ARLG Study Employs Innovative Model to Test Diagnostics for Extragenital Gonorrhea

June 23, 2019 – The study’s design, which researchers hope to use for other conditions, enabled testing of multiple diagnostic assays simultaneously and resulted in cost savings.

Molecular diagnostic assays have transformed the field of infectious diseases, allowing for swift and sensitive detection of organisms previously challenging to diagnose, but it can be difficult to study how these new tests perform. Members of the Antibacterial Resistance Leadership Group (ARLG), which is facilitated by the DCRI, recently conducted a study of several assays used to detect extragenital gonorrhea and Chlamydia trachomatis. They say their latest research will help to quell the transmission of these infections and could change the landscape for how diagnostic tests are studied.

Prior to this study, there were no diagnostic tests approved by the U.S. Food and Drug Administration (FDA) for determining the presence of extragenital gonorrhea, despite recommendations from the U.S. Centers for Disease Control and Prevention for screening in certain populations, said the DCRI’s Vance Fowler, MD, MHS, (pictured), co-principal investigator for the ARLG.  As a result, few laboratories offered testing and clinicians lacked an FDA cleared diagnostic test. Lack of testing can result in the continued spread of the bacteria that causes gonorrhea, including drug-resistant strains.

Vance FowlerAccurate diagnostics that are more readily available will result in better detection and timely treatment, which could help to slow the rise of antibiotic resistance, Fowler said.

“Diagnosis is a major problem in antibacterial resistance, and gonorrhea has been identified by the U.S. Centers for Disease Control and the World Health Organization as a concerning bacterium with rapidly emerging resistance,” he said.

ARLG investigators collaborated with the National Institute of Allergy and Infectious Diseases (NIAID), the FDA, Cepheid, and Hologic on this unique study design that incorporated simultaneous testing of samples from a single patient’s pharynx and rectum on multiple diagnostic platforms. Results from this simultaneous testing were incorporated into a reference, or “gold,” standard that could then be used to assess whether each of the diagnostic platforms correctly diagnosed extragenital gonorrhea and chlamydia.

After establishing the reference standard, the study team conducted a clinical trial that enrolled more than 2,500 patients. The study tested a new design that allowed evaluation of multiple diagnostics from different companies simultaneously.

“This idea came from the work I do in my investigative lab, where we often reuse the same clinical samples to answer multiple questions,” Fowler said. “I began to realize that the same idea could be applied to evaluating new diagnostics — if we could test multiple diagnostics on the same patient enrolled into a single trial, we could potentially reduce costs associated with enrolling multiple patient cohorts. This is about enhancing pragmatism in the diagnostic space.”

In 2014, Fowler presented the concept of “one patient, more than one diagnostic” at a meeting sponsored by the National Institutes of Health.  Evaluating diagnostics for extragenital gonorrhea was a way to test this strategy. Fowler relied on the sexually transmitted infection expertise of his ARLG colleague and primary investigator of the project, Jeffrey Klausner, MD, MPH, from the University of California-Los Angeles. On May 23, 2019, two of the devices evaluated in this study received FDA clearance for use to detect pharyngeal and rectal gonorrhea and C. trachomatis, the first two devices approved for this indication.

Fowler sees wide applications for the design and believes the same technique of testing multiple diagnostics simultaneously could be used in many other conditions, such as urinary tract infections, bloodstream infections, and pneumonia.

This process could also benefit companies developing diagnostics in several ways.  First, the cost of enrolling patients into a Master diagnostic trial would be only a fraction of the conventional approach. Next, each company would ultimately receive the trial data relevant to their platform along with the reference standard for submission to the FDA for clearance of their diagnostic platform.

“Employing a platform such as this could enhance and facilitate the ability to develop and ultimately commercialize new diagnostic platforms, providing clinicians with more informed decision making in managing patients with infections caused by multidrug resistant bacteria,” Fowler said.

The ARLG develops, designs, implements, and manages a clinical research agenda to increase knowledge of antibacterial resistance. It aims to advance research by building transformational trials that will change clinical practice and reduce the impact of antibacterial resistance. The ARLG is facilitated by the DCRI and works under the centralized leadership of an executive committee and two principal investigators: Fowler and Henry ‘Chip’ Chambers, MD, of the University of California, San Francisco.

Other authors that collaborated on this study include Sarah Doernberg, MD,MAS, of the University of California-San Francisco.

Research reported in this article was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number UM1AI104681. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

DCRI Contributes to AHA Statement on HIV and Cardiovascular Disease

June 12, 2019 – The statement suggests that when treating people living with HIV who exhibit certain characteristics, clinicians should multiply conventional risk calculator scores by 1.5 to 2.

Gerald Bloomfield

The DCRI’s Gerald Bloomfield, MD (pictured), contributed to a statement from the American Heart Association recently published in Circulation that provides a thorough review of current knowledge on HIV-associated cardiovascular disease, as well as a gap analysis that details where more data are needed.

This statement was needed because currently no guidelines exist on how to address cardiovascular disease in people living with HIV, Bloomfield said. Because HIV used to be fatal, little is known about how people living with the virus experience cardiovascular disease. However, a number of observational studies have shown that as treatment for HIV has improved, people living with HIV are living longer and experiencing more age-related comorbidities, including cardiovascular disease.

“This population deserves special attention when assessing and treating for cardiovascular disease,” Bloomfield said. “We know that chronic exposure to HIV increases heart disease risk, so in treating people with HIV, we need to be aware that the underlying contributors to the disease may extend beyond traditional factors.”

For example, he explained, HIV affects heart muscle contraction in unique ways, increasing risk of heart failure. More data are needed to further understand the long-term impacts of these increased risks, as well as to address treatment and prevention. In addition to heart failure, the statement also addresses increased risk for heart attack and stroke which may be driven by the body’s chronic inflammatory response to the HIV virus.

Another important component of the paper, which distinguishes it from many statements made by the AHA, is that it examines how suggested guidelines could be applied outside the U.S.

“Because 70 percent people living with HIV live in Africa, our writing group thought it was important to discuss unique characteristics of HIV and cardiovascular disease in sub-Saharan Africa,” Bloomfield said. “If we had not addressed this, I think we would have been remiss.”

The paper also suggests that conventional risk calculators may under-predict risk for patients in this population and, for HIV+ patients with certain characteristics, recommends that clinicians multiply risk scores by 1.5 to 2.

“This is novel because there is no solid clinical trial data that supports this suggestion,” Bloomfield said. “However, because there are a large number of people living with HIV who are aging and clinicians are wondering what to do and how to treat them, we felt it was important to offer guidance now based on the best available evidence.”

Bloomfield added that studies are currently underway that will shed more light on this topic in a few years, such as the REPRIEVE trial, which the DCRI’s Pamela Douglas, MD, is working on.

Data Suggest Results From FDA-Mandated Testing Often Not Implemented in Clinical Practice

June 6, 2019 – Investigators were unsure how they would use genetic information to choose treatment choices, then often failed to follow through on their pre-stipulated plan to use this information.

Since 2010, the FDA has recommended that patients treated with clopidogrel undergo genetic testing to determine whether they have reduced metabolizer status. In these patients, certain enzymes that are important in metabolizing clopidogrel are less active, which makes it difficult to activate the drug and increases risk of cardiovascular events. However, findings from the DCRI recently published in JAMA Cardiology suggest that physicians are evenly split on how to incorporate results from this testing into decisions they make in clinical practice.

Thomas J. PovsicThe DCRI’s Thomas J. Povsic, MD, PhD (pictured), led a secondary analysis of a clinical trial that tested the safety of low dose rivaroxaban versus aspirin in addition to one of two P2Y12 inhibitors, clopidogrel or ticagrelor. For many clinical trials that involve clopidogrel, the FDA mandates that patients undergo the recommended genetic testing, with results reported to the investigators.

Investigators involved in the trial were asked whether they would use the test results to inform their decision to switch a patient’s P2Y12 inhibitor. The field of investigators was evenly split on their responses.

The results also showed inconsistencies between the investigators’ responses to this question and the actual treatment paths pursued. Of patients who were treated with ticagrelor, only one patient was switched to clopidogrel—despite the fact that investigators had said they would switch 93 patients based on their test results. Investigators had said they would make the decision to switch 27 of the patients who were treated with clopidogrel and who tested for reduced metabolizer status, but in the end, less than half (13) patients’ treatments were switched.

“We wanted to understand how the information provided by the testing affects physician behavior,” Povsic said. “What we found is that it really did not have an impact. Not only were investigators unsure at the beginning of a trial whether they would use the information to inform decisions, but they also were inconsistent with what they had originally said before they got the information. Even when investigators have the data, they are using the information less than a third of the time in reduced metabolizers on clopidogrel.”

Of the 3,037 patients enrolled in the trial overall, 24 had their P2Y12 inhibitor switched based on the provided genetic information.

“Although the FDA requires testing around this issue, our results show that only a small number of patients are actually impacted by the test results,” Povsic said. “Until we have clinical trial data that tells investigators the right approach to take or that genetic testing leads to improved patient outcomes, the evidence suggests that physicians will be hesitant to let this information influence their treatment decisions.”

Other DCRI contributors to this study include E. Magnus Ohman, MBBS; Matthew T. Roe, MD, MHS; Jennifer White, MS; and Frank W. Rockhold, PhD.

DCRI Co-Hosts Youth Tobacco Cessation Workshop at FDA

June 7, 2019 – The event drew nearly 900 registrants and discussed tobacco-cessation therapies that have been successful in youth populations, as well as gaps in knowledge surrounding e-cigarettes.

The DCRI and Institute for Advanced Clinical Trials for Children (I-ACT) co-hosted the Youth Tobacco Cessation: Strategies and Treatments Workshop on May 15 at the U.S. Food and Drug Administration (FDA) Headquarters in Silver Spring, Maryland.

Nearly 900 people registered to learn about existing experience with tobacco-cessation therapies in youth, the gaps in knowledge surrounding e-cigarettes, and expert recommendations for how to fill those gaps. The workshop speakers represented government agencies, research groups, youth advocacy groups, and the pharmaceutical industry. The FDA Acting Commissioner, Norman “Ned” Sharpless, MD, addressed the workshop participants.

“There is no dispute that years of progress to combat youth use of tobacco to prevent a lifetime of addiction to nicotine is now threatened by an epidemic of e-cigarette use among children,” Sharpless said. “These products are exposing a whole new generation of kids to nicotine and the possibility of addiction.”

The FDA, I-ACT and the DCRI will publish a meeting summary in the coming months. Workshop participants will use lessons learned during the workshop to help guide future use of resources to address youth tobacco cessation.

The topics addressed at the meeting included (slides can be found at the links below):

E-Cigarette Prevention in Youth: New Challenges, New Strategies

  • Brian King, PhD, MPH, Office on Smoking and Health, US Centers for Disease Control and Prevention – click to view slides
  • Kathleen Crosby, MPH, Center for Tobacco Products, FDA – click to view slides

The Science of Addiction in Adolescents

What Can We Learn from the Blueprint for Action?

Experience with Cessation Therapies in Adolescents

Addressing the Gaps: Where Should Treatment Efforts Be Focused?

DCRI Research Contributes to FDA Approval of First Drug for Rare Disease in Pediatric Patients

June 4, 2019 – The team used pharmacokinetic modeling to assess how the drug would behave in children, leading to FDA approval without conducting a pediatric clinical trial.

For the first time, pediatric patients with Lambert-Eaton myasthenic syndrome (LEMS) have a treatment that has been approved by the U.S. Food and Drug Administration (FDA).

A team that included researchers from the DCRI was involved in developing the supporting evidence that led to the FDA’s approval of Ruzurgi (amifampridine) tablets. In a relatively rare occurrence, the drug was approved for a patient population in which it was not tested in a clinical trial.

Jeff Guptill

Instead, the DCRI’s Jeffrey Guptill, MD, explained, the DCRI Pharmacometrics Center was able to embark on a project, led by Huali Wu, PhD, that used data from a trial in which the drug was given to adults. These data were used for pharmacokinetic modeling to predict how the drug would behave in patients aged 6 to less than 17.

“Mathematical models were developed to predict how amifampridine moves through the adult body,” Guptill (pictured) said. “We adapted these models to fit children with LEMS, which helps us draw conclusions about the drug and determine appropriate dosing in this population.”

LEMS is a rare autoimmune disorder that affects the communication between a patient’s nerves and muscles, causing weakness and other symptoms. Duke has one of the highest concentrations of LEMS patients in the U.S.

Ruzurgi also received Orphan Drug designation from the FDA, which offers incentives to encourage drug development for rare diseases.

Study Examines Predictors of Transplant or Death in IPF Patients

May 30, 2019 — Researchers examined clinical factors at the time of a patient’s enrollment in the IPF-PRO registry that might predict lung transplant or death.

Patients in a recent study on idiopathic pulmonary fibrosis (IPF) had about a 50 percent chance of dying or having a lung transplant over the course of the 30-month study, according to findings recently published in Respiratory Research.

The study, which is also highlighted in a recent blog and podcast, examined data from 662 patients with IPF, a progressive and fatal lung disease. These patients were the first of 1,000 to enroll in the IPF-PRO registry, a partnership between the DCRI and Boehringer-Ingelheim to learn more about the disease. All patients were enrolled between June 2014 and October 2017.

Laurie SnyderThe study, led by the DCRI’s Laurie Snyder, MD, MHS, (pictured), examined clinical factors at time of patient enrollment that might predict lung transplant or death. In order to be included in the study, patients had to have been diagnosed with IPF or newly confirmed at a site within the six months prior to the study’s beginning.

The clinical factor that most strongly predicted lung transplant or death was oxygen use at rest, which was associated with a three-and-a-half fold increase in either outcome over the follow-up period.“Interstitial lung diseases like IPF don’t allow oxygen to diffuse across lung tissue,” Snyder said. “Patients who need oxygen not only while walking, but also at rest, are likely more advanced in their disease state and have a higher risk of the outcomes we were examining.”

Patients who had worse lung function were also at greater risk. Lung function was measured at enrollment by forced vital capacity and diffusion capacity, or the capacity of the lungs to exchange oxygen. Patients who scored progressively lower on each of these measures were more likely to need a lung transplant or die before the study’s end.

The study also showed a relationship between age and outcomes. The data collected showed a J-shaped curve, with the youngest patients (around 50 years old) at the highest risk. Risk of lung transplant or death then declined until about age 62, and then escalated again as age increased.

Snyder hypothesizes this could be because the youngest patients have a familial form of IPF, which could be more devastating than non-familial IPF.

“Results like this are the power of the IPF-PRO Registry,” Snyder said. “This is one of the first times we’ve had multicenter data to examine that represents the real world, without limitations on age range or pulmonary function.”

Assistance for the study also came from the DCRI call center.

“Participation in a registry doesn’t mandate that patients come back to a participating center,” Snyder said. “The call center was able to provide a touchpoint to patients and help with data collection, which helped us figure out whether patients had been hospitalized or received lung transplants.”

Next steps for the registry and this research include a move toward longitudinal data. Snyder said the team plans to examine whether changes in clinical factors better predict mortality than singular data points collected at enrollment in the registry.

In addition to Snyder, other DCRI authors included Megan L. Neely, Anne S. Hellkamp, Emily O’Brien, and Scott Palmer.

DCRI study honored as practice-changing by New England Journal of Medicine

May 29, 2019 – The ARISTOTLE study found that apixaban was superior to warfarin in preventing stroke and decreasing risk of bleeding for patients with atrial fibrillation.

A DCRI-led study published in 2011 was recently honored by the New England Journal of Medicine’s editor-in-chief as one of 12 studies that has most changed clinical practice since 2000.

The ARISTOTLE study found that apixaban was superior to warfarin in treating patients with atrial fibrillation who have an increased risk of stroke. Apixaban was not only more effective than warfarin in preventing stroke, but also caused less bleeding. The trial included more than 18,000 patients from 39 countries.

Prior to his upcoming retirement, Jeffrey Drazen, the editor-in-chief of the New England Journal of Medicine, looked back at the science the journal published over the 19 years he spent in the role. From more than 80,000 submissions and nearly 4,000 published studies, he selected 12 to highlight as “Drazen’s Dozen” of “practice-changing and lifesaving papers.”

“This is really quite an honor, as there are plenty of trials that are equally important,” said the DCRI’s Christopher Granger, MD (pictured), who served as a primary investigator and co-chair on ARISTOTLE. “This is a tribute to a great collaboration—both among so many people at the DCRI and worldwide, especially my co-chair Lars Wallentin from Uppsala University in Sweden.”

The DCRI team also credits its industry partners, Bristol-Myers Squibb and Pfizer, with contributing to the success of ARISTOTLE. The DCRI’s John Alexander, MD, MHS, who worked on ARISTOTLE, started studying apixaban with colleagues from Bristol-Myers Squibb in 2005, but the drug had an unfavorable risk-benefit profile in patients with acute coronary syndrome. By contrast, ARISTOTLE, according to Alexander, was “a home run.”

“It has been a rare privilege to be so intimately involved in the development of a drug that has made, and is making, such a difference in patients’ lives,” Alexander said. “I’ve been involved with a lot of trials, but none have had as great an impact on patient care as ARISTOTLE.”

Apixaban is now the most commonly initiated drug for stroke prevention for patients with atrial fibrillation, Granger said. It is easier to use than warfarin because warfarin is associated with several food and drug interactions and requires monitoring.

“It is gratifying to be able to generate evidence that can be used to help improve patients’ lives,” Granger said. “This honor aligns nicely with the DCRI’s mission to share knowledge that improves patient care around the world—we have been able to publish and share knowledge gained from ARISTOTLE that we now use every day in our practice.”

The DCRI’s Renato Lopes, MD, PhD, started working on the trial as a DCRI fellow, and later became part of the core leadership team of the study as a DCRI faculty member.

“When you work on a trial for so long and put in so much effort, it becomes part of your life,” Lopes said. “We are pleased that ARISTOTLE is still generating knowledge and helping patients all over the world, and it’s extremely rewarding and gratifying to be recognized for the work done by so many to make the trial successful.”

In addition to the primary manuscript published in 2011, there have been over 60 publications from ARISTOTLE with over half published in high-impact journals.

Other DCRI faculty who contributed to ARISTOTLE include Hussein Al-Khalidi, PhD, who was the statistician, and Sana Al-Khatib, MD, MHS, who ran clinical events classification for the trial. Many operational staff also contributed to ARISTOTLE’s success.

Duke joins Baseline Health Consortium to get patients more involved in research

May 16, 2019 – The DCRI’s Adrian Hernandez, MD, MHS, and Manesh Patel, MD, will serve as Duke’s representatives to the consortium.

Verily, an Alphabet company, today announced a new Project Baseline initiative, the Baseline Health System Consortium, composed of Verily, Duke University Health System, Vanderbilt University Medical Center, University of Mississippi Medical Center, Mayo Clinic, Regional Health in South Dakota and University of Pittsburgh. The strategic collaboration will identify and develop solutions to significant challenges in clinical research, including making research more accessible and engaging for patients, clinicians, researchers and research sponsors alike.

Adrian Hernandez

United by a vision of transforming clinical research, the consortium partners will embark on a pilot in 2019 to analyze existing research programs, and use tools and technology developed through Project Baseline, including the Baseline Platform — an end-to-end evidence generation platform — to make it faster and easier to conduct studies, capture health information in a more efficient way and generate better evidence to support scientific discovery. The consortium partners sit at the nexus of clinical research and clinical care, and are uniquely positioned to help Verily iterate on its technology to bridge the gap between research and care and further precision medicine.

“The clinical research system fails to provide the evidence that patients and clinicians need to make good health and healthcare decisions,” said the DCRI’s Robert Califf, MD, former FDA commissioner and advisor, Verily. “By developing useful tools and approaches, this robust collaboration has the potential to drive more efficient and effective research as we link patients, advocacy groups, clinicians, health systems and researchers.”

Verily launched Project Baseline in 2017 with the Project Baseline Health Study to develop the technology and tools to help researchers create a more comprehensive map of human health. Duke University School of Medicine, a collaborator in the Health Study, will partner with Verily on this next phase. The DCRI’s Adrian Hernandez, MD, MHS, Vice Dean of Duke University School of Medicine and a principal investigator for the Health Study (pictured), is joined by leaders in health research Manesh Patel, MD, Duke University Health System; Russell Rothman, MD, MPP, Vanderbilt University Medical Center; Javed Butler, MD, MPH, MBA, University of Mississippi Medical Center; Veronique L. Roger, MD, MPH, Mayo Clinic; Drew Purdy, MD, Regional Health in South Dakota; and Kathleen McTigue, MD, MPH, MS, University of Pittsburgh, as representatives to the consortium. Robert Harrington, MD, professor and chair of the Department of Medicine at Stanford Medicine, will chair the Steering Committee, building on Stanford Medicine’s role as a partner in the Health Study.

“We’re proud to be part of this group of institutions committed to changing research and creating a more deeply connected community of patients, researchers and clinicians,” Hernandez said. Project Baseline logo“Part of improving research means that we have to collect better feedback from patients and capture health outside of the four walls of the clinic. The consortium builds on the foundation we’ve created with the Project Baseline Health Study and will help us develop and test tools that could aid our ambitious goal of improving human health.”

“This consortium has a unique opportunity to harness data from past and present research programs, analyze what works and doesn’t work, and use the insights to improve the methodology of clinical research more broadly,” said Harrington of Stanford. “By embracing tools and technology to take research into the modern age, we hope to provide greater value in research to both patients and researchers and maximize what we learn about human health from every clinical and research interaction.”

In founding the consortium and partnering with sophisticated health systems, Verily continues to build a robust research ecosystem, with the goal of delivering modern solutions for faster evidence generation and discovery. In February, Verily announced it was joining forces with the American Heart Association (AHA) on Research Goes Red, a new initiative to engage women in heart health research and discovery. Earlier this month, Verily launched the Project Baseline Heart Biomarker Study, expanding its research into risk factors for heart disease.

Verily launched Project Baseline in 2017 with the goal of transforming clinical research through improved real-world evidence generation and by involving more people and clinicians through accessible and engaging studies. Its first initiative was the Project Baseline Health Study, a longitudinal observational study in partnership with Duke University School of Medicine, Stanford Medicine, Google and the American Heart Association to collect, organize and analyze broad phenotypic health data from a diverse cohort of participants over several years. Verily’s interdisciplinary team has also developed the Baseline Platform, an evidence generation platform designed to engage patients and clinicians in research, make it easier and faster to run clinical studies and collect high quality, comprehensive data in the real world. For more information, please visit www.projectbaseline.com.

DCRI joins Digital Therapeutics Alliance

May 15, 2019 – The DCRI will bring its regulatory experience and clinical expertise to the conversation surrounding digital therapeutics.

The DCRI has joined a new alliance focused on bringing digital therapeutics solutions to patients.

The Digital Therapeutics Alliance (DTA), formed in 2017, works to improve access to digital therapeutics for patients, providers, and payers, in an effort to reduce costs and enhance individualized health care. The DTA currently has 25 members, and the DCRI is the first academic member.

“The DTA seeks to broaden the global digital therapeutics conversation within their organization, and the DCRI brings a different perspective,” said the DCRI’s Scott Kollins, PhD (pictured top), who helped lead the DCRI’s application process to join the alliance. “This is a good way for to us to continue and amplify our work in digital therapeutics and potentially become leaders in the space.”

Kollins, whose research focuses on neuroscience and behavioral science, said the focus on clinically validated, technology-based interventions sets the DTA apart from other digital health organizations.

“Digital health is a broad umbrella term that can refer to many things,” Kollins said. “The DTA distinguishes itself by focusing on evidence-based therapeutic interventions that can prevent, manage, or treat a medical disorder or disease.”

The DCRI, Kollins said, can help companies clinically evaluate these interventions in a quickly growing space that can be difficult to regulate.

“I think the value of the DCRI comes from being able to help manufacturers distinguish themselves from many other companies and apps that are out there claiming they can do certain things, such as improve attention or depression or obesity, without any evidence,” he said. “Both with our clinical research and our regulatory knowledge, we can be the ones who are helping digital therapeutics companies rise above the din.”

As Kollins explored the opportunity for the DCRI to join the DTA, it eventually became clear that he was not the only DCRI faculty member who was interested in the idea.

Ann Marie NavarCardiologist Ann Marie Navar, MD, PhD (pictured bottom), was also looking into the alliance, engaging in conversation with Bray Patrick-Lake, the DCRI’s director of stakeholder engagement who also serves as a founding strategic advisor to the DTA.

Patrick-Lake brings her expertise in patient engagement to the alliance and said she looks forward to the work the DCRI can do to help advance the work of framing and defining the digital therapeutics industry.

“It was important to ensure that the patient voice was front and center,” she said. “For example, accessibility is crucial for patients, but we can’t increase access without evidence that an intervention works. The DCRI can help with the evidence piece through clinical trials, which can in turn improve access issues, such as reimbursement mechanisms. Joining the Digital Therapeutics Alliance enables the DCRI to implement rigor in the development of a new field.”

Navar agreed, adding that although digital therapeutics is currently a hot topic in healthcare, more work needs to be done to effectively deliver solutions to patients. She hopes that the DCRI’s membership in the DTA is a step toward completing this work.

“The promise of digital therapeutics is great, but for now we’re seeing mostly hype and clinically have seen very little on the delivery side,” Navar said. “At the DCRI, we feel that this is an area where strong clinical research is needed to help define where these solutions can actually make a difference on health.”

As the DCRI’s chief of digital health and strategy, Satasuk Joy Bhosai, MD, MPH, spends much of her time thinking about these opportunities. Bhosai is part of the DCRI committee working on the alliance.

“There are a lot of new digital technologies popping up, but we need to help provide guidance around clinical evaluation,” she said. “We can partner with innovators shaping these technologies to help them ensure their innovations actually translate to meaning.”

Now that the DTA membership is official, Kollins said, one of the first steps is to bring together researchers within the DCRI who are pursuing work in this space.

“There are many people within the organization doing relevant work, but this is a good time to centralize that work and set some strategy around digital therapeutics,” Kollins said.

“To be recognized as a digital therapeutic requires that a product go through a series of rigorous clinical trials to substantiate its outcomes,” said Megan Coder, executive director of the DTA. “The DCRI has a deep reputation in inclusive clinical trial design and execution and we welcome them to membership at DTA as our first academic member.”

Use of supportive palliative care lags for heart patients

May 3, 2019 – Patients tend to be sicker and miss full benefits by the time palliative care is provided.

While heart disease is the leading cause of death in the United States, relatively few of these patients receive a referral to palliative care focusing on quality of life and value-based treatment decisions.

When heart patients are referred to palliative care, they are typically nearing death and therefore benefit from hospice services geared to end-of-life, according to a study lead by Duke Health researchers.

“Hospice care is a subset of palliative care that is generally provided when a patient has about six months left to live,” said Haider J. Warraich, MD (pictured), a former DCRI fellow and lead author of the study appearing online Friday in JAMA Network Open.

“Palliative care is much broader, focusing on improving quality of life, easing pain and suffering and assuring that the patients’ treatments going forward are in line with their values and goals,” Warraich said. “There’s a huge gap that patients with heart disease face that has resulted in them not receiving this type of care.”

Warraich and senior author, Arif Kamal, MD, a palliative care specialist at Duke Cancer Institute, reviewed referrals to palliative care from a large national database to determine when and how often patients with cardiovascular disease were referred to palliative care.

The study included more than 1,800 patients with heart disease who had been referred to palliative care from 2015-2017. Of those, about 29 percent were bed-bound, meaning they were in the late stages of disease. By comparison, only about 10 percent of cancer patients, who are the largest group referred to palliative care, are bed-bound.

General medicine physicians increased referrals of heart patients to palliative care, from 43.2 percent in 2015 to 52.9 percent in 2017. But the proportion of referrals from cardiologists declined, from 16.5 percent in 2015 to 10.5 percent in 2017.

“Our data highlight the enormous potential for increased partnerships between cardiologists and palliative care specialists in providing comprehensive, high-touch, supportive care to all affected by advanced heart disease,” Kamal said.

In addition to Kamal and Warraich, study authors include Steven P.Wolf, Robert Mentz, Joseph G. Rogers, and Greg Samsa.