Hyperlipidemia Not Associated With Cardiovascular Risk in Older Adults

August 20, 2019 – Recent findings suggest that elevations in low-density lipoprotein cholesterol levels may not confer additional risk in populations 75 or older.

Although hyperlipidemia is a well-established factor that indicates risk for cardiovascular events in younger adults, findings from a recent DCRI study show that this measure may not be an accurate predictor in adults 75 or older.

The study, led by DCRI fellow Michael Nanna, MD, (pictured), examined 2,667 older adults with no known cardiovascular disease to determine the association between hyperlipidemia, or elevated low-density lipoprotein cholesterol (LDL) levels, and cardiovascular events. The study team assessed events over a 5-year period in patients with and without hyperlipidemia and recently published results in the Journal of the American Geriatrics Society.

“We wanted to look at this population because although there is a robust body of evidence for the association in younger adults, there is not as much evidence for the older population,” Nanna said. “We are caring for more and more older adults in the clinical setting, so it is increasingly important for us to understand how to assess and stratify their risk.”

The study team split its participants into three groups: no other risk factors—which was defined as free of smoking, diabetes, and hypertension; one non-hyperlipidemia risk factor; and two or more non-hyperlipidemia risk factors. In the group with no other risk factors, cardiovascular event rates were similar between those with and without hyperlipidemia. In the other two groups, there was also no association between hyperlipidemia and cardiovascular events.

“These findings show that in older adults, we should be looking more at cardiovascular risk factors such as hypertension and diabetes rather than LDL levels to identify people for aggressive risk reduction strategies,” Nanna said.

Although the investigators did not find an association between hyperlipidemia and increased risk, Nanna emphasized that these findings should not be misinterpreted to imply that statins are ineffective. “In younger adults, statins have been shown to lower cardiovascular risk across a large range of LDL levels, and randomized trials of statins in older adults are on the horizon,” he said.

“These data highlight the importance of conducting well-done randomized clinical trials to investigate the safety and efficacy of statin therapy for both primary and secondary prevention in older adults,” said the DCRI’s Eric Peterson, one of the co-authors of the study.

Other DCRI contributors to this study include Ann Marie Navar, MD, PhD.


DCRI and Responsum Health Announce Collaboration to Connect Uterine Fibroids Patients

August 13, 2019 – Responsum Health, a company that creates patient platforms for chronic diseases, will create a patient-centered information portal and community hub that will synchronize with the DCRI’s COMPARE-UF patient registry.

The DCRI is partnering with Responsum Health, an innovative creator of personalized patient newsfeeds and support platforms, to improve the quality of life for patients with uterine fibroids. They are joined in this effort by The White Dress Project and CARE About Fibroids, two of the nation’s top uterine fibroids patient advocacy organizations. The announcement follows Fibroids Awareness Month, recognized in July.

Through the partnership, Responsum will commit to developing and promoting a unique, uterine fibroids patient-centered information portal, similar to its work in other therapeutic areas. This new platform will serve the dual goals of providing comprehensive, understandable, and trustworthy information while helping to connect a nationwide community of patients. The new web-based tool and app, Responsum for UF, will synchronize with the DCRI’s unique patient registry, COMPARE-UF (Comparing Options for Management: Patient-centered Results for Uterine Fibroids).

The COMPARE-UF registry is funded by the Agency for Healthcare Research and Quality (AHRQ), in collaboration with the Patient-Centered Outcomes Research Institute (PCORI). DCRI serves as the Data and Statistical Coordinating Center.

The registry has enrolled more than 3,000 women from nine medical centers. By sharing their experiences with uterine fibroids treatments, these women are helping doctors understand symptom relief patterns, impact on pregnancy, and the need for additional treatment. The goal of COMPARE-UF is to help patients and their doctors make informed decisions about treatment options.

COMPARE-UF will follow the patients in its registry, who are women between the ages of 18 and 54 who have been diagnosed with uterine fibroids and who are not in the transition to menopause.

“We are very excited to be working with Responsum, CARE About Fibroids, and The White Dress Project to develop innovative ways for women to share their experiences with uterine fibroids, as well as to get the best possible information about their choices for treatment,” said Dr. Evan Myers, principal investigator of COMPARE-UF at DCRI.

“We look forward to collaborating with the Duke Clinical Research Institute to help collect valuable insights from women with uterine fibroids,” said Andrew Rosenberg, founder of Responsum Health. “By bringing the patient experience to bear through our partnerships with The White Dress Project and CARE About Fibroids, we will create an online tool, newsfeed, and support platform that fills a vital information gap while simultaneously convening an authentic, welcoming online community for women with uterine fibroids.”

“We are thrilled to partner with the Duke Clinical Research Institute and Responsum Health as we continue to fulfill our mission of heightening public awareness and creating a greater sense of urgency around the toll and challenge of uterine fibroids,” said Jenny Rosenberg, executive director of CARE About Fibroids. “Combined with The White Dress Project’s incredible patient advocate network, we look forward to bringing the strategic communications capabilities along with the scientific and policy expertise of CARE About Fibroids to join this extraordinary opportunity to provide women with a trustworthy, online information platform to replace Dr. Google.”

“The White Dress Project is committed to growing, educating, and enriching a community of women who feel confident knowing they no longer have to suffer in silence with uterine fibroids,” said Tanika Gray Valbrun, executive director of The White Dress Project. “Our partnership with the Duke Clinical Research Institute and Responsum Health is a groundbreaking way to make sure women are better informed and equipped to be their own best advocates.”

DCRI Study Finds New Predictor of Health Care Costs

August 6, 2019 – New findings from the DCRI suggest that how military service members interpret their pain may be able to predict pain-related costs and total medical costs.

New data from a DCRI study suggest that pain catastrophizing, a measure determined by the results of a 13-item questionnaire that indicates how patients interpret their pain, could be important in predicting future health care utilization and costs in patients with musculoskeletal pain.

Trevor Lentz, PT, PhD, MPHA recently published study in the Journal of Pain, led by the DCRI’s Trevor Lentz, PT, PhD, MPH, (pictured), examined a cohort of 283 military service members returning from Afghanistan who reported musculoskeletal pain during a medical screening process in August or September 2011. These service members were asked to complete both the pain catastrophizing scale (PCS) and a body diagram that details the location of their pain. Scores on the PCS indicate how patients interpret their pain by measuring three components: rumination, or how often they think about their pain; magnification, or how much they emphasize their pain, and helplessness in managing their pain.

The study team examined the results of both to determine processes that influence the following outcomes at 12 months: incident use of opioids over a short term, chronic use of opioids, condition-specific medical visits, condition-specific medical costs, and total medical costs.

The team also looked at how pain intensity at intake, as well as disability, influenced these outcomes. However, prior to this study, not much was known about the role that pain catastrophizing or distribution of symptoms on a body diagram played in predicting outcomes.

“The influence of certain psychological factors, like pain catastrophizing, for predicting pain related clinical outcomes is well-established in the literature, but less is known about how these same factors influence healthcare utilization and costs,”  said the DCRI’s Steven George, PT, PhD, FAPTA, one of the study co-authors.

“We wanted to understand the processes that result in these outcomes by asking, ‘What are the underlying characteristics we need to attend to while developing outcomes prediction models and treatment pathways?’” Lentz said.

The data showed that pain catastrophizing informs both condition-specific costs and total costs. This means that patients with higher pain catastrophizing scores were more likely to experience higher healthcare costs, even after considering the level of pain intensity at intake. The score also acted as a partial indicator for how many condition-specific visits a person would have.

“As we move toward value-based care, it will be important for us to determine where and with whom costs will be concentrated, enabling us to intervene earlier to improve the cost effectiveness of pain-related care,” Lentz said.

The results suggest that certain outcomes, such as healthcare costs and utilization, could be more accurately predicted by weighing factors like pain catastrophizing in addition to pain intensity or disability. In contrast, neither pain catastrophizing nor body diagram score improved prediction of future opioid use beyond baseline pain intensity and disability.

The findings also indicate that different approaches may be needed for building predictive models for costs versus healthcare utilization. But the primary takeaway, Lentz said, is the new information about how pain catastrophizing can be used.

“Although we’ve found that pain catastrophizing is important in predicting clinical outcomes, it is rarely screened for or evaluated in clinical practice,” he said. “We need to raise awareness of this measure’s utility in prediction—especially because pain catastrophizing is modifiable and can be addressed through treatment.”

The DCRI’s Steven George, PT, PhD, FAPTA and Duke adjunct faculty Daniel Rhon, DSc, also contributed to the study.

DCRI, Cerner Partner on New Study Using Real-World Data

August 6, 2019 – The pilot project and study, called the Learning Registry, will use electronic health records from the Cerner Learning Health Network to evaluate the use and potential impact of proven therapies for chronic cardiovascular disease.

Cerner Corporation (Nasdaq: CERN), a global health platform and innovation company, has announced the development of the Cerner Learning Health NetworkSM to help clinicians more easily and efficiently gain health insights and guide care. Cerner aims to automate data collection from multiple sources, including the electronic health record (EHR), to rapidly give medical researchers access to important information that has the potential to transform patient care. Through combined technology and expertise, Cerner and the Duke Clinical Research Institute (DCRI) have joined together to pilot the Cerner Learning Health Network and innovate clinical research registries in the process.

Ann Marie NavarThe pilot project and study, named the Learning Registry by the DCRI, will use the Cerner Learning Health Network to evaluate the use and potential impact of proven therapies for chronic cardiovascular disease. Cerner and the DCRI aim to bring together data and intelligence to deliver clinicians insights on chronic cardiovascular disease, which if not treated properly can lead to heart disease and stroke. In the pilot project, the DCRI will use Cerner technology to analyze de-identified patient data from the University of Missouri Health Care and Ascension Seton, in partnership with Dell Medical School at The University of Texas at Austin, with the goal of finding the most effective treatment options.

“Collaborating with the DCRI on the Learning Registry to pilot the Cerner Learning Health Network is an exciting step forward in improving the health of those living with chronic cardiovascular disease,” said Art Glasgow, senior vice president, Strategic Growth, Cerner. “At Cerner, we’re committed to taking four decades of digitized data and transforming it into insights that can help clinicians make more informed treatment decisions. We have an opportunity to use clinical research and data-driven insights to develop an intelligent network of health systems that can truly improve health experiences and outcomes for patients.”

After the pilot project and study are complete, the Cerner Learning Health Network is expected to have wide-reaching applications in life sciences, pharmaceuticals and health care at large. The automation and streamlining of health data for clinical research has the potential to speed innovation and life-saving insights. More research on populations’ health gives clinicians additional tools to identify and treat a myriad of diseases and health concerns.

Clients will be able to leverage HealtheDataLabTM with the Cerner Learning Health Network to aggregate de-identified patient data from both Cerner and non-Cerner EHRs. HealtheDataLab is a ground-breaking tool that leverages the capabilities of HealtheIntent®, Cerner’s big data and insights platform for population health management. Researchers can use HealtheDataLab to take de-identified patient data, transform the data sets into research-ready formats and build complex models and algorithms to give providers more information to make more informed care decisions. By using predictive modeling and intelligence, the platform supports early identification of individuals who may be at risk for costly episodes of care and can help pinpoint the most effective and cost-efficient treatment options.

“Current models for clinical research and registries that rely on mostly manual chart abstraction are too expensive, too slow and too small to continue. We have to figure out better ways to leverage existing electronic resources to transform how we do clinical research,” said Dr. Ann Marie Navar (pictured), principal investigator and cardiovascular prevention researcher, DCRI. “The EHR is an obvious starting point and HealtheIntent has all the right ingredients. It incorporates data from multiple EHRs, can link to national mortality and claims databases and helps us to harness the power and information security of cloud computing.”

The DCRI plans to publish the research results from the pilot project in a study sponsored by Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, with several products used to treat and prevent cardiovascular disease.

DCRI Welcomes New Faculty

July 31, 2019 – A pediatric rheumatologist and a urologist have joined the DCRI.

Welcome to Mara Becker, MD, MSCE

Mara Becker, MD, MSCE, joined the DCRI on July 15 as an associate professor of pediatrics in the School of Medicine’s Division of Pediatric Rheumatology.Mara Becker, MD, MSCE

Becker comes to Duke from Children’s Mercy Kansas City, where she served as the associate chair of the department of pediatrics and division director for children’s rheumatology.

She received her MD degree from Jefferson Medical College in Philadelphia and her master’s degree in clinical epidemiology from University of Pennsylvania. She completed her residency in pediatrics and a fellowship in pediatric rheumatology at Thomas Jefferson University Hospital/duPont Hospital for Children in Wilmington, Delaware. She also completed an additional fellowship in pediatric clinical pharmacology at Children’s Mercy.

Her research interests have focused on identifying factors that enhance therapeutic response and minimize toxicity to drugs used for the treatment of rheumatic diseases in children.  Her current NIH-funded research is investigating methotrexate in Juvenile Idiopathic Arthritis, utilizing cellular biomarkers and genetic differences to predict drug response.

She has contributed to work published in journals such as the Journal of Pharmacology and Experimental Therapeutics, Arthritis & Rheumatology, and Arthritis Care & Research. She is actively serving in national organizations such as the FDA Arthritis Advisory Committee, the American Board of Pediatrics, the American College of Rheumatology, and the Childhood Arthritis Rheumatology Research Alliance.

Becker will also serve as vice chair for faculty development for the Department of Pediatrics at the Duke University School of Medicine, where she will focus on mentoring faculty at all levels and targeting opportunities for leadership development and career growth for faculty within the department.

“Dr. Becker’s expertise as a clinical pharmacology-trained pediatric investigator will make her a great fit with the DCRI pediatric group,” said the DCRI’s Rachel Greenberg, MD, assistant professor of pediatrics. “In addition, she brings a new depth to the program with her subspecialty training in pediatric rheumatology, extensive foundation in translational research, and experience in faculty career development.”

Welcome to Deborah Kaye, MD, MS

Deborah Kaye, MD, MS, will join the DCRI as an assistant professor in the School of Medicine’s Department of Surgery, Division of Urology on Aug. 19.Deborah Kaye, MD, MS

Prior to arriving at Duke, Kaye worked at the University of Michigan, where she was a clinical lecturer in the department of urology. Her research interests include developing and evaluating health care systems, tools, and processes, as well as exploring how to improve health care delivery systems. She is also interested in health care payment models and health outcomes in urologic oncology.

Kaye received her MD degree from the Medical College of Wisconsin and her master’s degree in health and health care research from the University of Michigan. She completed a residency at Johns Hopkins University, a Clinical Scholars Training Program at the NIH, and a combined urologic oncology and health services research fellowship at the University of Michigan.

Her work has appeared in journals such as New England Journal of Medicine, the Journal of Urology, and Cancer.

“Dr. Kaye will add meaningful insight to DCRI Urology,” said the DCRI’s Chuck Scales, MD, associate professor of surgery and population health sciences. “There are so many patients in need of treatment for urologic cancers, and her interest in improving health care delivery systems will ultimately help us to deliver on our mission of translating knowledge to better patient care.”

Open Data Critical to Clinical Research

July 30, 2019 – In a recent Perspective piece, the DCRI’s Frank Rockhold, PhD, outlines why data sharing is so important to the future of clinical research and shares suggestions for making the process more efficient.

Data sharing, especially at the individual patient level, is an integral component of enabling future research and improving patient care, according to a Perspective piece from the DCRI’s Frank Rockhold, PhD, (pictured)recently published in Clinical Trials.

The paper, which contains input from three contributors in addition to Rockhold, gives an overview of the current state of open data and data sharing and features strengths and weakness of current data access platforms. It also reviews successful examples of data sharing and makes suggestions about how to improve and streamline data sharing moving forward.

Data sharing has many benefits, including avoiding redundancy and duplicated efforts and encouraging collaboration. However, constraints also exist, such as confidentiality concerns and lack of time and resources.

“There are hurdles to clear, but the question at the center of the open discussion should not be whether data should be shared, but rather how and when responsible methods for doing so can be ushered in,” the writers note.

The future of data sharing lies in the hands of those involved in clinical research, Rockhold writes after laying out five suggested guidelines for data sharing and encouraging patient involvement and protection of patient rights.

“We believe the clinical research enterprise needs to come together to build on what exists and create a simpler model for truly open and responsible clinical trial data sharing,” he writes.

Duke Symposium Showcases Diverse Obesity Research, Patient Experiences

July 23, 2019 – The symposium convened multiple Duke obesity experts, community members, and patients to discuss current knowledge, challenges, and future opportunities.

Over 100 researchers, clinicians, community members, and patients came together to spotlight obesity-related research during the Transforming Obesity Research at Duke Symposium, which was co-hosted by the DCRI on June 21.

Attendees gathered at the DCRI to foster new collaborations and bolster opportunities for meaningful research, as well as to address causes of obesity, barriers in patient care, and treatment methods for the disease.

“It is interesting to see how many people at Duke are studyingPanelists speak at the Transdisciplinary Obesity Consortium Symposium. obesity, looking at it through their own perspective, but unaware of the other experts both at the university and within the community,” said the DCRI’s Sarah Armstrong, MD, associate professor of pediatrics, who co-hosted the symposium along with Matthew Roe, MD. “Each of them is examining [obesity], but through very different lenses.”

The day-long program included presentations, panel discussions, a debate, and breakout sessions. The DCRI’s Joseph Rogers, MD, chief medical officer of the Duke University Hospital System, provided the morning keynote highlighting the complex nature of obesity, rates across the U.S., and the shift in thinking that needs to occur to result in meaningful change.

Rogers’ call-to-action was an overarching theme of the symposium that carried into the patient perspectives panel, which introduced the attendees to six patients with the lived experience of obesity. Each person represented a different journey with weight loss, weight maintenance, and their accompanying health challenges. The panel asked the clinicians and researchers to listen, have compassion, and consider their patients’ quality of life. They also stressed that they are eager to be involved in research and invited the audience to continue advocating for patient engagement in their studies.

A solution-oriented panel then introduced tools and resources that attendees could utilize to close old knowledge gaps. They were followed by four Duke experts, who debated which obesity treatment approach is the most effective. Symposium organizers then divided participants into nine breakout groups to brainstorm critical questions in obesity research.

Following the group collaborations, Lesley Curtis, PhD, interim director of the DCRI and chair of the Department of Population Health Sciences, gave the afternoon keynote. Curtis focused on the opportunities and challenges inherent in applying big data to complex health problems like obesity, providing an overview of a learning health system model, available datasets and registries, and resources at Duke.

The symposium was made possible through the Duke University School of Medicine (SOM) Interdisciplinary Colloquia Fund, which provides support for colloquiums that bring together basic, translational, clinical, and data science faculty members with common interests in a biomedical problem or area. The event was a joint effort of the DCRI, SOM, CTSI, and the Transdisciplinary Obesity Consortium (TOC), directed by Armstrong and Roe. The TOC is a Duke organization dedicated to uniting and connecting obesity researchers and clinicians across Duke as they craft a strategic, campus-wide initiative.

The TOC meets monthly. Members may attend meetings, engage with sub-groups, contribute to the development of the patient panel, work with community stakeholders, and/or share data and other resources. To learn more about the TOC, contact Chris Clark at chris.clark@duke.edu or 919-668-7845.

DCRI Researchers Weigh In On Patient Data-Sharing

July 10, 2019 – The paper outlines potential benefits and challenges for adopting initiatives that would enable data sharing at an individual patient level.

Sharing data across clinical trials and cohort studies is key to continuous knowledge generation and healthcare innovation, according to a recent discussion paper from the National Academy of Medicine (NAM) that features contributions from the DCRI’s Eric Peterson, MD, MPH, FAHA, FACC, and Robert Califf, MD, MACC.

Data sharing is becoming increasingly prevalent in research; for example, all journals that are members of the International Committee of Medical Journal Editors (ICMJE) now required that articles reporting clinical trial results include a data sharing statement that details the study teams’ plans to share their data. The NAM writing group laid out a strategy for how sharing data from clinical trials can be made practical. They envision a learning health system in which knowledge gleaned from patient data leads to real-time improvements.

The paper outlined several examples of organizations that have successfully implemented strategies for data sharing. The DCRI’s Supporting Open Access for Researchers (SOAR) initiative was prominently featured as a pioneer in data sharing. SOAR has facilitated the sharing of clinical trials data from Bristol-Myers Squibb as well as clinical data from Duke University. Since SOAR’s inception in 2013, it has received 57 data requests, and 22 of these to date have been approved and are moving forward.

The paper’s authors see patient-level data sharing as not only a boon for patient care, but also as a positive for both the research and academic community. A data sharing strategy could lead to enhanced transparency in research and increased opportunity for collaboration. The paper also addresses potential barriers that may need to be addressed for successful data sharing strategies to take hold, including the need to protect patient privacy, as well as inconsistencies in data definitions across data sources.   The authors concluded that they feel that the future of data sharing is quite bright.

“With initiatives like SOAR, the DCRI is positioning itself as a thought leader in the data-sharing space,” Peterson said. “This effort is also allowing Duke to be one of the first institutions to freely share our clinical data to support researchers around the world.”

Warfarin Control Measures May Not Accurately Predict Risk in Atrial Fibrillation Patients

July 8, 2019 – The study results suggest that clinical factors may be more useful than international normalized ratio metrics in predicting future risk of bleeding or thrombotic events.

A metric typically used to determine doses of warfarin in patients with atrial fibrillation, international normalized ratio (INR), was once thought to be a potential indicator of future risk levels for bleeding or thrombotic events. However, research published recently in JAMA Cardiology by the DCRI’s Sean Pokorney, MD, MBA, suggests that historical INR values may not be the most accurate predictor of future events.

The study examined patients from the ORBIT-AF registry—5,545 patients for the bleeding analysis and 5,635 patients for the thrombotic event analysis. Data analysis was performed from August 2016 to February 2019.

Traditionally, patients’ risk of bleeding and thrombotic events has been estimated based on clinical factors. However, this study sought to determine whether past measures of INR control factored into this risk independently of clinical factors. It had been previously described that in patients with atrial fibrillation taking vitamin K antagonists, low international normalized ratio (INR) values mean higher risk of thrombotic events, while high INR values may signal higher risk for bleeding events.

“These results suggest that using metrics for warfarin control may not be helpful in predicting patients’ potential for future risk beyond the predictive capacity of risk scores using clinical factors,” Pokorney said. “It is just challenging to predict future bleeding or stroke events for patients on warfarin, since historical INR values are not predictive of future INR values.”

Other DCRI contributors to this study include Laine Thomas, PhD; Jonathan Piccini, MD, MHS; and Eric Peterson, MD, MPH.

Medical Misinformation Causes Underuse of Statins

July 2, 2019 – The DCRI’s Ann Marie Navar, MD, PhD, writes that medical misinformation surrounding statins is causing patients to stop or avoid statins, missing out on a major opportunity to prevent heart attacks and strokes.

Ann Marie NavarIn a recent Viewpoint piece published in JAMA Cardiology, the DCRI’s Ann Marie Navar said that the proliferation of medical misinformation around statins is causing often misguided fears about statins, leading patients to refuse or stop treatment.

“While there are true risks and side effects associated with statins, the popular media is abuzz with false reports about statin side effects,” Navar said. “The reality is that statins are one of the best studied, safest, and most effective medications we have to prevent heart disease.”

Navar likens the incorrect information about statins to the false perceptions that led to an anti-vaccination movement.

“Measles outbreaks are highly visible: a rash appears, public health agencies respond, headlines are made, and the medical community responds vocally,” she writes. “In contrast, when a patient who has refused a statin because of concerns stoked by false information has a myocardial infarction, the result is less visible. Nevertheless, cardiologists and primary care physicians observe the smoldering outbreak of statin refusal daily.”

In the piece, Navar advocates for clear and transparent communication so medical providers can establish trust with patients and fight against medical misinformation.