Author Interviews, Emory, Flu - Influenza, PLoS / 23.06.2015

MedicalResearch.com Interview with: Brooke Bozick Ph.D. Candidate Population Biology, Ecology, & Evolution Program Emory University MedicalResearch: What is the background for this study? Response: Previous research at the global scale has shown that air travel is important for the spread of disease. For example, much work has focused on the recent Ebola epidemic in Africa, identifying where this disease emerged and then using air travel networks to predict the path of spread from there. At a more local scale, other modes of transportation may be more important to structuring pathogen populations. We were interested in investigating seasonal influenza in the United States. Previous research has shown that once the winter influenza epidemic starts, it spreads very rapidly across the continental states, suggesting that the US may act as one large, well-mixed population. Previous work using genetic data to look for spatial structure at this scale didn’t identify any patterns. However, these studies used geographic proximity to define the distance between states; we wanted to see whether similar patterns existed at this spatial scale if we instead used movement data as a proxy for the distance between locations. Commuter movements have previously been shown to correlate with influenza timing and spread based on influenza-like-illness and mortality data. MedicalResearch: What are the main findings? Response: We found that spatial structure is detectable within the US. We used data on the genetic distance between sequences collected from different states and compared that to different measures of ‘distance’ between states—geographic proximity, the daily number of people flying between states and the daily number of commuters traveling between states using ground transportation—to see whether any correlations were present. Further, we did this for two different subtypes of seasonal influenza: A/H3N2 and A/H1N1. These subtypes have different epidemiological properties, so there was reason to believe that the observed patterns might differ depending on subtype. We found that some correlations were present for all the distance metrics studied, but that they were observed a greater proportion of the time when looking at commuter movements, and when looking at the A/H1N1 subtype. Since A/H1N1 is generally milder and spreads more slowly throughout the US compared to A/H3N2, we interpret this to mean that spatial structure is likely more easily detected in this subtype. If A/H3N2 spreads rapidly from coast to coast, any signature of spatial structure is likely obscured before we have a chance to observe it. (more…)
Author Interviews, Cancer Research, JAMA, NIH / 22.06.2015

MedicalResearch.com Interview with: Vinay Prasad, MD, MPH Medical Oncology Service, National Cancer Institute National Institutes of Health Bethesda, Maryland MedicalResearch: What is the background for this study? What are the main findings? Dr. Prasad: In medicine, there are two types of endpoints:  clinical endpoints and surrogate endpoints. Clinical endpoints, such as survival or quality of life, measure how a patient, feels, functions or lives.  In contrast, a surrogate endpoint is not a measure of patient benefit. Instead, it is merely hoped to correlate with one.  LDL levels are a surrogate for cardiovascular risk, for instance. Oncologists use and trust surrogate endpoints, such as response rate, progression free survival and disease free survival.  The majority of drug approvals and many guideline recommendations are based on improvements in surrogates.  Surrogates are assumed to correlate with overall survival, but we wanted to know if this was true, and under what circumstances. We reviewed all well done studies of surrogate-survival association.  We found that the majority--especially in the setting of metastatic disease--found a poor correlation between a surrogate and survival.  In fact, correlations were strong in only a handful of settings, such as adjuvant colorectal cancer.  Moreover, we found that correlations were always based on a subset of potentially informative literature, even when authors surveyed unpublished trials.  Missing data in these association studies raises the concern that correlations would be different if all data had been considered. Our overall conclusion was that most surrogate-survival correlations in oncology are based on weak evidence and are poor. (more…)
Author Interviews, Surgical Research, UCSF, Weight Research / 22.06.2015

MedicalResearch.com Interview with: Leslee L. Subak, MD University of California, San Francisco Professor, Departments of Obstetrics, Gynecology & Reproductive Sciences, Urology and Epidemiology & Biostatistics Chief of Gynecology, SF Veterans Affairs Medical Center UCSF Women's Health Clinical Research Center MedicalResearch: What is the background for this study? What are the main findings? Dr. Subak: Urinary incontinence is very common, affecting an estimated 30 million adults in the U.S., and may account for as much as $60 billion in annual medical costs. Incontinence can cause significant distress, limitations in daily functioning, and reduced quality of life. Obesity is an important risk factor, with each 5-unit increase in body mass index – a ratio of someone’s weight divided by the square of their height – above normal weight associated with far higher rates of incontinence.   The prevalence of incontinence has been reported to be as high as 70 percent among severely obese women, and 24 percent among severely obese men (BMI greater than 40, or more than about 100 pounds greater than ideal body weight). Since obesity is a risk factor for incontinence, several studies have examined whether weight loss is a treatment for incontinence among obese people with the condition.  Clinical trials have shown the low calorie diets, behavioral weight reduction, and bariatric surgery are associated with improvement in incontinence in obese women and men through one year, but evidence on the durability of this effect is lacking. We performed this study to examine changes in urinary incontinence and identify factors associated with improvement among women and men in the first 3 years following bariatric surgery. This study included 1987women and men in the Longitudinal Assessment of Bariatric Surgery-2 (LABS-2) study performed at 10 hospitals at 6 clinical centers in the U.S. who underwent bariatric surgery between 2005 and 2009.  The study participants ranged in age from 18 to 78 years old – the median age was 47. The analysis controlled for factors such as age, race, smoking status and recent pregnancy.  Nearly 79 percent of the participants in the study were women with 49% reporting at least weekly incontinence, compared with 2% of men reporting incontinence. Following surgery and large weight loss of 29% for women and 26% for men, substantial improvements in incontinence were observed, with a majority of women and men achieving remission at 3 years post-surgery. The more weight lost, the higher the chances of improvement. While the risk of relapse rose with each gain of about 10 pounds, overall there was substantial improvement for both women and men. People who were older, had severe walking limitations or were recently pregnant showed less improvement. (more…)
Author Interviews, Breast Cancer, JAMA, Race/Ethnic Diversity, Surgical Research, University Texas / 21.06.2015

Isabelle Bedrosian, M.D., F.A.C.S. Associate Professor, Department of Surgical Oncology, Division of Surgery, Medical Director, Nellie B. Connelly Breast Center The University of Texas MD Anderson Cancer Center, Houston, TXMedicalResearch.com Interview with: Isabelle Bedrosian, M.D., F.A.C.S. Associate Professor, Department of Surgical Oncology, Division of Surgery, Medical Director, Nellie B. Connelly Breast Center The University of Texas MD Anderson Cancer Center, Houston, TX Medical Research: What is the background for this study? What are the main findings? Dr. Bedrosian: There have been a number of reports on the rates of Breast Conserving Therapy (BCT) and mastectomy among women with early stage breast cancer. These reports have been discordant, with some suggesting that index mastectomy rates have increased and others suggestion Breast Conserving Therapy rates have actually increased. We hypothesized that these differences in reporting may be due to data source (ie tertiary referral centers vs population based studies) and turned to the NCDB, which captures 70% of cancer cases in the US and as such provides us with the most comprehensive overview on patient treatment patterns. (more…)
Author Interviews, BMJ, Imperial College / 21.06.2015

Mr. Angus Turnbull Imperial College School of Medicine, London UKMedicalResearch.com Interview with: Mr. Angus Turnbull Imperial College School of Medicine, London UK Medical Research: What is the background for this study? What are the main findings? Mr. Turnbull: Autopsy has been used to advance medical knowledge and understanding of pathological processes for millennia but increasing evidence indicates its decline in the UK and elsewhere. This study not only confirms that but suggests autopsy for learning purposes has almost disappeared. In the United Kingdom autopsy is divided into medico-legal autopsy (that required by law under the jurisdiction of HM Coroner) and consented autopsy (performed with the consent of the bereaved or their family). Over the past half-century, small single site studies have noted a marked decline in consented autopsy rates, however there has been no study for over 20 years to determine the extent of the decline nationwide. This study examined all acute NHS Trusts within England, NHS Boards in Scotland and Wales and Social Care Trusts in Northern Ireland. We found that the average autopsy rate (the percentage of adult inpatient deaths which under go consented autopsy) in the United Kingdom in 2013 was only 0.7%. The study showed that in nearly a quarter (23%) of all NHS Trusts in the United Kingdom, consented autopsy is now extinct. These findings may have implications for training, for research and for learning from mortality – a key aspect of patient safety. (more…)
Author Interviews, Lifestyle & Health, NYU / 19.06.2015

MedicalResearch.com Interview with: Stella Yi, PhD, MPH New York University Langone School of Medicine, Department of Population Health New York, NY 10016 MedicalResearch: What is the background for this study? What are the main findings? Dr. Yi: Sedentary behaviors, such as sitting time, are an emerging risk factor in the field of physical activity epidemiology. Recent studies have demonstrated the negative health consequences associated with extended sitting time, including metabolic disturbances and decreased life expectancy independent of the effects of regular exercise. We also assessed mean values of self-reported sitting time to characterize these behaviors in a diverse, urban sample of adults. The average New York City resident sits more than seven hours a day—greatly exceeding the three hours or more per day that is associated with decreased life expectancy. Among the findings:
  • At the lower economic end, individuals spent 6.3 hours per day sitting, while those with higher incomes spent 8.2 hours per day sitting
  • College graduates spent 8.2 hours per day sitting, compared with 5.5 hours per day for those with less than a high school education
  • Whites spent on average 7.8 hours per day sitting, African Americans spent 7.4 hours sitting, Hispanics spent 5.4 hours sitting, and Asian Americans spent 7.9 hours per day sitting
  • Sitting time was highest in Manhattan, compared to other boroughs.
In the current analysis, we also assessed the validity of a two-question survey method of sitting time during waking hours using accelerometers to measure sedentary time in a subsample of our study participants. The correlation between sitting time reported in the survey and accelerometer-measured sedentary time was modest (r=0.32, p<0.01) with wide limits of agreement. We interpreted this to mean that while self-reported sitting might be useful at the population-level to provide rankings and subgroups, it may be limited in assessing an individual’s actual behavior. (more…)
AHA Journals, Author Interviews, Cleveland Clinic, Stroke / 19.06.2015

Dr. Ken Uchino, MD Cleveland Clinic Main Campus Cleveland, OH 44195MedicalResearch.com Interview with: Dr. Ken Uchino, MD Cleveland Clinic Main Campus Cleveland, OH 44195 Medical Research: What is the background for this study? What are the main findings? Dr. Uchino: Stroke center designation started in 2003 and more hospitals have been certified as primary stroke centers over time. We asked the question how many are certified now? What are the characteristics of the hospitals that are certified? In 2013, nearly a third (23%) of acute short-term adult general hospitals with emergency departments were certified as stroke centers. 74% of the stroke centers were certified by the Joint Commission, a non-profit organization that certifies health care facilities and programs. 20% were certified by state health departments. States varied in percentages of hospitals that were certified, ranging from 4% in Wyoming to 100% in Delaware. Not unexpectedly larger hospitals and hospitals in urban locations were more likely to be certified as stroke centers. But a hospital being located in a state with so-called “stroke legislation” more than tripled the chance of being a certified stroke centers, even accounting for other factors. These states passed legislation to promote stroke centers and mandated stroke patients to be preferentially transported to qualified hospitals. (more…)
Author Interviews, C. difficile, Columbia, Gastrointestinal Disease, Microbiome, Pediatrics / 19.06.2015

Daniel E. Freedberg, MD, MS Assistant Professor of Medicine Division of Digestive and Liver Diseases Columbia University, New YorkMedicalResearch.com Interview with: Daniel E. Freedberg, MD, MS Assistant Professor of Medicine Division of Digestive and Liver Diseases Columbia University, New York Medical Research: What is the background for this study? Dr. Freedberg: Acid suppression medications are increasingly prescribed to relatively healthy children without clear indications, but the side effects of these medications are uncertain. Medical Research: What are the main findings? Dr. Freedberg: Acid suppression with (proton pump inhibitors ) PPIs or (histamine-2 receptor antagonists) H2RAs was associated with increased risk for C. diff infection in both infants and older children. Medical Research: What should clinicians and patients take away from your report? Dr. Freedberg: Increased risk for C. diff should be factored into the decision to use acid suppression medications in children.  Our findings imply that acid suppression medications alter the bacterial composition of the lower gastrointestinal tract. (more…)
Author Interviews, Cannabis, Columbia, Lancet / 18.06.2015

Deborah S. Hasin, Ph.D. Professor of Epidemiology Columbia University New York, New York 10032MedicalResearch.com Interview with: Deborah S. Hasin, Ph.D. Professor of Epidemiology Columbia University New York, New York 10032 MedicalResearch: What is the background for this study? What are the main findings? Dr. Hasin: The background for the study was the need to identify the causes of the marked increase in marijuana use among U.S. adolescents over the last several years, given that early adolescent marijuana use leads to a number of adverse health and psychosocial consequences, including cognitive decline, into adulthood. We had two main findings from the study:
  1. A comparison of the rates of adolescent marijuana use between states that ever passed a medical marijuana law and those that did not revealed that states with such laws had higher rates of teen marijuana use, regardless of when they passed the law; and
  2. When we compared the rates of teen marijuana use in these states before and after passage of the laws, we did not find a post-passage increase in the rates of teen marijuana use. This suggests that some common factor may be causing both the laws to be passed and the teens to be more likely to smoke marijuana in the states that passed these laws.
(more…)
Annals Internal Medicine, Author Interviews, Duke, Weight Research / 18.06.2015

William S. Yancy, Jr., MD, MHSc Research Associate Center for Health Services Research in Primary Care Durham, NC 27705 Associate Professor Department of Medicine Duke University Medical CenterMedicalResearch.com Interview with: William S. Yancy, Jr., MD, MHSc Research Associate Center for Health Services Research in Primary Care Durham, NC  27705 Associate Professor Department of Medicine Duke University Medical Center Medical Research: What is the background for this study? What are the main findings? Dr. Yancy: A number of studies have compared different diet approaches for weight management with many of these finding that several different diets can result in significant weight loss. This has led many experts to advise that we should offer a choice among these diet options to our patients who are seeking to lose weight. We know that adherence is the best predictor of weight loss during dietary interventions, so the thought is that patients will adhere better to a diet that they prefer, resulting in more successful weight loss. In addition, allowing choice enhances patient autonomy, which is patient-centered and has been shown to increase treatment adherence. However, the previous studies of various diet approaches did not let people choose a diet, so we don’t actually know if letting them choose will lead to better weight loss. Our study specifically tested this assumption. We randomized participants to a condition where they were allowed to choose between 2 common weight loss diets or to a condition where they were randomly assigned to one of the diets. The 2 diets we used were a low-carbohydrate diet without calorie restriction and a low-fat diet combined with calorie restriction. Participants received counseling about the diets, and about behavioral strategies and physical activity, in 19 group sessions over the span of 12 months. They also received 6 phone calls with motivational counseling in the latter half of the program. (more…)
Author Interviews, Biomarkers, Cancer Research, Mayo Clinic, MD Anderson, Nature / 18.06.2015

Eric Jonasch, MD Associate Professor Department of Genitourinary Medical Oncology University of Texas MD Anderson Cancer Center Houston, TXMedicalResearch.com Interview with: Eric Jonasch, MD Associate Professor Department of Genitourinary Medical Oncology University of Texas MD Anderson Cancer Center Houston, TX and Dr. Thai H. Ho, MD Ph.D. Department of Oncology Mayo Clinic Scottsdale ArizonaDr. Thai H. Ho, MD Ph.D. Department of Oncology Mayo Clinic Scottsdale Arizona Medical Research: What is the background for this study? What are the main findings? Response: The blueprints of a cell are encoded in DNA strands (its genome) which are highly compressed in order to fit into a tiny cell. The reading (called the epigenome) of these DNA ‘blueprints’ determines whether that cell will develop into a kidney cell or another type of cell. However, in cancer, errors occur either in the blueprints themselves or the cell makes mistakes in reading the blueprints. Cancers of the kidney affect more than 61,000 patients annually and over 13,000 patients die annually, making it one of the top 10 leading causes of cancer deaths. Studies have revealed that mutations occur in genes that regulate how our DNA ‘blueprints’ are compacted in greater than >50% of kidney cancers, making these genes as a group the most frequently mutated. In our study, we identified that these errors that initially arise in an early kidney cancer lead to propagation of these same errors in metastases, a phenomenon in which the cancer has spread to another organ and is a major cause of death. Furthermore, we generated a detailed map of these epigenomic changes in patient-derived tumors. (more…)
Author Interviews, JAMA, McGill, Parkinson's / 15.06.2015

Ron Postuma, MD, MSc Associate Professor Department of Neurology Montreal General Hospital Montreal, QuebecMedicalResearch.com Interview with: Ron Postuma, MD, MSc Associate Professor Department of Neurology Montreal General Hospital Montreal, Quebec Medical Research: What is the background for this study? What are the main findings? Dr. Postuma: The background is that we often think about Parkinson’s Disease as a single disease.  However, every clinician knows that there is a great deal of variability from patient to patient.  If we can understand the main aspects that separate patients into groups, we can target therapy better. The analysis used a semi-automated means to divide Parkinson’s patients into groups, using extensive information about motor and non-motor aspects of disease.  We found that the non-motor symptoms, especially cognition, sleep disorders, and blood pressure changes were the most powerful predictors of which group a patient would be in.  Based on these non-motor (and some motor aspects), the most accurate way to divide patients was into three groups - diffuse (many non-motor symptoms), pure motor, and intermediate (halfway between the other).  We then followed patients over time.  The diffuse group had, by far, the worse prognosis.  This was not only for the non-motor aspects, but the motor as well. (more…)
Author Interviews, Biomarkers, Leukemia, NYU, Pediatrics / 15.06.2015

Susan Schwab, PhD Assistant professor at NYU Langone Skirball Institute of Biomolecular Medicine MedicalResearch.com Interview with: Susan Schwab, PhD Assistant professor at NYU Langone Skirball Institute of Biomolecular Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Schwab:  T cell acute lymphoblastic leukemia (T-ALL) remains a devastating pediatric disease.  Roughly 20% of children do not respond to current therapies.  Furthermore, metastasis to the central nervous system is common in T-ALL, and intrathecal chemotherapy, even when successful at eradicating the cancer, causes serious long-term cognitive side-effects. Here we report that the chemokine receptor CXCR4 is essential for T cell acute lymphoblastic leukemia progression in both mouse and human xenograft models of disease.  Consistent with sustained disease remission in the absence of CXCR4, loss of CXCR4 signaling results in decreased levels of c-Myc, which is required for leukemia initiating cell activity.   T-ALL cells reside near cells generating the CXCR4 ligand CXCL12 in the bone marrow, and our data suggest that vascular endothelial cells may be an important part of the T-ALL niche. (more…)
Author Interviews, Cost of Health Care, Education, Johns Hopkins, Primary Care / 15.06.2015

MedicalResearch.com Interview with: Eric T. Roberts and Darrell Gaskin Johns Hopkins University Bloomberg School of Public Health Baltimore, MD Medical Research: What is the background for this study? What are the main findings? Response: This study looked at the implications of the Affordable Care Act’s expansion of Medicaid on the need for additional physicians working in primary care. Since 2014, 11 million low-income adults have signed up for Medicaid, and this figure will likely increase as more states participate in the expansion. Many new Medicaid enrollees lacked comprehensive health insurance before, and will be in need of primary and preventive care when their Medicaid coverage begins. In light of these questions, in this study, we projected the number of primary care providers that are needed to provide care for newly-enrolled adults. We forecast that, if all states expand Medicaid, newly-enrolled adults will make 6.1 million additional provider visits per year. This translates into a need for 2,100 additional full time-equivalent primary care providers. We conclude that this need for additional providers is manageable, particularly if Congress fully funds key primary care workforce training programs, such as the National Health Service Corps. (more…)
Author Interviews, Biomarkers, Kidney Disease, University of Pittsburgh / 14.06.2015

MedicalResearch.com Interview with: Raghavan Murugan MD, MS, FRCP, FCCP Associate Professor of Critical Care Medicine and Clinical and Translational Science Core Faculty, Center for Critical Care Nephrology, CRISMA Center, Raghavan Murugan MD, MS, FRCP, FCCP Associate Professor of Critical Care Medicine and Clinical and Translational Science Core Faculty, Center for Critical Care Nephrology, CRISMA Center, John Kellum, MD Professor and Vice Chair for Research Director, Bioengineering and Organ Support Program, CRISMA Center Director, Center for Assistance in Research using eRecord (CARe)John Kellum, MD Professor and Vice Chair for Research Director, Bioengineering and Organ Support Program, CRISMA Center Director, Center for Assistance in Research using eRecord (CARe) Department of Critical Care Medicine University of Pittsburgh Pittsburgh, PA Medical Research: What is the background for this study? What are the main findings? Response: In our prior studies, we found that nearly one-half of critically ill patients in the intensive care unit who receive dialysis die by 2 months after acute illness and more than one-third of surviving patients are dialysis dependent. We sought to examine whether simple patient characteristics and inflammatory biomarkers predicted death and non-recovery of kidney function after severe acute kidney injury. We found that a combination of four simple and readily available patient characteristics including older age, lower mean arterial pressure, need for mechanical ventilation, and higher serum bilirubin levels predicted death and dialysis dependence. Higher plasma concentration of interleukin (IL)-8 in combination with the clinical characteristics also increased risk prediction. To our knowledge, this study is the first large study to examine risk prediction for outcomes after severe acute kidney injury using a panel of biomarkers in a large cohort of critically ill patients receiving dialysis. (more…)
Author Interviews, Nutrition, PLoS, Race/Ethnic Diversity, Vanderbilt / 14.06.2015

MedicalResearch.com Interview with: Wei Zheng, MD, PhD, Professor of Medicine Anne Potter Wilson Chair in Medicine Director, Vanderbilt Epidemiology Center and Danxia Yu, PhD Research Fellow Vanderbilt Epidemiology Center Vanderbilt University School of Medicine Nashville, TN, 37203 Medical Research: What is the background for this study? What are the main findings? Response: The Dietary Guidelines for Americans (DGA) provide the most authoritative advice in the US about healthy eating. Higher adherence to the DGA, reflected by a higher Healthy Eating Index (HEI) score, has been found to be associated with lower risk of developing or dying from chronic diseases (e.g. diabetes, cardiovascular disease, and certain cancers) in several US studies. However, these studies recruited mostly non-Hispanic white individuals and middle to high income Americans. It has been reported that racial/ethnical background and socioeconomic status may influence food choices and diet quality. However, no previous study has adequately evaluated the association between adherence to the DGA and risk of death due to diseases in racial/ethnical minorities and low-income Americans. Therefore, it is uncertain whether the health benefits of adherence to the current DGA can be generalized to these underserved populations. We analyzed diet and mortality data from the Southern Community Cohort Study (SCCS), a large, prospective cohort study including approximately 85,000 American adults, 40-79 years old, enrolled from 12 southeastern states between 2002 and 2009. Two-thirds of the SCCS participants were African-American and more than half reported an annual household income <$15,000. During a mean follow-up of 6.2 years, we identified 6,906 deaths in the SCCS, including 2,244 from cardiovascular disease, 1,794 from cancer, and 2,550 from other diseases. Using multivariate analysis methods, we found that participants in the top 20% of the HEI score (highest adherence to the DGA) had only about 80% of the risk of death due to any diseases compared with those in the bottom 20% of the HEI score. This protective association was found regardless of sex, race and income levels. (more…)
Author Interviews, Beth Israel Deaconess, Blood Pressure - Hypertension, Technology / 14.06.2015

MedicalResearch.com Interview with: Neetika Garg, MD Fellow in Nephrology Beth Israel Deaconess Medical Center Division of Nephrology, Department of Medicine Boston, MA 02215 MedicalResearch: What is the background for this study? What are the main findings? Dr. Garg: One in every three Americans suffers from hypertension. Since high blood pressure (BP) frequently does not cause any symptoms, self-blood pressure monitoring at home and patient education are critical components of patient management. With more than 58% of the US adults owning a smartphone, mobile-based health technologies (most commonly in the form of applications or “apps”) can serve as useful adjuncts in diagnosis and management of hypertension. At the same time, several smartphone-based applications are advertised as having blood pressure measurement functionality, which have not been validated against a gold standard. In this cross-sectional study, we analyzed the top 107 hypertension related apps available on the most popular smartphone platforms (Google Android and Apple iPhone) to analyze the functional characteristics and consumer interaction metrics of various hypertension related apps. Nearly three-quarters of the apps record and track blood pressure, heart rate, salt intake, caloric intake and weight/body mass index. These app features can facilitate patient participation in hypertension management, medication adherence and patient-physician communication. However, it was concerning to find that 6.5% of the apps analyzed could transform the smartphone into a cuffless BP measuring device. None of these had any documentations of validation against a gold standard. Furthermore, number of downloads and favorable user ratings were significantly higher for these apps compared to apps without blood pressure measurement function. This highlights the need for greater oversight and regulation in medical device development. (more…)
Author Interviews, Diabetes, Immunotherapy, Kidney Disease, University of Michigan / 13.06.2015

MedicalResearch.com Interview with: Frank C. Brosius, MD Professor, Internal Medicine and Physiology Chief, Division of Nephrology University of Michigan Ann Arbor, MI Dr. Matthias Kretzler MD Professor, Internal Medicine Research Professor, Computational Medicine and Biology University of Michigan Ann Arbor, MI Katherine R. Tuttle MD Clinical Professor of Medicine, Division of Nephrology Medical & Scientific Director, Providence Medical Research Center/Sacred Heart Center Professor of Basic Medical Sciences, WWAMI Program Washington State University Medical Research: What is the background for this study? Response: Our University of Michigan team had found that JAK-STAT gene expression was increased in kidneys in patients with diabetic kidney disease and that these changes correlated with progression of kidney disease.  We subsequently substantiated these changes in other studies and have found that by increasing expression of just one of these genes, JAK2, in a single kidney cell type (podocytes) in mice that we can make their diabetic kidney disease much worse. At around the same time, investigators at Eli Lilly and Co. had FDA approval to test a JAK1-2 inhibitor, baricitinib, in patients with rheumatoid arthritis.  The Lilly scientists saw our human results and thought about using baricitinib in patients with diabetic kidney disease.  After initial discussions with Dr. Kretzler and myself they concluded that there was good reason to move ahead with this study and just 14 months after the initial meeting the phase 2 clinical trial of baricitinib in the treatment of patients with diabetic kidney disease was initiated. (more…)
Author Interviews, Diabetes, Lancet, McGill / 13.06.2015

MedicalResearch.com Interview with: Dr Ahmad Haidar Ph.D. Division of Experimental Medicine Department of Medicine, McGill University Montreal, QC, CanadaDr. Ahmad Haidar Ph.D Division of Experimental Medicine, Department of Medicine McGill University, Montreal, QC, Canada Medical Research: What is the background for this study? What are the main findings? Dr. Haidar: This is the first head-to-head-to-head comparison in outpatient setting of dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional pump therapy in children and adolescents with type 1 diabetes. The main finding is that the dual-hormone artificial pancreas seems to outperform the other two systems in reducing nocturnal hypoglycemia in camp settings when the patients are very physically active during the day. Medical Research: What should clinicians and patients take away from your report? Dr. Haidar: Glucagon has the potential to reduce nocturnal hypoglycemia if added to the artificial pancreas. However, this needs to be confirmed in larger and longer studies as the single-hormone artificial pancreas might be sufficient in home settings (this study was conducted at a camp, which is an environment different that home). (more…)
Author Interviews, Cost of Health Care, Endocrinology, OBGYNE, Yale / 12.06.2015

Aileen Gariepy, MD, MPH Assistant Professor Section of Family Planning Department of Obstetrics, Gynecology, and Reproductive Sciences Yale School of Medicine New Haven, CT 06510MedicalResearch.com Interview with: Aileen Gariepy, MD, MPH Assistant Professor Section of Family Planning Department of Obstetrics, Gynecology, and Reproductive Sciences Yale School of Medicine New Haven, CT Medical Research: What is the background for this study? What are the main findings? Dr. Gariepy: Women who have just given birth are often highly motivated to prevent a rapid, repeat pregnancy.  For women who desire the contraceptive implant, a highly effective reversible form of contraception that is placed in the arm and can last for 3 years, new research shows that it is more cost-effective to place the implant while women are still in the hospital after giving birth, compared to delaying insertion to the postpartum visit 6-8 weeks later which is currently the most common practice. When the costs associated with the implant insertion and the costs of unintended pregnancy are compared in women who receive immediate contraceptive implant insertion (while still in the hospital after giving birth) to women who are asked to come back in 6-8 weeks for the implant insertion (delayed insertion), immediate insertion is expected to save $1,263 per patient.  Based on these estimates, for every 1,000 women using postpartum implant, immediate placement is expected to avert 191 unintended pregnancies and save $1,263,000 compared with delayed insertion in the first year. Cost savings would continue to increase for the second and third year after insertion. In fact, over half of U.S. pregnancies are unintended.  Maternal and infant care costs for unintended pregnancies amount to $11.1 billion annually for public insurance programs alone. The immediate postpartum period (after delivery but before discharge home) provides an ideal opportunity for initiating contraceptives as patients are motivated and timing is convenient. However, the majority of insurance company policies do not provide coverage for insertion of the contraceptive implant when the new mother is still in the hospital.  This lack of reimbursement is the most significant barrier to providing this highly effective contraceptive method for women who have just delivered a baby.  Surprisingly, the reason most insurance companies do not offer reimbursement for immediate insertion is due to an outdated insurance protocol, “the global obstetric fee” which precludes separate reimbursement of individual procedures (like inserting the implant). The main reason that immediate insertion results in cost savings is because more women will get the implant compared to a strategy of delayed insertion.  Women can get pregnant again within 4 weeks of delivering a baby.  Starting contraception as soon as possible after giving birth is important because most women will resume sexual activity before their postpartum office visit and therefore will be at risk of pregnancy. And approximately 35% of women do not return for a postpartum visit. Even for women who want another pregnancy soon, the implant has benefits.  When women conceive and deliver a baby within 2 years of last giving birth, there is a significantly higher risk of poor maternal and neonatal outcomes, including preterm birth, low birth weight, and even early neonatal and maternal death.  Birth spacing is better for moms and babies. (more…)
Author Interviews, Cost of Health Care, JAMA, NYU, Surgical Research / 12.06.2015

Joseph A. Ladapo, MD, PhD Assistant Professor of Medicine Section on Value and Effectiveness Department of Population Health NYU School of MedicineMedicalResearch.com Interview with: Joseph A. Ladapo, MD, PhD Assistant Professor of Medicine Section on Value and Effectiveness Department of Population Health NYU Langone School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Ladapo: Routine tests before elective surgery are largely considered to be of low value, and they may also increase costs.  In an attempt to discourage their use, two professional societies released guidance on use of routine preoperative testing in 2002. We sought to examine the long-term national effect of these guidelines from the American College of Cardiology/American Heart Association and the American Society of Anesthesiologists on physicians' use of routine preoperative testing. While we found that overall rates of routine testing declined across several categories over the 14-year study period, these changes were not significant after accounting for overall changes in physicians’ ordering practices. Our findings suggest that professional guidance aimed at improving quality and reducing waste has had little effect on physician or hospital practice. (more…)
Author Interviews, Columbia, Heart Disease / 12.06.2015

Nicholas Tatonetti, PhD Department of Biomedical Informatics Department of Systems Biology, Department of Medicine Columbia University New York, NYMedicalResearch.com Interview with: Nicholas Tatonetti, PhD Department of Biomedical Informatics Department of Systems Biology, Department of Medicine Columbia University New York, NY Medical Research: What is the background for this study? What are the main findings? Dr. Tatonetti: For decades, researchers have studied the link between disease incidence and the seasons. We’ve known, for example, that those born when the dust mite population is highest (summer) will have an increased chance of developing asthma. Traditionally, diseases have been studied one at a time to identify these seasonal trends. Because of the rapid adoption of electronic health records, it is now possible to study thousands of diseases, simultaneously. That is what we did in this study. We evaluated over 1,600 diseases and discovered 55 that showed this seasonal trend. Many of these had been studied previously, but several are new discoveries — most prominently, we found that the lifetime risk of developing cardiovascular disease is highest for those born in the spring. (more…)
Author Interviews, Hospital Readmissions, JAMA, Stanford, Surgical Research / 12.06.2015

Jordan M. Cloyd, MD Department of Surgery Stanford University Stanford, CaliforniaMedicalResearch.com Interview with: Jordan M. Cloyd, MD Department of Surgery Stanford University Stanford, California Medical Research: What is the background for this study? What are the main findings? Dr. Cloyd: The motivation for the study was that, anecdotally, we had noticed that several of our patients who had been discharged on a weekend required readmission for potentially preventable reasons. We wanted to investigate whether the data supported the idea that weekend discharge was associated with a higher risk of hospital readmission. (more…)
Author Interviews, Breast Cancer, Duke, Genetic Research, JAMA / 11.06.2015

Michaela Dinan, Ph.D. Duke Clinical Research Institute and Duke Cancer Institute Department of Medicine Duke University School of Medicine Durham, North CarolinaMedicalResearch.com Interview with: Michaela Dinan, Ph.D. Duke Clinical Research Institute and Duke Cancer Institute Department of Medicine Duke University School of Medicine Durham, North Carolina Medical Research: What is the background for this study? What are the main findings? Response: I think it will be critical to further explore the implications of Oncotype DX breast cancer assay (ODX testing) in women with breast cancer.  The ODX test helps predict which cancers will be more aggressive as well as guide recommendations as to which patients would most likely benefit from chemotherapy. I think we should look to see what impact this test is really having on the use of chemotherapy and its associated costs and outcomes for real-world breast cancer patients. (more…)
Author Interviews, Brigham & Women's - Harvard, General Medicine, Hospital Readmissions / 11.06.2015

Jeffrey C. Schneider, M.D. Medical Director, Trauma, Burn & Orthopedic Program Assistant Professor, Dept. of Physical Medicine and Rehabilitation Harvard Medical School Spaulding Rehabilitation Hospital Boston, MA 02129MedicalResearch.com Interview with: Jeffrey C. Schneider, M.D. Medical Director, Trauma, Burn & Orthopedic Program Assistant Professor, Dept. of Physical Medicine and Rehabilitation Harvard Medical School Spaulding Rehabilitation Hospital Boston, MA 02129 Medical Research: What is the background for this study? What are the main findings? Response: Hospitalizations account for the largest share of healthcare costs in the U.S., comprising nearly one-third of all healthcare expenditures.  In 2011, readmissions within 30 days of hospital discharge represented more than $41 billion in hospital costs.  Financial penalties for excess 30-day hospital readmissions were instituted by the Centers for Medicare and Medicaid Services in 20124; more than 2,200 hospitals were fined a total of $280 million in reduced Medicare payments in fiscal year 2013. Most readmission risk prediction models have targeted specific medical diagnoses and have utilized comorbidities and demographic data as the central risk factors for hospital readmission. Yet, large U.S. administrative datasets have demonstrated poor discriminative ability (c-statistics: 0.55-0.65) in predicting readmissions. However, few studies have considered functional status as potential readmission risk factors. There is increasing evidence that functional status is a good predictor of other health outcomes.  To date, acute care hospital administrative databases do not routinely include functional status measures.  Therefore, inpatient rehabilitation setting is an ideal population in which to examine the impact of functional status on readmission risk, because: (1) inpatient rehabilitation patients often have complex care transitions after acute care discharge, and represent a significant proportion of total readmissions; 2) inpatient rehabilitation facilities routinely document functional status using a valid instrument—the FIM®; and (3) a majority of U.S. IRFs participate in one of the only national datasets that contain standardized functional data—the Uniform Data System for Medical Rehabilitation. Limitations of prior work include small and single-center study designs, narrowly defined patient populations, and defining readmissions beyond the 30-day period.  Overall, there is a lack of literature on the utility of function as a readmission predictor in a large population of medical patients. Moreover, function is a modifiable risk factor with potential to impact readmission outcomes if function-based interventions are instituted early. Therefore, the objective of this study was to compare functional status with medical comorbidities as predictors of acute care readmissions in the medically complex rehabilitation population. We hypothesized that acute care readmission prediction models based on functional status would outperform models based on comorbidities,and that the addition of comorbidity variables to function-based models would not significantly enhance predictive performance. (more…)
Author Interviews, Cost of Health Care, Kaiser Permanente, Long Term Care, Medicare / 11.06.2015

Yan S. Kim, MD PhD Delivery Science Fellow Division of Research Kaiser Permanente Northern California Oakland, CA 94612MedicalResearch.com Interview with: Yan S. Kim, MD PhD Delivery Science Fellow Division of Research Kaiser Permanente Northern California Oakland, CA 94612 Medical Research: What is the background for this study? What are the main findings? Dr. Kim: Long-term care hospitals first emerged in the 1980s as an alternative to lengthy acute-care hospital stays for patients with complex medical problems who need prolonged hospital-level care.  In 2002, Medicare changed its payment method for these facilities from cost-based to a lump sum per admission based on the diagnosis.  Under this system, which is still in place, Medicare pays these hospitals a higher rate for patients who stay a minimum number of days based on the patient's condition.  Shorter stays are paid much less and longer stays do not necessary generate higher reimbursements. Using Medicare data, we analyzed a national sample of patients who required prolonged mechanical ventilation – the most common, and among the most costly, conditions for patients in long-term care hospitals – to examine whether this payment policy has created incentives to base discharge decisions on payments.  We found that in the years after the policy’s implementation there was a substantial spike in the percentage of discharges on and immediately after the minimum-stay threshold was met, while very few patients were discharged before the threshold. By contrast, prior to 2002, discharges were evenly distributed around the day that later became the short-stay threshold.  These findings confirm that the current payment policy has created unintended incentives for long-term care hospitals to base the timing of patient discharges on payments and highlight how responsive these hospitals are to payment incentives. (more…)
Author Interviews, Biomarkers, Lung Cancer, Wistar / 11.06.2015

MedicalResearch.com Interview with: Qihong Huang, M.D., Ph.D. Associate professor in the Tumor Microenvironment and Metastasis Program The Wistar InstituteQihong Huang, M.D., Ph.D. Associate professor in the Tumor Microenvironment and Metastasis Program The Wistar Institute Medical Research: What is the background for this study? What are the main findings? Dr. Huang: Lung cancer is the leading cause of cancer deaths in both men and women in the United States and results in more deaths globally than breast, prostate and colon cancers combined. While the five year survival rate for early stage non-small cell lung cancer (NSCLC) is above 50%, it is less than 5% in patients with metastatic disease.  Clearly, early detection can save lives, but accurate screening tests for high-risk individuals are still lacking. Although low dose computed tomography (LDCT) has been successfully used for screening in high-risk populations, multiple negative factors are associated with recurrent LDCT screening, including false-positives and false-negatives, unnecessary invasive procedures, radiation exposure, global availability of the technology and cost. Although several non-invasive tests for lung cancer using body fluids such as blood, urine or sputum are under investigation, none are currently available. When low dose computed tomography is used for screening, patients who are 50 years old or older are frequently diagnosed with pulmonary nodules.  However, only a small fraction of the nodules detected are subsequently diagnosed as lung cancer.  In cases where it is difficult to differentiate malignant from benign nodules, it is recommended that patients with these indeterminate nodules be followed with serial LDCT, which increases radiation exposure and financial cost. A simple, inexpensive blood test that differentiates malignant from benign nodules would fill an important clinical need. In this study, we validated AKAP4 as a highly accurate biomarker in a cohort of 264 blood samples from patients with known non-small cell lung cance and 135 controls samples from two different sites including a subset of controls with high risk lung nodules.   When all 264 lung cancers were compared with all 135 controls, the area under the ROC curve (AUC) was 0.9714. When 136 stage I NSCLC lung cancers were compared with all controls, the AUC is 0.9795, and when all lung cancer patients were compared to 27 controls with histologically confirmed benign lung nodules – a comparison of significant clinical importance – the AUC was 0.9825. AKAP4 expression increases significantly with tumor stage but independently of age, gender, smoking history or cancer subtype. Follow-up studies in a small number of resected NSCLC patients revealed a decrease of AKAP4 expression post-surgical resection that remained low in patients in remission and increased with tumor recurrence. AKAP4 is a highly accurate biomarker for the detection of early stage lung cancer, lung cancer recurrence, and distinguishing malignant from benign lung nodules. (more…)
Author Interviews, Heart Disease, Karolinski Institute, NEJM, Technology / 11.06.2015

Jacob Hollenberg M.D., Ph.D. Assistant Professor, Cardiologist Head of Research, Centre for Resuscitation Science Karolinska Institutet, Stockholm, SwedenMedicalResearch.com Interview with: Jacob Hollenberg M.D., Ph.D. Assistant Professor, Cardiologist Head of Research, Centre for Resuscitation Science Karolinska Institutet, Stockholm, Sweden Editor’s note: Dr. Hollenberg and colleagues published two articles in the NEJM this week discussing CPR performed by bystanders in out-of-hospital cardiac arrests. MedicalResearch: What is the background for the first study? Dr. Hollenberg: There are 10,000 cases of cardiac arrest annually in Sweden. Cardiopulmonary Resuscitation (CPR) has been taught to almost a third of Sweden’s population of 9.7 million. In recent years the value of bystander CPR has been debated, largely due to a lack of a randomized trial demonstrating that bystander CPR is lifesaving. In this study, which included all cases of emergency medical services (EMS) treated and bystander-witnessed out-of-hospital cardiac arrests recorded in the Swedish Cardiac Arrest Registry from January 1, 1990, through December 31, 2011, our primary aim was to assess whether CPR initiated before the arrival of EMS was associated with an increase in the 30-day survival rate. MedicalResearch: What were the main findings? Dr. Hollenberg: Early CPR prior to arrival of an ambulance more than doubled the chance of survival. (30-day survival rate was 10.5% among patients who underwent CPR before EMS arrival, as compared with 4.0% among those who did not (P<0.001).) This association held up in all subgroups regardless of sex, age, cause of cardiac arrest, place of arrest, EKG findings or time period (year analyzed). MedicalResearch: How did the patients who survived cardiac arrest do from a disability standpoint? Dr. Hollenberg: We had cerebral performance scores from 474 patients who survived for 30 days after cardiac arrest. (higher scores indicate greater disability). At the time of discharge from the hospital, 81% of these patients had a score of category of 1. Less than 2% had category scores of 4 or 5. MedicalResearch: What should patients and providers take away from this report? Dr. Hollenberg:
  • For patients with an out-of-hospital cardiac arrest, CPR performed by bystanders before the arrival of emergency medical personnel, saves lives. This has been validated by both the size of this study and the consistency of the results over three decades.
  • CPR education needs to continue and to increase. In Sweden about one-third of the population has been taught CPR.       Legislation has recently been passed that mandates CPR be taught to all teenagers in school which should allow an entire generation to become familiar with this lifesaving technique.
  • The willingness of the public to become involved also needs to increase. We need new ways of educating lay people to recognize cardiac arrest and to motivate them to perform it. The knowledge that bystander CPR saves lives may enhance that motivation.
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Author Interviews, Heart Disease, JACC, Yale / 10.06.2015

James V. Freeman MD, MPH, MS Yale University School of Medicine New Haven, CTMedicalResearch.com Interview with: James V. Freeman MD, MPH, MS Yale University School of Medicine New Haven, CT Medical Research: What is the background for this study? What are the main findings? Dr. Freeman: Atrial fibrillation (AF) substantially increases the risk of major adverse clinical outcomes such as stroke and death, but it can also cause frequent symptoms, affect patient’s functional status, and impair their quality of life. While prior studies have reported the range of AF-related symptoms in patient populations, these studies were generally from highly selected patients and referral based practices, and may not reflect results in community practice or results with contemporary AF management. Using the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF), a large, contemporary, prospective, community-based outpatient cohort, we evaluated the type and frequency of symptoms in patients with Atrial fibrillation. In addition, we measured the degree to which physician assessed symptom severity (using the European Heart Rhythm Association [EHRA] classification system) was correlated with patient reported quality of life (assessed by the Atrial Fibrillation Effect on QualiTy-of-life [AFEQT] questionnaire). Finally, we association between symptoms or quality of life with clinical outcomes, including death, hospitalization, stroke and major bleeding. In our community-based study, the majority of AF patients (61.8%) were symptomatic (EHRA >2) and 16.5% had severe or disabling symptoms (EHRA 3-4). EHRA symptom class was well correlated with the AFEQT quality of life score (Spearman correlation coefficient -0.39). Over 1.8 years of follow-up, Atrial fibrillation symptoms were associated with a higher risk of hospitalization (adjusted HR for EHRA ≥2 vs EHRA 1 1.23, 95% CI 1.15-1.31) and a borderline higher risk of major bleeding. Lower quality of life was associated with a higher risk of hospitalization (adjusted HR for lowest quartile of AFEQT vs highest 1.49, 95% CI 1.2-1.84), but not other major adverse events including death. (more…)