Author Interviews, Biomarkers, Genetic Research, Infections, NEJM, UCSF / 13.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49751" align="alignleft" width="150"]Dr. Charles Chiu, M.D./Ph.D. Professor, Laboratory Medicine and Medicine / Infectious Diseases Director, UCSF-Abbott Viral Diagnostics and Discovery Center Associate Director, UCSF Clinical Microbiology Laboratory UCSF School of Medicine Dr. Chiu[/caption] Dr. Charles Chiu, M.D./Ph.D. Professor, Laboratory Medicine and Medicine / Infectious Diseases Director, UCSF-Abbott Viral Diagnostics and Discovery Center Associate Director, UCSF Clinical Microbiology Laboratory UCSF School of Medicine MedicalResearch.com: What is the background for this study? Would you describe what is meant by metagenomic sequencing? Response: Metagenomic next-generation sequencing (mNGS) is the use of technology to generate millions of sequence reads to diagnose infection sin patients by characterizing the full range of potential pathogens (bacteria, viruses, fungi, and parasites) in a single sample. Although shown to be a promising diagnostic tool for  infectious diseases in case reports and limited case series (Chiu and Miller Nature Reviews Genetics 20, 341-355 (2019)), to date the “real-life” utility of this approach for patient care has hitherto not been demonstrated.  This study is the first prospective, multi-center study of clinical mNGS testing for the diagnosis of neurological infections in acutely ill hospitalized patients presenting with meningitis and/or encephalitis.
Author Interviews, JACC, Kidney Disease, NYU/NYMC / 13.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49703" align="alignleft" width="225"]David Charytan, MD MSc Chief, Nephrology Division NYU Langone Medical Center New York, NY 10010 Dr. Charytan[/caption] David Charytan, MD MSc Chief, Nephrology Division NYU Langone Medical Center New York, NY 10010  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Cardiovascular events are much more frequent in patients with impaired kidney function (chronic kidney disease), and cardiovascular disease is the most common cause of death in advanced chronic kidney disease. This risk remains high despite the use of standard medical therapies including statins, the most commonly used cholesterol lowering agents. The PCSK9 inhibitor evolocumab is a new class of highly potent cholesterol lowering medications that can further reduce the risk of cardiovascular events in patients already taking statins. We analyzed data from the FOURIER trial, which randomized study patients with clinically evident atherosclerosis and an LDL cholesterol level >=70 mg/dL or HDL cholesterol level >= while on a statin, to assess the safety and efficacy of evolocumab, a PCSK9 inhibitor, compared with placebo in individuals with mild to moderate chronic kidney disease. There were several major findings
  • a) evolocumab appears to be equally safe in individuals with preserved and mild to moderately impaired kidney function
  • b) evolocumab appears to have preserved efficacy at preventing cardiovascular events as kidney function declines.
  • c) We were unable to detect any significant impact on kidney function.
  • In addition, because the baseline risk of cardiovascular events is much higher in individuals with  chronic kidney disease, the absolute benefits of treatment with evolocumab appear  to be magnified as kidney function declines. 
Author Interviews, JAMA, PTSD / 13.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49746" align="alignleft" width="178"]Dr. Heike Gerger | Senior Postdoc University of Basel | Faculty of Psychology | Clinical Psychology and Psychotherapy Basel | Switzerland Dr. Gerger[/caption] Dr. Heike Gerger | Senior Postdoc University of Basel | Faculty of Psychology | Clinical Psychology and Psychotherapy Basel | Switzerland MedicalResearch.com: What is the background for this study? Response: Posttraumatic stress disorder (PTSD) is one of the most prevalent mental disorders, with a high risk of chronicity, comorbidity, and functional impairment. PTSD is complicated to treat, and the debate on the most efficacious treatment approach is ongoing. Treatment guidelines for the treatment of PTSD typically recommend different types of trauma-focused psychotherapeutic treatments as first-line PTSD treatment. However, concerning pharmacological therapies recommendations are inconsistent.
Author Interviews, Environmental Risks, JAMA, Weight Research / 12.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49741" align="alignleft" width="100"]Lead author: Yong-Moon (“Mark”) Park, MD, PhD Postdoctoral fellow Epidemiology Branch National Institute of Environmental Health Sciences Dr. Park[/caption] Lead author: Yong-Moon (“Mark”) Park, MD, PhD Postdoctoral fellow Epidemiology Branch National Institute of Environmental Health Sciences [caption id="attachment_49742" align="alignleft" width="150"]Senior author: Dale P. Sandler, PhD Chief, Epidemiology Branch, National Institute of Environmental Health Sciences National Institutes of Health Dr. Sandler[/caption]   Senior author: Dale P. Sandler, PhD Chief, Epidemiology Branch, National Institute of Environmental Health Sciences National Institutes of Health MedicalResearch.com: What is the background for this study?   Response: A few studies had suggested that exposure to artificial light while sleeping was associated with obesity. However, the previous studies were cross-sectional, so we really do not know which came first - exposure to artificial light while sleeping or obesity. Another problem was that previous studies did not fully account for other characteristics that could affect this association, such as sleep duration and quality, calorie intake and dietary patterns, and physical activity. We studied nearly 44,000 women ages 35-74 from across the US who are enrolled in the Sister Study cohort. Women had body weight characteristics measured at baseline and provided self-reported information on weight at baseline and follow-up – on average 5.7 years later.
Author Interviews, Heart Disease, JACC / 12.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49654" align="alignleft" width="200"]J.L. Mehta, MD, PhD Distinguished Professor of Medicine and Physiology and Biophysics Stebbins Chair in Cardiology University of Arkansas for Medical Sciences Central Arkansas Veterans Healthcare System Little Rock, AR 72205 Dr. Mehta[/caption]

J.L. Mehta, MD, PhD

Distinguished Professor of Medicine and Physiology and Biophysics

Stebbins Chair in Cardiology

University of Arkansas for Medical Sciences

Central Arkansas Veterans Healthcare System

Little Rock, AR 72205

MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Aspirin is commonly used for primary prevention of cardiovascular disease events in a variety of subjects around the world. Recent studies, however, show that routine use of aspirin without assessment of risk for cardiovascular disease events may not be appropriate, and may even be harmful. 
Author Interviews, Psychological Science, Technology / 12.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49731" align="alignleft" width="200"]Brittany I. Davidson MA Doctoral Researcher in Information Systems University of Bath Ms. Davidson[/caption] Brittany I. Davidson MA Doctoral Researcher in Information Systems University of Bath MedicalResearch.com: What is the background for this study? What are the main findings? Response: Typically, research interested in the impact of technology, or more specifically, smartphones on people and society, use surveys to measure people’s usage. Almost always, these studies claim potential harms from using smartphones, like depression, anxiety, or poorer sleep. However, these studies simply ask people about  their behaviour rather than actually measuring it. In our study, we took 10 widely used surveys to  measure screen time, which typically asks how often people use their smartphone or how problematic their usage is. We compared this to people’s objective smartphone usage from Apple Screen time (e.g., minutes spend on iPhone, number of times they picked up their phone, and the number of notifications received). We found that there is a large discrepancy between what people self-report and what they actually do with their iPhone. This is highly problematic as the sweeping statements that claim smartphones (or technology more generally) have a negative impact on mental health are not  based on solid and robust evidence at this time, which leaves much to be desired in terms of what we really know about the  impacts of technology use on people.
Accidents & Violence, Author Interviews, Brain Injury, ENT, Pediatrics / 12.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49726" align="alignleft" width="144"]Amishav Bresler MD Department of Otolaryngology - Head and Neck Surgery Rutgers - New Jersey Medical School Dr. Bresler[/caption] Amishav Bresler MD Department of Otolaryngology - Head and Neck Surgery Rutgers - New Jersey Medical School  MedicalResearch.com: What is the background for this study? Response: This study was inspired by a personal experience with the rental scooters. The most recent American Academy of Otolaryngology-Head and Neck Surgery annual conference was in Atlanta this year. At the time of the conference, the scooter rental industry had recently entered the region. A friend of mine, another ENT resident, was encouraging others to use these scooters for transportation for both the novelty and convenience. However, he didn't even have a helmet! Here was a well-educated doctor who takes call for craniofacial injuries, who was about to get on a scooter without a helmet. This experience made me wonder if scooters were dangerous scooters and their overall impact on public health. In terms of the backgroud, the personal transportation industry is undergoing a revolution. The search for efficient and environmentally-friendly urban transportation ignited an ongoing debate in the United States regarding the role of motorized scooters. Although known to be a popular method of transportation in Europe and Asia, motorized scooters have only recently begun to make inroads in the United States. The gradual rise in popularity has been attributed to their convenience, affordability, and status as a “green” alternative to vehicles with combustion engines. These advantages combined with the fact electric scooters enable users to travel longer distances than conventional scooters present an attractive method of transportation to school, work, and leisure.
Author Interviews, Diabetes, Transplantation / 12.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49716" align="alignleft" width="200"]Dr. Rodolfo Alejandro, MD Professor of Medicine University of Miami Miller School of Medicine Co-Director of the Cell Transplant Center Director/Attending Physician of the Clinical Cell Transplant Program Diabetes Research Institute Dr. Alejandro[/caption] Dr. Rodolfo Alejandro, MD Professor of Medicine University of Miami Miller School of Medicine Co-Director of the Cell Transplant Center Director/Attending Physician of the Clinical Cell Transplant Program Diabetes Research Institute www.DiabetesResearch.org  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: In type 1 diabetes, the insulin-producing islets cells of the pancreas have been mistakenly destroyed by the immune system, requiring patients to manage their blood sugar levels through a daily regimen of insulin therapy. Islet transplantation has allowed some patients to live without the need for insulin injections after receiving a transplant of donor cells. Some patients who have received islet transplants have been insulin independent for more than a decade, as DRI researchers have published. Currently, islet transplantation remains an experimental procedure limited to a select group of adult patients with type 1 diabetes.Although not all subjects remain insulin independent, like the subjects described in this presentation, after an islet transplant a significant number of them continue with excellent graft function for over 10 years that allows them to have near-normal glucose metabolism in the absence of severe hypoglycemia on small doses of insulin. In 2016, the National Institutes of Health-sponsored Clinical Islet Transplantation Consortium reported results from its Food and Drug Administration (FDA)-authorized Phase 3 multi-center trial, of which the DRI was a part, indicating that islet transplantation was effective in preventing severe hypoglycemia (low blood sugar levels), a particularly feared complication in type 1 diabetes that can lead to seizures, loss of consciousness and even death. The study was a significant step toward making islet transplantation an approved treatment for people with type 1 diabetes and reimbursable through health insurance, as it is in several other countries around the world.  
Author Interviews, Diabetes, Weight Research / 11.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49712" align="alignleft" width="133"]MedicalResearch.com Interview with: Kalypso Karastergiou, MD, PhD Assistant Professor, Medicine, Endocrinology, Diabetes and Bone Disease Diabetes, Obesity and Metabolism Institute Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Response: Multiple studies, epidemiological as well as clinical, have established that body shape is an important and independent predictor of cardiovascular and metabolic disease risk and ultimately total mortality. Subjects that preferentially store weight in the abdominal area (often described as android, upper-body or apple-shape obesity) are at increased risk, whereas those who preferentially store weight in the lower body, in the gluteofemoral area (gynoid, lower-body or pear-shape), appear to be protected. The former is more common in men, whereas the latter in women, especially premenopausal women. The overarching questions in the field are: •What factors determine body shape? • Why are subjects with lower-body shape protected? • Can we exploit the physiological and pathophysiological mechanisms involved to improve stratification, prevention or treatment of obesity and related diseases? MedicalResearch.com: What are the main findings? Response: Up to date, studies in body shape have focused on the distribution of the adipose (fat) tissue. This report seeks to expand the investigation to other tissues as well. During the period from 1999-2006, 14,005 participants in the National Health and Nutrition Examination Survey (which represents the United States population), 20-69 years old, had a DXA test that allows total and regional estimation of fat, lean and bone tissue mass. This preliminary analysis shows that body shape is determined by coordinated changes in the head, trunk and limbs that involve the fat, as well as the other tissues. MedicalResearch.com: What should readers take away from your report? Response: This is an observational study that doesn’t allow us to draw conclusion as to cause and effect or prediction of future risk. It does suggest that body shape is a whole-body feature with systematic, coordinated changes in all body compartments and tissues. The observations should be replicated in other populations and in prospective studies. MedicalResearch.com: What recommendations do you have for future research as a result of this work? Response: This report generates more questions than it answers. • First of all, are there differences in the function of tissues that determine body shape between subjects with upper- versus lower body shape? • Which tissues drive differences in physiology and disease risk? • Can we identify the underlying molecular pathways? • Does any of these pathways represent a viable mechanistic target to prevent or treat disease and improve quality of life? Dislosures The study is partly funded by grants from the MSHS Translational Science Hub at Icahn School of Medicine at Mount Sinai (KL2TR001435) and the Einstein-Sinai Diabetes Research Center in New York City. Citation: ADA 2019 abstract 277-OR: Lean Tissues as Novel Determinants of Pear vs. Apple Body Shape and Metabolic Health in Humans KALYPSO KARASTERGIOU Diabetes 2019 Jun; 68(Supplement 1): -.https://doi.org/10.2337/db19-277-OR [wysija_form id="3"] [last-modified] The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website. Dr. Karastergiou[/caption]Kalypso Karastergiou, MD, PhD Assistant Professor, Medicine, Endocrinology, Diabetes and Bone Disease Diabetes, Obesity and Metabolism Institute Icahn School of Medicine at Mount Sinai  MedicalResearch.com: What is the background for this study?   Response: Multiple studies, epidemiological as well as clinical, have established that body shape is an important and independent predictor of cardiovascular and metabolic disease risk and ultimately total mortality. Subjects that preferentially store weight in the abdominal area (often described as android, upper-body or apple-shape obesity) are at increased risk, whereas those who preferentially store weight in the lower body, in the gluteofemoral area (gynoid, lower-body or pear-shape), appear to be protected. The former is more common in men, whereas the latter in women, especially premenopausal women. The overarching questions in the field are:
  • What factors determine body shape?
  • Why are subjects with lower-body shape protected?
  • Can we exploit the physiological and pathophysiological mechanisms involved to improve stratification, prevention or treatment of obesity and related diseases? 
Author Interviews, Clots - Coagulation, Heart Disease, JACC / 11.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49698" align="alignleft" width="200"]Prof. Dr. med. Dirk Sibbing, MHBA, FESC Oberarzt, Medizinische Klinik und Poliklinik I Ludwig-Maximilians-Universität (LMU) München Chairperson ESC Working Group on Thrombosis München, Germany Prof. Sibbing[/caption] Prof. Dr. med. Dirk Sibbing, MHBA, FESC Oberarzt, Medizinische Klinik und Poliklinik I Ludwig-Maximilians-Universität (LMU) München Chairperson ESC Working Group on Thrombosis München, Germany  MedicalResearch.com: What is the background for this consensus statement? What are the main findings that led to these conclusions? Response: The availability of different P2Y12 receptor inhibitors (clopidogrel, prasugrel, ticagrelor) with varying levels of potency has enabled physicians to contemplate individualized treatment concepts. Such concepts may include escalation or de-escalation of P2Y12 inhibiting therapy. Alternative DAPT strategies may be chosen according to the clinical setting (stable coronary artery disease vs. acute coronary syndrome), the stage of the disease (early vs. chronic treatment) and patient risk for ischemic and bleeding complications. As always in clinical medicine, guidance by means of biomarkers or risk scores is always helpful and warranted. Here specifically, a tailored DAPT approach may be potentially guided by platelet function (PFT) or genetic testing.
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JACC, Lung Cancer, Radiation Therapy / 10.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49629" align="alignleft" width="200"]Raymond H Mak, MD Assistant Professor of Radiation Oncology Harvard Medical School Dr. Mak[/caption]   Raymond H Mak, MD Assistant Professor of Radiation Oncology Harvard Medical School Radiation Oncology Brigham and Women's Hospital     [caption id="attachment_49693" align="alignleft" width="200"]Dr-Katelyn M. Atkins Dr. Atkins[/caption]   Katelyn M. Atkins MD PhD Harvard Radiation Oncology Program Dana-Farber Cancer Institute Brigham and Women’s Hospital Boston, Massachusetts     MedicalResearch.com: What is the background for this study? What are the main findings? 
  • Lung cancer remains the leading cause of cancer-related death worldwide and nearly half of patients will require radiation therapy as part of their care.
  • Cardiac toxicity following radiotherapy has been well-studied in breast cancer and lymphomas, however the impact of cardiac toxicity following lung cancer radiotherapy has historically been under-appreciated due to the high risk of lung cancer death.
  • Recent studies highlighting cardiac toxicity following lung cancer radiotherapy have been limited by small numbers of patients and, to our best knowledge, have not included validated cardiac event endpoints defined by the American Heart Association (AHA)/American College of Cardiology (ACC).
Author Interviews, Brigham & Women's - Harvard, Prostate Cancer, Weight Research / 10.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49690" align="alignleft" width="200"]Barbra Dickerman, PhD Research Fellow Department of Epidemiology Harvard T.H. Chan School of Public Health Boston, MA Dr. Dickerman[/caption] Barbra Dickerman, PhD Research Fellow Department of Epidemiology Harvard T.H. Chan School of Public Health Boston, MA MedicalResearch.com: What is the background for this study? Response: Obesity is associated with a higher risk of advanced prostate cancer and poorer prognosis after diagnosis. However, emerging evidence suggests that the specific distribution of body fat may be an important prognostic factor for prostate cancer outcomes. In this original investigation, we analyzed body fat distribution on computed tomography imaging and the risk of being diagnosed with, and dying from, prostate cancer. This study was conducted among 1,832 Icelandic men with over a decade of follow-up in the Age, Gene/Environment Susceptibility-Reykjavik Study.
Author Interviews, Gastrointestinal Disease / 10.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49661" align="alignleft" width="142"]William D. Chey, M.D., F.A.C.G. Director, Division of Gastroenterology Michigan Medicine Gastroenterology Clinic Ann Arbor, Michigan Dr. Chey[/caption] William D. Chey, M.D., F.A.C.G. Director, Division of Gastroenterology Michigan Medicine Gastroenterology Clinic Ann Arbor, Michigan MedicalResearch: What is the background for this study? Would you tell us what is meant by Functional Dyspepsia? Response: Functional dyspepsia (FD or meal-triggered indigestion) is a very common disorder affecting 11 percent - 29.2 percent of the world’s population, making it comparable in prevalence to Irritable Bowel Syndrome (IBS). However, unlike IBS, there is no FDA approved product to treat FD. Sufferers are often treated off-label with prescribed proton pump inhibitors (PPIs), histamine type-2 receptor antagonists (H2RAs), antidepressants, and prokinetics. While offering relief to a portion of FD patients, some of these have been associated with adverse events. Functional dyspepsia can have a negative effect on workplace attendance and productivity, with associated costs estimated in excess of $18 billion annually. In functional dyspepsia, which is typically recurring, meal-triggered indigestion with no known organic cause, the normal function and sensation of the stomach and intestines are altered. FD is accompanied by symptoms such as epigastric pain or discomfort, epigastric burning, postprandial fullness, inability to finish a normal sized meal, heaviness, pressure, bloating in the upper abdomen, nausea, and belching. When doctors diagnose FD, they often identify patients as those who have these symptoms for at least three months, with symptom onset six months previously. Caraway oil and peppermint oil have a history of helping some patients with functional dyspepsia. In multiple clinical studies, the combination of caraway oil and peppermint oil has been shown to manage FD and its accompanying symptoms, such as reducing the intensity of epigastric pain, pain frequency, dyspeptic discomfort, and the intensity of sensations of pressure, abdominal heaviness and fullness significantly better than control
Author Interviews, Hepatitis - Liver Disease, JAMA, Kaiser Permanente, Pharmacology / 10.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49631" align="alignleft" width="200"]Elizabeth A. McGlynn, PhD Vice President for Kaiser Permanente Research Executive Director Kaiser Permanente Center for Effectiveness and Safety  Dr. McGlynn[/caption] Elizabeth A. McGlynn, PhD Vice President for Kaiser Permanente Research Executive Director Kaiser Permanente Center for Effectiveness and Safety  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: A report from the Institute for Safe Medication Practices based on FDA data and observations from a Kaiser Permanente physician leader raised questions about whether direct acting antiviral medications for the treatment of Hepatitis C posed any significant safety risks for patients. Since the decision to take medications requires making tradeoffs between benefits (which had been clearly established in clinical trials) and risks (which are often harder to ascertain until drugs are in widespread use in the real world) we decided this was an important question to pursue.  We found no evidence of increased risks of significant side effects associated with taking these drugs.  In this cohort study of 33,808 patients in three large health systems we found lower adjusted odds of experiencing the following adverse events:  death, multiple organ failure, hepatic decompensation, acute-on-chronic liver event, and arrhythmia. 
Author Interviews, Diabetes, Vitamin D / 09.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49667" align="alignleft" width="142"]Anastassios G. Pittas, M.D MS Professor Co-Director, Diabetes and Lipid Center; Tufts University School of Medicine Dr. Pittas[/caption] Anastassios G. Pittas, M.D MS Professor Co-Director, Diabetes and Lipid Center; Tufts Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Observational studies have consistently reported an association between low blood vitamin D level and development of type 2 diabetes. However, whether vitamin D supplementation lowers risk of developing diabetes is not known. We designed and conducted the Vitamin D and diabetes (D2d) study to answer this question.  We randomized 2,423 people with prediabetes to 4,000 IU/day of vitamin D3 or placebo and followed them for new-onset diabetes with blood tests every 6 months for an average of 2.5 years. About 80% of participants had sufficient vitamin D level at baseline (25-hydroxyvitamin D level >= 20 ng/mL). The trial was designed to show a reduction of 25% or more in diabetes risk with vitamin D. The study was unable to show a reduction of 25% or more. At the end of the study, there was a 12% reduction in risk of developing diabetes with vitamin D, which missed statistical significance (hazard ration 0.88; 95% confidence interval 0.75 to 1.04). In a small subgroup of participants with vitamin D deficiency at baseline (25-hydroxyvitamin D level < 12 ng/mL) there was 62% reduction in risk of diabetes with vitamin D (hazard ration 0.38; 95% confidence interval 0.18 to 0.80).
Author Interviews, Diabetes, Diabetologia, Stroke / 09.06.2019

MedicalResearch.com Interview with: Rongrong Yang, PhD candidate Tianjin Medical University  MedicalResearch.com: What is the background for this study? Response: Worldwide, cerebrovascular disease (CBD) and type 2 diabetes mellitus (T2DM) are common disorders that have become among the top ten leading causes of death, killing approximately 8 million people in 2016. Both T2DM and CBD are complex genetic and lifestyle-related disorders. Genetic and familial environmental factors (e.g. foetal environment, maternal smoking and childhood socioeconomic status) have been shown to be involved in the development of both conditions. Accumulating evidence from previous studies suggests that T2DM is independently associated with an increased risk of CBD, especially ischemic CBD.
Allergies, Author Interviews, Cancer Research, Immunotherapy / 07.06.2019

MedicalResearch.com Interview with: Prof. Olivier Lambotte, MD, PHD Professor of Internal Medicine Paris XI University Medical School Research Director Control of Chronic Viral Infections DepartmentProf. Olivier Lambotte, MD, PHD Professor of Internal Medicine Paris XI University Medical School Research Director Control of Chronic Viral Infections Department MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Immune checkpoint inhibitors (ICIs) anti-programmed death-1 (PD-1) or anti-programmed death ligand-1 (PD-L1) have proven efficacy in the treatment of many cancers but patients may experience immune-related adverse events (irAEs). Immune checkpoint inhibitors is usually stopped when grade 2 or higher irAE occur. Data are very limited  on the safety of resuming treatment after such an event. We  studied all adult patients referred to the ImmunoTOX toxicity review board at the Gustave Roussy cancer center (Villejuif, France) in 2015-2017 with  irAE grade 2 or higher for whom the  rechallenge was questioned. Among 93 patients with a broad spectrum of cancers, 40 patients (43%) were rechallenged with the same anti-PD-1 or anti-PD-L1. The rechallenged and non-rechallenged groups did not differ in terms of age, time to initial irAE, irAE severity, or steroid use. With a median follow-up period of 14 months, the same irAE or a different irAE occurred in 22 patients (55%). The second irAEs were not more severe than the first. Earlier initial toxicity was associated with more frequent irAE recurrence.
Author Interviews, Cost of Health Care, Heart Disease, JAMA, University of Pennsylvania / 07.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49581" align="alignleft" width="180"]Sameed Khatana, MD, MPH Fellow, Cardiovascular Medicine, Perleman School of Medicine Associate Fellow, Leonard Davis Institute of Health Economics University of Pennsylvania Dr. Khatana[/caption] Sameed Khatana, MD, MPH Fellow, Cardiovascular Medicine, Perleman School of Medicine Associate Fellow, Leonard Davis Institute of Health Economics University of Pennsylvania  MedicalResearch.com: What is the background for this study?   Response: The Affordable Care Act (ACA) led to the largest increase in Medicaid coverage since the beginning of the program. However, a number of states decided not to expand eligibility. Studies of prior smaller expansions in Medicaid, such as in individual states, have suggested evidence of improved outcomes associated with Medicaid expansion. Additionally, studies of Medicaid expansion under the ACA of certain health measures such as access to preventive care and medication adherence have suggested some improvements as well. However, there have been no large, population-level studies to examine whether Medicaid expansion under the ACA led to changes in mortality rates. Given, a high burden of cardiovascular risk factors in the uninsured, we examined whether states that had expanded Medicaid had a change in cardiovascular mortality rates after expansion, compared to states that have not expanded Medicaid.
Author Interviews, Kidney Disease / 06.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49649" align="alignleft" width="150"]Rita R. Alloway, PharmD, FCCP Research Professor of Medicine Director, Transplant Clinical Research University of Cincinnati College of Medicine, Department of Internal Medicine Division of Nephrology  Kidney C.A.R.E. Program  (Clinical Advancement, Research & Education) Cincinnati OH 45267 Dr. Alloway[/caption] Rita R. Alloway, PharmD, FCCP Research Professor of Medicine Director, Transplant Clinical Research University of Cincinnati College of Medicine, Department of Internal Medicine Division of Nephrology Kidney C.A.R.E. Program (Clinical Advancement, Research & Education) Cincinnati OH 45267  MedicalResearch.com: What is the background for this study? Response: Transplant recipients are required to take lifelong immunosuppression to sustain the function of their transplant.  Unfortunately these immunosuppressants have significant side effects.  The most significant of these side effects are worsening kidney function, hypertension, hypercholesterolemia, post transplant diabetes, tremors and headaches.  Researchers focused on improving post transplant outcomes are looking for immunosuppressant regimens with similar efficacy while minimizing harmful side effects. Tacrolimus and steroids are the immunosuppressants associated with the worst side effect profiles.  This study eliminated both of these immunosuppressants and replace tacrolimus with belatacept.  Belatacept is a once monthly intravenous infusion with a more favorable side effect profile compared to tacrolimus.  In addition, since it is a monthly infusion, adherence can improved compared to an oral medication taken twice daily.
ASCO, Author Interviews, Cancer Research, Cost of Health Care, Race/Ethnic Diversity / 06.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49644" align="alignleft" width="161"]Blythe J.S. Adamson, PhD, MPH Senior Quantitative Scientist Flatiron Health Dr. Adamson[/caption] Blythe J.S. Adamson, PhD, MPH Senior Quantitative Scientist Flatiron Health MedicalResearch.com: What is the background for this study? Response: Racial disparities in access and outcomes have been documented across the full trajectory of cancer-related care. This includes access to prevention and screening, to early diagnosis, treatment, survival and other health outcomes. While these disparities have been well documented, finding mechanisms to reduce disparities is more challenging. One potential mechanism to reduce treatment disparities is to improve access to insurance coverage. The Affordable Care Act (ACA), passed in March 2010, included as its overall goals the improvement in healthcare quality and access, and enhancing equity in treatment and outcomes. The ACA allowed states to expand Medicaid to poor and near-poor adults, and this was implemented by many states starting in 2014. In addition, the ACA established private insurance marketplaces with income-based premium subsidies and limits on out-of-pocket spending for qualifying low-income enrollees. Prior research has demonstrated that ACA Medicaid expansions are associated with increased coverage and improved overall access for cancer survivors; and for newly diagnosed patients, the ACA was associated with increased coverage and shifts to earlier stage diagnosis for some cancers. To our knowledge, no research has yet demonstrated that the ACA coverage expansions affected the process of cancer care, specific cancer treatments received or specific treatment outcomes, let alone whether disparities were reduced.  In this study we looked at the time from advanced/metastatic diagnosis to start of systemic treatment for black vs. white patients and based on whether they were diagnosed at a time and in a state that had vs. had not implemented Medicaid expansion. Our study hypothesis was that Medicaid expansion reduced disparity in timely treatment of black patients compared to white patients with advanced cancer. We defined timely treatment as start of systemic therapy within 30 days of advanced/metastatic diagnosis. This is a retrospective observational study, not a randomized controlled trial. In other words, we selected a cohort of patients diagnosed with advanced or metastatic cancers over time and observed whether they received timely treatment. The Flatiron Health EHR-derived database was the principal data source for this research. Flatiron contributing practices include 280 cancer community based clinics and academic hospital outpatient settings (~800 sites of care) representing more than 2.2 million patients with cancer in the United States. Practices are located in 40 states. To produce the database, Flatiron extracted data from structured fields, including demographics, and recorded medication orders and administrations. Flatiron also abstracted unstructured data, using technology assisted review by highly trained clinicians. Abstracted data include diagnosis date, stage, and prescribed oral anticancer medications. The database used for research purposes was de-identified. We also used data from the Kaiser Family Foundation which has tracked Medicaid implementation policies for over twenty years, and the US Bureau of Labor Statistics from which we pulled state-year unemployment rates.
Author Interviews, Dermatology, FDA / 06.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49640" align="alignleft" width="148"]Stephanie L. Kuschel, B.A Indiana University School of Medicine Indianapolis, IN, 46202 Dr. Kuschel[/caption] Stephanie L. Kuschel, MD Indiana University School of Medicine Indianapolis, IN, 46202 Robert Dellavalle, MD, PhD, MSPH Professor of Dermatology and Public Health University of Colorado School of Medicine Colorado School of Public Health Chief, Dermatology Service US Department of Veterans Affairs Eastern Colorado Health Care System Denver, CO 80220  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Physicians can serve as external experts and voting members of FDA advisory committee panels, which help determine if a drug is acceptable for the US market. Considering that financial conflicts of interest (FCOI) have been shown to influence voting member habits, the FDA has regulations in place to minimize these FCOI. However, the FDA can grant waivers for some financially conflicted individuals if they meet certain requirements (like offering key insights that may out-weigh the risk of a possible FCOI). Additionally the FDA does not make stipulations regarding post-advisory role financial relationships. In fact, many former FDA committee advisors later engage in financial relationships with pharmaceutical companies. Some worry these post-hoc financial relationships could pose an ethical dilemma whereby future FDA advisory members are incentivized to alter their voting habits in expectation of future rewards. Others argue the situation may be more complex than expected. For example, the author of one study, found that while there was evidence for a pro-industry voting bias among committee members with exclusive financial relationships to the sponsoring manufacturer (of the drug under review), this was not the case for members with nonexclusive financial ties to both the sponsor and its competitors 1. Furthermore, the author found that advisors with many corporate ties were (on average) actually more likely than their peers without any financial ties to vote against the sponsor. The author argued that these advisors were more likely to be experienced researchers, and their voting habits may reflect their experience evaluating medical research. While this author and others have offered valuable insights into financial relationships of advisors during their advisory role, unfortunately little information is available regarding post-advisory role financial relationships and whether these relationship have any influence on the integrity of the voting process. The purpose of our study was to review Open Payment data on industry payments to former physician FDA dermatologic drug committee members. 
Accidents & Violence, Author Interviews, ENT, Pediatrics / 06.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49636" align="alignleft" width="200"]Dr. Garth Essig, MD Otolaryngologist The Ohio State University Wexner Medical Center.  Dr. Essig[/caption] Dr. Garth Essig, MD Otolaryngologist The Ohio State University Wexner Medical Center.  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Dog bites are a significant yet modifiable public health concern, but the true magnitude is difficult to estimate with such wide ranges in reporting, severity of injury and varieties of breeds that bite.  We reviewed bites from reports in the literature and from two regionally distinct medical centers. We concluded that bite frequency and severity could be attributed to certain breeds in this sample, if the breed is known. Our study also acknowledged the significant risk of biting with the mixed breed population, which creates a dilemma with identification.
Author Interviews, Cost of Health Care, JAMA, Mental Health Research / 06.06.2019

MedicalResearch.com Interview with: [caption id="attachment_48428" align="alignleft" width="200"]Hefei Wen, PhDAssistant Professor, Department of Health Management & PolicyUniversity of Kentucky College of Public Health Dr. Wen[/caption] Hefei Wen, PhD Assistant Professor, Department of Health Management & Policy University of Kentucky College of Public Health  MedicalResearch.com: What is the background for this study? Response: Medicaid is the principal payer of behavioral health services in the U.S. and expected to play an increasing role in financing behavioral health services following Medicaid expansions under the ACA.
Author Interviews, Opiods, Pain Research, Sleep Disorders / 05.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49610" align="alignleft" width="133"]Dr-Nicole Tang Dr. Tang[/caption] Nicole Tang, D.Phil, C.Psychol (Reader) Department of Psychology Warwick Sleep and Pain Lab University of Warwick MedicalResearch.com: What is the background for this study? What are the main findings? Response: Current guidelines recommend non-opioid therapy as the preferred treatment of chronic non-malignant (CNP) pain, with opioids reserved to situations “when benefits for pain and function are expected to outweigh risks” [1,10]. Whilst the effectiveness of opioid therapy is usually measured in terms of pain outcomes, less is known about its effect on day-to-day functions. A particular function of concern to patients with chronic non-malignant pain is the ability to get a good night's sleep. The current systematic review has identified a set of papers with relevant outcomes regarding the effect of opioid therapy on sleep quality and sleep architecture in CNP patients. It extends our understanding from the drug's respiratory depression effect in healthy individuals to the potential risks and utility of opioid therapy for chronic non-malignant pain patients with sleep disturbances. Whilst the narrative synthesis and the exploratory meta-analysis of a subset of data both suggest that the use of opioid therapy is associated with an overall report of sleep quality improvement, such an improvement is not consistently replicated across studies or substantiated by improvements in sleep parameters linked to deeper and better-sleep quality. Moreover, the improvement may be accompanied by undesirable side effects and increased daytime sleepiness that contradict with the very idea of improved sleep quality. We are also painfully aware of the methodological limitations of the studies reviewed; their exposure to different sources of biases has heightened the risk of result inflation. To many patients with chronic non-malignant pain, improved sleep is a top priority when evaluating the performance of a new drug and non-drug intervention. If we were to advance our current understanding of the opioid-sleep relationship, future trials need to be designed with this interdisciplinary question in mind such that validated measures of sleep can be incorporated as an outcome measure alongside pain.
Accidents & Violence, Author Interviews, Cost of Health Care, JAMA, Surgical Research, University of Michigan / 05.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49606" align="alignleft" width="156"]Dr. Mark R. Hemmila MD Associate Professor of Surgery Division of Acute Care Surgery University of Michigan Dr. Hemmila[/caption] Dr. Mark R. Hemmila MD Associate Professor of Surgery Division of Acute Care Surgery University of Michigan  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Traumatic injury has a tendency to be thought of as a disease that preferentially impacts younger people.  We wanted to explore the prevalence and impact of traumatic injury within the population of patients for whom Medicare is the third party payer. 
Author Interviews, Bayer, Biomarkers, Colon Cancer / 05.06.2019

MedicalResearch.com Interview with: Joseph Germino, M.D., PhD Vice President US Medical Affairs Oncology Bayer Healthcare Pharmaceuticals Whippany, N.J. 07981 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumor angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF), metastasis (VEGFR3, PDGFR, FGFR) and tumor immunity (CSF1R). This prospective pharmacokinetic (PK) ancillary study is part of a prospective phase II study evaluating treatment response with regorafenib in patients with chemorefractory metastatic colorectal cancer (mCRC) called TEXAN, which aimed to investigate correlations between overall survival (OS) and regorafenib, or its enterohepatic cycle-dependent active metabolites M-2 and M-5 concentrations. As measured by LC-MS/MS, the main findings showed that regorafenib, M-2 and M-5 were respectively 1.99 (1.03-2.73), 1.44 (0.89-2.49) and 1.61 (0.79-2.37) mg/L during the first cycle at day 15 (C1D15) and 1.90 (1.10-2.76), 1.29 (0.77-2.24) and 1.17 (0.45-2.42) mg/L at during the second cycle at day 15 (C2D15). 
ASCO, Author Interviews, Bayer, Leukemia, Pediatrics / 05.06.2019

MedicalResearch.com Interview with: Joseph Germino, M.D., PhD Vice President US Medical Affairs Oncology Bayer Healthcare Pharmaceuticals Whippany, N.J. 07981 MedicalResearch.com: What is the background for this study? Response: Sorafenib (Nexavar®) is an oral anticancer therapy approved in more than 100 countries worldwide. It is approved for the treatment of patients with advanced hepatocellular carcinoma (HCC); advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy; progressive, locally advanced or metastatic differentiated thyroid carcinoma (papillary/follicular/Hürthle cell), that is refractory to radioactive iodine (RAI). The AAML 1031 is a recently completed Phase III clinical trial evaluating the use of bortezomib and sorafenib in patients 30 years or younger with newly diagnosed acute myeloid leukemia (AML). At the 2019 ASCO Annual meeting, results of a report from the AAML1031 trial, which assessed whether intensification of Induction II chemotherapy (ADE or AraC/ Mitoxantrone) and liberalized stem cell transplant (SCT) donor source criteria improved clinical outcomes in patients with residual AML. 
Accidents & Violence, Author Interviews, Exercise - Fitness, Geriatrics, JAMA / 05.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49471" align="alignleft" width="150"]Teresa Liu-Ambrose, PT, PhDCanada Research Chair (Tier II), Physical Activity, Mobility, and Cognitive NeuroscienceDirector, Aging, Mobility, and Cognitive Neuroscience LaboratoryUniversity of British Columbia Dr. Liu-Ambrose[/caption] Teresa Liu-Ambrose, PT, PhD Canada Research Chair (Tier II), Physical Activity, Mobility, and Cognitive Neuroscience Director, Aging, Mobility, and Cognitive Neuroscience Laboratory University of British Columbia MedicalResearch.com: What is the background for this study? Response:  Falls in older adults are the third-leading cause of chronic disability and the leading cause of hospitalization for adults over age 65. Older adults who experience multiple falls are at increased risk for disability, loss of independence, and even death. How to best prevent falls in this high risk group is not well established. 
Author Interviews, JAMA, Pediatrics, Sexual Health / 04.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49588" align="alignleft" width="135"]Monika K. Goyal, M.D., MSCE Assistant chief of Children’s Division Emergency Medicine and Trauma Services Dr. Goyal[/caption] Monika K. Goyal, M.D., MSCE Assistant chief of Children’s Division Emergency Medicine and Trauma Services  MedicalResearch.com: What is the background for this study? Response: Adolescents are disproportionately affected by sexually transmitted infections (STIs) and often present to the emergency department for care. I have devoted almost 15 years of my career trying to improve the sexual health of teens through advocacy and the development of novel interventions in the emergency department to increase access to sexual health services for youths.