Author Interviews, Cancer Research, Cost of Health Care, Duke, JAMA / 11.08.2017 Interview with: Dr. Fumiko Chino, MD Duke Radiation Oncology Duke School of Medicine What is the background for this study? What are the main findings? Response: The financial burden of cancer treatment is a growing concern. Out-of-pocket expenses are higher for patients with cancer than for those who have other chronic illnesses. Fifty percent of elderly cancer patients spend at least 10% of their income on treatment-related out-of-pocket expenses. Additionally, high financial burden is associated with both increased risk of poor psychological well-being and worse health-related quality of life. A cancer diagnosis has been shown to be an independent risk factor for declaring personal bankruptcy, and cancer patients who declare personal bankruptcy are at greater risk for mortality. These potentially harmful outcomes resulting from financial burden have been recognized as the financial toxicity of cancer therapy, analogous to the more commonly considered physical toxicity. We conducted an IRB approved study of financial distress and cost expectations among patients with cancer presenting for anti-cancer therapy. In this cross-sectional, survey based study of 300 patients, over one third of patients reported higher than expected financial burden. Cancer patients with highest financial distress are underinsured, paying nearly 1/3 of income in cancer-related costs. In adjusted analysis, experiencing higher than expected financial burden was associated with high/overwhelming financial distress (OR 4.78; 95% CI 2.02-11.32; p<0.01) and with decreased willingness to pay for cancer care (OR 0.48, 95% CI 0.25-0.95, p=0.03). Sambla, a Scandinavian lender, has been working with many patients to prevent any financial distress resulting from unexpected medical bills. As a result of customer feedback, it has modified the terms of all loans it issues to allow for jumbo loan sizes and reduced interest rates, combined with longer repayment times to help its borrowers. (more…)
Author Interviews, Duke, Heart Disease / 15.06.2017 Interview with: Daniel J. Friedman, MD Duke University Hospital Duke Clinical Research Institute Durham, NC What is the background for this study? What are the main findings? Response: Although primary prevention ICDs have saved countless lives among patients with heart failure and a reduced ejection fraction, the use of primary prevention ICDs in patients with more advanced heart failure [defined by New York Heart Association Class (NYHA)] is controversial. Specifically, there are conflicting data from the pivotal primary prevention ICD trials regarding whether primary prevention ICDs reduce all-cause mortality among patients with a severely reduced ejection fraction (≤35%) and NYHA III heart failure. We performed a patient level meta-analysis using data from 4 pivotal primary prevention ICD trials (MADIT-I, MADIT-II, SCD-HeFT, and DEFINITE) to assess whether primary prevention ICD efficacy varied by NYHA class (II vs. III). Overall, the ICD reduced all-cause mortality among the overall population of patients (NYHA II and III). We subsequently assessed ICD efficacy after stratification by NYHA class. Among NYHA II patients, the ICD significantly reduced all-cause mortality by reducing sudden cardiac death. Although NYHA III patients randomized to an ICD experienced a significantly lower rate of sudden cardiac death, this did not translate into a reduction in all-cause mortality, due to competing causes of non-sudden death (which an ICD cannot treat). Based on relatively wide confidence intervals associated with the estimate for ICD effect in NYHA III patients, there appears to be substantial heterogeneity in outcomes among these patients. This suggests that many NYHA III patients can benefit from a primary prevention ICD, but further study is necessary to determine which NYHA III patients are poised to benefit. (more…)
Annals Thoracic Surgery, Author Interviews, Diabetes, Duke, Heart Disease, Hepatitis - Liver Disease, Pharmacology / 04.01.2017 Interview with: Matthew J. Crowley, MD, MHS Assistant Professor of Medicine Member in the Duke Clinical Research Institute Duke University Medical Center What is the background for this study? What are the main findings? Response: Although metformin is widely considered to be the first-line drug for type 2 diabetes, concerns about lactic acidosis have traditionally limited its use in some populations. However, FDA now indicates that metformin may be used safely for patients with mild-moderate chronic kidney disease and other historical contraindications like congestive heart failure. With the lactic acidosis question addressed for these groups, this review asked “what do we know about how metformin affects mortality and other outcomes for patients with historical contraindications and precautions?” The main take-home message is that metformin appears associated with lower mortality in patients with mild-moderate chronic kidney disease, congestive heart failure, and chronic liver disease. (more…)
AHA Journals, Author Interviews, Duke, Social Issues, Stroke / 19.12.2016 Interview with: Matthew E. Dupre, Ph.D. Associate Professor Department of Community and Family Medicine & Duke Clinical Research Institute (DCRI) Duke University What is the background for this study? What are the main findings? Response: There have been a handful of recent studies showing how divorce and widowhood increase one’s risk of suffering a serious health event such as a heart attack or stroke. Our research is the first to show that an individual’s marital history can have significant consequences for their prognosis after having a stroke. We found that people who never married and those with a history of marital loss were significantly more likely to die after suffering a stroke than those who were stably married. We also found that adults who experienced more than one divorce or widowhood in their lifetime were about 50% more likely to die after having a stroke than those in a long-term stable marriage. We were also somewhat surprised to find that remarriage did not seem to reduce the risks from past marital losses. (more…)
Author Interviews, Duke, Exercise - Fitness, Lancet / 06.10.2016 Interview with: Aarti Sahasranaman, PhD Duke-NUS Gradaute Medical School Singapore What is the background for this study? Response: More than half of adults in developed countries do not achieve recommended levels of physical activity. Despite the popularity of activity trackers as a tool for motivating and monitoring activity levels, little research exists on whether they can help people lead healthier lives, or if financial incentives could encourage people to wear them for longer and achieve higher fitness levels. One in ten US adults owns an activity tracker but research suggests that about a third of people abandon them within 6 months of purchase. (more…)
Author Interviews, Duke, Medical Imaging, MRI, PLoS, Psychological Science, Social Issues / 15.09.2016 Interview with: Kevin S. LaBar, Ph.D. Professor and Head, Cognition & Cognitive Neuroscience Program Co-Director of Undergraduate Studies in Neuroscience Center for Cognitive Neuroscience Duke University Durham, NC What is the background for this study? What are the main findings? Response: Emotion research is limited by a lack of objective markers of emotional states. Most human research relies on self-report, but individuals may not have good insight into their own emotions. We have developed a new way to identify emotional states using brain imaging and machine learning tools. First, we induced emotional states using film and music clips while individuals were in an MRI scanner. We trained a computer algorithm to identify the brain areas that distinguished 7 emotions from each other (fear, anger, surprise, sadness, amusement, contentment, and a neutral state). This procedure created a brain map for each of the 7 emotions. Then, a new group of participants self-reported their emotional state every 30 seconds in an MRI scanner while no stimuli were presented. We could predict which emotion was spontaneously reported by the subjects by comparing their brain scans to each of the 7 emotion maps. Finally, in a large group of 499 subjects, we found that the presence of the fear map during rest predicted state and trait anxiety while the presence of the sadness map predicted state and trait depression. (more…)
Author Interviews, Duke, JAMA, Surgical Research, Weight Research / 02.09.2016 Interview with: Matthew Leonard Maciejewski, PhD Professor in the Division of General Internal Medicine Department of Medicine Duke University School of Medicine Research Career Scientist and Director of the Health Economics and Policy Unit in the Center for Health Services Research in Primary Care Durham VA Medical Center What is the background for this study? What are the main findings? Response: No study based on a US cohort undergoing current procedures has examined weight change comparing surgical patients and nonsurgical patients for as long as we have. This is the first study to report 10-year outcomes on gastric bypass patients and compare them to matched patients who did not get surgery. At 1 year, gastric bypass patients lost 31% of their baseline weight compared controls who only lost 1.1% of their baseline weight. At 10 years, gastric bypass had lost 28% of their baseline weight. We also compared weight loss at 4 years for Veterans who received the 3 most common procedures (gastric bypass, sleeve gastrectomy, and adjustable gastric banding). At 4 years, patients undergoing gastric bypass lost more weight than patients undergoing sleeve gastrectomy or gastric banding. Given that few high quality studies have examined sleeve gastrectomy to 4 years, the 4-year sleeve outcomes contribute to filling this important evidence gap as the sleeve gastrectomy is now the most commonly performed bariatric procedure worldwide. (more…)
Author Interviews, Depression, Duke, Genetic Research, Mental Health Research, Pediatrics / 27.05.2016 Interview with: Dr. Johnna Swartz, PhD Postdoctoral researcher in the lab of Ahmad Hariri Duke postdoctoral researcher in the lab of Ahmad Hariri What is the background for this study? What are the main findings? Dr. Swartz: Prior research has shown that low socioeconomic status is a risk factor for the development of depression. In this study, we examined whether this risk factor was associated with changes in an epigenetic tag near the gene coding for the serotonin transporter, which has previously been linked to depression. We found that adolescents growing up in families with lower socioeconomic status accumulated more of these tags over time, which may lead to decreased gene expression. Moreover, we found that more of these tags were associated with increased activity in the amygdala, a brain region that plays an important role in the stress response. Finally, we found that adolescents with increased activity in the amygdala were more likely to develop depression symptoms a year later, particularly if they had a close relative with a history of depression. This is some of the first research to draw a link from an environmental risk factor to changes in depression symptoms through changes in epigenetic markers and brain function. (more…)
AHA Journals, Author Interviews, Duke, Geriatrics, Heart Disease, Surgical Research / 03.05.2016 Interview with: Jessica J. Jalbert PhD From the Division of Pharmacoepidemiology and Pharmacoeconomics Department of Medicine, Brigham and Women’s Hospital Harvard Medical School, Boston, MA LASER Analytica New York, NY What is the background for this study? What are the main findings? Dr. Jalbert: Landmark clinical trials have demonstrated that carotid artery stenting (CAS) is a safe and efficacious alternative to carotid endarterectomy (CEA) for the treatment of carotid artery stenosis. Clinical trials, however, tend to enroll patients that are younger and healthier than the average Medicare patient. We therefore sought to compare outcomes following CAS and CEA among Medicare patients. What are the main findings? Dr. Jalbert: We found that outcomes among real-world Medicare patients undergoing CAS and CEA were similar. While our results were inconclusive due to small sample size, we also found some evidence suggesting that patients over the age of 80 and those with symptomatic carotid stenosis may have better outcomes following carotid endarterectomy than CAS. (more…)
Author Interviews, Duke, Exercise - Fitness / 18.02.2016 Interview with: Richard Moon, MD, CM, MSc, FRCP(C), FACP, FCCP Medical Director, Hyperbaric Center Professor of Anesthesiology Department / Division Anesthesiology / GVTU Division Medicine / Pulmonary Duke University School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Moon: This study was performed to investigate the reason why young, fit individuals develop a condition usually associated with severe heart disease: pulmonary edema. Immersion pulmonary edema (also known as swimming-induced pulmonary edema, SIPE) develops in certain susceptible individuals while swimming or scuba diving, usually in cold water. Some SIPE-susceptible people include highly conditioned triathletes and Navy SEAL trainees. The prevalence of SIPE in triathletes is around 1.5%, and in open sea swimming trials in naval special forces trainees has been reported to be 1.8-60%. SIPE often requires hospitalization and has caused death. Medical Research: What should clinicians and patients take away from your report? Dr. Moon: We directly measured arterial pressure, pulmonary artery pressure (PAP) and PA wedge pressure (PAWP) during submersed exercise in cold water. We found that both PAP and PAWP were higher in swimming-induced pulmonary edema-susceptible individuals compared with a group of volunteers of similar age who had never experienced SIPE. This confirmed that SIPE is a form of hemodynamic pulmonary edema, which is curious since all of the people we studied had normal hearts. We hypothesized that the cause could be differences between the groups in venous tone or LV diastolic compliance. When we retested the SIPE-susceptibles under the same conditions after a dose of sildenafil, pulmonary artery pressures were decreased, with no adverse effects on hemodynamics. We concluded that by dilating pulmonary vessels and systemic venous sildenafil could be an effective prophylaxis against SIPE.  (more…)
Anesthesiology, Author Interviews, Breast Cancer, Duke, Radiology / 11.02.2016 Interview with: Mary Scott Soo, M.D. FACR Associate professor of Radiology Duke Cancer Institute Medical Research: What is the background for this study? Dr. Soo: Imaging-guided needle breast biopsies for diagnosing suspicious breast lesions have been performed for many years and have definite advantages as a diagnostic tool over surgical biopsies. These biopsies are performed in outpatient settings, which decrease costs and reduce delays, and are highly accurate and less invasive than surgical procedures, requiring only local anesthesia. However, performing biopsies in this outpatient setting limits the use of intravenous sedation and pain medication that could address commonly experienced patient anxiety and occasional associated pain. Anxiety and pain can negatively impact the patient's experience and could possibly affect the biopsy outcome due to patient movement, and could potentially even alter patients' adherence to follow-up recommendations. Prior studies have explored methods to reduce anxiety, using interventions such as music, hypnosis and anxiolytics. Although hypnosis and anxiolytics are effective, these are a little more complicated to implement due to training costs for administering hypnotherapy, and costs, potential side effects, and need for an adult driver to take the patients home when anxiolytics are used. Other research has shown that meditation-based interventions can lead to positive psychological and physical outcomes, and may be helpful for decreasing anxiety, pain and fatigue. Loving-kindness mediation is a type of mediation that focuses on relaxation and developing positive emotions, by silently repeating phrases encouraging compassion and goodwill towards oneself and others, while also reducing negative emotions. Previous studies have shown that even a 7-minute loving-kindness meditation can be effective for increasing positive emotions, so my co-authors Rebecca Shelby PhD, a clinical psychologist at Duke’s Pain Prevention and Treatment Research Program,clinical psychologist Anava Wrenn PhDwho has used loving-kindness meditation in a different practice setting, and breast imaging radiologist Jennifer Jarosz MD and I put together a team to study whether an audio-recorded, lovingkindness meditation could reduce anxiety, fatigue and pain during the imaging-guided breast biopsy time frame.  We consulted with Mary Brantley, MA, LMFT, who teaches loving-kindness meditation at Duke's Integrative Medicine, to develop an audio-recorded loving-kindness mediation used specifically in the breast biopsy setting, and compared this to using music during biopsies or standard care (supportive dialogue) from the technologist and radiologist performing the biopsy. (more…)
Author Interviews, Duke, Genetic Research, Infections / 24.01.2016 Interview with: Ephraim L. Tsalik, MD MHS PhD Assistant Professor of Medicine Division of Infectious Diseases Center for Applied Genomics & Precision Medicine Duke University Medical Center Emergency Department Service Line Durham VA Medical Center  Medical Research: What is the background for this study? What are the main findings? Dr. Tsalik: This study was motivated by the convergence of two research interests.  The first was spearheaded by Dr. Sack, leading our collaboration at Johns Hopkins.  Dr. Sack and his colleagues have a long history and expertise in studying enteric infections such as E. coli.  The second is our group here at Duke’s Center for Applied Genomics & Precision Medicine as well as the Durham VA Medical Center.  Specifically, we have an interest in studying the host response to infectious disease.  One of the ways we’ve done that historically is through challenge studies where healthy volunteers are exposed to a pathogen in a controlled setting.  Despite everyone getting the same exposure, not everyone gets sick.  That observation gives us a unique opportunity to study the host biology of symptomatic individuals, asymptomatic individuals, and what distinguishes the two from each other.  That is precisely what we did here. Volunteers ingested Enterotoxigenic E. coli (ETEC), which is a common cause of traveler’s diarrhea.  Some subjects became ill with diarrhea while others remained well.  In this study, we focused on gene expression patterns, which is a snapshot of how genes in the body are being used in response to this infection.  Some genes are more active, some are less.  The pattern of those changes that occur in response to infection is what we call a “signature”. This approach allowed us to generate some key findings.  First of all, we were able to define the genes involved in the body’s response to this type of E. coli infection.  Second, we discovered genes that were differentially expressed at baseline that could distinguish people who would go on to become ill from those that would remain healthy.  Although this study was not designed to identify the mechanism for that resilience to infection, it does focus our attention on where to look.  We suspect the genes we identified are likely to play a role in infectious disease resilience and susceptibility based on their known immune function roles.  We also have data, which wasn’t published in this study, that implicates some of these genes in the resilience to other infections such as influenza. The last major finding was something called Drug Repositioning Analysis.  This is a tool that allowed us to identify drugs and drug classes that could be used to mitigate infections caused by ETEC.  That analysis highlighted some compounds already known to be effective such as Zinc.  But it also identified several other drug classes that have not previously been investigated and could be important tools to combat such infections especially as antibiotic resistance looms. (more…)
Author Interviews, Duke, Heart Disease, Kidney Disease / 03.01.2016 Interview with: Renato D. Lopes MD, MHS, PhD Duke University Medical Center Duke Clinical Research Institute Durham, NC 27705   John P. Vavalle, MD, MHS Assistant Professor of Medicine Division of Cardiology UNC Center for Heart & Vascular Care Medical Research: What is the background for this study? What are the main findings?  Dr. Lopes: Patients with varying degrees of underlying renal failure who presented for primary percutaneous coronary intervention (PCI) for the treatment of ST-segment elevation myocardial infarction (STEMI) were studied as part of the APEX-AMI trial. Baseline renal dysfunction portends a worse prognosis in patients undergoing PCI. However, the association between clinical outcomes and angiographic results with baseline renal function in this population of STEMI patients is not clearly defined.  We report the results of a trial population with a full spectrum of underlying renal function (normal to dialysis dependent) and developed a prediction model for the development of acute kidney injury following primary percutaneous coronary intervention. In summary, patients with worse underlying renal function had worse angiographic outcomes, higher mortality, and were less likely to be treated with evidence-based medications.  The rate of acute kidney injury (AKI) after PCI appears to increase with worsening underlying renal function, except for those with Class IV chronic kidney disease where the rate of AKI was lowest.  Our novel prediction model for the development of AKI found that the strongest predictors of AKI were age and presenting in Killip Class III or IV. (more…)
Author Interviews, Duke, Heart Disease, JACC, Kidney Disease / 08.12.2015 Interview with: Daniel Friedman, MD Cardiology Fellow Duke University Hospital Durham, North Carolina MedicalResearch: What is the background for this study? What are the main findings? Dr. Friedman: Cardiac resynchronization therapy (CRT) has been demonstrated to reduce heart failure hospitalizations, heart failure symptoms, and mortality in randomized clinical trials. However, these well-known trials either formally excluded or did not report enrollment of patients with more advanced chronic kidney disease (CKD), which we defined as a glomerular filtration rate of <45ml/minute. Since advanced CKD has been associated with an increased risk of adverse outcomes among patients with a variety of pacemakers and defibrillators, many have questioned whether the risks of CRT may outweigh the benefits in this population. Furthermore, many have hypothesized that the competing causes of morbidity and mortality among advanced CKD patients who meet criteria for CRT may mitigate clinical response and net benefit. Our study assessed the comparative effectiveness of CRT with defibrillator (CRT-D) versus defibrillator alone in CRT eligible patients with a glomerular filtration rate of <60ml/minute (Stage III-V CKD, including those on dialysis). We demonstrated that CRT-D use was associated with a significant reduction in heart failure hospitalization or death in the overall population and across the spectrum of CKD. The lower rates of heart failure hospitalization or death was apparent in all subgroups we tested except for those without a left bundle branch block. Importantly, we also demonstrated that complication rates did not increase with increasing severity of CKD. (more…)
AHA Journals, Author Interviews, Duke, Exercise - Fitness, Heart Disease, Social Issues / 18.11.2015 Interview with: Lauren Cooper, MD Fellow in Cardiovascular Diseases Duke University Medical Center Duke Clinical Research Institute Medical Research: What is the background for this study? Dr. Cooper: The HF-ACTION study, published in 2009, showed that exercise training is associated with reduced risk of death or hospitalization, and is a safe and effective therapy for patients with heart failure and reduced ejection fraction. Subsequently, Medicare began to cover cardiac rehabilitation for patients with heart failure. However, many patients referred to an exercise training program are not fully adherent to the program. Our study looked at psychosocial reasons that may impact participation in an exercise program. Medical Research: What are the main findings? Dr. Cooper: We found that patients with higher levels of social support and fewer barriers to exercise exercised more than patients with lower levels of social support and more barriers to exercise. And patients who exercised less had a higher risk of cardiovascular death or heart failure hospitalization compared to patients who exercised more. (more…)
Accidents & Violence, Duke, Ophthalmology / 17.11.2015 Interview with: Christina R. Prescott, M.D., Ph.D Assistant Professor of Ophthalmology Johns Hopkins Wilmer Eye Institute Medical Research: What is the background for this study? What are the main findings? Dr. Prescott: I wanted to look at the most common causes of severe ocular injuries, with the hope of helping to focus injury prevention strategies. From 2002 to 2011, the mean hospital charge for inpatient hospitalizations due to eye injuries increased from $12,430 to $20,116, when controlling for inflation.  This increase paralleled the increase of mean hospital charges for all inpatient stays during the same time period, even when controlling for length of stay, which actually decreased slightly.  Costs were highest at large hospitals and for older patients.  Race, insurance, and gender were less strongly correlated to cost. (more…)
AACR, Author Interviews, Duke, Immunotherapy / 14.11.2015 Interview with: Jiayuh Lin, Ph.D. Associate Professor, College of Medicine, The Ohio State University Medical Research: What is the background for this study? What are the main findings? Dr. Jiayuh Lin: Pancreatic cancer is one of the most serious forms of cancer.  Because of the poor response to chemotherapy as conventionally used, patients with any stage of pancreatic cancer may appropriately be considered candidates for clinical trials using novel agents. IL-6 signaling plays an important role in oncogenesis and high serum IL-6 levels is a poor prognostic factor for overall survival in pancreatic cancer. Therefore, IL-6 is considered as a viable target for pancreatic cancer therapy.  We utilized a drug discovery method with Multiple Ligand Simultaneous Docking and drug repositioning to identify an existing FDA-approved drug Bazedoxifene with previously unknown biological function as an IL-6/GP130 inhibitor.  Bazedoxifene can inhibit cell viability of pancreatic cancer cells expressing IL-6 and suppressed pancreatic tumor growth in vivo. (more…)
AHA Journals, Author Interviews, Duke, Education, Gender Differences, Heart Disease / 10.11.2015 Interview with: Pamela S. Douglas, MD, MACC, FASE, FAHA Ursula Geller Professor of Research in Cardiovascular Disease Duke University School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Douglas: The impetus for our study was the concern that cardiology as a profession might be enhanced by greater diversity. By not attracting women in larger numbers (9% of FACCs are female), our fellowships have incomplete access to the talent pool of outstanding residents, and we do not have a diverse group of clinicians to care for our increasingly diverse patient population, or of researchers to explore potentially important health care disparities. Our findings were twofold: first, job descriptions for men and women cardiologists are dramatically different. Men are much more likely to do invasive procedures while women are more likely to see patients and perform imaging/noninvasive tests.  While there were slightly more women working part time than men this was still rare, and the difference in number of days worked was just 6, across an entire year. The second finding was that there was a significant difference in compensation. Unadjusted, this was over $110, 000 per year; after very robust adjustment using over 100  personal, practice, job description and productivity measures, the difference was $37, 000 per year, or over a million dollars across a career. A separate independent economic analysis of wage differentials yield a similar difference of $32,000 per year. (more…)
Author Interviews, Duke, JAMA, Pharmacology, Stroke / 10.11.2015 Interview with: Ying Xian, PhD Assistant Professor of Medicine. Member in the Duke Clinical Research Institute Medical Research: What is the background for this study? What are the main findings? Dr. Xian: Intravenous tissue plasminogen activator (tPA) is the only FDA approved medical therapy to reduce disability and improve outcomes for patients with acute ischemic stroke. But treatment with tPA also carries the risk of symptomatic intracranial hemorrhage (sICH), which is often fatal. Nearly half of ischemic stroke patients are taking antiplatelet drugs such as aspirin and/or clopidogrel prior to stroke. We found these patients had higher risk for sICH when treated with tPA. But the risk is relatively small. For every 147 patients on aspirin treated with tPA, only 1 more symptomatic intracranial hemorrhage as compared with those treated with tPA without prior antiplatelet therapy. The risk is slightly higher among those on dual antiplatelet therapy of aspirin and clopidogrel (number needed to harm 60). Despite the higher bleeding risk, patients treated with tPA on prior antiplatelet therapy appeared to have better functional outcomes in terms of ambulatory status and modified Rankin scale than those not on prior antiplatelet therapy. Therefore, overall the benefits of thrombolytic therapy may outweigh the risks. (more…)
Author Interviews, Duke, Heart Disease, Pharmacology / 10.11.2015 Interview with: Lauren Cooper, MD Fellow in Cardiovascular Diseases Duke University Medical Center Duke Clinical Research Institute Medical Research: What is the background for this study? What are the main findings? Dr. Cooper: Heart failure guidelines recommend routine monitoring of serum potassium and renal function in patients treated with a mineralocorticoid receptor antagonist (MRA). Specific monitoring recommendations include: within 2-3 days of initiation of the drug, again at 7 days, monthly for at least 3 months, then every 3 months thereafter. However, no large studies had evaluated compliance with these safety recommendations in routine clinical practice. Using Medicare claims data from 2011, we evaluated monitoring of serum creatinine and potassium levels among patients with heart failure initiated on an MRA. After MRA initiation, rates of guideline-recommended laboratory monitoring of creatinine and potassium were low. Of 10,443 Medicare beneficiaries included in this study, 91.6% received pre-initiation testing; however, only 13.3% received appropriate testing in the first 10 days after drug initiation and 29.9% received appropriate testing in the first 3 months. Only 7.2% of patients received guideline-recommended laboratory monitoring both before and after MRA initiation. Chronic kidney disease was associated with a greater likelihood of appropriate testing (relative risk, 1.83; 95% CI, 1.58-2.13), as was concomitant diuretic use (relative risk, 1.78; 95% CI, 1.44-2.21). (more…)
AHA Journals, Author Interviews, Duke, Outcomes & Safety, Stroke, Surgical Research / 04.11.2015 Interview with: Soko Setoguchi-Iwata, M.D MPH Adjunct Associate Professor Department of Medicine Duke Clinical Research Institute Medical Research: What is the background for this study? What are the main findings? Dr. Setoguchi: Medicare made a decision to cover Carotid Artery Stenting (CAS) in 2005 after publication of SAPPHIRE, which demonstrated the efficacy of Carotid Artery Stenting vs Carotid Endarterectomy in high risk patients for CEA. Despite the data showing increased carotid artery stenting dissemination following the 2005 National Coverage Determination, peri-procedural and long-term outcomes have not been described among Medicare beneficiaries, who are quite different from trial patients, older and with more comorbidities in general population. Understanding the outcomes in these population is particularly important in the light of more recent study, the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), which established CAS as a safe and efficacious alternative to CEA among non-high-surgical risk patients that also expanded the clinical indication of carotid artery stenting. Another motivation to study ‘real world outcomes in the general population is expected differences in the proficiency of physicians performing stenting in trial setting vs. real world practice setting. SAPPHIRE and CREST physicians were enrolled only after having demonstrated  Carotid Artery Stenting proficiency with low complication rates whereas hands-on experience and patient outcomes among real-world physicians and hospitals is likely to be more diverse. We found that unadjusted mortality risks over study period of 5 years with an mean of 2 years of follow-up in our population was 32%.  Much higher mortality risks observed among certain subgroups with older age, symptomatic patients and non-elective hospitalizations.   (more…)
Author Interviews, Breast Cancer, Duke, Genetic Research, JAMA / 27.08.2015

Michaela Ann Dinan Ph.D. Assistant Professor in Medicine Member of Duke Cancer Institute Duke University School of Interview with: Michaela Ann Dinan Ph.D. Assistant Professor in Medicine Member of Duke Cancer Institute Duke University School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Dinan: For many years we have known that overall, women with early stage, hormone receptor positive breast cancer show an overall survival benefit from the receipt of adjuvant chemotherapy.  However, depending on the age of the patient, we have also known that between 3 to 10% of patients appear to be truly experiencing this survival benefit and that we are treating a lot of women unnecessarily.  The use of the Oncotype DX assay has provided additional information for patients to assess who at low risk of disease progression and can forgo chemotherapy. In this study we looked to see whether the adoption of this assay was associated with reduce rates of chemotherapy in women over the age of 65.  We found that somewhat surprisingly, there was no overall association with receipt of the assay and use of chemotherapy.  However, in women who had high risk disease, receipt of the assay was associated with reduced rates of chemotherapy use.  In patients with low risk disease, receipt of the assay was associated with increased chemotherapy use. (more…)
Author Interviews, Clots - Coagulation, Duke, Heart Disease, JACC / 09.08.2015

Connie N. Hess, MD, MHS Duke Clinical Research Institute Duke University Durham, North Interview with: Connie N. Hess, MD, MHS Duke Clinical Research Institute Duke University Durham, North Carolina Medical Research: What is the background for this study? What are the main findings? Dr. Hess: Guidelines recommend the use of anticoagulation for thromboembolic prophylaxis in atrial fibrillation and also recommend use of dual antiplatelet therapy to reduce cardiovascular events after myocardial infarction and percutaneous coronary intervention.  The use of triple therapy in patients with indications for DAPT and anticoagulation is challenging due to the increased bleeding risk associated with this regimen.  The optimal antithrombotic regimen in this population has not yet been defined. This study specifically focused on older patients, a population that is at greater risk for Atrial Fibrillation-related stroke and recurrent events after MI but also higher risk for bleeding. Despite a growing population of older patients with indications for triple therapy, these patients have been underrepresented in clinical trials and are therefore understudied. We found that relative to DAPT, patients on triple therapy had a similar risk of 2-year major adverse cardiac events but a significantly increased risk of bleeding requiring hospitalization, including greater risk of intracranial hemorrhage. (more…)
Author Interviews, Duke, Education, Heart Disease, JAMA / 22.07.2015

Carolina Malta Hansen, M.D Duke Clinical Research Interview with: Carolina Malta Hansen, M.D Duke Clinical Research Institute Medical Research: What is the background for this study? What are the main findings? Dr. Hansen: Approximately 300,000 persons in the United States suffer an out-of-hospital cardiac arrest every year and under 10% survive. Cardiopulmonary resuscitation (CPR) and defibrillation within the first few minutes of cardiac arrest can increase the chance of survival from under 10% to over 50%. In 2010, the HeartRescue program in North Carolina initiated statewide multifaceted interventions to improve care and outcomes for cardiac arrest patients in North Carolina. The project included public training programs in defibrillators and compression-only CPR at schools, hospitals and major events such as the N.C. State Fair, plus additional instruction for EMS and other emergency workers on optimal care for patients in cardiac arrest. We found that following these four years of initiatives to improve care and outcomes for cardiac arrest patients, the proportion of patients who received bystander CPR and first responder defibrillation increased by more than 25% to approximately 50%, the combination of bystander CPR and first responder defibrillation increased from 14% to 23%. Survival with favorable neurologic outcome increased from 7% to 10% and this increase was only observed among patients who received bystander CPR. Finally, we found that compared to patients who received CPR and defibrillation by emergency medical services (EMS), patients who received bystander and/or first responder CPR, defibrillation, or both, were more likely to survive. The combination of bystander CPR and bystander defibrillation was associated with the best survival rates but remained low during the study period with no increase over time. (more…)
Author Interviews, Colon Cancer, Duke, Weight Research / 10.07.2015

S. Yousuf Zafar, MD, MHS Associate Professor of Medicine Duke Cancer Institute Duke Clinical Research Interview with: S. Yousuf Zafar, MD, MHS Associate Professor of Medicine Duke Cancer Institute Duke Clinical Research Institute Medical Research: What is the background for this study? What are the main findings? Dr. Zafar: Multiple studies have suggested that obesity and colorectal cancer are related. For instance, obesity has been linked with an increased incidence of colon cancer. Obesity has also been associated with a greater risk of colon cancer recurrence. To date, no study has looked at the role of obesity in outcomes for patients with metastatic colorectal cancer. In our study of over 6000 patients receiving treatment for metastatic olcolorectal cancer, we found that patients with the lowest body mass index (BMI) were at greatest risk for worse survival. This does not mean that obesity is good. More likely, it means that those who are very underweight are least able to tolerate the best treatment, or being very underweight is a biologic marker of poor prognosis. (more…)
Author Interviews, Duke, Heart Disease, JAMA / 24.06.2015

Sean D. Pokorney, MD, MBA Division of Cardiology, Duke University Medical Center Duke Clinical Research Institute, Durham, North Carolina Interview with: Sean D. Pokorney, MD, MBA Division of Cardiology, Duke University Medical Center Duke Clinical Research Institute, Durham, North Carolina Medical Research: What is the background for this study? Dr. Pokorney: About 350,000 people die of sudden cardiac death in the US each year. Patients who have weakened heart function, particularly those with heart muscle damage as a result of a heart attack, are more likely to experience sudden cardiac death.  Defibrillators have been around since the 1980s, and have prolonged countless lives.  A previous study showed that 87% of patients who had a cardiac arrest were eligible for an implantable-cardioverter defibrillator (ICD) beforehand but did not get an ICD implanted prior to their arrest.  The timing of ICD implantation is critical, as studies have not found a benefit to ICD implantation early after myocardial infarction (MI).  Guidelines recommend primary prevention ICD implantation in patients with an EF ≤ 35% despite being treated with optimal medical therapy for at least 40 days after an MI.  Given the need to wait for at least 40 days after an MI, ICD consideration is susceptible to errors of omission during the transition of post-MI care between inpatient and outpatient care teams.  Also, the benefit of ICDs remains controversial among older patients, as these patients were underrepresented in clinical trials. Medical Research: What are the main findings? Dr. Pokorney: We looked at Medicare patients discharged from US hospitals after a heart attack between 2007 and 2010.  We focused on those patients who had weak heart function, and this left us with a little over 10,300 patients from 441 hospitals for our study.  This was an older patient population with a median age of 78 years.  We looked to see how many of these patients got an ICD within the first year after MI, and how many patients survived to 2 years after their heart attack.  Only 8% of patients received an ICD within 1 year of their heart attack.  ICD implantation was associated with a third lower risk of death within 2 years after a heart attack, and this was consistent with the benefit that were seen in the randomized clinical trials.  Importantly, 44% of the patients in our study were over 80 years old, and we found that the relationship between ICD use and mortality was the same for patients over and under age 80 years.  Increased patient contact with the health care system through early cardiology follow-up or re-hospitalization for heart failure or MI was associated with higher likelihood of ICD implantation.  Rates of ICD implantation remained around 1 in 10 patients within 1 year of MI even among patients with the largest heart attacks and the weakest hearts (lowest ejection fractions), who were least likely to have improvement in their heart function over time.  Similarly, even after excluding patients at highest risk for non-arrhythmic death (prior cancer, prior stroke, and end stage renal disease), ICD implantation rates remained around 1 in 10 patients. (more…)