Author Interviews, CT Scanning, Pain Research / 28.11.2018

MedicalResearch.com Interview with: Alessandro Napoli MD PhD Department of Radiological, Oncological and Pathological Sciences Sapienza University of Rome  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Disc Herniation in the lumbar region can create intense pain in the lower back and along the leg as a result of nerve compression. People suffering disc herniation may either experience a spontaneous relief from the pain or requiring further medical actions in order to improve quality of life and going back to work and daily activities. When the pain is not responding to usual conservative care (both physical and pharmacological therapy) surgery is often considered a valid option.However, most of the people (despite the intense pain) would possibly avoid surgery. For this reason, Interventional percutaneous therapies such as intraforaminal injection of steroid have become more popular. Pulsed radiofrequency is a percutaneous therapy that may have the potential to rapidly relief the pain in a long lasting way by means of single 10 minutes procedure. We decided to undertook a randomized clinical trial to test the clinical benefit of pulsed radiofrequency therapy using intraforaminal injection as a control group. in both groups percutaneous approach was guided under precise guidance of CT images. Pulsed radiofrequency group patients experience a faster and more durable pain control during the 1 year period follow up. Incidence of retreatment or cross-over was significantly higher in the injection only group. (more…)
Author Interviews, Immunotherapy, Multiple Sclerosis / 27.11.2018

MedicalResearch.com Interview with: Dietmar P. Berger, MD, PhD Head of Global R&D Atara Biotherapeutic MedicalResearch.com: What is the background for this study? Response: Epstein-Barr virus (EBV) is present in B lymphocytes, plasma cells and epithelial cells of over 95% of individuals over the age of 40.  Multiple studies have shown that nearly all patients with Multiple Sclerosis (MS) are EBV positive, including a recent presentation at the 2018 ECTRIMS Congress in Berlin that showed 100% of MS patients are positive for EBV (Ruprecht et. al). Current B cell directed therapies such as anti-CD20 therapies have demonstrated an effect on  Multiple Sclerosis activity. These therapies work by depleting B cells including those infected by EBV. Our belief is that loss of EBV-specific T cell function (e.g., T cell exhaustion) occurs in patients who develop Multiple Sclerosis, which results in the accumulation of EBV infected B and plasma cells in the CNS leading to the autoreactive immune cycle seen in MS patients. The increasing evidence of a link between EBV infection and the development of MS led to the initiation of a Phase 1 study to investigate the use of an autologous T-cell immunotherapy (ATA190) to selectively target and deplete EBV infected cells in patients with progressive MS. As T cell immunotherapies (like ATA190) are designed to penetrate the central nervous system, this approach was felt to be particularly useful in  Multiple Sclerosis where the inflammatory response and infected B lymphocytes and plasma cells are inaccessible inside the CNS to the vast majority of classic targeted agents. (more…)
Annals Internal Medicine, Author Interviews, Columbia, Genetic Research, Kidney Disease / 27.11.2018

MedicalResearch.com Interview with: Hila Milo Rasouly, PhD Postdoctoral research scientist Ali Gharavi Lab Columbia University MedicalResearch.com: What is the background for this study? Response: Genome sequencing is increasingly used in clinical medicine to help make a clinical diagnosis and make predictions about potential future complications. The diagnostic yield and limitations for different indications are still being worked out.  We are interested in studying the applications of genome sequencing for chronic kidney diseases. It is estimated that 10% of adults have chronic kidney disease (CKD), and amongst them, 10% are caused by single-gene (Mendelian) forms of disease. The American College of Medical Genetics and Genomics developed guidelines on how to interpret genetic variants in order to make a genetic diagnosis. Our lab has been engaged in studying the yield and impact of genetic testing for  CKD, and in the course of our research, we realized that a very large number of individuals have genetic variants that may be classified as pathogenic based on automated application of the guidelines. However, in majority of these cases, the genetic variant was much too frequent in the population to be plausibly disease-causing or did not match up well with the clinical diagnosis. This led us to wonder about the risk of false-positive genetic diagnosis. To analyze this risk for false-positive genetic diagnosis, we analyzed the genome sequence of 7,974 self-reported healthy adults. (more…)
Author Interviews, Autism, Nature, Pediatrics / 27.11.2018

MedicalResearch.com Interview with: Michael Lombardo, PhD Assistant professor of Psychology the University of Cyprus  MedicalResearch.com: What is the background for this study? Response: Autism is a diagnostic label we give to children with difficulties in the areas of social-communication and restricted, repetitive stereotyped behaviors and interests. The diagnosis is made based on observations about behavior and is a consensus label, meaning that clinicians can show high degrees of agreement that a given set of behaviors is ‘autism’. But aside from the diagnostic label, there is a fair degree of heterogeneity within patients that have the diagnosis. One way in which patients are heterogeneous is with regard to early language development. Some toddlers with autism are minimally verbal, while at the other end, many toddlers with autism develop language typically. An important question to answer is whether that kind of difference in language development indicates a subtype with different underlying biology. To examine this question, we first split toddlers with autism into two subtypes defined by their language outcome at 4 years of age. Some toddlers were classified as poor language outcome, because their language performance was 1 standard deviation below typical norms. Other toddlers with autism had relatively good language outcome, as their language performance by 4 years of age was within 1 standard deviation of typical norms. We also measured the biology behind these two autism subtypes. First we used functional magnetic resonance imaging (fMRI), which is a non-invasive method to look at blood oxygenation response that changes according to a task. Blood oxygenation changes are an indirect measure of neural activity. We used fMRI during natural sleep at around 29 months of age while the toddlers were played language stimuli through headphones to elicit neural responses to speech. Second, we measured molecular aspects of biology, by taking blood samples, isolating leukocyte cells, and then quantifying gene expression for all protein coding genes in the genome, at around the same time as the fMRI scan. (more…)
Author Interviews, JAMA, Neurology, Stroke / 27.11.2018

MedicalResearch.com Interview with: Giacomo Koch, MD, PhD Laboratorio di Neurologia Clinica e Comportamentale Fondazione S. Lucia I.R.C.C.S. Italy MedicalResearch.com: What is the background for this study? What are the main findings?  Response: We show in this paper that non invasive stimulation of the cerebellum in patients with stroke is able to improve motor functions. In particular we found that after three weeks of repetitive TMS of the intact cerebellum patients with hemiparesis due to stroke in the cerebral hemisphere remarkably improved their ability to walk and keep their balance, thus highly reducing the risk of fall.  (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA, Pharmacology / 26.11.2018

MedicalResearch.com Interview with: Abiy Agiro, PHD HealthCore Inc Wilmington, Delaware  MedicalResearch.com: What is the background for this study? Response: Biosimilar approval pathway, authorized in 2010 by the Biologics Price Competition and Innovation Act as part of the Affordable Care Act, aims to increase adoption of biosimilar products and generate significant cost savings to payers and patients alike. Biosimilar filgrastim, used to prevent febrile neutropenia, is one of the first biosimilars to be approved in the United States. A large scale, post-approval real-world analysis was needed that compares biosimilar filgrastim to the original drug for safety and efficacy. (more…)
Author Interviews, Cancer Research, JAMA / 26.11.2018

MedicalResearch.com Interview with: Ola Landgren, MD, PhD Professor of Medicine Chief, Myeloma Service Department of Medicine Memorial Sloan Kettering Cancer Center New York, NY 10065 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Meta-analysis show that minimal residual disease (MRD) negativity is a strong predictor of longer progression-free survival (PFS). Emerging data show that an increasing proportion of newly diagnosed multiple myeloma patients obtain MRD negativity after modern combination therapy, even in the absence of bone marrow transplant. The first generation of 3-drug combination therapy (RVd) was associated with quite high rates of peripheral neuropathy which may be life-long. The current study was designed to define the rates of peripheral neuropathy in newly diagnosed multiple myeloma treated with the second generation of 3-drug combination therapy (KRd), and per default delayed transplant (i.e. collection of stem cells which were stored for potential future use). This single arm, phase 2 study found no cases of grade 3 peripheral neuropathy. The rates of MRD negativity wereunprecedented; 28 of 45 patients achieved MRD-negative CR (62%). The durability of MRD-negative CR has been observed up to 70 months (median duration 52.4 months). Patients who achieved MRD negativity by the end of cycle 8 had a 78% reduced risk of progression. The results were regardless of age or cytogenetic risk category. The results from this second generation of 3-drug combination therapy (KRd) without transplant,  compare favorably to first generation of 3-drug combination therapy (RVd) followed by stem cell transplant. (more…)
Author Interviews, Heart Disease, JAMA, Lifestyle & Health, Nutrition / 26.11.2018

MedicalResearch.com Interview with: Ravi B. Patel, MD Division of Cardiology, Department of Medicine Northwestern University Feinberg School of Medicine Chicago, Illinois MedicalResearch.com: What is the background for this study? What are the main findings? Response: The digital attention of scientific articles can be readily quantified using the Altmetric score. The Altmetric score is a weighted measure, incorporating a variety of media platforms. We aimed to characterize the Top 10% of articles by Altmetric score among 4 major cardiovascular journals (Circulation, European Heart Journal, Journal of the American College of Cardiology, and JAMA Cardiology) in 2017. Our primary findings were: 1) nearly half of the most disseminated articles were not original research investigations, 2) the most common article topic was nutrition/lifestyle, and 3) there was a weak but significant correlation between Altmetric scores and citation number.  (more…)
Alzheimer's - Dementia, Author Interviews, CMAJ, Pharmacology / 26.11.2018

MedicalResearch.com Interview with: Jennifer Watt, PhD Clinical Epidemiology and Health Care Research Institute of Health Policy, Management, and Evaluation University of Toronto MedicalResearch.com: What is the background for this study?   Response: Behavioral and psychological symptoms of dementia (e.g. aggression, agitation) are common among persons living with dementia. Pharmacological (e.g. antipsychotics) and non-pharmacological (e.g. reminiscence therapy) interventions are often used to alleviate these symptoms. However, antipsychotics are associated with significant harm among older adults with dementia (e.g. death, stroke). Regulatory agencies such as the Food and Drug Administration (FDA) and Health Canada issued black box warnings to advise patients and clinicians of this potential for harm. And initiatives were championed to decrease the use of antipsychotics in persons living with dementia. In response, we have seen a rise in the use of other pharmacological interventions, such as trazodone (an antidepressant). Its potential to cause harm in older adults with dementia is largely unknown. (more…)
Accidents & Violence, Author Interviews, Mental Health Research, Race/Ethnic Diversity, Social Issues / 26.11.2018

MedicalResearch.com Interview with: "USA - NY - City of New York Police VARIATION" by conner395 is licensed under CC BY 2.0Dr. Jordan E. DeVylder, PhD Graduate School of Social Service Fordham University, New York, New York MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study is intended to address the lack of empirical research on police violence from a public health perspective. The main findings are that police violence is relatively widespread in Baltimore and New York City, is disproportionately directed toward people of color and sexual or gender minorities, and is associated with psychological distress, suicidal behavior, and psychosis-like symptoms. (more…)
Author Interviews, Dermatology, JAMA / 26.11.2018

MedicalResearch.com Interview with: Dr Tarun Narang MD MNAMS Department of Dermatology, Venereology, and Leprology Postgraduate Institute of Medical Education and Research Chandigarh, India MedicalResearch.com: What is the background for this study? Response: Acne is one of the most common dermatological problem for which the patients seek medical care. Post acne scarring is a complication of acne, resulting in long lasting physical disfigurement and low self esteem in the affected individuals. Even though there are various methods like microneedling, chemical peeling, cryorolling and ablative lasers to address the post acne atrophic scarring, these procedures are office based hence physician dependent. A home based treatment modality that can treat post acne atrophic scarring with a comparable efficacy to the procedural modalities of treatment will be beneficial to the patient. Our study was done to assess the efficacy of a topical modality of treatment, tazarotene gel, 0.1% in the management of post acne atrophic scarring in comparison to an established method, the microneedling. (more…)
Author Interviews, Environmental Risks, JAMA, Melanoma / 24.11.2018

MedicalResearch.com Interview with: Reza Ghiasvand, PhD Oslo Centre for Biostatistics and Epidemiology Faculty of Medicne University of Oslo Oslo, Norway  MedicalResearch.com: What is the background for this study? Response: Melanoma is the most dangerous type of skin cancer. It is estimated that about 288,000 individuals will be diagnosed and about 61,000 will die from it in 2018, with the majority of patients in Australia, New Zealand, Europe and North America. Ultraviolet (UV) exposure (from both the sun and tanning beds) is the most important preventable risk factor for melanoma. However, the association between UV exposure and melanoma is complex and does not accord with a simple model in which risk increases directly with exposure. An individual risk of melanoma also depends on personal characteristics such as skin color and skin sensitivity to the UV exposure, hair color, number of moles, and age. It has been hypothesized that the pattern of UV exposure may play a role in melanoma development in different body sites. For example, melanoma on the trunk (chest and back) has been linked to the recreational UV exposure such as sunbathing and frequent sunburns in people with high number of moles on their body. In contrast, melanomas on the head and neck have been linked to constant sun exposure such as occupational UV exposure, mainly in older people. Epidemiologic and molecular evidence in support of this hypothesis has been published based on analyses of small datasets. Also, melanoma on legs and arms is less studied under this hypothesis. In our study, we examined UV exposure (sunbathing, sunburn and sunbed use) and pigmentary factors (skin, eye, and hair color, freckling, and number of moles), and risk of melanoma on different body sites. We used information from the Norwegian Women and Cancer Study, a population-based cohort study that started in 1991, and includes more than 161,000 Norwegian women followed for an average of 18 years. (more…)
Author Interviews, BMJ, Brigham & Women's - Harvard, Diabetes, Occupational Health / 24.11.2018

MedicalResearch.com Interview with: "Night Shift" by Yuchung Chao is licensed under CC BY-ND 3.0Dr. Zhilei Shah PhD Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety Ministry of Education Key Lab of Environment and Health, School of Public Health Tongji Medical College, Huazhon University of Science and Technology Wuhan,  China MedicalResearch.com: What is the background for this study? Response: Shift work has progressed in response to changes in economic pressure and greater consumer demand for 24-hour services. There are many economic advantages to increased shift work, including higher employment, increased services to customers, and improved trade opportunities. Currently, one in five employees in the U.S. works nonstandard hours in the evening, night, or rotating shifts. However, shift work, especially night shift work, has been associated with a higher risk of chronic diseases, including type 2 diabetes, cardiovascular disease, and several types of cancer. Compelling evidence has shown that body weight and lifestyle behaviors, such as smoking, diet, and physical activity can influence type 2 diabetes risk. Among shift workers, excess adiposity and increased smoking are frequently and consistently reported, whereas the evidence on physical activity and diet is mixed. Additionally, no previous study has examined the joint associations of rotating night shift work duration and unhealthy lifestyle factors with risk of type 2 diabetes, or evaluated their potential interactions. Therefore, we prospectively assessed the joint association of rotating night shift work and established type 2 diabetes lifestyle risk factors with risk of type 2 diabetes and quantitatively decomposed the proportions of the joint association to rotating night shift work alone, to lifestyle alone and to their interaction in two large US cohorts. (more…)
Author Interviews, CDC, Exercise - Fitness, JAMA, Lifestyle & Health / 24.11.2018

MedicalResearch.com Interview with: Emily N Ussery, PhD Epidemiologist LT, US Public Health Service Physical Activity and Health Branch National Center for Chronic Disease Prevention and Health Promotion Centers for Disease Control and Prevention  MedicalResearch.com: What is the background for this study? Response: Sitting for too long and being physically inactive can have negative health consequences, and it is important to understand how common these behaviors are among US adults. This study describes sitting time and leisure-time physical activity reported by US adults in a national survey. (more…)
Author Interviews, Hospital Readmissions, JAMA, Schizophrenia, University of Pittsburgh / 22.11.2018

MedicalResearch.com Interview with: Hayley D. Germack PHD, MHS, RN Assistant Professor, School of Nursing University of Pittsburgh MedicalResearch.com: What is the background for this study? What are the main findings? Response: As nurse scientists, we repeatedly witness the impact of having a serious mental illness (i.e. schizophrenia, bipolar disorder, and major depression disorder) on patients’ inpatient and discharge experience. As health services researchers, we know how to make use of large secondary data to illuminate our firsthand observations. In 2016, Dr. Hanrahan and colleagues (https://www.sciencedirect.com/science/article/pii/S0163834316301347) published findings of a secondary data analysis from a large urban hospital system that found 1.5 to 2.4 greater odds of readmission for patients with an  serious mental illness diagnosis compared to those without. We decided to make use of the AHRQ’s HCUP National Readmissions Database to illuminate the magnitude of this relationship using nationally representative data. We found that even after controlling for clinical, demographic, and hospital factors, that patients with SMI have nearly 2 times greater odds of 30-day readmission.  (more…)
Asthma, AstraZeneca, Author Interviews, Pulmonary Disease / 22.11.2018

MedicalResearch.com Interview with: “Asthma Inhaler” by NIAID is licensed under CC BY 2.0Sean O'Quinn MPH Director, Patient Reported Outcomes AstraZeneca  MedicalResearch.com: What is the background for this study? How does benralizumab differ from traditional medications for asthma? Response:  FASENRA™ (benralizumab 30mg for subcutaneous injection as add-on maintenance therapy in severe eosinophilic asthma for patients 12 years and older) has a strong clinical profile, including powerful efficacy against exacerbations and the ability to improve lung function. Benralizumab is a respiratory biologic that binds directly to the IL-5α receptor on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis. (NOTE: The mechanism of action of FASENRA in asthma has not been definitively established.) Benralizumab is not indicated for treatment of other eosinophilic conditions or for relief of acute bronchospasm or status asthmaticus. The most common adverse reactions include headache and pharyngitis. Dependence on rescue medications is indicative of poor asthma control. In the Phase III SIROCCO/CALIMA trials, patients with severe eosinophilic asthma had significantly reduced exacerbation frequency and improved lung function when treated with benralizumab 30mg Q8W (first three doses Q4W) vs. placebo. Less was known about the effects of benralizumab on rescue medication usage—specifically daily total rescue medication use, daytime and nighttime rescue medication use, and nighttime awakenings requiring rescue medication use. The aim of this analysis was to understand the potential treatment effects of benralizumab on these parameters.  (more…)
Author Interviews, JAMA, Weight Research / 22.11.2018

MedicalResearch.com Interview with: Ching-Ti Liu, PhD Department of Biostatistics Boston University School of Public Health Boston, Massachusetts MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Being overweight and obese are increasing worldwide and this obesity epidemic threatens to reverse the gains in life expectancy achieved over the past century. However, many investigators have observed, paradoxically, that overweight individuals are associated with a lower mortality risk. These results may suffer from a potential confounding due to illness or reverse causality in which preexisting conditions may alter both body weight and the risk of death.  Recently published studies have tried to mitigate this reverse causal bias by implementing sample exclusion and they came to a different conclusion: between BMI and all-cause mortality there is an increased risk of death for the entire range of weights that are in the overweight and obesity ranges. However, the elimination strategies may lead to the loss of generalizability or precision due to over-adjustment. In addition, the traditional investigations have only utilized a subject’s weight at a single point in time, which makes it difficult to adequately address bias associated with reverse causality. Currently, the idea incorporating a subject’s weight history has been proposed to deal with the concern of reverse causality, but the existing works had been based on a subject’s recall or self-reported data, which may lead to misclassification and, therefore, result in overestimating the risk of mortality. To help assess the relevance of being overweight or obese to the risk of death in the general population, we conducted a prospective study, using an individuals’ maximum BMI before the beginning of survival follow-up instead of their weight status at a single point in time, using data from the Framingham Heart Study (FHS). We observed increasing risk of mortality across various BMI categories (overweight < obese I < obese II) relative to normal weight using maximum BMI over 24 years of weight history. (more…)
Author Interviews, Cleveland Clinic, Heart Disease, JACC, Surgical Research / 22.11.2018

MedicalResearch.com Interview with: Peter Hu MD Cleveland ClinicPeter T. Hu MD Department of Cardiology Cleveland Clinic MedicalResearch.com: What is the background for this study? What are the main findings? Response: Among patients with blockages in multiple coronary vessels, we studied predictors and outcomes of having a staged versus one-time multivessel percutaneous coronary intervention. By "staged" we mean performing coronary intervention only on one vessel, letting the patient recover, and fixing the other blockages at a later date. We know that multivessel coronary artery disease is very common - present in up to 2/3 of patients who require coronary interventions. Previous studies in patients with STEMI (ST-elevation myocardial infarction) suggested that staged multivessel PCI was associated with lower risk of death compared with one-time multivessel revascularization. Outside of STEMI patients, very little data exist in a broader group of patients who undergo coronary interventions to multiple vessels. In our study, we found an association between doing a staged PCI and lower long-term mortality benefit compared with fixing multiple blockages at once. What was surprising was there seemed to be a correlation with the degree of benefit from staged PCI based on the symptoms and signs the patient presented with. The association with improved outcomes was strongest in patients with STEMI, followed by those with NSTEMI, unstable angina, and stable angina, respectively. We also found that the decision to perform staged PCI was driven by patient and procedural characteristics, as well as other unmeasured site variation.  (more…)
Author Interviews, Gastrointestinal Disease, Microbiome, NEJM, Pediatrics, Probiotics / 22.11.2018

MedicalResearch.com Interview with: Stephen Freedman MDCM, MSc Alberta Children's Hospital Foundation Professor in Child Health and Wellness Sections of Pediatric Emergency Medicine and Gastroenterology Alberta Children's Hospital & Research Institute University of Calgary Calgary, AB  MedicalResearch.com: What is the background for this study? Response: Vomiting and diarrhea remain extremely common diseases in children and are the most common reason children are brought for emergency department care in North America.  While we have options to reduce vomiting there historically has been little physicians can offer to reduce the severity of the diarrhea. Probiotics have recently emerged as an option with some early evidence of benefit in clinical trials but the studies performed to date have been small and few little research has been conducted in North America in outpatient or emergency department children. The one study to date that was performed in a US emergency department did not find probiotic use to be beneficial.  Given the increasing importance of clarifying this issue we undertook this study. (more…)
AHA Journals, Author Interviews, Blood Pressure - Hypertension / 20.11.2018

MedicalResearch.com Interview with: Adam Bress, Pharm.D Department of Population Health Sciences School of Medicine University of Utah MedicalResearch.com: What is the background for this study? What are the main findings? o   The background here is that the new 2017 ACC/AHA BP guidelines lowered the threshold for antihypertensive medication initiation and intensification from <140 mmHg in most patients to <130 mm Hg. o   We used contemporary, population-based studies of US adults to estimate the potential population health impact of achieving and maintaining the lower treatment targets recommended in the 2017 ACC/AHA BP guidelines compared to previous guidelines. o   We found that achieving and maintain the lower thresholds recommended in the 2017 ACC/AHA BP guidelines over 10 years would:
  • Prevent 3.0 million CVD events compared to currently blood pressure and treatment levels
  • Prevent 0.5 million more events compared to achieving and maintain JNC7 goals
  • Prevent 1.4 million more events compared to achieving and maintain JNC7 goals
o   We estimated the size of the population health impact of achieving and maintaining the lower blood pressure treatment targets in the 2017 ACC/AHA BP guidelines compared to previous guidelines.
  • Achieving and maintaining the lower blood pressure thresholds for antihypertensive medication initiation and titration by the 2017 guidelines, are projected to prevent ~20% and ~90% more CVD events over ten years compared to achieving and maintaining JNC7 or JNC8 goals respectively.
o   Although we estimated more adverse events with the lower treatment goal, what our analysis found is that the benefits of achieving and maintaining the 2017 high blood pressure treatment recommendations far outweighs the risks. Many adverse events from high blood pressure treatment can be managed medically – and the lower threshold for treatment could potentially help millions of Americans lower their chances of developing heart disease or dying from heart attacks, strokes and other cardiovascular events, (more…)
Author Interviews, Heart Disease, JACC, Surgical Research, Technology / 20.11.2018

MedicalResearch.com Interview with: Evolut TAVR PlatformDr. Shazia Afzal MD University Hospital Düsseldorf, Medical Faculty, Division of Cardiology, Pulmonology and Vascular Medicine, Düsseldorf, Germany MedicalResearch.com: What is the background for this study? Response: Since its introduction in 2002, transcatheter aortic valve replacement (TAVR) emerged to an increasingly important interventional procedure in the field of structural heart disease. Widespread use in Europe, the USA and Canada lead to continuous technological development and improved patient’s safety, procedural success and clinical outcome. In 08/2017 one of the market leaders introduced its latest generation valve model -the CoreValve Evolut PROTM- which was especially designed to mitigate paravalvular leakage after valve deployment. We conducted the first prospective study which directly compares the Evolut PROTM with its direct predecessor the Evolut RTM as a head-to-head analysis especially focusing on hemodynamic performance and clinical outcome in a real-world setting. To ensure comparability between groups, we performed propensity score matching with special interest in CT-derived data to guarantee equitable anatomical conditions. Since both valves are on the market but sold at different prices the pivotal question is whether the Evolut PROTM reaches its target. In a highly budget restricted health care system with limited refunding cost-effectiveness evolves to a substantial discussion point in daily clinical practice. Our results may not be marketing friendly but we think of relevance for the interventional community.  (more…)
Author Interviews, CMAJ, HIV, Sexual Health / 20.11.2018

MedicalResearch.com Interview with: Rachel Rodin Centre for Communicable Diseases and Infection Control Public Health Agency of Canada MedicalResearch.com: What is the background for this study? What are the main findings? Response: On December 1, 2016 (World AIDS Day), the Honourable Jody Wilson-Raybould, federal Minister of Justice, committed to working with provinces and territories, affected communities, and medical professionals to examine the criminal justice system’s response to non-disclosure of HIV status in the context of sexual relations. To this end, Justice Canada worked with the Public Health Agency of Canada (PHAC), provincial and territorial public health and justice counterparts, and a variety of other stakeholders to develop a comprehensive report on the issue of HIV non-disclosure. As part of this work, Justice Canada asked PHAC to provide an assessment of the most recent medical science on sexual HIV transmission risk. In collaboration with external peer reviewers, PHAC undertook a systematic review of the full body of scientific evidence on sexual HIV transmission risk. The review found that the risk of sexual transmission of HIV is negligible when an individual is taking antiretroviral therapy as prescribed and maintains a suppressed viral load. The review also concluded that the risk remains low when the individual is on antiretroviral therapy with varying viral load, or is not on antiretroviral therapy but uses condoms.    (more…)
Accidents & Violence, Author Interviews, Pediatrics / 20.11.2018

MedicalResearch.com Interview with: "Pondering a firearm" by Dan Foy is licensed under CC BY 2.0Erin Morgan PhD Student | Department of Epidemiology University of Washington MedicalResearch.com: What is the background for this study? What are the main findings? Response: Going into this study we were interested in looking at youth exposure to unsafely stored firearms. Unsafely stored firearms in the household, especially those that are stored unlocked, are a known risk factor for adolescent suicide. We were also interested in looking into a population of children and teens who are at particularly heightened risk for suicide and unintentional injury—those living with an adult who misuses alcohol. Overall, we found that about 30% of those under the age of 18 live in a firearm owning home and among those youth, around 55% lived with a firearm stored in a way other than locked and unloaded. Among those in firearm owning household, we also found that when compared to youth living with a survey respondent that did not report alcohol misuse, those living with an adult that did misuse alcohol were 20% more likely to reside in a home where the firearm was stored unsafely; children were 27% more likely to live in a home reporting unlocked storage, specifically. (more…)
Alcohol, Author Interviews, CDC, JAMA, Primary Care, USPSTF / 20.11.2018

MedicalResearch.com Interview with: Dr. Carol Mangione M.D., M.S.P.H., F.A.C.P Ronald Reagan UCLA Medical Center Division Chief of General Internal Medicine and Health Services Research Professor of Medicine. Barbara A. Levey, MD, and Gerald S. Levey, MD Endowed chair in medicine David Geffen School of Medicine University of California MedicalResearch.com: What is the background for this study? What are the main findings? Response: Unhealthy alcohol use is relatively common and is increasing among U.S. adults. Alcohol use is the third leading cause of preventable death in the U.S. and contributes to more than 88,000 deaths per year. In pregnancy, it also leads to birth defects and developmental problems in children. The Task Force found that screening tests and brief counseling interventions can help detect and reduce unhealthy alcohol use among adults, and in turn help prevent negative consequences related to alcohol use. For adolescents ages 12 to 17, clinicians should use their best judgment when deciding whether or not to screen and refer their patients to counseling, until we have better studies available. (more…)
Author Interviews / 19.11.2018

MedicalResearch.com Interview with: Jace B. King, PhD Department of Radiology and Imaging Sciences Interdepartmental Program in Neuroscience University of Utah, Salt Lake City MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Aberrant brain connectivity is believed to be a robust neurobiological underpinning in individuals with autism spectrum disorder. To date, the majority of functional connectivity fMRI studies have focused on the strength of the relationship between coactivating regions of the brain during a resting state. An often-replicated finding suggests individuals with autism demonstrate increased short-range functional connectivity and decreased long-range functional connectivity. Our study focuses on the temporal domain of functional connectivity fMRI data acquired using long duration multiband, multiecho acquisitions. We used two different measurements of the temporal synchrony between brain regions to establish that, on average, individuals with autism exhibit prolonged functional connectivity in multiple regions associated with a diagnosis of the disorder. A number of these findings were then replicated in a large multisite dataset (Autism Brain Imaging Data Exchange). Additionally, we found a strong positive relationship between the duration of functional connectivity in multiple brain regions and symptoms relating to social dysfunction in individuals with autism suggesting that they may need to hang on to neural connections just a bit longer in order to process social queues and quickly changing novel sensory information. (more…)
Author Interviews, Diabetes, Heart Disease, JAMA, Weight Research / 19.11.2018

MedicalResearch.com Interview with: "Obesity runs rampant in Indiana." by Steve Baker is licensed under CC BY-ND 2.0Haris Riaz MD (Cardiology Fellow Haitham Ahmed MD, MPH , Preventive Cardiologist, Cleveland Clinic, Ohio MedicalResearch.com: What is the background for this study? What are the main findings? Response: Elevated cholesterol (specially low density lipoprotein) has been causally linked to the development of coronary artery disease whereas the causal relationship between obesity and cardiovascular disease has remained controversial. This is important because of increasing epidemic of obesity and metabolic syndrome. Mendelian randomization studies provide one way of determining a causal association where we can look at the outcomes of individuals stratified by the presence or absence of a particular allele. Since these alleles are randomly distributed in the population of interest, this is "nature's randomized trial" in that the particular allele is naturally distributed and hence minimal risk of bias. In other words, lets say that I hypothesize that a particular gene "A" is linked with coronary artery disease. If the given gene is indeed causally linked with coronary artery disease, patients with activation of that gene should have significantly greater risk of developing coronary artery disease. Based on these principles, we conducted a systematic review and meta-analysis of the available evidence and found that the risk of developing coronary artery disease and diabetes is significantly increased with obesity. Although hypothesis generating, we think that these findings may suggest a causal association between obesity and cardiovascular disease.  (more…)
Alzheimer's - Dementia, Author Interviews, JAMA / 19.11.2018

MedicalResearch.com Interview with: "A neonate with Down's?" by Sadasiv Swain is licensed under CC BY 2.0Rosalyn Hithersay LonDowns Kings College, London  MedicalResearch.com: What is the background for this study? What are the main findings? Response: In our research group, we have been following a large group of adults with Down syndrome in the UK to track changes with ageing in their health and cognitive function. It has been known for some time now that people with Down syndrome are at high risk for developing dementia due to Alzheimer’s disease. This new study has shown the huge impact that this risk has on mortality for these adults. We found that dementia is now the likely underlying cause of death in more than 70% of adults with Down syndrome aged over 35 years. This is a much bigger proportion of deaths due to Alzheimer’s disease compared to the general population: in England and Wales only 17.5% of deaths past the age of 65 would be related to dementia of any kind.  (more…)
Author Interviews, Environmental Risks / 19.11.2018

MedicalResearch.com Interview with: Dr. Gilbert Rochon, III PH.D., MPH Adjunct Professor, Dept. of Global Health Management & Policy Tulane University’s School of Public Health & Tropical Medicine Senior Consultant with MSF Global Solutions, LLC New Orleans MedicalResearch.com: What is the background for this study? Response: Having observed the frequency with which President Donald Trump characterized changes in regulatory policies and funding levels with respect to public health and the environment as eliminating or curtailing "unnecesssary Obama-era regulations," I became curious as to the full extent and impact of such deregulation and under-funding of health and environmental safeguards. In the process, I found it necessary to review federal government contributions to public health and the environment under all previous presidents.  (more…)
Author Interviews, JAMA, Ophthalmology, Pediatrics / 19.11.2018

MedicalResearch.com Interview with: "i have a lazy eye but it's a good thing" by jessica mullen is licensed under CC BY 2.0Eileen E. Birch, PhD Director, Crystal Charity Ball Pediatric Vision Evaluation Center Retina Foundation of the Southwest Adjunct Professor of Ophthalmology UT Southwestern Medical Center   MedicalResearch.com: What is the background for this study? What are the main findings?  Response: We previously reported that amblyopia, but not nonamblyopic strabismus or anisometropia, is associated with slower reading speed (Kelly et al  Journal of AAPOS 2015) and that this is related to abnormal eye movements and unstable fixation associated with amblyopia (Kelly et al 2017).  We have also shown that amblyopic children are slower at completing Scantron answer sheets (JAMA Ophthalmology 2018).  We thought that these difficulties experiences in school-age children with amblyopia might affect their self-perception. (more…)
Author Interviews, OBGYNE, Omega-3 Fatty Acids / 18.11.2018

MedicalResearch.com Interview with: “omega 3” by Khaldaa Photographer is licensed under CC BY 2.0Philippa Middelton MPH Associate Professor Healthy Mothers, Babies and Children South Australian Health and Medical Research Institute Adelaide, Australia  MedicalResearch.com: What is the background for this study? What are the main findings? Response: For several decades, it has been known that fish or fish oils can lengthen gestation. In our Cochrane review of 70 studies and nearly 20,000 women we show that fish oil (mainly as omega-3 fatty acid supplements), prevents premature birth, specifically
  • An 11% reduction in premature birth < 37 weeks gestation;
  • And a 42% reduction in premature birth < 34 weeks gestation.
(more…)