Author Interviews, Prostate, Prostate Cancer, Urology / 26.11.2015

MedicalResearch.com Interview with: Isaac Yi Kim, MD, PhD Acting Chief and Associate Professor, Division of Urology Rutgers Robert Wood Johnson Medical School Chief, Section of Urologic Oncology and Young Suk "Joseph" Kwon, MD Post-doctoral fellow  Section of Urologic Oncology Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey New Brunswick, NJ 08903 Medical Research: What is the background for this study? Response: Although PSA < 10 ng/mL is a typically required condition under which many active surveillance (AS) protocols operate, this current guideline may predispose lower risk patients with incongruently elevated PSA to aggressive and potentially unnecessary therapies. Specifically, urologists infrequently encounter patients with PSA > 10 ng/ml but biopsy demonstrating a relatively lower risk prostate cancer (PCa). Therefore, we wanted to test whether active surveillance may be a viable option in some men with a histologically favorable risk prostate cancer and serum PSA between 10 and 20 ng/ml. Medical Research: What are the main findings? Response: We compared oncologic outcomes in men with favorable biopsy histology and varying PSA levels: low, intermediate, and high PSA levels. The rates of upstaging and upgrading were similar between the intermediate PSA (IP) (≥10 and 20) and low PSA (LP) (<10) group. In contrast, the high PSA  (HP) (≥20) group had higher incidences of both upstaging (p=0.02) and upgrading to ≥4+3 (p=0.046) compared to the IP group. BCR-free survival rates revealed no pair-wise inter-group differences, except between low PSA and high PSA . (more…)
Author Interviews, Diabetes, Macular Degeneration, Ophthalmology / 26.11.2015

MedicalResearch.com Interview with: Karina Birgitta Berg MD Department of Ophthalmology Oslo University Hospital Oslo, Norway  Medical Research: What is the background for this study? What are the main findings? Dr. Berg: Neovascular age-related macular degeneration (nAMD) has been the leading cause of vision loss in the elderly population of Western countries. Inhibition of vascular endothelial growth factor (VEGF) with medications such as bevacizumab and ranibizumab injected into the eye, has dramatically reduced the incidence of social blindness from this disease. Bevacizumab was marketed for intravenous cancer treatment, while ranibizumab was later developed and approved for intraocular treatment of nAMD. Due to similar clinical effects and a strikingly low cost compared to ranibizumab, bevacizumab has remained widely used as an off-label treatment for the treatment of nAMD. In order to preserve vision results over time, most patients need injections repeatedly. Treatment on a monthly basis has shown good vision improvement, while monitoring monthly and treating only when signs of recurrences appear, is less successful. The aim of a treat-and-extend protocol is to gradually increase the treatment intervals, while avoiding potentially harmful recurrences. This treatment modality has become commonly used, entailing fewer patient visits and less burden upon health care systems. The multicenter prospective randomized Lucentis Compared to Avastin Study (LUCAS) was aimed at comparing the efficacy and safety of bevacizumab versus ranibizumab when following a treat-and-extend protocol. The patients received monthly injection treatment until inactive disease was achieved. The treatment interval was then increased by two weeks at a time up to a maximum of 12 weeks. In the event of a recurrence, the treatment interval was reduced by two weeks at a time. The study demonstrated equivalent results in vision improvement with bevacizumab and ranibizumab after two years of treatment. Treatment according to a treat-and-extend protocol was safe with good visual results when extending up to 10 weeks, while recurrences at 12-week intervals had a negative impact on the final results on vision. (more…)
Author Interviews, NEJM, OBGYNE / 26.11.2015

MedicalResearch.com Interview with: Arri Coomarasamy, MBChB, MD, FRCOG Professor of Gynaecology and Reproductive Medicine University of Birmingham Medical Research: What is the background for this study? What are the main findings? Professor Coomarasamy: Progesterone is a natural hormone that is essential to maintain a healthy pregnancy, and more than 60 years ago clinicians and researchers began to ask if progesterone supplementation in the first trimester of pregnancy could help to reduce the risk of miscarriage for women with a history of recurrent miscarriage. The evidence achieved in some small controlled clinical trials conducted before the PROMISE (progesterone in recurrent miscarriage) trial suggested a benefit from progesterone therapy, but without sufficient certainty to usefully guide clinical practice. Five years after it began, the PROMISE trial has provided a definitive result. It is clear, it is important, and it is not the result that many anticipated. Our study of more than 800 women with a history of unexplained recurrent miscarriage has shown that those who received progesterone treatment in early pregnancy were no less likely to miscarry than those who received a placebo (or dummy treatment). This was true whatever their age, ethnicity, and medical history. (more…)
Author Interviews, Genetic Research, Nature, Weight Research / 26.11.2015

MedicalResearch.com Interview with: Dr. Andrew Whittle, joint first-author of the paper and a postdoc in the Prof. Vidal-Puig’s lab at the time the research was conducted. Medical Research: What is the background for this study? Dr. Whittle: Antonio Vidal-Puig heads the disease model core of the University of Cambridge Metabolic Research Laboratories at the Wellcome Trust-MRC Institute of Metabolic Science (IMS). His laboratory has a long-standing interest in the mechanisms that regulate how adipose tissue stores, burns or releases energy. The group studies mice that have increased or reduced susceptibility to obesity and its metabolic complications, in order to dissect the molecular pathways that underpin these phenotypes. Their long-term goal is to develop more effective strategies to manipulate the body’s own regulatory pathways, both to reduce obesity itself or limit the negative impact that excess lipids have on other important metabolic organs. Professor Hideaki Bujo from Toho University Medical Center in Japan has been working for a number of years to understand the role of specific lipoprotein receptors in vascular biology. Specifically he has shown that LR11 is cleaved to release a short soluble for of the protein, sLR11, which can effect changes to vascular smooth muscle cell migration. To further his studies he generated a knock-out mouse model completely lacking LR11. One of the first observations his group made was that these mice remained leaner than control animals. I and Meizi Jiang (a postdoc in the Bujo lab) conducted a collaborative study of the LR11 knockout mice (Lr11-/-), to investigate the mechanisms by which a lack of LR11 resulted in mice being protected from diet-induced obesity.  (more…)
ADHD, Author Interviews, BMJ, Pharmacology / 26.11.2015

MedicalResearch.com Interview with: Dr. Ole Jakob Storebø Region Zealand, Child and Adolescent Psychiatric Department, Roskilde Region Zealand Psychiatry Psychiatric Research Unit, Slagelse University of Southern Denmark Department of Psychology Faculty of Health Science, Odense Denmark Medical Research: What is the background for this study? What are the main findings? Dr. Storebø: Despite widespread use of methylphenidate for the treatment of children and adolescents with attention deficit hyperactivity disorder (ADHD), a comprehensive systematic review of its benefits and harms has not yet been conducted. Over the past 15 years, several reviews investigating the efficacy of methylphenidate for ADHD (with or without meta-analyses) have been published. Each of these reviews, however, has several shortcomings and these are described in detail in the review. The most important concerns are that none of these reviews are based on a pre-published protocol, and most assessed neither the risk of bias (systematic errors) of included trials nor adverse events. Moreover, none of these reviews considered the risk of random errors. Therefore, their interpretation of findings is unlikely to have taken into account the poor reporting of adverse events, the impact of combining data from small trial samples, or the impact of risk of bias on their analyses; information about adverse events is also missing from several RCTs. Because of this it is our opinion that these previous reviews might have overestimated the true treatment effect. We found that Methylphenidate may improve ADHD symptoms, general behaviour and quality of life in children and adolescents aged 18 years and younger with ADHD. We rated the evidence to be of very low quality and, as a result, we cannot be certain about the magnitude of the effects from the meta-analyses. The evidence is limited by serious risk of bias in the included trials, under-reporting of relevant outcome data, and a high level of statistical variation between the results. We found no evidence for serious adverse events, but a lot of non-serious adverse events. Most of these are well known but the number of adverse events might even be higher than the number we found due to underreporting of adverse events. We know very little about the long term effects or harms as most of the trials in our review did not measure outcomes beyond 6 months. The risk of rare, serious adverse events seem low over the short duration of follow-up of the trials that reported on harms, but in general there was inadequate reporting of adverse events in many trials. (more…)
Author Interviews, Cost of Health Care, Health Care Systems, JAMA, Outcomes & Safety / 25.11.2015

MedicalResearch.com Interview with: Anup Das Medical Scientist Training Program Department of Health Management and Policy University of Michigan, Ann Arbor Medical Research: What is the background for this study? What are the main findings? Response: The Centers for Medicare & Medicaid Services (CMS) recently added a new measure of episode spending to the Hospital Value Based Purchasing program. Participation in this program allows hospitals to receive a financial bonus if they perform well on the included measures. This is the first spending measure in the program, and this change now incentivizes hospitals to improve their quality as well as their spending. The measure evaluates spending from three days before a hospitalization through 30 days post-discharge. In this study, we find that while high-cost hospitals had higher spending levels in each of the three components of an episode of care (pre-admission, index admission, and post-discharge), differences in post-discharge spending were the main determinants of hospital performance on this measure. High-cost hospitals spent on average $4,691 more than low-cost hospitals in post-discharge care. The majority of post-discharge spending comes from skilled nursing facility or readmission costs. Similarly, hospitals that did worse on this new measure of spending over time did so because of increases in their post-discharge spending. (more…)
Author Interviews, Heart Disease, JAMA, UT Southwestern / 25.11.2015

Ambarish  MedicalResearch.com Interview with: Ambarish Pandey M.D. Division of Cardiology University of Texas Southwestern Medical Center Dallas, TX Medical Research: What is the background for this study? What are the main findings? Dr. Pandey: Pulmonary artery (PA) catheters have been used for invasive bedside hemodynamic monitoring for past four decades. The ESCAPE trial, published in October 2005, demonstrated that use of  Pulmonary Artery catheter was not associated with a significant improvement in clinical outcomes of patients with heart failure. Accordingly, the current ACC/AHA guidelines discourage the routine use of PA catheter for routine management of acute heart failure in absence of cardiogenic shock or respiratory failure (Class III). Despite the significant evolution of available evidence base and guideline recommendations regarding use of  Pulmonary Artery catheters, national patterns of PA catheter utilization in hospitalized heart failure patients remain unknown. In this study, we observed that use of PA catheter among patients with heart failure decline significantly in the Pre-ESCAPE era (2001 – 2006) followed by a consistent increase in its use in the Post-ESCAPE era (2007-2012). We also observed that the increase in use of  Pulmonary Artery catheters is most significant among heart failure patients without underlying cardiogenic shock or respiratory failure. (more…)
Author Interviews, Genetic Research, Pediatrics / 25.11.2015

MedicalResearch.com Interview Grant S Schulert MD, PhD Clinical Fellow, Division of Rheumatology Cincinnati Childrens Hospital  Medical Research: What is the background for this study? What are the main findings? Dr. Schulert: Influenza infection causes millions of illnesses annually, but most of those are relatively mild.  In a subset of cases, patients can become critically ill, even if they are relatively young and healthy.  Several previous reports had observed in these critically ill patients features of a hyperinflammatory syndrome known as HLH (hemophagocytic lymphohistiocytosis) or MAS (macrophage activation syndrome).  This hyperinflammation can be triggered by other infections as well as in a subtype of juvenile arthritis, but there is also a familial form occurring in early childhood with known genetic causes.  Our questions with this study were 1) how often are features consistent with HLH/MAS seen in fatal H1N1 influenza infections and 2) do patients with fatal H1N1 infection have genetic mutations associated with HLH/MAS? Our collaborator Paul Harms, MD, and his team at the Michigan Center for Translational Pathology, University of Michigan Medical School identified 16 cases of fatal H1N1 influenza infection.  Based on their clinical features, between 41-88% of these patients could be categorized as having a hyperinflammatory HLH/MAS.  We then used processed tissue samples from the patients for whole exome genetic sequencing, which reads the entire genetic code of every gene in a person. Five patients carried mutations in genes which cause HLH, and several others carried mutations in genes linked to MAS.  This suggests that there may be genetic risk factors for developing fatal hyperinflammatory syndromes in H1N1 infection. (more…)
Author Interviews, Cancer Research, Cost of Health Care / 25.11.2015

MedicalResearch.com Interview with: Xuesong Han, PhD Director, Surveillance and Health Services Research American Cancer Society, Inc. Atlanta, GA 3030 Medical Research: What is the background for this study? What are the main findings? Dr. Han: People with private insurance are more likely to be screened and more likely to be diagnosed at an early stage of cancer. An early provision of the Affordable Care Act implemented in September 2010 allows young adults to remain on their parents’ health insurance plan until age 26 years, following which there has been an increase in private insurance coverage among young adults aged 19-25 years. For young adults, the uterine cervix is the only cancer site for which screening is recommended with a starting age of 21 years, and diagnosis of cervical cancer at early stages allows use of fertility-sparing treatment. Using data before and after the dependent coverage expansion provision of ACA, we found that compared with 26-34 year-olds who were not affected by the policy change, women 21-25 years of age experienced a net increase of 9 percentage points in early stage disease and 11.9 percentage points in receipt of fertility-sparing treatment. (more…)
Abuse and Neglect, Accidents & Violence, Author Interviews, Pediatrics / 25.11.2015

Dr. Ffion C Davies Consultant in Emergency Medicine & Paediatric Lead University Hospitals of Leicester NHS Trust Leicester Royal Infirmary Leicester UKMedicalResearch.com Interview with: Dr. Ffion C Davies Consultant in Emergency Medicine & Paediatric Lead University Hospitals of Leicester NHS Trust Leicester Royal Infirmary Leicester UK Medical Research: What is the background for this study? Dr. Davies: This study is from the Trauma Audit Research Network data, which is a major trauma database receiving data from nearly all hospitals in England and Wales. A 2012 TARN report on major trauma in children showed a peak of injuries resulting from child abuse in the younger age group. In this study we analysed the database in more detail, in order to profile this peak of injuries from non-accidental injury (NAI). Medical Research: What are the main findings? Dr. Davies: The main findings are that severe injury and death resulting from non-accidental injury occurs nearly always in the under 5 year old age group, and 75% of cases are under 1 year old. This contrasts with reports in the media, whereby high profile deaths in children from non-accidental injury are often older children. This probably reflects reporting bias, because those children experienced a prolonged period of abuse, despite involvement of health and social services. Our study shows that very small infants are the most likely to die, or to sustain severe head injuries. (more…)
Author Interviews, OBGYNE, Outcomes & Safety / 25.11.2015

MedicalResearch.com Interview with: Dr William L Palmer Honorary research fellow Dr Foster Unit, Department of Primary Care and Public Health, Imperial College London, London Medical Research: What is the background for this study? Dr. Palmer: For the majority of women and their newborns, their care will be safe and result in good outcomes. However, previous research has suggested that outcomes across a range of healthcare areas might be worse at weekends. We therefore undertook to investigate whether there was an association between day of delivery and complications, using a range of different outcomes: perinatal mortality and - for both women and neonate - injury, infection and emergency readmission rates. Our analysis was based on every delivery to public health services in the NHS in England across a two-year period so accounting for some 1.3 million births. To account for possible differences in case-mix and maternal characteristics we controlled for a range of factors including gestational age, delivery type, maternal age, birth-weight, and pre-existing diabetes or hypertension.  (more…)
Author Interviews, Cognitive Issues / 24.11.2015

MedicalResearch.com Interview with: Catherine Mewborn, B.A. Neuropsychology and Memory Assessment Laboratory Department of Psychology University of Georgia Medical Research: What is the background for this study? Response: Vision and cognitive functioning both tend to decline as individuals age. Processing speed, or the speed at which an individual can process information, is particularly vulnerable to age-related declines. In previous studies, cognition has typically been measured using traditional paper-and-pencil tests; however, these tests can be quite complex and recruit many different abilities. We wanted to use a simpler test to assess processing speed in the hopes of tapping into the more basic abilities that underlie performance on more complex cognitive tasks. For this study, we chose a measure of visual processing speed called critical flicker fusion, or CFF. We tested how well CFF could predict cognition in both younger and older adults. Medical Research: What are the main findings? Response: As expected, younger adults had better visual processing speed than older adults. Interestingly, in both age groups, CFF significantly predicted performance on a test of executive functioning, which assess abilities such as problem-solving and shifting attention between different tasks. (more…)
Accidents & Violence, Author Interviews, Pediatrics / 24.11.2015

MedicalResearch.com Interview with: N.J. Scheers, PhD Former manager of CPSC's Infant Suffocation Project BDS Data Analytics, Alexandria, VA Medical Research: What is the background for this study? What are the main findings? Dr. Scheers: There are no federal regulations for crib bumpers. The American Academy of Pediatrics, the Canadian Pediatric Society, the National Institutes of Health, and others have long recommended against crib bumper use. Crib bumper manufacturers have a long-standing voluntary safety standard aimed at making crib bumpers safe. Neither of these approaches has worked to prevent deaths from bumpers.  Medical Research: What are the main findings? Dr. Scheers: Using data from the Consumer Product Safety Commission (CPSC), the research identified 48 deaths from crib bumpers from 1985-2012. Reports of the deaths increased significantly and were three times higher from 2006 through 2012 than in previous years. In most of the deaths, the crib bumpers were the only source of suffocation, rebutting beliefs that other items in the cribs (comforters, pillows, blankets) caused the deaths. In other deaths, wedging occurred between the bumper and other objects such as pillows and infant recliners. All of these deaths would have been preventable if crib bumpers had not been in the cribs. The study linked more deaths to crib bumpers than the 48 indicated in the CPSC data. A review of data from the National Center for the Review and Prevention of Child Deaths reveals reports of 32 bumper-related deaths from 37 states from 2008-2011. That puts the number of fatalities tied to crib bumpers at 77 and suggests the actual number is much higher. The study identified 146 injuries from 1990-2012. Eleven were “near-misses” in which the babies were rescued before they died. These were near-suffocations, chokings, strangulations, and falls from infants using bumpers to climb out of the cribs. There were reports of poor bumper design, such as a lack of bottom bumper ties, or construction problems, such as bumper ties and decoration that detached. Parents often buy bumpers to prevent slat entrapments or to prevent infants bumping their heads in the cribs. This is the first study to show that these events occurred even with a bumper present. (more…)
AHRQ, Author Interviews, Heart Disease, Race/Ethnic Diversity / 24.11.2015

MedicalResearch.com Interview with: Kamila B. Mistry, PhD MPH Senior Advisor, Child Health and Quality Improvement Agency for Healthcare Research and Quality US Department of Health and Human Services Rockville, MD 20857  Medical Research: What is the background for this study? What are the main findings? Dr. Mistry: This study, conducted by researchers at the Agency for Healthcare Research and Quality (AHRQ), was seeking to explore what impact the Affordable Care Act (ACA) may have on the nation’s well-documented racial/ethnic disparities in insurance coverage, access to medical care, and preventive services utilization. We used pre-ACA (2005-2010) household data from AHRQ’s Medical Expenditure Panel Survey to examine patterns of coverage, access, and utilization, by race/ethnicity, for nonelderly adults who are targeted by ACA coverage expansion provisions.

Our analysis found that racial/ethnic minorities were disproportionately represented among groups targeted by the ACA. We also found that targeted groups had lower rates of coverage, access, and preventive services utilization, and some racial/ethnic disparities were widest within these groups.

(more…)
Author Interviews, Pediatrics, Tobacco Research / 24.11.2015

MedicalResearch.com Interview with: William G. Shadel, PhD Associate Director, Population Health Program Senior Behavioral Scientist RAND Corporation Pittsburgh, PA  15213  Medical Research: What is the background for this study? What are the main findings? Dr. Shadel: The tobacco industry spends almost all of its multi-billion dollar advertising budget at retail point-of-sale locations.  A key feature of their advertising strategy includes the tobacco power wall, a prominent behind the cashier display of hundreds of cigarette and tobacco product brands.  The power wall also displays posters for those tobacco products as well as pricing information.  As such, it conveys a lot of positive messages about tobacco products to consumers. The purpose of this experiment was to evaluate whether hiding or moving the tobacco power wall from its highly conspicuous location reduced teens’ smoking risk when they shop at convenience stores.   The study took place in the RAND StoreLab (RSL), a life-sized replica of a convenience store that was constructed to explore a range of options for regulating tobacco products at point-of-sale retail locations.  A sample of 271 teens (ages 11-17) was randomized to one of three experimental conditions: cashier (the tobacco power wall was located in its usual location, behind the cashier); side wall (the tobacco power wall was moved from behind the cashier to an out of the way location in the RSL); and hidden (the tobacco power wall was located behind the cashier, but was hidden behind an opaque wall).  After teens finished shopping in the RSL, they completed questionnaires that measured their susceptibility to future smoking. Teens assigned to the condition where the power wall was hidden were significantly less likely to report that they would smoke in the future, compared with those that were assigned to the cashier condition.  Locating the power wall to a sidewall had no effect on smoking susceptibility. (more…)
Author Interviews, Diabetes, FASEB, Nutrition, Yale / 24.11.2015

MedicalResearch.com Interview with: David L. Katz, MD, MPH, FACPM, FACP, FACLM Director, Yale University Prevention Research Center Griffin Hospital President, American College of Lifestyle Medicine Founder, True Health Initiative Medical Research: What is the background for this study? What are the main findings? Dr. Katz: the evidence that nuts in general, and walnuts in particular, have health promoting properties is vast and conclusive.  In our own prior research, we have shown that daily ingestion of walnuts ameliorates overall cardiac risk in type 2 diabetics (http://www.ncbi.nlm.nih.gov/pubmed/19880586) and that the same intervention improves cardiac risk and body composition in adults at risk for diabetes (http://www.ncbi.nlm.nih.gov/pubmed/23756586).  Our prior studies, and work by others, suggest that despite their energy density, walnuts may exert a favorable influence on calorie intake and weight, because of their very high satiety factor.  We also know that walnuts are highly nutritious overall, and suspect that those who add walnuts to their diets are apt to 'bump' something less nutritious out, thereby improving the overall quality of their diets as measured objectively. Accordingly, we designed the new study to look at the effects of daily walnut ingestion on diet quality, weight, and cardiac risk measures in a larger cohort of adults at risk for type 2 diabetes (ie, central obesity, indications of insulin resistance) over a longer period of time.  We also wondered whether the addition of some 350 daily calories from walnuts would result in the displacement of a comparable number of calories from other sources, so we compared the effects of the intervention with, and without, counseling to help people 'make room' for the walnut calories. We found again that walnuts improved overall cardiac risk status, as measured by endothelial function- essentially, a direct measure of blood vessel health and blood flow.  We also found that adding walnuts to the diet significantly improved overall diet quality, and did not lead to weight gain.  Walnuts also improved the lipid profile.  When walnut intake was combined with counseling for overall calorie intake, there was a significant decline in waist circumference. (more…)
Annals Thoracic Surgery, Author Interviews, Heart Disease, Technology / 24.11.2015

MedicalResearch.com Interview with: Neeraj Shah, MD, MPH Cardiology Fellow Department of Cardiology Lehigh Valley Health Network Allentown, PA. Medical Research: What is the background for this study? What are the main findings? Dr. Shah:  Congestive heart failure (CHF) affects 5.8 million Americans, with prevalence as high as 10% in individuals aged 65 years or more. There are long wait times for heart transplants. Left ventricular assist devices (LVADs) have been shown to significantly improve outcomes in end stage CHF patients. In the current situation of limited donor hearts, the utilization of LVAD technology is likely to increase over time. Moreover, the LVAD technology has improved considerably over time. The first generation devices were bulky and pulsatile in nature and of limited durability, whereas the second and third generation devices are smaller, longer lasting and exhibit “continuous flow”. The United States Food and Drug Administration (FDA) approved continuous flow devices in 2008. Presently, continuous flow devices account for over 95% of LVAD implants. Our aim was to examine the trends in utilization, in-hospital mortality, procedure related complications and cost of care after LVAD implantation from 2005 to 2011, and to study any differences in the pulsatile flow era from 2005-2007, compared to continuous flow era from 2008-2011. We used the Nationwide Inpatient Sample (NIS), which the largest all-payer US national hospitalization database, for our study. We identified LVAD implants using International Classification of Disease, 9th edition (ICD-9) procedure code 37.66. NIS data showed that there were 2,038 LVAD implantations from 2005 to 2011. LVAD utilization increased from 127 procedures in 2005 to 506 procedures in 2011, with a sharp increase after the year 2008 (from 149 procedures in 2007 to 257 procedures in 2008). In-hospital mortality associated with LVAD implantation decreased considerably from 47.2% in 2005 to 12.7% in 2011 (p<0.001), with a sharp decline in mortality after the year 2008 (from 38.9% in 2007 to 19.5% in 2008). Average length of stay (LOS) decreased from 44 days in the pulsatile-flow era to 36 days in the continuous-flow era. Cost of hospitalization increased from $194,380 in 2005 to $234,808 in 2011 but remained steady from 2008 to 2011. There was a trend of increased incidence of major bleeding and thromboembolism and decreased incidence of infectious and iatrogenic cardiac complications in the continuous-flow era. Thus, there has been a considerable increase in utilization of LVADs and decline in in-hospital mortality and LOS after LVAD implantation. These changes strongly coincide with US FDA approval of continuous flow devices in 2008. (more…)
Author Interviews, Blood Pressure - Hypertension, Emergency Care, Vanderbilt / 24.11.2015

MedicalResearch.com Interview with: Candace D. McNaughton, MD MPH FACEP Assistant Professor Emergency Medicine Research Department of Emergency Medicine, Research Division Vanderbilt University Medical Center Medical Research: What is the background for this study? What are the main findings? Dr. McNaughton: Hypertension, or high blood pressure, affects 1/3rd of adults in the United States and more than 1 billion people worldwide.  It is also the #1 risk factor for cardiovascular disease such as heart attack and stroke, so it is very important to treat. The burden of hypertension in the emergency department is not well understood.  The ER is not usually thought of as a place where perhaps we could or should be addressing hypertension; that has traditionally be left up to primary care providers. Through this study, our goals were to gain a better understanding of how many ER visits were either related to hypertension or were solely because of hypertension, and to determine whether this changed from 2006 to 2012. We found that emergency room visits related to or solely for hypertension were common and that they both rose more than 20% from 2006 to 2012. Visits to the emergency department specifically for hypertension were more common among patients who were younger, healthier, and less likely to have health insurance. Despite increases in the number of ER visits related to hypertension, the proportion of patients who were hospitalized did not increase; this suggests that doctors in emergency departments may be more aware of hypertension and/or may be managing it without having to hospitalize patients. (more…)
Annals Internal Medicine, Author Interviews, Hepatitis - Liver Disease / 24.11.2015

MedicalResearch.com Interview with: Dr. Tianhua He MD Beijing China, 100005 Medical Research: What is the background for this study? What are the main findings? Response: The prevalence of Hepatitis C (HCV) infection is high (17%) in US prisons. And about 30% of all HCV-infected persons in US spend part of the year in correctional facilities. However, most state prisons offer no routine screening for Hepatitis C. Undiagnosed and untreated inmates, after releasing, will contribute to the spread of the disease in society. HCV infection is now the leading cause of liver cancer, and the most common indication for liver transplant. With the recently launched highlyy effective antiviral drugs, previous studies have shown that treating infected prisoners was cost-effective. However, no studies yet have evaluated the effect of interventions including screening and treatment among prisoners on prevention of Hepatitis C transmission and reduction of disease burden, neither the cost effectiveness of such interventions. (more…)
Author Interviews, Kaiser Permanente, OBGYNE, Pediatrics / 24.11.2015

MedicalResearch.com Interview with: Erica P. Gunderson, PhD, MPH, MS, RD Senior Research Scientist, Division of Research, Cardiovascular and Metabolic Conditions Section Kaiser Permanente Northern California Oakland, CA 94612 Medical Research: What is the background for this study? Dr. Gunderson: Gestational diabetes mellitus (GDM) is a disorder of glucose tolerance affecting 5-9 percent of all U.S. pregnancies (approximately 250,000 annually), with a 7-fold higher risk of progression to type 2 diabetes. Strategies during the postpartum period for prevention of diabetes focus on modification of lifestyle behaviors, including dietary intake and physical activity to promote weight loss. Lactation is a modifiable postpartum behavior that improves glucose and lipid metabolism, and increases insulin sensitivity, with favorable metabolic effects that persist post-weaning. Despite these metabolic benefits, evidence that lactation prevents type 2 diabetes remains inconclusive, particularly among women with gestational diabetes mellitus (GDM). Among women with GDM, evidence that lactation prevents diabetes is based on only two studies with conflicting findings. The Study of Women, Infant Feeding and Type 2 Diabetes after GDM Pregnancy, also known as the SWIFT Study, is the first to measure breastfeeding on a monthly basis during the first year after delivery and the first to enroll a statistically significant number of women with gestational diabetes, and to evaluate social, behavioral and prenatal risk factors that influence development of type 2 diabetes, as well as breastfeeding initiation and success. (more…)
Alcohol, Author Interviews, Gender Differences, NIH / 24.11.2015

MedicalResearch.com Interview with: Aaron White, PhD Senior Scientific Advisor to the Director Office of the Director National Institute on Alcohol Abuse and Alcoholism National Institutes of Health Bethesda, MD Medical Research: What is the background for this study? What are the main findings? Dr. White: Recent studies and anecdotal evidence suggest that alcohol use by women in the United States might be on the rise and that long-standing gender gaps in drinking and related consequences might be narrowing. Using data from the National Survey on Drug Use and Health, we found that differences in the drinking patterns of females and males ages 12+ narrowed between 2002 and 2012 for current drinking (drinking at least once in the last 30 days), number of drinking days per month, past year DSM-IV alcohol abuse, and past-year driving under the influence of alcohol. For instance, the percentage of women who drank in the previous 30 days rose from 44% to 48%, while for men the percentage decreased from 57% to 56%. Average drinking days per month increased for women from 6.8 to 7.3 days, but dropped for males from 9.9 to 9.5 days. Driving under the influence (DUI) declined for both, but less so for females (from 10.3% to 7.9%) than males (from 19.0% to 14.4%), thereby narrowing the gender gap for DUI. Analyses revealed additional changes within specific age groups in the population. (more…)
Author Interviews, Gender Differences, Heart Disease, JAMA, Stroke / 23.11.2015

MedicalResearch.com Interview with: Bob Siegerink PhD Frits R. Rosendaal MD, PhD Department of Clinical Epidemiology Leiden University Medical Center Leiden, the Netherlands Medical Research: What is the background for this study? What are the main findings? Response: The rates of death due to arterial thrombosis have been declining in the past years, which means that there are more patients with a high burden of disease. Arterial thrombosis is a uncommon disease in the young, but the burden of the disease might have a profound impact on their lives. We analyzed data form the RATIO study, in which we followed women with a ischemic stroke and myocardial infarction for up to 20 years. During this time, overall mortality was 2-4 times higher compared to the general population. This increase in risk was mainly driven by deaths from acute vascular events and persisted over the whole course of the follow up. (more…)
Author Interviews, Pediatrics, Smoking, Tobacco / 23.11.2015

MedicalResearch.com Interview with: Dr. Andrea C. Villanti PhD, MPH Director, Regulatory Science and Policy Schroeder Institute for Tobacco Research and Policy Studies at Truth Initiative Washington, DC 20001 Medical Research: What is the background for this study? What are the main findings? Dr. Villanti: Awareness, interest, and use of electronic cigarettes (e-cigarettes) have increased since the products were introduced in the U.S. in 2006. Between 2012 and 2013, 8.3% of young adults reported current e-cigarette use compared to 4.2% of adults overall. One factor likely driving e-cigarette use as well as the use of other tobacco products is advertising, which has been demonstrated to promote the initiation and continued use of cigarettes. Advertising is critical for raising awareness about newly introduced products, and has been shown to influence initiation, experimentation, and progression to regular combustible cigarette smoking in youth. This study used a randomized control trial to assess the impact of brief exposure to four e-cigarette print advertisements (ads) on perceptions, intention, and subsequent use of e-cigarettes and cigarettes among young adults (age 18-34). It found that exposure to e-cigarette ads may enhance curiosity and limited trial of e-cigarettes in never users. Other findings include:
  • Compared to the control group, ad exposure was associated with greater curiosity to try an e-cigarette among never e-cigarette users (18.3% exposed vs. 11.3% unexposed), and greater likelihood of e-cigarette trial at follow-up among never users of cigarettes and e-cigarettes (3.6% exposed vs. 1.2% unexposed).
  • Exploratory analyses did not find an association between ad exposure and cigarette trial or past 30-day use among never users at follow-up, nor cigarette use among smokers over time.
  • Curiosity to try an e-cigarette mediated the relationship between ad exposure and e-cigarette trial among e-cigarette never users.
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Author Interviews, Heart Disease, JACC, Surgical Research / 23.11.2015

MedicalResearch.com Interview with: Chunsheng Wang, MD Department of Cardiovascular Surgery, Shanghai Cardiovascular Institution and Zhongshan Hospital Fudan University, Shanghai, China Medical Research: What is the background for this study? What are the main findings? Dr. Wang: Transcatheter aortic valve replacement (TAVR) has been widely used in high-risk patients for surgical aortic valve replacement. However, the majority of the TAVR devices were designed for aortic valve stenosis with significant valve calcification. For most of these devices, predominant aortic regurgitation remained to be a technological challenge because of questionable anchoring, which can result in a high incidence of valve migration and paravalvular leak. Consequently, the guidelines from the United States and the Europe suggest that candidates with predominant aortic regurgitation (>grade 3+) or noncalcified valve should not undergo TAVR. Patients with predominant aortic regurgitation who are at prohibitive risk for surgery need an alternative treatment. A new generation of transcatheter aortic valve devices with secure anchoring is needed. Six patients with native aortic regurgitation without significant valve calcification (age, 61 to 83 years; mean age, 75.50±8.14 years) underwent transapical implantation of the J-Valve prosthesis (JieCheng Medical Technology Co.,Ltd., Suzhou, China), a self-expandable porcine valve. Implantations were successful in all patients. During the follow-up period (from 31 days to 186 days, mean follow-up was 110.00±77.944 days), only 1 patient had trivial prosthetic valve regurgitation, and none of these patients had paravalvular leak of more than mild grade. There were no major postoperative complications or mortality during the follow-up. Our study demonstrated the feasibility of transapical implantation of the J-Valve system in high-risk patients with predominant aortic regurgitation. (more…)
Author Interviews, Breast Cancer, Nature / 23.11.2015

MedicalResearch.com Interview with: Paul K Newton PhD Professor of Aerospace & Mechanical Engineering, Mathematics, and Norris Comprehensive Cancer Center USC Viterbi University of Southern California University Park Campus Los Angeles, CA  90089-4012  Medical Research: What is the background for this study? What are the main findings? Dr. Newton: We obtained a longitudinal data set of 446 breast cancer patients from Memorial Sloan Kettering Cancer Center, tracked from 1975 to 2009. All of the patients had primary breast cancer at the time they entered, with no metastatic tumors. All subsequently developed metastatic breast cancer. From this time-resolved data set, we first developed what we called tree-ring diagrams showing the full spatiotemporal patterns of progression. We then used this information to develop a Markov chain dynamical model of metastatic breast cancer. This is a model based on the concept that where the disease currently is located strongly influences where it will spread next. The systemic nature of metastatic breast cancer is clearly shown in these kinds of network based models. The main findings are that survival depends very strongly on where the first metastatic tumor develops. For example, if the first metastatic tumor appears in the bone, as happens in roughly 35% of the patients, survival is much better than if it appears in the brain (less than 5% of the patients). Furthermore, for those patients with a first met to the bone, survival is far better for those who develop their next met in the lung area, as compared with those that develop it in the liver. Metastatic sites are categorized as `spreader’ sites, or `sponge’ sites. Bone and chest wall are generally the primary spreader sites of metastatic breast cancer, dynamically involved in spreading the disease throughout the metastatic process. On the other hand, liver seems to be a key sponge site, where circulating tumor cells most likely accumulate. If one were to focus on an active therapeutic program targeting metastatic sites, most likely the spreader sites would give the most bang-for-buck in terms of survival. (more…)
Author Interviews, Dermatology, JAMA, Melatonin, Pediatrics, Sleep Disorders / 23.11.2015

MedicalResearch.com Interview with: Prof. Bor-Luen Chiang Vice Superintendent, National Taiwan University Hospital Professor of Graduate Institute of Clinical Medicine and Pediatrics National Taiwan University Attending Physician, Department of Medical research National Taiwan University Hospital and Yung-Sen Chang, MD MPH Attending physician, Department of Pediatrics, Taipei City Hospital Renai Br. Adjunct Attending Physician, Department of Pediatrics National Taiwan University Children’s Hospital Adjunct Instructor, School of Medicine, National Yang-Ming University Medical Research: What is the background for this study? Prof. Chang: Sleep disturbance is a common disorder in the children with atopic dermatitis (AD) (reported in 47 to 60%), but no effective way of managing this problem had been established. In our preceding study, we found that lower nocturnal melatonin level was significantly associated with sleep disturbance in the patients with AD. Melatonin is a hormone secreted by the pineal gland which plays an important role in sleep regulation. In addition to sleep-inducing effects, melatonin also has anti-inflammatory and immunomodulatory properties which might be helpful for the management o fatopic dermatitis. Furthermore, melatonin has an excellent safety profile with minimal adverse effects, making it a good choice for children. Therefore, we aimed to evaluate whether melatonin is effective for improving the sleep problems and the dermatitis severity in children with atopic dermatitis. Medical Research: What are the main findings? Prof. Chang: From our double-blind, placebo-controlled crossover study, we found that after melatonin treatment, the sleep onset latency shortened by 21.4 minutes compared with placebo (from a mean of 44.9 minutes to 21.6 minutes). The Scoring Atopic Dermatitis Index (higher scores representing more severe dermatitis) also decreased by 9.9 compared with placebo (from a mean of 49.1 to 40.2). No adverse events were reported throughout the study. (more…)
Author Interviews, Pharmacology, Pulmonary Disease / 23.11.2015

MedicalResearch.com Interview with: Imre Noth, M.D. Professor of Medicine and Director of the Interstitial Lung Disease Programme The University of Chicago Medical Research: What is the background for this study? What are the main findings? Dr. Noth: In 2014, OFEV® (nintedanib) became one of the first FDA-approved drug treatments for idiopathic pulmonary fibrosis (IPF), a rare and serious lung disease that causes permanent scarring of the lungs. In this post-marketing surveillance study in the United States, treatment with OFEV in the real-world clinical setting showed a safety profile consistent with that observed in clinical trials supporting its approval by the FDA. Post-marketing surveillance of the safety and tolerability of OFEV in the United States has been collected in the Boehringer Ingelheim drug safety and reporting database since OFEV was first approved on October 15, 2014. Until May 31, 2015, 3,838 people were treated with OFEV for a length of time ranging from 14 to 265 days (on average 88 days).  The most frequently reported side effects were gastrointestinal in nature and included diarrhea, nausea, vomiting and decreased appetite. Diarrhea was the most frequently reported individual side effect, occurring at a similar frequency to that observed in the clinical trials supporting approval. No new safety concerns were identified. (more…)
Author Interviews, Emergency Care, Mental Health Research, Stanford / 22.11.2015

MedicalResearch.com Interview with: Arica Nesper, MD, MAS Resident Physician Stanford/Kaiser Emergency Medicine Residency Stanford University Medical Center Department of Emergency Medicine Stanford Medical Research: What is the background for this study? What are the main findings? Dr. Nesper: Patients with severe mental illness are a distinct demographic in the emergency department. Unfortunately, resources to help these vulnerable patients are frequently the target of funding cuts. We aimed to describe the effect of these cuts on our emergency department and the care provided to our patients. In this study we evaluated data from before our county mental health facility cut its inpatient capacity by half and closed its outpatient unit, and compared this data with data collected after this closure. We found that the mean number of daily psychiatric consultations in our emergency department more than tripled and that the average length of stay for these patients increased by nearly eight hours. These two data combined demonstrate a five-fold increase in daily emergency department bed hours for psychiatric patients, placing a significant strain on the emergency department and demonstrating a delay in definitive care provided to these vulnerable patients. (more…)
Author Interviews, Autism, Pediatrics, PNAS / 21.11.2015

MedicalResearch.com Interview with: Lauren Kenworthy, PhD Associate professor of Neurology, Pediatrics, and Psychiatry George Washington University School of Medicine Director of the Center for Autism Spectrum Disorders Children’s National Health System Medical Research: What is the background for this study? What are the main findings? Dr. Kenworthy: Connectivity among brain regions may account for variability in autism outcomes not explained by age or behavioral measures, according to a study. We have previously shown that behavioral assessments of intelligence, baseline adaptive behavior and executive functions in people with autism can explain some of the variation in outcomes and function, but we have not been able to explain all of the variance in outcome (e.g. Pugliese et al 2015a, 2015b). In this study, we found that 44% of the study group experienced significant change in scores on adaptive behavior between the initial scan and follow-up. Connectivity between three resting-state networks, including the salience network, the default-mode network, and the frontoparietal task control network, was linked not only to future autistic behaviors but also to changes in autistic and adaptive behaviors over the post-scan period. Further, connectivity involving the salience network and associated brain regions was associated with improvement in adaptive behaviors, with 100% sensitivity and around 71% precision. (more…)