Author Interviews, Emory, PTSD / 09.06.2017

MedicalResearch.com Interview with: Jennifer Stevens, PhD Director, Neuroscience of Memory, Emotion, and Stress Laboratory Instructor, Dept of Psychiatry & Behavioral Sciences Emory University School of Medicine MedicalResearch.com: What is the background for this study?  Response: Post-traumatic stress disorder (PTSD) was once thought to be a disorder of combat veterans, however, we now know that more than 60% of Americans experience a traumatic event during their lifetimes, and that this can have negative consequences for mental and physical health. Many people recover from the psychological effects of trauma without any intervention, but a significant proportion have long-lasting debilitating symptoms. Supported by the NIH, the cutting edge of PTSD research includes new strategies for preventing the disease, rather than treating PTSD after patients have been living with symptoms for months to years. In order to prevent the disease, it is critical that we are able to quickly identify people who will be at risk for the disease following a trauma, so that preventive strategies can be deployed bedside in the emergency room or in the battlefield. In the current study, we used functional MRI to predict which individuals would recover from trauma, and which individuals would have long-lasting symptoms of PTSD. (more…)
Author Interviews, JAMA, Karolinski Institute, Pharmacology, Schizophrenia / 09.06.2017

MedicalResearch.com Interview with: Jari Tiihonen, MD, PhD Professor, Department of Clinical Neuroscience Karolinska Institutet Stockholm, Sweden  MedicalResearch.com: What are the limitations of existing analyses of the comparative effectiveness of antipsychotics? Response: It has remained unclear if there are clinically meaningful differences between antipsychotic treatments in relapse prevention of schizophrenia, due to the impossibility of including large unselected patient populations in randomized controlled trials, and due to residual confounding from selection biases in observational studies. (more…)
Author Interviews, Heart Disease, JAMA, Race/Ethnic Diversity, Social Issues / 09.06.2017

MedicalResearch.com Interview with: Dr. Ayodele Odutayo MD MSc DPhil(pending) Centre For Statistics in Medicine, University of Oxford Resident Physician (PGY1), Post-Doctoral Fellow, Applied Health Research Centre St. Michael’s Hospital, University of Toronto   MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previously published studies have reported increasing gaps in life expectancy among adults belonging to different socioeconomic strata and suggested that much of this gap was mediated through behavioural and metabolic risk factors. In this study, we found that from 1999-2014, there was an increasing gap in the control of cardiovascular risk factors between high income adults compared to adults with incomes at or below the poverty line. The proportion of adults at high cardiovascular risk (predicted risk of a cardiovascular event ≥20%), the mean systolic blood pressure and the percentage of current smokers decreased for high income adults but did not change for adults with incomes at or below the poverty line. Notably, the income disparity in these cardiovascular risk factors was not wholly explained by access to health insurance or educational attainment. Trends in the percentage of adults with diabetes and the average total cholesterol level did not vary by income. (more…)
Author Interviews, Pharmacology, Pulmonary Disease, University of Michigan / 09.06.2017

MedicalResearch.com Interview with: Kevin R. Flaherty, M.D., M.S. Professor, Department of Internal Medicine Associate Director, T32 Multidisciplinary Training Program in Lung Diseases Chair, Pulmonary Fibrosis Foundation Clinical Care Network Steering Committee University of Michigan Medicine  MedicalResearch.com: What is the background for this study? What are the main findings? Response: This is a new post-hoc analysis, recently presented at the 2017 American Thoracic Society (ATS) conference, which sought to further assess the efficacy of Ofev (nintedanib), an FDA-approved drug treatment for idiopathic pulmonary fibrosis (IPF), and its effect on lung function in those with this disease. IPF is a rare and serious lung disease that causes permanent scarring of the lungs and affects as many as 132,000 Americans. The analysis examined pooled data from the two placebo-controlled, global Phase III INPULSIS trials, which evaluated the efficacy and safety of 52 weeks’ treatment with nintedanib in people with IPF. In both trials, a higher proportion of people treated with placebo than nintedanib had disease progression from baseline to week 52, as defined by the proportions of patients with ≥5% or ≥10% declines in lung function, as measured by forced vital capacity (FVC) % predicted. Additionally, a lower proportion of patients treated with placebo than nintedanib had no decline or an improvement in FVC % predicted. These data support the initial findings from the Phase III INPULSIS trials which found that more patients treated with nintedanib versus placebo had an absolute decline in FVC of less than 5%. In this subgroup analysis, we assessed the proportions of patients from the two INPULSIS trials treated with nintedanib and placebo who had no decline or an improvement in lung function from baseline to week 52 using pooled data for this post-hoc analysis. In terms of those who participated, a total of 864 patients were included (519 treated with nintedanib, 345 treated with placebo). Baseline characteristics including age, gender and FVC were similar between the subgroups of patients who had no decline or an improvement in FVC and those whose FVC declined, and between the nintedanib and placebo groups within each subgroup. (more…)
Author Interviews, Brigham & Women's - Harvard, NEJM, Ophthalmology / 08.06.2017

MedicalResearch.com Interview with: Elisabetta Patorno, MD, DrPH Assistant Professor of Medicine, Harvard Medical School Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? Response: Lithium, a widely used medicine to treat bipolar disorder, has been associated with a 400 fold increased risk of Ebstein’s anomaly, a congenital malformation of the heart, and a 5 fold increased risk of cardiac defects overall in infants when taken early in pregnancy, based on the results from the International Register of Lithium Babies in the 1970’s. Beyond this data, most of the information on the safety of lithium during pregnancy accumulated in the last 40 years is based on case reports and small studies with conflicting results. Despite these concerns and the limited information, lithium remains a first-line treatment for the 1% of women of reproductive age with bipolar disorder in the U.S. population, due to its recognized efficacy during pregnancy and the postpartum period, and due to the presence of a larger body of evidence showing increased risk of congenital malformations for other mood stabilizers, such as valproate. (more…)
Author Interviews, Infections, Merck / 08.06.2017

MedicalResearch.com Interview with: Sanjay Merchant, PhD Executive Director Center for Observational and Real-world Evidence (CORE) Merck MedicalResearch.com: What is the background for this study? What are the main findings? Response: In February, the World Health Organization (WHO) published its first ever list of antibiotic-resistant “priority pathogens” that pose the greatest threat to human health. The list highlights in particular the threat of gram-negative bacteria that are resistant to multiple antibiotics, referred to as multidrug-resistant (MDR) bacteria, which have built-in abilities to find new ways to resist treatment. MDR Pseudomonas aeruginosa (MDR PsA) is listed as one of the pathogens in the Critical category in terms of need for new therapies. It poses an urgent threat. We set out to better understand the clinical and economic burden associated with hospital-onset MDR PsA so that appropriate treatment strategies can be employed to mitigate resistance. Our findings were presented at ASM Microbe 2017. Mortality rates for hospital-onset MDR PsA patients (20.1%) were almost twice as high compared to patients who did not have MDR PsA (11.5%). The MDR PsA patient group had a significantly higher odds ratio for mortality even after controlling for various factors that may impact mortality. Hospital-onset MDR PsA patients spent six additional days in the hospital when compared to patients who did not have MDR PsA infections. These findings highlight the public health threat of MDR PsA among hospitalized patients and the need for timely and effective therapy. (more…)
Author Interviews, Microbiome, Nutrition / 07.06.2017

MedicalResearch.com Interview with: Prof. Avraham A. Levy Department of Plant and Environmental Sciences Prof. Eran Elinav Department of Immunology Prof. Eran Segal Department of Computer Science And Applied Math Weizmann Institute of Science, Rehovot Israel MedicalResearch.com: What is the background for this study?  Response: We performed a type of clinical trial that is very powerful in comparing short term effects of interventions - a crossover trial. In this trial, each subject is compared to themselves; in our case, we compared increased short-term (1 week) consumption of industrial white bread vs. matched consumption of artisanal sourdough-leavened whole-wheat bread - which we originally viewed as radical opposites in terms of their health benefits. We measured various clinical end points - weight, blood pressure, various blood tests - and also the gut microbiome. To our great surprise, we found no difference between the effects those two breads had on the various end points that we measured. This does not mean that bread consumption had no effect - but that this effect was generally similar for its two types. In fact, when we analyzed our data when pooling together the two bread types (i.e., testing whether bread of any type had an effect), we found that just one week of bread consumption resulted in statistically significant changes to multiple clinical parameters - on the one hand, we saw a reduction in essential minerals in the blood (calcium, magnesium, iron) and an increase in LDH (marker of tissue damage); on the other hand, we saw an improvement in markers of liver and kidney function, inflammation markers and cholesterol levels. In terms of the microbiome, we have found only a minimal difference between the effects of the two bread (two microbial taxa that were increased with white bread) - but in general, we saw that the microbiome was very resilient to this intervention. This is surprising as the current paradigm in the field is that a change in nutrition rapidly changes the makeup of the microbiome. We say that this is probably dependent on the kind of change - as we had a nutritional change here which was significant enough to change clinical parameters, which we tend to think of as very stable, and yet had a minimal effect on the microbiome. At this point, there were two possible explanations to what we saw: The first is that bread had an effect in our intervention, but it was very similar between those two very distinct types. The second is that these two distinct types indeed had different effects, but they were different for each subject - and thus cancel out when we look at the entire population. (more…)
Author Interviews, Biomarkers, Pediatrics, Pulmonary Disease / 07.06.2017

MedicalResearch.com Interview with: Jegen Kandasamy MD Division of Neonatology Assistant Professor/Director, Rare Disease Program and Congenital Anomalies Program University of Alabama at Birmingham Birmingham, Alabama  MedicalResearch.com: What is the background for this study? Response: Preterm infants, especially those that are born with a birth weight of 750 grams or less, are prone to a lung disease called bronchopulmonary dysplasia (BPD) because the development of lungs in these infants takes place in an environment that has more oxygen than that available in utero. Recently, pulmonary blood vessel growth and function has been hypothesized to play a causal role in the pathogenesis of BPD. Vascular endothelial cell function has been shown to affect hyperoxia-induced lung damage in animal studies. An important source of human vascular endothelial cells is the umbilical cord of newborn infants. These human umbilical venous endothelial cells (HUVEC) have been used to measure endothelial cell function in various diseases but never in diseases related to the newborn infants from whom they were derived. In addition, the mitochondria in various cells in our body respond to oxygen toxicity by creating, as well as consuming, reactive oxygen species (ROS) that mediate most of the effects of oxygen-induced damage. Therefore, we designed this study to measure mitochondrial function in vascular endothelial cells obtained from the umbilical cords of prematurely born infants at the time of their birth. We then compared these mitochondrial functional measures between infants who later died or developed BPD versus those who survived without BPD. (more…)
Author Interviews, JAMA, Pediatrics, Weight Research / 07.06.2017

MedicalResearch.com Interview with: Elsie M. Taveras, MD, MPH Ofer and Shelly Nemirovsky MGH Research Scholar Chief, Division of General Academic Pediatrics, Department of Pediatrics Mass General Hospital for Children Professor of Pediatrics, Harvard Medical School Professor in the Department of Nutrition, Harvard T.H. Chan School of Public Health Boston, MA MedicalResearch.com: What is the background for this study? Response: We designed this study to test the effectiveness of two interventions that linked clinical and community approaches in improving childhood body mass index (BMI) and obesity prevalence. Another important question we set out to understand was whether there were outcomes aside from BMI and obesity that mattered most to families of children with obesity. (more…)
Author Interviews, JAMA, Lifestyle & Health, OBGYNE, Weight Research / 07.06.2017

MedicalResearch.com Interview with:   Professor Helena Teede MBBS, FRACP, PhD Executive Director Monash Partners Academic Health Research Translation Centre Director Monash Centre for Health Research and Implementation Monash University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Reproductive aged women are gaining weight rapidly both before and during pregnancy. Here in 1.3 million pregnancies internationally we show that almost 3 in 4 have unhealthy weight gain (half with excess weight gain and one quarter with inadequate gain) MedicalResearch.com: What should readers take away from your report? Response: For women establish your healthy weight for your height and try to stay within this for better fertility, pregnancy and for your and your child's health. Regardless of your starting weigh,  aim to gain within targets in pregnancy. Seek help to do so. For health professionals: unhealthy weight gain in pregnancy is now the norm, we must monitor women in pregnancy wand support them to gain healthy weight for better health outcomes. Weighing is not enough with health professionals needing skills in healthy conversations and support strategies for women. For governments and policy makers this life stage around pregnancy is an optimal time to tackle obesity prevention and is targeted by WHO. (more…)
Author Interviews, Cost of Health Care, JAMA, Nursing, University of Pittsburgh / 06.06.2017

MedicalResearch.com Interview with: Kristin Ray, MD, MS Assistant Professor Health Policy Institute University of Pittsburgh School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: We were interested in understanding how nurse practitioners and physician assistants are working with specialist physicians to provide specialty care. Much has been described and studied about nurse practitioners and physician assistants providing primary care, but the literature about their role in specialty care is more sparse. There have been many concerns over time about the supply of specialist physicians, heightening our interest in the role of nurse practitioners and physician assistants in working with specialist physicians. We focused on examining whether care to physician specialist's patients by nurse practitioners and physician assistants has increased over time as well as examining characteristics of patients seen by nurse practitioners and physician assistants. We found that visits with NPs and PAs for specialty care have increased over time, but remains a small fraction of specialty care overall. (more…)
ASCO, Author Interviews, Colon Cancer, Exercise - Fitness, Nutrition, UCSF / 06.06.2017

MedicalResearch.com Interview with: Dr. Erin Van Blarigan, ScD Assistant Professor, Department of Epidemiology and Biostatistics UC San Francisco MedicalResearch.com: What is the background for this study? Response: There are over 1.3 million colorectal cancer survivors in the United States. Cancer survivors often seek guidance on what they can do to lower their risk of cancer recurrence and death. In response to patient interest and the need for improved survivorship care, the American Cancer Society (ACS) published guidelines on nutrition and physical activity for cancer survivors. The guidelines are to: 1) achieve and maintain a healthy body weight; 2) engage in regular physical activity; and 3) achieve a dietary pattern that is high in vegetables, fruits, and whole grains. (more…)
Author Interviews, Cost of Health Care, Emergency Care / 06.06.2017

MedicalResearch.com Interview with: Kevin Hoffman, DO Emergency medicine resident Lakeland Health in Saint Joseph, Michigan MedicalResearch.com: What is the background for this study? Response: In this study, we researched emergency department providers’ understanding of the costs of care for three routine patient presentations. Our study differed from the majority of previous studies with the use of clinical vignettes and cost determination for the entire visit. This is in contrast to previous research which focused on cost assessment of individual tests or medications. We wanted to use a study design that was more realistic and applicable to the way we work in the emergency department (ED). The hope is that with this research based on clinical scenarios that the data will be more easily translated back into potential changes and ways to improve efficiency in the ED. (more…)
Author Interviews, Neurological Disorders / 06.06.2017

MedicalResearch.com Interview with: Bernhard Ross, Ph.D. Rotman Research Institute Baycrest Centre ON, Toronto  MedicalResearch.com: What is the background for this study? What are the main findings? Response: We know from previous research that brain function for hearing is more strongly developed in musicians. The effect of a musician’s long-term training leads to a neuroplastic effect where their brain has more neurons involved in auditory processing. These neurons show stronger activity during listening to sound than in non-musicians and these findings strongly encouraged us to study neuroplasticity of the adult brain. We were interested in understanding why the neuroplastic effects of training and learning are so clearly expressed in professional musicians. The study’s main finding was that actively making sound, by playing a musical instrument, changed brain responses for listening and perception. Most importantly, neuroplastic brain changes occurred very quickly, within one hour of listening and making sound. In contrast, brain changes were observed after days in previous studies that only had participants listening to sounds. Another finding was that brain responses to hearing a sound are different when a person produces the sound themselves compared to listening to a recorded sound or a sound made by another person. This difference demonstrates that brain networks of intention, movement planning, movement execution, and expectation are involved when making a sound. We compared playing a real instrument with pressing a button for hearing a sound and found larger changes in the brain’s response to actively playing a musical instrument than pressing a button to elicit the same sound. (more…)
Author Interviews, Melatonin, Sleep Disorders / 06.06.2017

MedicalResearch.com Interview with: David C. Brodner, M.D. Founder and Principle Physician, The Center for Sinus, Allergy, and Sleep Wellness Double Board-Certified in Otolaryngology (Head and Neck Surgery) and Sleep Medicine Assistant Clinical Professor Florida Atlantic University College of Medicine Medical Director, Good Samaritan Hospital Sleep Laboratory Senior Medical Advisor, Physician’s Seal, LLC® MedicalResearch.com: What is the background for this study? Response: Chronic sleep and wakefulness disorders affect an estimated 50 to 70 million Americans, and long-term sleep deprivation has been associated with negative health consequences, including an increased risk of diabetes, hypertension, heart attack, stroke, obesity and depression. Sleep/wake cycles are regulated by melatonin, levels of which normally begin to rise in the mid- to late evening and remain high for the majority of the night. Levels begin to decline towards early morning, as the body’s wake cycle in triggered. Melatonin levels typically decline with age, with a significant decrease after age 40. And as people age, their bodies may no longer produce enough melatonin to ensure adequate sleep. In addition to difficulties falling asleep, sleep in older populations can include fragmented and sustained sleep problems. Melatonin supplementation has been shown to promote and maintain sleep in older populations. In this study, we compared the pharmacokinetics (PK) profile of REMfresh®, a continuous release and absorption melatonin (CRA-melatonin), with that of a leading immediate-release melatonin (IR-melatonin) formulation. (more…)
Author Interviews, Depression, Kidney Disease / 06.06.2017

MedicalResearch.com Interview with: Kathy Aebel-Groesch, MSW,LCSW Manager, Social Work Services DaVita Inc. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Chronic pain and depression can impact quality of life and adherence to treatment regimen among patients with end-stage renal disease (ESRD). Previous research has demonstrated that patients with ESRD experience pain and depression more frequently than the general population. From 2016, CMS has required that all eligible ESRD patients are evaluated regularly for pain and depressive symptoms. We assessed pain and depression symptom scores among patients of a large dialysis organization (LDO) over the period Mar-Oct 2016. Pain was assessed monthly by LDO nurses using the Wong-Baker pain scale (0-10). Depression screenings were conducted biannually by LDO social workers using the PHQ-2 (scale 0-6) and excluded patients with existing diagnosis of depression or bipolar disorder, cognitive impairment or language barrier, and those who were hospitalized or refused screening. A total of 688,346 pain responses from 160,626 individual patients and 223,421 depression screening responses from 158,172 patients were considered. A score of 0 (no pain) was reported for 83.5% of pain responses and 65.7% of patients had a 0 score in all pain assessments. A score of 10 (most severe pain) was reported at least once during the study period by 3.0% of patients. Patients with a pain score of 10 were more frequently female (55%) and patients on peritoneal dialysis were less likely to have a pain score of 10 than those on other modalities. A depression score of 0 (patient answered "Not at all" to both “Little interest or pleasure in doing things” and “Feeling down, depressed, or hopeless”) was reported for 69.1% of all responses and 62.6% of patients had a 0 score in all assessments; 1.8% of patients had at least one score of 6 (patient responded “Nearly every day” to both questions) and 9.7% had at least one score of 3 or more. Patients with a score of 0 were more likely to be male vs. female, HHD vs. PD or ICHD, ≥ age 70 years. The majority of ESRD patients did not report pain symptoms and, among those not excluded from screening due to an existing diagnosis of depression or other reason, the majority did not report symptoms of depression. However, routine assessment of pain and depression enables the timely identification of new or increased symptoms, thus allowing earlier implementation of interventions that may improve patient experience. The LDO has since revised its depression screening policy to remove diagnosis of depression from exclusion criteria and to administer the PHQ-9 to patients with a PHQ-2 score ≥ 3. (more…)
Accidents & Violence, Author Interviews, Cannabis / 06.06.2017

MedicalResearch.com Interview with: Mitchell L. Doucette, MS PhD Candidate The William Haddon Jr Fellowship in Injury Prevention 2017 Co-Fellow Center for Injury Research and Policy Department of Health Management and Policy Johns Hopkins Bloomberg School of Public Health Baltimore, MD 21205 MedicalResearch.com: What is the background for this study? Response: Currently in the U.S., 8 states have legalized marijuana for recreational use and an additional 28 states permit marijuana for medical use. Some states have instituted a legal driving limit for marijuana intoxication, 5 ng/mL, and for Colorado specifically, research indicates the average time from law enforcement dispatch to blood sample collection was 2.32 hours—a period of time outside the window of legal sample collection under state law and peak THC detectability. Countries with similar marijuana driving limits perform roadside oral fluid testing for establishing intoxication at point of arrest. (more…)
Alcohol, Author Interviews, Cognitive Issues / 05.06.2017

MedicalResearch.com Interview with: Dr. Anya Topiwala, BA (Hons) BMBCh (Oxon) MRCPsych DPhil Clinical lecturer Department of Psychiatry University of Oxford MedicalResearch.com: What is the background for this study? Response: I thought the question of whether moderate alcohol consumption is harmful or protective to the brain was a really interesting and important one, particularly because so many people drink this amount. There were a few studies reporting that a little alcohol may protect against dementia or cognitive decline, but the few brain imaging studies were conflicting in their results and had methodological limitations. We examined whether alcohol consumption over a 30-year period was associated with brain imaging and memory decline in a group of 550 non-alcohol dependent individuals from the remarkable Whitehall II cohort. Subjects completed questionnaires and had clinical examinations approximately every 5 years over the 30 years of the study, and had detailed brain scans at the end. (more…)
Addiction, Alcohol, Author Interviews, Pediatrics / 05.06.2017

MedicalResearch.com Interview with: Suniya S. Luthar, Ph.D. Foundation Professor of Psychology Arizona State University Professor Emerita Columbia University's Teachers College President-elect, American Psychological Association's Div.7 (Developmental) MedicalResearch.com: What is the background for this study? What are the main findings? Response: Over the last 20 years, we have found that kids in high achieving schools report higher use of drugs and alcohol than do their counterparts in national normative samples. This particular study was the first in which we followed up samples of high school students through young adulthood, to track levels of substance abuse and addiction. Our findings showed consistently elevated use of various substances across the years. Of greatest concern were diagnoses of dependence (that is, not just abuse of substances but actual addiction to them); among 26 year olds, rates of these diagnoses were two to three times those in national norms. (more…)
AHA Journals, Author Interviews, Hepatitis - Liver Disease, Stroke / 05.06.2017

MedicalResearch.com Interview with: Neal S. Parikh, M.D. Administrative Chief Resident Department of Neurology Weill Cornell Medicine & NewYork-Presbyterian Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: In contrast to the gastrointestinal and systemic hemorrhagic and thrombotic complications of cirrhosis, little was known about the risk of cerebrovascular complications. In this analysis of Medicare beneficiaries' claims data, we found cirrhosis to be associated with stroke, with associations appearing to be stronger for hemorrhagic stroke than for ischemic stroke. We controlled for demographic variables and stroke risk factors and relevant comorbidities, and our results were essentially unchanged in multiple sensitivity analyses. (more…)
Accidents & Violence, Author Interviews, Cost of Health Care / 05.06.2017

MedicalResearch.com Interview with: Tom Gaither, MD, MAS Department of Urology San Francisco, CA 94143 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Admission to the hospital because of bicycle crashes has increased over the past 15 years. We aimed to estimate the costs due to these bicycle crashes. From 1999 to 2013, the total costs due to these injuries (direct medical costs, work loss costs, and pain and suffering) were $209 billion dollars. Costs due to non-fatal injuries have increased by 137% over the study period. In 2013, the total direct and indirect costs were $24 billion dollars, which is approximately doubling the costs due to occupational injuries in the US. (more…)
Author Interviews, CMAJ, OBGYNE / 05.06.2017

MedicalResearch.com Interview with: Giulia Muraca, MPH, PhD(c) Vanier Canada Graduate Scholar School of Population and Public Health Child & Family Research Institute Faculty of Medicine University of British Columbia  MedicalResearch.com: What is the background for this study? Response: The rate of cesarean delivery has increased dramatically over the last 30 years. And in an effort to curb the rising trend in caesarean delivery, The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine have recently advocated for increased use of operative vaginal delivery (forceps/vacuum delivery) as a strategy to reduce the cesarean delivery rate. The evaluation of approaches to achieve this end are underway and the current discourse surrounding operative vaginal delivery centers on methods to promote these important skills. But, the truth is, we don’t yet fully understand the balance of risks and benefits to mothers and their babies following operative vaginal delivery compared with caesarean delivery. The preferred choice given these two options relies heavily on how far the baby’s head has descended in the birth canal. If the baby’s head has descended far enough that it is visible and on the perineum, then the use of an instrument has clear advantage. However, when the fetal head is engaged in the maternal pelvis, but has not descended so far down the birth canal, the decision between these modes of delivery becomes much less clear. These deliveries are called midpelvic deliveries. And it’s an increase in these midpelvic deliveries that would have the most potential as a strategy to reduce the cesarean delivery rate, and as a result, it is these deliveries that we were interested in studying. Operative vaginal deliveries are carried out in approximately 14% of all term births in Canada and those that occur when the baby is at midpelvic station account for over 20% of all operative vaginal deliveries. This translates to about 2-3% of all term, singleton deliveries in Canada or about 10,000 deliveries per year overall. The literature on perinatal and maternal outcomes contrasting midpelvic operative vaginal delivery and caesarean delivery is based on studies undertaken 25 to 30 years ago that are no longer reflective of the current obstetric practice.  This was the impetus for our study. We reasoned that before we decide to encourage increased OVD we should first get a sense of the safety of such procedures compared to cesarean delivery as provided by contemporary maternity care providers. (more…)
Author Interviews, Brigham & Women's - Harvard, Gender Differences, JAMA, Mental Health Research / 05.06.2017

MedicalResearch.com Interview with: Carl G Streed Jr. M.D. Pronouns: he, him, his, himself Fellow, Division General Internal Medicine & Primary Care  Brigham & Women’s Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: The National Institutes of Health (NIH) has underscored the need to better understand the health of gender minorities, including transgender and gender non-conforming individuals. Prior investigations of gender minorities are limited by the lack of national gender identity data. In 2013, the Centers for Disease Control and Prevention (CDC) developed a gender identity question for the Behavioral Risk Factors Surveillance System (BRFSS); states had the option to administer this module beginning 2014. Our study aims to examine the health status of gender minorities in the US compared to cisgender peers. Compared to cisgender adults, gender minority adults are younger, less likely to be non-Hispanic white, married or living with a partner, have a minor child in the household, or be English speaking; but are more likely to have lower income, be unemployed, be uninsured, have unmet medical care due to cost, be overweight, and report depression. Gender minority adults, compared to cisgender adults, are more likely to report: poor or fair health; difficulty concentrating, remembering, or making decisions; and being limited in any way. These outcomes remained significant after adjustment. (more…)
Author Interviews, JAMA, Salt-Sodium / 05.06.2017

MedicalResearch.com Interview with: Jennifer Poti, PhD Research Assistant Professor Nutritional Epidemiology Gillings School of Global Public Health University of North Carolina at Chapel Hill MedicalResearch.com: What is the background for this study? Response: Although strong evidence links excessive sodium intake to hypertension, a leading risk factor for cardiovascular disease, the majority of American children and adults have sodium intake that exceeds the recommended upper limit for daily sodium intake. To lower sodium intake at the population-level, the Institute of Medicine has recommended that reducing sodium in packaged foods will be essential and has emphasized the need to monitor sodium in the US food supply. However, little is known about whether sodium in packaged foods has changed during the past 15 years. (more…)
Author Interviews, Hand Washing, Infections / 05.06.2017

MedicalResearch.com Interview with: Donald Schaffner, PhD Extension Specialist in Food Science and Distinguished Professor Rutgers-New Brunswick MedicalResearch.com: What is the background for this study? Response: We been interested in handwashing and cross-contamination research for more than 15 years. About 10 years after I started as a faculty member I was approached about doing research in this area. The first paper republished has turned into my most highly cited paper. I think it was mostly a matter of being in the right place at the right time, with the right idea. This latest bit of research came out of my ongoing participation in the Conference for Food Protection. This is an unusual meeting, and unlike any other scientific conference. It’s a group of industry scientists, government regulators, and academics would get together every two years to help the FDA Center for Food Safety and Applied Nutrition update a document called the Model Food Code. The code has no regulatory standing, but it is used by state health agencies as the basis for state food codes that regulate restaurants, supermarkets, and other food service establishments. There are several provisions in the code that we wanted to try to impact with our research. The code currently states that hands must be washed in warm water. The plumbing section of the code also states that hand wash sinks must be capable of dispensing water at 100°F. We wanted to explore whether there was any scientific basis statements. In some recent survey-based research, graduate student that is also the first author on this manuscript surveyed the Internet for the kind of advice was offered on handwashing posters that provide advice on how to wash your hands. He found that the recommendations varied widely including recommendations on how long to wash your hands. (more…)
Author Interviews, Dermatology, Genetic Research, Yale / 05.06.2017

MedicalResearch.com Interview with: Keith Adam Choate, MD, PhD, FAAD Associate Professor of Dermatology, Genetics and Pathology Director of Research, Dermatology Yale University School of Medicine New Haven, CT MedicalResearch.com: What is the background for this study? What are the main findings? Response:  Over the last 10 years, we have systematically been examining patients with ichthyosis to identify new genetic causes of this group of disorders.  We found that autosomal recessive mutations in KDSR cause ichthyosis and that the resulting skin disease is effectively treated with isotretinoin. (more…)
Author Interviews, Gender Differences, Pediatrics / 05.06.2017

MedicalResearch.com Interview with: Michael S. Dunbar, PhD Associate Behavioral Scientist RAND Corporation MedicalResearch.com: What is the background for this study? Response: Sexual minority college students suffer from mental health problems like anxiety and depression at higher rates than their heterosexual peers. If they aren’t addressed, these types of issues can have serious negative effects on things like academic achievement, employment, and quality of life –among others. This study analyzed information from a survey about mental health needs and use of mental health services. The survey was completed by over 33,000 students from nine University of California campuses, nine California State University campuses and 15 California community colleges. The results were weighted to help reflect California’s college student population. (more…)
ASCO, Author Interviews, Cancer Research / 05.06.2017

MedicalResearch.com Interview with: Dr. Kelly Garneski Paulson, MD, PHD Fred Hutchinson Cancer Research Center Seattle, WA   MedicalResearch.com: What is the background for this study? What are the main findings? Response: Merkel cell carcinoma (MCC) is an aggressive skin cancer with increasing impact. Currently, there are more than 2000 new cases of MCC diagnosed each year in the US. Over one third of patients will develop metastatic disease. Most cases of Merkel cell carcinoma are caused by a virus (Merkel cell polyomavirus). In these cancers, the viral oncoproteins (cancer causing proteins) are highly expressed (exclusively on tumor tissue), immunogenic and are necessary for cancer growth.  These oncoproteins are thus ideal targets for cancer immunotherapy, making MCC a great cancer in which to study and develop immunotherapy.  Indeed, immunotherapies are effective in MCC, with observed response to checkpoint inhibitor mono therapy on the order of 35-55%, although complete responses remain rare. In our first trial, we treated four patients with metastatic Merkel cell carcinoma with endogenous T cell therapy (ex vivo expanded polyclonal T cells recognizing Merkel cell polyomavirus). One patient developed a complete response, but three patients rapidly progressed. Interestingly, we observed that the patient with the complete response had low levels of PD-1 expression on the virus specific transferred T cells. We thus hypothesized adding adding an immune checkpoint inhibitor (avelumab, anti-PD-L1) to the transferred T cells would be acceptably safe and potentially improve clinical effectiveness. (more…)
Author Interviews, Pharmacology / 05.06.2017

MedicalResearch.com Interview with: William D. Chey, M.D., F.A.C.G. Director, Division of Gastroenterology Michigan Medicine Gastroenterology Clinic Ann Arbor, Michigan MedicalResearch.com: What is the background for this study? Response: Functional Dyspepsia (FD), which is persistent or recurring upper abdominal pain, burning, or fullness with no known organic cause, is a relatively common and often frustrating condition. The precise causes of this condition are unknown, but problems with mild inflammation, leakiness of the lining of the gut, overactive sensation, and abnormal contractions of the upper digestive tract are thought to play a role in many patients. FD often reoccurs over time and it is an area of high unmet medical need. Functional Dyspepsia can have a significant impact on quality of life. Currently, off-label medications are used to treat FD, as there is no U.S. Food and Drug Administration (FDA)-approved pharmaceutical product for the condition. An estimated 62 percent of FD patients suffer from Epigastric Pain Syndrome (EPS, which is epigastric pain or burning), while an estimated 73 percent of FD patients suffer from Postprandial Distress Syndrome (PDS, which is early fullness, pressure and heaviness); 35 percent suffer from both. In this study, we compared the efficacy of a unique encapsulated formulation of caraway oil and l-Menthol, the primary component in peppermint oil), (COLM-SST) to placebo in patients taking their usual Functional Dyspepsia medications. Caraway oil contains carvone and d-limonene, which have gastroprotective and prokinetic effects; l-Menthol has anti-inflammatory, prokinetic, analgesic and gastroprotective effects. (more…)
ASCO, Author Interviews, Cancer Research, NYU / 05.06.2017

MedicalResearch.com Interview with: Prof Francisco J Esteva MD PhD Director of the breast medical oncology program at Perlmutter Cancer Center. NYU Langone Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Trastuzumab is a monoclonal antibody directed against the human epidermal growth factor receptor 2 (HER-2). Trastuzumab therapy has been shown to improve survival in patients with early-stage and metastatic her-2 positive breast cancer. In this study, we compared the safety and efficacy of the trastuzumab originator (Herceptin) to a trastuzumab biosimilar (CT-P6) in patients with stage I-III HER-2 positive breast cancer receiving neoadjuvant chemotherapy. The study was a randomized phase III trial. We found the pathological complete response rates were similar in both groups. Both antibodies were safe. Pharmacokinetic studies showed similar plasma concentrations for the trastuzumab originator and the proposed biosimilar. (more…)