AHA 2018: Multifaceted interventions improve adherence to evidence-based measures in high-risk CV disease

November 10, 2018 – The DCRI’s Renato Lopes, MD, MHS, PhD, contributed to two late-breaking clinical trials from the BRIDGE initiative.

Cardiovascular diseases remain the leading cause of death globally–particularly in low and middle-income countries, where 80 percent of the burden resides–yet research has shown that patients with high cardiovascular risk often fail to receive evidence-based therapies in community practice.

It is well established that statins, antiplatelet therapy, and angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) lower the long-term risk of cardiovascular events in patients with atherothrombotic disease. However, registries have shown that utilization of these therapies in practice is suboptimal and that care gaps are even wider in low- and middle-income countries. Trials studying the effects of quality improvement interventions on the use of these therapies have rarely been conducted in lower-resource settings.

To help address this evidence gap, BRIDGE (Brazilian Intervention to Increase Evidence Usage in Practice), a quality improvement initiative, was launched 10 years ago. This initiative conducts randomized trials to examine the impact of multifaceted quality improvement interventions on use of evidence-based therapies and clinical outcomes. The DCRI’s Renato Lopes MD, MHS, PhD, was co-chair of the BRIDGE-Acute Coronary Syndrome (ACS) trial, which revealed in 2012 that this type of intervention can improve the use of evidence-based therapies and clinical outcomes in ACS patients.

Results from two additional studies, BRIDGE-Cardiovascular Prevention and BRIDGE-Stroke, were presented Saturday at the 2018 American Heart Association Scientific Sessions in Chicago. Lopes was an investigator on both of these studies, testing the same concept as BRIDGE-ACS — this time in patients with stroke and high cardiovascular risk.

“The two studies, led by Brazilian investigators, showed that in general, multifaceted quality improvement interventions resulted in significant improvement in the use of evidence-based therapies, although they were not powered to assess impacts on clinical outcomes,” Lopes said. “Our interventions are relatively simple and feasible, so they could form the basis of quality improvement programs to maximize use of evidence-based interventions to manage patients with stroke and high cardiovascular risk.”

BRIDGE-CV was a cluster-randomized clinical trial including 1,619 patients with established atherothrombotic disease from 40 outpatient clinics or primary care units. The intervention tested involved case management, audit and feedback reports, and distribution of educational materials to health care providers and patients. The primary endpoint was the adherence to combined evidence-based therapies. Institutions that received a multifaceted intervention adhered to 73.5 percent of evidence-based therapies while the control group that received routine care adhered to just 58.7 percent.

The BRIDGE-Stroke trial examined the impact of a multifaceted quality improvement intervention to increase the adherence to 10 evidence-based performance metrics therapies for acute ischemic stroke and transient ischemic attack patients. This two-arm, cluster-randomized trial included 1,624 patients from 36 hospitals in Brazil, Argentina, and Peru. The intervention group adhered to 85.3 percent of the evidence-based performance measures, and the control group adhered to 77.8 percent, a difference that was not statistically significant. Although the intervention did not result in an overall improvement in adherence to evidence-based performance measures relative to standard of care, individual care elements did improve, including a significant increase in the use of thrombolysis and smoking cessation.

Additional DCRI contributors to BRIDGE-Stroke included Ying Xian, Janet Prvu Bettger, and Eric Peterson.

BRIDGE-CV is funded by Amgen as an investigator-initiated trial. BRIDGE-Stroke is funded by the Brazilian Ministry of Health in partnership with Hospital do Coração (HCor) – Programa Hospitais de Excelência à Serviço do SUS (PROADI-SUS). This study also received educational support from Boehringer Ingelheim and Lepetit Pharma.

AHA 2018: Rivaroxaban, warfarin have similar risks of stroke and bleeding for obese Afib patients

November 10, 2018 – Patients on rivaroxaban had significantly lower healthcare costs than patients who took warfarin.

New study results examining the comparative effectiveness, safety, and costs of rivaroxaban and warfarin among morbidly obese patients with non-valvular atrial fibrillation (NVAF) were presented Saturday at the 2018 American Heart Association (AHA) Scientific Sessions in Chicago.

Obesity and morbid obesity are associated with an increased risk of developing NVAF, which may be more severe and persistent this population. Anticoagulation is the standard of care for prevention of embolic events in patients with NVAF, with warfarin and direct-acting oral anticoagulants (DOACs) significantly reducing the risk of stroke in these patients. Because limited data exist regarding clinical outcomes of DOACs in patients with NVAF who are morbidly obese, care guidelines currently recommend against use of these therapies.

Although the study revealed that treatment with rivaroxaban and with warfarin resulted in similar risk, patients who took rivaroxaban, a DOAC, required significantly less total healthcare resource utilization and costs per patient per year, inclusive of medication costs, due to fewer inpatient and outpatient encounters than with patients on warfarin. Rivaroxaban has also been associated with reduced intracranial hemorrhage in NVAF patients when compared with warfarin.

The study used two large, geographically diverse, U.S. healthcare claims databases to examine health outcomes, resource utilization and costs for morbidly obese NVAF patients treated with rivaroxaban or warfarin from December 1, 2010 to December 31, 2016. A total of 267,467 adult patients met entry criteria, and 3,563 matched pairs of patients treated with rivaroxaban or warfarin were identified. Rivaroxaban and warfarin patients were 1:1 propensity score matched, helping reduce selection biases from measured confounders, such as comorbidities, and improving the internal validity of the estimates.

Rivaroxaban and warfarin had similar effectiveness (stroke: 1.4 percent versus 1.6 percent) and safety (major bleeding: 2.2 percent versus 2.7 percent), yet rivaroxaban was associated with lower total healthcare costs per patient per year than warfarin (total costs: $48,552 versus $52,418). This was primarily driven by lower hospitalization rate (50.2 percent versus 54.1 percent), shorter length of stay (7.5 versus 9.1 days), and less utilization of outpatient services (86 versus 115 encounters per patient per year). Routine monitoring of the anticoagulant effect of rivaroxaban is not recommended, contributing to this reduced use of outpatient services.

“This type of study is where comparative effectiveness research really shines,” said lead author and presenter Eric D. Peterson, MD, MPH, of the DCRI.

“We were able to gain real-world insights into outcomes and costs in this relatively rare patient population,” Peterson said. “Our findings extend the results of the ROCKET AF trial and add to the pharmacokinetic and pharmacologic data supporting the use of rivaroxaban in overweight and obese patients with NVAF without the need for routine monitoring. This will reassure clinicians that current dosing strategies are adequate and efficient in these populations.”

Janssen Scientific Affairs, LLC, funded this study.

AHA 2018: High-dose spironolactone does not improve congestion among high-risk acute heart failure patients

November 10, 2018 – An analysis showed the addition of high-dose spironolactone offered no benefit in those with heightened risk for poor response to standard loop diuretics.

For clinicians treating patients with acute heart failure (AHF), managing fluid overload is a critical component of treatment in the hospital. Water retention leads to breathing problems and swelling, and standard hospital care involves removing excess fluid using diuretics.

However, many patients do not fully respond to standard diuretics and end up leaving the hospital with excess fluid. These patients are at increased risk of death or rehospitalization.Stephen Greene

ATHENA-HF, a trial conducted by the Heart Failure Network from 2014 to 2016, assessed whether congestion would improve in AHF patients if high-dose spironolactone was added to usual therapy. The primary endpoint was a proportional change in NT-proBNP, a blood test commonly used as a marker of heart failure severity.

The trial included patients with a wide degree of risk and showed no benefit in the overall population. However, the investigators proposed that patients at highest risk of not responding to standard therapy could benefit from high-dose spironolactone.

Testing that theory, a secondary analysis of the trial focused on patients with kidney disease and other risk factors for diuretic resistance. The results of that analysis were presented today at the annual Scientific Sessions of the American Health Association in Chicago.

“Our study aimed to examine those patients who have a difficult time losing excess fluid with usual in-hospital care,” said the DCRI’s Stephen Greene, MD, who led the study. “We wanted to see if high-dose spironolactone could offer any extra benefit in the subsets of patients who do not adequately respond to typical diuretic therapy.”

“Would giving high-dose spironolactone to these high-risk patients result in them losing extra fluid, feeling better, and further lowering of NT-proBNP? Based on our study, the short answer is no.”

The researchers looked at many characteristics that put patients at increased risk of poor response to standard in-hospital care, such as kidney disease, diabetes, lower blood pressure, and high loop diuretic dose. In all of these subgroups, high-dose spironolactone did not provide extra lowering of NT-proBNP or any signal of benefit, he said.

Greene cautioned, however, that the analysis has limitations.

“Because of the design of the ATHENA-HF trial , this analysis looked at patients at risk for poor diuretic response. We weren’t able to look at the treatment effect among patients with confirmed poor diuretic response,” he said. “This is a big difference. In fact, we ended up seeing that many patients at risk for poor response actually ended up responding fairly well to standard therapy. If we studied addition of high-dose spironolactone in a population with confirmed poor urine output despite days of standard therapy, we might have seen a different result.”

Diuretic resistance is a major problem in heart failure and developing effective treatment strategies must be research priority, Greene said.

“As a field, we still need to keep searching for effective therapies to tackle this problem,” he said

Other DCRI contributors to the study included G. Michael Felker, Anna Giczewska, Hrishikesh Chakraborty, Adam DeVore, Marat Fudim, Steven McNulty, Robert Mentz, and Adrian Hernandez.

New clinical trial to compare ED treatment protocols for sickle cell disease complications

November 6, 2018 – The DCRI and the Duke University School of Nursing will collaborate on the phase III trial.

When patients with sickle cell disease arrive at a hospital emergency department (ED), they are often in significant pain from an acute vaso-occlusive episode (VOE), a common complication of sickle cell disease. With no standard treatment approach in most EDs, patients are likely to receive doses of pain medication that are highly variable. This results in pain treatment that patient surveys frequently describe as inadequate.

Sickle cell disease is a group of inherited red blood cell disorders in which patients have an abnormal protein in their red blood cells that can cause a range of serious symptoms and complications. It is a lifelong illness, although its severity varies widely from person to person.

COMPARE-VOE, a new study led by the DCRI and the Duke University School of Nursing, is designed to determine whether an individual patient-based analgesic protocol would provide greater relief than a protocol based on the patient’s weight. The study was recently funded by two companion grants from the National Heart, Lung and Blood Institute, which is seeking to test recommendations for VOE treatment that it issued in 2014.

“VOE pain can be sudden, excruciating, and unpredictable,” said Huiman Barnhart, PhD, principal investigator for the DCRI’s data coordinating center for COMPARE-VOE (pictured left). “With no standard approach to managing this pain in the emergency department, the variability in practice means pain is often managed sub-optimally. The primary goal of this study is to improve patient-reported pain scores between their arrival and departure from the ED.”

A major challenge in conducting such a trial is the ED setting – most patients are in too much pain to provide informed consent. Because of this logistical difficulty, patients will be randomized beforehand during a routine clinic visit; if they later visit the ED for a VOE, their assigned protocol will be immediately available to ED healthcare providers. While patients will be told what pain medication they are taking, they will not know their assigned protocol.

COMPARE-VOE is a phase III randomized clinical trial based on a pilot study recently completed by the School of Nursing. The earlier trial determined that the patient-specific protocol had greater pain reduction than the weight-based protocol. Patients also experienced fewer side effects from opioid dosing, and were admitted to the hospital less often when using the patient-specific approach. Those findings, however, were limited to two sites.

“The emergency setting adds a lot of complexity,” said Paula Tanabe, PhD, professor at the School of Nursing (pictured right). Tanabe led the pilot study and is the principal investigator for COMPARE-VOE’s clinical coordinating center.

“Each participating ED has to have a strong research infrastructure with ED physicians and hematologists who are willing to participate, and, of course, the ED is a very busy place. Fortunately, by randomizing patients ahead of time with a set of criteria, their treatment plan is already in place.”

The patient-specific approach is determined through an algorithm that allows for dose variation according to what patients require rather than their weight. Most study data will come directly from patients in the ED; they are given a scale of 0-100, and can mark a spot on a ruler to rate their pain at the start and the finish of their visit, according to Tanabe.

“If this trial confirms those initial findings that a patient-specific approach is superior to one that is weight-based, we hope to be able to definitively recommend the most effective way to treat sickle cell disease patients in the emergency department,” Barnhart said.

Other DCRI contributors to the study include Beth Martinez, Sheri Ussery, Coleen Crespo, Hongqui Yang, Robert Bigelow, Kyle West, and Samantha Cage.

DCRI and Duke genomics center receive $9 million grant

November 1, 2018 -The DCRI, in concert with the Duke Center for Applied Genomics and Precision Medicine, will serve as the coordinating center for a new project to promote genomic medicine in clinical practice.

The National Human Genome Research Institute, which is part of National Institutes of Health, has awarded two grants to Duke that will total about $9 million over five years.

One grant establishes the Duke Center for Applied Genomics and Precision Medicine, in partnership with the DCRI, as the coordinating center for a national initiative to move genomic medicine into broader clinical practice. Genomic medicine is a discipline that uses DNA and other molecular information to guide treatment and care.

“Genomic medicine has great potential to improve health, but its widespread implementation has been hampered by the lack of evidence of its clinical utility,” said principal investigator Geoffrey Ginsburg, MD, PhD, director of the Duke Center for Applied Genomics and Precision Medicine. “These new pragmatic genomic medicine clinical trials will provide that evidence.”

“As the coordinating center for this national network, we will create the genomic medicine knowledge base where ideas can be shared so that everyone can begin to use this in practice, whether in community clinics or academic medical centers,” Ginsburg said.

An additional grant from the National Human Genome Research Institute will fund one of the genomic network’s projects. The grant supports an initiative at Duke to gather the family medical histories of low-income patients to assess inherited risks for cancer, cardiovascular diseases and liver diseases. Lori Orlando, MD, is the principal investigator of that project.

“Family health history is the most important and most readily available predictor of disease risk we have. Yet, it is broadly underutilized in clinical practice. Our study is building a platform that will help providers follow evidence -based guidelines for risk management,” Orlando said. “We believe this platform will help individuals who live in areas that don’t have easy access to genetic counseling or genetic testing.”

DOACs as safe and effective as warfarin for patients with atrial fibrillation

October 30, 2018 – A new systematic review updates previous reviews comparing DOACs with warfarin.

Patients with atrial fibrillation are at increased risk for embolic stroke, heart failure, and cognitive impairment. Oral anticoagulation with vitamin K antagonists, such as warfarin, have been a standard for stroke prevention but are difficult to monitor and are associated with adverse food and drug interactions. Direct-acting oral anticoagulants (DOACs), such as dabigatran and apixaban, rivaroxaban, and edoxaban, are approved to treat atrial fibrillation, but it is unclear if they are as effective or safe as warfarin for preventing stroke.

Researchers from the DCRI led by Co-Chief Fellow Angela Lowenstern, MD, reviewed 117 published studies to compare DOACs with warfarin in preventing thromboembolic events and bleeding complications. Their review appears in the current issue of the Annals of Internal Medicine.

They found that the four available DOACs are at least as effective and safe as warfarin for patients with nonvalvular AF. Dabigatran is superior to warfarin in preventing stroke or systemic embolism. Apixaban is also superior to warfarin in preventing stroke or systemic embolism, and also has less risk for major bleeding. These findings provide evidence for the safety and efficacy of DOACs in treatment of patients. The medications also had similar benefits across several patient subgroups and seemed safe and efficacious for a wide range of patients with nonvalvular atrial fibrillation.

Further randomized clinical trials are needed to directly compare oral anticoagulants, including thrombin inhibitors and individual Xa inhibitors, the researchers noted.

In addition to Lowenstern, the study’s authors include Sana M. Al-Khatib, MD, MHS; Lauren Sharan, MD; Ranee Chatterjee, MD, MPH; Nancy M. Allen LaPointe, PharmD, MHS; Bimal Shah, MD, MBA; Ethan D. Borre, BA; Giselle Raitz, MD; Adam Goode, DPT, PhD; Roshini Yapa, MBBS; J. Kelly Davis, BA; Kathryn Lallinger, MSLS; Robyn Schmidt, BA; Andrzej S. Kosinski, PhD; Gillian D. Sanders, PhD.

Data science internship opportunity for Duke master’s students in quantitative fields

October 19, 2018 – Duke students who are scheduled to graduate in spring of 2020 or later are encouraged to apply.

The DCRI, in partnership with Duke Forge (Duke’s center for health data science), is now accepting applications for the Health Data Science Internship Program. Duke students who are pursuing a master’s degree in Statistical Science, Biostatistics and Bioinformatics, Electrical and Computer Engineering, Computer Science, Mathematics, Economics, Computational Biology and Bioinformatics, or other quantitative fields and are scheduled to graduate in spring of 2020 or later are invited to apply. Students will learn as part of teams addressing important challenges that impact the health of the people and communities served by Duke.

Students accepted into the program will enjoy cooperative learning opportunities in collaboration with the Department of Biostatistics and Bioinformatics Biostatistics Core and will receive hands-on experience putting their data science, statistics, or machine learning skills to work as they contribute to multidisciplinary teams. Interns will be based in the DCRI’s Center for Predictive Medicine and will work on projects in collaboration with clinical and research organizations across Duke convened by the Duke Forge. Projects will involve advanced quantitative methods including statistics and machine learning, and career development opportunities will also be provided.

Each intern will receive an hourly wage and must commit to participating a minimum of 10 hours per week during the spring and fall semesters of 2019 and the spring semester of 2020. Because of the nature of project work, applicants must indicate their availability for full-time work in summer 2019 at the time of application. Though it may be possible to support a limited number of interns for fall and spring only, it is highly desirable that interns commit to full-time summer work, and applicants with summer 2019 availability will be given preference during the selection process.

Interested students should apply by submitting the following:

  • A professional resume
  • A list of completed coursework relevant to data science and the grades earned in each course
  • Indication of summer availability
  • Names and contact information of two academic or professional references (with a preference for recommendations from Duke University faculty with whom you have studied or conducted research)

Applications are due by close of business on NOVEMBER 2, 2018. Completed applications, as well as any questions about the program, should be emailed to hannah.l.campbell@duke.edu.

DILIN expands research on drug-induced liver injury

October 18, 2018 – The network’s latest award allows more study on the impact of genetics, specific drugs, and supplements on liver injury.

Drug-induced liver injury (DILI) affects thousands of patients every year, and is the most common reason for both medication withdrawal and U.S. Food and Drug Administration (FDA) regulatory actions concerning drugs. Up to 9 percent of all adverse drug reactions reported to health authorities come from DILI, and several hundred medications and herbal and dietary supplements have been implicated.

Established in 2003 by The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the Drug-Induced Liver Injury Network (DILIN) collects and analyzes cases of liver injury to help better understand their source. DILIN consists of one data coordinating center (DCC) and several clinical centers across the country.

From the start, the DCRI has served as the DCC for DILIN. With its NIDDK award renewed every five years since inception, DILIN’s DCC is the longest-running in DCRI history. In that time, according to the DCRI’s Huiman Barnhart, PhD (pictured), the program has significantly grown and evolved.

“Our research focus over the years has shifted to genetics, specific drugs, and supplements,” said Barnhart, the DCC’s principal investigator since 2011. “For instance, we’re increasingly looking at whether patients’ particular genes make them more susceptible to liver injury when taking certain drugs. And while that research is still exploratory, we’re collecting DNA in the hopes of a significant discovery one day.”

Establishing a diagnosis of DILI can be tricky due to the presence of other potential causes, and the injury can range from mild and transient to severe and protracted, according to Barnhart. To help distinguish causes, the DCC has developed standardized procedures that identify and characterize cases. DILIN researchers are also preparing to conduct controlled, clinical studies that will include collection of more data, serum, DNA, and tissue specimens.

About 20 percent of DILI reports are now related to herbal and dietary supplements, Barnhart said.

“We are seeing more and more patients now with injuries due to supplements, and that trend has been growing over time,” she said. “So we’re seeking more data to fully understand what is going on with those supplements – they’re unregulated, of course, and manufacturers don’t always reveal every ingredient. Running chemical analyses on these products now is helping to reveal illegal and potentially dangerous drugs not on the label.”

In 2013, an outbreak of acute liver injury was attributed – with data from the DCC – to a multi-ingredient nutritional supplement marketed for weight loss, bodybuilding and energy-enhancing aid. The DCC researchers noticed a spike in enrollment due to this supplement in the specific time period and shared the data with the FDA. One of the company’s products was found to contain a synthesized version of aegeline, an herb naturally found in Southeast Asia. In 2013, more than 40 cases of acute hepatitis, including several instances of acute, fatal liver failure, were linked to the same product. Under pressure from the FDA, the product was withdrawn from the market.

“With real-time monitoring of liver injuries, our data can help the FDA with early detection,” said Barnhart. “While the agency doesn’t have the oversight to regulate these products, they can still visit the company and send a warning letter to stop production and potentially save lives.”

The DCC also collaborates with LiverTox, a government website launched in 2012 to provide up-to-date and comprehensive information on DILI by sharing case studies with healthcare providers and specialists. The site covers an increasing number of commercially available drugs and supplements suspected to cause injury.

“We provide LiverTox with a case registry to help with scientific analysis and the clinical patterns of liver injury,” said Barnhart. “The registry allows secure submission of specific cases to highlight trends due to different medications. Drug records on LiverTox reveal the hepatoxicity of individual agents – so far, more than 1,000 agents have been described and indexed.”

The DCC’s research is also finding racial variations in DILI by collecting more data from African-American and Hispanic patients. Genome-wide association studies help detect and confirm specific genetic risk factors, and study data could support the use of genetic variants as biomarkers for susceptibility to DILI for a given medication.

“We’re especially seeing variations in the human leukocyte antigen region, which helps regulate the human immune system,” said Barnhart. “There may be a rare variant in that region of the genome that makes such patients more susceptible to DILI. So the next stage in our research will include deep sequencing in that region.”

Data management has also evolved since DILIN’s start 15 years ago. Collection began with paper case report forms before the data were migrated to InForm, an electronic data capture (EDC) platform, used until earlier this year. The DCC recently moved the DILIN data entry platform to RaveX, a web-based EDC that allows data entry anywhere with internet access, according to the DCRI’s Katherine Galan, data management project leader on DILIN since 2009.

“We’re the first project at the DCRI to use RaveX,” Galan said. “Making that first switch was quite a feat because enrollment is always ongoing with DILIN. While many of the sites are still adapting to the new database, in the long run, we expect the system to be much easier than anything we’ve had before.”

“Part of the challenge is that DILIN is a very complex study, and not always straightforward. With a new grant every five years, in a sense we’re always in start-up mode with new amendments and protocols. And now with this new grant including a clinical trial, it will be very interesting to see how the process evolves.”

The network’s first clinical trial, made possible by its latest grant renewal, will look at how patients might be treated with liver injury, according to Barnhart.

“In most cases, they have needed to stop the drug and recover from their injury,” she said. “But through the new clinical trial, we hope to identify treatments for those patients with severe liver injury and not recovering after stopping the drug.”

“These are some of the ways we can have the most impact on the general public,” Barnhart said. “It’s all about making sure that safe medications are prescribed to patients and that only safe herbal and dietary supplements are on the market.”

VERITAS shows virtual assistant with clinical oversight as effective as traditional physical therapy

October 15, 2018 – VERA™, a virtual rehabilitation platform, also enabled a substantial reduction in costs and rehospitalizations.

The DCRI and Reflexion Health today announced positive results from a randomized controlled clinical trial, “Virtual Exercise Rehabilitation In-home Therapy: A Research Study (VERITAS).” VERITAS was designed to evaluate the cost and clinical non-inferiority of using a virtual rehabilitation platform to deliver physical therapy following total knee replacement (TKR) surgery. In the study, VERA™, Reflexion Health’s FDA-cleared Virtual Exercise Rehabilitation Assistant, with clinician oversight enabled a substantial reduction in post-acute costs and rehospitalizations while being as effective as traditional physical therapy.

Conducted independently by the DCRI, VERITAS is the first large-scale randomized controlled clinical trial that compares virtual physical therapy with traditional physical therapy.

Janet Bettger“Physical therapy is a critical component of recovery for patients following total joint replacement surgery. As people live longer and these surgeries become more common, it is important to identify solutions that maintain or improve outcomes while decreasing the burden on patients and providers,” said the DCRI’s Janet Prvu Bettger, ScD, associate professor with the Duke Department of Orthopedic Surgery and principal investigator of the study. “We are pleased with the results of the study which show that Reflexion Health’s VERA coupled with remote clinician oversight, is a cost-effective paradigm for physical therapy – one that is more convenient for patients while providing clinicians greater insight into the recovery process.”

VERITAS was a multi-center, randomized controlled trial that enrolled 306 adult participants scheduled for TKR surgery at four U.S. sites. Of the consented participants, 287 completed the trial. The treatment group concluded with 143 adults who received Reflexion Health’s VERA both pre- and post-surgery, compared with a control group of 144 adults who received traditional in-home or clinic-based physical therapy at participating sites. Clinical outcomes, health service use, and costs were examined for three months after surgery.

The study results demonstrated an average cost savings of $2,745 per patient for those who received virtual physical therapy using VERA technology with clinical oversight when compared to usual care with traditional physical therapy. Virtual physical therapy met its secondary effectiveness endpoints of non-inferiority for reducing disability and improving knee function. Compared with usual care, safety endpoints for patients with virtual physical therapy were similar.

“VERITAS provides the highest level of evidence that VERA is a more cost-effective, patient-centered alternative to traditional care,” said Joseph Smith, MD, PhD, chief executive officer of Reflexion Health. “The strength of these results should give providers and payors the proof they need to adopt VERA. Engaging and delighting patients with a convenient and connected solution in the comfort of their own home, while providing similar or better clinical outcomes and dramatically reducing overall healthcare costs is a win for everyone.”

Full results from the VERITAS trial will be presented at the American Health Association of Hip and Knee Surgeons Annual Meeting taking place November 2-4 in Dallas.

DCRI’s CEC team hosts unique event with Stanford

October 11, 2018 – The Duke/Stanford CEC Summit brought together experts in clinical events classification from around the globe.

A unique, collaborative meeting aimed at establishing consistent standards globally for clinical events classification (CEC) and adjudication in clinical trials is being celebrated as a success and vital starting point for future work.

The first-ever Duke/Stanford CEC Summit was held Sept. 26-27 at the Chicago Hilton O’Hare, jointly hosted by the DCRI and the Stanford Center for Clinical Research (SCCR). Approximately 80 attendees took part in the two-day event.

“This meeting is all about bringing scientific rigor around CEC,” said Summit Co-Chair Renato Lopes, MD, PhD, faculty co-director of DCRI’s CEC team. “Our goal was to review how we do it now, but also predicting and trying to anticipate the future. Getting the right players in the room is critical – from academic, industry people, regulatory, and operational people – and try to share best practices, share experiences, and come to consensus. Or we recognize the things where there is no consensus, and there, try to innovate and inform the field.”

Numerous speakers and panelists from beyond Duke and Stanford supported that aim, with presenters representing the U.S. Food and Drug Administration (FDA), Harvard University, Cleveland Clinic, George Clinical, the Cardiovascular Research Foundation, ACI Clinical, Cardialysis, and more.

DCRI speakers included Professor of Biostatistics and Bioinformatics Frank Rockhold, PhD; CEC Co-Director Schuyler Jones, MD; CEC-Safety Surveillance Director of Operations Matt Wilson, RN; and Safety Surveillance Program Manager Ghazala Haque, MBBS, MHS.

Abraham Gutman, CEO of AGMednet – one of several CEC Summit sponsors – was impressed by the dialogue at the event, noting “people were able to ask the key questions that are in everybody’s mind, but never had a forum to ask.”

“I have heard a number of things (at the meeting) that are contradictory in a good way, in that people have different opinions,” he added. “My hope is that…we will find the commonalities in the processes that different people have been putting together and be able to use those more across projects in a way that…will achieve a better result.”

Event organizers look forward to sharing a white paper in the coming weeks that summarizes the learnings and opportunities identified at the meeting.

“This is just the beginning,” Lopes concluded. “We really hope that we’re going to create a core group of people that will meet every year and discuss and follow up on the action items …and move forward over the years. We can refine the discussion, we can create documents…that can model and help people do CEC all over the world.”

“I think this meeting is long overdue,” remarked Karen Hicks, medical officer with the U.S. FDA. “There was such active engagement – so many questions. There’s many CECs throughout the world and I think we’re all grappling with the same questions about how to do the job better.”