Duke University Hospital again named among nation’s best by U.S. News

August 14, 2018 – Seven specialties also earned top ratings in this year’s report.

Duke University Hospital has been named to the national Honor Roll as the No. 19 medical center in the country by U.S. News & World Report, which released its annual hospital rankings today.

Duke University Hospital also remains the No. 1 hospital in North Carolina and No. 1 in the Raleigh-Durham metropolitan area.

Honor Roll designations were awarded to the top 20 hospitals out of nearly 5,000 institutions across the country. Rankings consider patient safety, survival rates, technology, and the hospital’s excellence in a number of specialties.

Seven adult specialties at Duke University Hospital also earned top-25 rankings in this year’s report:

  • Cardiology and Heart Surgery (No. 15)
  • Nephrology (19)
  • Ophthalmology (No. 6)
  • Orthopedics (No. 11)
  • Pulmonology (No. 17)
  • Rheumatology (No. 12)
  • Urology (No. 12)

In addition, Duke Regional Hospital ranked No. 10 in North Carolina and No. 4 in the Raleigh-Durham Metro area. Duke Raleigh Hospital ranked No. 14 in North Carolina and No. 6 in the Raleigh-Durham area.

Partnerships between clinicians and researchers could change health care

August 13, 2018 – Clinical Data Research Networks are a valuable tool in expanding access to data and patients, a new study finds.

A new paper published in BMC Health Services sheds light on the motivations and challenges of engaging clinicians in the research process. In particular, it highlights the role of Clinical Data Research Networks (CDRNs) in providing access to data, patients, and health systems.

Among the authors is the DCRI’s Rowena Dolor, MD.

The authors conducted 60 semi-structured interviews with clinicians from a variety of disciplines and healthcare settings to get their insights into the benefits of, and barriers to, engaging with research.

What emerged were five themes:

  • The importance of research with relevance and benefits to clinics and patient populations
  • The difficulties of balancing research with existing patient care demands
  • A need for clear and continuous two-way communication about research
  • The demand for tailored compensation approaches to meet provider preferences
  • A need for increased clinician awareness about CDRNs

The authors concluded that their findings “can be used to guide the development of strategies to better engage providers in research in clinical settings, which could ultimately improve patient outcomes.”

Palmer, other Duke researchers receive NIH awards for training program

August 2, 2018 – The awards will support dedicated research track for resident-investigators within the departments of Pediatrics, Medicine, and Surgery.

Scott Palmer, MD, MHS, faculty director of the DCRI’s Respiratory Medicine group, is one of three Duke faculty members who recently received two R38 awards from two institutes within the National Institutes of Health—the National Institute of Allergy and Infectious Diseases and the National Heart, Lung, and Blood Institute.

The other Duke recipients are Sallie Permar, MD, PhD, professor of pediatrics, immunology, and molecular genetics and microbiology; and David Harpole, MD, professor of surgery, associate professor in pathology, and resident research director. Both awards provide approximately $884,000 over five years to support dedicated research track for resident-investigators within the departments of Pediatrics, Medicine, and Surgery.

The awards will support Duke’s Stimulating Access to Research during Residency (StARR) program. StARR is intended to address the declining number of opportunities for medical and scientist trainees to conduct research. The program trains physician-scientists in all aspects of biomedical research in order to cultivate investigators who will lead the development, implementation, and evaluation of new clinical modalities to prevent, diagnose, and treat disease states affecting the heart, lungs, and blood. Instructors will train residents in the three departments in areas that span the biomedical research continuum (basic/translational, early phase clinical trials and pharmacokinetics, and late phase clinical trials and outcomes) with a the goal of improving overall lifetime health.

Duke School of Medicine Dean Mary E. Klotman also recently announced plans to form a new Office for Physician-Scientist Development at Duke to coordinate Duke’s efforts in the recruitment, development, mentorship, and retention of physician-scientist across career levels. A search is underway for an Associate Dean for Physician-Scientist Development that will be responsible for the operational and strategic oversight of these new initiatives.

“Duke’s receipt of these important awards and establishment of this new office will catapult our ongoing efforts to encourage and help develop more physician-scientists, the number of which has been steadily decreasing,” said Klotman. “Physician-scientists bring a knowledge of both laboratory and clinical research that is essential for translating discovery.”

Better management of hyperphosphatemia to improve patient outcomes in end-stage renal disease

July 31, 2018 – The HiLo trial aims to define the optimal serum phosphate target in patients with end-stage renal disease undergoing hemodialysis.

One of the most time-consuming and labor-intensive challenges for patients with end-stage renal disease (ESRD) and their care teams is managing phosphate, according to Duke Nephrology’s and the DCRI’s Myles Wolf, MD, MMSc.

Because the kidney is responsible for excreting phosphate, hyperphosphatemia – when phosphate levels in the blood are abnormally elevated – is a nearly universal complication of ESRD. In addition to the potential cardiovascular risk posed by hyperphosphatemia, excessive use of phosphate binders to lower blood phosphate levels may also lead to calcium overload and impaired appetite, which can threaten patients’ nutritional status.

Clinical outcomes among patients with ESRD who are undergoing dialysis have improved modestly in recent years, but rates of hospitalization and mortality remain unacceptably high and quality of life is often diminished.

“Poor outcomes in ESRD are driven primarily by increased risk of cardiovascular disease and hyperphosphatemia is thought to contribute,” Wolf said. “Yet guidelines for how to best manage hyperphosphatemia are based on expert opinion rather than clinical trial data. For decades, we’ve inferred the need to lower serum phosphate from observational and pre-clinical studies, but we never proved if our approach is or is not helping patients.”

A new trial seeks to answer that question. Recently funded by a grant from the National Institutes of Diabetes and Digestive and Kidney Diseases, the HiLo study will be a pragmatic, multicenter outcomes trial that compares management of phosphate to either higher or lower serum phosphate targets. The low target (5mg/dl) aligns with current standard of care according to Wolf, the study’s principal investigator, while the higher goal (6-7 mg/dl) is the intervention strategy.

In its primary analysis, Hi-Lo will compare all-cause hospitalization rates between the lower and higher serum phosphate arms. Key secondary analyses will compare all-cause mortality and patient-reported outcomes.

About 4,400 patients being treated with hemodialysis are expected to enroll in the 45-month study across more than 120 dialysis facilities operated by large, mid-sized and smaller dialysis organizations in the United States. Consistent with its pragmatic design, HiLo will acquire data entirely from electronic health records at the point of clinical care, supported by a bioinformatics platform built and managed by the DCRI.

“By embedding rigorous research into clinical care delivery, HiLo addresses a question of great importance to patients and clinicians,” according to the University of Pennsylvania’s Laura Dember, MD, a member of the HiLo Steering Committee.

Dietitians who currently work in dialysis units, rather than traditional study coordinators, will contribute to the design and implementation of the HiLo protocols.

“Dietitians are among the most motivated caregivers on dialysis teams,” Wolf said. “They have great relationships with their patients and deliver high level, patient-centric care.”

HiLo will be conducted by the DCRI and collaborators across the country, including the University of Utah, Northwestern University, University of Pennsylvania, DaVita Clinical Research, Dialysis Clinics, Inc., and others. The trial is a demonstration project of the NIH Healthcare Systems Research Collaboratory, which supports the design and rapid execution of pragmatic clinical trials.

“It is gratifying to be a part of this remarkable collaboration between government, industry, academia and clinician-scientists to shed light on one of the key unanswered questions in the care of patients receiving hemodialysis,” said Geoffrey Block, MD, of Denver Nephrology, a member of the HiLo Steering Committee.

DCRI faculty to receive inaugural health data science awards

July 30, 2018 – The awards are part of Duke’s larger health data sciences initiative.

Two DCRI faculty members are among the recipients of the first Chair’s Pilot Project Grants in Health Data Science. The awards, announced this week by Duke’s Department of Medicine, are intended to grow the department’s involvement in health data science and support research to improve the quality of care for patients at Duke Health. The awards are also part of Duke’s larger health data sciences initiative led by Duke Forge.

Priority is given to projects that use data from Duke University Health System and are focused on improving patient outcomes at Duke Health. The awards will fund one year of research, with the opportunity for an additional year of funding.

The DCRI’s Ann Marie Navar, MD, PhD, co-chairs the department’s health data science effort.

The recipients of the awards are:

  • Sreekanth Vemulapalli, MD, assistant professor of medicine, for a project entitled “Machine Learning for Improved Identification of Rare and Common Cardiovascular Diseases”
  • Neha Pagidipati, MD, MPH, assistant professor of medicine, for a project entitled “A Health Data Science Approach to Personalized Obesity Management”

Incorporating real-world data into high-quality analysis

July 26, 2018 – A new article by DCRI researchers outlines strategies for integrating new types of data sources into traditional clinical trials.

Michael Pencina

A new article published in the Annals of Internal Medicine challenges the false dichotomy between randomized controlled trials (RCTs) and “real-world” data analysis. In “Deriving Real-World Insights from Real-World Data: Biostatistics to the Rescue,” the DCRI’s Michael Pencina, PhD, (pictured left) and Frank Rockhold, PhD, (pictured right) along with Boston University’s Ralph D’Agostino, examine the perceived limitations of traditional RCTs and propose ways that evidence gathered from electronic health records (EHRs) and other sources can be used to generate new insights into clinical outcomes and health.

Traditional RCTs are crucial for establishing causal relationships between the use of a therapy and an outcome. But while RCTs help researchers avoid important kinds of bias, they are often difficult, time-consuming, and expensive. And because their data is typically drawn from specialized research settings and carefully selected populations, concern has been raised how accurately their findings match “real-world” patient experiences and situations.

However, large volumes of biological and health outcomes data are now accumulating from sources such as EHRs, clinical registries, insurance claims databases, and information collected from personal devices and apps. Access to this wealth of information is allowing researchers to conduct new kinds of studies, but the use of problematic techniques and methods, as well as fundamental issues with data quality, can impose limits on the usefulness of real-world data.

In the article, Pencina, Rockhold, and D’Agostino describe strategies for overcoming these limitations and making effective and appropriate use data drawn from diverse sources and settings. Approaches such as embedding randomization within EHRs and other data sources, fitting models to RCT data and translating the model to a different population of interest, and matching variables from longitudinal datasets hold promise for enhancing the rigor and reproducibility of analyses performed on real-world data.

The authors conclude by suggesting that adopting a view in which different data sources and analytical methods are seen as potentially complementary rather than in opposition will expand the range of possibilities in clinical research, all while still allowing a commitment to rigorous, high-quality analysis.

Innovations in Medicare Advantage could improve care for seriously ill patients

July 24, 2018 – A new report from the Margolis Center for Health Policy outlines how recent changes in the Medicare Advantage program make it an ideal laboratory for testing new care delivery models.

Researchers at the DCRI and the Margolis Center for Health Policy have released a report on Medicare Advantage’s innovations for seriously ill patients.

Medicare Advantage is a type of health insurance provided by Medicare. Its financing structure, combined with recent statutory and regulatory changes, allow greater flexibility for delivering non-medical services and make it a fertile testing ground for new models of delivering care to patients with serious and advanced illness.

To learn more about new approaches that have been piloted in the Medicare Advantage space, the researchers examined three models developed by third-party firms that contract with Medicare Advantage plans: Aspire Health, Landmark Health, and Turn-Key Health.

These models are designed to improve care quality and reduce emergency department visits and hospitalizations by providing care management and high-touch, non-medical services that are poorly reimbursed in a traditional fee-for-service environment. The design and functions of these models, the researchers said, inform key steps that can be taken to accelerate the spread of these approaches throughout the broader health system, including encouraging payment reforms in traditional Medicare; rigorously studying the impact of serious illness models to expand the evidence of their impact on utilization, quality, and cost; and supporting workforce development initiatives to prepare providers for participation in value-based models.

The report was written by Andrew Olson, Matthew Harker, Robert Saunders, and Donald H. Taylor, Jr. (pictured).


Duke partners with Vivli to engage in a new era of open science

July 19, 2018 – The DCRI’s Frank Rockhold, PhD, will serve on the steering committee for the new data sharing and analytics platform.

Duke University School of Medicine has announced a partnership with Vivli, a nonprofit organization that today launched a new data sharing and analytics platform. With the launch of the Vivli platform, researchers worldwide will have a simple yet secure way to discover, share and analyze data from clinical trials, regardless of who sponsored the research or where the research took place.  Vivli, Duke and other partners hope that sharing data from clinical trials will expedite the development of cures and treatments for diabetes, Alzheimer’s, malaria and other diseases.

“Duke University School of Medicine is pleased to partner with the Vivli organization to foster the principles of open science and data access from clinical studies,” said Adrian Hernandez, MD, vice dean of clinical research in the School of Medicine (pictured right). “At Duke, we are committed to developing research polices, platforms and methods to provide appropriate access to research information, with the ultimate goal of expediting the development of new treatments to improve the health of patients around the world.”

Hernandez added that during fiscal year 2017, Duke led 494 clinical trials that were conducted locally.

The new platform allows researchers to store and share clinical trial data across all diseases, nations and research entities. Vivli also allows researchers to freely combine and analyze data from multiple trials using state of the art tools. This means researchers can validate research findings—from confirming a treatment’s safety to identifying side effects—and avoid duplicative studies, thus reducing costs and shielding research participants from unnecessary risks. The data can also be combined to ask new research questions, such as how a disease evolves over time, and gain information to inform the design of future studies.

Frank Rockhold, PhD, professor of biostatistics and bioinformatics at Duke University School of Medicine and a member of the DCRI (pictured left), has worked with ViAdrian Hernandezvli for more than four years as scientific advisor and as a member of its leadership team.  As part of this new partnership, he will be the representative for Duke on the Vivli steering committee and will continue as a senior academic advisor.

“The partnership between Duke and Vivli will combine the academic trial and data disclosure expertise of the Duke University School of Medicine with the passion and experience of Vivli and its other partners to provide a huge step forward in making clinical trial data available to researchers in a way that recognizes and respects the rights of patients and the contributions of the trialists,” said Rockhold.

The Vivli platform, powered by Microsoft, was built with grants from the Doris Duke Charitable Foundation, the Laura and John Arnold Foundation and the Leona M. and Harry B. Helmsley Charitable Trust.

Julius Wilder receives Clinical, Translational, and Outcomes Research Award from AASLD

July 11, 2018 -The award is presented to young researchers studying liver disease.

The DCRI’s Julius Wilder, MD, PhD, has received a Clinical, Translational, and Outcomes Research Award from the American Association for the Study of Liver Diseases (AASLD).

The award, which totals $200,000 over two years, is intended to foster career development for individuals performing clinical, translational, or outcomes research in a liver-related area and who have shown commitment to excellence at an early stage of their research study.

Wilder’s award will fund a project to contextualize why poor people, people of color, and people whose native language is not English are at a disadvantage for being listed for liver transplantation. The data generated by Wilder’s study will result in the creation of a intervention project to help patients with end stage liver disease circumnavigate perceived barriers to listing for transplantation.

“Once an individual has end stage liver disease, transplantation is their best option,” Wilder said. “Many lives are lost every year because individuals were unable to gain access to this precious resource. This award will allow me to identify barriers and create solutions for people with end stage liver disease who require a liver transplantation.”

Wilder earned his MD and PhD at Duke and was a DCRI Fellow. He has been a DCRI faculty member since 2016.

The DCRI welcomes new faculty members

July 10, 2018 – The seven new faculty members come from the departments of Pediatrics, Cardiology, Neurology, and others.

Stephen J. Balevic, MD, MHS

Stephen J. Balevic, MD, MHS, joined the DCRI on July 1 as an assistant professor in the departments of Pediatrics and Internal Medicine at Duke University Medical Center. He was most recently an adult and pediatric rheumatology fellow at Duke University, and a pediatric clinical research fellow at the DCRI.

Balevic completed medical school at the Marshall University School of Medicine in his home state of West Virginia, and a combined internal medicine and pediatric residency at the Medical University of South Carolina. He obtained his MHS degree with a concentration in clinical pharmacology through the Clinical Research Training Program at Duke University/UNC School of Pharmacy, and his bachelor’s degree from UNC-Chapel Hill.

Balevic’s research interests are in clinical pharmacology, precision medicine, and clinical trials.

Satasuk Joy Bhosai, MD, MPH

Satasuk Joy Bhosai Satasuk Joy Bhosai, MD, MPH, joined the DCRI on July 1 as a Hospitalist Physician with Duke Health and a member of the executive leadership team for the DCRI Innovations group. Most recently she completed her residency at Duke, during which time she completed the Duke Management and Leadership Program. In that program, Bhosai designed multiple health systems leadership initiatives focused on patient safety, quality improvement, and digital innovations.

She earned her medical degree from the University of California, San Francisco, completing the global health pathways program. She holds an MPH degree with a focus in health management from Yale University, School of Public Health and Yale School of Management, as well as bachelor’s degrees in anthropology and neuroscience from Pomona College. She was a Fulbright scholar at the National Cancer Institute/Prince Mahavahiralongkorn Cancer Center in Thailand.

Bhosai’s work addresses gaps in access to high-quality care. Through previous public health work in Africa and Asia, she developed innovations dedicated to improving access to health services. She is the co-founder of ChatrHealth, a software group that specializes in creating patient safety applications for hospitals and providers, which has been supported by large academic centers and the World Bank. Bhosai has worked with Health 2.0, directing the Matchpoint program, which pairs industry leaders with health tech startups.

Michael L. James, MD, FAHA, FNCS

Luke JamesMichael L. (Luke) James, MD, FAHA, FNCS, joined the DCRI as an associate professor of anesthesiology and neurology on April 1. He is also associate director of Duke Clinical Anesthesiology Research Endeavors (CARE), a departmental initiative to further organize clinical research efforts in all areas of anesthesia and perioperative research at Duke University, and associate director of the Duke Brain Injury Translational Research Center.

James joined the Duke faculty in 2006 and has been the Duke principal investigator for multiple large, multi-center intracerebral hemorrhage and brain trauma trials. He has served in the clinical research unit for anesthesiology, as part of the neurocognitive core for the Cardiothoracic Surgical Trials Network, on the Duke IRB, and at Duke’s sister medical school in Singapore.

In addition to maintaining an active clinical practice, in recent years James’s focus has shifted towards clinical research. He and his research collaborators continue to advance translatable therapeutic opportunities into human investigation for acute intracerebral hemorrhage and brain trauma. Their current research focuses on noninvasive measurement of brain temperature and metabolism, systemic effects of acute neurological injury, gonadal hormone modulation of neuroinflammation, and the therapeutic potential of apoE-mimetic peptides.

James has worked to foster long-term multidisciplinary collaboration in all subspecialties that practice neurocritical care. He has served on the Board of Directors of the Society for Neuroscience in Anesthesiology and Critical Care, represent the Neurocritical Care subspecialty at the United Council of Neurological Subspecialties, and played central roles in the Neurocritical Care Society and Society of Critical Care Medicine.

James received his MD degree from Louisiana State University and his bachelor’s degree from Vanderbilt University. He completed residencies in neurology and anesthesiology with fellowships in neurocritical care, neuroanesthesia, and vascular neurology.

Amber J. Oberle, MD

Amber OberleAmber J. Oberle, MD, joined the DCRI as a medical instructor in the Department of Medicine’s Pulmonary, Allergy, and Critical Care division on July 1.

She earned her medical degree from Creighton University School of Medicine in Omaha, NE and completed a residency in internal medicine and a fellowship in pulmonary and critical care medicine at Indiana University. She holds a BS degree in chemistry from Creighton University.

Oberle’s research focuses on asthma and other pulmonary diseases. While at Indiana University, she founded the Adult Asthma Center, dedicated to managing severe asthma and complex airway diseases. Oberle is a member of the American Thoracic Society and the American College of Chest Physicians.


Kishan S. Parikh, MD

Kishan ParikhKishan S. Parikh, MD, joined the DCRI as an assistant professor in the Department of Medicine’s Cardiology division on July 1. He most recently completed a fellowship in Advanced Heart Failure, Mechanical Circulatory Support, and Transplant at Duke University. Prior to that, he was a cardiology fellow at Duke, where he was chief cardiovascular fellow, and a clinical research fellow at the DCRI under the mentorship of Adrian Hernandez and G. Michael Felker. He also pursed additional coursework in clinical pharmacology training at the UNC Eshelman School of Pharmacy during his DCRI fellowship.

He earned his medical degree from Feinberg School of Medicine, Northwestern University and completed his residency in the Department of Medicine, University of Chicago, where he served as chief resident. He holds a bachelor’s degree in biology from Northwestern.

Parikh’s research interests are focused on improving care for pulmonary hypertension and heart failure, and bringing the fields closer to the concept of targeted therapy. More specifically, he aims to integrate the clinical approach to pulmonary hypertension and heart failure with prediction of therapeutic response. He currently serves as co-principal investigator and principal investigator for several Phase I and II trials of investigational agents and mobile health monitoring in pulmonary hypertension, and he led a first-in-man study of invasive hemodynamic monitoring in pulmonary arterial hypertension. He also has studied use of pharmacogenetics in heart failure.

He served on the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) for Peripheral Venous Disease and continues to serve as a Duke Margolis Center for Policy fellow focused on the use of real-world evidence in regulatory decision making. He helped plan and synthesize a report for a recent DCRI Think Tank on heart failure with preserved ejection fraction.

 Kathleen Welsh-Bohmer, PhD

Kathleen Welsh-BohmerKathleen (Kathie) Welsh-Bohmer, PhD, joined the DCRI on May 1 to lead Alzheimer’s disease trials. She is a professor of psychiatry and neurology at Duke University as well as the chief of the Medical Psychology Clinical Professional Unit, the professional home for the more than 200 academic psychologists within the Duke Health system.

Clinically trained as a neuropsychologist, Welsh-Bohmer’s research activities have been focused on developing effective prevention and treatment strategies to delay the onset of cognitive disorders occurring in later life. She was the principal investigator of the Cache County Memory Study, an epidemiological study of an exceptionally long-lived population that established key environmental modifiers affecting Alzheimer’s disease onset and progression.

Since 2006 Welsh-Bohmer has directed the Joseph and Kathleen Bryan Alzheimer’s Center in the Duke Department of Neurology, where she leads a large multidisciplinary team focused on discovering the biological basis of Alzheimer’s disease and developing methods to enhance early diagnosis and speed drug discovery. Since 2011, she has led the neuropsychology scientific operations of a Phase III global clinical trial to delay the onset of Alzheimer’s disease entitled the “TOMMORROW” study.

Welsh-Bohmer joined the Duke University faculty in 1987. She received her PhD and master’s degree from the University of Virginia, postdoctoral specialization in neuropsychology from the University of Iowa, and her bachelor’s degree from Duke. She is board certified by the American Psychological Association in the practice of neuropsychology.

Christina M. Wyatt, MD

Christina M. Wyatt, MD, joined the DCRI as an associate professor in the Department of Medicine’s Nephrology division and an associate director for the DCRI fellowship program on July 1. Prior to joining the DCRI, she was an associate professor in the Department of Medicine, Division of Nephrology, Icahn School of Medicine at Mount Sinai in New York. Since 2017, she served as Associate Chair for Clinical and Translational Research in the Mount Sinai Department of Medicine.

Wyatt earned her medical degree from Duke University School of Medicine. She completed her residency and was chief resident in the Department of Medicine and completed a fellowship in the Division of Nephrology at the Mount Sinai School of Medicine. She also holds an MS degree in biostatistics with a focus on clinical research methods from Columbia University’s Mailman School of Public Health. She received her bachelor’s degree in history from Duke.

Wyatt’s research focuses on nephrology and kidney disease, particularly kidney disease and medication toxicity in patients with or at risk for HIV infection. She has published extensively on these topics and currently serves on the editorial boards of Kidney International and JAIDS. She is a member of numerous scientific working groups and is on the Executive Committee for Kidney Disease: Improving Global Outcomes (KDIGO), an international guidelines organization.​