DCRI begins early-stage clinical trial of antimalarial drug

September 10, 2018 – The study is being conducted by the Duke Early Phase Clinical Research team at the DCRI.

Enrollment has begun in a phase I clinical trial to test the safety of a new investigational drug designed to treat malaria, as well as its effect on the human body. The first-in-human study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

In 2016, an estimated 216 million new malaria cases and 445,000 deaths occurred, primarily among children living in sub-Saharan Africa, according to the World Health Organization (WHO). Although several approved treatments for the mosquito-borne disease exist, increasing drug resistance among the malaria-causing parasites is diminishing their effectiveness.

Michael Cohen-Wolkowiez

“The increasing problem of drug resistance demands that we continue to find new and effective treatment options for malaria infection,” said NIAID Director Anthony S. Fauci, MD.

The new study, led by principal investigator Michael Cohen-Wolkowiez, MD, PhD, faculty director of Duke Early Phase Clinical Research and professor of pediatrics at the DCRI, is testing an investigational drug called DM1157, invented at Portland State University and developed by DesignMedix, both based in Portland, Oregon. The novel treatment is a modified form of chloroquine, an established antimalarial drug that kills malaria parasites once they have infected human red blood cells.

Many strains of Plasmodium falciparum parasites, which cause the deadliest form of malaria, are now resistant to chloroquine, and the parasites can expel the drug before it can affect them. Like chloroquine, DM1157 interferes with the parasite’s metabolism, but it also inhibits the parasite’s ability to expel the drug. Results of earlier tests in animals suggest that DM1157 could have the same safety and efficacy as chloroquine.

“Development of new drugs for malaria will allow us to successfully treat resistant infections in a patient population in desperate need of these therapies,” Cohen-Wolkowiez said. “At Duke, we are uniquely positioned to evaluate drugs such as DM1157 because we have experience conducting first-in-human studies and are the only academic institution participating in the NIAID DMID Phase I Clinical Trial Units for Therapeutics consortium. We also have unique expertise in developing protocols with multiple parts that increase operational efficiencies substantially.”

The study will enroll up to 104 healthy volunteers between the ages of 18 and 45 years old. Volunteers will be randomly assigned to one of three groups: the first group (56 volunteers) will fast overnight and then receive either a single dose of the experimental drug at one of seven dosage levels (9 milligrams [mg] through 900 mg) or a placebo. The second group (40 volunteers) will also fast overnight and then receive either one dose containing 150, 300, 600, or 900 mg of DM1157, or a placebo. The volunteers in the second group will repeat this routine for two more consecutive days. The third group (8 volunteers) will be given either a single 300-mg dose of the investigational drug or placebo after eating a high-fat meal to determine whether the investigational drug has different effects when taken with food. Volunteers in each of the three groups will be monitored for adverse effects throughout the trial and will provide blood samples for at least five days after their last dose. The study is expected to be completed by June 2019.

DCRI and Cerner collaborate on new cardiac risk app

August 28, 2018 – The app is designed to pull patient health data from multiple sources in order to provide a more comprehensive summary of a patient’s health.

The DCRI and Cerner are working together to develop an atherosclerotic cardiovascular disease (ASCVD) Risk Calculator app, designed as a tool to increase communication between the person and their doctor about ways to live a healthier life and risk factors for heart disease and stroke.

Ann Marie NavarThe app helps health care providers estimate 10-year and lifetime ASCVD risk for patients based on information like age, race, sex, blood pressure, cholesterol levels, smoking status and diabetes status. If untreated, ASCVD can lead to heart attack and sudden cardiac arrest, as well as fatal and nonfatal stroke. To facilitate shared decision-making between the person and their doctor to guide treatment decisions, the app was designed to factor in a person’s willingness to take action to improve their health and the risks and benefits of potential therapies.

Guidelines from the American College of Cardiology and American Heart Association now emphasize using the 10-year calculator to identify adults for statin therapy,” said Pierre Elias, MD,  cardiology fellow at Columbia University and former medical student at Duke University School of Medicine. “We wanted an app that would make it easier for clinicians to calculate risk at the point of care. Whether it’s the primary care clinic or a cardiologist’s office, I can’t tell you the number of times this can get missed when there are so many other problems to manage. Making it faster and easier to get news you can use leads to better patient care.”

The DCRI and Cerner worked together to develop the software through the Cerner Open Developer Experience that encourages innovators to build apps that advance the health care industry. Through Cerner’s open source code, doctors from the DCRI provided clinical direction to create an app that could be embedded within Cerner’s electronic health record (EHR) for each patient. Cerner wrote, maintains and hosts the ASCVD Risk Calculator under an open source license.

“We developed the app to be able to pull important patient health data across multiple EHR suppliers at different venues of care in order to get a full picture of how to improve that patient’s health,” said the DCRI’s Ann Marie Navar, MD, PhD, who led the collaboration. “Cerner’s open platform encourages collaboration, which will help advance the way care is delivered regardless of the specific platform people are using.”

The ASCVD Risk Calculator app is available to providers in the SMART App Gallery and the Cerner Open Developer Experience (code) App Gallery.

Pain intensity can predict healthcare utilization for physical therapy patients

August 24, 2018 – A study by DCRI researchers finds that baseline disability and changes in pain levels can help predict which patients will require further treatment.

Monitoring for specific characteristics could help healthcare providers more accurately predict which patients will require additional care, according to a recent study by DCRI researchers.

The study, led by DCRI Fellow Trevor Lentz, PhD, appears in BMC Health Services Research.

Trevor LentzTreatment for musculoskeletal pain is a widespread and costly condition, with many patients requiring additional downstream care. Current payment models in the United States have led many health care services organizations to prioritize early identification of individuals at risk for downstream healthcare use at the onset of treatment.

In this study, the researchers examined data from the Orthopedic Physical Therapy – Investigative Network’s (OPT-IN) Optimal Screening for Prediction of Referral and Outcome (OSPRO) validation cohort study, a longitudinal prospective study of individuals with knee, shoulder, back or neck pain seeking physical therapy in the United States. They collected potential predictors by self-reported questionnaires at initial evaluation using an online study website. Participants were directed back to the study website four weeks after the initial evaluation to again complete questions on pain intensity, disability, and pain-related psychological distress. At six months and one year after baseline evaluation, individuals reported use of opioids, injection, surgery, diagnostic tests or imaging, and emergency room visits for their pain condition over the follow-up period.

Subsequent pain-related healthcare utilization was reported by 43 percent of the study sample that completed the one year follow-up. Baseline disability and four-week change in pain intensity were important global predictors of subsequent healthcare utilization. Age, insurance status, comorbidity burden, baseline pain, and four-week changes in pain intensity, disability and pain-related psychological distress predicted specific service utilization.

These findings, the researchers concluded, suggest treatment monitoring of specific response variables could enhance identification of those at risk for future healthcare utilization in addition to baseline assessment.

In addition to Lentz, the study’s authors included the DCRI’s Steven George, PhD, and the University of Florida’s Jason M. Beneciuk.

A perspective on leadership

August 21, 2018 – DCRI founder and former U.S. Food and Drug Administration Commissioner Robert Califf, MD, provides some thoughts on the past and future of the DCRI.

By Robert Califf, MD

The DCRI is currently experiencing its fourth transition in leadership since its founding in 1996. It seems like only yesterday that we were first imagining what could be accomplished if we organized an entity that convened talented staff and faculty leadership within an operational infrastructure—one that was purposefully designed to enable faculty in leading and conducting multisite clinical research in concert with remarkably creative staff professionals.

Early Successes, Early Challenges

Our early experience was shaped by significant success with research done in acute care cardiology and undergirded by the decades of development that went into the Duke Databank for Cardiovascular Disease. Despite this promising foundation, building the DCRI nevertheless entailed substantial risk. We endured many sleepless nights as we tested the capacity of an academic medical center to work with other academic leaders and clinical research sites around the world to generate large volumes of high-quality evidence in conjunction with industry, the National Institutes of Health, and other federal agencies. However, the result of these early efforts was not only a large and productive organization, but also the development of a generation of leaders in clinical and translational research, as highlighted recently in Forbes.

Growth and Transition

Successfully navigating changes in leadership is essential for any institution. After a period of initiation and leadership, I left the DCRI in 2006 to found the Duke Translational Medicine Institute (now the Duke Clinical and Translational Science Institute) when we received our first CTSA grant. At this point Dr. Robert Harrington, a faculty cardiologist, took the reins. During his tenure, he improved upon deficiencies that had evolved during my tenure and moved the DCRI to a new level by focusing on worldwide collaborations in multiple therapeutic areas while building the depth and diversity of quantitative sciences. Stanford University wisely recruited Dr. Harrington from Duke in 2012, doubtless seeking to leverage his considerable administrative and leadership skill, as well as his knowledge of clinical research, to complement its globally prominent discovery science and technology enterprises.

During this interval, the global research enterprise was pivoting toward the use of “real-world evidence” and an approach that blended health services research, quality assessment, and clinical trials. Dr. Eric Peterson, a highly accomplished outcomes research leader who was already an integral part of the DCRI faculty community, was well-suited to take the helm and steer the organization in this new direction. His leadership of key projects for the Databank for Cardiovascular Disease, the Society of Thoracic Surgeons Registry, the precursor to the American College of Cardiology registries, and the American Heart Association’s “Get With The Guidelines” effort paved the way for the current focus on real-world evidence.

The DCRI’s achievements under Eric’s leadership are substantial. Over the 6 years he led the organization, hundreds of clinical trials and other research studies were conducted. In the first 20 years of the DCRI from 1997 to 2017, DCRI faculty and staff published 12,230 peer-reviewed manuscripts and 2,192 of these were published in journals with an impact factor of 10 or higher. Eric’s tenure saw a marked acceleration in the pace of academic productivity, with more than 5,500 manuscripts published; of these, 1,090—20 percent—appeared in journals with an impact factor of 10 or higher. Dozens of fellows have been educated, a program to train fellows at the NIH has continued successfully, almost $1.5 billion in research funding was awarded, and substantial indirect costs have been generated for the institution. More than 130 faculty across multiple therapeutic areas and scientific disciplines have DCRI appointments. The institution is thriving while contributing to new and related efforts in the Department of Population Health Sciences and the Department of Biostatistics and Bioinformatics, and it’s also forging new alliances with the clinical and information technology communities.

Looking Back, Moving Forward

Now, after 6 years as DCRI director, Eric has decided to take a new direction in his career, and Dr. Lesley Curtis has stepped in as interim director. Dr. Curtis is an experienced and able leader, researcher, and administrator, one with a track record as an inspirational pioneer in combining real-world data with novel methods to produce real-world evidence that can guide decisions about health and healthcare. While the institution prepares to undertake a global search preparatory to recruiting a new leader, as the founding director of the DCRI, I find myself reflecting on the job and the characteristics and circumstances that should be considered by the next generation of leaders. What have been the key factors in the DCRI’s success?

First and foremost, the DCRI was built on strong collaboration among clinical investigators, biostatisticians, informaticians, and operational staff. Over time, the array of collaborators expanded to include health services researchers, economists, epidemiologists, and data scientists. Because the DCRI is poised at the interface of industry, government and academia, its relative independence is critically important. This independence encompasses the ability to manage financial issues in ways that allow the DCRI to grow and invest in its own future. The operational and financial needs of multisite research are different than single-site research done internally at Duke; the job titles and responsibilities are complex and sometimes idiosyncratic to the clinical research industry and distinct from other parts of the university. And the regulated information technology environment has required a level of attention to auditable issues that was not present in the rest of the medical center until recently.

Accordingly, the DCRI needed its own human resources, legal, and information technology structures that were part of Duke but were also constituted as independently operating units with decision-making authority. The DCRI’s matrix leadership structure (with scientific leadership on one side, business/operations leadership on the other, woven together in a matrix system of organization), while unusual for an academic medical center, is also central to the institute’s success. The huge educational investments in fellowships and faculty development have greatly aided the creation of a mission-driven culture of research on campus with a size and scope that are hard to match. Substantial effort is needed to produce and sustain operational expertise. Likewise, the development of faculty leaders who are clinical experts but who also devote significant time to research concerning the diseases and problems afflicting the patients they care for gives Duke an edge in the national competition for grants and contracts. More importantly, the research driven by the DCRI has benefitted from the close involvement of researchers with deep, first-hand knowledge of clinical issues, generating the evidence that gives patients and clinicians the knowledge that truly informs practice.

However, the multifarious and sometimes competing priorities of different funders and sponsors across the clinical research enterprise can present challenges for the DCRI. While in some ways the DCRI invented the “technology-enhanced megatrial” with the GUSTO study, the enormous clinical need and large amounts of money involved attracted the interests of business, and for-profit contract research organizations now dominate this arena. At the same time, Duke’s relatively conservative institutional approach to interaction with for-profit entities has made the large amounts of capital in this space used for investment in technology upgrades inaccessible to the DCRI, which is thus highly dependent on its own operating margins for investment in large-scale research infrastructure.

In addition, academic centers continue to grapple with the diverse interests of faculty and an organizational structure that tends to aggregate resources in siloed departments. This in turn leads to friction about the allotment of faculty time and effort and competitive infrastructure investments, pressure that Dean Klotman is now addressing through the “One Duke” effort. Finally, the field of clinical research as an academic endeavor continues to suffer broadly from “Rodney Dangerfield syndrome”—it “don’t get no respect” relative to the perceived primacy of basic science and discovery research.

Despite these challenges, the DCRI is a robust organization that continues to generate high-quality, reliable evidence across the spectrum from early translation to population studies. It also continues to pioneer new methodologic approaches to research, most notably the use of electronic health records, claims data, and wearable devices and sensors in the development of actionable evidence. Its faculty and staff play critical roles in the development of academic and regulatory standards through organizations such as the Clinical Trials Transformation Initiative and the Cardiac Safety Research Consortium. Its pediatrics component has several of the largest most important NICHD long-term grants and contracts for therapeutics (the Pediatric Trials Network) and epidemiology (ECHO), which together account for almost $200 million in funding over 9-10 years. It also serves as the coordinating center for the NIH-funded Health Care Systems Research Collaboratory and the pioneering National Patient-Centered Clinical Research Network (PCORnet), both of which are engaged in critically important proof-of-concept research in the arena of pragmatic clinical trials. And it co-leads the Antibiotic Resistance Leadership Group, a long-term NIH consortium dealing with critical issues in antibiotic resistance. These are only a few of the many areas in which DCRI is setting the pace for future research, filling critical national needs for evidence and conducting complex research with the high-quality operations needed for multisite research.

Evolving Challenges and New Opportunities

Clinical research is changing, and our local environment is complex. Faculty will thrive if they have access to robust infrastructure that can deliver proposals, operations, and data that match the design and analysis that represent the academic “sweet spot” for faculty effort. The transition to a digital information environment has massively expanded access to data that must be organized and approached with appropriate research methods in order to enable a learning health system. We are moving away from a construct oriented around clinical research sites toward one based on clinical research systems. And because large health systems now own most of U.S. clinical research sites, a common infrastructure for operations, contracting, and ethics review is being established.

Our own efforts at Duke should show the way in transforming the fundamental idea of research from a set of activities comprising a “set-aside” distinct from other missions, to a construct in which learning through research is a fundamental attribute of the health system. The power of closer collaboration among the Duke Health System and Duke Office of Clinical Research (DOCR), the DCRI, and the Department of Population Health Sciences, further enabled by the expansion of the quantitative science expertise across campus, could unleash a powerful, higher-quality, and less expensive institutional effort in clinical and population research consistent with Dean Klotman’s vision of “One Duke.”

This period of transition is a perfect time to imagine what is possible if we pull together, take advantage of a successful past that has changed the way clinical research is done, and create a new approach that will bring the clinical care and research worlds into a common learning system. A new leader for DCRI will need to consolidate the successful strategies and infrastructure of the past, “ride the wave” of changes in the new digital learning health environment, and lead the organization with vision while balancing the tensions inherent in the job.

I can see that many people from a diverse array of backgrounds could be up to the task. The ability to navigate a rapidly evolving environment while providing inspiration and leadership to faculty and staff is a more important consideration than is specific research discipline. I am certain that Dr. Curtis will continue to enhance the DCRI as previous leaders have until a permanent successor is chosen. There has never been a more exciting time for clinical research, and I’m confident that the DCRI can lead the transition to a learning health system.

This post originally appeared on Duke Forge.

Gout could increase heart disease risk

August 20, 2018 – In a recent study, patients with gout had a twofold increased risk of death from heart failure compared to people who never had gout.

Having a type of inflammatory arthritis called gout may worsen heart-related outcomes for people being treated for coronary artery disease, according to new research.

A recent study in The Journal of the American Heart Association sought to clarify older research on the link between cardiovascular disease and gout, which occurs in people with high levels of uric acid in the blood.

In the U.S., gout affects nearly 6 million men and 2 million women, or about 4 percent of the population, according to the Arthritis Foundation. The buildup of uric acid can form needle-like crystals in a joint and cause sudden pain, tenderness, redness, warmth and swelling, often in the big toe. But it’s also associated with a greater risk of kidney disease, diabetes, cancer and sleep apnea.

Researchers from the DCRI studied data from more than 17,000 patients, including 1,406 who had gout at the start of the study and were being treated for cardiovascular risk factors. After following patients for an average of 6.4 years, researchers found that “in spite of aggressive medical therapy,” the gout was linked to worse outcomes and death.

“Among patients who had gout at the beginning of the study or who developed it during follow-up, their risk of either dying of cardiovascular disease or having a heart attack or stroke was 15 percent higher than patients who never developed gout,” said the study’s lead author, Neha Pagidipati, MD, MPH.

Patients who had gout at any point during the study had a twofold increased risk of heart failure death compared to people who never developed gout.

While past research showed people with gout have an increased risk of cardiovascular disease, “a lot of those studies were done decades ago, before modern preventative therapy like statins became extremely common,” Pagidipati said. “We wanted to take a more contemporary look at the relationship between gout and future heart disease in patients with known coronary artery disease.”

Many patients don’t even realize a link exists between gout and heart problems, she said, and the new findings show the need for patients to talk to their physicians about added risks.

“Also, from a physician’s perspective, it’s important to consider that patients with gout may be at increased risk for cardiovascular disease even if they’re already treating them with all the standard therapies. It’s something to have on their radar,” Pagidipati said.

Although it’s unclear why gout might increase the risk of cardiovascular disease, she said possible reasons include increased oxidative stress and inflammation.

“We know that people who have a high level of inflammation are at an increased risk for cardiovascular disease, and we also know gout is characterized by periods of acute inflammation,” Pagidipati said. “The link may have to do with that.”

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”