Annals Internal Medicine, Author Interviews, Breast Cancer, Mammograms / 12.01.2016

MedicalResearch.com Interview with: Susan K. Boolbol, MD, FACS Chief, Division of Breast Surgery Chief, Appel-Venet Comprehensive Breast Service Co-Director, Breast Surgery Fellowship Mount Sinai Beth Israel Associate Professor of Surgery Icahn School of Medicine at Mount Sinai New York, NY 10003 Medical Research: What is the background for these new recommendations? Dr. Boolbol: To make this final recommendation, the Task Force conducted a comprehensive review of the science since its 2009 recommendation and considered the public comments it received on its 2015 draft recommendation statement. Based on all of this, the task force issued their recommendations. Medical Research: What are the main changes from current guidelines? Dr. Boolbol: Presently, there are several different guidelines and recommendations regarding screening mammography. Depending on the group issuing the guidelines, the recommendations vary from annual mammography beginning at 40 years old to biennial mammograms from 50 to 74 years old. The Task Force continues to find that the benefit of mammography increases with age, and recommends biennial screening in women ages 50 to 74. (more…)
Author Interviews, Clots - Coagulation, FDA, Heart Disease, JAMA, Johns Hopkins / 12.01.2016

MedicalResearch.com Interview with:
Victor Serebruany, MD, PhD
HeartDrug Research, Towson, Maryland
Department of Neurology Johns Hopkins University Baltimore, Maryland Medical Research: What is the background for this study? What are the main findings?

Dr. Serebruany: Missing data are common challenges to the validity of trial results, yet it is unclear how to characterize the extent of missing data.  We compared the published lost-to-follow-up rates to incomplete follow-up rates determined from subject records submitted to the FDA for major oral antithrombotic trials.  The 21 trials having both sets of rates included 270,089 patients followed for a median duration of 20 months.  The mean published lost-to-follow-up rates is 0.4% (median 0.3%, range 0.005% to 2%), consistently much lower than the FDA incomplete follow-up rates: mean 12% (median 13%, range 2% to 23%).  There is no correlation between the publication and FDA-calculated  rates (R 0.07, p = 0.76).   The FDA rates exceed greatly the endpoint rate differences: mean 1.3% (median 1,0%, range 0.2% to 3.0%). Medical Research: What should clinicians and patients take away from your report? Dr. Serebruany: That the FDA incomplete follow-up rates greatly exceed the endpoint rate differences raises questions of whether the endpoint differences may be due to differential follow-up rather than drug effect.  That they greatly exceed the measures routinely reported for trials, i.e., lost-to-follow-up rates, suggests that current trial reporting is inadequate.  Completeness of follow-up and other indicators of trial data quality should be considered when interpreting trial results. (more…)
Author Interviews, Cost of Health Care / 12.01.2016

MedicalResearch.com Interview with: Paul Barr MSc, PhD Assistant Professor of Health Policy and Clinical Practice The Dartmouth Institute for Health Policy & Clinical Practice  Medical Research: What is the background for this study? What are the main findings? Dr. Barr: I belong to the Preference Laboratory, a group of researchers in The Dartmouth Institute for Health Policy & Clinical Practice, who focus on research to improve patient engagement in their health care. One of our areas of interest is mental health, especially depression given the high and increasing prevalence of this condition in America and worldwide. Previous research has found that individuals with depression are not fully engaged in the treatment decision making process and may not be aware of their options. Decision aids are short tools that provide information on available treatment options and information about those options that is important to patients and clinicians, which can facilitate greater patient engagement through shared decision making.  To develop these tools, it is important to identify the information important to patients and clinicians when making treatment decisions. By conducting a national survey of individuals with depression and clinicians who treat depression across the US, we found that patients and clinicians felt that the effectiveness of treatment, potential side-effects and time to recovery were important to discuss. However, where patients wanted to know about about cost and insurance coverage of treatment, clinicians did not focus on these priorities. Yet when asked to take the patient’s perspective, clinicians had the same priorities as patients, including cost and insurance coverage. In addition, only 18% of patient respondents reported experiencing a high level of shared decision making on the CollaboRATE survey (www.collaboratescore.org).  (more…)
Author Interviews, Mineral Metabolism, Supplements / 12.01.2016

MedicalResearch.com Interview with: Prof. Peter Lay PhD Professor of Inorganic Chemistry School of Chemistry | Faculty of Science Director, Vibrational Spectroscopy Core Facility Research Portfolio The University of Sydney Medical Research: What is the background for this study? What are the main findings? Response: My group has been studying the molecular mechanisms of chromium(VI)-induced cancers and the biochemistry of vanadium over the last three decades. Vanadium drugs have been in clinical trials for their anti-diabetic effects that occur via species with very similar chemistry to chromium(VI).  The more we understood the biochemistry of each, the more we questioned whether the efficacies of anti-diabetic chromium(III) supplements were associated with the generation of carcinogenic chromium(VI) and chromium(V). To test this, we conducted experiments to either provide evidence for our hypothesis or disprove it.  This work commenced some 15 years ago with studies on the changes in the nature of chromium(III) supplements exposed to simulated gastrointestinal juices, as well as in human and animal blood serum over times that mimicked the residence time of the supplements in the human body. We discovered that all supplements were changed to a range of different Cr(III) species in both the GI tract and the blood.1,2  Common species were observed, but the rates at which they formed were dependent on the nature of the chromium(III) supplement.  Both the supplements themselves and the chromium(III) species that formed in blood serum were partially oxidised to Cr(VI) at concentrations of the oxidant, hydrogen peroxide (a type of bleach), found in the blood of people with type II diabetes.1,2 One of the clinical features of patients with type II diabetes is increased levels of oxidants, such as hydrogen peroxide, in their blood and cells. These oxidants are associated with many of the side-effects of type II diabetes that are associated with reduced life expectancy. These transformed chromium(III) species bound to blood proteins were more easily oxidised to chromium(VI) than the administered Cr(III) supplements.  The faster a particular chromium(III) supplement reacted with blood proteins to form these easily oxidised chromium(III)-protein species, the more active was the Cr(III) supplement in its anti-diabetic activity in animal and human studies reported by other groups.1-5  According to many health and regulatory bodies, chromium(III) has minimal or no efficacy in glucose metabolism and no other beneficial effects, such as weight loss or muscle building, in well conducted human and animal trials with non-diabetic subjects. This is consistent with our proposed mechanism of action. It is only under oxidising physiological conditions associated with type II diabetes that chromium(III) can be partially transformed to sufficient concentrations of carcinogenic chromium(VI) to enable significant biological activity.  In a large clinical trial where diabetic patients were treated with high doses of chromium(III) picolinate (one of the least efficacious supplements in animal studies), there was no efficacy in patients with controlled type II diabetes. Only those patients with uncontrolled type II diabetes exhibited improved glucose metabolism.  These patients, who have the highest concentrations of oxidants with the ability to transform chromium(III) to chromium(VI) in blood, are therefore at the greatest risk of developing Cr-induced cancers. Even where efficacy was observed, glucose metabolism was only reduced to the levels in patients with controlled type II diabetes; i.e., no patients exhibited a return to normal glucose metabolism.4,5 Coupled with all of this information our separate studies showed that chromium(VI) and chromium(V), but not chromium(III), are strong inhibitors of protein tyrosine phosphatase (PTP) enzymes.  The relevance of this is that drugs that inhibit PTPs activate circulating insulin in people with type II diabetes.  That is, it causes insulin to bind more strongly to cells involved in glucose metabolism (such as fat cells) to bring about the cascade of biochemical reactions that import glucose into cells and metabolise it.1-5 Thus we were able to link all of the animal, human and in vitro studies to show that physiological conditions under which chromium(III) had the highest probability of being transformed to chromium(VI) were also those in which chromium(III) supplements were most active.1-5 Moreover, we were able to provide a mechanism of activity that required chromium(VI) and chromium(V) to be generated for insulin enhancing activity.1-5  What remained was to establish whether we could observe Cr(VI) and Cr(V) in cells treated with chromium(III) supplements. This has now been established in our most recent study6 that have just been published. Contrary to the press releases of the dietary supplement industry, the published paper was carefully planned to mimic those conditions found in vivo.  The chromium(III) supplement chosen was that which had a chemical structure most closely resembling those generated in blood plasma. Thus we were able to complete the circle in linking our extensive studies on the biochemistry of chromium(III) species generated from chromium(III) supplements in the blood and show that such species were absorbed by the relevant cells and partially oxidised to chromium(VI) and chromium(V). (more…)
Author Interviews, JAMA, OBGYNE, Pediatrics / 11.01.2016

MedicalResearch.com Interview with: Annie Gatewood Hoen, PhD  Assistant Professor of Epidemiology and of Biomedical Data Science and Juliette Madan, MD, MS Associate Professor of Pediatrics The Geisel School of Medicine at Dartmouth Dartmouth-Hitchcock Medical Center Lebanon, NH 03756 Medical Research: What is the background for this study? What are the main findings? Response: When newborns are delivered they begin the process of acquiring vast numbers of bacteria that are critical for healthy nutrition and for immune training for a lifetime of health. Diseases such as obesity, heart disease, colitis, autism, and even cancer risk is associated with particular patterns in the gut microbiota; interestingly breast milk exposure is associated with decreased risk of many of these diseases. The intestinal microbiome plays a critical role in development, and delivery mode (cesarean section versus vaginal delivery) and feeding method (breast milk vs. formula) are important determinants of microbiome patterns.  We observed the intestinal microbiome in 6 week old infants and how it relates to delivery type and feeding. We were particularly interested in examining patterns in the microbiome in infants who received combination feeding of both breast milk and formula, an area that has been understudied. We prospectively studied 102 infants and, with gene sequencing of bacteria, identified important patterns in microbiome composition that differed greatly based upon delivery method and between feeding groups.  Babies who were combination fed (formula and breast milk) had an intestinal microbiome that was more similar to babies who were exclusively formula fed than breast fed babies. We identified individual bacteria that were differentially abundant between delivery mode and feeding groups. (more…)
Author Interviews, Cancer Research, JAMA, Transplantation / 11.01.2016

MedicalResearch.com Interview with: Sergio A. Acuna, MD Graduate Student at St. Michael's Hospital and IHPME University of Toronto Medical Research: What is the background for this study? Dr. Acuna: Solid organ transplant recipients are known to be at greater risk of developing cancers compared to the general population; however, because they are also at high increased risk of mortality from non-cancer causes, the risk of cancer morality in this population is unclear. As previous studies on this topic have reported disparate findings, the cancer mortality risk in this population remained uncertain. Medical Research: What are the main findings? Dr. Acuna: Our study provides conclusive evidence that solid organ transplant recipients are at increased risk of cancer mortality. Our findings demonstrate that solid organ transplant recipients are at increased risk of cancer death compared to the general population regardless of age, transplanted organ, and year of transplantation, and indicate cancer is a substantial cause of death in this population. (more…)
Author Interviews, Exercise - Fitness, JAMA, Orthopedics, Pain Research / 11.01.2016

Daniel Steffens, Ph.D. The George Institute for Global Health The University of SydneyMedicalResearch.com Interview with: Daniel Steffens, Ph.D. The George Institute for Global Health The University of Sydney Medical Research: What is the background for this study? Dr. Steffens: Back pain is a leading cause of disease burden globally. At present, a variety of interventions, such as getting a mattress that can help with back pain, exercise, education, back belts and shoe insoles, are commonly prescribed to prevent an episode of low back pain. Guidelines lack clear recommendations for prevention of low back pain and the effectiveness of the range of possible prevention strategies for low back pain is not clear. Our study aimed to investigate the effectiveness of these interventions for prevention of low back pain. (more…)
Author Interviews, Heart Disease, Sleep Disorders / 11.01.2016

MedicalResearch.com Interview with: Sunil Sharma MD, FAASM Associate Professor of Medicine Director, Pulmonary Sleep Medicine Associate Director, Jefferson Sleep Disorders Center Thomas Jefferson University and Hospitals Philadelphia, PA 19107 Medical Research: What is the background for this study? Dr. Sharma: Congestive heart failure (CHF) is the most common cause of hospital admission and readmissions in United States. More health care dollars are spent on CHF than any other diagnosis. A large chunk of this cost is due to hospital admission.  An estimated 50% of the CHF patients are readmitted within 6 months of discharge. The recent Protection Affordable Care Act (ACA) imposes penalties on hospitals for readmissions within first 30-days. It is therefore imperative to find ways to impact the natural history of the disease. Sleep disordered breathing is a common disorder associated with CHF. It is estimated that up to 70% of the patient with CHF may have SDB. Studies have shown that untreated SDB can worsen CHF and treatment of Sleep disordered breathing has been shown to improve heart function (ejection fraction).  (more…)
AHA Journals, Author Interviews, Frailty, Geriatrics, Heart Disease, Johns Hopkins / 10.01.2016

MedicalResearch.com Interview with: Ariel R. Green, M.D., M.P.H Assistant Professor of Medicine Johns Hopkins University School of Medicine Medical Research: What is the background for this study? What are the main findings? Response: Implantable cardioverter-defibrillators (ICDs) are widely used to prevent sudden cardiac death in patients with systolic heart failure. Older adults with heart failure often have multiple coexisting conditions and are frail, increasing their risk of death from non-cardiac causes. Our understanding of outcomes in older patients with ICDs is limited. Medical Research: What should clinicians and patients take away from your report? Response: Our major finding was that more than 10% of patients currently receiving ICDs for primary prevention of sudden cardiac death (meaning that they have never had a potentially lethal arrhythmia but are at risk for one, usually due to systolic heart failure) are frail or have dementia.​ Patients with these geriatric conditions had substantially  higher mortality within the first year after ICD implantation than those without these conditions. Frailty and dementia were more strongly associated with mortality than were traditional comorbidities such as diabetes. (more…)
Author Interviews, JAMA, Surgical Research, Weight Research / 10.01.2016

MedicalResearch.com Interview with: Dr. Sigrid Bjerge Gribsholt MD, PhD Student Department of Endocrinology and Internal Medicine, Aarhus University Hospital 8000 Aarhus C Medical Research: What is the background for this study? What are the main findings? Response: Based on our clinical experiences we became aware that surgical, medical and nutritional symptoms were common in this group of patients. To enlighten the prevalence and severity we decided to undertake the study. Our main findings include that 88% of the patients felt better or much better than before surgery and 8% felt worse. Furthermore, we found that 68% of the patients had been in contact with the health care system. (more…)
Author Interviews, Genetic Research, UT Southwestern / 09.01.2016

MedicalResearch.com Interview with: Rhonda Bassel-Duby, Ph.D. and Dr. Chengzu Long, PhD Department of Molecular Biology UT Southwestern Medical Center Dallas, TX 75390-9148 Medical Research: What is the background for this study? What are the main findings? Response: Duchenne muscular dystrophy (DMD), which was first described by Duchenne de Boulogne (1806-1875) in 1860s, is one of the most severe and common type of muscular dystrophy. DMD is caused by mutations in the gene for dystrophin (DMD) on the X chromosome and affects approximately 1 in 3500 to 5000 boys. Without dystrophin, a large cytoskeletal protein, muscles degenerate, causing myopathy. Symptoms can be visible between 1 to 6 years old. Most Duchenne muscular dystrophy patients are confined to a wheelchair by age 12. Death of DMD patients usually occurs by age 25, typically from breathing complications and cardiomyopathy. Hence, therapy for  Duchenne muscular dystrophy necessitates sustained rescue of skeletal, respiratory and cardiac muscle structure and function. Although several gene therapies have been tested, there is no curative treatment so far. Duchenne muscular dystrophy arises from a monogenic mutations in dystrophin gene. This makes DMD an ideal disease model for CRISPR-mediated gene editing therapeutics, a major breakthrough in gene engineering in the past three years. This system can remove the defect within the gene. In 2014, in a first proof of concept study, Olson’s team used CRISPR-mediated gene editing to correct the dystrophin gene mutation in the germline of DMD mouse model. In this new paper, we advanced the same technology to postnatal muscle tissues by delivery gene editing components via a harmless adeno-associated virus. Skeletal and cardiac muscle showed progressive rescue of dystrophin protein. (more…)
Author Interviews, Cost of Health Care, JAMA, Stanford, Surgical Research / 08.01.2016

MedicalResearch.com Interview with: Sam P. Most, M.D., F.A.C.S. Professor, Departments of Otolaryngology-Head & Neck Surgery and Surgery (Division of Plastic Surgery, by courtesy) Chief, Division of Facial Plastic & Reconstructive Surgery Stanford University School of Medicine Stanford, CA  Medical Research: What is the background for this study? What are the main findings? Dr. Most: Insurance companies often require patients to try a 6 or more week treatment with nasal steroids prior to allowing nasal surgery to proceed. This is true even in cases of physician-documented severe or extreme anatomic nasal obstruction that we know will not respond to medical therapy. We sought to examine this from a cost and quality-of-life perspective. We found that while the up-front cost of surgery is obviously much higher than medical therapy, when viewed from an effect on improvement of quality of life (or lack thereof, in the case of medical therapy), the surgical therapy became more cost effective as years passed by. (more…)
Alcohol, Author Interviews, Lancet, Pediatrics / 08.01.2016

MedicalResearch.com Interview with: Svetlana Popova, M.D., Ph.Ds., M.P.H. Senior Scientist Social and Epidemiological Research, Centre for Addiction and Mental Health Associate Professor, Epidemiology Division, Dalla Lana School of Public Health, University of Toronto Associate Professor, Factor-Inwentash Faculty of Social Work, University of Toronto Graduate Faculty Associate Member, Institute of Medical Science, University of Toronto MedicalResearch: What is the background for this study? Dr. Popova: It has been known for many years that prenatal alcohol exposure is associated with a number of adverse health consequences for both the mother and developing fetus. Women who consume alcohol during pregnancy place their child(ren) at risk of developing Fetal Alcohol Spectrum Disorders (FASD), and can experience a number of other adverse pregnancy outcomes including stillbirth, spontaneous abortion, premature birth, intrauterine growth retardation, and low birth weight. It was also previously known that people with FASD have many comorbidities (the simultaneous presence of two or more chronic diseases or conditions in a patient) due to the permanent damage of prenatal alcohol exposure on the fetus. However, until now it was unknown how many and what type of diseases, and at what frequencies they occur. Therefore, we reviewed the medical and epidemiological literature to identify the disease conditions that have been found to occur in people with FASD. Then based on the identified studies we estimated the pooled (combined) prevalence of the comorbid conditions found to occur among individuals with Fetal Alcohol Syndrome (FAS; the most severe and visibly identifiable form of FASD). We restricted our analysis to FAS because it is the only expression of FASD in the World Health Organization’s International Classification of Diseases, version 10 (ICD-10). (more…)
Author Interviews, Dermatology, JAMA, Melanoma, Technology / 08.01.2016

MedicalResearch.com Interview with: Marc Haspeslagh, MD Dermpat, Ardooie, Belgium Department of Dermatology University Hospital, Ghent, Belgium Medical Research: What is the background for this study? Dr. Haspeslagh: In daily practice, most pathology laboratories process skin biopsy specimens without access to the clinical and /or dermoscopic images. In pigmented skin tumors, this information can be crucial to process and diagnose the lesion correctly. With increasingly smaller diameter lesions undergoing biopsy, these focal changes are only visible with dermoscopy; therefore, communication of this dermoscopic information to the pathologist is important. In many dermatopathology laboratories, this communication is often insufficient or totally absent, and one can presume that these suspicious areas are often missed with the standard random sectioning technique that examines less than 2% of the tissue. To overcome this diagnostic limitation we developed in 2013 a new method for processing skin biopsies, were we routinely take an ex vivo dermoscopic image of most tumoral skin lesions. In combination with marking specific and suspected areas seen on the ex vivo dermoscopy (EVD) with nail varnish, EVD with derm dotting is a simple and easy method that brings this crucial information to the pathologist and in the slides to be examined (Am J Dermatopathol 2013; 35(8),867-869). (more…)
Author Interviews, Nutrition, Weight Research / 08.01.2016

MedicalResearch.com Interview with: Russell Keast Ph.D., CFS Professor Centre for Advanced Sensory Science (CASS) School of Exercise and Nutrition Sciences, Faculty of Health Deakin University Melbourne Burwood Campus Burwood, VIC 3125 Medical Research: What is the background for this study? What are the main findings? Dr. Keast: Fatty acids are detected at various stages of food consumption and digestion via interactions with nutrient receptors upon the tongue and within the gastrointestinal (GI) tract. This chemoreception initiates functional responses, i.e., taste perception, peptide secretion and alterations in GI motility that play a fundamental role in food consumption, hedonics and satiety. In obesity, both GI and taste detection of fatty acids is attenuated and this may predispose individuals to increased consumption of high-fat foods, or foods containing greater concentrations of fat.  In other word overweight and obese people are less sensitive to fat and this is associated with overconsumption of fatty foods leading to weight gain. (more…)
Author Interviews, Depression, Hormone Therapy, JAMA, Menopause / 08.01.2016

MedicalResearch.com Interview with: Eleni Petridou, MD, MPH, PhD Marios K. Georgakis, MD Department of Hygiene, Epidemiology and Medical Statistics School of Medicine National and Kapodistrian University of Athens Athens, Greece Medical Research: What is the background for this study? Response: Previous epidemiologic studies have shown that women during their reproductive life are more vulnerable (by a factor of two) to depression than men; this has been particularly evident during peaks of intense fluctuations of ovarian hormones, like the premenstrual, perimenopausal and postpartum periods. Endogenous (natural) female sex hormones, however, have been shown in various experimental studies to possess neuroprotective and anti-depressive properties. Production of these hormones is diminished after menopause; therefore, age at menopause can be used as a proxy of the lifetime exposure to endogenous hormones. Our research hypothesis was whether longer exposure to endogenous sex hormones has a cumulative anti-depressive action, i.e., whether later age at menopause decreases the risk for postmenopausal depression. (more…)
Author Interviews, Lancet, Nutrition, Sugar, Weight Research / 08.01.2016

MedicalResearch.com Interview with: Kawther Hashem MSc RNutr (Public Health) Nutritionist and Researcher Action on Sugar Wolfson Institute of Preventive Medicine, Queen Mary, University of London London UK Medical Research: What is the background for this study? What are the main findings? Response: The calculations showed that a 40% reduction in free sugars added to Sugar Sweetened Beverages (SSBs) over five years would lead to an average reduction in energy intake of 38 kcal per day by the end of the fifth year. This would lead to an average reduction in body weight of 1.20kg in adults,  resulting in a reduction in overweight and obese adults by approximately half a million and 1 million respectively. This would in turn prevent between 274,000-309,000 obesity-related type 2 diabetes over the next two decades. Policies such as this will reduce cases of overweight and obesity and type 2 diabetes, this will have a major clinical impact and reduce healthcare costs. (more…)
Author Interviews, Exercise - Fitness, Heart Disease, JAMA, Nutrition / 08.01.2016

MedicalResearch.com Interview with: Dalane W. Kitzman, M.D. Professor, Cardiology Sticht Center on Aging Gerontology and Geriatric Medicine Translational Science Institute Wake-Forest Baptist Health Winston-Salem, NC Medical Research: What is the background of the research? Dr. Kitzman: Heart Failure With Preserved Ejection Fraction (HFPEF) is a relatively recently recognized disorder.  It used to be thought that it was rare.  However, we now realize that HFPEF is the dominant form of heart failure in America.  It is also the fastest growing cardiovascular disorder.  Interestingly, this disorder occurs almost exclusively among older persons, particularly women.  The need is great because outcomes in persons with HFPEF (death, rehospitalization, health care costs) are worsening.  This stands in contrast to most other cardiovascular disorders which are on the decline and / or are experiencing greatly improved outcomes.  Remarkably, all of the large studies that have used medications in HFPEF that seemed they should be ‘sure bets’ showed no benefit for their primary outcomes.  Thus, this is also the only major cardiovascular disorder where there is no proven medication treatment.  That means physicians take ‘educated guesses’ in choosing treatment for this large group of patients. The main symptom in patients with chronic HFPEF is shortness of breath and and fatigue with exertion.  We showed in 2002 in JAMA that when we objectively measured this symptom with expired gas analysis (Peak VO2), this was as severely decreased in HFPEF as in patients with HFREF (severely reduced EF), the classic, well accepted form of heart failure.  That and other studies helped lead to acceptance of HFPEF as a true Heart Failure disorder. We first showed 5 years ago that 4 months of exercise training improves peak VO2 and quality of life in patients with HFPEF.  In fact, exercise remains the only proven means to improve these patients’ chronic symptoms. The goal of our study was to determine if weight loss diet also improved peak VO2 and quality of life in HFPEF patients, alone and in combination with exercise training.  This was based on the under-recognized fact that over 80% of Heart Failure With Preserved Ejection Fraction patients are overweight or obese.  It was already known that weight loss diet in other groups of older persons improves peak VO2 and quality of life.  And small studies of weight loss surgery in the other form of HF (HFREF) suggested that weight loss can improves symptoms, peak VO2, and quality of life.  However, there had never been a study of weight loss, by diet or other means, in HFPEF.  In fact, it had been thought, based on observational data, that weight loss diet might be contraindicated in HFPEF. So we recruited 100 overweight / obese patients age 60 years and older with this disorder from our community; 80% were women.  The exercise was standard exercise training that we’d previously shown was effective.  The meals for the weight loss diet were prepared in our metabolic kitchen by a regisered dietition.  Patients made out menus selecting preferred foods.  Well balanced, healthy, nutritious, but very palatable.  The portions were controlled so that there was a 350 caloric deficit per day deficit, on average.  Pateints made their own breakfast with guidance, unlimited of certain fruits and vegetables, and occasional “free days”, such as for holidays.  Patients loved the meals and wanted to continue after the 5 month study. (more…)
Author Interviews, Cost of Health Care, Primary Care / 07.01.2016

MedicalResearch.com Interview with: Sapna Kaul, Ph.D Huntsman Cancer Institute 2000 Circle of Hope Salt Lake City, UT 84112 Medical Research: What is the background for this study? What are the main findings? Dr. Kaul: The United States has the highest healthcare expenditures in the world, and close to one-third of these expenditures are believed to be unnecessary. One potential reason for these unnecessary expenditures is that patients may ask for medical services that are unnecessary. At the same time, primary care physicians (PCP) could find it difficult to refuse to prescribe unnecessary medical services as they may worry that it may compromise patient satisfaction. Also, there is a shortage of primary care workforce in the U.S. and PCPs may have insufficient time to effectively address patient requests. We investigated 2 types of unnecessary medical practices initiated by patient requests: (1) providing unnecessary specialty referrals, and (2) prescribing brand-name drugs when generic alternatives were available. To explore these practices, we used data on 840 U.S. PCPs from a national survey of physicians conducted in 2009. Over 50% of primary care physicians reported providing unnecessary specialty referrals and 39% prescribed brand-name drugs at patient requests. Several provider and organizational factors, such as physician specialty and solo/2-person practice, were related to reporting unnecessary practices. (more…)
Author Interviews, C. difficile, Hospital Acquired, Infections, Microbiome / 07.01.2016

MedicalResearch.com Interview with: Casey M. Theriot, Ph.D. Assistant Professor Infectious Disease College of Veterinary Medicine Department of Population Health and Pathobiology North Carolina State University Raleigh, NC 27607 Medical Research: What is the background for this study? What are the main findings? Dr. Theriot: This study is an extension of the work we did in 2014 in our Nature Communications paper (Theriot et al. Antibiotic-induced shifts in the mouse gut microbiome and metabolome increase susceptibility to Clostridium difficile infection, 2014). We really wanted to know how different antibiotics that varied in their mechanism of action altered the gut microbiota in different ways and also in turn how this altered the bile acids present in the small and large intestine of mice. Primary bile acids are made by the host and are further converted to secondary bile acids by members of the microbiota in the large intestine. We know from previous work that secondary bile acids can inhibit the growth of C. difficile, but no one has looked in depth at the bile acid makeup in the actual gut before in the context of C. difficile. In this study we show that specific antibiotics that significantly alter the large intestinal gut microbiota and deplete all secondary bile acids allow for C. difficile to grow without any inhibition. We also showed that C. difficile spores are always germinating in the small intestine, which means in order to prevent this pathogen from colonizing the gut, we will have to target the growth of the pathogen. Moving forward the focus will be on trying to repopulate the gut with bacteria that are capable of restoring the secondary bile acid pools in order to inhibit C. difficile. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, PTSD, Vanderbilt / 07.01.2016

MedicalResearch.com Interview with: Mayur Patel, MD, MPH, FACS Assistant Professor of Surgery & Neurosurgery Vanderbilt University Medical Center Staff Surgeon and Surgical Intensivist Nashville VA Medical Center Medical Research: What is the background for this study? Dr. Patel: Post-traumatic stress disorder (PTSD) can occur in patients after the traumatizing events of critical illness. Survivors of critical illness have reported PTSD symptoms months to even years after critical illness, possibly related to nightmare-like experiences, safety restraints creating communication barriers, and protective mechanical ventilation causing feelings of breathlessness and fear of imminent death. But, the epidemiology of PTSD after critical illness is unclear with wide ranging estimates (0-64%) and largely fails to distinguish past PTSD from new PTSD specifically resulting from the critical care experience. Our study provides estimates on new cases of PTSD stemming specifically from the ICU experience. Pre-existing PTSD has rarely been systematically assessed in prior cohorts, and our work took extra effort to distinguish pre-existing PTSD from new PTSD cases. Civilian populations have dominated the literature of PTSD after critical illness, and this research is the first to also include the expanding and aging Veteran population.  (more…)
Author Interviews, Blood Clots, Endocrinology, Hormone Therapy, Pharmacology / 07.01.2016

MedicalResearch.com Interview with: Ida Martinelli MD, PhD A Bianchi Bonomi Hemophilia and Thrombosis Center Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Italy  Medical Research: What is the background for this study? What are the main findings? Dr. Martinelli: Hormonal therapies are associated with an increased risk of venous thromboembolism. Patients with acute deep-vein thrombosis or pulmonary embolism require anticoagulation, but women of childbearing potential require also an adequate contraception, as oral anticoagulants cross the placenta potentially leading to embryopathy or fetal bleeding. This study was aimed to evaluate the safety of hormonal therapies together with anticoagulant therapies in terms of recurrent venous thrombosis and uterine bleeding. We demonstrated for the first time that women who take oral anticoagulants can safely use hormonal therapies, as their risk of recurrent venous thromboembolism or uterine bleeding is not increased. (more…)
Author Interviews, Gender Differences, Mental Health Research, Race/Ethnic Diversity / 07.01.2016

MedicalResearch.com Interview with: Silvia Sara Canetto, Ph.D., Professor Faculty in the Department of Psychology, and Affiliate Faculty in the Center for Women's Studies and Gender Research, Department of Ethnic Studies, and in the Human Development and Family Studies Department Colorado State University  Medical Research: What is the background for this study? Dr. Canetto: In the United States, older men of European descent (so called white men) have significantly higher suicide rates than any other demographic group. For example, their suicide rates are significantly higher than those of older men of African, Latino or Indigenous descent, as well as relative to older women across ethnicities. Behind these facts there is a cultural story, not just individual journeys of psychological pain and despair. Colorado State University’s Silvia Sara Canetto has spent a large portion of her research career seeking to uncover cultural stories of suicide. A professor in the College of Natural Sciences’ Department of Psychology, Canetto adds a new chapter to that story in an article recently published in the journal Men and Masculinities. The article features a critical review of theories and research on suicide among older men. (more…)
Author Interviews, Breast Cancer, Geriatrics, Mammograms / 07.01.2016

MedicalResearch.com Interview with: Professor Charles Hennekens MD Dr.P.H Sir Richard Doll Professor Senior Academic Advisor to the Dean Charles E. Schmidt College of Medicine Florida Atlantic University 777 Glades Road Boca Raton, FL 33431 Medical Research: What is the background for this study? What are the main findings? Prof. Hennekens: Randomized evidence indicates clear benefits of mammography in middle age and, at present, most guidelines recommend regular mammography for women up to age 74.  In collaboration with colleagues at Baylor Medical College and Meharry Medical School we were able to link the Surveillance, Epidemiology, and End Results (SEER) data to the Medicare administrative claims data.  We found that, up to 84 years, screening was more common among whites than blacks and women receiving regular annual screening mammography had lower risks of mortality from breast cancer. (more…)
Author Interviews, JAMA, Stroke / 07.01.2016

MedicalResearch.com Interview with: Michael F. Waters, MD, PhD Department of Neurology Department of Neuroscience McKnight Brain Institute University of Florida College of Medicine Gainesville, Florida Medical Research: What is the background for this study? What are the main findings? Dr. Waters: This study was based on a subgroup of medically managed patients with severe, symptomatic, intracranial, atherosclerotic disease. Historically we know that these patients have a very high rate of additional strokes, and multiple studies have attempted to determine the best management for these patients. In SAMMPRIS, we were able to prove that aggressive medical management was superior to stenting in these patients. However, certain patients in the medically managed group still had a very high rate of repeat strokes, as much as 30% of those with certain risk factors. This study was an attempt to identify those risk factors to determine which patients were at the greatest risk for another stroke. (more…)
Author Interviews, Cancer Research, Heart Disease, Pediatrics / 07.01.2016

MedicalResearch.com Interview with: Daniel A. Mulrooney, MD, MS Cancer Survivorship Jude Children's Research Hospital TN 38105-3678 Medical Research: What is the background for this study? What are the main findings?  Dr. Mulrooney:  This is a cross-sectional analysis performed in the St. Jude Lifetime Cohort Study (SJLIFE), an ongoing study designed to facilitate longitudinal evaluation of health outcomes among adults previously treated for childhood cancer.  Following patients over the life spectrum can be challenging making it difficult to understand the long-term health effects of childhood cancer therapy.  Previous studies have relied on self-report, registry, or death certificate data.  Our study is novel because we clinically evaluated cancer survivors on the St. Jude campus and identified substantial, asymptomatic cardiac disease (cardiomyopathy, coronary artery disease, valvular disease, and conduction/rhythm disorders).
  • Cardiomyopathy was present in 7.4% of survivors and newly identified by screening in 4.7%.
  • Coronary artery disease was present in 3.8% of survivors and newly identified by screening in 2.2%.
  • Valvular disease (regurgitation or stenosis) was present in 28% of survivors and newly identified by screening in 24.8%.
  • Conduction or rhythm abnormalities were present in 4.4% of survivors and newly identified by screening in 1.4%.
The prevalence of these cardiac findings might be expected in an older population but not necessarily in this young adult (median age at time of study 31 years, range: 18-60) population.    (more…)
Author Interviews, BMJ, Brigham & Women's - Harvard, OBGYNE, Pharmacology / 07.01.2016

MedicalResearch.com Interview with: Brittany M. Charlton, ScD Instructor Boston Children's Hospital and Harvard Medical School Researcher, Harvard Chan School Department of Epidemiology Boston, MA 02115   Medical Research: What is the background for this study? What are the main findings? Dr. Charlton: Even though oral contraceptives can be over 99% effective with perfect use, almost 10% of women become pregnant within their first year of use. Many more women will stop using oral contraceptives when planning a pregnancy and conceive within just a few months. In both of those examples, a woman may inadvertently expose her offspring during pregnancy to exogenous sex hormones. We conducted a nationwide cohort study in Denmark in order to investigate whether oral contraceptive use shortly before or during pregnancy was associated with an increased risk of major birth defects in the offspring. Our main finding was that there was no increased risk of having a birth defect associated with oral contraceptive exposure. These results were also consistent when we broke down the birth defects into different subgroups, like limb defects. (more…)
Author Interviews, Biomarkers, NEJM, OBGYNE / 06.01.2016

MedicalResearch.com Interview with: Stefan Verlohren, MD, PhD Consultant and Senior Lecturer Maternal-Fetal Medicine Klinik für Geburtsmedizin / Department of Obstetrics Charité Campus Mitte Berlin  Medical Research: What is the background for this study? What are the main findings? Dr. Verlohren: Preeclampsia affects 2–5% of pregnancies worldwide, and is a potentially life threatening syndrome for both mother and child. Treatment options for preeclampsia are very limited, with delivery being the only ‘cure’; however, early detection and monitoring are beneficial for improving maternal and fetal outcomes. Development of preeclampsia is very difficult to predict: its clinical presentation is variable and its signs and symptoms overlap with other conditions. There has been an unmet medical need for improved prediction of preeclampsia, i.e. predicting which women will develop preeclampsia and which will not. Women with suspected preeclampsia are often hospitalized until preeclampsia and related adverse outcomes are ruled out. Others who require hospitalization may be overlooked because their symptoms were nonspecific (e.g. headache). Preeclampsia has been linked with impaired function of the placenta. Placental development is highly dependent on blood vessel formation; before and during preeclampsia, levels of molecules involved in blood vessel inhibition or growth are altered in the maternal bloodstream. In particular, soluble fms-like tyrosine kinase-1 (sFlt-1) (a molecule that inhibits blood vessel growth) is increased and placental growth factor (PlGF) (a molecule that encourages blood vessel growth) is decreased. This study has established that the ratio of these two molecules (sFlt-1:PlGF) can be used to predict whether preeclampsia will develop or not. The sFlt-1:PlGF ratio can be calculated with a blood test (the Elecsys® sFlt-1 immunoassay and Elecsys® PlGF immunoassay). PROGNOSIS has validated the sFlt-1:PlGF ratio cutoff level of 38 for prediction of preeclampsia. For women with suspected preeclampsia, the Elecsys® immunoassay sFlt-1:PlGF ratio of 38 or below has a high negative predictive value to rule out preeclampsia or adverse fetal outcomes in the next week. A Elecsys® immunoassay sFlt-1:PlGF ratio of more than 38 indicates that preeclampsia or fetal adverse outcomes may develop in the next four weeks. In conjunction with other diagnostic and clinical information, the Elecsys® immunoassay sFlt-1:PlGF ratio can be used to guide patient management. (more…)
AHRQ, Author Interviews, Cost of Health Care / 06.01.2016

MedicalResearch.com Interview with: Asako Moriya, Ph.D. Service economist Center for Financing, Access and Cost Trends Agency for Healthcare Research and Quality (AHRQ). Rockville, Maryland  Medical Research: What is the background for this study? Dr. Moriya: While the Affordable Care Act (ACA) has increased insurance coverage and improved access to care among millions of Americans, the law’s potential impacts on the labor market are also important policy considerations. There was speculation that employers would reduce work hours to avoid the ACA employer mandate and also that ACA coverage expansion through Medicaid and the Health Insurance Marketplace would create work disincentives. We wanted to test these speculations using data from a nationally representative sample of approximately 60,000 households interviewed monthly up until June 2015. (more…)
Author Interviews, Cancer Research, Genetic Research, Personalized Medicine, Technology / 06.01.2016

MedicalResearch.com Interview with: Dr Bissan Al-Lazikani Team leader in computational biology The Institute of Cancer Research London Medical Research: What is the background for the canSAR database? What are the main uses for the tool? Dr. Al-Lazikani: Drug discovery is a difficult, time consuming and expensive venture that frequently ends in late stage drug failures - especially in oncology. As with any complex venture, decisions throughout the drug discovery pipeline can be empowered by having access to the right information at the right time. But for drug discovery this means bringing together billions of experimental data from very diverse areas of science spanning genomics, proteomics, chemistry and more. We developed canSAR to help guide our own drug discovery efforts by integrating these huge, diverse data and by analysing the data and deriving hidden links and knowledge from them. This means that we can answer questions in minutes that would have taken weeks using previously available public resources. But, more importantly, canSAR analyses and links these data in a way that allows us  to derive knowledge that was hidden before. For example, one of the main ways canSAR is used is to help select the best druggable targets for drug discovery. Using canSAR we were able to uncover many druggable cancer proteins that were previously overlooked, and we are delighted to see that several of these proteins are now the subjects of drug discovery and development projects both by us and by others. We took the decision to make canSAR publicly and freely available because we believe that cancer drug discovery is a vast challenge that requires openness and data sharing worldwide. It has been embraced by the community is being used by tens of thousands of cancer scientists worldwide, both in academia and industry, to generate hypotheses for experiments and select targets for drug discovery. (more…)