New stroke quality improvement initiative targets center of the “stroke belt”

February 17, 2017 -The IMPROVE Stroke Care program aims to improve every element of stroke care in North Carolina

A new DCRI-led program is looking for ways to improve systems of stroke care across North Carolina and beyond.

Stroke kills more than 130,000 Americans each year, making it the fifth-leading cause of death in the nation. Every year, more than 795,000 people in the United States have a stroke. Many of these strokes occur in the southeastern United States, in an 11-state region known as “the stroke belt.” North Carolina, which occupies the middle of this region, is sometimes described as the “buckle” of the belt.

In early 2015, the American Heart Association/American Stroke Association (AHA/ASA) updated their guidelines to recommend endovascular therapy in eligible acute ischemic stroke patients. However, for this therapy to be of benefit for the largest number of stroke patients, integrated and coordinated systems of care need to include public stroke awareness and education, patient and family recognition of stroke, and carry through rapid Emergency Medical Services  access and transportation to the appropriate inpatient setting and beyond.

Early action is important for improving outcomes for stroke patients. Patients who arrive at the emergency room within 3 hours of their first symptoms often have less disability three months after a stroke than those who received delayed care. Ensuring rapid care in North Carolina is particularly difficult, however, as there are only four certified comprehensive stroke centers in the state.

The IMPROVE Stroke Care program was created to develop a regional integrated stroke system in North Carolina that identifies, classifies, and treats patients with acute ischemic stroke more rapidly and effectively with reperfusion therapy. Based on similar programs developed to improve systems of care around heart attacks, IMPROVE Stroke Care will develop a network of stroke centers and other hospitals to implement best practices and integrate state of the art technologies into regional systems of stroke care. The DCRI’s System and Implementation Research and Outcomes operations teams will provide expertise in health system engineering and data reports to share across the program to improve process and clinical outcomes.

The initial costs of the program will be funded through a series of philanthropic grants from various sources totaling $3 million. The DCRI’s Bradley Kolls, MD, PhD (pictured left), and Carmen Graffagnino, MD (pictured right), medical director of the Duke Comprehensive Stroke Center, will serve as principal investigators for the project.

One of IMPROVE Stroke Care’s novel elements is the use of new data capture technologies. Key data elements will be defined, collected, and fed back in real time to drive practice improvement. Participating centers will have real-time feedback on their performance metrics, utilizing novel data capture methods and mobile applications that operate independently of existing electronic health records or primary databases but are able to interact with them. This approach is based on earlier work done by the Duke Telestroke Network, which provides remote consultations for acute stroke diagnosis and treatment recommendations to affiliates across the state.

“We’ve come up with an innovative way of capturing data automatically through the Telestroke Network,” Kolls said. “This is a new strategy for collecting data on the systems of care throughout the state.”

The investigators also noted that stroke care has enormous financial costs; the total direct cost of stroke in the United States is expected to reach $184 billion in 2030. Initiatives such as IMPROVE Stroke Care save millions of dollars through reduced disability, improved functional outcomes, as well as reduced nursing home and re-hospitalization costs.

Ultimately, Graffagnino said, the real value of IMPROVE Stroke Care is in bringing together experts from every field of stroke care to address one of the Stroke Belt’s most serious public health threats.

“This is the whole village getting to solve this problem, not just doctors,” he said. “I think that’s really important.”

More extremely preterm babies survive, live without neurological impairment

February 16, 2017 – Overall survival and development of infants born at 23, 24 weeks improving, study finds.

Babies born at just 22 to 24 weeks of pregnancy continue to have sobering outlooks — only about 1 in 3 survive.

But according to a new study led by Duke Health and appearing Feb. 16 in the New England Journal of Medicine, those rates are showing small but measurable improvement. Compared to extremely preterm babies born a decade earlier, the study found a larger percentage are developing into toddlers without signs of moderate or severe cognitive and motor delay.

Changes to prenatal care, including greater use of steroids in mothers at risk for preterm birth, could have contributed to increased survival and fewer signs of developmental delay in these infants, the authors said.

“The findings are encouraging,” said lead author Noelle Younge, MD, a neonatologist and assistant professor of pediatrics at Duke. “We see evidence of improvement over time. But we do need to keep an eye on the overall numbers, as a large percentage of infants born at this stage still do not survive. Those who survive without significant impairment at about age 2 are still at risk for numerous other challenges to their overall health.”

The researchers analyzed the records of 4,274 infants born between the 22nd and 24th week of pregnancy, far earlier than the 37 to 40 weeks of a full-term pregnancy. The babies were hospitalized at 11 academic medical centers in the Neonatal Research Network, part of the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health.

About 30 percent of infants born at the beginning of the study (between 2000 and 2003),  survived. That proportion increased to 36 percent for babies born toward the end of the study (from 2008 to 2011), with the best outcomes for children born at 23 and 24 weeks. Overall survival for babies born at 22 weeks remained the same throughout the study, at just 4 percent.

Over the 12-year study period, the proportion of infants who survived but were found to have cognitive and motor impairment at 18 to 22 months stayed about the same (about 14 to 16 percent). But the proportion of babies who survived without evidence of moderate or severe neurological impairment improved from 16 percent to 20 percent.

“Researchers in the Neonatal Research Network reported in 2015 that survival was increasing in this vulnerable population,” Younge said. “One concern was that the improved survival might have been accompanied by a greater number of infants who went on to have impairments in the long term, such as cerebral palsy, developmental delay, hearing and vision loss. However, we actually are seeing a slight improvement. Because children continue to develop over years, it’s important to continue to track this data so families and providers can make the best decisions in caring for these infants.”

Improvements in survival and neurodevelopment may be the result of a number of factors, including declining rates of infection in the infants, along with the increased use of steroids in expectant mothers that can help mature and strengthen the fetus’s lungs prior to birth. At the beginning of the study, 58 percent of the expectant mothers had received steroids to boost fetal development. That figure increased to 64 percent by the end of the study.

“The culture of neonatal intensive care units has really changed in the past decade,” said senior author C. Michael Cotten, MD, a neonatologist and professor of pediatrics at Duke.  “We’ve taken a big focus on preventing infections, and there’s a lot more encouragement and support for the use of mother’s milk than there was 15 years ago, which has also been linked to better outcomes.”

Extremely preterm infants are highly susceptible to infections. Neonatal intensive care units have reported steady decreases in infection rates among extremely preterm infants over the past two decades.

“This is important because infections have been associated with greater risk of neurologic problems,” Cotten said.

In addition to their work with the Neonatal Research Network studying strategies to improve outcomes for preterm babies, the Duke researchers continue to study environmental and genetic factors, as well as the babies’ gut bacteria and metabolomics.

“We’re are always looking at how we can make further headway and continue to improve survival and reduce illness in this population,” Cotten said. “The results of this study are encouraging, but there’s still a long way to go.”

In addition to Younge and Cotten, study authors were Ricki F. Goldstein; Carla M. Bann; Susan R. Hintz; Ravi M. Patel; P. Brian Smith; Edward F. Bell; Matthew A. Rysavy; Andrea F. Duncan; Betty R. Vohr; Abhik Das; Ronald N. Goldberg; and Rosemary D. Higgins.

Black, female patients more likely to report angina symptoms after heart attack

February 7, 2017 – A new DCRI study also found that 6-week angina was most strongly associated with unplanned rehospitalization for heart attack patients.

Black and female patients are more likely to report persistent angina symptoms following hospitalization for heart attack, according to a new study by DCRI researchers.

The study appears in the Feb. 7 issue of Circulation. The DCRI’s Tracy Wang, MD, MHS, MSc, served as senior author.

Race and gender disparities in cardiac care have been well-documented, but until now there has been little research into angina symptom frequency and rehospitalization risk following a heart attack. More than 1.5 million Americans experience a heart attack each year, and many of these patients experience angina symptoms afterwards. These symptoms usually include pain or tightness in the chest.

In this study, DCRI researchers and their colleagues analyzed data from the TRANSLATE-ACS study (Treatment with Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome). TRANSLATE-ACS is one of the largest, prospective, longitudinal studies in the United States, observing the treatment and outcomes of more than 12,000 heart attack patients treated with coronary stenting procedures at 233 hospitals.

For this study, the researchers included data from 11,595 patients from 231 hospitals across the United States. Of these patients, there were 7,726 (66.6 percent) white male patients, 2,816 (24.3 percent) white female patients, 616 (5.3 percent) black male patients, and 437 (3.8 percent) black female patients. Among all patients, 29.7 percent reported angina at 6 weeks, and 20.6 percent had angina at one year after hospital discharge.

Compared to white patients, black patients were more likely to have angina at 6 weeks (female: 44.2 percent versus 31.8 percent; male: 33.5 percent versus 27.1 percent) and 1 year (female: 49.4 percent versus 38.9 percent; male: 46.3 percent versus 31.1 percent). Rates of 1-year unplanned rehospitalization were highest among black female patients (44.1 percent), followed by white female patients (38.4 percent), black male patients (36.4 percent), and white male patients (30.2 percent).

The researchers also found that 6-week angina was most strongly associated with unplanned rehospitalization.

These findings, the researchers concluded, demonstrate that significant race and gender disparities among heart patients still exist. Addressing these disparities is key to improving outcomes among the groups most affected, particularly black women.

In addition to Wang, the study’s author’s included Connie N. Hess, MD, MHS; Lisa A. Kaltenbach, MS; Jacob A. Doll, MD; David J. Cohen, MD; and Eric D. Peterson, MD, MPH.

Klotman to become new school of medicine dean and vice chancellor for health affairs

January 30, 2017 – Mary E. Klotman, MD, will assume the role July 1.

Mary E. Klotman, MD, a pioneering physician-scientist and nationally recognized leader in academic medicine, will become the next Dean of the Duke University School of Medicine and Vice Chancellor for Health Affairs, announced A. Eugene Washington, MD, Duke Chancellor for Health Affairs and President and CEO of the Duke University Health System (DUHS). Klotman will assume this role July 1, 2017. For nearly seven years, she has served with distinction as the Chair of Duke’s Department of Medicine.

“Mary Klotman is a visionary leader, deft executive administrator, and congenital collaborator with an unwavering commitment to excellence,” said Washington. “She has amply demonstrated her exceptional ability to engage diverse groups to successfully advance all the missions of our academic health system. I am confident Mary will continue to excel in capitalizing on the enormous talent and promise of our people in Duke Health to improve health worldwide.”

Klotman has been a national leader in science and academic medicine through her roles in the Alliance for Academic Internal Medicine where she is President of the Association of Professors of Medicine and her role on the Council for the Association of American Physicians. Throughout her career she has served on numerous NIH study sections that have informed the direction of research in HIV. She is also a member of the National Academy of Medicine, formerly the Institute of Medicine.

“The next leader of the Duke University School of Medicine needs to have keen instincts about how to best support clinical and basic research while adapting nimbly and creatively to a changing health landscape,” said Duke University President Richard Brodhead. “In Mary Klotman, Duke has found a dean with all the tools to do this job brilliantly. She has impressed colleagues across the university with her strength of purpose, clarity, judgment, and love of Duke. Duke Health can look forward to a great new chapter with Mary in this new role leading the School of Medicine.”

Over the past three decades, Klotman has amassed a record of sterling achievements as a scientist. She and her long-standing collaborators clearly identified HIV in cells unique to the kidney and have demonstrated a separate evolution of the virus in the kidney that now has led to additional critical questions as the science moves toward strategies for cure. The group also identified the contribution of specific viral proteins to the pathogenesis of HIV-associated nephropathy. While advancing the science of HIV, the collaborative nature of the group supported the early careers of a number of investigators.

At Duke, Klotman has led the Department of Medicine during a period of robust growth and national acclaim, while also contributing significantly to the broader Duke Health enterprise. As chair, she has recruited and appointed a group of highly talented division chiefs (9) and vice chairs, and Duke has now climbed to the number three department of medicine in the country in NIH research funding. The department has also consistently recruited a diverse and exceptionally talented housestaff. In addition, she has championed faculty/trainee career development programs including the creation of the Lefkowitz Society for research intensive trainees, and Career Academies for the faculty. Through her roles as Chair of the Board of the Private Diagnostic Clinic, membership on the Board of Directors of DUHS and positions on institutional leadership committees, she has tirelessly sought to align the success of the department with the success of the institution.

Klotman was selected following a national search by a 23-member search committee (see below), comprised of representatives from across the Duke Health and Duke University communities, and led by Theodore Pappas, MD, and Blanche Capel, PhD.

Klotman will oversee one the nation’s top medical schools, and she will partner closely with Duke Health leadership to establish a more integrated clinical enterprise.

“I am tremendously honored and humbled to have been selected as the next Dean of what I know to be among the finest medical schools in the country,” said Klotman. “Duke’s greatest strength is its people and I look forward to working collaboratively with colleagues within Duke Health and across Duke University to further advance this institution that has so profoundly influenced me.”

Prior to coming back to Duke, Klotman served as the Chief of the Division of Infectious Diseases at Mount Sinai for 13 years. In addition, she was the co-director of Mount Sinai’s Global Health and Emerging Pathogens Institute, a program designed to translate basic science discoveries into clinical therapeutics for newly emerging and re-emerging infectious diseases. Before Mt. Sinai, Klotman worked at the National Institutes of Health in the Laboratory of Tumor Cell Biology under the direction of Robert Gallo.

A magna cum laude graduate of Duke University, Klotman completed medical school at Duke, and later residency and fellowship training in infectious diseases at Duke as well.  She has also received the Duke University School of Medicine Distinguished Alumni Award.

Klotman and her husband Paul, who is CEO, President and Executive Dean of Baylor College of Medicine, have two adult sons, Sam married to daughter-in-law Jessica, and Alex.

“Today is a great day for our School of Medicine, Duke Health, and Duke University,” said Washington. “We are very fortunate to have Mary Klotman as our next Dean and Vice Chancellor.”

Gene therapy for Pompe disease effective in mice, poised for human trials

January 26, 2017 -A single dose of gene therapy could augment or replace frequent enzyme infusions.

After decades investigating a rare, life-threatening condition that cripples the muscles, Duke Health researchers have developed a gene therapy they hope could enhance or even replace the only FDA-approved treatment currently available to patients.

The gene therapy, demonstrated in mice, is described in a new study published online in the journal Molecular Therapy – Methods & Clinical Development. The therapy uses a modified virus to deliver a gene to the liver where it produces GAA, an enzyme missing in people with Pompe disease.

Study authors have received approval from the FDA to launch a phase I clinical trial in humans and are currently working to secure funding.

Pompe disease is an inherited condition that affects approximately 1 in 20,000 babies and can also appear in adulthood. People with the condition lack the enzyme GAA, which means their bodies can’t metabolize the sugar, glycogen. As a result, glycogen builds up in the muscles. In babies, this leads to improper muscle development and, if undiagnosed and untreated, can lead to respiratory problems, heart failure and death.

“The outlook for Pompe disease is much improved since enzyme replacement has become available — it can reverse involvement of the heart and prolong survival,” said senior author Dwight Koeberl, MD, PhD, professor of pediatrics and a medical genetics specialist at Duke.

“But not everyone responds to this treatment,” Koeberl said. “Many patients make some antibodies, and this can really interfere with treatment. Some infants still die from Pompe disease. Others have to add immune suppression to their treatment, which can lead to other complications. Gene therapy could help these patients.”

The Duke-led research team found that a single small dose of gene therapy was as effective as enzyme replacement therapy (ERT) in clearing the buildup of glycogen from the muscles in mice. A larger dose offered superior results to ERT. A single treatment spurred the liver to continuously produce GAA without additional treatment, the study authors said. Enzyme therapy requires infusions once or twice a month to lower glycogen levels in the muscles.

Unlike ERT, the gene therapy doesn’t trigger an immune response, a reaction that can limit successful treatment in about half of babies with Pompe. In fact, the gene therapy appeared to reverse immune responses in mice that had previously developed antibodies in response to enzyme replacement, Koeberl said.

The gene therapy uses an inactivated form of adeno-associated virus (AAV), which does not cause illness and has been used as a delivery system for hemophilia B and muscular dystrophy treatments, among others, Koeberl said.

The emerging gene therapy is just the latest development for a team of scientists at Duke that has been working for three decades to study the causes and potential treatments for glycogen-storage diseases and specifically Pompe.

“When we enter our careers in the field of genetics, we are faced with the many unmet needs for patients with rare diseases,” said the DCRI’s Priya Kishnani, MD (pictured) , chief of the medical genetics division at the Duke University School of Medicine. “Before enzyme replacement became available for Pompe disease in 2006, we would continue to give parents bad news — take your beautiful baby home; he or she will die within their first year of life. I knew we had to do something about this.”

Kishnani has researched Pompe for 25 years, beginning under prominent geneticist Y.T. Chen, the previous chief of the medical genetics division at Duke. In the 1990s and 2000s, Chen and Kishnani worked with biotech firm Genzyme to develop ERT and lead clinical trials.

Since then, Kishnani and dozens of other Duke physicians have been national leaders in Pompe disease, continuing to research the condition, improve the delivery of ERT, manage immune responses to the drug and improve genetic counseling for families.

The Duke team has helped develop a blood test to diagnose Pompe and a biomarker to monitor severity of the disease and patients’ response to treatment. For nearly 10 years, Kishnani has led a group of physicians to advocate nationally for universal newborn screening, which became a formal recommendation of the U.S. Department of Health and Human Services in 2015. The team’s next step is to develop small molecule or oral drugs that could suppress the buildup of glycogen in the muscles.

“There’s a rich heritage of expertise on glycogen storage disease at Duke, spanning about 40 years,” Kishnani said. “We have continued to grow from the era of cloning the genes to developing animal models, to collaborating with pharma to conduct clinical trials here at Duke. I think we have come full circle, from bench to bedside and back to the bench in every aspect of the disease.”

In addition to Koeberl, study authors include Sang-oh Han; Giuseppe Ronzitti; Benjamin Arnson; Christian Leborgne; Songtao Li; and Federico Mingozzi.

Regional systems of care can improve key processes in treating heart attack patients

January 24, 2017 – The American Heart Association’s Mission: Lifeline STEMI Systems Accelerator project is the first effort to regionalize STEMI care across the United States.

Efforts to regionalize and optimize care for ST-segment–elevation myocardial infarction (STEMI) patient care can result in shorter reperfusion times, which improve patient care.

Primary percutaneous coronary intervention (PCI) is the preferred method of revascularization for STEMI patients. For these patients, timely reperfusion is essential to ensuring the best possible outcomes. Current guidelines recommend that patients undergo PCI no more than 90 minutes after the first point of care.

Christopher Fordyce, MD

However, between 30 and 50 percent of patients do not receive care within that timeframe. The American Heart Association’s Mission: Lifeline STEMI Systems Accelerator project, the first effort to regionalize STEMI care nationally, was developed to improve reperfusion times by coordinating efforts by emergency medical service (EMS) providers and hospitals.

In a study published this month in Circulation: Cardiovascular Interventions with an editorial comment by Harvey White of Auckland City Hospital, a team of researchers led by former DCRI Fellow Christopher Fordyce, MD, MHS, MSc, examined whether implementing these improvements was associated with system performance improvement.

The STEMI Systems Accelerator program was developed and implemented in 16 US metropolitan areas between March 2012 and July 2014. It included 171 hospitals and 23,809 patients. For this study, Fordyce and his colleagues contacted STEMI Systems Accelerator coordinators at each participating hospital before and after the program was implemented to answer a series of questions about four key process in reperfusion care for STEMI patients:

  • Prehospital cardiac catheterization laboratory activation for patients presenting directly via EMS to a PCI-capable hospital
  • Single-call primary PCI transfer protocol for patients presenting to a non-PCI-capable hospital
  • Emergency department bypass for patients presenting directly via EMS to a PCI-capable hospital
  • Emergency department bypass for patients transferred from a non-PCI-capable hospital to a PCI-capable hospital

This information was then compared to patient data compiled over the same period. The researchers found that uptake of each process increased after implementing the STEMI Systems Accelerator program: pre-hospital catheterization laboratory activation increased from 62 percent to 91 percent, single-call transfer protocol from an outside facility from 45 percent to 70 percent, emergency department bypass for EMS direct presenters from 48 percent to 59 percent, and emergency department transfers increased from 56 to 79 percent.

The researchers also noted significant differences in median first medical contact-to-device times among groups implementing pre-hospital activation (88 minutes implementers versus 89 minutes preexisting versus 98 minutes non-implementers). Patients treated at hospitals implementing single call transfer protocols had shorter median first medical contact-to-device times (112 versus 128 versus 152 minutes). Emergency department bypass was also associated with shorter median first medical contact-to-device times for emergency medical services direct presenters (84 versus 88 versus 94 minutes) and transfers (123 versus 127 versus 167 minutes).

These findings, Fordyce and his colleagues concluded, illustrate that programs such as STEMI Systems Accelerator can produce a quick and meaningful impact in key processes. Efforts to optimize STEMI systems should continue to focus of these processes, they added.

In addition to Fordyce, the study’s authors included Hussein R. Al-Khalidi, PhD; James G. Jollis, MD; Mayme L. Roettig, RN, MSN; Joan Gu, MS; Akshay Bagai, MD, MHS; Peter B. Berger, MD; Claire C. Corbett, MMS; Harold L. Dauerman, MD; Kathleen Fox, RN, BS; J. Lee Garvey, MD†; Timothy D. Henry, MD; Ivan C. Rokos, MD; Matthew W. Sherwood, MD, MHS; B. Hadley Wilson, MD; and Christopher B. Granger, MD.

U.S. health care reform should consider cost-effectiveness, says national panel co-chair

January 19, 2017 – Cost-effectiveness analyses can help policymakers make more informed decisions, says the DCRI’s Gillian Sanders-Schmidler.

As both houses of Congress consider repeal of the Affordable Care Act and enacting alternative health care reform in its stead, a New England Journal of Medicine Perspective by the co-chairs of the 2nd Panel for Cost Effectiveness in Health and Medicine argue that applying cost-effectiveness analyses to reveal the trade-offs between available treatments can help stakeholders, including patients, caregivers, providers, and payers, make decisions that help Americans obtain the most health possible for the available resources. The panel’s new guidelines, published this fall, evaluate costs and impacts beyond the health care sector and provides tools to incorporate patient perspectives on value.

“As lawmakers consider repeal of the Affordable Care Act, replacements should consider formal cost-effectiveness analysis that considers impacts of interventions that are most important to patients and other stakeholders as well as consequences to caregivers, social services and others outside the health care sector,” said Gillian Sanders-Schmidler, PhD.

Sanders-Schmidler is a member of the Outcomes Research and Assessment Group within the DCRI and of the Duke-Margolis Center for Health Policy. She is an Associate Professor in the Division of Clinical Pharmacology, Department of Medicine at Duke University Medical Center. Her research focuses on developing evidence-based decision models to evaluate the comparative effectiveness of alternative prevention, treatment, and management strategies for chronic diseases – and the translation of such models into formats/tools that patients, healthcare providers, and policymakers can use in their decision-making process. She is co-chair of the 2nd Panel for Cost Effectiveness in Health and Medicine.

UV light can aid hospitals’ fight to wipe out drug-resistant superbugs

January 17, 2017 – Adding UV light to standard cleaning cut transmission of 4 resistant bacteria by 30 percent

A new tool — a type of ultraviolet light called UVC — could aid hospitals in the ongoing battle to keep drug-resistant bacteria from lingering in patient rooms and causing new infections.

Some hospitals have already begun using UVC machines in addition to standard chemical disinfection to kill potentially dangerous bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), but research on their effectiveness has been preliminary.

A large randomized trial led by Duke Health and published in The Lancet finds use of UVC machines can cut transmission of four major superbugs by a cumulative 30 percent. The finding is specific to patients who stay overnight in a room where someone with a known positive culture or infection of a drug-resistant organism had previously been treated.

“Some of these germs can live on the environment so long that even after a patient with the organism has left the room and it has been cleaned, the next patient in the room could potentially be exposed,” said Deverick J. Anderson, MD, an infectious disease specialist at Duke Health and lead investigator of the trial, which included more than 21,000 patients. “Infections from one of these bugs are tough and expensive to treat and can be truly debilitating for a patient. For hospitals, these infections also cause a burden of costs that often aren’t reimbursable.”

The researchers focused on four drug-resistant organisms: MRSA, vancomycin-resistant enterococci (VRE), C. difficile and Acinetobacter.

The trial was conducted from 2012 to 2014 at nine hospitals in the Southeast, including three Duke University Health System hospitals, a Veterans Affairs hospital, and small community health care settings.

The facilities used a portable machine called the Tru-D SmartUVC to disinfect rooms where patients with the target bacteria had been staying. For about 30 minutes, the machine emits UVC light into an empty room, the light bouncing and reflecting into hard-to-reach areas such as open drawers or between cabinets and fixtures. The light waves kill bacteria by disrupting their DNA.

The trial compared standard disinfection with quaternary ammonium to three other cleaning methods: using quaternary ammonium followed by UV light; using chlorine bleach instead of quaternary ammonium and no UV light; and cleaning with bleach and UV light.

Overall, the most effective strategy was using quaternary ammonium followed by UV light. This combination was particularly effective against transmission of MRSA.

The researchers found that using chlorine bleach instead of quaternary ammonium cut transmissions of VRE by more than half. Adding UV light to the bleach regimen was even more successful, cutting VRE transmission by 64 percent.

None of the cleaning methods significantly reduced the incidence of C. difficile, an infection that takes hold in the gut. The incidence of Acinetobacter was limited to one case, so researchers did not include it in their analyses.

UVC machines are now being manufactured by several companies and are priced upwards of $90,000. Hospitals could save money by reducing costly infections, but that may not be enough to offset the economic impacts of leaving patient rooms vacant for an additional 30 minutes for cleaning, Anderson said.

“There is such a push in the hospital environment to turn rooms over that really any amount of added time is viewed as a potential issue,” Anderson said. “In a large hospital, you might have 100 rooms that are vacated and turned over in one day.”

Hospitals have to be strategic to enable extra disinfection time while considering varied discharge times, the demand for patient rooms and availability of the machines, Anderson said. Even with these factors — which change daily — hospitals in the trial achieved 90 percent compliance, meaning they disinfected 90 percent of the targeted rooms following the exact trial protocol.

UVC light is just one of numerous methods hospitals can add to standard disinfection regimens to continue to cut infection rates for all pathogens, including drug-resistant organisms, Anderson said. Strategies such as stringent hand-washing, precautions for staff contact with infected patients and prudent use of antibiotics in patients also play a role, he said.

The Duke researchers are planning to look at other day-to-day strategies hospitals can use to manage infections, such as non-ultraviolet lights that are safe to use near people but also can halt the proliferation of germs.

The study was sponsored by the CDC Prevention Epicenters Program (U54CK000164), the National Institute of Allergy and Infectious Diseases (K23AI095357) and the National Center for Advancing Translational Sciences (UL1TR001111). Tru-D SmartUVC, Ecolab, Clorox and Angelica Corporation and Shared Linen Services donated materials used in the trial.

In addition to Anderson, study authors include Luke F. Chen; David J. Weber; Rebekah W. Moehring; Sarah S. Lewis; Patricia F. Triplett; Michael Blocker; Paul Becherer; J. Conrad Schwab; Lauren P. Knelson; Yuliya Lokhnygina; William A. Rutala; Hajime Kanamori; Maria F Gergen; and Daniel J. Sexton. Study authors Rutala and Weber disclosed that they have received consulting fees from Clorox. The other authors declared no competing interests.

Blood pressure intervention programs vary in effectiveness, but show promise

January 12, 2017 – A new study suggests that community-based programs can help lower hypertension rates among participants.

Community-based blood pressure intervention programs show promise for improving participants’ blood pressure, according to a new study conducted by DCRI researchers.

The study, published this month in the Journal of Clinical Hypertension, examined the American Heart Association’s (AHA) Check. Change. Control . (CCC) program. CCC was a multi-intervention community-based initiative to improve blood pressure control in 18 cities in the United States.

High blood pressure is the leading cause of cardiovascular disease in the nation, affecting more than 78 million adults. In 2010, the AHA announced a plan to reduce deaths from cardiovascular disease and stroke by 20 percent by 2020. The CCC program was launched in 2013 as a part of this effort. In each of 18 target cities, AHA staff worked with volunteers and community partners to implement a cost-effective, scalable plan to enroll participants in an evidence-based hypertension management program that utilized blood pressure self-monitoring. In total, more than 4,000 patients were enrolled across all of the target cities.

In this study, the DCRI’s Monique Anderson, MD, MHS, and her colleagues sought to evaluate the CCC’s effectiveness using site enrollment goals, participant engagement, and blood pressure change from first to last measurement. The researchers collected data on each site’s program planning, pre-implementation, and post-implementation status using questionnaires. Blood pressure and demographic data logged by participants were obtained from the AHA’s web-based personal health portal. These data were used to estimate enrollment, engagement, and blood pressure outcomes for each of the 18 campaigns, as well as for the overall program.

Between January 1 and March 31, 2013, 4,069 adults were enrolled into the CCC program at the 18 sites. The median age of participants at each site was 51 years, and almost 75 percent of all participants were female.

The researchers found considerable variation in patient outcomes among the sites. Expected enrollment ranged from 350 to 1,200 patients. Actual enrollment ranged from 74 to 422 participants; the percent of actual versus expected enrollment for each site ranged from 9.3 percent to 120.6 percent. Participant engagement, defined as more than eight recorded blood pressure measurements over a 4-month period, averaged 14.7 percent and ranged from 0 percent to 52.8 percent. The highest 25th sites had a mean continuous patient engagement of 37.4 percent, the middle 50th 10.0 percent, and the lowest 25th 1.1 percent.  The highest 25th sites experienced a −13.7 mm Hg average reduction in blood pressure, the middle 50th a −3.3 mm Hg average reduction, and the lowest 25th a +1.1 mm Hg average increase in systolic blood pressure.

The most high-enrolling sites recruited at senior residential institutions and service organizations, held hypertension management classes, and worked closely with community partners. These top-performing sites also distributed blood pressure cuffs, regularly checked blood pressure at engagement activities, and trained volunteers.

Despite the large variation in outcomes among the sites, the CCC program was successful in reducing overall blood pressure. By focusing on factors shared by the most successful sites, the researchers concluded, future programs may have even more success in improving participants’ blood pressure.

In addition to Anderson, the study’s authors included Rachel Peragallo Urrutia, MD, MSc; Emily C. O’Brien, PhD; Nancy M. Allen LaPointe, PharmD; Alexander J. Christian, BSPH; Lisa A. Kaltenbach, MS; Laura E. Webb; Angel M. Alexander, MSPH; Paramita Saha Chaudhuri, PhD; Juliana Crawford; Patrick Wayte MBA; and Eric D. Peterson, MD, MPH.

More focused, pragmatic randomized studies on atrial fibrillation needed, study finds

December 15, 2016 – Researchers call for more studies addressing the clinical management of atrial fibrillation while examining the quality of evidence underlying the AHA/ACC/HRS clinical practice guidelines on atrial fibrillation, and how they have changed over time.

A recent study by DCRI researchers and colleagues published online December 14 in JAMA Cardiology describes the changes over time in the joint American College of Cardiology (ACC), American Heart Association (AHA) and Heart Rhythm Society (HRS) guidelines on the management of atrial fibrillation and the distribution of recommendations across classes and levels of evidence.

Both the ACC and the AHA have published clinical practice guidelines on atrial fibrillation, which are used widely to guide patient care in the United States, since 2001. In 2011, the Heart Rhythm Society came on board as a primary author and stakeholder. This study was intended to determine whether there have been meaningful changes in the strength of recommendations and quality of evidence used in the guidelines since 2001.

Classes of recommendations and levels of evidence are organized in a ranking system used in evidence-based practices in medicine to define and denote the strength of the results measured in a clinical trial or research study. Level A recommendations represent the highest quality evidence backed by multiple randomized controlled trials or meta-analyses. This is followed by level B, which represents findings from a moderate-quality trial or analysis, and level C, which is derived from non-randomized, less robust studies.

This study examined recommendations from the AHA/ACC/HRS clinical practice guidelines on atrial fibrillation from 2001, 2006, 2011 and 2014. For each recommendation, the researchers documented class of recommendation, level of evidence, and atrial fibrillation category. Even with a noteworthy increase ( more than 200 percent) in the number of published randomized trials focused on atrial fibrillation between 2001 and 2014, there was no notable change in the use of level A evidence.

“The ACC/AHA/HRS AF Guidelines play a critical role in providing recommendations for the treatment of atrial fibrillation,” said the DCRI’s Jonathan Piccini, MD, MHS, the study’s senior author. “Health systems, practices, and providers use them not only to guide clinical care, but also to help assess quality of care. However, guidelines are only as good as the evidence underlying them. Despite great advances in the treatment of atrial fibrillation, a lot of important clinical questions remained unanswered. For example, rate control – a key component of AF care – does not have any treatment recommendations supported by the highest level of evidence. Thus, as we design new trials in the future, we need to make sure they address practical treatment decisions in a pragmatic way that helps practicing clinicians.”

The researchers also pointed out that the atrial fibrillation guidelines lag when compared to those of other common diseases, such as unstable angina and heart failure, due to the unique challenges posed by the study and treatment of atrial fibrillation. The study did not consider any revisions to the aims and methodology used by ACC/AHA/HRS over the study period and did not use clinical practice guidelines from other organizations, such as the European Society of Cardiology or the American College of Chest Physicians.

These findings, the researchers concluded, do not diminish the value of the AHA/ACC/HRS guidelines but instead highlight the need for additional high-quality studies targeted to specific and pragmatic clinical questions in atrial fibrillation.

In addition to Piccini, other contributing authors included Adam S. Barnett, William R. Lewis, Michael E. Field, Gregg C. Fonarow, Bernard J. Gersh, Richard L. Page, Hugh Calkins, Benjamin A. Steinberg, and Eric D. Peterson.