. Donohue, Ph.D. Associate professor and Vice Chair for Research Graduate School of Public Health Department of Health Policy and Management University of PittsburghMedicalResearch.com Interview with:
Julie M. Donohue, Ph.D.

Associate professor and Vice Chair for Research
Graduate School of Public Health Department of Health Policy and Management
University of Pittsburgh

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

Dr. Donohue: We looked at data on medication use from January through September 2014 on 1 million Affordable Care Act-established marketplace insurance plan enrollees. Our analysis found that among people who enrolled in individual marketplaces, those who enrolled earlier were older and used more medication than later enrollees. Marketplace enrollees, as a whole, had lower average drug spending per person and were less likely to use most medication classes than patients enrolled in employer-sponsored health insurance. However, marketplace enrollees were much more likely to use medicines for hepatitis C and for HIV, which is particularly important given the general concerns about the rising costs of these medications for consumers.

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Physical Therapy May Equal Surgery For Spinal Stenosis, But Many Patients Don’t Complete Treatments

Anthony Delitto, PT, Ph.D, FAPTA Professor and Chair Department of Physical Therapy Associate Dean for Research, SHRS School of Health and Rehabilitation Sciences Pittsburgh,MedicalResearch.com Interview with:
Anthony Delitto, PT, Ph.D, FAPTA

Professor and Chair
Department of Physical Therapy
Associate Dean for Research, SHRS
School of Health and Rehabilitation Sciences
University of Pittsburgh

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

Dr. Delitto: I work with a team, many of whom were authors on the paper, and we see a lot of patients with lumbar spinal stenosis. Some of them did very well with Physical Therapy and avoided surgery. Some people didn’t do well and we ended up having surgery. We really wanted to do a study that compared, in a randomized format, doing surgery vs. a non-surgical approach to lumbar spinal stenosis. The idea we had was to really put the two approaches head to head – a randomized trial of surgery vs. physical therapy for people with lumbar spinal stenosis. We decided only to recruit patients after they had consented to surgery in order to avoid the pitfalls of previous studies where people crossed over after being assigned to a group, for example, being assigned to surgery and then deciding against having surgery.

Medical Research: What should clinicians and patients take away from your report?

Dr. Delitto: Probably the biggest point to put across to physicians, patients and practitioners, one of the things we realized was: patients don’t exhaust all of their non-surgical options before they consent to surgery. And physical therapy is one of the non-surgical options. The obvious finding is, when you compare the two groups, they seem to do the same. The results were equivalent at two years. Now, embedded in that, there are patients who did well in surgery, and patients who failed in surgery. There are patients who did well in Physical Therapy, and there are patients who failed with PT. But when we looked across the board at all of those groups, their success and failure rates were about the same. So it tells us that for the most part there were equivalent outcomes at two years.

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Sitting, Watching TV Increases Diabetes Risk In Predisposed Individuals

MedicalResearch.com Interview with:
Bonny Rockette-Wagner, Ph.D.

Director of physical activity assessment,
University of Pittsburgh Graduate School of Public Health and
Andrea Kriska, Ph.D.
Professor of epidemiology, University of Pittsburgh
Graduate School of Public Health

Researchers’ Note:

Drs. Kriska and Rockette-Wagner: It should be noted that this study looked at adults at high risk for diabetes. Not everyone in the general population would be at high risk. We would hypothesis that the risk increase from TV watching may be lower in those not at high risk for diabetes, but obviously could not test that in our study population.

MedicalResearch: What is the background for this study?

Response: In this research effort focused on participants in the Diabetes Prevention Program (DPP) study (published in 2002 and funded by the National Institute of Digestive and Diabetes and Kidney Diseases [NIDDK] section of the US National Institutes of Health [NIH]). That study enrolled 3,234 overweight US adults (1996–1999) of at least 25 years of age with the goal of delaying or preventing type 2 diabetes in high risk individuals with either a metformin drug or lifestyle intervention. The DPP demonstrated that the lifestyle intervention was successful at reducing the incidence of diabetes and achieving its goals of 150 minutes per week of moderate intensity activity (such as brisk walking) and a 7% weight loss (New England Journal of Medicine, 2002). There was no goal to reduce sitting in the Diabetes Prevention Program.

Results from other studies suggest that it is unclear if interventions focusing on increasing physical activity also reduce time spent sitting. This current investigation examined whether the Diabetes Prevention Program lifestyle intervention, which was shown to be effective at increasing physical activity, also decreased self-reported sitting time. The effect of sedentary behavior on diabetes development was also examined.

MedicalResearch: What are the main findings?

Response: For the lifestyle participants, a reduction in reported TV watching alone and the combination of TV watching and work sitting was observed. This reduction was significantly greater than any changes seen in the other two randomized groups, who did not receive the intervention. Because these reductions were accomplished without an explicit program goal to reduce sitting we feel optimistic that with better awareness of sitting behaviors and goal setting to reduce sitting it may be possible to have an even greater impact than what was achieved in this cohort.

Additionally, our results showed that for every hour spent watching TV there was a 3.4% increased risk of developing diabetes during the 3 year follow-up period in individuals at high risk for diabetes. This finding means that reductions in sitting can translate into a positive health effect separate from improvements in moderate-vigorous activity.

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Can Phthalates Alter Sex Development During Pregnancy?

Dr. Jennifer Adibi, MPH ScD University of Pittsburgh, Public Health Assistant Professor, Epidemiology Assistant Professor, Department of Obstetrics/Gynecology and Reproductive Sciences Affiliate, Department of Obstetrics/Gynecology and Reproductive Sciences University of California, San FranciscoMedicalResearch.com Interview with:
Dr.
Jennifer Adibi, MPH ScD
University of Pittsburgh, Public Health
Assistant 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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Early Onset, Frequent Hot Flashes Linked To Increased Cardiovascular Disease Risk

Dr. Rebecca Clark Thurston Ph.D Associate Professor of Psychiatry, Epidemiology, Psychology, and Clinical and Translational Science University of PittsburghMedicalResearch.com Interview with:
Dr. Rebecca Clark Thurston Ph.D
Associate Professor of Psychiatry, Epidemiology, Psychology, and Clinical and Translational Science
University of Pittsburgh

 

MedicalResearch: What is the background for these studies? What are the main findings?

Dr. Clark Thurston: The understanding of women’s cardiovascular disease and the role that reproductive factors play in women’s cardiovascular health is evolving. There are some studies showing links between menopausal hot flashes and cardiovascular disease risk in women. These studies help further refine this understanding. We showed in two separate studies that women who have hot flashes, particularly frequent hot flashes early in midlife, have poorer vascular health on certain indices.

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Liver Fibrosis Starts Early After Hepatitis C Infection

Adeel A. Butt, MD, MS, FACP, FIDSA Adjunct Associate Professor of Medicine and Clinical and Translational Science University of Pittsburgh School of MedicineMedicalResearch.com Interview with:
Adeel A. Butt, MD, MS, FACP, FIDSA
Adjunct Associate Professor of Medicine and Clinical and Translational Science
University of Pittsburgh School of Medicine

 

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

Dr. Butt: Studying clinical consequences of hepatitis C virus (HCV) infection is often limited by the lack of knowledge of actual time of infection. We used the Electronically Retrieved Cohort of HCV-Infected Veterans (ERCHIVES), a well-established national cohort of HCV infected veterans and corresponding HCV-uninfected controls, to identify patients with a known time frame for HCV infection. Our primary aim was to determine the rate of liver fibrosis progression among HCV-infected persons over time, with and to determine factors associated with development of cirrhosis and hepatic decompensation among these persons.

Among 1840 persons who were HCV+ and 1840 HCV− controls, we found that fibrosis progression started early after HCV infection tapered off after 5 years. After 10 years of follow-up, 18.4% of HCV+ and 6.1% of HCV- persons developed liver cirrhosis. Nine years after diagnosis of cirrhosis, only 1.8% of HCV+ and 0.3% of HCV- persons had developed hepatic decompensation.

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Dabigatran Carries Risk of GI Bleeding; Risk Greater in Kidney Disease, Black Patients

Inmaculada Hernandez, PharmD PhD Student, Health Services Research and Policy Deparment of Health Policy and Management Graduate School of Public Health University of Pittsburgh Pittsburgh, PA 15261MedicalResearch.com Interview with:
Inmaculada Hernandez, PharmD

PhD Student, Health Services Research and Policy
Deparment of Health Policy and Management
Graduate School of Public Health
University of Pittsburgh Pittsburgh, PA 15261

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

Response: The approval of dabigatran was considered a major contribution to the therapeutic arsenal of anticoagulants since warfarin, whose therapeutic management is complicated, was the only oral anticoagulant approved before 2011. Clinicians therefore considered dabigatran a very promising drug; however, the safety warnings released by the regulatory agencies and the reports of bleeding published in 2011 raised concerns about the safety profile of dabigatran. By the time we initiated our study, the FDA had concluded that dabigatran was associated with similar rates of bleeding than warfarin. However, the results of this observational study were not adjusted by patient characteristics. We therefore compared the risks of bleeding with dabigatran and warfarin adjusting for patient characteristics and using propensity score methods to mitigate selection biases, which observational studies are sensitive to.

We found that dabigatran was associated with a higher risk of major bleeding and gastrointestinal bleeding than warfarin. However, the risk of intracranial bleeding was lower with dabigatran. In addition, we found that the increased risk of bleeding with dabigatran was specially higher for African Americans and for patients with chronic kidney disease.

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Study Highlights Need To Minimize Familial Suicide Tendency

Dr. Brent David MD Academic Chief, Child and Adolescent Psychiatry at Western Psychiatric Institute and Clinic Professor of Psychiatry, Pediatrics & Epidemiology University of Pittsburgh School of Medicine MedicalResearch.com Interview with:
Dr. Brent David MD
Academic Chief, Child and Adolescent Psychiatry at Western Psychiatric Institute and Clinic Professor of Psychiatry, Pediatrics & Epidemiology
University of Pittsburgh School of Medicine

Medical Research: What is the background for this study?

Dr. David: There are now many studies that show that suicide and suicidal behavior run in families. A family history of suicide increases the risk for suicide attempt and vice versa, so that we believe that the trait that is being passed from parent to child is a tendency to act on suicidal thoughts, resulting in either an attempt or an actual suicide. However, what was not not known was the mechanism by which parents transmitted the risk of suicidal behavior to their children, and what the precursors of suicidal behavior looked like in individuals who were at risk for suicidal behavior, but had not yet engaged in a suicide attempt. Therefore, we conducted a high-risk family study, in which studied the children of parents with mood disorders, about half of whom also had a history of a suicide attempt.

Medical Research: What are the main findings?

Dr. David: We followed 701 offspring for an average of 5.6 years, and found that those offspring whose parents had made a suicide attempt were almost 5 times more likely to make a suicide attempt themselves, even after accounting for mood disorder in parent and child and past suicidal behavior in the offspring. We found three main pathways by which suicidal behavior was passed from parent to child:

  • Parental mood disorder was transmitted to children, and that was a precursor of a suicide attempt.
  • Parent attempt was related to offspring impulsive aggression, which in turn increased the risk for mood disorder, which then increased the likelihood of a suicide attempt. (We define impulsive aggression as a tendency to response with hostility or aggression to provocation or frustration.
  • Finally, there is a direct path from parent attempt to child attempt, with no precursors or intervening variables.

Implications for clinicians and patients:

  • First, these findings highlight that a parental history of a suicide attempt increases the risk of an attempt in the parent’s children. Clinicians who take care of adults who have attempted suicide should make sure that children are assessed as they are at increased risk and that parents know what to look for in the future in order to get their children into needed treatment.
  • Second, the transmission of suicidal behavior from parent to child can be attenuated by preventing the transmission of mood disorder, and of impulsive aggression. There are now evidence based interventions that reduce the likelihood of a child of a depressed parent from developing depression; these treatment involve cognitive behavioral principles and may also involve family interventions. There are now good family-based interventions for impulsive aggression that can attenuate the risk that the child or adolescent will go on to develop a mood disorder, which in turn greatly increases the risk for suicidal behavior.

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Low-Risk ICU Patients Can Still Develop Acute Kidney Injury

MedicalResearch.com Interview with:
Florentina E. Sileanu BS
Center for Critical Care Nephrology and Clinical Research, Investigation, and Systems Modeling of Acute Illness Center
Departments of Critical Care Medicine and Department of Biostatistics,
University of Pittsburgh Graduate School of Public Health and
Dr. John A. Kellum, MD, MCCM
Professor of Medicine, Bioengineering and Clinical & Translational Science
Vice Chair for Research
Center for Critical Care Nephrology,
University of Pittsburgh School of Medicine
Pittsburgh, PA

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

Response: Acute Kidney Injury (AKI) affects millions of Americans each year resulting in increased short and long-term complications including need for dialysis and death. Many trials recruiting subjects at risk for AKI have focused on those with other (e.g. cardiovascular and respiratory) organ failures because these patients are at highest for AKI. However, patients without these conditions might not be at low-risk for AKI. We explored whether Acute Kidney Injury occurring as a single organ failure or occurring before other organ failures would be associated with the same outcomes as in sicker patients. Using a large, academic medical center database, with records from July 2000 through October 2008, we identified a “low-risk” cohort as patients without cardiovascular and respiratory organ failures defined as not receiving vasopressor support or mechanical ventilation within the first 24 hours of ICU admission. We were able to show that low-risk patients have a substantial likelihood of developing AKI and that the relative impact on mortality of AKI is actually greater for low-risk patients (OR, 2.99; 95% 2.62-3.41) than for high-risk patients (OR, 1.19; 95% 1.09-1.3).

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Gene Mutation Identified In Metastatic Breast Cancer

Dr. Ryan Hartmaier PhD Postdoctoral Associate Magee-Womens Research Institute (MWRI) and the University of Pittsburgh Cancer InstituteMedicalResearch.com Interview with:
Dr. Ryan Hartmaier PhD
Postdoctoral Associate
Magee-Womens Research Institute (MWRI)
and the University of Pittsburgh Cancer Institute

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

Response: The inhibition of signaling through the estrogen receptor is a major target in breast cancer therapy. However, within recurrent disease others have recently identified point mutations within the estrogen receptor as a mechanism of resistance to this therapy.
We undertook a comprehensive study of breast cancer progression by applying many next-generation sequencing technologies to a collection of paired primary-metastasis tissue samples from 6 patients. We placed special emphasis on the identification of structural variants (i.e. translocations, duplications, inversions, and deletions) acquired in metastatic breast cancer. In one patient with recurrent disease while on endocrine therapy, we identified a fusion gene between ESR1 (estrogen receptor alpha) and DAB2 (disabled-2). In vitro functional studies indicate that this fusion is constitutively active and hormone independent.
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Hepatitis C: Progression to Liver Fibrosis Starts Early

Adeel A. Butt, MD, MS, FACP, FIDSA Vice Chair for Faculty Affairs Department of Medicine Hamad Medical Corporation, Doha, Qatar Adjunct Associate Professor of Medicine and Clinical and Translational Science University of Pittsburgh School of MedicineMedicalResearch.com Interview with:
Adeel A. Butt, MD, MS, FACP, FIDSA Vice Chair for Faculty Affairs
Department of Medicine Hamad Medical Corporation, Doha, Qatar
Adjunct Associate Professor of Medicine and Clinical and Translational Science
University of Pittsburgh School of Medicine

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

Dr. Butt: Precise rate of progression of liver disease in Hepatitis C (HCV) infection is unknown because the precise time of infection with HCV is seldom known. Knowledge of liver disease progression is critical to determine the optimal time for treatment.

We found that progression of liver disease starts early after acquiring HCV infection. This is more rapid than was previously thought. About 18% of HCV infected persons develop cirrhosis within 10 years of acquiring HCV infection, which is 3-fold higher than demographically similar HCV uninfected persons.
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More CT Scans Done For Minor Head Trauma Than Guidelines Recommend

Dr. Jennifer Marin MD MSc Director of Emergency Ultrasound, Division of Pediatric Emergency Medicine Assistant Professor of Pediatrics and Emergency Medicine University of Pittsburgh School of MedicineMedicalResearch.com Interview with:
Dr. Jennifer Marin MD MSc

Director of Emergency Ultrasound
Division of Pediatric Emergency Medicine
Assistant Professor of Pediatrics and Emergency Medicine
University of Pittsburgh School of Medicine

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

Dr. Marin: Overuse of diagnostic imaging in the emergency department has become a focus of concern from policy makers, patients, and physicians. There are evidence-based clinical decision rules and policy recommendations published in order to optimize the use of such imaging. However, physicians don’t necessarily use these tools in their decision-making. Head computed tomography (CT) imaging for patients with minor head trauma is a common CT performed in the emergency setting. Our study sought to evaluate how often physicians adhered to the American College of Emergency Physicians (ACEP) Clinical Policy on Neuroimaging. The policy outlines which patients warrant a CT in the setting of minor head trauma based on certain factors, such as age, mechanism of injury, and signs and symptoms of head trauma. What we found is that when the policy recommends that a head CT be performed, it is obtained more than 90% of the time. However, when a head CT is not recommended, it is actually obtained in nearly half of those patients. We hope this will draw attention to decision rules and clinical policies, such as that from ACEP, and remind physicians that using these tools can assist in appropriate imaging practices.
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Addictions May Predispose To Excessive Gestational Weight Gain

Michele D. Levine Ph.D. Associate Professor of Psychiatry and Psychology Western Psychiatric Institute and Clinic Department of Statistics, University of Pittsburgh, Pittsburgh PAMedicalResearch.com Interview with:
Michele D. Levine Ph.D.

Associate Professor of Psychiatry and Psychology
Western Psychiatric Institute and Clinic
Department of Statistics, University of Pittsburgh, Pittsburgh PA

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

Dr. Levine: Many women quit smoking as a result of pregnancy.  However, psychiatric disorders, which are prevalent among smokers can contribute to weight gain.  Thus, we sought to examine the relationship between maternal psychiatric disorders and gestational weight gain in a sample of pregnant former smokers. Results from the present study demonstrate that the rates of psychiatric disorders were high among pregnant former smokers and that more than half of women gained more weight than recommended by the IOM.  Although a history of having had any psychiatric disorder was not associated with gestational weight gain, a history of alcohol use disorder specifically was positively related to gestational weight gain.

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Atrial Fibrillation: More Bleeding With Dabigatran Than Warfarin

Yuting Zhang, Ph.D. Associate Professor and Director Pharmaceutical Economics Research Group University of Pittsburgh Graduate School of Public Health Department of Health Policy and Management.MedicalResearch.com Interview with:
Yuting Zhang, Ph.D.

Associate Professor and Director
Pharmaceutical Economics Research Group
University of Pittsburgh Graduate School of Public Health
Department of Health Policy and Management.

Medical Research: What are the main findings of the study?

Dr. Zhang: Patients with atrial fibrillation who take the blood thinner dabigatran are at greater risk for major bleeding and gastrointestinal bleeding than those who take warfarin, indicating that greater caution is needed when prescribing dabigatran to certain high-risk patients. High-risk groups include those who are 75 and older; African Americans; those with chronic kidney disease; and those with seven or more co-existing medical problems.

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Bariatric Surgery Effective For Both Weight Loss and Diabetes Remission

Anita P. Courcoulas M.D., M.P.H., F.A.C.S Professor of Surgery Director, Minimally Invasive Bariatric & General Surgery University of Pittsburgh Medical Center MedicalResearch.com Interview with: 
Anita P. Courcoulas M.D., M.P.H., F.A.C.S
Professor of Surgery
Director, Minimally Invasive Bariatric & General Surgery
University of Pittsburgh Medical Center

Medical Research: What are the main findings of the study?

Dr. Courcoulas: This paper was not a study but a summary of findings from a multidisciplinary workshop (and not a consensus panel) convened in May 2013 by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute. The goal of the workshop was to summarize the current state of knowledge of bariatric surgery, review research findings on the long-term outcomes of bariatric surgery, and establish priorities for future research.
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VOMS Test Better Identifies Symptoms and Impairment Following Concussion

Anthony P. Kontos, Ph.D. Assistant Research Director UPMC Sports Medicine Concussion Program Associate Professor Department of Orthopaedic Surgery University of PittsburghMedicalResearch.com Interview with:
Anthony P. Kontos, Ph.D.
Assistant Research Director
UPMC Sports Medicine Concussion Program
Associate Professor
Department of Orthopaedic Surgery
University of Pittsburgh

Medical Research: What are the main findings of the study?

Dr. Kontos: Our new Vestibular/Ocular Motor Screening (VOMS) examination was able to accurately identify nearly 90% of patients with a concussion. In our study of 64 concussed patients approximately five days post-injury and 78 healthy control-group patients who were administered VOMS by trained clinicians, we also found that more than 60% of patients with a concussion reported symptoms or had impairment on the VOMS following their injury. The VOMS, which was developed in conjunction with an interdisciplinary team of experts, assesses five areas of the vestibular ocular system: smooth pursuits, saccades (rapid eye movement), horizontal vestibular ocular reflex (VOR), visual motion sensitivity (VMS), and near-point-of-convergence (NPC) distance.

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Type 1 Diabetes: New Model Predicts Major Outcomes

MedicalResearch.com Interview with:
Dr. Sabita Soedamah-Muthu
Division of Human Nutrition,Wageningen University
Wageningen, the Netherlands
and Prof Trevor Orchard
Department of Epidemiology,
Graduate School of Public Health,
University of Pittsburgh, Pittsburgh, PA, USA

Medical Research: What are the main findings of the study?

Answer: We present a new prognostic model combining information on age, glycated haemoglobin, waist-hip ratio, albumin/creatinine ratio and HDL (good) cholesterol to assess the 3, 5 and 7 year risk of developing major outcomes in patients with type 1 diabetes.
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Adverse Childhood Experiences Common in Military Men

John Blosnich, Ph.D., M.P.H., Post-doctoral fellow at the Center for Health Equity Research and Promotion Veterans Affairs Pittsburgh Healthcare System.
MedicalResearch.com Interview with:
John Blosnich, Ph.D., M.P.H.,
Post-doctoral fellow at the Center for Health Equity Research and Promotion
Veterans Affairs Pittsburgh Healthcare System.

Medical Research: What are the main findings of the study?

Dr. Blosnich: I think there are two main findings from our study:

First, since the beginning of the All-Volunteer U.S. military in 1973, there has been a shift in childhood experiences among men who have served in the military.

Second, the childhood experiences of women who have served in the military have been largely similar across the Draft and All-Volunteer Eras.
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Assigning Low Income Medicare Enrollees to Least Expensive Plan May Save Billions

MedicalResearch.com Interview with:
Yuting Zhang, Ph.D.
Associate professor
Graduate School of Public Health Department of Health Policy and Management.
University of Pittsburgh

MedicalResearch: What are the main findings of the study?

Dr. Zhang: Since 2006, the government has randomly assigned low-income enrollees to stand-alone Part D plans, based upon the region in which they live. If low-income Medicare Part D enrollees were assigned to the least expensive plan instead of a random plan, the government and beneficiaries could save more than $5 billion in the first year.
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Cancer Center Advertisements Focus on Emotional Appeals

Yael Schenker, MD, MAS Assistant Professor Division of General Internal Medicine Section of Palliative Care and Medical Ethics University of Pittsburgh Pittsburgh, PA  15213 MedicalResearch.com Interview with:
Yael Schenker, MD, MAS
Assistant Professor
Division of General Internal Medicine
Section of Palliative Care and Medical Ethics
University of Pittsburgh
Pittsburgh, PA  15213

MedicalResearch: What are the main findings of the study? 

Dr. Schenker: We analyzed the content of cancer center advertisements placed in top TV and magazine media markets in 2012.  Out of 1427 advertisements that met our initial search criteria, we found 409 unique advertisements that promoted clinical services at 102 cancer centers across the country.  These advertisements promoted cancer treatments (88%) more often than cancer screening (18%) or supportive services (13%).  Provision of information about clinical services was scant.
For example, 27% of advertisements mentioned a benefit of advertised services and 2% quantified these benefits.  2% mentioned a risk of advertised services and no advertisements quantified these risks.  5% mentioned costs or insurance coverage and no advertisements mentioned availability under specific insurance plans.  In contrast, use of emotional appeals was frequent (85%).  Emotional appeals commonly evoked hope for survival, focused on treatment advances, used fighting language, and/or evoked fear.  Nearly half of all advertisements included patient testimonials, overwhelmingly focused on stories about survival or cure.  Only 15% of testimonials included a disclaimer (for example, “most patients do not experience these results”) and none described the outcome that a typical patient may expect.
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Diabetes Associated with Brain Pathology, but Not Amyloid Accumulation

Rosebud O Roberts, M.B., Ch.B. Professor of Epidemiology Professor of Neurology Mayo ClinicMedicalResearch.com Interview with:
Rosebud O Roberts, M.B., Ch.B.
Professor of Epidemiology
Professor of Neurology
Mayo Clinic


MedicalResearch.com: What are the main findings of the study?

Dr. Roberts: We found that among persons 70 years and older, people with type 2 diabetes had a reduced glucose uptake (hypometabolism) in  brain cells.  We also found a similar association for people without type 2 diabetes but who had elevated hemoglobin A1c levels levels at the time of enrollment (HBA1c is a measure of glucose control, and represents the average blood glucose levels over a 3 month period). However, we did not find an association of diabetes with increased brain amyloid accumulation.  Our findings were based on an investigation of the association of type 2 diabetes with markers of brain pathology: brain hypometabolism was assessed by 18F-fluorodeoxyglucose positron emission tomography [PET] and amyloid accumulation was assessed by 11-C Pittsburgh Compound B PET imaging.
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