Alcohol, Author Interviews, JAMA, Weight Research / 12.03.2019

MedicalResearch.com Interview with: Alice R Carter MSc Doctor of Philosophy Student MRC Integrative Epidemiology Unit Population Health Science, Bristol Medical School University of Bristol MedicalResearch.com: What is the background for this study?   Response: Higher body mass index and alcohol intake have been shown to increase the risk of liver disease. Some studies have looked at their combined effect by comparing the risk of liver disease between individuals with both high BMI and high alcohol intake and individuals with low BMI and low alcohol intake. However, these studies have produced mixed results. Some possible reasons for that are errors in self-reported BMI and alcohol intake, other factors confounding the association of BMI & alcohol intake with liver disease risk and changes in lifestyle that individuals with ill health may have been advised to adopt. One way to overcome these limitations is to use a technique called Mendelian randomisation. This method uses genetic differences between individuals that influence their characteristics (e.g. their body mass and how much alcohol they drink) to help understand whether these characteristics are causally related to diseases. Our study used this method to explore the joint effects of BMI and alcohol consumption on liver disease and biomarkers of liver injury. 
Author Interviews, Columbia, Nutrition, OBGYNE, Pediatrics / 12.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47856" align="alignleft" width="194"]Cynthia Gyamfi-Bannerman, MD, MScEllen Jacobson Levine and Eugene JacobsonProfessor of Women's Health in Obstetrics and GynecologyDirector, Maternal-Fetal Medicine Fellowship ProgramCo-Director, CUMC Preterm Birth Prevention Center Columbia University Dr. Gyamfi-Bannerman[/caption] Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of Women's Health in Obstetrics and Gynecology Director, Maternal-Fetal Medicine Fellowship Program Co-Director, CUMC Preterm Birth Prevention Center Columbia University MedicalResearch.com: What is the background for this study? What are the main findings? Response: In 2016 our group published the findings of the Antenatal Late Preterm Steroids (ALPS) trial in the NEJM.  We found that administration of antenatal corticosteroids to women at high risk for delivery from 34-36 weeks decreased breathing problems in their neonates.  This treatment had been traditionally only given at less than 34 weeks. The current paper is a cost analysis of that trial.  We found that the treatment was also cost effective.  From a cost perspective treatment was both low cost and highly effective (the options are low cost, low effect/low cost/high effect, high cost/low effect, high cost/high effect). 
Author Interviews, Diabetes, Pharmaceutical Companies, Weight Research / 12.03.2019

WeightControl.com Interview with: [caption id="attachment_47883" align="alignleft" width="142"]Dr. Lynn Kramer, MD FAANVP and Chief Clinical Officer & Chief Medical OfficeEisai Co., Ltd Dr. Kramer[/caption] Dr. Lynn Kramer, MD FAAN VP and Chief Clinical Officer & Chief Medical Office Eisai Co., Ltd WeightControl.com: What is the background for this announcement? Response: On February 25th, Eisai announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application to potentially update the label for BELVIQ® (lorcaserin HCI) CIV 10 mg twice-daily/BELVIQ XR (lorcaserin HCI) CIV once daily to include long-term efficacy and safety data from CAMELLIA-TIMI 61, a clinical trial of BELVIQ in 12,000 overweight and obese patients with cardiovascular (CV) disease and/or multiple CV risk factors such as type 2 diabetes mellitus (T2DM).
Author Interviews, Brigham & Women's - Harvard, Critical Care - Intensive Care - ICUs, Infections, JAMA / 12.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47886" align="alignleft" width="125"]Chanu Rhee, MD,MPHAssistant Professor of Population MedicineHarvard Medical School / Harvard Pilgrim Health Care InstituteAssistant Hospital EpidemiologistBrigham and Women’s Hospital Dr. Rhee[/caption] Chanu Rhee, MD,MPH Assistant Professor of Population Medicine Harvard Medical School / Harvard Pilgrim Health Care Institute Assistant Hospital Epidemiologist Brigham and Women’s Hospital  MedicalResearch.com: What is the background for this study? Response: Sepsis is the body’s reaction to a serious infection that results a cascade of inflammation in the body and organ dysfunction, such as low blood pressure, confusion, or failure of the lungs, kidneys, or liver.   Sepsis is a major cause of death, disability, and cost in the U.S. and around the world.  Growing recognition of this problem has led to numerous sepsis performance improvement initiatives in hospitals around the country.  Some of these efforts have also been catalyzed by high-profile tragic cases of missed sepsis leading to death, which may have contributed to a perception that most sepsis deaths are preventable if doctors and hospitals were only better at recognizing it. However, the extent to which sepsis-related deaths might be preventable with better hospital-based care is unknown.  In my own experience as a critical care physician, a lot of sepsis patients we treat are extremely sick and even when they receive timely and optimal medical care, many do not survive.  This led myself and my colleagues to conduct this study to better understand what types of patients are dying from sepsis and how preventable these deaths might be. 
Abbvie, Author Interviews, Dermatology, Immunotherapy / 11.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47874" align="alignleft" width="200"]Anne Robinson, Pharm DExecutive Scientific DirectorAbbVie Dr. Robinson[/caption] Anne Robinson, Pharm D Executive Scientific Director AbbVie MedicalResearch.com: What is the background for the risankizumab data presented at the American Academy of Dermatology 2019 Annual Meeting? Response: Abstracts presented by AbbVie at the American Academy of Dermatology (AAD) 2019 Annual Meeting highlight additional data from the Phase 3 clinical trial program evaluating the safety and efficacy of risankizumab, an investigational interleukin-23 (IL-23) inhibitor. The registrational program for risankizumab evaluated more than 2,000 adult patients with moderate to severe plaque psoriasis across four pivotal studies.
Author Interviews, Diabetes, Nutrition, Salt-Sodium, Weight Research / 09.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47854" align="alignleft" width="200"]Megan A McCrory, PhD, FTOSResearch Associate ProfessorDept of Health SciencesSargent College of Health and Rehabilitation SciencesBoston University 02215 Dr. McCrory[/caption] Megan A McCrory, PhD, FTOS Research Associate Professor Dept of Health Sciences Sargent College of Health and Rehabilitation Sciences Boston University 02215 MedicalResearch.com: What is the background for this study? Response: The prevalence of overweight and obesity has increased in the US, along with documented increases in portion size in the food supply. Fast food is popular, making up about 11% of adult daily calorie intake in the US, and over 1/3 of U.S. adults eat at fast food establishments on any given day. We therefore sought to examine changes in portion size, calories, and selected nutrients in fast-food entree, side, and dessert menu items across the years 1986, 1991, and 2016.
Author Interviews, Depression, Nutrition, Supplements, Weight Research / 08.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47759" align="alignleft" width="89"]Prof. Marjolein Visser PhDProfessor of Healthy AgingHead section Nutrition and HealthDepartment of Health Sciences, Vrije Universiteit AmsterdamAmsterdam Public Health research institute Dr. Visser[/caption] Prof. Marjolein Visser PhD Professor of Healthy Aging Head section Nutrition and Health Department of Health Sciences, Vrije Universiteit Amsterdam Amsterdam Public Health research institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: More than 40 million Europeans experience a major depressive disorder. One in ten men, and one in five women suffer from clinical depression at least once during their lifetime. Depression is one of the most prevalent and disabling disorders in the EU. Given the increasing prevalence of depression, more people are actively searching for ways to decrease their risk through lifestyle modification, but are often overwhelmed by confusing and contradictory information. The MooDFOOD prevention trial is the largest randomized clinical trial to study the effects of nutritional strategies on the prevention of major depressive disorder. Over 1000 overweight or obese participants identified as being at elevated risk for depression but who were not currently depressed, from four European countries -the Netherlands, the United Kingdom, Germany and Spain, took part in the study. Participants were randomized to either take nutritional supplements containing folic acid, vitamin D, zinc, selenium or to a pill placebo, and half of participants also received a behavioral lifestyle intervention intended to change dietary behaviors and patterns.
Author Interviews, Diabetes, Statins / 08.03.2019

MedicalResearch.com Interview with: Fariba Ahmadizar, PharmD, MSc, PhD Department of Epidemiology Erasmus University Medical Centre Rotterdam, the Netherlands MedicalResearch.com: What is the background for this study? Response: Several observational studies and trials have already reported an increased risk of incident type 2 diabetes in subjects treated with statins; however, most of them lack details, meaning that there were limited studies on the association of statin use with glycemic traits. Studies on this association underestimated type 2 diabetes incident cases due to including either questionnaire-based data, short follow-up time or lack of a direct comparison between different statin types, dosages and duration of use with respect to diabetes-related outcomes.
Author Interviews, Pediatrics / 08.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47838" align="alignleft" width="200"]Prof. Angela Morgan PhDNHMRC Practitioner Fellow and Leads the Speech and Language GroupMurdoch Children's Research Institute Prof. Morgan[/caption] Prof. Angela Morgan PhD NHMRC Practitioner Fellow and Leads the Speech and Language Group Murdoch Children's Research Institute MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Approximately 5% of school-aged children have a communication impairment that affects speech, language, or both. There are many subtypes of speech sound disorders, but the most severe is  (CAS), which impacts sequencing of speech movements. Childhood apraxia of speech  occurs in around 1 in 1000 children. In persistent cases of CAS, speech cannot easily be understood throughout life. Although CAS is rare, unravelling its neurobiological causes is likely to identify brain networks crucial to more common and less severe forms of speech disorders. Here we provide comprehensive speech and neuroimaging data on a large novel family where one parent and 11 children presented with features of childhood apraxia of speech. Brain MRI scanning revealed changes in core parts of the brain responsible for speech production. Even though CAS manifests as a problem with talking, we found disruptions in an underlying pathway of the brain normally associated with language (the meaning and grammar of what we say), rather than speech production. Our findings identify disruption of the dorsal language stream as a novel finding in developmental speech disorders. Overall, our data confirm the early role of this stream in auditory-to-articulation transformations. 
Author Interviews, Blood Pressure - Hypertension, Heart Disease, Sleep Disorders / 07.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47830" align="alignleft" width="200"]Dr Manolis S Kallistratos MD, PhD, FESC,EHSAsklepeion General HospitalGreece Dr. Kallistratos[/caption] Dr Manolis S Kallistratos MD, PhD, FESC,EHS Asklepeion General Hospital Greece  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Lifestyle changes represent the cornerstone of treatment of arterial hypertension. Alcohol and salt reduction may decrease blood pressure levels by 2 to 8 mmHg. In our study 60 minutes of midday sleep decrease 24 hours systolic blood pressure levels by up to 3 mmHg in well controlled hypertensives. That is an effect as potent as other well-established life style changes. The magnitude of blood pressure decrease might seem small, but a drop in blood pressure as small as 2 mmHg can reduce the risk of cardiovascular events by up to 10 percent. 
Author Interviews, Cost of Health Care, Kidney Disease, Medicare, Transplantation / 07.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47825" align="alignleft" width="100"]Allyson Hart MD MSDepartment of Medicine, Hennepin Healthcare,University of MinnesotaMinneapolis, Minnesota Dr. Hart[/caption] Allyson Hart MD MS Department of Medicine, Hennepin Healthcare, University of Minnesota Minneapolis, Minnesota MedicalResearch.com: What is the background for this study? What are the main findings? Response: Kidney transplantation confers profound survival, quality of life, and cost benefits over dialysis for the treatment of end-stage kidney disease. Kidney transplant recipients under 65 years of age qualify for Medicare coverage following transplantation, but coverage ends after three years for patients who are not disabled. We studied 78,861 Medicare-covered kidney transplant recipients under the age of 65, and found that failure of the transplanted kidney was 990 percent to 1630 percent higher for recipients who lost Medicare coverage before this three-year time point compared with recipients who lost Medicare on time. Those who lost coverage after 3 years had a lesser, but still very marked, increased risk of kidney failure. Recipients who lost coverage before or after the three-year time point also filled immunosuppressive medications at a significantly lower rate than those who lost coverage on time.
Alzheimer's - Dementia, Author Interviews, BMJ, Hormone Therapy / 07.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47814" align="alignleft" width="142"]Tomi Mikkola MDAssociate ProfessorHelsinki University HospitalDepartment of Obstetrics and GynecologyHelsinki, Finland Dr. Mikkola[/caption] Tomi Mikkola MD Associate Professor Helsinki University Hospital Department of Obstetrics and Gynecology Helsinki, Finland MedicalResearch.com: What is the background for this study? What are the main findings? Response: In Finland we have perhaps the most comprehensive and reliable medical registers in the world. Thus, with my research group I have conducted various large studies evaluating association of postmenopausal hormone therapy use and various major diseases (see e.g. the references in the B;MJ paper). There has been various smaller studies indicating that hormone therapy might be protective for all kinds of dementias, also Alzheimer’s disease. However, we have quite recently shown that hormone therapy seems to lower the mortality risk of vascular dementia but not Alzheimer’s disease (Mikkola TS et al. J Clin Endocrinol Metab 2017;102:870-7). Now in this upcoming BMJ-paper we report in a very large case-control study (83 688 women with Alzheimer’s disease and same number of control women without the disease) that systemic hormone therapy was associated with a 9-17% increased risk of Alzheimer’s disease. Furthermore, this risk increase is particularly in women using hormone therapy long, for more than 10 years. This was somewhat surprising finding, but it underlines the fact that mechanisms behind Alzheimer’s disease are likely quite different than in vascular dementia, where the risk factors are similar as in cardiovascular disease. We have also shown how hormone therapy protects against cardiovascular disease, particularly in women who initiate hormone therapy soon after menopause.
Author Interviews, Education, Health Care Systems, Outcomes & Safety, University of Pennsylvania / 07.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47812" align="alignleft" width="179"]Jeffrey H. Silber, MD, PhDDirector, Center for Outcomes ResearchNancy Abramson Wolfson Endowed Chair in Health Services ResearchChildren's Hospital of PhiladelphiaProfessor of Pediatrics, Anesthesiology and Critical CarePerelman School of Medicine, University of PennsylvaniaProfessor of Health Care ManagementWharton School, University of Pennsylvania Dr. Silber[/caption] Jeffrey H. Silber, MD, PhD Director, Center for Outcomes Research Nancy Abramson Wolfson Endowed Chair Health Services Research Children's Hospital of Philadelphia Professor of Pediatrics, Anesthesiology and Critical Care Perelman School of Medicine, University of Pennsylvania Professor of Health Care Management Wharton School, University of Pennsylvania  MedicalResearch.com: What is the background for this study? Response: This was a year-long randomized trial that involved 63 internal medicine residency programs from around the US.  In 2015-2016, about half of the programs were randomized to follow the existing rules about resident duty hours that included restrictions on the lengths of shifts and the rest time required between shifts (the standard arm of the trial) and the other half of the programs didn’t have those shift length or rest period rules (the flexible arm of the trial).  We measured what happened to the patients cared for in those programs (the safety study), and other studies examined how much sleep the residents received, and how alert they were at the end of shifts (the sleep study), and previously we published on the educational outcomes of the interns. To measure the impact on patient outcomes when allowing program directors the ability to use a flexible shift length for their interns, we compared patient outcomes after the flexible regimen went into place to outcomes the year before in the same program. We did the same comparison for the standard arm. Then we compared the difference between these comparisons. Comparing before and after the implementation of the trial within the same program allowed us to be more confident that a particularly strong or weak program, or a program with especially sick or healthy patients, would not throw off the results of the study. The trial was designed to determine, with 95% confidence, if the flexible arm did not do more than 1% worse than the standard arm. If this were true for the flexible arm, we could say the flexible regimen was “non-inferior” to the standard regimen.
Author Interviews, FDA, JAMA / 06.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47817" align="alignleft" width="200"]Craig Alexander Garmendia, PhDOffice of Bioresearch Monitoring Operations, Office of Regulatory AffairUS Food and Drug AdministrationMiami, Florida Dr. Garmendia[/caption] Craig Alexander Garmendia, PhD Office of Bioresearch Monitoring Operations Office of Regulatory Affairs US Food and Drug Administration Miami, Florida MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Clinical trials under the U.S. Food and Drug Administration’s (FDA) purview have been shown to suffer from falsified data. While the FDA warns researchers when falsified data are discovered, these data still make their way into medical literature. In this novel study, Dr. Garmendia and colleagues conducted a systematic review to examine the effects of publications containing falsified data on meta-analyses using sensitivity analyses. Almost half of all meta-analyses had conclusions altered by publications containing falsified data, while nearly one-third of all analyses had considerable changes in outcomes.
Author Interviews, Depression, OBGYNE, Weight Research / 05.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47752" align="alignleft" width="150"]Jun Ma, MD, PhD, FAHA, FABMRProfessor and Associate Head of Research, Department of MedicineDirector, Center for Health Behavior ResearchThe University of Illinois at Chicago Dr. Jun Ma[/caption] Jun Ma, MD, PhD, FAHA, FABMR Professor and Associate Head of Research Department of Medicine Director, Center for Health Behavior Research The University of Illinois at Chicago MedicalResearch.com: What is the background for this study? What are the main findings? Response: Obesity and depression are major public health problems. Obesity affects 40% of United States (US) adults. About 20% in US women and 13% in men experience major depressive disorder at some point in their lifetime and, additionally, many adults have elevated depressive symptoms that do not meet clinical diagnostic criteria but can nevertheless negatively affect their health and quality of life. Obesity and depression share common risk factors, such as poor diet and lack of exercise, and cause other health problems, such as diabetes and cardiovascular disease. People with obesity are at increased risk of being depressed and, likewise, people with depression are at increased risk of being obese. Consequently, obesity and depression often co-occur. To date, there has been no integrated therapy to effectively treat patients affected by both conditions at the same time. The RAINBOW randomized clinical trial addressed this gap. The main finding from the trial is that, among adult patients with obesity and depression, a collaborative care intervention integrating behavioral weight loss treatment, problem-solving therapy, and as-needed antidepressant medications significantly improve weight loss and depressive symptoms over one year compared with usual care, which patients received through their primary care physicians. 
Author Interviews, Dermatology, Pharmaceutical Companies / 05.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47805" align="alignleft" width="155"]Dr. James Q. Del Rosso, D.O., FAOCD, DermatologistResearch Director and Principal InvestigatorDel Rosso Dermatology Research Center, Las Vegas, NVGalderma Consultant Dr. Del Rosso[/caption] Dr. James Q. Del Rosso, D.O., FAOCD, Dermatologist Research Director and Principal Investigator Del Rosso Dermatology Research Center, Las Vegas, NV Galderma Consultant MedicalResearch.com: What is the background for this study? What are the main findings?
  • The ANSWER study, a 12-week, randomized, multicenter, Phase 4, Phase 3b in Canada and Europe clinical trial, is the first study of its kind to compare the efficacy and safety of combination therapy with Oracea® (doxycycline, USP) 40 mg Capsules + Soolantra® (ivermectin) Cream, 1% versus Soolantra® (ivermectin) Cream, 1% monotherapy in 273 adults with severe papulopustular rosacea (IGA 4) at clinical trial sites in the United States, Canada and Europe (Czech Republic, Poland, Hungary and Germany).
  • Results showed the combination therapy with Oracea Capsules + Soolantra Cream was well tolerated and effective with a faster onset of action than Soolantra Cream given as monotherapy. Key highlights of the study include:
  • The mean reduction in percentage of inflammatory lesions from baseline to Week 12 was significant with combination therapy compared to monotherapy (80.29% vs. 73.56%, respectively; p=0.032).
  • 5 times as many patients taking combination therapy achieved 100% clearance of inflammatory lesions by Week 12 compared with monotherapy (17.8% vs. 7.2%, respectively; p=0.006).
  • Over 2 times as many patients taking combination therapy achieved 100% clear (IGA 0) by Week 12 compared with monotherapy (11.9% vs. 5.1%, respectively; p=0.043).
  • Combination therapy was generally well tolerated and no discontinuation of treatments due to side effects.
Author Interviews, Diabetes, Exercise - Fitness, JAMA, Lifestyle & Health, Weight Research / 05.03.2019

MedicalResearch.com Interview with: Giuseppe Pugliese, MD, PhD for the Italian Diabetes and Exercise Study 2 (IDES_2) Investigators Department of Clinical and Molecular Medicine ‘‘La Sapienza’’ University Diabetes Unit, Sant’Andrea University Hospital Rome, Italy MedicalResearch.com: What is the background for this study? Response: There is a growing epidemic of obesity and type 2 diabetes worldwide, which are causally related to the increasing prevalence of “physical inactivity”, i.e., an insufficient amount of moderate-to-vigorous physical activity according to current guidelines, and “sedentariness”, i.e., too many hours, especially if uninterrupted, spent in a sitting or reclined position.  These two unhealthy behaviors exert their detrimental effects independently of each other and are very common among people suffering from type 2 diabetes, who would therefore benefit from increasing physical activity and reducing sedentary time, as recommended by current guidelines. However, such a behavior change is generally difficult for a number of internal and external barriers and requires behavioral interventions targeting both physical activity and sedentary habits.  Unfortunately, there is no definitive evidence that this is indeed feasible and, particularly, that, if adopted, change in behavior can be maintained in the long term. 
Author Interviews, Lung Cancer, Nature, Technology / 05.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47795" align="alignleft" width="200"]Saeed Hassanpour, PhDAssistant ProfessorDepartments of Biomedical Data Science,Computer Science, and EpidemiologyGeisel School of Medicine at DartmouthLebanon, NH 03756 Dr. Hassanpour[/caption] Saeed Hassanpour, PhD Assistant Professor Departments of Biomedical Data Science, Computer Science, and Epidemiology Geisel School of Medicine at Dartmouth Lebanon, NH 03756 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Lung cancer is the deadliest cancer for both men and women in the western world. The most common form, lung adenocarcinoma, requires pathologist’s visual examination of resection slides to determine grade and treatment. However, this is a hard and tedious task. Using new technologies in artificial intelligence and deep learning, we trained a deep neural network to classify lung adenocarcinoma subtypes on histopathology slides and found that it performed on par with three practicing pathologists.
Annals Internal Medicine, Author Interviews, Cancer Research, Prostate Cancer / 05.03.2019

MedicalResearch.com Interview with: Charlotte Skriver, PhD student, MSc Danish Cancer Society Research Center Statistics & Pharmacoepidemiology Danish Cancer Society Copenhagen  MedicalResearch.com: What is the background for this study?   Response: The drug aspirin is widely used due to its established protection against cardiovascular diseases. Increasing evidence also supports an effect of aspirin use on reducing the risk of and mortality from colorectal cancer and possibly other cancer types. Recent studies have suggested that aspirin use after a diagnosis of prostate cancer may improve the prognosis. We examined whether use of low-dose aspirin was associated with survival after prostate cancer in a nationwide study of prostate cancer patients in Denmark.
Author Interviews, Clots - Coagulation, Heart Disease, JAMA / 05.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47707" align="alignleft" width="144"]Geoffrey Barnes, MD, MScAssistant ProfessorVascular and Cardiovascular MedicineUniversity of Michigan Dr. Barnes[/caption] Geoffrey Barnes, MD, MSc Assistant Professor Vascular and Cardiovascular Medicine University of Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: Both aspirin and warfarin are commonly used medications meant to prevent thrombotic complications, but might increase rates of bleeding complications. We used a multi-center anticoagulation collaborative to explore how often patients being treated with warfarin were also taking aspirin but without a clear indication. We found that more than one-third (37.5%) of warfarin-treated patients without a clear reason for aspirin therapy were receiving aspirin. And these patients on both warfarin and aspirin experienced higher rates of bleeding and emergency department visits for bleeding than the patients taking warfarin alone. There were no differences in the rate of thrombotic events between the patients taking warfarin alone or those taking warfarin plus aspirin. 
Author Interviews, Dermatology, Surgical Research / 05.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47406" align="alignleft" width="130"]Hooman Khorasani, M.D. Cosmetic Surgeon & Mohs Skin Cancer Surgeon Icahn School of Medicine at Mt. Sinai Dr. Khorasani[/caption] Hooman Khorasani, M.D. Cosmetic Surgeon & Mohs Skin Cancer Surgeon Icahn School of Medicine at Mt. Sinai MedicalResearch.com: What is the background for this study? Response: Lipomas are tumors composed of mature fat cells located just beneath the skin surface. They are the most common soft tissue tumor and are estimated to occur in 1% of the population. These benign tumors are more common in overweight individuals, diabetics, patients with elevated serum cholesterol, and those suffering from familial multiple lipomatosis. Most of these tumors are treated for cosmetic reasons; however, large lipomas can also cause significant functional impairment. Traditional treatment includes surgical removal and / or liposuction. Deoxycholic acid is a member of the bile acid family that assists in the breakdown of fat. We investigated the use of deoxycholic acid injections to reduce the size of large lipomas prior to surgical removal.
AACR, Author Interviews, Biomarkers, MD Anderson / 05.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47785" align="alignleft" width="200"]Vassiliki Papadimitrakopoulou, MDProfessor of MedicineDepartment of Thoracic/Head and Neck Medical OncologyMD Anderson Cancer Center in Houston Dr. Papadimitrakopoulou[/caption] Vassiliki Papadimitrakopoulou, MD Professor of Medicine Department of Thoracic/Head and Neck Medical Oncology MD Anderson Cancer Center in Houston MedicalResearch.com: What is the background for this study? What are the main findings? Response: 30% of patients with newly diagnosed advanced NSCLC can be treated successfully with targeted therapies, often yielding higher response rates than chemotherapy or immune checkpoint inhibitors. Selecting first-line therapy for patients with NSCLC requires assessment of an expanding list of guideline-recommended genomic biomarkers (EGFR, ALK, ROS1, BRAF, RET, MET amplification and exon 14 skipping, and ERBB2, with NTRK newly added) Standard-of-care (SOC) testing relies on tissue, which is limited by biopsy-related risks, specimen insufficiency, and lab processing duration, which hamper timely optimal treatment selection -          NILE is a large, prospective, multicenter, head-to-head study of SOC tissue-based genomic testing to plasma-based comprehensive cfDNA genomic testing (Guardant360®). For the four biomarkers with FDA approved therapies, up to 34% of patients were tested by SOC tissue testing versus 95% with cfDNA testing. NILE met its primary endpoint - cfDNA performed similar to tissue in the detection of guideline-recommended biomarkers and cfDNA results were delivered significantly faster than SOC tissue testing (median 9 days vs. 15 days).Using cfDNA testing first, 87% of patients with a guideline-recommended biomarker would have been detected, compared to 67% if SOC tissue testing was first.
Author Interviews, Dermatology, Heart Disease, JAMA, Race/Ethnic Diversity / 04.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47582" align="alignleft" width="150"]Francis Alenghat, MD, PhD Assistant Professor of Medicine Section of Cardiology University of Chicago Dr. Alenghat[/caption] Francis Alenghat, MD, PhD Assistant Professor of Medicine Section of Cardiology University of Chicago MedicalResearch.com: What is the background for this study? What are the main findings? Response: Psoriasis has been associated with higher rates of atherosclerotic cardiovascular disease (ASCVD), potentially due to higher-than-normal levels of systemic inflammation. Whether this association varies by race was unknown. Also, it was unclear whether patients with psoriasis have more frequent ASCVD because of higher rates of traditional cardiovascular risk factors (smoking, diabetes, hypertension, hyperlipidemia) or because of components intrinsic to psoriasis itself. We found that, amongst a large population of patients with psoriasis, patients of both sexes and most ages had elevated ASCVD rates compared to those without psoriasis. Overall, African American patients with psoriasis had a 15% ASCVD prevalence, whereas it was 10% in white patients with psoriasis. Increased ASCVD associated with psoriasis occurred at earlier ages in African American patients compared to white patients. Traditional cardiovascular risk factors were common in patients with psoriasis and appeared to play a large role in the driving the higher rates of ASCVD in these patients, but even in patients with psoriasis but without any documented traditional risk factors, ASCVD rates were elevated compared to patients without psoriasis. 
Author Interviews, Columbia, Nutrition / 04.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47779" align="alignleft" width="200"]Sonia Y. Angell, MD MPHDivision of General MedicineDepartment of Medicine, Columbia University Irving Medical CenterNew York, NY   Dr. Angell[/caption] Sonia Y. Angell, MD MPH Division of General Medicine Department of Medicine, Columbia University Irving Medical Center New York, NY   MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Trans fatty acid in the diet increases the incidence of coronary heart disease in the population. In 2006, a policy restricting restaurant use of trans fat went into effect in NYC. This study measured the change in trans fatty acid serum concentration among a representative sample of the NYC population between 2004 and 2013-2014, and whether the change varied by frequency of restaurant food dining. Overall, blood trans fatty acid serum concentration went down by 57%. Among people who dined out less than one time a week, it went down 51% and in those who dined out 4 or more times a week, it went down 61.6%.  In fact, in 2013-2014 there was no longer a significant increase in the serum trans fatty acid concentrations among those who ate restaurant foods frequently compared with those who ate out rarely. 
Author Interviews, Brigham & Women's - Harvard, Health Care Systems, JAMA, Mental Health Research / 04.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47775" align="alignleft" width="125"]Mark S. Bauer, M.D.Professor of Psychiatry, EmeritusHarvard Medical SchoolCenter for Healthcare Organization and Implementation Research (CHOIR)VA Boston Healthcare System-152MBoston, MA 02130 Dr. Bauer[/caption] Mark S. Bauer, M.D. Professor of Psychiatry, Emeritus Harvard Medical School Center for Healthcare Organization and Implementation Research VA Boston Healthcare System-152M Boston, MA 02130 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Collaborative Chronic Care Models (CCMs) have extensive evidence for their effectiveness in a wide variety of mental health conditions.  CCMs are frameworks of care that include several or all of the following six elements:  work role redesign for anticipatory, continuous care; self-management support for individuals in treatment; provider decision support; information system support for population-based and measurement-guided care; linkage to community resources; and organization and leadership support. However, evidence for Collaborative Chronic Care Model effectiveness comes almost exclusively from highly structured clinical trials.  Little is known about whether CCMs can be implemented in general clinical practice settings, and the implementation evidence that does exist derives primarily from studies of the CCM used in primary care settings to treat depression. We conducted a randomized, stepped wedge implementation trial using implementation facilitation to establish CCMs in general mental health teams in nine US Department of Veterans Affairs medical centers. We found that establishing Collaborative Chronic Care Models was associated with reduced mental health hospitalization rates and, for individuals with complex clinical presentations, improvements in mental health status.  Additionally, standardized assessment of team clinicians indicated that facilitation improved clinician role clarity and increased focus on team goals.
AACR, Author Interviews, Colon Cancer / 04.03.2019

MedicalResearch.com Interview with: Ronit Yarden, PhD, MHSA Director of Medical Affairs Colorectal Cancer Alliance, a patient advocacy organization Washington, D.C.  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The colorectal Cancer Alliance is a patient advocacy group (the largest advocacy group for colorectal cancer) and its mission is to provide support to patients, survivors, their caregivers and family members as well as advocate on their behalf for.  The organization is also committed to raise awareness for screening and early detection of colorectal cancer to help save lives and to provide funding for innovative colorectal cancer research. As part of our support we sought to identify some of the clinical, emotional and financial experiences and unmet needs of patients under 50 years old.  We conducted an online survey that was promoted through social media and 1195 patients and survivors completed our survey. 
Author Interviews, Cognitive Issues, Education, Social Issues / 04.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47767" align="alignleft" width="128"]Marja Aartsen, PhDResearch professor at NOVA - Norwegian Social Research / OsloMetOslo Metropolitan University Dr. Aartsen[/caption] Marja Aartsen, PhD Research professor at NOVA Norwegian Social Research / OsloMet Oslo Metropolitan University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our study is part of a larger project “Life course influences on health trajectories at older age” conducted at the University of Geneva, of which dr. Stéphane Cullati is the principle investigator (see for more information on the project https://cigev.unige.ch/index.php?cID=887). The aim of that research project is to examine in what way retrospective life course precursors from childhood to late adulthood have long-term impacts on current health trajectories at older age. A number of studies in this project are now published among which our study on childhood conditions and cognitive functioning and cognitive decline in later life. In our research, we were particularly interested in the origins of cognitive decline in later life.  Studies among children show that the childhood is an important phase in the development of the brain. Growing up in environments in which people are cognitively stimulated stimulates the brain to develop more complex neuronal networks and larger brain reserves, which may compensate for the neuronal losses that occur when people get older. This effect is long visible, even at old age as a number of important studies recently provided quite solid evidence for the beneficial effect of advantaged childhood conditions on level of cognitive functioning in later life. However, not many studies investigated the relation between childhood conditions and the speed of cognitive decline in later life. Those that did found inconsistent results. We reasoned that part of the inconsistencies in study findings might stem from differences in the analytical approach (not sensitive enough), too little cognitive change because of a short follow-up, too young people, or too small sample (all causing too little power to find statistically significant effects) or differences in the measurement of the childhood conditions. To overcome these potential limitations, we used a large study sample with long follow-up, used a multidimensional measurement of childhood condition, and applied a powerful analytical technique. 
Author Interviews, Immunotherapy / 04.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47762" align="alignleft" width="200"]Edward Kim, MD MSAssistant Professor of MedicineDivision of Rheumatology, Allergy and ImmunologyDirector, UNC Allergy and Immunology ClinicUniversity of North Carolina at Chapel HillChapel Hill, NC Dr. Kim[/caption] Edwin Kim, MD MS Assistant Professor of Medicine Division of Rheumatology, Allergy and Immunology Director, UNC Allergy and Immunology Clinic University of North Carolina at Chapel Hill Chapel Hill, NC  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background is that egg allergy remains one of the most common food allergies in childhood and although most patients will outgrow the allergy, it seems that many will carry into their teen years. As a result patients still have many years of risk of anaphylaxis, poor quality of life and potential nutritional deficits. The ability to introduce some amount of egg into the diet could have profound benefit to allergy patients. The main findings are that after completing up to 4 years of egg oral immunotherapy (OIT), most patients are able to introduce at least baked egg products into the diet. The subset of patients who showed a lasting benefit by passing a food challenge 4-6 weeks after stopping the OIT, generally did even better by being able to introduce lightly cooked egg like scrambled, boiled, or fried in addition to baked egg products. This benefit to the diet seemed to last up to 5 years after stopping egg oral immunotherapy. In addition to the safety, quality of life and nutrition benefits, recent data suggesting that bringing baked egg into the diet can speed up outgrowing the allergy provides a further benefit.
Allergies, Author Interviews, Pediatrics / 04.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47726" align="alignleft" width="200"]Todd Green MD Vice President, Medical Affairs North AmericaDBV TechnologiesAssociate Professor of PediatricsUniversity of Pittsburgh School of Medicine Dr. Green[/caption] Todd Green MD  Vice President, Medical Affairs North America DBV Technologies Associate Professor of Pediatrics University of Pittsburgh School of Medicine MedicalResearch.com: What is the background for this announcement? What is Viaskin Peanut? Response: Peanut allergy is one of the most common food allergies and can cause severe, potentially life-threatening allergic reactions, including anaphylaxis. Unfortunately, there are no FDA-approved treatment options for peanut or other food allergies – leaving patients with avoidance and readiness to manage reactions to accidental exposures as their only option. Viaskin Peanut uses epicutaneous immunotherapy or EPIT, a method of delivering biologically active compounds to the immune system through the skin. Patients receive about 1/1,000th of a peanut with each daily dose of peanut protein – the equivalent of one peanut every three years – which activates the immune system with very minimal exposure. In February 2019, DBV announced that its planned resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin Peanut in the treatment of peanut-allergic children 4 to 11 years of age is anticipated in the third quarter of 2019. DBV is working diligently on its resubmission package, bringing us one step closer to providing an FDA-approved treatment for peanut-allergic children and their families. Viaskin Peanut previously received Breakthrough and Fast Track designations for the treatment of peanut-allergic children from the FDA in 2015 and 2012, respectively. 
Author Interviews, Cognitive Issues, Heart Disease, JAMA, Stroke / 04.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47709" align="alignleft" width="200"]Sarah Parish, MSc, DPhil Professor of Medical Statistics and Epidemiology MRC Population Health Research Unit Nuffield Department of Population Health University of Oxford Dr. Parish[/caption] Sarah Parish, MSc, DPhil Professor of Medical Statistics and Epidemiology MRC Population Health Research Unit Nuffield Department of Population Health University of Oxford MedicalResearch.com: What is the background for this study? Response: Acquiring reliable randomized evidence of the effects of cardiovascular interventions on cognitive decline is a priority. In this secondary analysis of 3 randomized intervention trials of cardiovascular event prevention, including 45 029 participants undergoing cognitive testing, we estimated the association of the avoidance of vascular events with differences in cognitive function in order to understand whether reports of non-significant results exclude worthwhile benefit.