Author Interviews, Outcomes & Safety / 11.10.2016

MedicalResearch.com Interview with: Bala N. Hota, MD Department of Internal Medicine Rush Medical College Chicago, IL MedicalResearch.com: What is the background for this study? Response: There has been a proliferation of online ranking systems that seek to rate the quality of health care systems. Rush University Medical Center (RUMC) has consistently scored highly on patient safety measurement systems. For example, RUMC has received nine consecutive “A” grades for safety from the Leapfrog Group, and was recently ranked “4 stars” in the CMS 2016 star ranking system. In the 2015-2016 US News and World Report Ranking System, however, Rush received a low score for quality, a 1 out of 5 possible points, which was a surprise. To understand these results, the RUMC quality team began a process to validate the data and methods of the US News hospital ranking system. What was found was a surprise – the data backing the ranking system produced by US News had flaws, leading to the low score. Specifically, data were missing from the data set used for the US News analysis, including whether a condition was present on admission in 10% of cases; dates of service were also missing from all cases. The quality team at RUMC then conducted an analysis using national data, and simulated the impact of these data flaws on national rankings.
Author Interviews, Cost of Health Care, Hospital Readmissions / 10.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28723" align="alignleft" width="182"]Kathleen Carey, Ph.D. Professor, Department of Health Law, Policy and Management School of Public Health Boston University Boston MA 02118 Dr. Kathleen Carey[/caption] Kathleen Carey, Ph.D. Professor, Department of Health Law, Policy and Management School of Public Health Boston University Boston MA MedicalResearch.com: What is the background for this study? What are the main findings? Response: The ACA’s Hospital Readmissions Reduction Program (HRRP) imposes Medicare reimbursement penalties on hospitals with readmission rates for certain conditions if they exceed national averages. A number of observers have expressed serious concern over the program’s impact on safety-net hospitals, which serve a high proportion of low income patients who are more likely to be readmitted – often for reasons outside hospital control. Many have argued that the HRRP should adjust for socio-economic status. However, Medicare does not want to lower the standard of quality for these hospitals.
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, JAMA, Outcomes & Safety / 10.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28715" align="alignleft" width="200"]Dr. Jared Conley Dr. Jared Conley[/caption] Jared Conley, MD, PhD, MPH Department of Emergency Medicine Massachusetts General Hospital Harvard Medical School Boston, MA 02114 MedicalResearch.com: What is the background for this study? What are the main findings? Response: As the U.S. healthcare system seeks to improve the health of populations and individual patients, there is increasing interest to better align healthcare needs of patients with the most appropriate setting of care—particularly as it relates to hospital-based care (accounting for 1/3 of total U.S. healthcare costs). Avoiding hospitalization—as long as safety and quality are not compromised—is often preferred by patients and the added benefit of potentially making care more affordable further promotes such care redesign efforts. There is a growing body of research studying alternative management strategies to hospitalization; we sought to comprehensively review and analyze this work. Alternative management strategies reviewed include outpatient management, quick diagnostic units, observation units, and hospital-at-home.
Author Interviews / 10.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28711" align="alignleft" width="174"]Susan P. Y. Wong, MD Acting Instructor Division of Nephrology University of Washington Seattle VA Puget Sound Health Care Syste Dr. Susan Wong[/caption] Susan P. Y. Wong, MD Acting Instructor Division of Nephrology University of Washington Seattle VA Puget Sound Health Care System MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is not known what proportion of US patients with advanced chronic kidney disease (CKD) go on to receive renal replacement therapy (RRT) with maintenance dialysis or kidney transplantation. Most of what is known about treatment practices for advanced CKD in the US comes from the United States Renal Data System (USRDS), our national registry of RRT. However, the USRDS does not collect information on patients who reach the advanced stages of CKD but do not receive RRT. To address this knowledge gap, we conducted a retrospective study of a national cohort of 28,568 adults with advanced CKD (a sustained estimated glomerular filtration rate <6.8% among similarly aged patients described in these other countries. Despite the fact that age is strongly associated with limited survival and quality of life after dialysis initiation, our findings suggest that dialysis initiation practices were far more liberal among older patients in our study cohort than reported for other developed countries.
Author Interviews, Breast Cancer, ESMO, Immunotherapy / 10.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28705" align="alignleft" width="170"]Gabriel N. Hortobagyi, MD, FACP, F.A.S.C.O. Professor of Medicine Nellie B. Connally Chair in Breast Cancer Department of Breast Oncology Co-Director, Multidisciplinary Breast Cancer Research Program University of Texas MD Anderson Cancer Center Houston, Texas Prof. Gabriel N. Hortobagyi[/caption] Gabriel N. Hortobagyi, MD, FACP, F.A.S.C.O. Professor of Medicine Nellie B. Connally Chair in Breast Cancer Department of Breast Oncology Co-Director, Multidisciplinary Breast Cancer Research Program University of Texas MD Anderson Cancer Center Houston, Texas MedicalResearch.com: What is the background for this study? What are the main findings? Response: MONALEESA-2 is a Phase III randomized, double blind, placebo controlled, multicenter global registration trial to evaluate the safety and efficacy of LEE011 in combination with letrozole compared to letrozole alone in postmenopausal women with HR+/HER2- advanced breast cancer who received no prior therapy for their advanced breast cancer. The primary efficacy results from the pivotal MONALEESA-2 study show LEE011 (ribociclib) plus letrozole significantly extended progression-free survival (PFS) compared to a standard of care, letrozole, as a first-line treatment in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (HR= 0.556; 95% CI: 0.429-0.720; p=0.00000329)1. The results demonstrate that LEE011 plus letrozole reduced the risk of death or progression by 44% over letrozole alone, significantly extending PFS across all patient subgroups. More than half of women with measurable disease taking LEE011 plus letrozole saw their tumor size shrink by at least 30% during treatment (overall response rate (ORR) in patients with measurable disease = 53% vs 37%, p=0.00028)1.
Author Interviews, Gastrointestinal Disease, Infections, PLoS / 10.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28701" align="alignleft" width="133"]Brian K. Coombes, PhD Professor & University Scholar Associate Chair, Graduate Education Department of Biochemistry & Biomedical Sciences Assistant Dean, Biochemistry Graduate Program Canada Research Chair in Infectious Disease Pathogenesis Dr. Brian Coombes[/caption] Brian K. Coombes, PhD Professor & University Scholar Associate Chair, Graduate Education Department of Biochemistry & Biomedical Sciences Assistant Dean, Biochemistry Graduate Program Canada Research Chair in Infectious Disease Pathogenesis MedicalResearch.com: What is the background for this study? Response: North Americans have among the highest reported prevalence and incidence of inflammatory bowel disease (IBD) in the world. This is a lifelong disease that often strikes people in their early years, leading to decades of suffering, increased risk of colorectal cancer, and 50% increased risk of premature death. Compared to the general population, quality of life for those with Crohn’s disease is low across all dimensions of health. The need to understand the root origins of this disease and to use this information to invigorate a new pipeline of treatments and preventions has never been more pressing.
Author Interviews, Pharmacology, Schizophrenia / 10.10.2016

Antony Loebel, M.D. Executive Vice President and Chief Medical Officer, Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma GroupAntony Loebel, M.D. Executive Vice President and Chief Medical Officer Sunovion Head of Global Clinical Development Sumitomo Dainippon Pharma Group MedicalResearch.com: What is the background for this study? Response: Lurasidone hydrochloride (HCl) is an atypical antipsychotic approved by the FDA for the treatment of schizophrenia in 2010. There are a number of publications on lurasidone studies, pooled data that were included in a network meta-analysis of RCTs in schizophrenia. The meta-analysis compares lurasidone with other antipsychotics using RCTs where both medications were studied at the same time. Such approach (meta-analysis of similarly designed trials) allows for a state of the art review of efficacy, safety and tolerability of medications where direct head-to-head trials are not available.
Alzheimer's - Dementia, Author Interviews, Genetic Research, JAMA, Race/Ethnic Diversity / 10.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28675" align="alignleft" width="200"]Dr Tamara Shiner MD PhD Specialist in Neurology Neurology Division Tel Aviv Sourasky Medical Centre Dr Tamara Shiner[/caption] Dr Tamara Shiner MD PhD Specialist in Neurology Neurology Division Tel Aviv Sourasky Medical Centre MedicalResearch.com: What is the background for this study? What are the main findings? Response: Although in the past believed to be sporadic, there is much emerging evidence for a significant genetic contribution to Dementia with Lewy bodies (DLB). Hetrozygosity for common mutations in the GBA gene have been shown to be more frequent among DLB patients and Parkinson's disease patients than in the general population. We found that GBA mutations are in fact exceptionally frequent among Ashkenazi Jewish (AJ) patients with Dementia with Lewy bodies. Our results indicate that one in three of all Ashkenazi DLB patients carry mutations in this specific gene (compared to approximately 6% in the general Ashkenazi Jewish population). We also found that those who carry these mutations have a more severe disease phenotype.
Author Interviews, Infections, NEJM / 10.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28693" align="alignleft" width="155"]Simon I. Hay, BSc, DPhil, DSc Professor of Global Health University of Washington Director of Geospatial Science Institute for Health Metrics and Evaluation (IHME). Prof. Simon Hay[/caption] Simon I. Hay, BSc, DPhil, DSc Professor of Global Health University of Washington Director of Geospatial Science Institute for Health Metrics and Evaluation (IHME). MedicalResearch.com: Why did you undertake this study? Response: As malaria control has not been routinely informed by subnational variation of malaria burden, we undertook the study to highlight the potential for high-resolution maps of disease burden to better understand the epidemiology of malaria as well as the contribution of recent control efforts as well as to better inform future malaria control efforts.
Author Interviews, Ophthalmology, UCLA / 10.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28685" align="alignleft" width="120"]Pravin U. Dugel, MD Retina Consultants of Arizona Phoenix, Arizona; USC Roski Eye Institute Keck School of Medicine University of Southern California Los Angeles, California Dr. Pravin Dugel[/caption] Pravin U. Dugel, MD Retina Consultants of Arizona Phoenix, Arizona; USC Roski Eye Institute Keck School of Medicine University of Southern California Los Angeles, California  MedicalResearch.com: What is the background for this study? Response: OASIS is an acronym for “OcriplASmIn for Treatment for Symptomatic Vitreomacular Adhesion including Macular Hole”.  It was a Phase IIIB, randomized, prospective, sham-controlled, double-masked, multicenter clinical study. The goal of the study was to further evaluate the long-term (24 months) efficacy and safety of a single injection of 0.125mg of ocriplasmin in patients with symptomatic vitreomacular adhesion (VMA) and vitreomacular traction (VMT), including macular hole (MH). OASIS evaluated 220 patients with symptomatic VMA/VMT.  One hundred forty-six patients received ocriplasmin while 74 served as a sham control group. In the latter group, no intravitreal injection was administered. 
Author Interviews, ESMO, Pharmacology / 09.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28678" align="alignleft" width="144"]Paolo Bossi MD Medical Oncologist Head and Neck Cancer Department IRCCS Istituto Nazionale dei Tumori Foundation Milan, Italy Dr. Paolo Bossi[/caption] Paolo Bossi MD Medical Oncologist Head and Neck Cancer Department IRCCS Istituto Nazionale dei Tumori Foundation Milan, Italy MedicalResearch.com: What is the background for this study? What are the main findings? Response: Precise, clear and unbiased reporting of adverse events (AE) is essential to ensure safety of the new drugs. It is crucial also in engaging patients and physicians in a shared decision making: before starting a new treatment I need to discuss with my pt what are the expected benefits and what the toxicities of a new drugs. However, in parallel to the discovery and development of new drugs, little attention has been paid to modernization of the way of collecting toxicities. This line of reasoning is particularly true for new or "relatively new" drugs, such as immunotherapy (IT) and targeted agents (TT). So, we analysed all the trials that lead to the approval of TT or IT from 2000 – 2015 retrieved by FDA database.
Author Interviews, Depression, Mental Health Research, Pharmacology / 09.10.2016

MedicalResearch.com Interview with: Antony Loebel, M.D. Executive Vice President and Chief Medical Officer, Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma GroupAntony Loebel, M.D. Executive Vice President and Chief Medical Officer Sunovion Head of Global Clinical Development Sumitomo Dainippon Pharma Group MedicalResearch.com: What is the background for this study? Response: Early predictors of subsequent clinical response are important in the treatment of depression, since 6-10 weeks of treatment are often required before full antidepressant response may occur. Early identification of patients who are unlikely to eventually achieve a response permits clinicians to intervene early to adjust the dose of medication, or switch to an alternative therapy. Multiple studies in major depressive disorder (MDD, unipolar) have reported that early improvement at 2 weeks is significantly predictive of treatment response at 6-8 weeks.The most common early improvement criterion is a 20-25% reduction in the Hamilton Depression Rating Scale (HAM-D) or the Montgomery-Asberg Depression Rating Scale (MADRS) scores1-6. Major depressive disorder with mixed features (MDD-MF) has recently been recognized as a diagnostic subtype in DSM-5. No research we are aware of has examined the predictive value of early improvement in patients diagnosed with MDD-MF. The aim of the current post-hoc analysis was to evaluate the value of early improvement in the MADRS or the Clinical Global Impressions, Severity (CGI-S) scale as predictors of response to lurasidone in patients with MDD-MF.
Author Interviews, OBGYNE, Pediatrics, Vaccine Studies / 09.10.2016

MedicalResearch.com Interview with: Ameae M. Walker Vice Provost for Academic Personnel Distinguished Teaching Professor Biomedical Sciences School of Medicine University of California, Riverside MedicalResearch.com: What is the background for this study? What are the main findings? Response: There has previously been some evidence that immune cells in breast milk could pass through the wall of the immature gut, but if active they, like antibodies in milk, were considered likely a form of passive immunity. We now show that in addition to some maternal cells being active in the newborn (i.e. that they do contribute to passive cellular immunity), there are, more importantly, others that go to the thymus where they participate in selection of the neonate’s T cells. In this fashion, the neonate develops cells that recognize antigens against which the mother has been vaccinated – a process we have dubbed maternal educational immunity.
Author Interviews, Genetic Research, Nature / 08.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28658" align="alignleft" width="173"]Victor Guryev PhD Team Leader European Research Institute for the Biology of Ageing (ERIBA Dr. Victor Guryev[/caption] Victor Guryev PhD Team Leader European Research Institute for the Biology of Ageing (ERIBA) MedicalResearch.com: What is the background for this study? Response: Decoding of human genomes progresses at an enormous speed. Thirteen years after completion of the first human genome reference, we now obtained full genome information for tens of thousands individuals. This number is expected to reach millions in the next few years. Processing this information is a challenge on its own: we learned how to detect small changes such as single nucleotide variants (SNVs), but identification of larger, structural DNA variants (SVs) is far from being perfect.
Author Interviews, Weight Research / 08.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28653" align="alignleft" width="200"]Li-Jun Yang MD Professor, Hematopathology University of Florida Dr. Li-Jun Yang[/caption] Li-Jun Yang MD Professor, Hematopathology University of Florida MedicalResearch.com: What is the background for this study? Response: Irisin, an exercise-induced myokine, promotes converting subcutaneous (sc) fat-storing adipocytes into fat-burning adipocytes, namely “browning”. Although beneficial effects of irisin such as browning and weight loss in obese animal have been observed in mice, the effect of irisin in human adipocytes is controversial. Moreover, the mechanisms of irisin’s anti-obesity are not clear and systemic studies are not available using human adipose tissues. In our study, we aimed at exploring at the multiple levels in the mechanisms of irisin’s anti-obesity effects using human adipocytes and human adipose tissues.
Author Interviews, Cancer Research, Cost of Health Care, ESMO, Melanoma / 08.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28647" align="alignleft" width="200"]Prof. dr Lidija Kandolf Sekulovi Prof. Kandolf[/caption] Prof. dr Lidija Kandolf Sekulovic MD, PhD EADO project access to innovative medicines coordinator Interdisciplinary Melanoma team, Department of Dermatology Medical Faculty, Military Medical Academy Belgrade, Serbia MedicalResearch.com: What made you set out to organize this survey? Response: Before 2011 there were no effective treatment options for metastatic melanoma patients, but that have tremendously changed in the last 5 years. Now we have innovative medicines which are able to prolong overall survival of these patients to more than 18 months, and in some patients, durable responses lasting for up to 10 years are not infrequently reported. However, the access to these medicines is restricted, and patients and physicians are facing more and more difficulties to obtain them. This is especially the case for countries of Eastern and South-Eastern Europe, where majority of patients are still treated with palliative chemotherapy that does not prolong overall survival. We wanted to explore this issue more deeply, to map the access to innovative medicines between 1st May 2015 to 1st May 2016, and particularly the access to first-line treatment recommended by ESMO and EDF/EORTC/EADO guidelines that are based on scientific evidence and which are published in 2015 and 2016.
Author Interviews, Biomarkers, Cancer, Prostate Cancer, UT Southwestern / 08.10.2016

MedicalResearch.com Interview with: Dr Ryan Hutchinson MD and Yair Lotan MD Department of Urology University of Texas Southwestern Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: The United States Preventative Services Task Force recommendation against PSA screening generated significant controversy. Research since then has relied heavily on survey data to examine the impact of the recommendation on PSA screening practices. In a hotly charged issue such as this, such data can carry significant bias. We examined a large, whole-institution data in the years before and after the USPSTF recommendations reflecting actual practice and found that the changes in PSA use at our institution, if any, were small. This is more consistent with behavior seen after the vast majority of practice recommendations.
Addiction, Author Interviews, NYU/NYMC, Pediatrics, Tobacco, Tobacco Research / 08.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28638" align="alignleft" width="150"]Professor Michael Weitzman MD New York University's College of Global Public Health and The Departments of Pediatrics and Population Health New York University School of Medicine NYU Langone Medical Center Dr. Michael Weitzman[/caption] Professor Michael Weitzman MD New York University's College of Global Public Health and The Departments of Pediatrics and Population Health New York University School of Medicine NYU Langone Medical Center MedicalResearch.com: What is the background for this study? Response: There is a marked and rapidly increasing epidemic of hookah (waterpipe) use in the US. Hookah use appears to be as, or even more, dangerous than cigarette use. There are data suggesting that one hookah session is comparable to smoking 5 packs of cigarettes in terms of exposure to toxins. The CDC and WHO both have issued warnings that hookah pipe use may eradicate much or all of the progress of the past 50 years of tobacco control efforts.
Author Interviews, Critical Care - Intensive Care - ICUs, JAMA, Pediatrics / 07.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28718" align="alignleft" width="133"]Dr. Lars W. Andersen MD MPH Department of Emergency Medicine, Beth Israel Deaconess Medical Center Boston, Massachusetts Department of Anesthesiology and Research Center for Emergency Medicine, Aarhus University Hospital, Aarhus, Denmark Dr. Lars W. Andersen[/caption] Dr. Lars W. Andersen MD MPH Department of Emergency Medicine, Beth Israel Deaconess Medical Center Boston, Massachusetts Department of Anesthesiology and Research Center for Emergency Medicine, Aarhus University Hospital, Aarhus, Denmark MedicalResearch.com: What is the background for this study? What are the main findings? Response: Pediatric in-hospital cardiac arrest continues to carry a very high mortality. Thanks to companies such as AEDLeader, professional healthcare staff are able to obtain relevant equipment to help people in need. The health of patients is the priority of any paramedic or doctor. Given the relative rarity of these events at most centers and the acuity and complexity of cardiac arrest, few randomized trials exist. Moreover, few observational studies have addressed the effectiveness of intra-cardiac arrest interventions, including the use of medications and advanced airway management. This is further highlighted in the current American and international guidelines, which provide limited guidance to providers in regards to advanced airway management during pediatric in-hospital cardiac arrest. The primary objective of our study was to establish whether there is an association between tracheal intubation during in-hospital pediatric cardiac arrest and outcomes. As respiratory failure and hypoxia are common prior to cardiac arrest in children, there is a good rational for early advanced airway management in this population.
Author Interviews, Electronic Records, JAMA, NYU/NYMC, Technology / 07.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28567" align="alignleft" width="144"]Saul Blecker, MD, MHS Department of Population Health New York University Langone School of Medicine, New York, NY 10016 Dr. Saul Blecker,[/caption] Saul Blecker, MD, MHS Department of Population Health New York University Langone School of Medicine, New York, NY 10016 Saul.Blecker@nyumc.org MedicalResearch.com: What is the background for this study? What are the main findings? Response: The identification of conditions or diseases in the electronic health record (EHR) is critical in clinical practice, for quality improvement, and for clinical interventions. Today, a disease such as heart failure is typically identified in real-time using a “problem list”, i.e., a list of conditions for each patient that is maintained by his or her providers, or using simple rules drawn from structured data. In this study, we examined the comparative benefit of using more sophisticated approaches for identifying hospitalized patients with heart failure.
AACR, Author Interviews, Cancer Research, Genetic Research / 07.10.2016

MedicalResearch.com Interview with: Riccardo Taulli, PhD Assistant Professor of Biochemistry Dept. of Oncology, University of Turin Via Santena 5, 10126 Torino, Italy MedicalResearch.com: What is the background for this study? Response: Rhabdomyosarcoma is a muscle-derived pediatric cancer for which therapeutic options have not improved significantly over the past decades, especially for its metastatic form. MicroRNAs are small regulatory molecules that control gene expression at the post-transcriptional level, fine tuning a wide number of cellular mechanisms, processes and behaviors. In our work, we underwent a large microRNA isolation and sequencing effort using human samples of the three major rhabdomyosarcoma subtypes, along with cell lines and normal muscle, to identify novel molecular circuits with therapeutic potential.
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Surgical Research / 06.10.2016

MedicalResearch.com Interview with: Diego Lopez Harvard medical student and Dr. Andrew Loehrer MD former surgical resident at MGH senior author: David C. Chang, PhD, MPH, MBA Associate Professor of Surgery Director of Healthcare Research and Policy Development Department of Surgery Massachusetts General Hospital Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Income inequality in the United States has been increasing in recent decades, and has become an important in this election cycle. Although income inequality is often framed in terms of its effects on politics and the economy, little attention has been paid to its effect on the healthcare system. In our study, we set out to evaluate the way in which counties with differing levels of income inequality made use of the healthcare system while controlling for the overall income (as well as other demographic variables). We found that areas with higher income inequality were associated with higher Medicare expenditures.  And these effects are independent of – meaning they are in addition to – the known effect of poverty on healthcare utilization.
AHA Journals, Author Interviews, Heart Disease, Pharmacology / 06.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28606" align="alignleft" width="180"]Xiaoxi Yao, PhD, MPH, MS Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery Mayo Clinic Rochester, MN Dr. Xiaoxi Yao[/caption] Xiaoxi Yao, PhD, MPH, MS Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery Mayo Clinic Rochester, MN MedicalResearch.com: What is the background for this study? What are the main findings? Response: Atrial fibrillation (AF) is the most common arrhythmia requiring treatment, affecting 3-6 million Americans. AF is associated with a 5 fold risk of stroke, which can be substantially reduced by oral anticoagulants. For over a half century, warfarin was the only option for long-term oral anticoagulation in the U.S., but the use of warfarin can be cumbersome. Warfarin has numerous interactions with food and other drugs, and requires regular lab testing and dose adjustment. Since 2010, four non–vitamin K antagonist oral anticoagulants (NOACs) have been approved by the FDA. In comparison to warfarin, the fixed-dosage NOACs provide more convenient therapeutic options and demonstrated at least equivalent efficacy and safety in large phase III clinical trials. However, the outcomes achieved in idealized clinical trial settings may not necessarily translate to routine clinical practice. In this large cohort of patients with nonvalvular AF, we assessed the real-world effectiveness and safety of three NOACs (dabigatran, rivaroxaban, and apixaban), comparing each agent with warfarin. We found apixaban was associated with lower risks of both stroke and major bleeding, dabigatran was associated with similar risk of stroke but lower risk of major bleeding, and rivaroxaban was associated with similar risks of both stroke and major bleeding in comparison to warfarin.
Author Interviews, Gastrointestinal Disease, Pancreatic / 06.10.2016

MedicalResearch.com Interview with: Dr. Pouria Jandaghi Functional Genome Analysis, Deutsches Krebsforschungszentrum Heidelberg, Germany Department of Human Genetics, McGill University University and Genome Quebec Innovation Centre Montreal, Canada MedicalResearch.com: What is the background for this study? Response: Although the overall five-year survival of all patients with cancer stands at 63%, for pancreatic cancer patients, it is a disheartening 8% - a number that remains largely unchanged for three decades. Of the patients diagnosed with pancreatic cancer, about 85% exhibit pancreatic ductal adenocarcinoma (PDAC). Most of these patients die within 4 to 6 months after diagnosis. The poor prognosis is caused by the its detection at only late stages, and lack of effective options for chemotherapy. The widely used chemotherapeutic agent gemcitabine, confers a median survival advantage of only 6 months, and resistance to therapy develops in the vast majority of patients. Given this poor prognosis of patients with PDAC, there is an urgent need to find more effective therapies. In this study, we set out to investigate potential therapeutic targets by dissecting gene expression profiles of tumors and control samples. Candidate targets were validated with respect to their suitability and analyzed functionally.
Author Interviews, Duke, Exercise - Fitness, Lancet / 06.10.2016

MedicalResearch.com Interview with: Aarti Sahasranaman, PhD Duke-NUS Gradaute Medical School Singapore MedicalResearch.com: 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.
Author Interviews, Cost of Health Care, Ophthalmology, Pharmacology / 06.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28618" align="alignleft" width="166"]Aleksandra Rachitskaya, MD Assistant Professor of Ophthalmology Retina Service, Department of Ophthalmology Cole Eye Institute Cleveland, OH 44195 Dr. Aleksandra Rachitskaya[/caption] Aleksandra Rachitskaya, MD Assistant Professor of Ophthalmology Retina Service, Department of Ophthalmology Cole Eye Institute Cleveland, OH 44195 MedicalResearch.com: What is the background for this study? Response: The Centers for Medicare and Medicaid Services (CMS) Open Payments database lists payment records from drug and device manufacturers to physicians. Anti-vascular endothelial growth factor (anti-VEGF) agents such as ranibizumab (Lucentis®, Genentech, Inc., San Francisco, CA), aflibercept (Eylea™, Regeneron, Tarrytown, NY) and off-label bevacizumab (Avastin®, Genentech, Inc., San Francisco, CA) are used for a variety of indications in ophthalmology. The current study examined the payments made to ophthalmologists related to ranibizumab and aflibercept and correlated those payments to provider usage of these medications. The former was achieved by utilizing Centers for Medicare and Medicaid Services (CMS) Provider Utilization and Payment database.
Author Interviews, Blood Pressure - Hypertension, Brigham & Women's - Harvard, Heart Disease, JACC, Salt-Sodium / 06.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28435" align="alignleft" width="130"]Nancy Cook ScD Professor of Medicine, Harvard Medical School Professor in the Department of Epidemiology Harvard T.H. Chan School Public Health Brigham & Women’s Hospital Division of Preventive Medicine Boston, MA 0221 Dr. Nancy Cook[/caption] Nancy Cook ScD Professor of Medicine, Harvard Medical School Professor in the Department of Epidemiology Harvard T.H. Chan School Public Health Brigham & Women’s Hospital Division of Preventive Medicine Boston, MA 02215 MedicalResearch.com: What is the background for this study? What are the main findings? Response: The association of sodium intake with later mortality has been controversial. While there is a well-accepted effect on blood pressure, the effects of sodium on later cardiovascular disease, and particularly mortality, have been subject to dispute. While the adverse effects of high sodium are now widely accepted, effects at lower levels of sodium intake are less clear. Some recent studies have found a J-shaped relationship, with increased disease rates among those consuming lower levels of sodium, contrary to the effects on blood pressure. In contrast, we found a direct linear relationship of usual intake of sodium with later mortality over 20 years of follow-up. Those with the lowest sodium intake experienced the lowest mortality. Our measure of intake was based on the average over 1-3 years of several measures of 24hr urine sodium excretion, the gold standard of sodium measurement. This is much more precise than measurements based on a single 24hr sodium excretion or especially on a spot urine sample, which is used in many publications that found the J-shaped curve. Our data were assessed in a healthy cohort of men and women without hypertension or cardiovascular disease, so had less potential bias due to these factors. We thus believe that our results showing the lowest mortality among those consuming the lowest levels of sodium are more accurate.
Author Interviews, Education, JAMA, Mental Health Research, Pediatrics / 06.10.2016

MedicalResearch.com Interview with: [caption id="attachment_28494" align="alignleft" width="144"]Laurie Miller Brotman, PhD Bezos Family Foundation Professor of Early Childhood Development Director, Center for Early Childhood Health and Development Department of Population Health NYU Langone Medical Center Dr. Laurie Brotman[/caption] Laurie Miller Brotman, PhD Bezos Family Foundation Professor of Early Childhood Development Director, Center for Early Childhood Health and Development Department of Population Health NYU Langone Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Children attending high-poverty schools are often exposed to an accumulation of stressors and adverse childhood experiences that can interfere with optimal mental health and learning. This study examines mental health and academic outcomes through second grade in nearly 800 Black and Latino children who participated in a randomized controlled trial of ParentCorps--a family-centered, school-based intervention in pre-kindergarten. In the original trial, elementary schools with pre-k programs serving primarily Black and Latino children from low-income families were randomized to receive ParentCorps or standard pre-k programming. ParentCorps includes professional development for pre-k and kindergarten teachers on family engagement, social-emotional learning, and behavioral regulation, and a program for families and pre-k students provided over four months at the school by specially trained pre-k teachers and mental health professionals. ParentCorps creates a space for families to come together, reflect on their cultural values and beliefs, and set goals for their children. Parents learn a set of evidence-based strategies and choose which ones fit for their families—such as helping children solve problems and manage strong feelings, reinforcing positive behavior, setting clear rules and expectations, and providing effective consequences for misbehavior. Teachers and parents help children learn social, emotional and behavioral regulation skills such as identifying feeling sad, mad, or scared, calming bodies during stressful situations, paying attention, and solving problems together. This three year follow-up study finds that ParentCorps as an enhancement to pre-k programming in high-poverty schools results in fewer mental health problems (behavioral and emotional problems) and better academic performance through second grade.
Author Interviews, Bone Density, JAMA, Mental Health Research, Mineral Metabolism, Pediatrics / 06.10.2016

MedicalResearch.com Interview with: Alexis Jamie Feuer MD Assistant Professor of Clinical Pediatrics Weill Cornell Medical College MedicalResearch.com: What is the background for this study? Response: Osteoporosis is a debilitating disorder characterized by low bone density and increased risk of fractures. Adolescence and young adulthood are critically important times for accruing peak bone density and failure to obtain adequate bone mass by early adulthood may result in future osteoporosis. In children, the use of certain medications can lead to a decrement in the acquisition of bone mass. Past studies have shown that stimulant medications, such as those used to treat Attention Deficit Hyperactivity Disorder (ADHD), may slow the rate of linear growth in children. To date, little research has been done to see what effects stimulant use may have on bone density and bone accrual in children. Stimulants exert their effects via activation of the sympathetic nervous system, and as there is mounting evidence that indicates the sympathetic nervous system plays a critical role in the acquisition of bone density, we sought to determine if there is any association between stimulant medication use and bone mass in the pediatric population.