Rao named as editor of Circulation: Cardiovascular Interventions

June 25, 2018 – Rao was previously the associate editor for the Journal of the American College of Cardiology and the American Heart Journal.

Sunil RaoThe DCRI’s Sunil V. Rao, MD, will become the new editor-in-chief of Circulation: Cardiovascular Interventions, one of 12 American Heart Association (AHA) scientific journals, on July 1.

Circulation: Cardiovascular Interventions, an American Heart Association journal that launched in 2008, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease and vascular disease, with priority placed on original research and on randomized trials and large registry studies that advance clinical practice and patient outcomes.

“I am honored and thrilled to be editor-in-chief for Circulation: Cardiovascular Interventions,” Rao said. “We have a great team that is dedicated to upholding the impeccable research brand of Circulation and making the journal the leading source of impactful interventional science.”

Rao is Professor of Medicine at Duke University Health System, Chief of Cardiology at the Durham Veterans Affairs Health System, and a member of the DCRI. His main research interests deal with pharmacological and interventional therapies for acute coronary syndromes, as well as bleeding and blood transfusion complications among patients with ischemic heart disease. He has led several clinical trials in the interventional cardiology space, and he has published over 200 papers in leading medical journals.

Rao is a former associate editor for the Journal of the American College of Cardiology and the American Heart Journal. In addition, he was the Editor-in-Chief for the ACC CathSAP 5 and will be the meeting chair for the 2019 Society for Cardiovascular Angiography and Interventions Annual Scientific Sessions.

“We are confident that Dr. Rao will bring the highest level of dedication and commitment to excellence in the publication of cardiovascular intervention research,” said Mark Estes, MD, chair of the AHA’s Scientific Publishing Committee and Professor of Medicine at the New England Cardiac Arrhythmia Center at Tufts University School of Medicine.

Health insurance marketplaces offer better decision-making tools, but cost estimates vary widely

June 21, 2018 – A study by DCRI and University of Pennsylvania researchers found that the same health insurance plan considered by the same patient had widely varying total costs on the public and private exchanges.

From November 2016 to January 2017, more than 12 million Americans selected a health insurance plan on the Affordable Care Act’s public marketplaces and many others used federally approved private online exchanges to select a health plan.

In a study published in the Journal of General Internal Medicine, the DCRI’s Charlene Wong, MD, MSHP, and colleagues from the University of Pennsylvania evaluated consumer-facing web sites to evaluate how the choice environments and availability of decision tools, comparing these resources with those available in the previous year’s open enrollment period. These tools include decision aids like estimators for total out-of-pocket costs, provider lookup, drug lookup and pop-up definitions of insurance and health terminology.

One of the most influential tools for consumers may be those that offer total cost estimates that integrate the premium cost with deductibles and estimates of copays or coinsurance that are based on the consumer’s anticipated use of health care in the upcoming year. However, in the 2016-2017 open enrollment period, the research team found that the same health insurance plan considered by the same patient had widely varying total costs on the public and private exchanges – an average of $1,526 for the same plan in each state reviewed.

“Decision support tools are valuable, but only if consumers understand them and if they are accurate,” Wong said. “We are encouraged that the exchange sites we reviewed all have provider lookup mechanisms – an important factor for continuity of care and avoiding high out-of-network charges – but many sites still lack information on drug formularies and quality ratings. Without accurate information on what drugs are covered under a given plan, patients will have difficulty assessing how much they may owe for prescriptions under a new plan.”

The team also found that the proportion of exchanges presenting plans in order of premium cost has decreased, while best fit and total cost estimate options have increased. Wong and her colleagues previously found that the order in which plans are presented can influence consumer choice. For 2016-2017, the team found that some private exchanges are making explicit and implicit plan recommendations (for example by flagging a plan as “recommended” or displaying certain plans in a separate display area on the page). More research is needed on how the features of the choice environment influence consumer plan choices and whether they accurately address consumer needs in the complex decision-making process of selecting a health plan.

NICHD renews $96 million federal contract for Pediatric Trials Network

June 19, 2018 – The award will fund the network for an additional eight years.

The DCRI’s Pediatric Trials Network (PTN) team has been awarded $96 million by the National Institute of Child Health and Human Development (NICHD) to design and lead pediatric trials over the next eight years.

Daniel Benjamin

An alliance of several of the country’s preeminent pediatric experts and medical centers, the PTN was founded in 2010 with a $95 million grant from the National Institutes of Health (NIH) and conducts the majority of the DCRI’s pediatric clinical trials, studying the formulation, dosing, efficacy, and safety of off-patent drugs and medical devices used in pediatric patients.

“Over the last eight years, we have been able to conduct 26 clinical trials in 13 different therapeutic areas enrolling over 8,000 children, which is more than triple the scope of work that was outlined in the initial NIH contract,” said Daniel Benjamin, Jr., MD, PhD, principal investigator and chair of the PTN.

Benjamin was the original awardee of the NIH contract in 2010. He and the PTN’s program manager, Gary Furda, helped secure the second award for an additional eight years. Additional DCDRI faculty supporting the contract include Christoph Hornik, MD; Kanecia Zimmerman, MD; and Michael Cohen-Wolkowiez, MD, PhD.

“Danny and his primary supporters on the faculty side are outstanding in what they do and their passion for improving the health of children is unmeasured,” said Taylor Nguyen, a senior business development associate at Duke who was part of the grant-writing group. “The incredible results that the PTN team has produced over the course of the last eight years are largely due to their commitment and passion and how they go above and beyond in the work they do.”

“In the first eight years of the PTN, we were able to transform neonatal and obesity trials,” Benjamin said. “Over the next eight, we will have people rethink the way drug studies are done for breastfeeding women and mental health for children.”

Benjamin intends for the PTN to lead the way in revolutionizing the way clinical trials are conducted in children.

“We will continue designing larger trials and make these large trials more efficient,” he said. “With all the operational excellence at the DCRI, the junior and mid-career faculty, and our very determined staff at the PTN sites working together round the clock in various capacities and doing exceptional work for the network, no goal is big enough.”

African-Americans less likely to receive statin therapy at recommended levels, study finds

June 13, 2018 – Researchers used data from the PALM registry to compare treatment of African-American and white patients.

African-Americans are less likely to receive statin therapy at levels recommended by current guidelines, according to a study by DCRI researchers published this week in JAMA Cardiology.

Michael NannaDemographics, clinical characteristics, socioeconomic status, patient beliefs, and clinician factors all contributed to this discrepancy, the researchers said.

African-American patients are at higher risk for atherosclerotic cardiovascular disease, yet previous research has shown that African-Americans are less likely to receive statin therapy when indicated compared with white individuals. The reasons for these differences are not well understood.

In this study, led by Duke Cardiology Fellow Michael Nanna, MD, researchers sought to better understand the treatment patterns of African-Americans receiving statin therapy. To do so, they examined data from the Patient and Provider Assessment of Lipid Management (PALM) registry. PALM is a repository of patients from across the United States with cardiovascular risk factors warranting consideration of lipid-lowering therapies, as well as patients already on statin therapy.

Using the PALM registry, Nanna and his colleagues identified 5,689 patients from 138 health care practices who were eligible for statin therapy. Of these patients, 806 were African-American (14.2 percent) and 4,883 were white (85.8 percent). Among those treated, just 269 African-American patients received statin therapy at the recommended level (33.3 percent), compared to 2,145 white patients (43.9 percent). The median low-density lipoprotein cholesterol levels of patients receiving treatment were higher among African-American than white individuals.

The researchers found that African-American patients were less likely than white patients to believe statins were safe (36.2 percent vs. 57.3 percent) or effective (70.0 percent vs. 74.4 percent). African-Americans were also less likely to trust their clinician (82.3 percent vs. 93.8 percent).

These differing beliefs about statins, cholesterol, and medical care may contribute to ongoing disparities in statin therapy, the researchers noted.

“What we found is that this is a complex issue,” Nanna said. “The treatment differences are partially explained by clinical factors but socioeconomic, patient belief and provider characteristics all contributed as well. What this means is that in order to identify how to improve our treatment, we will need to take a multi-dimensional approach.

“Ultimately, we need to build trust with our patients, be consistent in our application of guideline-recommendations and educate both our clinicians and patients on the appropriate therapies for risk reduction.”

In addition to Nanna, other Duke authors included the DCRI’s Ann Marie Navar, MD, PhD; Pearl Zakroysky, MPH; Qun Xiang, MS; Tracy Y.Wang, MD, MHS, MSc; and Eric D. Peterson, MD, MPH.

State Medicaid programs test whether offering incentives increases adoption of healthy behaviors

June 11, 2018 – A new report found early signs of success in incentive programs for healthy behaviors.

State efforts to help Medicaid beneficiaries engage in specific health behaviors show early signs of success, according to a new report. The report, which discovered 18 state Medicaid programs and nearly all Medicaid managed care plans are offering incentives for health behaviors, found that programs targeting preventive services and smoking cessation sparked the most initial success. The analysis was developed by researchers at the Duke-Margolis Center for Health Policy with funding from the Robert Wood Johnson Foundation. The DCRI’s Charlene Wong, MD, was one of the report’s authors.

The programs provide incentives for Medicaid recipients to lose weight, control diabetes, manage blood pressure, attend pregnancy visits, and more. A range of incentives are used, including gift cards, reduced insurance premiums, and monetary penalties. Among the report’s findings:

  • A Wisconsin program saw 22 percent of Medicaid beneficiaries quit smoking after receiving both financial incentives and counseling, compared to quit rates of 14 percent for smokers who only received counseling.
  • Similarly, an Idaho program saw their “well-child visit” rates jump from 40 percent to 66 percent after incentives were offered.

Overall, researchers found substantial variation in the results of the efforts, and limited and mixed evidence on whether the programs are linked to improvements in people’s health. In addition, while states and Medicaid managed care plans devoted significant effort to advertise and inform beneficiaries about the programs, only two states out of 10 participating in a related federal grant program met their enrollment targets. The report considers further administrative challenges for the programs, including higher than expected costs for administration and data systems.

Researchers note that the long-term viability of these incentive programs will depend on more evidence about the effectiveness of these incentives on long-term health outcomes, optimal program design, and the impact on vulnerable populations.

Curtis and Tcheng named to NESTcc data quality subcommittee

June 7, 2018 – The subcommittee will develop data quality standards for NESTcc partners and make recommendations for their implementation.

The DCRI’s Lesley Curtis, PhD, and James Tcheng, MD, have been named to the Data Quality Subcommittee of the National Evaluation System for health Technology Coordinating Center (NESTcc).

Lesley CurtisThe Data Quality Subcommittee and a Methods Subcommittee will develop data quality and methodological standards for the NESTcc Network Collaborators, the organizations partnering with NESTcc to generate and analyze real-world data. The subcommittees will also design processes for demonstrating conformance to the standards and make recommendations for their implementation. These standards will build upon existing bodies of work and leverage subcommittee members’ knowledge and experience from similar initiatives, including PCORnet, Sentinel, and MDEpiNet.

“Our Data Quality and Methods Subcommittees are comprised of national leaders in the areas of data quality and methods standards. Establishing these subcommittees is an essential step in ensuring confidence in the quality of medical device real-world data and real-world evidence generated by partnerships with NESTcc,” said Rachael L. Fleurence, PhD, Executive Director of NESTcc. “We look forward to their counsel and collaboration as NESTcc prepares to launch its first set of industry test cases to demonstrate the functionality of the NESTcc Data Network and we prepare to open the NESTcc Front Door for public inquiries for collaborating with the NESTcc Data Network.”

Curtis, who is the co-lead of the PCORnet Distributed Research Network Operations Center and previously co-led the Data Core for FDA’s Mini-Sentinel Initiative, will chair the Data Quality Subcommittee.

Data Quality Subcommittee Members

  • Jeffrey Brown, PhD, Harvard Pilgrim HealthCare Institute/ Harvard Medical School
  • Lesley Curtis, PhD, MS, Duke University School of Medicine
  • Sarah Horn, PhD, Medtronic
  • John Laschinger, MD, U.S. Food and Drug Administration (FDA)/ Center for Devices and Radiological Health (CDRH)/ODE/DCD/SHDB
  • Aaron Lottes, PhD, Cook Research Incorporated
  • Keith Marsolo, PhD, Cincinnati Children’s Hospital Medical Center
  • Frederick Masoudi, MD, MSPH, University of Colorado Anschutz Medical Campus
  • Joe Ross, MD, MHS, Yale University
  • Art Sedrakyan, MD, PhD, Weill Cornell Medicine
  • James Tcheng, MD, Duke University Health System
  • Charles Viviano, MD, PhD, U.S. Food and Drug Administration (FDA)/ Center for Devices and Radiological Health CDRH/ODE/DRGUD

NESTcc was established in 2016 to support the sustainable generation and use of timely, reliable, and cost-effective real-world evidence throughout the medical device lifecycle, using real-world data that meets robust methodological standards and is generated in the course of clinical care and everyday life by patients, providers, or payers, and for the purpose of enhancing regulatory and clinical decision-making.

DCRI-led think tank addresses opportunities and challenges of digital technology in health care

June 4, 2018 – The DCRI brought together national leaders to address the promise and challenges facing digital health technologies in the transformation of health care.

A paper published today in the Journal of the American College of Cardiology summarized the proceedings of a multi-faceted think tank meeting organized by the DCRI in December 2016 in Washington DC. A cross-section of stakeholders including academics, industry and regulatory representatives convened at the meeting to address both the potential of and challenges facing digital health technologies in the transformation of health care in the United States.

“The primary aims of this meeting were to really understand the landscape of digital technology and how it’s currently being used in health care,” said former DCRI Fellow Abhinav Sharma, MD, first author of the study. “We wanted to dive in deep to identify issues and barriers with regards to the development of these technologies and their adoption, and to identify solutions using perspectives from providers, industry, regulatory agencies, payers and professional societies, to use this innovation to drive better delivery of health care.”

According to Sharma, modern health care is literally shifting from clinics and hospitals to the palm of a patient’s hand. There are many examples of how a patient can now enter information on their cellphone and through a dynamic decision algorithm, find out exactly how they should be treated and medicated from the comfort of a familiar home setting. Digital technology is being used not only as a diagnostic tool, but also as a decision support tool, to recruit patients for clinical trials and for informed consent.

“Digital technology is completely revolutionizing the way that we think about health care,” said Sharma, “and it is becoming so much more necessary as our health care costs explode on an unprecedented scale, increasingly lessening our ability to take in, treat and manage complicated diseases in a traditional brick and mortar hospital setting.”

But with all these potential upsides, there are also countless challenges that need to be addressed. According to Sharma, one of the biggest concerns is health data privacy. With a lot of money being pushed into cellphone apps and other digital platforms, it becomes even more critical to ensure there is some degree of regulation on how health data is utilized and the way it is stored and the privacy that comes along with it, so issues like the ones that have happened with popular social media platforms recently can be avoided.

“Interoperability of data is another major challenge, where health record platforms in multiple institutions have no way of connecting with one another,” said Sharma. “There is also an inherent ‘productivity paradox’, where there is a visible decrease in productivity because people don’t really know how to use all this new technology such as gadgets and devices, and the data generated from them to improve the delivery of health care without losing valuable time, energy and resources,” he said.

“Ultimately, we need to make sure our enthusiasm for technology doesn’t outpace our need to validate them,” said Sharma. “Both users and developers need to weigh all new inventions and devices against their preexisting counterparts and see whether or not they improve upon or increase the quality, cost and use of care in comparison.”

The paper strongly advocates the rapid development and implementation of innovation networks on a local, regional and national scale, combining brainpower from academics, entrepreneurs, agencies, associations/societies and regulatory bodies such as the Food and Drug Administration, to review novel technology as soon as it hits the market.

“Digital technology like cellphones have completely revolutionized and changed the way we think about health care,” said Sharma. “When you think of the computational power just in the phone alone, it completely outsmarts most of the computers that we have had in the past.”

According to Sharma, leveraging this phone-based and app-based technology is where a lot of the future is going to be headed. But as digital innovations become more readily available, establishing a proper framework for their appropriate use and rigorous standards of regulation become even more essential.

In addition to Sharma, other authors included Robert A. Harrington, Mark B. McClellan, Mintu P. Turakhia, Zubin J. Eapen, Steven Steinhubl, James R. Mault, Maulik D. Majmudar, Lothar Roessig, Karen J. Chandross, Cheryl A. Boyce, Eric M. Green, Bakul Patel, Andrew Hamer, Jeffrey Olgin, John S. Rumsfeld, Matthew T. Roe and Eric D. Peterson.

Temporarily blocking splanchnic nerve improved outcomes in patients with acute heart failure

May 29, 2018 – A novel intervention acutely reduced intra-cardiac filling pressures and improved cardiac output and patient symptoms.

In a first-in-man proof-of-concept study, DCRI researchers recently tested a new therapeutic approach for the treatment of acute heart failure (HF). Promising results identified the splanchnic nerve as a potential therapeutic target for improvement in acute HF.

Marat FudimDCRI Fellow Marat Fudim, MD, presented the study May 26 at the European Society of Cardiology’s Heart Failure 2018 congress in Vienna, Austria. The DCRI’s Adrian Hernandez, MD, MHS; Schuyler Jones, MD; Cynthia Green, PhD; and Manesh Patel, MD, co-authored the study, which was published simultaneously in Circulation.

The study objective was to assess the effect of a temporary splanchnic nerve block (SNB) on hemodynamic, laboratory, and functional outcomes in patients admitted for acute HF. The trial was prospective, open-label, and included a single-arm intervention in five patients who were hospitalized at Duke University Medical Center between April and November 2017.

Each patient had an established history of HF with elevated intra-cardiac filling pressures on baseline right heart catheterization. The average age was 55 years, four of five patients were male, and ischemic cardiomyopathy was observed in three of the cases. Patients with coagulopathies and those on oral anticoagulants or P2Y inhibitors were excluded.

Five of the seven patients underwent the procedure, which involved a right heart catheterization in the supine position. A bilateral temporary percutaneous SNB with lidocaine was then injected into nerves close to the spine using fluoroscopic guidance in a prone position.

“We basically tried to numb as many nerves as possible going to the abdominal compartment,” said Fudim. “Once the patients were turned back over, we measured pulmonary artery mean and pulmonary capillary wedge pressures for 90 minutes. And what we found was that the pressures dropped immediately – below baseline. And there were no hemodynamic complications, including bleeding.”

Moreover, according to Fudim, patients reported an acute improvement in secondary outcomes during the procedure, including less shortness of breath and an increase in average 6-minute walk distance by 31 meters from immediately before to after the procedure, which however did not meet statistical significance.

The abdominal vascular compartment provides the main storage for intravascular blood volume, and decreased “storage space” could contribute to the complex pathophysiology of HF. Volume overload and inappropriate volume redistribution from the abdominal to the thoracic compartments may increase intra-cardiac pressures and bring on acute HF symptoms, Fudim said.

“Patients with HF essentially push fluid from their belly into the chest, which the heart can’t handle,” he said. “So the question was whether blocking the nerves would shift that fluid from the chest back to the belly – and it did. This is the first time we’ve had evidence of this nerve’s importance – the procedure was able to redistribute the fluid appropriately.”

The minimally invasive and regional nerve block indicated that the splanchnic vascular compartment may play a key role in both acute and chronic HF. These findings suggest that continued research into the use of SNB to treat HF could be of interest, according to Fudim.

“Though promising, however, we’re very cautious to propose this as a therapeutic intervention at this time,” he said. “The procedure can only be performed by an anesthesiologist, and the results are temporary. In addition, the lack of a control group is a major limitation to our study. More testing for safety and efficacy is needed before potential clinical application.”

Califf receives Walter C. Alvarez Award

May 22, 2018 – The award, presented by the American Medical Writers Association, is given for excellence in health care communications.

The American Medical Writers Association announced today that DCRI founder and former Commissioner of the U.S. Food and Drug Administration (FDA) Robert Califf, MD, has received the 2018 Walter C. Alvarez Award. An internationally recognized expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science. He is also a member of the National Academy of Medicine.

Califf is currently the Vice Chancellor for health data science; Director of Duke Forge, Duke University’s multidisciplinary center for actionable health data science; and the Donald F. Fortin, MD, Professor of Cardiology in the Duke University School of Medicine. Additionally, he works as a scientific advisor for Verily Life Sciences, a member of the Alphabet family of companies formed by Google. From 2015 to 2016 he served as Deputy Commissioner for Medical Products and Tobacco, and then as Commissioner of Food and Drugs from 2016-2017 at the FDA.

Named in honor of Walter C. Alvarez, MD, the award is presented annually at the Medical Writing and Communication Conference to honor excellence in communicating health care developments and concepts to the public. Califf will receive his award and give his address on Friday, November 2 at the General Session.

ISPOR honors DCRI’s Reed Johnson with prestigious lifetime achievement award

May 21, 2018 – The award recognizes Johnson’s work in health economics and outcomes research.

The DCRI’s Reed Johnson, PhD, one of the most widely published experts in the field of health applications of stated-preference research, was recently recognized by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). He has been selected as the recipient of the  Avedis Donabedian Lifetime Achievement Award for his outstanding, life-long contribution to the improvement of health outcomes.

Johnson was among the honorees for ISPOR’s 2018 Scientific and Leadership Awards, which are designed to foster and recognize excellence and outstanding technical achievement and leadership in health economics and outcomes research. He was presented the award today at ISPOR’s International Conference in Baltimore.

With over 140 publications in books and peer-reviewed journals, Johnson has four decades of academic and research experience in health and environmental economics and has helped pioneer the development of basic non­market valuation techniques which are widely used for benefit-cost analysis in health and environmental economics, through his work with the U.S. Environmental Protection Agency’s environmental economics research program during the 1980s.

Currently working on quantifying patients’ willingness to accept risks and side effects in return for therapeutic benefits and estimating general time equivalences among health states, Johnson’s research has used a survey-research method called discrete-choice experiments to quantify patients’ willingness to accept tradeoffs among treatment benefits and harms.

“Until quite recently, this research has been far from the mainstream focus of comparative-effectiveness analysis and health-technology assessment, however, recent interest in patient-centric healthcare provided an audience for the idea that patient-preference data could help inform regulatory decision making,” said Johnson.

“Because clinical benefits and risks are measured in different units, regulators must implicitly assign subjective importance weights to clinical outcomes,” he said.  “Evidence on patients’ own importance weights for those outcomes is a way to explicitly incorporate the patient voice in such decisions. It is evident that this year’s Donabedian award was used to recognize the importance of this idea, rather than to recognize me personally.”

Johnson led the first U.S. Food and Drug Administration (FDA)­sponsored study on patients’ willingness to accept benefit-risk tradeoffs for new health technologies. The study was used to develop recent FDA guidelines on submitting patient-preference data to support regulatory reviews of medical devices.

“The methods that Dr. Johnson has helped to develop over the last 25-30 years are now being appreciated and applied as we develop new approaches to patient centered research,” said the DCRI’s Shelby Reed, PhD, President of ISPOR and Director of the DCRI’s Preference Evaluation Research Group where she works alongside Johnson. “His winning this very prestigious award is recognition of the importance of patient preference and patient preference research at a greater level.”

Reed has worked with Johnson for the last four years on the Preference Evaluation Research Group, where they translate patients’ concerns and preferences into quantitative scientific evidence and address questions about representativeness and how to quantify the relative importance of different aspects of care and outcomes. According to Reed, Johnson has not only been the driver for the initial success of the group, but also the reason more and more people are acknowledging and recognizing the group’s work.

“Dr. Johnson is very generous in his mentorship and I continue to learn a tremendous amount from him, said Reed. “I congratulate him for this much deserving honor.”