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December 8, 2016

Research Notes

Marcellus Shale impact fees are well spent overall

Two Bradford campus professors have issued a report on how Marcellus Shale impact fees are used and accounted for in Pennsylvania.

Shailendra N. Gajanan, economics faculty member, and Stephen F. Robar, political science faculty member, received a grant from the Center for Rural Pennsylvania, which sponsors studies of interest to the Pennsylvania General Assembly.

In 2012, Pennsylvania instituted a fee for new gas wells being drilled in the Marcellus Shale via fracturing, or fracking. It allowed wells to be drilled in areas that had earlier not been considered productive gas fields. Representatives from municipalities and counties where new wells were being drilled asked the legislature for help in paying for infrastructure such as roads and bridges that received heavy truck traffic, emergency preparation for spills or explosions, and work to accommodate runoff.

An impact fee was created to help those municipalities and counties. About 60 percent of the fees collected go to places near to where drilling has occurred.

Gajanan and Robar examined these state locations’ annual financial statements for 2007-09 and 2011-13, when drilling activity began to increase in Pennsylvania. They found that, on average, municipalities and counties were paying more for roads and police coverage.

The pair then examined the difference in expenditures in places with Marcellus drilling versus those without and found that, where there was no drilling, there wasn’t an increase in expenditures for roads and police coverage.

Finally, they asked municipal and county representatives to fill out a survey about how they spent or intended to spend their money from the impact fees. Most places, they found, spend their money on the same things — chiefly infrastructure, emergency preparedness, stormwater and sewer systems, and judicial services.

Municipalities and counties as a whole also placed a third of the funds in capital reserve to use on future projects.

Overall, Gajanan and Robar found that the financial impact of Marcellus Shale drilling on municipalities and counties was real and that those governments spent the money in the way they had said they would.

However, financial records revealed that these counties and municipalities did not separate income lines for the impact fees, which were often co-mingled with other funds. Therefore, they recommended that the legislature investigate requiring a stronger reporting structure to ensure that funds are spent as intended.

They also noticed that, although municipalities and counties with wells get the majority of the impact fees, nearby communities can be affected but not receive funds. For example, a remote township where wells are being drilled may receive impact fees, but a borough 20 miles away might not receive additional funds, even though it is bearing the burden of housing most of the workers for that well project.

Consequently, Gajanan and Robar also recommended that the legislature devise a more equitable formula for distributing money to all municipalities and counties feeling the effect of Marcellus Shale drilling.

The report, “Analysis of Act 13 Spending by Pennsylvania Municipalities and Counties,” can be found at under “Reports.”

NIH grant seeks better evaluation of CF patients

Man Inhaling Through Inhaler MaskCystic fibrosis (CF) causes the accumulation of dehydrated mucus in the lungs, which can lead to chronic infection, inflammation and respiratory failure and drastically affect the lives of CF patients. These ever-changing complexities often make it difficult for doctors to decide which therapies will be most effective in treating the disease.

To develop better evaluation methods, the National Institutes of Health (NIH) awarded a research team in the Swanson School of Engineering and the School of Medicine a $1.7 million grant to develop new mathematical models of liquid and ion transport in the human lung. These models could allow doctors to rapidly personalize interventions for patients suffering from CF and other lung diseases and administer the most effective treatment by simply studying a cell culture from the patient’s nose.

Robert Parker, chemical and petroleum engineering faculty member in the Swanson school, and Tim Corcoran, faculty member in medicine, bioengineering and chemical engineering at the School of Medicine, will lead the study as co-principal investigators. Three co-investigators will join the study: pediatrics faculty member Carol Bertrand and pulmonary, allergy and critical care medicine faculty members Joe Pilewski and Mike Myerburg.

Said Corcoran: “We know that mucus hydration and clearance are important factors in CF lung disease. We’ve developed nuclear imaging techniques to measure how mucus and water move in the lungs. This lets us understand the individual lung pathologies of our patients and may allow us to predict what therapies will help them. The techniques we are using were actually developed here, and we’re pretty much the only ones using them.”

The researchers will begin by collecting data from patients with CF, biological parents of patients with CF who carry the CF mutation and healthy controls. After sampling and culturing of human nasal epithelial (HNE) cells — under Myerburg’s direction — Corcoran will use aerosol-based nuclear imaging to measure mucus clearance and airway surface liquid dehydration in the lungs.

Once the researchers have collected data from the patients’ HNE cell cultures and lung imaging, they will use advanced computational techniques to find the correlation between the nasal cell physiology and lung physiology. Parker will lead the group’s effort to translate the data collected from the test subjects into multi-scale mathematical models that provide cell- and organ-level visualizations of the patients’ physiology.

Said Parker: “The mathematical models — through a framework of differential equations — describe how basic physiological processes contribute to experimental outcomes. We can link all of the information we’ve gathered from lab experiments, physiology studies and clinical studies to better predict how a patient will respond to different therapies. By creating millions of simulations over a broad spectrum of patients, we can identify the underlying biological mechanism and understand how the patients will respond to treatment through the painless, non-invasive sampling of the HNE cells.”

Ultimately, the researchers hope to show that nasal cell sampling and interpretation of the data by the computer models can lead to a highly personalized approach to treating a patient with CF that could begin as early as birth. This would greatly enhance a patient’s quality of life, increase life expectancy and limit progress of the disease.
“We are always going to be limited by the number of patients we can test,” added Parker. “However, we can bridge the gap between the full set of all CF patients and a smaller set of CF patients with similar symptoms who are likely to respond to treatment in a similar way. The mathematical models will help us create those sets and let us predict outcomes and design treatments for individual patients.”

Improvements recommended for children with medical complexity

Care of children with medical complexity who have significant chronic health problems resulting in extensive health care needs requires an optimized framework with the medical home as the foundation of an integrated care system, according to a new American Academy of Pediatrics clinical report published online in Pediatrics. The report was led by Amy Houtrow, faculty member in physical medicine and rehabilitation and pediatrics at the School of Medicine and vice chair in the Department of Physical Medicine and Rehabilitation for pediatric rehabilitation medicine in the School of Medicine, and a colleague from Women & Children’s Hospital of Buffalo. Houtrow notes that opportunities exist for health care providers, payers and policy makers to develop strategies to enhance care delivery and to decrease costs.

One-third of overall health care spending on children is accounted for by 1 percent of kids — children with medical complexity. A medically complex child, for example, may have a genetic condition associated with a congenital heart defect, difficulty with swallowing, cerebral palsy and a urologic condition.

Said Houtrow: “While there aren’t many children who are medically complex, it is important for schools, daycares and hospitals to pay special attention to them because of their extensive needs. Educating pediatricians and other health care providers to understand how to help care for children with medical complexity will help to improve treatment and care.”
Outcomes include decreasing unplanned hospital admissions, decreasing emergency department use, ensuring access to health services, limiting out-of-pocket expenses for families and improving patient and family experiences, quality of life and satisfaction with care.

The overall objective of any framework of care for children with medical complexity should be to maximize health, development and family functioning through coordinated patient- and family-centered care along with providing proactive, rather than reactive, care to avert critical medical and health events as much as possible, according to the authors of the report.

Mammal hearts regenerate using zebrafish cells

Many lower forms of life on earth exhibit an extraordinary ability to regenerate tissue, limbs and even organs, a skill that was lost among humans and other mammals. Now, a Swanson school researcher has used the components of the cellular “scaffolding” of a zebrafish to regenerate heart tissues in mammals, specifically mice, as well as exhibiting promising results in human heart cells in vitro.

The findings offer promise to overcoming heart disease, the leading cause of death for men and women.

The study, led by Yadong Wang, the William Kepler White-ford Professor in Bioengineering and the principal investigator of the Biomaterials Foundry, discovered that a single administration of extracellular matrices (ECM) from zebrafish hearts restored the function of the mouse heart and regenerated adult mouse heart tissues after acute myocardial infarction.

Said Wang: “The heart beats as if nothing has happened to it. And our approach is really simple.”

The study also found that the zebrafish ECM protected human cardiac myocytes — specialized cells that form heart muscle — from stresses.

ECM are the architectural foundations of tissues and organs; not only do they provide a “scaffolding” on which cells can grow and migrate, they assist in the signaling necessary for the organ to develop, grow or regenerate.

In mammals, the heart quickly loses the ability to regenerate after the organism is born, except for a brief period after birth. In lower animals, such as zebrafish, the heart retains that ability throughout their lives: up to 20 percent of a zebrafish’s heart can be damaged or removed, and within days the heart’s capacity has been fully restored.

Wang and his team first separated the ECM from the cells so that the recipient heart would not reject the treatment. They did this by freezing the zebrafish cardiac tissue, causing the cell membranes to burst and allowing the researchers to retrieve the ECM, a process called decellularization. Wang noted that he and his colleagues are among the first to decellularize non-mammalian tissues for applications in regenerative medicine. They then injected the ECM into the hearts of mice with damaged heart muscles and watched the hearts repair themselves.

“It’s difficult to inject foreign cells into a body because the body will recognize them as foreign and reject them; that’s not the case with ECM,” said Wang. He explained that, because ECMs are composed of collagen, elastin, carbohydrates and signaling molecules and have no cell surface markers, DNA or RNA from the donor, the recipient is less likely to reject the treatment.

Wang said that restored function starts almost immediately, and healing is noticeable as early as five days after treatment; within a week, his team could see the heart beating more strongly than the hearts of the untreated animals.

The researchers tested the effectiveness of ECM from normal zebrafish and from zebra-fish with damaged hearts, in which the ECM had already begun the healing process. They found that while both types of ECM were effective in repairing damage to the mice hearts, the ECM obtained from the zebrafish hearts that were healing were even more potent in restoring heart function in the mice.

Wang is working on a process to regenerate nerves in mammals using the same process and hopes to expand the heart treatments to larger animals in a future study.
The study was published in Science Advances.

The work was funded in part by the American Heart Association and NIH.

Mascaro funds soil moisture study

The Mascaro Center for Sustainable Innovation (MCSI) has provided seed funding of $49,912 for a research and education effort that will look at changes in soil moisture, particularly in areas where the natural environment interacts with urban areas. Taking a “living lab” approach to gathering data for the research, the project will encourage students and faculty to gather large quantities of soil moisture observations and generate a dataset for evaluating hypotheses about sustainable urban hydrology.

Said Brian Thomas, faculty member in the Dietrich School of Arts and Sciences’ Department of Geology and Environmental Science and principal investigator of the study: “Soil moisture is a great indicator of important information about watershed storage, water quality, nutrient content and ecological communities. The lack of soil moisture observation hinders urban hydrological studies, so we are going to engage sustainability-minded students to work inside and outside of the lab to gather data and come up with ways to assess green infrastructure for storm water management.”

Co-investigators on the study include Daniel Bain and Emily Elliott, faculty members in geology and environmental science, and David Sanchez, faculty member in the Swanson school’s Department of Civil and Environmental Engineering.

Palliative care improves quality of life

People living with serious illness who receive palliative care have better quality of life and fewer symptoms than those who don’t receive palliative care, according to a new study by researchers at the School of Medicine. Published in JAMA, the Journal of the American Medical Association, the study is a meta-analysis of the effect of palliative care as it relates to patients’ quality of life, symptom burden and survival.

Palliative care focuses on providing patients with relief from their symptoms, pain and stress of a serious illness, whatever the diagnosis. Palliative care can either refer to a specific service that is provided by physicians and nurses who have received specialized training, or an overall approach to care for patients with serious illness, which would include palliative care provided by a specialist or by a non-palliative care specialist (like an oncologist or a primary care physician).

This study took a broad approach and looked at the philosophy of palliative care.

The researchers conducted a systematic review of 43 trials of palliative care interventions, including 12,731 adults with serious illness and 2,479 of their family caregivers. Researchers also performed a meta-analysis to investigate the overall association between palliative care and three outcomes often linked with palliative care: patients’ quality of life, symptom burden and survival. A meta-analysis is the statistical process of combining the results of multiple trials, which gives researchers an overall effect for interventions.

Said Dio Kavalieratos, medicine faculty member and lead author of the study: “Taken all together, this is a very compelling message: People’s quality of life and symptoms improved; their satisfaction with their health care improved — all during what is likely one of the most difficult periods of their lives.”

Researchers also determined that palliative care was associated with improvements in advance care planning, patient and caregiver satisfaction with care and lower health care use. There was mixed evidence of improvement with site of death, patient mood, health care expenditures and caregiver quality of life, mood or burden.

“Historically, palliative care has overwhelmingly focused on individuals with cancer, but anyone with a serious illness, be it cancer, heart failure, multiple sclerosis or cystic fibrosis, deserves high-quality, individualized care that focuses on reducing their suffering and improving their quality of life,” Kavalieratos said. “We need to find ways of integrating palliative care concepts in patients’ usual care experiences so it isn’t a luxury, but a standard part of health care for those living with serious illness.”

Over the past five years, much attention has been paid to the idea that palliative care improves patients’ survival, Kavalieratos added. Although some individual studies had shown that, the association didn’t play out when multiple studies were pooled together in the meta-analysis.

“As a field, we need to develop new methods of studying how palliative care impacts people with serious illness and their caregivers,” Kavalieratos added. “These methods should not burden patients and caregivers who participate in this research, but also need to be rigorous enough to capture what’s going on at this critical point in people’s lives.”

The researchers received funding support from the Agency for Healthcare Research and Quality; the National Heart, Lung and Blood Institute; the National Institute of Nursing Research; and NIH.

Ten staff members from Pitt were involved in the study; also contributing were researchers from the University of North Carolina-Chapel Hill, the University of Alabama-Birmingham, the University of Toronto and Virginia Tech.

Opioid-exposed newborn care standards urged

Increasing prenatal opioid use has resulted in a rapidly growing population of opioid-exposed newborns. However, there is a wide variation in the type of care that these newborns receive and more research is needed to establish best practices and standards of care, according to new research from Children’s Hospital and the School of Medicine published online in Academic Pediatrics.

The study analyzed care practices for newborns with neonatal abstinence syndrome (NAS), a condition that results from opioid withdrawal and is associated with significant health care costs related to prolonged newborn hospital stays.

Said Debra Bogen, the lead author and a pediatrics faculty member in the School of Medicine: “The opioid epidemic has not spared pregnant women and their children. As a result, we have seen a significant increase in the numbers of newborns who require care in our nation’s nurseries.”

In many institutions, NAS care is provided in neonatal intensive care units (NICUs), an approach that is expensive and may not be necessary for infants who are not critically ill. Furthermore, the resulting separation of mother and child may be counterproductive to optimal care.

To assess comprehensive NAS care practices nationwide, including infant drug screening, pharmacologic treatment, rooming-in, infant feeding practices and discharge planning, Bogen and colleagues conducted an online survey in collaboration with members of the Better Outcomes through Research for Newborns Network of the Academic Pediatric Association, a national collaborative of pediatric clinicians and researchers.

The team surveyed nursery site leaders from 76 hospitals in 34 states about hospital policies and practices regarding care for infants exposed to opioids for at least the last three weeks before delivery.

They found that 80 percent of the hospitals had protocols for newborn drug exposure screening and 90 percent used risk-based approaches. However, observation periods for opioid-exposed newborns varied widely and were inconsistent with national recommendations.

For example, 44 percent of hospitals observed infants exposed to opioids that are active for a short duration in the body for more than three days, the recommended time, while 47 percent of hospitals observed newborns exposed to long-acting opioids for fewer than five days, the recommended time. The wide variation combined with a lack of data to support current expert recommendations point to this as an important but poorly understood area, according to the study authors.

In addition, the team also found variation in how long mothers and infants were separated, feeding practices and in what stage of treatment infants were discharged.

“Our survey confirms that although most nurseries have implemented standardized protocols, wide variation in the actual policies exist in regards to supportive care approaches, feeding methods and duration of observation for NAS,” noted Bogen.

“Additionally, most newborns administered drugs for NAS are cared for in NICUs and separated from their mothers at a time when they will benefit most from maternal contact. The high level of variation in care suggests the need to identify optimal care strategies for this rapidly growing population of infants.”

The study was supported by NIH.

Researchers from Dartmouth-Hitchcock Medical Center, the University of Iowa, the University of Massachusetts Medical School and the Academic Pediatric Association also contributed to the study.

Anticoagulation should be resumed after bleeding

Researchers from the pharmacy, public health and medicine schools have undertaken what they say is the first analysis of how to treat patients on anticoagulants who suffer a major bleeding event, a clinical practice that routinely gives doctors pause, while also evaluating a new drug. They aimed to provide much-needed guidance to clinicians trying to balance the risks of stroke versus bleeding when determining the best treatment.

The analysis, published in Stroke, determined that resuming anticoagulation therapy after a person suffers a major bleeding event was associated with a higher likelihood of stroke-free survival than discontinuing anticoagulation.

Furthermore, restarting therapy with the new oral anticoagulant dabigatran was associated with a lower risk of recurrent hemorrhage in these cases than the old standby drug warfarin.

People take anticoagulants to avoid blood clots when they have a risk for stroke or heart attack, but the downside is that these medications increase a person’s risk of severe bleeding — such as in the brain or gut — because the blood isn’t clotting as well as it otherwise might.

Said lead author Inmaculada Hernandez, a pharmacy faculty member who completed this work as a doctoral student at public health: “If a patient who is on an anticoagulant to avoid a stroke has a major bleeding event, doctors are faced with a catch-22: Discontinue the anticoagulant to avoid future bleeding, but again place their patient at increased risk of stroke; or resume the anticoagulant to continue avoiding a stroke, but then have to worry about another bleeding event.”

Added co-author Yuting Zhang, health policy and management faculty member in public health, and Hernandez’s doctoral dissertation committee chair: “It causes a lot of uncertainty for physicians, especially because patients at highest risk of recurrent bleeding also are at highest risk of stroke.”

The research team obtained 2010-12 data from a random sample of Medicare beneficiaries. They then followed nearly 90,000 people who had filled prescriptions for the anticoagulants warfarin, which has been used as a medication since 1954, and dabigatran, which was approved by the U.S. Food and Drug Administration in 2010. More than 1,500 of those people suffered a major bleeding event while using one of the drugs. About half of those people resumed one of the two anticoagulants a few months after the bleeding, while the others did not.

The risk of dying from any cause or having a stroke was 23-34 percent higher in patients who discontinued anticoagulation therapy compared to those who resumed it. People who took dabigatran after their initial bleeding event had nearly half the risk of another major bleeding event within one year compared with those who took warfarin.

Said senior author Samir Saba, medicine faculty member and associate chief of cardiology at UPMC Heart and Vascular Institute: “Our results should encourage clinicians to seriously consider resuming anticoagulation among patients who survived a major bleeding event, particularly if the source of bleeding was identified and addressed. They should also take into account that the benefit-to-risk ratio of post-hemorrhage use of anticoagulation is not the same for all medications.”

Additional authors on this research were Maria M. Brooks of public health and a colleague from the University of Otago in New Zealand.

This research was funded by the Commonwealth Foundation, the Agency for Healthcare Research and Quality and the National Institute of Mental Health.

New childhood cancer researcher supported

To conduct innovative research and give more children the opportunity to participate in clinical trials, Jean M. Tersak, a School of Medicine faculty member, has been awarded a one-year, $50,000 grant from the St. Baldrick’s Foundation, a volunteer-powered charity dedicated to raising money for childhood cancer research.

The funding will help Tersak recruit a clinical data quality specialist for Children’s Hospital who will check the data collected from pediatric cancer clinical trials in real time to provide more accurate data for researchers. Improved efficiency will enhance the ability to conduct clinical trials, ultimately translating to additional opportunities for patients diagnosed with cancer.

Said Tersak, an oncologist in the Division of Pediatric Hematology/Oncology at Children’s Hospital, who also directs its survivorship program: “Cancer in children is devastating for families. I want to try to make the days the best they can be while walking this journey.”

—Compiled by Marty Levine

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