Author Interviews, Dermatology, Immunotherapy / 08.03.2016

MedicalResearch.com Interview with: Dr. Andrew Blauvelt MD MPH President of Oregon Medical Research Center  MedicalResearch.com: What is the background for this study? Dr. Blauvelt: Secukinumab (brand name Cosentyx)is a monoclonal antibody directed against interleukin 17A, a key cytokine involved in psoriasis pathogenesis. Efficacy and safety of secukinumab treatment for moderate-to severe psoriasis has been previously published. There are relatively few head-to-head comparison studies between biologic therapies for psoriasis, making direct comparison of these drugs difficult. (more…)
Author Interviews, JAMA / 07.03.2016

MedicalResearch.com Interview with: Dr. Agnes Dechartres MD, PhD Centre de Recherche Epidémiologie et Statistique Paris, France MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Dechartres: In general, the availability of trial results is not optimal, with about half of the results from clinical trials, especially those with negative results, not being published in journals. To improve the availability of results, the FDA Amendment Act (FDAAA) requires results to be posted at ClinicalTrials.gov for all trials evaluating FDA-approved drugs, devices, or biologics within one year of trial completion. However, some previous methodological studies showed poor compliance with this law1-3. Rare diseases are defined by a prevalence of fewer than 200,000 people, but overall, they may affect up to 25 million people in North America. The limited number of patients affected by each rare disease makes this research particularly challenging, and the access to information on all trials conducted and their results is even more necessary. In this study, we aimed to describe the characteristics of completed phase 3 or 4 trials of rare diseases registered at ClinicalTrials.gov and assess whether their results were publicly available. We found a substantial proportion of single-group trials and trials not randomized. Many trials were also conducted in a single-center. Concerning the availability of results, 36 months after trial completion, results were posted at ClinicalTrials.gov for 35% of trials, published in journals for 47%, and publicly available (ie, posted at ClinicalTrials.gov or published in journals) for 63%. Among the trials likely subject to the FDAAA, 68% had results posted at ClinicalTrials.gov: 4% had results posted at 12 months and 57% at 36 months. We also found that 21% of studies not concerned by the FDAAA had results posted. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Hand Washing, Health Care Systems, JAMA, UCSF / 07.03.2016

MedicalResearch.com Interview with: Dr. Andrew Auerbach MD Professor of Medicine in Residence Director of Research Division of Hospital Medicine UCSF and Jeffrey L. Schnipper, MD, MPH Associate Physician, Brigham and Women's Hospital Associate Professor of Medicine, Harvard Medical School Department of Medicine Brigham and Women's Hospital     MedicalResearch.com: What is the background for this study? Response: The Affordable Care Act required the Department of Health and Human Services to establish a program to reduce what has been dubbed a “revolving door of re-hospitalizations.” Effective October 2012, 1 percent of every Medicare payment was deducted for a hospital that was determined to have excessive readmissions. This percentage has subsequently increased to up to 3 percent. Penalties apply to readmitted Medicare patients with some heart conditions, pneumonia, chronic lung disease, and hip and knee replacements. Unfortunately, few data exist to guide us in determining how many readmissions are preventable, and in those cases how they might have been prevented. MedicalResearch.com: What are the main findings? Response: Our main findings were that 27 percent of readmissions were preventable, and that the most common contributors to readmission were being discharged too soon, poor coordination between inpatient and outpatient care providers, particularly in the Emergency Departments and in arranging post acute care. (more…)
Author Interviews, Breast Cancer, FASEB / 07.03.2016

MedicalResearch.com Interview with: Michelle L. Halls BBiomedSci(Hons), PhD NHMRC Career Development Fellow Drug Discovery Biology Theme Monash Institute of Pharmaceutical Sciences Monash University Parkville Australia  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Halls: Stress causes an increase in the release of hormones including adrenaline. Previous studies have found a link between stress and metastases in triple negative breast cancer. However, what occurs inside a cancer cell in response to adrenaline to drive cancer progression was not known. We have found that adrenaline can directly act on triple negative breast cancer tumour cells via a cell surface receptor called the beta2-adrenoceptor. We identified changes in signalling within the cell that make the tumour cell highly invasive by mapping the signalling pathways that were activated in these cells in response to stress. We found that different signalling pathways converge to amplify the final signal. This ‘positive signalling loop’ was linked to the increased invasion of these cells in response to stress, and was not identified in less aggressive breast cancer cells. This may allow future research to identify new ways to intervene and slow cancer progression. New therapies are important for triple negative breast cancer, as it is particularly aggressive and currently has limited treatment options. (more…)
Author Interviews, Dengue, Lancet, OBGYNE / 07.03.2016

MedicalResearch.com Interview with: Mrs Enny S Paixão London School of Hygiene & Tropical Medicine London UK  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Dengue is a vector borne disease endemic in more than 100 countries (mainly in South America and southeast Asia) and is spreading to new areas, with outbreaks of increasing magnitude and severity. It is estimated that each year, 390 million people are infected with dengue and 96 million develop clinical symptoms. Despite of the importance of this disease, the effects of disease during pregnancy on fetal outcomes remain unclear. Using the published scientific literature, we investigated the risk of stillbirth, miscarriage, preterm birth, and low birth weight for women who had dengue infection during pregnancy. This study showed some evidence that dengue infection alone, in the absence of clinical symptoms, does not affect the outcome of pregnancy, but also that clinical dengue during pregnancy seems to increase the frequency of stillbirth, prematurity, and low birthweight. (more…)
Author Interviews, Lancet, Neurological Disorders, Pain Research / 07.03.2016

MedicalResearch.com Interview with: Nadine Attal, MD PhD Professeur associée de l'UVSQ INSERM U 987 et CETD CHU Ambroise Paré 92100 Boulogne-Billancourt MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Attal: The background for this study is based on the findings of experimental studies in animals and healthy subjects indicating that botulinum toxin type A  (BTX-A) may have analgesic activity independent of its effect on muscle tone. BTX-A has been reported to have analgesic effects against peripheral neuropathic pain in prior trials, but the quality of the evidence was generally low, as it was derived mostly from small pilot studies and no study has evaluated the relevance of repeated administrations for the treatment of NP. Furthermore, the clinical profiles of the patients responding to BTX-A have not been fully characterized. MedicalResearch.com: What should clinicians and patients take away from your report? Dr. Attal: They should take away that two repeated subcutaneous administrations of botulinum toxin type A are effective in peripheral  neuropathic pain but mostly in patients with allodynia and/or limited thermal deficits. BTX-A also appears to be particularly effective on paroxysmal pain (ie electric shock like pain). Finally, the efficacy of a second administration of BTX-A is enhanced over the first injection. (more…)
Author Interviews, Biomarkers, Cleveland Clinic, Genetic Research, Personalized Medicine, Prostate, Prostate Cancer, Urology / 07.03.2016

MedicalResearch.com Interview with: Eric A. Klein, MD Chairman, Glickman Urological and Kidney Institute Cleveland Clinic MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Klein: Prostate cancer is an enigma. While this tumor is the second leading cause of cancer death among American men, most newly diagnosed disease detected by PSA screening is biologically indolent and does not require immediate therapy. Currently, the main clinical challenge in these men is to distinguish between those who can be managed by active surveillance from those who require curative intervention. Current clinical and pathological tools used for risk stratification are limited in accuracy for distinguishing between these scenarios. An abundance of research in the last decade has provided evidence that genomics can offer meaningful and clinically actionable biological information to help inform decision making, and current National Comprehensive Cancer Network (NCCN) guidelines on prostate cancer endorse the use of commercially available genomic tools for men considering active surveillance.[1] It has been previously shown that the 22-gene genomic classifier, Decipher, accurately predicts the likelihood of metastasis and prostate cancer specific mortality when measured on tissue from radical prostatectomy specimens.[2] In multiple validation studies, it performed with higher accuracy and discrimination compared to clinical risk factors alone. The current study[3] is the first to examine whether the use of Decipher might aid decision making when measured on biopsy tissue at the time of diagnosis. Men with available needle biopsy samples were identified from a study cohort that previously had Decipher performed on their matched radical prostatectomy tissue. In this cohort of mixed low, intermediate and high risk men, Biopsy Decipher predicted the risk of metastasis 10 years post RP with high accuracy, outperforming NCCN clinical risk categorization, biopsy Gleason score and pre-operative PSA. Furthermore, this study showed that Decipher reclassified 46% of patients into lower or higher risk classification compared to NCCN classification alone. The study also showed that Biopsy Decipher can identify men that are at high risk for adverse pathology as defined by the presence of primary Gleason pattern 4 or greater. (more…)
Author Interviews, Chemotherapy, Pancreatic, Vanderbilt / 07.03.2016

MedicalResearch.com Interview with: Alexander A. Parikh, M.D., M.P.H. Associate Professor of Surgery Director of Hepatobiliary, Pancreatic and GI Surgical Oncology Director, Vanderbilt Pancreas Center Vanderbilt University Medical Center Nashville, TN MedicalResearch.com: What is the background for this study? Dr. Parikh: Although adjuvant chemotherapy has been proven to increase survival after successful resection of pancreatic cancer and has become the standard of care worldwide, the use of adjuvant chemoradiation is more controversial. The vast majority of randomized trials have failed to show a significant improvement in survival with the use of chemoradiation after pancreatic cancer resection. Furthermore, our own report from the multi-institutional Central Pancreatic Consortium (CPC) published several years ago failed to show a benefit in the use of chemoradiation except in high-risk groups such as lymph node positive disease. The purpose of the current study was to investigate the patterns of recurrence with the use of adjuvant chemotherapy or chemoradiation in hopes of explaining some of these differences. It was our hypothesis that systemic chemotherapy would prevent distant recurrence (and perhaps local) while chemoradiation would only prevent local recurrence and thereby have less impact on overall survival. MedicalResearch.com: What are the main findings? Dr. Parikh: The main findings demonstrated that adjuvant chemotherapy led to an improvement in both local and distant recurrence with a corresponding improvement in overall survival while chemoradiation only led to an improvement in local recurrence but not distant nor overall survival. (more…)
Author Interviews, Heart Disease, JACC, Surgical Research / 06.03.2016

MedicalResearch.com Interview with: Seung-Whan Lee, MD, PHD Associate professor, Asan Medical Center University of Ulsan College of Medicine on behalf of our investigators.  Medical Research: What is the background for this study? Response: Survival benefit of successful coronary Chronic Total Occlusion  (CTO) recanalization has been a rationale behind PCI for CTOs. However, this knowledge is based on many observational studies that predate the widespread use of dedicated devices or techniques, drug-eluting stents (DESs), and current standards of medical management, making them low-quality evidence from the current perspective. Medical Research: What are the main findings? Response: Our study showed that successful PCI using DES was not associated with a lower risk for mortality compared with failed CTO-PCI. The revascularization strategy for non-CTO vessels, high frequency of subsequent CABG in patients with failed PCI, and high procedural success with low life-threatening complication rate may all have contributed to our study finding. (more…)
Author Interviews, Cannabis, Mental Health Research / 06.03.2016

MedicalResearch.com Interview with: Dr. Rashmi Patel MA (Cantab) MA BM BCh PGDip (Oxon) MRCPsych Clinical Lecturer in General Psychiatry Kings College London MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Patel: Previous studies suggest that cannabis use is associated with an increased risk of developing a psychotic disorder but, until now, little was known about the effects of cannabis on people with an established psychotic disorder. Using novel text mining techniques, we investigated the association of cannabis use with the clinical outcomes of over 2,000 people following their first episode of psychosis. We found that cannabis use was associated with significantly poorer clinical outcomes including a 50% increased frequency of hospital admission and 35 additional days spent in hospital in the 5 years after first receiving treatment. We also found that the poor outcomes associated with cannabis use may be linked to antipsychotic treatment failure. (more…)
Author Interviews, Breast Cancer, Cancer Research, Genetic Research / 06.03.2016

MedicalResearch.com Interview with: Rong Li, Ph.D., Professor Holder of the Tom C. & H. Frost Endowment Department of Molecular Medicine Institute of Biotechnology Co-Leader, Cancer Development and Progression Program Cancer Therapy & Research Center University of Texas Health Science Center at San Antonio  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Li: The breast cancer susceptibility gene BRCA1 is well known for its function in double strand break DNA repair. However, the ubiquitous role of BRCA1 in DNA repair may not be sufficient to explain its tissue-specific tumor suppressor function in vivo. Using the “awesome power” of mouse genetics, we identified a previously unappreciated crosstalk between BRCA1 and a transcription regulator in mammary gland development. Importantly, we provide compelling evidence that this BRCA1 function is independent of its well-established DNA repair activity. MedicalResearch.com: What should clinicians and patients take away from your report? Dr. Li: The newly identified DNA repair-independent function of BRCA1 may provide new tools and targets for early prevention of BRCA1-associated breast cancer. (more…)
AACR, Author Interviews, Cancer Research, Lung Cancer, MD Anderson, Nutrition, Sugar / 05.03.2016

MedicalResearch.com Interview with: Xifeng Wu, M.D., Ph.D Professor of Epidemiology and Dr. Stephanie Claire Melkonian  PhD Epidemiologist, Postdoctoral Research Fellow The University of Texas MD Anderson Cancer Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Glycemic index (GI) assigns foods an indexed value to show how quickly and how much carbohydrates in the food cause blood glucose levels to rise after eating and is a measure of overall carbohydrate quality. Glycemic load (GL) is a related measure that is calculated by multiplying Glycemic index by the amount of carbohydrates in grams in that specific food and by the amount consume, then dividing by 100. Previous studies have investigated the association of GI and GL with certain types of cancer, including colorectal, stomach, and pancreatic cancer, but there has been limited research into the association with lung cancer. We conducted a study using patients and control subjects from an ongoing case-control study of lung cancer conducted at MD Anderson. The patients were newly diagnosed and had not received treatment other than surgery. The healthy control subjects were selected from patient lists at Kelsey-Seybold Clinics, a large physician group in the Houston area. The study results encompass 1,905 cases and 2,413 controls. Using data collected from in-person interviews regarding health histories and dietary behaviors, we were able to categorize the study subjects according to their dietary Glycemic index and GL. What we found was that individuals in the highest category of GI were at an almost 50% increased risk for developing lung cancer as compared to those in the lowest group. This association was different based on different subtypes of cancer. Most interestingly, however, among those individuals that never smoked, high Glycemic index was associated with an almost 2 fold increased risk of lung cancer. In other words, we found a more profound association between GI and lung cancer in never smokers in this study. (more…)
Author Interviews, Cancer Research, Lancet, Leukemia, OBGYNE, Pediatrics / 04.03.2016

MedicalResearch.com Interview with: Erin Marcotte, Ph.D. Assistant Professor Division of Epidemiology and Clinical Research Department of Pediatrics University of Minnesota MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Marcotte: Recently there have been several studies that indicate a higher risk of immune-related disorders, such as type-I diabetes, asthma, and allergies, among children born by cesarean delivery. Our analysis used pooled data from 13 independent studies of childhood leukemia that were conducted in 9 different countries. We used data on over 33,000 children to investigate the relationship between birth by cesarean delivery and risk of childhood leukemia. We did not find an association between cesarean delivery overall and childhood leukemia. However, when we looked at emergency cesarean deliveries and pre-labor (planned) cesarean deliveries separately, we found a 23% increase in risk of acute lymphoblastic leukemia among children born by pre-labor cesarean delivery. (more…)
Author Interviews, OBGYNE, Pain Research / 04.03.2016

MedicalResearch.com Interview with: Matthew S. Robbins, MD, FAHS Associate Professor of Clinical Neurology, Albert Einstein College of Medicine Chief of Neurology, Jack D. Weiler Hospital Montefiore Medical Center Director of Inpatient Services, Montefiore Headache Center Associate Program Director, Neurology Residency MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Robbins: It is now well-established that having a history of migraine increases the risk of having vascular and obstetrical complications for pregnant women.  What is not known is if having active migraine during pregnancy would increase complications later on in that very same pregnancy.  Having severe migraine attacks during pregnancy may indicate particularly severe and active disease.  We evaluated pregnant women who presented to the hospital setting with acute, severe migraine attacks, and then reviewed their records for what happened during the same pregnancy when they delivered.  We found that compared to local and national rates, pregnant women with severe migraine attacks presenting to the hospital have increased rates of preeclampsia, preterm delivery, and low birthweight.  This risk was particularly elevated in pregnant women age 35 years or older. (more…)
Author Interviews / 04.03.2016

MedicalResearch.com Interview with: Amina Salamova PhD School of Public and Environmental Affairs and School of Public Health Indiana University Bloomington Bloomington, Indiana MedicalResearch.com: What is the background for this study? Dr. Salamova: Flame retardants are industrial chemicals that are added to a wide variety of commercial and consumer products to slow the spread of fire and delay ignition. These chemicals are used in electronics, furniture, building insulation, textiles, and many other products.  While flame retardants serves a purpose of saving lives in the case of fire, the extensive use of these chemicals has resulted in a widespread environmental contamination.  These chemicals can escape the products in which they are used by evaporation or weathering off of the product. Flame retardants have been found in indoor and outdoor air, water, soil and sediment, plants, animals and people around the world. There is some evidence that some of the chemicals are toxic. Number of toxicological reports suggest that these chemicals are toxic to our reproductive and neurological systems and that exposure to these chemicals is associated with learning disabilities, obesity, and endocrine disruption. Despite these findings there are still many unknowns about the adverse health effects of these chemicals on human health. Large and long-term biological monitoring programs are needed, in which large populations are monitored in terms of exposure to these chemicals. However, one of the difficulties in conducting long-terms biomonitoring programs is the lack of an easy, convenient, and cost-effective biological marker of exposure.  Biological marker of exposure is a measurement of a specific chemical or its metabolite in a specific tissue in the human body, which accurately reflects the level of exposure to the chemical of interest. Conventionally, most of the studies on flame retardants in human tissues have focused on measurements in milk, blood and urine. But using these tissues is either limited in terms of population, or collection – the tissues are invasive or complicated to collect. In fact these problems are often cited as common reasons for people’s refusal to participate in the study and donate tissues. This is especially significant for the most vulnerable populations, such as children, pregnant women and elderly. This is important, because it has been shown that children are at higher risk of exposure to flame retardants as concentrations found in children’s blood are higher than those found in adults. Clearly, there is a need to find a convenient noninvasive biomarker of exposure to flame retardants and that was the goal of this study. The discovery of an easily available biomarker should ease the way for further research to determine the human impact of these chemicals commonly found in the environment. Human hair and nails are good examples of noninvasive biomarkers. Compared to other tissues, these samples are easy to collect. Collection is also less expensive – anyone can do it at home. In fact, that is what we asked the participants in our study to do – they collected nails at home and mailed the samples to us. Also, these matrices are stable, so you don’t need anything special for their transport to the lab and storage. These are slowly growing tissues, thus they can provide information on both past and present exposure. In order to examine hair and nails as biomarkers of exposure to flame retardants, we collected hair, fingernail, toenails, and blood samples (simultaneously) from 50 residents of Bloomington, Indiana, mostly students. We wanted to know if we would be able to see any flame retardants in hair and nails, and if the levels in these samples would be correlated with the levels in blood.  (more…)
Author Interviews, BMJ, Coffee, Karolinski Institute, Multiple Sclerosis / 04.03.2016

MedicalResearch.com Interview with: Anna Hedström PhD student Karolinski Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previous studies on the influence of coffee consumption on multiple sclerosis (MS) risk have yielded inconclusive results, perhaps largely due to statistical power problems since these studies comprised few cases. Caffeine consumption has a protective effect on neuroinflammation and demyelination in animal models of MS. We therefore aimed to investigate whether coffee consumption is associated with MS risk, using two large population-based case-control studies (a Swedish study comprising 1620 cases and 2788 controls, and a United States study comprising 1159 cases and 1172 controls). The risk of multiple sclerosis was reduced by approximately 30% among those who reported a high coffee consumption, around six cups daily, compared to those who reported no coffee consumption. The risk of multiple sclerosis decreased with increasing coffee consumption. Potentially important influential factors were taken into consideration, such as smoking and adolescent obesity. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Stroke / 04.03.2016

MedicalResearch.com Interview with: Hakan Ay MD, FAHA Associate Professor of Neurology and Radiology Stroke Service, Department of Neurology Director of Stroke Research, A.A. Martinos Center, Department of Radiology Massachusetts General Hospital Harvard Medical School Boston MA, USA Medical Research: What is the background for this study? What are the main findings? Dr. Ay: Recurrent stroke is an important public health problem. One quarter of all strokes are recurrent strokes. Approximately one out of every 10 patients with stroke develops a second stroke within the next 2 years. The most critical period for recurrence after stroke is the first 90 days; approximately half of recurrent strokes that occur within 2 years occur within the first 90 days. The RRE tool was developed at the Massachusetts General Hospital in 2010 to assess the 90-day risk of recurrent stroke. The RRE was subsequently tested in a separate cohort of patients with transient stroke symptoms (mini strokes) admitted to the Massachusetts General Hospital in 2011. The current study expands upon prior two studies by showing that the RRE tool provides reliable risk estimates when tested in cohorts of patients recruited from different academic centers in various parts of the world. The study reports that the RRE can stratify approximately one-half of patients with stroke either at high-risk or at low-risk with a reasonable accuracy. (more…)
Author Interviews, Global Health, Heart Disease, Infections, JAMA / 04.03.2016

MedicalResearch.com Interview with: Thomas Pilgrim, Prof. Dr. med. Oberarzt, Invasive Kardiologie Universitätsspital Bern Bern Switzerland MedicalResearch.com: What is the background for this study? Dr. Pilgrim: Three quarters of all children worldwide grow up in regions endemic for rheumatic heart disease. Clinically manifest rheumatic heart disease represents only the tip of the iceberg: only one in in 5 to 8 children with valvular lesions consistent with rheumatic heart disease have a heart murmur or clinical symptoms; the remaining children have clinically silent disease that goes undetected unless echocardiography is performed. An understanding of incidence, prevalence, and progression of disease is an important prerequisite to guide active surveillance and secondary prevention. We therefore performed a school-based cross-sectional study among more than 5000 children from 26 schools in Nepal. The objective of the study was to assess prevalence of clinically silent and manifest rheumatic heart disease as a function of age, gender and socioeconomic status and to estimate the age-specific incidence from available prevalence data. MedicalResearch.com: What are the main findings? Dr. Pilgrim: In our population-based observational cross-sectional study, the prevalence of borderline or definite rheumatic heart disease among schoolchildren in Eastern Nepal amounted to 10.2 (95% CI 7.5-13.0) per 1000 children between the ages of 5 and 15 years, and was more common in girls as compared to boys. The prevalence increased across age categories in a nearly linear fashion from 5.5 (95% CI 3.5-7.5) per 1000 in children 5 years of age to 16.0 (95% CI 14.9-17.0) in children 15 years of age, while the average incidence remained stable at 1.1 per 1000 children per year. The prevalence of clinically silent rheumatic heart disease was 5 times higher compared to manifest disease and the ratio of manifest to subclinical disease increased with increasing age. (more…)
Author Interviews, Genetic Research, Heart Disease, JACC / 04.03.2016

MedicalResearch.com Interview with: Silvia G Priori ,MD, PhD and Andrea Mazzanti, MD Medical Research: What is the background for this study? What are the main findings? Response: The study investigates a novel therapeutic approach for Long QT Syndrome type 3: a malignant varian of long QT Syndrome a disease in which the risk of arrhythmias is proportional to the prolongation of QT interval. LAQT3 is caused by gain of function mutations in the gene SCN5A that encode for the alpha subunit of the cardiac sodium channel. These mutations increase the late sodium current (INa late) that prolongs the QT interval and predisposes the heart to develop life-threatening ventricular arrhythmias. In 1996 we demonstrated in an animal model of Long QT Syndrome type 3 that administration of mexiletine was able to shorten QT interval and the same results were obtained in LQT3 patients treated with mexiletine : these data provided rational for the adoption in clinical practice guidelines to recommend the use of mexiletine to shorten QT interval in LQT3 patients with the expectation that shortening QT interval would reduce the risk of arrhythmic death. In this setting, our study is the first to provide data in support of the view that mexiletine shortens QT interval and reduces the probability to experience arrhythmic events. (more…)
Author Interviews, Hand Washing, Hospital Acquired, Infections / 04.03.2016

MedicalResearch.com Interview with: Dr Laurence Senn, médecin associée Service de médecine préventive hospitalière Mont Paisible Lausanne MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Senn: Pseudomonas aeruginosa is a ubiquitous environmental bacterium that can cause infection in patients severely ill, and is thus a major cause of nosocomial infections in intensive care units. During an environmental investigation on potential reservoirs of P. aeruginosa, the liquid hand soap was found highly contaminated with this pathogen. The fact that unopened soap containers were found contaminated with P. aeruginosa proved that the contamination occurred during product manufacturing. Contaminated batches had been used in our hospital over the previous 5 months. In order to evaluate the burden of this contamination on patients, our infection control team conducted an epidemiological investigation combining two molecular methods. First, we analyzed with a classical molecular typing method all P. aeruginosa isolated from patients during the period of exposition to the contaminated soap. Secondly, we targeted the analysis on some isolates sharing the same genotype that the one found in the soap with a modern, recently developed tool which consists in sequencing the whole genome of the bacteria. This method allowed us to have the "fingerprint" of each isolate. Our investigation ruled out any impact of the contaminated soap on patients. (more…)
Author Interviews, Education / 04.03.2016

MedicalResearch.com Interview with: Paul L. Morgan, Ph.D. Associate Professor, Department of Education Policy Studies Director, Educational Risk Initiative Faculty Affiliate, Child Study Center Research Associate, Population Research Institute Faculty Affiliate, Prevention Research Center The Pennsylvania State University University Park, PA MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Morgan: The U.S. is at of risk declining economic competitiveness due to its lower levels of educational attainment in science, technology, engineering, and mathematics (STEM) relative to other countries (see http://www.nap.edu/catalog/12999/rising-above-the-gathering-storm-revisited-rapidly-approaching-category-5). Concurrently, the U.S. has a well-established “leaky STEM pipeline” in which children who are racial or ethnic minorities, females, or from low income families are especially unlikely to grow up to be employed in STEM positions. Large science achievement gaps are disproportionately experienced by these same groups of children. Yet the U.S. is increasingly transitioning to a knowledge economy necessitating higher levels of scientific thinking, problem solving, and technical competency. The causes of these science achievement gaps have been poorly understood. Most of the existing empirical work on science achievement gaps has used cross-sectional designs. The samples also have largely been of older students attending middle or high schools. As a result, the early onset, over-time dynamics, and risk factors for science achievement gaps have been largely unknown. Our study helps inform policy, research, and practice by establishing that science achievement gaps emerge by the elementary grades and then largely remain stable as children continue throughout middle school. These gaps are mostly explained by children’s knowledge about their general surroundings acquired by the primary grades. Children’s reading and mathematics achievement also help to explain their science achievement, as do income inequality and school racial and income segregation. We find that children from traditionally marginalized groups (e.g., those who are Black, Hispanic, or from low-income families) are especially likely to enter school with general knowledge gaps. These same children often continue to experience science achievement gaps throughout elementary and middle school. However, factors modifiable by parents, educators, and policymakers largely explain these children’s gaps and so might be the target of early and sustained intervention efforts.  (more…)
Author Interviews, Depression, JAMA, Johns Hopkins / 04.03.2016

MedicalResearch.com Interview with: Katherine L. Musliner, PhD National Centre for Register-Based Research, Department of Economics and Business Economics, Aarhus University, Aarhus, Denmark The Lundbeck Foundation Initiative for Integrative Psychiatric Research Department of Mental Health The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland   MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is great variation among patients with depression in terms of long-term illness course. This variation may be indicative of underlying differences in the cause of the illness, and from a practical perspective, it also has implications for treatment and allocation of public health resources. Our goal was to identify different trajectories of depression course by examining inpatient and outpatient contacts for depression at psychiatric treatment facilities in Denmark (where healthcare is free) during the 10-year period following patients’ initial depression diagnosis. We found that the majority of patients (77% in our sample) followed a trajectory characterized by a brief period of contact with the psychiatric treatment system and no contact for depression during the remainder of the 10-year follow up period. Patients with more prolonged contact either had a drawn out initial period of contact lasting as long as five years (13%), left depression treatment for several years only to return with a depression diagnosis years later (7%) or exhibited a chronic course (3%). (more…)
Author Interviews, Breast Cancer, Chemotherapy, Lancet / 04.03.2016

MedicalResearch.com Interview with: Massimo Cristofanilli, MD, FACP Professor of Medicine Associate Director of Translational Research and Precision Medicine Department of Medicine-Hematology and Oncology Robert H Lurie Comprehensive Cancer Center Feinberg School of Medicine Chicago, IL 60611  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Cristofanilli: The majority of breast cancer are estrogen-receptor positive and therefore candidate for treatment with endocrine therapy in the adjuvant and advanced settings. The most significant issue in the management of estrogen-receptor positive metastatic breast cancer is the development of drug resistance. Very few effective options are available for patients that demonstrate progression of disease while on standard endocrine therapy, particularly in premenopausal women and/or women that have even progressed on chemotherapy. The study demonstrated that the combination of fulvestrant with palbociclib, a novel inhibitor of CDK4/6 kinases, significantly improve response to treatment and delays disease progression with minimal toxicity.  (more…)
Author Interviews, Cost of Health Care, Medicare, NYU, Orthopedics / 04.03.2016

MedicalResearch.com Interview with: Richard Iorio, MD Dr. William and Susan Jaffe Professor of Orthopaedic Surgery Chief of the Division of Adult Reconstructive Surgery NYU Langone Medical Center  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Iorio: NYU Langone Medical Center’s Department of Orthopaedic Surgery realized early that alternate payment strategies based on value rather than volume were going to be increasing in prevalence and represent the future of compensation strategies  As leaders in orthopaedics, we knew that we must embrace this change and develop strategies and effective protocols to successfully navigate this alternative payment universe. In 2011, NYU Langone’s Hospital for Joint Diseases was chosen as a pilot site for CMS’s Bundled Payment Care Initiative, focusing on Medicare patients undergoing a total joint replacement. Beginning in 2013, we implemented protocols developed at our hospital focusing on preoperatiive patient selection criteria in an effort to ensure better outcomes for Medicare patients who underwent total joint replacements. Under a bundled payment program, hospitals assume financial responsibility for any complications over the entire episode of care 90 days after surgery, including postsurgical infections and hospital readmissions. We compared year over year outcomes from year 1 to year 3 of this program, and found:
  • Average hospital length of stay decreased from 3.58 days to 2.96 days;
  • Discharges to inpatient rehabilitation or care facilities decreased from 44 percent to 28 percent;
  • Average number of readmissions at 30 days decreased from 7 percent to 5 percent; from 11 percent to 6.1 percent at 60 days; and from 13 percent to 7.7 percent at 90 days;
  • The average cost to CMS of the episode of care decreased from $34,249 to $27,541 from year one to year three of the program.
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Author Interviews, Heart Disease, Lipids, Pharmacology, University of Pennsylvania / 03.03.2016

MedicalResearch.com Interview with: Dr. Richard L. Dunbar MD MS Assistant Professor of Medicine, Attending Physician, Preventive Cardiovascular Medicine Clinic, Member, Institute for Translational Medicine and Therapeutics, University of Pennsylvania School of MedicineMember, Institute for Diabetes, Obesity and Metabolism, University of Pennsylvania School of Medicine and Dr. Harsh Goel WellSpan Academic Hospitalists Department of Medicine, York Hospital, PA  MedicalResearch.com: What is the background for this analysis? Response: Niacin is the first cholesterol lowering treatment to prevent heart attacks and lower long term mortality. It thus provided the first proof that lowering cholesterol reduces cardiovascular risk. However, it is generally poorly tolerated due to almost universal flushing, limiting use. The better-tolerated statin drugs overshadowed niacin, rightly dominating hyperlipidemia therapy. Despite their advantages, statins are far from perfect, leaving important gaps. Firstly, at least 10% of patients simply don’t tolerate statins. Secondly, about 40% of patients have insufficient cholesterol lowering, leaving them far from their target LDL-cholesterol levels. Finally, even though statins lower cardiovascular risk, they by no means eliminate it and significant residual risk remains even in patients who respond to them. The relatively poor tolerance of niacin motivated development of an extended-release alternative which was dosed very differently from the established cardioprotective regimen used in the Coronary Drug Project (CDP) and the Stockholm Ischemic Heart Disease Study (SIHDS), the two landmark trials that proved niacin's benefits. These trailblazing trials used 3 grams of niacin divided throughout the fed portion of the day as 1 gram thrice daily with meals. In sharp contrast, the alternative regimen was severely handicapped by a profoundly lower dose of only 2 grams per day. Perhaps worse, the alternative regimen dosed all of the niacin at one sitting, at bedtime before the overnight fast, rather than three times a day before meals. We believe these were critical departures from the established cardioprotective niacin regimen, insofar as they severely undermined the alternative regimen’s efficacy. Accordingly, when added to statins, the alternative regimen failed to recapitulate the benefits seen with the established cardioprotective regimen in two recent large clinical trials, the AIM-HIGH trial and the HPS2-THRIVE trial. Besides the inherent flaws of the alternative regimen, there were also major issues with the trial designs which likely contributed to null results. From a practice standpoint, this is worrisome, because clinicians may draw erroneous conclusions from the trials of the alternative regimen, and thereby deny a significant population of hyperlipidemic patients the benefits of a well-proven cardioprotective therapy, i.e. the population which does not tolerate or does not respond adequately to statins (almost 50% of at risk patients). Hence, we embarked on a critical analysis and review of the alternative regimen with a special focus on the AIM-HIGH and HPS2-THRIVE trials to bring to light the pitfalls of comparing radically different regimens of what is nominally the same drug. (more…)
Author Interviews, Geriatrics, JAMA, Ophthalmology, Primary Care / 03.03.2016

MedicalResearch.com Interview with: Dr. Albert Siu M.D., M.S.P.H. Chair of the U.S. Preventive Services Task Force Chairman and professor of the Brookdale Department of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai Director of the Geriatric Research, Education, and Clinical Center James J. Peters Veterans Affairs Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Siu: Impaired vision is a serious and common problem facing older adults and can affect their independence, ability to function, and quality of life. When the Task Force reviewed the research around screening older adults for vision impairment in a primary care setting, we concluded that the current evidence is insufficient to assess the balance of benefits and harms. As a result, we issued an I statement, which is consistent with the 2009 final and 2015 draft recommendations. MedicalResearch.com: What should clinicians and patients take away from your report? Dr. Siu: Older adults who are having problems seeing should talk to their primary care doctor or an eye specialist. Primary care doctors can explore the various causes of vision problems and do an eye exam to check for refractive error. An eye specialist can do a full eye exam to look for and treat refractive errors and other eye conditions that affect vision, such as cataracts and age-related macular degeneration (AMD). With regards to clinicians, in the absence of clear evidence, they should use their clinical judgment when deciding whether to screen patients who have not reported any concerns about their vision. (more…)
ASCO, Author Interviews, Biomarkers, Breast Cancer, Chemotherapy, Genetic Research, Journal Clinical Oncology / 03.03.2016

MedicalResearch.com Interview with: Oleg Gluz, MD West German Study Group Breast Center Niederrhein Evangelical Hospital Bethesda Moenchengladbach, Germany MedicalResearch.com: What is the background for this study? Dr. Gluz: PlanB trial is a Phase III chemotherapy study performed in patients with clinically high risk HER2 negative breast cancer. After early amendement, Recurrence Score (Oncotype Dx) as a selection criterion for or against chemotherapy together with central pathology review were included into the study. Patients with very low RS of below 12 and up to 3 positive lymph nodes were recommended to omit chemotherapy based on the low genomic recurrence risk. Chemotherapy was omitted in about 15% of all patients. For the first time we present prospective data comparing a genomical tool (Oncotype Dx) and an independent central pathology review for grade, ER, PR, and Ki-67 from a large phase III study combined with an exploratory analysis on early relapse risk. MedicalResearch.com: What are the main findings? Dr. Gluz: The study has two major findings: We have found a significant discordance in risk assessment between prognostic tools (grade by local and central lab, Oncotype Dx, Ki-67). Patients treated by endocrine therapy alone based on very low Recurrence Score had an excellent disease free survival of 97% after 3 years of follow up. (more…)
Author Interviews, Biomarkers, Brain Injury / 03.03.2016

MedicalResearch.com Interview with: Mr. Jim Joyce Chairman and CEO of Aethlon MedicalResearch.com: What is the background for this study? What are the main findings? Mr. Joyce: Our research into the neurodegenerative disease Chronic Traumatic Encephalopathy (CTE), was inspired by the death of Tom McHale, who was a former teammate and the second person diagnosed with CTE by our colleagues at the Boston University CTE Center. CTE is characterized by exposure to repetitive head trauma and at present, can only be diagnosed post-mortem, thus creating a significant need for a non-invasive method to diagnose and monitor CTE in living individuals. The aim of our study was to examine exosomal tau levels in plasma as a potential CTE biomarker. Our research team originally discovered the presence of exosomal tau in circulation and then established methods to quantify exosomal tau, which we refer to as a TauSome™, which we believe to be the first potential blood test to detect CTE living individuals. For this study, researchers examined 78 former National Football League players and 17 former athletes of non-contact sports, with preliminary findings suggesting that exosomal tau in plasma may be a noninvasive, accurate biomarker for CTE. The study results, published in the journal of Alzheimer’s disease, can be accessed here: http://content.iospress.com/articles/journal-of-alzheimers-disease/jad151028?resultNumber=7&totalResults=48&start=0&q=exosome&resultsPageSize=10&rows=10. (more…)
Author Interviews, Breast Cancer, Cancer Research, JNCI, Lymphoma / 03.03.2016

MedicalResearch.com Interview with: David Hodgson, MD, MPH, FRCPC Associate Professor University of Toronto Toronto, ON Canada   MedicalResearch.com: What is the background for this study? Dr. Hodgson: We know that treatment for childhood Hodgkin lymphoma can cause some side effects that arise years after treatment is  finished. In particular, radiotherapy given to the chest of adolescent females increases the risk of developing breast cancer in young adult survivors. But there are very little data about whether the early initiation of breast cancer screening will prevent breast cancer deaths in these survivors, and what kinds of screening is optimal. This is important because less than half of these young survivors are undergoing breast cancer screening, and in some jurisdictions early screening is not covered by insurance. MedicalResearch.com: What are the main findings? Dr. Hodgson: Because there has not been, and likely never will be, a large randomized screening trial for these patients, we used all the available information about their breast cancer risk, other health issues and the effectiveness of screening, and created a mathematical model that allows us to estimate the number of breast cancer deaths prevented by starting screening at age 25 for women who had received chest RT as teenagers. We found that one would have to invite about 260 survivors to early mammographic screening to prevent one breast cancer death, which compares favorably to other accepted reasons for breast cancer screening. Using MRI for screening, approximately 80 women would have to be invited to prevent one breast cancer death, because MRI is so much more sensitive than mammography. One of the problems with MRI, however, is that a substantial number of women will have "false positive" tests - abnormal findings that are not really cancer. (more…)