Alzheimer's - Dementia, Author Interviews, Cognitive Issues, Duke, Neurology / 24.09.2019

MedicalResearch.com Interview with: Juan Helen Zhou, PhD, on behalf of the co-authors Associate Professor and Principal Investigator Neuroscience and Behavioural Disorders (NBD) Programme Duke-NUS Medical School, SingaporeJuan Helen Zhou, PhD, on behalf of the co-authors Associate Professor and Principal Investigator Neuroscience and Behavioural Disorders (NBD) Programme Duke-NUS Medical School, Singapore  MedicalResearch.com: What is the background for this study? Response: Alzheimer’s disease and cerebrovascular disease are among the leading disorders affecting the elderly, with up to 50 per cent of dementia patients showing co-occurrence of both disorders. It is therefore of great interest to understand the influence of co-occurring Alzheimer’s disease and cerebrovascular disease pathologies on brain changes, and examine if such changes are able to track early differential disease progression. Past cross-sectional studies have suggested that Alzheimer's disease and cerebrovascular disease pathologies contribute independently to brain functional and structural changes, and cognitive decline. Our study sought to demonstrate the independent contributions of both pathologies to brain functional networks in a longitudinal cohort of mild cognitive impairment patients, often regarded as early stage of the disease. (more…)
Author Interviews, CT Scanning, JAMA, Lung Cancer, UCSF / 23.09.2019

MedicalResearch.com Interview with: Joshua Demb, PhD, MPH Postdoctoral Scholar, Moores Cancer Center University of California, San Diego Health Science Research Specialist Veterans Affairs San Diego Healthcare System MedicalResearch.com: What is the background for this study? Response: Our study leveraged radiation dose data from 72 facilities performing CT scans around the United States to learn more about the radiation dose used for lung cancer screening scans, as well as possible institutional predictors that might be associated with higher dose.  Currently, the American College of Radiology has recommendations for how these low-dose lung cancer screening scans should be performed. However, it is unclear how much adherence there currently is to these guidelines. Our findings indicated that there is wide variation in the distribution of radiation doses for low-dose lung cancer screening scans both within- and between facilities in our sample—in some cases this variation led to doses higher than the ACR recommendations.   (more…)
Author Interviews, Cost of Health Care, JAMA, University of Pittsburgh / 23.09.2019

MedicalResearch.com Interview with: Coleman Drake, PhD Assistant Professor, Department of Health Policy and Management Affiliate faculty member Center for Pharmaceutical Policy and Prescribing University of Pittsburgh MedicalResearch.com: What is the background for this study? Response: Every year, the Centers for Medicare and Medicaid Services puts out of notice of proposed changes to the rules governing the Health Insurance Marketplaces created by the Affordable Care Act (e.g., healthcare.gov). The most recent notice for 2020 (issued in 2019) considered eliminating automatic reenrollment for Marketplace enrollees. On the one hand, requiring that enrollees actively select a health plan to stay insured is a good thing because it forces them to consider their options – we know that people make better health plan choices when they consider their choices. On the other hand, creating an administrative barrier to staying insured could cause some people to become uninsured. Since 3.4 million Marketplace enrollees used automatic enrollment in 2019, eliminating it might cause a spike in the uninsured rate. (more…)
Author Interviews, Heart Disease, Pediatrics, Smoking, UCSF / 23.09.2019

MedicalResearch.com Interview with: Gregory M Marcus, MD, MAS Professor of Medicine in Residence Endowed Professor in Atrial Fibrillation Research University of California, San Francisco Associate Chief of Cardiology for Research, UCSF Health University of California, San Francisco MedicalResearch.com: What is the background for this study? What are the main findings? Response: Smoking remains the most common preventable cause of death and disability. We previously found evidence that tobacco smoke exposure in the young may lead to atrial fibrillation, the most common heart rhythm disturbance, later in life. Here we leveraged the multi-generational nature of the Framingham Heart Study to demonstrate that parental smoking was a risk factor for offspring atrial fibrillation. At least some of this relationship was explained by a greater propensity to smoke in offspring of smoking parents. These findings demonstrate a potentially new harmful effect of smoking pertinent to the most vulnerable population, our children. It also demonstrates how parental behaviors can have meaningful adverse consequences to their children decades later. (more…)
Author Interviews, Herpes Viruses, Science, University of Pennsylvania, Vaccine Studies / 23.09.2019

MedicalResearch.com Interview with: Harvey M. Friedman, MD Professor of Medicine/Infectious Diseases University of Pennsylvania Philadelphia, PA 19104-6073  MedicalResearch.com: What is the background for this study? Response:  Mice and guinea pigs are the animal models used to evaluate candidate vaccines for preventing genital herpes. My lab has been working on such a vaccine. Our candidate vaccine contains 3 immunogens. One immunogen is a protein on the virus that is required for the virus to enter cells (viruses need to enter cells to replicate). The other two immunogens are proteins on the virus that help the virus escape immune attack. Our intent is to produce antibodies to these 3 proteins by immunization and that the antibodies will bind to the proteins on the virus and block the protein functions. The virus then will not be able to enter cells and will not be able to use its evasion strategies to avoid the immune responses generated by the vaccine. Our vaccine aimed at preventing immune evasion is novel as a component of a genital herpes vaccine.  (more…)
Author Interviews, Dengue, Duke, Vaccine Studies / 21.09.2019

MedicalResearch.com Interview with: Dr Shee-Mei Lok, PhD Professor in the Emerging Infectious Disease program Duke-NUS, a school of National University of Singapore MedicalResearch.com: What is the background for this study? Response: Dengue virus consists of four different serotypes (DENV1-4) and within each serotypes, there are multiple strains. In terms of the viral particle shape, our previous research work using some laboratory adapted strains showed these DENV2 strains are very interesting in that it can change shape from the smooth spherical surface particles when grown at mosquito physiological temperature (29oC) and then becomes bumpy surfaced particles when incubated at human physiological temperature (37oC). This ability to transform into different virus surface structures helps the virus to escape from the immune system of the human host. Hence understanding the mechanism of how this occur is important for therapeutics and vaccine development. Here we also identified a laboratory adapted virus strain that do not showed this structural changes. We showed some differences in their amino acid sequences and We showed some differences in their amino acid sequences and mutating these residues coupled with observing their surface structures showed which residues are important for this temperature induced structural change. Results showed that subtle mutations at different places on the envelope protein can destabilize the virus allowing them to change in structure when temperature is elevated. Due to the poor selection pressure of the artificial laboratory tissue culture system, gradual mutations of the virus is accumulated causing the virus to have bumpy surface morphology. (more…)
Author Interviews, Heart Disease, NEJM, Vanderbilt / 18.09.2019

MedicalResearch.com Interview with: Daniel Muñoz, M.D, M.P.A Assistant Professor of Medicine, Division of Cardiology Medical Director for Quality, Vanderbilt Heart & Vascular Institute Medical Director, Cardiovascular ICU Vanderbilt University Medical Center Nashville, Tennessee MedicalResearch.com: What is the background for this study? Response: Despite advances in the prevention and treatment of cardiovascular disease, it remains the number one global killer of both men and women. Patients face a variety of barriers to getting the care need, including cost and complexity of medication regimens. Innovative strategies are needed to improve the delivery of preventive care, especially when it comes to socio-economically vulnerable individuals. The polypill, a fixed-dose combination of 3 blood pressure lowering medications and a cholesterol lowering medication, may be a strategy for improving cardiovascular disease prevention. We enrolled 303 patients at a community health center in Mobile, Alabama. Half of the patients were assigned to take a daily polypill, while the other half received their usual medical care. Participants underwent a standard medical exam, blood pressure measurement, and blood cholesterol testing during their initial visit, a 2-month visit, and a 12-month visit. MedicalResearch.com: What are the main findings?
  • Participants in the polypill group experienced a greater reduction in both systolic blood pressure and LDL cholesterol level, as compared with participants in the usual care group. These differences translate to an approximate 25% reduction in the risk of experiencing a cardiovascular event.
  • At 12 months, adherence to the polypill regimen, as assessed based on pill counts, was 86%.
  • The vast majority of our study participants were African-American (96%), with three quarters reporting an annual income below $15,000.
(more…)
Author Interviews, Emory, Heart Disease / 13.09.2019

MedicalResearch.com Interview with: Viola Vaccarino, MD, PhD Wilton Looney Professor and Chair in Cardiovascular Research Dept. of Epidemiology, Rollins School of Public Health Professor, Dept. of Medicine, School of Medicine Emory University MedicalResearch.com: What is the background for this study? Response: Psychological stress has been linked to increased risk for cardiovascular disease. The mechanisms have not been clear. One hypothesis has been that chronic or repeated exposure to psychological stress can cause a phenomenon of “wear-and-tear” of the vascular system due to activation of the neuroendocrine stress systems, eventually leading to accelerated plaque formation and adverse cardiovascular events. However, this has never been demonstrated in humans. In some individuals, psychological stress can induce a transitory impairment of the endothelium, a phenomenon known as endothelial dysfunction. A healthy endothelium is essential in blood flow regulation and in maintaining cardiovascular health. (more…)
Author Interviews, Cancer Research, JAMA, MRI, Prostate Cancer, UCLA / 12.09.2019

MedicalResearch.com Interview with: Rajiv Jayadevan, MD and  Leonard S. Marks, MD Department of Urology UCLA MedicalResearch.com: What is the background for this study? Response: Men with low risk prostate cancer often enter “active surveillance” programs. These programs allow patients to defer definitive treatment (and avoid their associated side effects) until more aggressive disease is detected, if at all. Patients typically undergo a “confirmatory biopsy” 6 to 12 months after diagnosis to verify that their disease is low risk, and then undergo repeat biopsies every 1 to 2 years. These biopsies have traditionally been performed under the guidance of transrectal ultrasonography. Transrectal ultrasonography is unable to accurately visualize tumors within the prostate, necessitating that biopsy cores be obtained systematically from all parts of the prostate. MRI-ultrasonography fusion biopsy is a newer technology that has been shown to characterize biopsy findings more accurately than transrectal ultrasonography, leading to improved disease detection. This technology also allows us to visualize tumors within the prostate, and directly target these tumors during a biopsy session. (more…)
Author Interviews, Emory, Health Care Systems, JAMA, Kidney Disease, Transplantation / 11.09.2019

 A retraction and replacement have been issued due to a major coding error that resulted in the reporting of incorrect data in this study surrounding the difference in transplant rates between for-profit and non-profit dialysis centers. Please see link below:

Bauchner H, Flanagin A, Fontanarosa PB. Correcting the Scientific Record—Retraction and Replacement of a Report on Dialysis Ownership and Access to Kidney Transplantation. JAMA. 2020;323(15):1455. doi:10.1001/jama.2020.4368

MedicalResearch.com Interview with: Rachel Patzer, PhD, MPH Associate Professor Director, Health Services Research Center Department of Medicine Department of Surgery Emory University School of Medicine   MedicalResearch.com: What is the background for this study? Response: We know that historically, for-profit dialysis facilities have been shown to have lower rates of kidney transplantation than patients who receive treatment in non-profit dialysis facilities. However, these studies are outdated, and did not examine access to living donor transplantation or include the entirety of the end-stage kidney disease population  (more…)
AstraZeneca, Author Interviews, Brigham & Women's - Harvard, Diabetes, Heart Disease / 10.09.2019

MedicalResearch.com Interview with: Dr. David Berg MD Senior Fellow in Cardiovascular Medicine and Critical Care Medicine Brigham and Women’s Hospital Postdoctoral Research Fellow with the TIMI Study Group. MedicalResearch.com: What is the background for this study? Response: Heart failure is a frequent and important complication of type 2 diabetes mellitus (T2DM), but there are limited tools for identifying which patients with T2DM are at the highest risk of developing heart failure. In this study, we developed and validated the TIMI Risk Score for Heart Failure in Diabetes [TRS-HF(DM)], a novel clinical risk score that identifies patients with T2DM who are at heightened risk for hospitalization due to heart failure. Fortunately, the risk score also identifies patients who have the greatest absolute reduction in the risk of hospitalization for heart failure with a new class of glucose-lowering therapies called sodium-glucose cotransporter-2 (SGLT2) inhibitors.  (more…)
AHA Journals, Author Interviews, Blood Pressure - Hypertension, University of Pennsylvania / 09.09.2019

MedicalResearch.com Interview with: Jordana Cohen, MD, MSCE Assistant Professor of Medicine and Epidemiology Renal-Electrolyte and Hypertension Division Center for Clinical Epidemiology and Biostatistics Perelman School of Medicine University of Pennsylvania MedicalResearch.com: What is the background for this study? Response: In the June 18, 2019 issue of Annals of Internal Medicine, we published a systematic review and meta-analysis evaluating the cardiovascular risks of white coat hypertension (WCH; i.e. elevated office blood pressure and normal out-of-office blood pressure). The goal of the meta-analysis was to clarify previous mixed results regarding the risks of untreated WCH and treated WCH. The meta-analysis examined 27 studies – including 64,273 patients – and demonstrated that untreated WCH is associated with an increased risk of cardiovascular events (36%), all-cause mortality (33%), and cardiovascular mortality (109%) compared to normotension. This risk was strongest in studies with a mean age ≥55 years or that included participants with cardiac risk factors, such as diabetes and chronic kidney disease. We found no increased cardiovascular risk associated with treated white coat hypertension. (more…)
Author Interviews, Brigham & Women's - Harvard, Clots - Coagulation, Diabetes, Heart Disease, Lancet / 08.09.2019

MedicalResearch.com Interview with: Deepak L. Bhatt, MD, MPH, FACC, FAHA, FSCAI, FESC Professor of Medicine, Harvard Medical School Executive Director of Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart & Vascular Center MedicalResearch.com: What is the background for this study? Response: Dual antiplatelet therapy (DAPT) is known to improve outcomes in patients with acute coronary syndromes (ACS), prior myocardial infarction (MI), or recent coronary stenting. What was unknown is whether patients with diabetes and stable coronary artery disease – a group generally believed to be at high ischemic risk – would benefit from initiation of long-term DAPT with low-dose aspirin plus ticagrelor versus low-dose aspirin (plus placebo). This is what THEMIS was designed to test, with THEMIS-PCI designed prospectively to examine those patients specifically who had a history of previous percutaneous coronary intervention (PCI). (more…)
Author Interviews, Cannabis, Columbia, Gender Differences / 06.09.2019

MedicalResearch.com Interview with: Morgan Philbin, PhD MHS Assistant Professor Department of Sociomedical Sciences Columbia University School of Public Health MedicalResearch.com: What is the background for this study? Response: Marijuana is the most frequently used substance in the United States (US) after alcohol and tobacco. In 2017, 15.3% of the US population ages 18 and up reported past-year marijuana use (MU) and 9.9% past month use. Individuals who identify as lesbian, gay, or bisexual (LGB), also report higher levels of marijuana use and marijuana use disorder than their heterosexual counterparts. Researchers have begun to explore potentially modifiable factors, such as state-level marijuana policies, that affect marijuana use and related outcomes at the population-level and within subgroups—though as of yet not among sexual minority populations. We therefore examined whether LGB individuals living in states with medical marijuana laws (MMLs) have higher levels of marijuana use and marijuana use disorder compared to LGB individuals in states without MMLs. (more…)
Author Interviews, Cost of Health Care, JAMA, Medical Imaging, UCSF / 05.09.2019

MedicalResearch.com Interview with: Rebecca Smith-Bindman, MD Professor, Department of Radiology and Biomedical Imaging, Epidemiology and Biostatistics Philip R. Lee Institute for Health Policy Studies University of California, San Francisco MedicalResearch.com: What is the background for this study? Response: Medical imaging increased rapidly from 2000 to 2006. The rise in imaging can be attributed to improvements in technical aspects of imaging, strong physician and patient demand, and strong financial incentives. While imaging contributes to accurate disease diagnosis and improved treatment, imaging can also increase costs and patient harms, such as incidental findings, overdiagnosis, anxiety, and radiation exposure associated with increased risk of cancer. Potential overuse of diagnostic testing has been addressed by the American Board of Internal Medicine Foundation’s Choosing Wisely Campaign and initiatives by payers to reduce imaging through payment reductions, but there remains uncertainty in the impact of these initiatives on imaging rates.The objective of our study was to evaluate recent trends in medical imaging. Our study assessed imaging from 2000 through 2016 among individuals enrolled in diverse U.S. integrated healthcare systems and among individuals residing in Ontario, Canada and assessed changes in medical imaging utilization over time by country, health system, and patient demographic factors. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Chemotherapy / 04.09.2019

MedicalResearch.com Interview with: Bishal Gyawali, MD, PhD Department of Medicine Brigham and Women’s Hospital  MedicalResearch.com: What is the background for this study? Response: Cancer drugs are prescribed to the patients based on results from trials. Usually, these are superiority trials meaning the cancer drugs prove that they are better than the treatment we already have. Recently, more and more cancer drugs are approved on the basis of non-inferiority trials. In these trials, the cancer drugs only prove that they are not worse than the treatment we already have ( instead of proving they are better). Such an approach is considered justified if the new drug provides any other benefit such as lower cost, easy to administer or improved quality of life. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Medicare / 28.08.2019

MedicalResearch.com Interview with: Jose F. Figueroa, MD, MPH Instructor , Harvard Medical School, Department of Medicine Brigham and Women’s Hospital  MedicalResearch.com: What is the background for this study? Response: Hospitalizations related to ambulatory-care sensitive conditions are widely considered a key measure of access to high-quality ambulatory care. It is included as a quality measure in many national value-based care programs. To date, we do not really know whether rates of these avoidable hospitalizations are meaningfully improving for Medicare beneficiaries over time. (more…)
Author Interviews, Flu - Influenza, Pulmonary Disease, Stem Cells, University of Pennsylvania / 22.08.2019

MedicalResearch.com Interview with: Andrew E. Vaughan, PhD Assistant Professor, Biomedical Sciences School of Veterinary Medicine University of Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: Severe respiratory infections, including influenza, can progress to acute respiratory distress syndrome (ARDS), wherein barrier function and gas exchange are compromised.  It’s a very life threatening scenario.  This is due in part to loss of alveolar type 2 (surfactant producing) and type 1 cells (gas exchanging).  Interestingly alveolar type 2 cells are also stem cells in the lung.  We wondered whether transplant of these cells might aid in recovery from severe influenza infection, and sure enough, it did! (more…)
AHA Journals, Author Interviews, Brigham & Women's - Harvard, Heart Disease, Nutrition, Vegetarians / 22.08.2019

MedicalResearch.com Interview with: Megu Baden, MD, PhD Department of Nutrition Harvard T. H. Chan School of Public Health Boston, MA02115  MedicalResearch.com: What is the background for this study? Would you give an example of healthful vs non-healthful plantbased diet? Response: Plant-based diets are recommended for health and recently also for their environmental benefits. However, most previous studies defined it as either vegetarian or non-vegetarian, and importantly, without differentiation for the quality of plant foods. As you know, not all plant foods are equally good to our health. Therefore, to capture the quality of plant-based diets, we established overall, healthful and unhealthful plant-based diet indices. A higher score on the overall plant based diet index indicates greater intake of all types of plant foods and less of animal foods. A higher score on the healthful plant based diet index indicates greater intake of only healthy plant foods (whole grains, fruits, vegetables, nuts, legumes, vegetable oils, tea/coffee), and less of less healthy plant foods (fruit juices, refined grains, potatoes, sugar-sweetened beverages, sweets/desserts) and animal foods. A higher score on the unhealthful plant based diet index indicates greater intake of only less healthy plant foods, and less of healthy plant foods and animal foods. In this study, we used these plant-based diet indices and investigated the associations between 12-year changes in plant-based diet quality and subsequent total and cause-specific mortality in two large US cohorts. (more…)
Author Interviews, Brigham & Women's - Harvard, Global Health, Infections, Lancet, Pediatrics / 21.08.2019

MedicalResearch.com Interview with: Tori Cowger, MPH Ph.D Student | Population Health Sciences Department of Epidemiology Harvard T.H. Chan School of Public Health  MedicalResearch.com: What is the background for this study? Response: Globally, approximately one million cases of tuberculosis disease (TB) and 233,000 TB-related deaths occurred among children aged younger than 15 years during 2018. TB in children and adolescents is clinically and epidemiologically heterogeneous, making diagnosis, care, and prevention challenging. Understanding this heterogeneity can inform TB care and prevention efforts, and efforts to eliminate disparities in TB incidence and mortality in these groups. In this study, we describe the epidemiology of TB among children and adolescents in the United States, and report TB incidence rates for US territories and freely associated states and by parental country of birth, which have not been previously described. (more…)
Author Interviews, Pediatrics, University of Michigan, Vitamin D / 21.08.2019

MedicalResearch.com Interview with: Eduardo Villamor, M.D., M.P.H., Dr.P.H. Professor, Epidemiology School of Public Health University of Michigan Ann Arbor, Michigan MedicalResearch.com: What is the background for this study? Response: Vitamin D deficiency has been related to adverse mental health outcomes, including depression and schizophrenia, in adults.  Some studies have suggested a potential role of vitamin D status prenatally on other neurodevelopmental outcomes in childhood.  However, few studies had extended into adolescence which is the life period when certain mental health issues that predict disease later in life, namely behavioral problems, first appear.  (more…)
Author Interviews, Brain Cancer - Brain Tumors, Imperial College / 20.08.2019

MedicalResearch.com Interview with: Georgios Giamas, (Dr. Biol. Hum.) Professor of Cancer Cell Signalling Director of Research and Knowledge Exchange University of Sussex -School of Life Sciences Visiting Professor, Imperial College, London MedicalResearch.com: What is the background for this study? Response: This study focuses on Glioblastoma (GBM), which is one of the most aggressive solid tumours for which treatment options and biomarkers are limited. MedicalResearch.com: What are the main findings? - Glioblastoma cells produce nanosized vesicles (aka: extracellular vesicles) that contain specific protein signatures, which can indicate the behaviour and phenotype of the respective cells of origin. -We have identified and described certain vesicle-associated biomarkers that correspond to the most aggressive brain cancers. -Our results can provide insights for the development of new diagnostic and therapeutic methods as well as personalized treatment strategies (more…)
Author Interviews, Endocrinology, NIH, Pediatrics / 19.08.2019

MedicalResearch.com Interview with: Kenneth S. Korach, Ph.D. Senior Principal Investigator Chief, Receptor Biology Section Reproductive and Developmental Biology Laboratory NIEHS/NIH MedicalResearch.com: What is the background for this study? Response: Lavender oil is among the most popular essential oils used today. Our society deems essential oils and other homeopathic remedies as safe alternatives for medical treatment, personal hygiene commodities, aromatherapy, and cleaning products; however, there are many natural products that have effects on the human body, similar to potent synthetic drugs. (more…)
Author Interviews, Breast Cancer, Brigham & Women's - Harvard, Genetic Research / 19.08.2019

MedicalResearch.com Interview with: Tengteng Wang, PhD, MSPH, MBBS Postdoctoral Research Fellow Department of Epidemiology Harvard T.H. Chan School of Public Health Channing Division of Network Medicine Brigham and Women's Hospital MedicalResearch.com: What is the background for this study? Response: Chronic inflammation is a key player in the development of multiple cancer types, including breast cancer. Aspirin is one of the major non-steroidal anti-inflammatory drugs (NSAIDs) which clearly has anti-inflammatory properties. Given this, substantial evidence from laboratory and population studies suggests that taking aspirin may reduce the risk of developing breast cancer. However, the association of aspirin use with death outcomes following breast cancer diagnosis remains inconclusive and inconsistent across studies. Therefore, we choose to focus on mortality outcomes in this paper and we hypothesized that the inconsistent results for aspirin in relation to mortality could be due to differences in the association by patients’ biological profiles, specifically DNA methylation profiles here.  (more…)
Author Interviews, Bayer, FDA, Prostate Cancer / 16.08.2019

MedicalResearch.com Interview with: Neal D. Shore, MD, FACS Director, CPI, Carolina Urologic Research Center Atlantic Urology Clinics Myrtle Beach, South Carolina Neal D. Shore, MD, FACS is the Medical Director for the Carolina Urologic Research Center. He practices with Atlantic Urology Clinics in Myrtle Beach, South Carolina. Dr. Shore discusses the recent announcement that the FDA has approved Nubeqa®(darolutamide),  for the treatment of patients with non-metastatic castration-resistant prostate cancer..  MedicalResearch.com: What is the background for this study? How does NUBEQA®(darolutamide) differ from other treatments for nmCRPC?  Response: In 2017, patients did not have an approved therapy for non-metastatic castration-resistant prostate cancer, or nmCRPC. If untreated, patients with this diagnosis will go on to develop metastases, or progression of the cancer throughout the body. NUBEQA® (darolutamide) became the third and most recently approved treatment for nmCRPC, demonstrating a benefit of metastasis-free survival, or MFS. NUBEQA is different due to its adverse event and safety profile reported in the Phase III ARAMIS trial. In that study, there were no significant findings of falls and fractures as well as other adverse events reported from the earlier Phase III trials.  (more…)
Author Interviews, JAMA, Outcomes & Safety, Surgical Research, University of Michigan / 15.08.2019

MedicalResearch.com Interview with: Kyle Sheetz, MD, MSc Research Fellow Center for Healthcare Outcomes and Policy University of Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: Various patient safety organizations and clinical societies continue to advocate for volume thresholds as a means to improve the short-term safety and overall effectiveness of high risk cancer surgeries in the United States. We asked two questions with this study: 1) What proportion of U.S. hospitals meet discretionary volume standards? 2) Do these standards differentiate hospitals based on short-term safety outcomes (mortality and complications)? We found that a relatively low proportion of hospitals meet even modest volume standards put forth by the Leapfrog Group. These standards did not differentiate hospitals based on outcomes for 3 of 4 high risk cancer operations reported by the Leapfrog Group. However, using higher thresholds, we were able to demonstrate a significant relationship between higher hospital volume and better outcomes, which has been reported numerous times. (more…)
Author Interviews, Cancer Research, Cleveland Clinic, Weight Research / 15.08.2019

MedicalResearch.com Interview with: Siran M. Koroukian, PhD Director, Population Cancer Analytics Shared Resource Case Comprehensive Cancer Center Director, Population Health and Outcomes Research Core Associate Professor Department of Population and Quantitative Health Sciences School of Medicine Case Western Reserve University Cleveland, OH MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previous studies have shown that obesity-associated cancers (OACs) have been increasing in younger people. Using data from over 6 million cancer cases from 2000-2016, we identified the specific age/sex/race-ethnicity groups that were most affected by increases in OACs. We found a substantial shift of obesity-associated cancers to younger age groups, with the most notable increases occurring to the 50-64 age group. In addition, we observed the greatest percentage increase in the number of OAC cases during the study period in Hispanic men and women, as well as for cancers of the thyroid, gallbladder, liver and intrabiliary duct. (more…)
Author Interviews, Cancer Research, FDA, Vaccine Studies / 14.08.2019

MedicalResearch.com Interview with: Dr. Graca Dores MD MPH US Food and Drug Administration Center for Biologics Evaluation and Research Office of Biostatistics and Epidemiology Division of Epidemiology Silver Spring, Maryland Oklahoma City, OK MedicalResearch.com: What is the background for this study? Would you briefly explain what Sipuleucel-T is used for?  Response: Sipuleucel-T was the first therapeutic vaccine approved by the U.S. Food and Drug Administration (FDA) in 2010.  It is indicated for the treatment of asymptomatic or minimally symptomatic, metastatic, castration-resistant prostate cancer (CRPC; prostate cancer that spreads while an individual is on hormone-blocking therapy).  During the preparation of this product, the patient’s cells are collected (leukapheresis), sent for processing to generate a dose of patient-specific vaccine, and then administered intravenously back to the patient.  This process is repeated approximately every two weeks for a total of three doses. Except for the pre-marketing clinical trials that were reviewed during the sipuleucel-T approval process, post-marketing studies that have evaluated the safety profile of sipuleucel-T are scarce. Therefore, we used the FDA’s Adverse Event Reporting System (FAERS) database to summarize the adverse events reported to FDA by industry, medical professionals, and consumers.  We also assessed whether sipuleucel-T and specific adverse events (product-event pairs) were reported more than expected compared to all other drug/biologic-adverse event pairs in the FAERS database. (more…)
Author Interviews, JAMA, Mayo Clinic, Pancreatic, USPSTF / 14.08.2019

MedicalResearch.com Interview with: Dr. Chyke A. Doubeni, M.D., M.P.H. Dr. Doubeni is a family physician and The inaugural director of the Mayo Clinic Center for Health Equity and Community Engagement Research MedicalResearch.com: What is the background for this study? Response: The U.S. Preventive Services Task Force uses systematic review of existing research to make recommendations on clinical preventive services that are delivered in primary care, with the goal to promote and improve health for all Americans. Although pancreatic cancer is an uncommon condition in the general population, it is often deadly. Pancreatic cancer is now the third most common cause of cancer death in the United States, and could become the second leading cause if current trends continue. The vast majority of people with pancreatic cancer are diagnosed at a late stage and, unfortunately, even when caught early enough when surgery could be most effective, only a little over one-third of patients survive beyond five years. (more…)
Author Interviews, Blood Pressure - Hypertension, Duke, Heart Disease, JAMA, Race/Ethnic Diversity / 14.08.2019

MedicalResearch.com Interview with: Yuichiro Yano MD Assistant Professor in Family Medicine and Community Health Duke University  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: African Americans are disproportionally affected by hypertension-related cardiovascular disease compared with other racial/ethnic groups in the United States and have higher blood pressure levels inside and outside the clinic than whites and Asians. However, little is known, among African Americans, regarding whether higher mean blood pressure measured outside of the clinic setting on 24-hour ambulatory blood pressure monitoring is associated with an increased risk for cardiovascular disease events, independent of blood pressure measured in the clinic setting. (more…)