Study finds children carry implicit bias toward peers who are overweight

June 23, 2017 – Participants were more likely to think positively of children who are healthy weight.

Even children as young as 9 years old can carry a prejudice against their peers who are overweight, according to a new study led by Duke Health researchers. They might not even realize they feel this way.

The study, published online today in the journal Pediatrics, sheds important insight into implicit weight bias in children and could serve as a starting point for further studies on the subject.

“When children are stigmatized for being overweight, it can cause further weight gain and other health consequences,” said Asheley Skinner, PhD, associate professor of medicine at Duke University School of Medicine, member in the DCRI, and the study’s lead author. “Given that, we felt that it was important to determine if we could identify unconscious attitudes towards weight in this 9-to-11 age group.”

The study included 114 children. The authors used a research method that primes subjects by using quick flashes of a series of carefully selected images that depict the study topic, juxtaposed with neutral images. Skinner said the study is the first to use this method, known as the Affect Misattribution Procedure, to consider attitudes that children have about weight.

The image used to measure bias showed a child engaging in an activity that was either related or unrelated to weight, like running or participating in class. Photographs alternately showed children involved in the activities who were either healthy weight or overweight, but were otherwise similar.

Study participants first viewed an image of a child engaging in an activity, followed by a neutral, abstract image. They then rated the abstract image “good” or “bad.”

After study participants saw these photographs, they were shown a neutral, abstract image, and asked to rate it as “good” or “bad.” On average, participants rated 64 percent of the abstract images preceded by images of children who were healthy weight as “good,” but did so for only 59 percent of second images preceded by children who were overweight, a difference that was statistically significant among the participants.

In the absence of bias, the study’s authors suggest that there would have been equal percentages of “good” ratings, since the preceding images of children performing the same activity were similar except for weight. The gap between “good” ratings therefore represented an overall implicit bias rate of 5 percent against the children who were overweight, according to the authors.

Previous studies by Keith Payne, PhD, of the University of North Carolina at Chapel Hill (UNC) and a co-author on the current study, have measured similar rates of implicit racial bias among adults. In this study, participants who were healthy weight had higher rates of implicit bias than those who were underweight or overweight.

“The main takeaway is that weight bias and a preference for thin people appears to start at a fairly young age,” Skinner said. “Knowing that this kind of implicit bias exists among children this age allows us to potentially be more aware of the unintended ways that children who are overweight might be stigmatized.”

“Implicit bias is important because it may underlie decisions among children about friendship, participation on sports teams and even bullying,” added senior author Eliana Perrin, MD, professor of pediatrics at Duke and the study’s co-principal investigator. “It’s essential to raise awareness about this kind of bias because it can have real consequences for children.”

Perrin said the work benefited from an interdisciplinary approach, with a research team that included physicians and social scientists, including co-principal investigator Andrew Perrin, PhD, a sociologist at UNC.

In addition to Skinner, E. Perrin, Payne and A. Perrin, co-authors include Janna Howard, Abigail Panter, Anna Bardone-Cone, Cynthia M. Bulik, and Michael J. Steiner.

The study was supported by the National Institutes of Health/National Cancer Institute (R24CA186212). The authors report no financial conflicts.

Drones carrying automated external defibrillators could prove lifesaving for cardiac arrest patients

June 20, 2017 – Investigators call for more research to see whether drone delivery of automated external defibrillators (AEDs) has the potential to be a “game changer” for patients who experience sudden cardiac death (SCD).

An editorial by Duke researchers published today in Circulation, the official journal of the American Heart Association, analyzes a potentially revolutionary solution to overcoming delays in getting an AED to the site of a patient who experiences cardiac arrest within a suitable window of time after a 911 call – AED-equipped drones.

SCD, or cardiac arrest, is a sudden unexpected loss of heart function, usually due to development of a very rapid disorganized heart rhythm that makes it impossible for the heart to continue to pump blood to the body. SCD is a leading cause of death in the United States and worldwide. The current treatment is primarily CPR and calling emergency medical services to shock the heart with an AED and administer medications.

However, each minute that passes lowers the survival rate by an additional 10 percent. Overall current survival to 30 days after out-of-hospital cardiac arrest is very low and remains one of medicine’s most vexing public health problems. When cardiac arrest occurs in a small area with an AED close at hand, such as an airplane or a casino, survival rates are much higher – 40 percent or more.

“An AED is basically a portable device that checks the heart rhythm and can send an electric shock to the heart to try to restore a normal rhythm,” said the DCRI’s Daniel Mark, director of outcomes research.

According to Mark, first author of the editorial, anyone can use an AED to help save a life. However, the only two current options of making these lifesaving devices accessible for use in a devastating emergency are placing retrievable static AEDs in public locations or having first responders physically bring one to the emergency site.

“The problem with static AEDs is that they are static,” said Mark. “And while community-wide emergency medical systems are in place to attempt delivering interventions to cardiac arrest patients within eight minutes of a 911 call, the absolute survival for out-of-hospital cardiac arrest continues to remain at or below 10 percent and we need to be able to get AEDs to the patients who need them much faster than we do now.”

Recent research published in multiple medical journals, including Circulation and JAMA, have begun to look at a novel answer: drone delivery of AEDs. However, there are many technical challenges in designing a drone for this sort of work. The drone must be not only very fast and capable of carrying the weight of an AED but also highly reliable, able to function in all weather conditions, and include advanced onboard collision avoidance technology and radar.

“In the United States, despite much interest and excitement, there are a considerable number of barriers to operating drones for medical purposes,” Mark said. “The Federal Aviation Administration that regulates our airspace, for starters, will require serious persuasion in the form of rigorous safety information before they will likely be willing to let drones fly beyond the line of sight of the operators in the U.S.”

“It is undoubtedly a revolutionary idea that needs to be explored,” Mark said. “But even as the engineers develop better drone technology and all the regulatory hoops are jumped through, we still have to prove the idea really works. We have to show that we can get a drone to a cardiac arrest site within three minutes of a 911 call and that once it arrives, the AED is used for its intended purpose.

“It’s not enough to show this can be done in a few cases. We need to show it can be done routinely and that doing this actually improves survival after cardiac arrest at the community level. And of course, we need to show that establishing and maintaining this service is economically viable.”

“I don’t have any doubts that eventually we would get the right combination of technology and regulation to be able to see the idea of AED-equipped drones through,” Mark said. “But are we close? No. Not yet.”

In addition to Mark, other contributing authors included Steen M. Hansen, Monique L. Starks, and Mary L. Cummings.

DCRI names Bray Patrick-Lake director of stakeholder engagement

June 15, 2017 – She will lead participant engagement work on several DCRI projects.

The DCRI has appointed Bray Patrick-Lake as its director of stakeholder engagement.

Bray Patrick-LakePatrick-Lake previously served as director of stakeholder engagement for the Clinical Trials Transformation Initiative (CTTI) and director of patient engagement for the Duke Clinical and Translational Science Institute (CTSI). She also served as co-chair of the advisory committee to the NIH Director for the Precision Medicine Initiative Cohort Program (now All of Us), which was launched by the Obama administration in 2015 to create new models of patient-powered research and provide clinicians with new tools and therapies. Recently, Patrick-Lake was named to the National Academies of Science, Engineering, and Medicine Health Science Policy board.

In her new role, Patrick-Lake will lead the DCRI’s participant engagement work on Project Baseline, a partnership with Verily, Duke, and Stanford to develop a well-defined reference, or “baseline” of health, and the NIH Environmental Influences on Child Health Outcomes (ECHO) program.

“The DCRI is committed to researching, understanding and supporting participant engagement in clinical trial design, conduct, and oversight,” Patrick-Lake said. “Multi-stakeholder teams can better advance high-quality, efficient research that’s also patient-centric. The culture at the DCRI supports a multi-stakeholder approach—we value all partners and all people. And when we do this, we succeed and innovate.”

Patrick-Lake has founded and led several non-profit organizations including the PFO Research Foundation, which she launched in response to the lack of definitive scientific information regarding the condition of patent foramen ovale (PFO). Patrick-Lake was motivated to work on issues of clinical trial design, informed consent, and data sharing after she participated in an aborted PFO clinical trial during which she had a device implanted in her heart. The data from that trial were never published or shared with patients and investigators.

“By understanding the challenges in research and bringing all parties’ unique skills, assets, and perspectives to the table, we can develop innovative solutions and do better research,” Patrick-Lake said.

Patrick-Lake holds a BS in zoology from the University of Georgia and a Masters in Forensic Sciences degree from National University in La Jolla, California.

American Heart Association funds trials to study, treat childhood obesity

June 14, 2017 -The projects include both clinical and basic science research on the causes and effects of obesity in children.

Duke Health and DCRI researchers will launch four projects this summer to better understand and treat the health impacts of childhood obesity.

The projects include clinical and population health research on the most effective treatments for childhood obesity and basic science research on differences in gut bacteria among children who are overweight compared to those in a healthy weight range, and how those differences might influence their risk of obesity and response to treatment.

Duke will conduct the studies as part of the American Heart Association’s Strategically Focused Research Network (SFRN) for children, which will provide $3.7 million over the next four years for the research. The DCRI’s Jennifer Li, MD (pictured), chief of the Division of Pediatric Cardiology at Duke University School of Medicine, will lead the work.

“Unfortunately, up to a third of children are obese or overweight,” said Li, who is also a professor of medicine and of pediatrics. “This is a generation of kids who might not do as well as their parents because they face a future risk of heart attacks, diabetes and stroke. This grant can help us figure out the best interventions, including those that might work on a larger scale in communities across the country.”

The clinical research portion will focus on the effectiveness of two existing Duke programs called Bull City Fit and Healthy Lifestyles, which the health system has offered since 2012. These programs combine regular exercise, nutrition classes, family involvement and monthly medical evaluations.

The AHA-funded clinical trial will enroll 350 youngsters and will be the most comprehensive study to date on the program’s impact on weight, physical fitness, quality of life, family engagement and more, said principal investigator Sarah C. Armstrong, MD, a pediatrician and associate professor of pediatrics.

“The proposed work aligns in mission with the American Heart Association’s goals of improving child health and well-being,” Armstrong said. “It’s exciting to get to work with an organization that so clearly supports children and their future health.

Cardiologist Svati Shah, MD, an associate professor of medicine and member of the Duke Molecular Physiology Institute and the DCRI, will lead the basic science research defining how molecular pathways associated with children’s gut bacteria could influence their obesity risks and other outcomes. Shah is also leading a project for a different AHA SFRN launched in 2016 to study heart failure in adults.

Asheley Skinner, PhD, associate professor of medicine, will lead the population-health project examining obesity treatment programs across the country to evaluate different models and their effectiveness.

For the fourth project, Skinner, also a member of the DCRI, will lead training for scientific, clinical and population health professionals on issues related to childhood obesity, cardiovascular disease and their prevention and treatment.

In addition to Duke, the AHA will fund projects at three other institutions to study pediatric heart health and diseases: Children’s National Health System in Washington, D.C., the University of Utah and Northwestern University.

Study creates benchmarks for evaluating community-based palliative care

June 13, 2017 – Understanding the components of a community-based palliative care model is the first step to designing incentives to encourage its spread, researchers say.

Use of palliative care, an interdisciplinary approach to caring for individuals with life-limiting illness focused on improving quality of life, is increasing as our population ages and evidence about its benefits grows. However, there is still little information about which care activities are necessary for delivering high-quality palliative care in the community.

A team led by Nrupen Bhavsar, PhD, MPH, of Duke’s division of general internal medicine and Donald H. Taylor, Jr, PhD (pictured), of the DCRI, the Margolis Center for Health Policy, and the Sanford School of Public Policy, worked with partners at Four Seasons Hospice organization to conduct a time and motion study at three care settings, resulting in a detailed process map. The team calculated the time spent on patient care, administrative duties, care coordination, and other activities.

“There is wide variation in how providers deliver palliative care,” said Taylor, “this study is the first step to designing incentives for high-value palliative care, including the development and sharing of best practices and generating evidence that can help us establish a value-based payment model.”

The study was published in the Journal of Palliative Medicine. Other members of the research team include Janet Bull, MD, MBA of Four Seasons, and Kate Bloom, MPH, Jonathan Nicolla, MBA, Callie Gable, BA, Abby Goodman, BS, Andrew Olson, MPP, and Matthew Harker, MPH, MBA.  Olson and Harker are members of the DCRI and Duke-Margolis.

Funding for this research was made possible, in part, by the Centers for Medicare & Medicaid Innovation through grant 1C1CMS331331.

DCRI’s Neurosciences Medicine concludes an active spring

June 7, 2017 – DCRI faculty and staff presented their most recent research at several conferences over the past few months.

As DCRI’s Neurosciences Medicine therapeutic area grows, faculty and business development have prioritized developing a presence at top neurological and psychiatric meetings around the world. This spring, the DCRI exhibited at two such conferences to demonstrate excellence in thought leadership and research: the American Academy of Neurology (AAN) conference in Boston, Massachusetts, and the World Intracranial Hemorrhage Conference (WICH) in Baltimore, Maryland.

neurosciences-med-sponsor.pngAAN Conference

Jeffrey Guptill, MD, assistant professor of Neurology and associate director of the Early Phase Unit (DEPRU) and Aatif Husain, MD, professor of Neurology and Global Sleep and Epilepsy Trials lead at DCRI observed and contributed to scientific presentations at AAN and met with potential sponsors focused on early phase trials and the importance of EEGs in research. Danny Laskowitz, MD, director of Neurosciences Medicine, also represented the group at AAN and co-hosted the “AAN continues to be a crucial platform for DCRI Neurosciences to have visibility in our industry,” said Laskowitz. “It is the largest arena for us to showcase our latest research and the excellence in thought leadership we’ve assembled in Neurosciences Medicine.”

​Other attendees from the DCRI included Chief Operating Officer Baljit (Boo) Samra, Jennifer Hart, assistant director Business Development for Neurosciences Medicine, and members of the Grants and Proposal Services team: Andrew Miles, Jen Fitzpatrick, and Betsy Younce. The reception served as a “thank you” to current stroke and ADHD sponsors for their dedication and collaboration with DCRI’s Neurosciences Medicine. In addition to current booth.pngsponsors, potential sponsors attended as well, creating a great networking experience for all.​

World Intracranial Hemorrhage Conference

Following AAN, DCRI’s Neurosciences Medicine traveled to Baltimore in early May. WICH is the first conference of its kind—dedicated exclusively to acute hemorrhagic brain conditions. Due to DCRI’s work on a phase II study in intracranial hemorrhage (CATCH trial), it was essential for the coordinating center to have a presence and voice at this groundbreaking event.

Michael Luke James, MD, anesthesiologist and critical care specialist-neurologist, and Jen Hart presented, “A proof of concept study to evaluate the administration of CN-105 in participants with acute supratentorial intracerebral hemorrhage.” CN-105, after 20 years of research, culminated in a promising new therapeutic for a patient population with no current options. Laskowitz and James designed the trial, and the study presentation was a collaboration between DCRI Neurosciences Medicine and Duke’s Neurology and Anesthesiology departments​.

Transforming registries into robust platforms for clinical trials

June 6, 2017 -Newly released recommendations from the Clinical Trials Transformation Initiative’s (CTTI) Registry Trials Project pave the way for efficiently transforming patient registries into reusable platforms for conducting clinical trials.​

CTTI recently unveiled a new set of recommendations to utilize existing and prospective patient registries to facilitate high quality, efficient registry-embedded clinical trials. The recommendations provide an essential framework for assessing and designing registries and can be applied to existing registries or used for developing new ones.

John Alexander

“The goal of these recommendations is to increase the practice of leveraging existing patient registries to facilitate high-quality clinical trials at lower costs,” said DCRI’s John Alexander, MD (pictured), co-chair, CTTI. According to him, existing registries collect data for the purpose of generating clinically usable information and evidence. “While registries have long been used to support non-randomized safety evaluations, their use for randomized or non-randomized efficacy evaluations is a newer practice,” he said.

“Depending on type-characteristics, some registries are more appropriate than others for conducting clinical trials. Regardless, CTTI’s Registries Trials Project has found a clear opportunity for registries to create a sustainable infrastructure to conduct clinical trials,” added Jules Mitchel, PhD, president, Target Health Inc. According to Mitchel, the new recommendations are the next step towards evolving how both researchers and sponsors think about clinical trial conduct, with faster, fit for purpose clinical trials as the end goal.

To determine if an existing registry is appropriate for embedding clinical trials, the new CTTI recommendations propose assessing whether the registry data demonstrates relevancy and robustness to support regulatory decision-making. The registry data must also have assurance of patient protections with the maintenance of patient and data privacy. To design a new registry suitable for embedding clinical trials, the CTTI recommendations advocate following software industry guidelines, as well as guidance documents provided by regulatory agencies, to assure that the registry complies with both industry and regulatory standards.

While the scale and scope of this project was limited to patient registries, CTTI’s multidisciplinary team believes that many of the principles and tools listed in these recommendations can potentially be applied to other health care systems and existing data sources, or those available within claims databases, to facilitate more cost-effective and competent clinical trials.

“We hope that with these recommendations, people will approach the design and conduct of clinical trials in a more systematic way that will ensure useful, high-quality data, including for FDA approval, on new devices and drugs,” Alexander said.

Established by the FDA and Duke University in 2007, the CTTI is a public-private partnership hosted by Duke University and based at the DCRI with a mission to develop and drive adoption of practices that increase the quality and efficiency of clinical trials.

Project team leaders included Duke’s James Tcheng, Celgene’s Dawn Flick, FDA’s John Laschinger, and Medtronic’s Ted Lystig. Other team members were Duke’s Sunil Rao and Emily Zeitler, Chunrong Cheng and Kristen Miller from the FDA, Christopher Dowd from the Cystic Fibrosis Foundation, Nicolle Gatto from Pfizer, Lauren Mclaughin from the Michael J Fox Foundation for Parkinson’s Research, Patient Representative Stephen Mikita, Daniel Mines from Merck, Magnus Petterson from AstraZeneca, Celgene’s Arlene Swern, and Mitchel. The current and previous project managers were Duke’s Sara Calvert and CTTI’s Steve Mikita, respectively.

More information about CTTI’s recommendations is available both on the Registry Trials Project page and in a webinar recording.

Duke hosts Precision Medicine World Conference

May 26, 2017 – The DCRI’s Robert Califf, MD, was among the speakers at the gathering of academics, entrepreneurs, and healthcare professionals.

Hundreds of people representing a broad spectrum of healthcare, research and technology converged on Duke University on May 24 and 25 for the Precision Medicine World Conference (PMWC). The gathering spotlighted the rapid growth of biomedical technologies spurring initiatives that enable the translation of precision medicine into direct improvements in healthcare.

The conference, co-hosted by Duke Health and Duke University, marked the first time the PMWC was held on the East Coast. This year’s theme was “Translating the Power of Precision Technologies into Better Health Care.” More than 30 sessions were held over the two days, featuring a total of more than 100 speakers from the healthcare and biotechnology sectors.

Geoffrey Ginsburg, MD, PhD (pictured), director of Duke Center for Applied Genomics and Precision Medicine and conference co-chair along with Chancellor Emeritus Ralph Snyderman, MD, said the meeting reflects a powerful convergence of important disciplines – ranging from genome sciences and data sciences to information technology, tissue and genetic engineering, behavioral science, and immune and cancer biology.

Francis Collins, MD, PhD, director of the National Institutes of Health (NIH), outlined NIH’s “All of Us” precision medicine initiative to study the impact of genes and environment. The study hopes to enroll 32,000 volunteers by the end of 2017 and 1 million by 2022. The data it collects will be accessible to researchers.

“This is a pretty exciting time to contemplate where we are in precision medicine and where we are going,” said Collins. Collins later received a PMWC Luminary Award, which recognizes recent contributions of leaders who have accelerated personalized medicine into the clinical marketplace.

The conference was co-hosted by Ginsburg and Snyderman.

Medical claims may not be enough to assess clinical outcomes in research trials

May 24, 2017 – According to DCRI researchers, while medical claims may be a reasonable resource to assess myocardial infarction (MI) and stroke outcomes, caution is still needed.

A recent study by DCRI researchers published May 24 in JAMA Cardiology found that one-year post-MI rates of recurrent MI, stroke and bleeding were lower when identified by medical claims than when adjudicated by physicians. The study also observed that the accuracy of medical claims in identifying events was, at best, modest for MI and stroke, using physician adjudication as gold standard, and lower for bleeding events.

“Pragmatic clinical trials have proposed use of readily-available data, such as patient medical claims, to assess clinical events, but the accuracy of billed diagnoses in identifying potential events is unclear,” said DCRI Fellow Patricia Guimaraes, MD, lead author of the study. According to Guimaraes, previous studies on the topic have all been limited to patients older than 65 years as they use data from Medicare.

“We wanted to take advantage of the TRANSLATE-ACS data–a study that included post-MI patients of all ages–and explore whether medical claims can accurately assess cardiovascular and bleeding events in an all-aged post-MI population,” Guimaraes said.

TRANSLATE-ACS, or Treatment with Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome, was an observational, longitudinal study led by the DCRI and the American College of Cardiology Foundation. It examined post-discharge care patterns and treatment adherence of 12,365 patients enrolled at 233 U.S. hospitals, and evaluated the safety, effectiveness, and healthcare costs of antiplatelet therapy use among contemporary acute MI patient populations treated with percutaneous coronary intervention.

For the JAMA study, DCRI researchers obtained medical claims data for all rehospitalizations occurring within a year of the index acute MI in patients enrolled in the TRANSLATE-ACS study. They identified recurrent MI, stroke, and bleeding events based on diagnosis and procedure codes in the acquired medical bills. These clinical events were independently signed off by physicians based on medical record review.

“Our results suggest that we need to be cautious about using medical claims as the only method of event ascertainment, especially for bleeding events,” Guimaraes said. “Medical claims have limited accuracy in identifying bleeding events, which suggests the need for an alternative approach to ensure good safety surveillance in cardiovascular studies.”

According to Guimaraes, to improve the accuracy of events collected through existing billing claims, the coding algorithms used to find events can be further developed.

“We can ensure a broad search for events as done in the TRANSLATE-ACS study and ascertain events through different methods to avoid missing or over/under-classifying events,” she said.

In addition to Guimaraes, other authors included Arun Krishnamoorthy, Lisa A. Kaltenbach, Kevin J. Anstrom, Mark B. Effron, Daniel B. Mark, Patrick L. McCollam, Linda Davidson-Ray, Eric D. Peterson and Tracy Y. Wang.

Iron supplements do not improve exercise ability in heart failure patients

May 18, 2017 – High-dose oral iron supplements failed to improve peak exercise capacity and had little effect in replacing iron stores in chronic heart failure patients with anemia and reduced left ventricular ejection fraction, states a paper published in the Journal of the American Medical Association.

Iron deficiency – which occurs in around one-half of these patients – is an independent predictor of mortality. Two earlier trials had found that intravenous iron increased exercise capacity and quality of life in this population. The utility of inexpensive, readily available oral iron supplementation in heart failure was unknown.

Adrian Hernandez

The JAMA paper reports on the findings from a randomized, double-blind study known as the Oral Iron Repletion effects on Oxygen UpTake in Heart Failure (IRONOUT HF) trial. This investigated the effect of oral iron polysaccharide (150 mg twice daily) compared with matching placebo. Involving 225 patients at 23 U.S. sites between September 2014 and November 2015, IRONOUT HF was an NIH-sponsored multi-center trial.

The JAMA paper concluded that high-dose oral iron minimally repleted iron stores and did not improve exercise capacity in patients with heart failure with reduced left ventricular ejection fraction. The study findings do not support the use of oral iron supplementation to treat iron deficiency in these patients, say the authors.

“We are still trying to find the most straightforward approach to improving the health of patients with chronic heart failure,” said co-author Adrian F. Hernandez, MD, MHS, director of Health Services Outcomes Research at the DCRI. “Unfortunately in this study, we learned that oral iron therapy is not sufficient to improve anemia and ability to exercise in these patients. Intravenous iron supplementation may be more helpful, and is being investigated in a newly-launched large outcomes study called HEART-FID.”

Aimed at enrolling more than 3,000 adult patients across North America, HEART-FID will assess the efficacy and safety of iron therapy using intravenous ferric carboxymaltose, relative to placebo, in the treatment of patients with heart failure, iron deficiency and a reduced ejection fraction. Outcome measures will include the 12-month rate of death, hospitalization for worsening heart failure, and the six-month change in six-minute walk test for patients in heart failure with iron deficiency.

In addition to Hernandez, DCRI and Duke authors of the JAMA paper were Steven McNulty, MS; G. Michael Felker, MD; and Kevin J Anstrom, PhD.