AACR, Author Interviews, HPV, University Texas, Vaccine Studies / 27.04.2015

Jacqueline Hirth, PhD, MPH Assistant Professor andMedicalResearch.com Interview with: Jacqueline Hirth, PhD, MPH Assistant Professor and Dr. Abbey B. Berenson MD, MMS, PhD Center for Interdisciplinary Research in Women's Health Obstetrics and Gynecology The University of Texas Medical Branch at Galveston TexasDr. Abbey B. Berenson MD, MMS, PhD Center for Interdisciplinary Research in Women's Health Obstetrics and Gynecology The University of Texas Medical Branch at Galveston Texas

Medical Research: What is the background for this study? What are the main findings? Response: In this sample of young women, vaccination was effective at reducing prevalence of vaccine-type HPV (6,11,16,18) compared to women who were unvaccinated. We also found a dose response, with young women who received at least 2 doses of the 3 dose vaccine series having a lower rate of vaccine-type HPV compared to those who only received one dose (8.6% compared to 16.9%, respectively). (more…)
Author Interviews, Cancer Research, Hepatitis - Liver Disease, UCSD / 27.04.2015

Lisa M. Nyberg, MD, MPH Transplant Hepatologist Director, Hepatology Research Kaiser Permanente, Garfield Specialty Center San Diego, CA 92111MedicalResearch.com Interview with: Lisa M. Nyberg, MD, MPH Transplant Hepatologist Director, Hepatology Research Kaiser Permanente, Garfield Specialty Center San Diego, CA  92111 Medical Research: What is the background for this study? What are the main findings? Dr. Nyberg: The overall cancer rates were higher in patients with Hepatitis C (HCV) vs those without HCV. Of note, though, the HCV cohort had higher rates of alcohol abuse, tobacco use, cirrhosis and diabetes mellitus (DM). However, even after stratification for the variables alcohol abuse, tobacco use, body mass index (BMI) and DM; the increased cancer rates remained significant for total cancer sites, liver cancer and NHL. Note that this study does not establish a cause and effect relationship between Hepatitis C and cancer. A strength of this study is that it is an evaluation of a large patient population (n=35,712 with HCV and 5,297,191 without HCV). Limitations of the study are those inherent in epidemiological studies using large databases. For example, confounders may not be accurately recorded in automated databases (smoking and alcohol abuse may be under-recorded). (more…)
Author Interviews, Nutrition / 27.04.2015

Esther Lopez-Garcia, PhD Dept. Preventive Medicine and Public Health School of Medicine Universidad Autónoma de Madrid Madrid,SpainMedicalResearch.com Interview with: Esther Lopez-Garcia, PhD Dept. Preventive Medicine and Public Health School of Medicine Universidad Autónoma de Madrid Madrid,Spain Medical Research: What is the background for this study? What are the main findings? Dr. Lopez-Garcia: Health-related quality of life (HRQL) is a global indicator of perceived health status, which includes physical and mental domains. Assessing the association between individual foods and HRQL is important because both the food industry and the population as a whole are interested in knowing whether general well-being could be improved by consuming specific foods. Several biological mechanisms might support an association between consumption of yogurt and better Health-related quality of life. However, to our knowledge, the effect of yogurt on HRQL has not yet been studied in epidemiological investigations in the general population. Thus, the objective of this article was to examine the prospective association between habitual yogurt consumption and the physical and mental components of HRQL among the general adult population. In this study, we found no association between yogurt consumption and the physical and mental components of HRQL after 3.5 years of follow-up of a population-based cohort. The results also held for whole-milk and reduced-fat yogurt. (more…)
Author Interviews, Breast Cancer, Genetic Research / 27.04.2015

Nasim Mavaddat M.B.B.S. MPhil PhD PhD Centre for Cancer Genetic Epidemiology Department of Public Health and Primary Care University of Cambridge, Cambridge, UKMedicalResearch.com Interview with: Nasim Mavaddat M.B.B.S. MPhil PhD PhD Centre for Cancer Genetic Epidemiology Department of Public Health and Primary Care University of Cambridge, Cambridge, UK MedicalResearch: What is the background for this study? What are the main findings? Dr. Mavaddat: Recent large-scale genome wide association analyses have led to the discovery of genetic variation- called single nucleotide polymorphisms (SNPs) associated with breast cancer risk. Individually these variants confer risks that are too small to be useful for risk prediction. But when combined as a single score, called a polygenic risk score (PRS), this score may be used to stratify women according to their risk of developing breast cancer. This stratification could guide strategies for screening and prevention. Our study was a large international collaboration involving 41 research groups from many different countries and included 33,673 breast cancer patients and 33,381 controls. We found that the genetic variants act more or less independently, and that the more risk variants a woman has the higher her risk of breast cancer. When women were ranked according to their PRS, women with scores in the top 1% had a threefold increased risk of breast cancer. This translates into an absolute risk of breast cancer of 29% by age 80. By contrast, women with the lowest 1% scores had a risk of 3.5%. The PRS was effective in stratifying women with and without a family history of breast cancer, so that highest risk was for women with a family history and a high PRS. Finally, we showed that the PRS was better at predicting the risk of ER-positive breast cancer (potentially relevant to the application of risk stratification to chemoprevention for example, with tamoxifen, raloxifene or aromatase inhibitors). There has been much debate as to whether genomic profiles are useful for individual risk prediction, especially in the context of the preventative strategies available at the present time. The estimates provided in this study will help inform these debates. (more…)
AACR, Author Interviews, Biomarkers / 27.04.2015

MedicalResearch.com Interview with: Joanna Kitlinska, PhD Assistant Professor Georgetown University Medical Center Department of Biochemistry and Molecular & Cellular Biology Washington, DC 20057 MedicalResearch: What is the background for this study? What are the main findings? Dr. Kitlinska: Neuroblastoma is a pediatric malignancy with extremely heterogeneous phenotypes, ranging from spontaneously regressing to aggressive, untreatable tumors. Consequently, treatment strategies vary significantly between patients, depending on the initial risk assessment. Given the severe late effects of anti-cancer treatment administered to infants and children, proper disease stratification is of utmost importance for neuroblastoma patients. Due to their neuronal origin, neuroblastomas secrete neuropeptide Y (NPY), a small protein normally released from mature nerves. This, in turn, may result in elevated NPY levels in blood of neuroblastoma patients. We have found that serum NPY is particularly high in patients with aggressive, metastatic disease. Consequently, patients with elevated NPY levels have significantly worse survival. This finding is in agreement with our previous data indicating crucial role for NPY in stimulation of neuroblastoma tumor growth. (more…)
Author Interviews, Cancer Research, OBGYNE / 27.04.2015

MedicalResearch.com Interview with: Joanna Kitlinska, PhD Assistant Professor Georgetown University Medical Center Department of Biochemistry and Molecular & Cellular Biology Washington, DC 20057 MedicalResearch: What is the background for this study? What are the main findings? Dr. Kitlinska: Neuroblastoma is a pediatric tumor which arises due to defects in normal fetal neuronal development. Although the disease is associated with genetic changes, there are also clinical and experimental data implicating non-genetic factors in its etiology. We hypothesized that maternal stress during pregnancy can be one such factor, as it leads to fetal hypoxia and elevated cortisol levels – the two factors known to alter normal neuronal development and increase aggressiveness of neuroblastoma. Indeed, using an animal model of neuroblastoma, we have found that offspring of mothers which have been subjected to stress during pregnancy develop tumors twice as frequently as those from intact pregnancies. Moreover, tumors developing in prenatally-stressed mice were spreading more often to distant organs. (more…)
Author Interviews, Education, Outcomes & Safety / 27.04.2015

MedicalResearch.com Interview with: Henry J. Michtalik MD, MPH, MHS Department of Medicine, Johns Hopkins University Armstrong Institute for Patient Safety and Quality Baltimore, MarylandMedicalResearch.com Interview with: Henry J. Michtalik MD, MPH, MHS Department of Medicine, Johns Hopkins University Armstrong Institute for Patient Safety and Quality Baltimore, Maryland Medical Research: What is the background for this study? What are the main findings? Dr. Michtalik: Current healthcare reform emphasizes providing high-value, evidence-based care.  Compliance with practice guidelines and best-practices remains a challenge in the ever-changing healthcare environment.  Multiple methods are typically used to enhance compliance with these guidelines, including physician education, computerized order entry systems with clinical decision support, provider feedback, and payment incentives.  These strategies are used for many conditions, including heart failure and venous thromboembolism (VTE), blood clots. The purpose of this study was to examine the impact of an individualized physician dashboard and pay-for-performance program on improving VTE prophylaxis rates amongst hospitalists.  We performed a retrospective analysis of over 3000 inpatient admissions to a hospitalist service.  We examined the impact of a web-based hospitalist dashboard which provided VTE prophylaxis feedback, both alone and in combination with a pay-for performance program which provided a small financial payment for achieving compliance rates greater than 80%. We found that compliance significantly increased from 86% during baseline to 90% during the dashboard alone phase.  Addition of the pay-for-performance program further increased compliance to 94%.  The fastest improvement occurred during the dashboard only phase.  Annual physician payments ranged from $53 to $1244, with 17 of the 19 payments under $1000. (more…)
Annals Internal Medicine, Author Interviews, Hepatitis - Liver Disease / 26.04.2015

Stefan Zeuzem, MDProfessor of Medicine Chief Department of Medicine Goethe University Hospital FrankfurtMedicalResearch.com Interview with: Stefan Zeuzem, MD Professor of Medicine Chief Department of Medicine Goethe University Hospital Frankfurt Medical Research: What is the background for this study? What are the main findings? Dr. Zeuzem: Interferon- and ribavirin-free regimens are needed to treat HCV infection. The objective of the study was to evaluate the safety and efficacy of grazoprevir (NS3/4A-protease-inhibitor) and elbasvir (NS5A-inhibitor) in previously untreated patients with chronic hepatitis C (without and with liver cirrhosis). Among 421 participants, 194 (46%) were women, 157 (37%) were non-white, 382 (91%) had genotype-1 infection, and 92 (22%) had cirrhosis. Of 316 patients receiving immediate treatment, 299/316 achieved SVR12 (undetectable HCV 12 weeks after treatment), including 144/157  with genotype-1a, 129/131  with genotype-1b, 18/18  with genotype-4, 8/10 with genotype-6, 68/70 with cirrhosis, and 231/246 without cirrhosis. Virologic failure occurred in 13 patients including 1 breakthrough and 12 relapses, and was associated with baseline NS5A-polymorphisms and emergent NS3- and/or NS5A-variants. Serious adverse events occurred in 9 (2.8%) and 3 (2.9%) patients in the active and placebo arms, respectively; none were considered drug-related. (more…)
Author Interviews, CDC, Infections, Lancet, Vaccine Studies / 25.04.2015

Mary J Hamel, M.D. Chief, Strategic and Applied Sciences Unit, And Deputy Branch Chief for Science, CDC Malaria Branch US Centers for Disease Control and Prevention 1600 Clifton Rd, NE, MS A06 Atlanta GA 30333MedicalResearch.com Interview with: Mary J Hamel, M.D. Chief, Strategic and Applied Sciences Unit, And Deputy Branch Chief for Science, CDC Malaria Branch US Centers for Disease Control and Prevention 1600 Clifton Rd, NE, MS A06 Atlanta GA 30333 Dr. Hamel was principal investigator at the Siaya site in western Kenya. Medical Research: What is the background for this study? What are the main findings? Dr. Hamel: Major progress has been made in malaria control during the past decade with the scale up of proven interventions including insecticide treated nets (ITNs), indoor residual spraying, effective diagnosis and treatment for malaria, and intermittent preventive treatment of malaria in pregnancy. Nonetheless, malaria remains a major cause of morbidity and mortality, and a leading cause of pediatric death worldwide. An estimated 198 million cases of malaria and 580,000 deaths occurred in 2013 – most of these in African children. Now we face additional challenges in malaria control – the emergence of insecticide and drug resistance threatens some of our most effective interventions. New tools are needed to reach the goal of malaria elimination and eventual eradication. Vaccines are some of our most cost-effective interventions, and an effective malaria vaccine would be an important addition to our current malaria control tools. This week, the RTS,S Clinical Trials Partnership published the final vaccine efficacy and safety results from the RTS,S/AS01 malaria vaccine phase 3 trial in the Lancet (Efficacy and safety of RTS,S/AS01 malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trial, http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)60721-8/abstract). This large randomized controlled double-blind phase 3 clinical trial was conducted in 11 sites in 7 African countries across a range of malaria transmission levels. In all, 15,460 children and young infants were enrolled in two age-categories, those first vaccinated at 5-17 months of age (referred to as children), and those first vaccinated at 6-12 weeks of age (referred to as young infants) who received the RTS,S/AS01 vaccine along with their routine childhood immunizations. Participants were randomized into 3 groups – the first group received three doses of the RTS,S/AS01 vaccine followed 18 months later by a booster dose; the second group received three doses of the RTS,S/AS01 vaccine without a booster; and the third group received a comparator vaccine. All participants received an ITN. Children were followed for an average of 48 months and infants for an average of 38 months. We found that vaccine efficacy was modest. Vaccine efficacy against clinical malaria in children was 36% with a booster and 28% without, and vaccine efficacy against severe malaria was 32% with a booster and non-significant without.   Efficacy results in young infants were lower than those in children– vaccine efficacy against clinical malaria was 36% with a booster and 28% without, and vaccine efficacy against severe malaria was non-significant. However, impact, defined as the number of cases averted per 1000 participants vaccinated, was substantial in both age-categories, and highest where malaria burden was greatest. In children who received the booster, during 4 years follow-up, 1700 cases of clinical malaria were averted per 1000 children vaccinated. In young infants, during 3 years follow-up, nearly 1000 cases were averted per 1000 young infants vaccinated. The safety findings were comparable overall in the different study arms, but two safety findings are notable. Meningitis occurred more frequently among children (but not young infants) who received RTS,S/AS01 than among those who received the comparator vaccines. There was no relationship between when the vaccine was administered and when meningitis occurred, most cases occurred in only two study sites, and the finding may be due to chance. If RTS,S/AS01 is licensed, post-licensing studies will be done to establish the significance of this finding. Both children and young infants experienced more episodes of fever and associated febrile convulsions during the 7 days following vaccination; convulsions occurred in 2.2 - 2.5/1000 vaccine doses. (more…)
Author Interviews, Heart Disease, JACC, Stroke, University of Pennsylvania / 25.04.2015

Jay Giri, MD MPH Director, Peripheral Intervention Assistant Professor of Clinical Medicine University of PennsylvaniaMedicalResearch.com Interview with Jay Giri, MD MPH Director, Peripheral Intervention Assistant Professor of Clinical Medicine University of Pennsylvania MedicalResearch: What is the background for this study? What are the main findings? Dr. Giri: Carotid artery stents are placed by vascular surgeons or interventional cardiologists to decrease the risk of long-term stroke in patients with severe atherosclerotic disease of the carotid artery.  When these procedures are performed, there is a risk of releasing small amounts of debris into the brain’s circulation, causing a stroke around the time of the procedure (peri-procedural stroke).  In order to mitigate this issue, embolic protection devices (EPD) have been developed to decrease the chances of small debris reaching the brain. Two types of EPD exist.  The first is a small filter meant to catch the debris released by placement of the carotid stent (distal filter EPD). The second is a more complex device type that leads to transient halting of blood flow to the brain in the carotid artery being stented (proximal EPD). Debris-containing blood is removed from the body prior to allowing normal blood flow to proceed back to the brain after stent placement. Our prior research has shown that nearly all (>95%) of domestic carotid stenting procedures are performed with utilization of one of these devices.  We sought to compare important clinical outcomes of stroke and death between these 2 device types within a large national sample of patients undergoing carotid stenting. Some small prior studies have investigated whether the total amount of debris reaching the brain is less with proximal embolic protection devices.  These studies have shown mixed results.  However, no prior study has investigated important clinical outcomes of stroke and death in relation to these devices. We found that overall uptake of proximal embolic protection devices utilization in America has not been robust.  Less than 7% of all domestic CAS procedures are performed with this technology.   Our analysis showed that in-hospital and 30-day stroke/death rates with proximal EPD and distal filter EPD were similar (1.6% vs. 2.0%, p = 0.56 and 2.7% vs. 4.0%, p = 0.22, respectively). (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Hand Washing, Hospital Acquired / 25.04.2015

Ojan Assadian, M.D., DTMH Professor for Skin Integrity and Infection Prevention Institute for Skin Integrity and Infection Prevention School of Human & Health Sciences University of Huddersfield Queensgate, Huddersfield UKMedicalResearch.com Interview with: Ojan Assadian, M.D., DTMH Professor for Skin Integrity and Infection Prevention Institute for Skin Integrity and Infection Prevention School of Human & Health Sciences University of Huddersfield Queensgate, Huddersfield UK MedicalResearch: What is the background for this study? What are the main findings? Prof. Assadian: Although medical gloves serve as an important mechanical barrier to prevent healthcare workers’ hands from getting contaminated with potentially pathogenic microorganisms, their inappropriate and incorrect use may support microbial transmission, eventually resulting in indirect horizontal cross-contamination of other patients. We conducted a clinical study designed to determine the efficacy of a newly developed synthetic antibacterial nitrile medical glove coated with an antiseptic, polyhexamethylen-biguanid hydrochloride (PHMB), on its external surface, and compared this antibacterial glove to an identical non-antibacterial glove in reducing surface contamination after common patient care measures in an intensive care unit. We found significantly lower numbers of bacteria on surfaces after performing typical clinical activities such as intravenous fluid handling, oral toilet, or physiotherapy, if touched with antibacterial gloves. (more…)
AACR, Author Interviews / 25.04.2015

MedicalResearch.com Interview with: Neel S. Madhukar Graduate student in the lab of Olivier Elemento, PhD, Associate Professor Head, Laboratory of Cancer Systems Biology Department of Physiology and Biophysics Institute for Computational Biomedicine Weill Cornell Medical College Medical Research: What is the background for this study? What are the main findings? Response: It takes on average 2.6 billion dollars and 10-15 years to develop a single new drug. Despite massive investment in drug discovery by pharmaceutical companies, the number of drugs obtaining FDA approval each year has remained constant over the past decade. One of biggest bottlenecks in the process of developing a new drug is to understand precisely how a drug works, that is, what it binds to in cells, how it binds, and what it does when it is bound. This process is collectively called target identification and characterization of mechanisms of action. At present, target identification is a slow and failure-prone process, driven by laborious experimentation. Every time we seek to develop a new drug, such laborious experimentation needs to be redone from scratch. We are not learning from data acquired from our past successes and failures. (more…)
AHA Journals, Author Interviews, Depression, Duke, Heart Disease, Race/Ethnic Diversity / 24.04.2015

Dr. Robert J. Mentz MD Assistant Professor of Medicine Director, Duke University Cooperative Cardiovascular Society Advanced Heart Failure and Cardiac Transplantation Duke University Medical Center Duke Clinical Research InstituteMedicalResearch.com Interview with: Dr. Robert J. Mentz MD Assistant Professor of Medicine Director, Duke University Cooperative Cardiovascular Society Advanced Heart Failure and Cardiac Transplantation Duke University Medical Center Duke Clinical Research Institute Medical Research: What is the background for this study? What are the main findings? Dr. Mentz: Previous studies have shown that depression is associated with worse outcomes in heart failure patients; however, most of these prior studies were conducted in primarily white patient populations. The impact of depressive symptoms on outcomes specifically in blacks with heart failure has not been well studied. We used data from the HF-ACTION trial of exercise training in heart failure patients, which collected data on depressive symptoms via the Beck Depression Inventory (BDI-II), to assess the association between depressive symptoms and outcomes in black patients as compared with white patients. We found that in blacks with heart failure, baseline symptoms of depression and worsening of symptoms over time were both associated with increased all-cause mortality/hospitalization. (more…)
Author Interviews, Dermatology, Genetic Research, Melanoma / 23.04.2015

Pedram Gerami, M.D.Associate Professor of Dermatology Director, Melanoma Research Northwestern Skin Cancer Institute Northwestern UniversityMedicalResearch.com Interview with: Pedram Gerami, M.D. Associate Professor of Dermatology Director, Melanoma Research Northwestern Skin Cancer Institute Northwestern University MedicalResearch: What is the basis and background for performing this study? Dr. Gerami: Most of the existing literature shows that Sentinel Lymph Node Biopsy (SLNB) will identify 25 to 35 percent of patients who will ultimately die of metastatic melanoma. Hence while SLNB is reported to be the strongest predictor of outcome for melanoma, the vast majority of patients who ultimately die of metastatic melanoma have a negative Sentinel Lymph Node Biopsy result. Hence in this study we aimed to determine whether a GEP assay developed by Castle bioscience could be used independently or in conjunction with SLNB to better detect those patients who are at high risk for developing metastatic disease and dying from melanoma. MedicalResearch: What are the findings of the study? Dr. Gerami: Our study, which examined the use of a Gene Expression Profile (GEP) assay developed by Castle Biosciences and Sentinel Lymph Node Biopsy alone and in combination in a multi-center cohort of 217 patients, demonstrated that the use of the GEP identified more than 80 percent of patients who develop melanoma Combining the two methods showed that patients predicted to be high risk based on the GEP test alone had similar rates of disease progression whether they were SLNB positive or negative. Patients who were SLNB negative and predicted to be low risk using the GEP test had lower rates of disease progression than the SLNB negative group as a whole. (more…)
AACR, Author Interviews, Cancer Research, NIH, Vaccine Studies / 22.04.2015

Daniel C. Beachler, PhD, Postdoctoral fellow Infections and Immunoepidemiology Branch of the National Cancer Institute (NCI) MedicalResearch.com Interview with: Daniel C. Beachler, PhD Postdoctoral fellow Infections and Immunoepidemiology Branch of the National Cancer Institute (NCI) Medical Research: What is the background for this study? What are the main findings? Dr. Beachler: HPV is a common sexually transmitted infection. Individuals can acquire HPV infections in the epithelium of their cervical, anal and oral sites, and occasionally these infections lead to cancer. There are three prophylactic HPV vaccines on the market that can protect against HPV at these sites among those not been previously exposed to HPV. This study examined the effect of HPV vaccination of 18-25 year old women at all three anatomic sites. The combined multi-site HPV vaccine efficacy has not been reported previously. It was unknown whether the vaccine may protect non-infected sites against HPV infection or re-infection in women exposed to HPV prior to vaccination. We observed that the HPV vaccine provides the strongest protection at all three sites among women unexposed to HPV before vaccination. Additionally, we observed some protection at the non-infected sites in women who were previously infected with HPV. (more…)
Author Interviews, CDC, Cost of Health Care, Heart Disease, JACC, Stroke / 22.04.2015

Guijing Wang, PhD Senior health economist Division for Heart Disease and Stroke Prevention Centers for Disease Control and PreventionMedicalResearch.com Interview with: Guijing Wang, PhD Senior health economist Division for Heart Disease and Stroke Prevention Centers for Disease Control and Prevention Medical Research: What is the background for this study? What are the main findings? Dr. Wang: Our study is one of the first to analyze the impact of hospital costs related to atrial fibrillation (or AFib) in a younger stroke population. To determine these findings, we examined more than 40,000 hospital admissions information involving adults between the ages of 18 and 64 with a primary diagnosis of ischemic stroke between 2010 and 2012. Although AFib is more common among those ages 65 and older, with strokes among younger adults on the rise in the U.S., we wanted to take a comprehensive look at AFib’s impact on hospital costs for these patients. AFib is associated with a 4- to 5-fold increased risk of ischemic stroke, which is the most common type of stroke. Overall, our research found that AFib substantially increased hospital costs for patients with ischemic stroke – and that was consistent across different age groups and genders of those aged 18-64. Of the 33,500 first-time stroke admissions, more than seven percent had AFib, and these admissions cost nearly $5,000 more than those without the condition. In addition, we found that both the costs of hospitalization, as well as the costs associated with AFib, were higher among younger adults (18-54) than those aged 55 to 64. (more…)
Author Interviews, Brigham & Women's - Harvard, Mental Health Research, Stroke, Toxin Research / 22.04.2015

Elissa Hope Wilker, Sc.D. Beth Israel Deaconess Medical Center Cardiovascular Epidemiology Research Harvard Medical SchoolMedicalResearch.com Interview with: Elissa Hope Wilker, Sc.D. Beth Israel Deaconess Medical Center Cardiovascular Epidemiology Research Harvard Medical School Medical Research: What is the background for this study? What are the main findings? Dr. Wilke: Long-term exposure to ambient air pollution is associated with cerebrovascular disease and cognitive impairment, but the impact on structural changes in the brain is not well understood. We studied older adults living in the greater Boston area and throughout New England and New York and we looked at the air pollution levels and how far they lived from major roads. We then linked this information to findings from MRI studies of structural brain images. Although air pollution levels in this area are fairly low compared to levels observed in other parts of the world, we found that people who lived in areas with higher levels of air pollution had smaller brain volumes, and higher risk of silent strokes. The magnitude of association that we observed for a 2 µg/m3 increase in fine particulate matter (PM2.5) (a range commonly observed across urban areas) was approximately equivalent to one year of brain aging. The association with silent strokes is of concern, because these are associated with increased risk of overt strokes, walking problems, and depression. (more…)
Author Interviews, Autism, Education, Emory, JAMA, Pediatrics / 22.04.2015

MedicalResearch.com Interview with: Lawrence Scahill, MSN, PhD and Karen Bearss, PhD Department of Pediatrics, Marcus Autism Center Children’s Healthcare of Atlanta and Emory University Atlanta, Georgia Medical Research: What is the background for this study? What are the main findings? Response: Autism spectrum disorder (ASD) affects an estimated 0.6 to 1% of children worldwide. In young children with ASD (e.g. 3 to 7 years of age) up to 50% also have disruptive behaviors such as tantrums, aggression, self-injury and noncompliance. When present, these disruptive behaviors interfere with the child’s readiness to make use of educational and other supportive services. The presence of disruptive behaviors also hinders the acquisition of routine daily living skills. Parent Training has been shown to be effective for young children with disruptive behaviors who do not have Autism spectrum disorder – but it has not be well-studied in children with ASD. The current multisite study shows that parent training is effective in reducing serious behavioral problems in young children with ASD. This is the largest randomized trial of a behavioral intervention in children with ASD.  180 children were randomly assigned to parent training or parent education. Both treatments were delivered individually to parents over 24 weeks. Serious behavioral problems were reduced by almost 50% in the parent-training group compared to about 30% for parent education. A clinician who was blind to treatment assignment rated positive response in 69% of children in the parent training group compared to 40% for parent education. In addition, 79% of children who showed a positive response to parent training at the end of the 24-week trial maintained benefit at 6 months post treatment. Parent training provided parents with specific strategies on how to manage tantrums, aggression, self-injury and noncompliance in children with autism spectrum disorder. Parent education provided up-to-date and useful information about ASD, but no instruction on how to address behavioral problems. Parents were engaged in the study treatments as evidenced by the low drop-out rate of 10% . (more…)
Author Interviews, CDC, Hepatitis - Liver Disease, Outcomes & Safety / 22.04.2015

MedicalResearch.com Interview with: Chong-Gee Teo, MD, PhD Chief, Laboratory Branch Division of Viral Hepatitis CDC Medical Research: What is the background for this study? Dr. Teo: Hepatitis C outbreaks in the course of providing healthcare continue to occur. Some happen when hepatitis C virus (HCV) is transmitted to patients following breakdowns in safe injection and infection control practices, and mishaps during surgery. Another route of provider – to patient HCV transmission is diversion, self-injection and substitution of opioids intended for anesthetic use (collectively referred to as “tampering”). A patient acquires infection when an HCV-infected provider, who is an injecting drug user, self-injects from a syringe prefilled with opioid anesthetic, fills the syringe with a volume substitute (e.g., saline or water), and then administers the adulterated preparation to the patient. The study consisted of two parts: 1) to quantify the extent that anesthetic opioid tampering contributes to hepatitis C outbreaks by analyzing healthcare-associated outbreaks occurring between 1990 and 2012 in developed countries. 2) to estimate the probabilities of provider-to-patient transmission reflecting the “real-world” setting in which a patient presents for health care, unaware of risks posed by procedures conducted by a provider who may or may not be an injecting drug user or HCV infected. (more…)
AACR, Author Interviews, Biomarkers, Cancer Research / 22.04.2015

Dr. Timothy Yap MD, PhD Timothy Yap, MD, PhD, NIHR BRC The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust London, United Kingdom.MedicalResearch.com Interview with: Timothy Yap, MD, PhD, NIHR BRC The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust London, United Kingdom. Medical Research: What is the background for this study? What are the main findings? Dr. Yap: This is a novel phase I trial assessing for the first time if the PARP inhibitor olaparib can be combined with the AKT inhibitor AZD5363. The study was undertaken at the Royal Marsden and The Institute of Cancer Research in London, England. This targeted combination was based on strong preclinical rationale demonstrating synergy between both drugs in BRCA positive tumors and also antitumor activity in non-BRCA positive tumors. Although olaparib was recently approved by the FDA for treating advanced ovarian cancer associated with defective BRCA genes, antitumor efficacy in different non-BRCA tumors is yet to be established. The key finding for this study was that it was indeed possible to combine both drugs safely, with multiple patients with different cancers responding, including patients with and without BRCA1/2 mutations. We also assessed a new intrapatient dose escalation phase I trial design in this study, and demonstrated that the novel design could be successfully implemented, with completion of the dose escalation phase in 2 schedules of the combination with just 20 patients in 7.5 months. (more…)
Author Interviews, Heart Disease, JACC, NYU, Obstructive Sleep Apnea, Sleep Disorders / 22.04.2015

Dr. Larry Chinitz MD Professor of Medicine and Director, Cardiac Electrophysiology NYU Langone Medical CenterMedicalResearch.com Interview with: Dr. Larry Chinitz MD Professor of Medicine and Director, Cardiac Electrophysiology NYU Langone Medical Center MedicalResearch: What is the background for this study? What are the main findings? Dr. Chinitz: The treatment algorithms proposed currently for maintenance of sinus rhythm in patients with atrial fibrillation focus on use of anti-arrhythmic drugs and catheter ablation. Data available to evaluate the effect of modification of known adverse clinical factors on atrial fibrillation recurrence is scant. Obstructive sleep apnea in a known factor associated with both new onset atrial fibrillation as well as its recurrence after catheter ablation. Through a meta-analysis of available data we found that use of continuous positive airway pressure in patients with sleep apnea was associated with a 42% relative risk reduction in recurrence of atrial fibrillation. This effect was similar across patient groups irrespective of whether they were medically managed or with catheter ablation. (more…)
AACR, Author Interviews, Genetic Research, Melanoma, NYU, Personalized Medicine, Wistar / 21.04.2015

Melissa Wilson, MD, PhD Assisstant Professor Perlmutter Cancer Center NYU Langone Medical Center New York, NYMedicalResearch.com Interview with: Melissa Wilson, MD, PhD Assisstant Professor Perlmutter Cancer Center NYU Langone Medical Center New York, NY Medical Research: What is the background for this study? What are the main findings? Dr. Wilson: Metastatic cutaneous melanoma is an extremely aggressive form of skin cancer.  Traditionally, it has been characterized by clinicopathologic characteristics.  More recently, melanoma tumors have also been stratified by common somatic mutations for which targeted therapies have been developed or are under investigation, including BRAF, NRAS and KIT.  In addition to somatic mutations, aberrant intracellular signaling pathways and cell cycle disruption contribute to melanoma pathogenesis.  Indeed, recent next generation sequencing studies have identified a number of new genes involved in melanomagenesis.  A comprehensive evaluation and understanding of concurrent and mutually exclusive mutations in tumors has been lacking.  Therefore, we developed a comprehensive custom targeted capture of 108 genes previously implicated in melanoma pathogenesis.  We used the targeted panel to perform massively parallel sequencing on 94 well-established human melanoma cell lines, 67 patient-derived xenografts (PDX), and 5 cell lines made from PDX, all untreated. Samples were clustered based on deleterious mutations.  Eighty-three percent of samples had deleterious mutations in the MAPK signaling pathway (including BRAF, RAS) and NF1.  Ten percent of samples had PI3K pathway mutations which were predominantly associated with BRAF mutations.  TP53 was found to be mutated in 24% of the samples and were also associated with mutations in the MAPK pathway.  Mutations in chromatin remodeling genes were mutually exclusive with each other, but were associated with BRAF and NRAS mutations.  Of particular interest, five of the 10 NF1mutated samples harbored likely deleterious mutations in MAP3K5 or MAP3K9, suggesting the potential involvement of JNK signal transduction pathway in a cohort of samples. (more…)
Author Interviews, Emergency Care / 21.04.2015

Dr Mayris P Webber Dr.PH. MPH Bureau of Health Services Fire Department of the City of New York Brooklyn, NY Professor of Clinical Epidemiology & Population Health Montefiore Medical Center NYMedicalResearch.com Interview with: Dr Mayris P Webber Dr.PH. MPH Bureau of Health Services Fire Department of the City of New York Brooklyn, NY Professor of Clinical Epidemiology & Population Health Montefiore Medical Center NY Medical Research: What is the background for this study? What are the main findings? Dr. Webber:
  • To date, we and others have found adverse health outcomes associated with World Trade Center (WTC)  exposure among New York City’s first responders such as firefighters, police officers, and other rescue and recovery workers. We conducted the first study to concentrate on the health impact of the disaster on emergency medical service (EMS) workers.
  • In keeping with previous research on WTC’s first responders, we found that the WTC attacks adversely affected the physical and mental health of approximately 2,000 New York City Fire Department (FDNY) EMS who performed rescue and recovery work at the site.
  • We analyzed selected physical and mental health conditions that have been certified as being linked to the aftermath of the WTC attacks under the James Zadroga 9/11 Health and Compensation Act of 2010.
  • Over a 12 year period, between September 11 2001 and December 31 2013, the proportion of newly diagnosed cases of gastroesophageal reflux disease (GERD) was 12.1%; obstructive airways disease (OAD) 11.8%; rhinosinusitis 10.6%; and cancer 3.1%.
  • In their most recent mental health survey, nearly 17% of EMS workers reported symptoms consistent with depression; 7% with post-traumatic stress disorder (PTSD); and 3% with harmful alcohol use.
  • Compared with EMS workers who did not work at the WTC site, EMS workers who worked at the WTC site in the morning of 9/11 (i.e., most intensely exposed) were at greatest risk for nearly all of the health conditions analyzed.
  • For example, they were almost four times as likely to have GERD and rhinosinusitis, seven times as likely to have probable PTSD, and twice as likely to have probable depression. (We use the term probable because we used screening questionnaires instead of professional diagnoses for these mental health conditions).
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Author Interviews, Hand Washing, Infections / 21.04.2015

dr-erwin-duizer.pngMedicalResearch.com Interview with: Erwin Duizer, PhD Head of section Enteric Viruses Centre for Infectious Diseases Control National Institute for Public Health and the Environment The Netherlands Medical Research: What is the background for this study? Dr. Duizer: Hand hygiene is important for interrupting the transmission chain of viruses through hands. Alcohol-based hand disinfectants are widely used in hospitals and healthcare facilities, due to convenience, rapidity, and broad acceptance by healthcare personnel. The effectiveness of alcohol-based hand disinfectant has been shown for bacteria and enveloped viruses but their effectiveness in reducing transmission of non-enveloped viruses, such as norovirus, is less certain. Therefore we tested, in a joint project of the RIVM and Wageningen University, the virucidal activity of a propanol based product and an ethanol based product in quantitative carrier tests. Additionally, the virus reducing effect of hand washing (according to health care guidelines) and the use the propanol based product was tested in a quantitative finger pad test. (more…)
Author Interviews, Cost of Health Care, Medicare, Ophthalmology / 21.04.2015

MedicalResearch.com Interview with: Dan Gong BA Yale University School of MedicineMedicalResearch.com Interview with: Dan Gong BA Yale University School of Medicine ------------ James C. Tsai, M.D., M.B.A. President - New York Eye and Ear Infirmary of Mount Sinai Delafield-Rodgers Professor and Chair Department of Ophthalmology Icahn School of Medicine at Mount Sinai Medical Research: What is the background for this study? What are the main findings?
  • Congress first introduced the Medicare Physician Fee Schedule built on the resource-based relative value scale (RBRVS) in the Omnibus Budget Reconciliation Act of 1989. Until recently, Medicare payments to physicians were adjusted annually based on the sustainable growth rate (SGR) formula.
  • When adjusting physician payments, one controversial belief by policymakers was the assumption that in response to fee reductions, physicians would recuperate one-half of lost revenue by increasing the volume and complexity of services.
  • This study questioned this assumption that this inverse relationship between Medicare payment and procedural volume is uniform across all procedures. In particular, glaucoma procedures have not been studied in the past.
  • Using a fixed effects regression model, we found that for six commonly performed glaucoma procedures, four did not have any significant Medicare payment and procedural volume relationship (laser trabeculoplasty, trabeculectomy with and without previous surgery, aqueous shunt to reservoir). Two procedures, laser iridotomy and scleral reinforcement with graft, did have significant and inverse associations between Medicare payment and procedural volume. (more…)
Author Interviews, Hearing Loss, JCEM, Mineral Metabolism / 21.04.2015

Dr. Kai-Jen Tien MD Division of Endocrinology and Metabolism, Department of Internal Medicine Chi Mei Medical Center, Tainan, TaiwanMedicalResearch.com Interview with: Dr. Kai-Jen Tien MD Division of Endocrinology and Metabolism, Department of Internal Medicine Chi Mei Medical Center, Tainan, Taiwan Medical Research: What is the background for this study? What are the main findings? Response: Previous studies investigating the relationship between osteoporosis and sudden sensorineural hearing loss were rare. Most of the studies were of small sample size, or cross-sectional designs and their results were inconclusive. Our population-based study found an approximately 1.76-fold increase in the incidence of sensorineural hearing loss for patients with osteoporosis compared with the comparison group.Patients with more severe osteoporosis may have a higher risk of SSNHL than patients with osteoporosis of milder severity. (more…)
AACR, Author Interviews, Breast Cancer, UCSD / 21.04.2015

Presented by Dr. Maura N. Dickler MD Associate member of the Breast Medicine Service at Memorial Sloan Kettering Cancer Center and Weill Medical College of Cornell University in New YorMedicalResearch.com Interview with: Presented by Dr. Maura N. Dickler MD Associate member of the Breast Medicine Service at Memorial Sloan Kettering Cancer Center and Weill Medical College of Cornell University in New York Medical Research: What is the background for this study? This year, breast cancer will claim the lives of nearly 40,000 women in the United States, and up to half of these women will have a disease that is driven by the estrogen receptor.
  • Although medicines have been approved for the treatment of hormone receptor-positive breast cancer for decades, more treatment options are needed.
  • Resistance to endocrine therapies causes morbidity and mortality for women with metastatic estrogen receptor-positive (ER+) breast cancer as many patients relapse or develop resistance to available hormonal agents via estrogen-dependent and estrogen-independent mechanisms.
  • Dual-acting investigational Selective Estrogen Receptor Degrader (SERDs) could potentially lead to a new treatment option for people with hormone receptor-positive breast cancer and may help overcome resistance to current anti-hormonal medicines.
  • GDC-0810 is a dual-acting investigational next-generation oral SERD that works in a number of ways to prevent estrogen fueling tumor growth. It is not only designed to target the estrogen receptor (ER) as an antagonist, but also to cause degradation of the ER protein. In preclinical studies, GDC-0810 was shown to induce tumor regressions in both tamoxifen sensitive and tamoxifen resistant tumor models in vivo.
Medical Research: What are the main findings?
  • Clinical data from the dose-escalation portion of a Phase I/IIa study evaluating GDC-0810 appears to have an acceptable safety profile with encouraging anti-tumor activity in postmenopausal women with advanced breast cancer positive for the estrogen receptor (ER), all of whom were previously treated with standard endocrine therapy.
  • Promising anti-tumor activity was observed in 38% of patients on study for six months or longer. At all doses tested, there was robust engagement of the estrogen receptor by GDC-0810 as demonstrated by fluoroestradiol (FES) PET scans.  Overall, the most common adverse events of any grade related to GDC-0810 were diarrhea, nausea and fatigue.
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AACR, Author Interviews, Cancer Research / 20.04.2015

Presented by Dr. Jeffrey R. Infante, MD 2015 American Association for Cancer Research Director of the Drug Development Program Sarah Cannon Research Institute in Nashville, Tennessee.MedicalResearch.com Interview with: Presented by Dr. Jeffrey R. Infante, MD 2015 American Association for Cancer Research Director of the Drug Development Program Sarah Cannon Research Institute in Nashville, Tennessee. Medical Research: What is the background for this study?
  • Inhibition of Checkpoint Kinase 1 (Chk1) may be effective at enhancing the effects of chemotherapeutic agents in tumor cells that lack other key cell cycle checkpoint regulators, such as the tumor suppressor protein p53 (p53 mutant tumors).
  • In a broad range of pre-clinical models, GDC-0425, an oral, selective Chk1 inhibitor, enhanced the efficacy of the chemotherapy drug gemcitabine. Greater efficacy was also observed in cancer cell lines lacking p53 activity.
  • Based on its proposed mechanism of action in enhancing the cytotoxicity of DNA damaging chemotherapy, GDC-0425 was evaluated in combination with a standard dose of gemcitabine.
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