Author Interviews, Brigham & Women's - Harvard, Exercise - Fitness, Race/Ethnic Diversity, Social Issues / 03.08.2020

MedicalResearch.com Interview with: Marc Weisskopf, PhD, ScD Cecil K. and Philip Drinker Professor of Environmental Epidemiology and Physiology Departments of Environmental Health and Epidemiology Harvard T.H. Chan School of Public Health Boston, MA 02115  MedicalResearch.com: What is the background for this study? Response: There is a long history of health disparities by race. We were interested to see whether these also show up in professional football players, with the thought that perhaps the advantages that come with being an elite athlete in a sport (e.g. related to income, potential access to carte, prestige) might minimize health disparities. (more…)
Author Interviews, Dermatology, FDA, Regeneron, Sanofi / 31.07.2020

MedicalResearch.com Interview with: Elizabeth Laws, PhD Vice President and Global Project Head for Dupilumab/Dupixent Sanofi Marcie Ruddy, MD, MA Strategic Program Direction, Immunology and Inflammation Regeneron  Dr. Laws and Dr. Ruddy discuss the FDA approval of a 300 mg single-dose pre-filled pen for Dupixent® (dupilumab) for all indications in patients aged 12 years and older.   MedicalResearch.com: What is the background for this announcement? What are the main indications for Dupixent? Response: Until now, Dupixent 300 mg dose was available only in pre-filled syringe for administration. The approval of the pre-filled pen provides an additional, easy-to-use option for patients to self-administer Dupixent. Dupixent is approved to treat patients aged 6 years and older with uncontrolled moderate-to-severe atopic dermatitis (AD) and can be used with or without topical treatments. Dupixent is also approved for use with other medicines for the maintenance treatment of uncontrolled moderate-to-severe eosinophilic or oral steroid dependent asthma in patients aged 12 years and older, and with other medicines for the maintenance treatment of uncontrolled chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults, respectively. The pre-filled pen is approved for use in patients prescribed Dupixent who are 12 years of age and older across current indications, at the 300 mg dose. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Heart Disease, JAMA / 28.07.2020

MedicalResearch.com Interview with: Frank Wharam, MD, MPH Department of Population Medicine Harvard Medical School and Harvard Pilgrim Healthcare Institute Boston, MA 02215 MedicalResearch.com: What is the background for this study? Response:  There is substantial concern that high-deductible health plans increase people’s risk of major adverse health events such as heart attack and stroke. No studies have examined this question. This study examines the effects of a transition to a high-deductible health plan on the risk of major adverse cardiovascular outcomes (myocardial infarction and stroke). The study group included individuals with risk factors for cardiovascular disease who were continuously enrolled in low-deductible (<$500) health plans during a baseline year followed by up to 4 years in high-deductible (≥$1000) plans after an employer-mandated switch. The matched control group included individuals with the same risk factors who were contemporaneously enrolled in low-deductible plans.  We examined time to first major adverse cardiovascular event, defined as myocardial infarction or stroke.  (more…)
Annals Internal Medicine, Author Interviews, Brigham & Women's - Harvard, Osteoporosis / 28.07.2020

MedicalResearch.com Interview with: Daniel Hal Solomon, MD, MPH Associate Physician, Brigham and Women's Hospital Professor of Medicine, Harvard Medical School Brigham and Women's Hospital Department of Medicine Rheumatology, Immunology Boston, MA 02115 Editor’s note: Prolia® is the trade name for denosumab.  MedicalResearch.com: What is the background for this study? Response: We conducted this study to assess whether delays in denosumab (injections were associated with an increased risk of fractures. In a prior study, we found that the improvements in bone mineral density were reduced among patients who delayed injections. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Dental Research, Esophageal, Gastrointestinal Disease / 24.07.2020

MedicalResearch.com Interview with: Mingyang Song, MD, ScD. Division of Gastroenterology Clinical and Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School Department of Nutrition and Department of Epidemiology Harvard T.H. Chan School of Public Health Boston, Massachusetts MedicalResearch.com: What is the background for this study? Response: Recent studies showed a presence of dysbiotic oral microbiome in patients with esophageal and gastric cancer, suggesting a link between oral health and these cancers. However, how periodontal disease and tooth loss may influence the risk of these cancers has been inconsistent.  MedicalResearch.com: What are the main findings? Response: Our findings support a possible role of oral health in the development of upper GI cancer. Individuals with periodontal disease and tooth loss are at higher risk of developing esophageal and gastric adenocarcinoma. The risk is particularly high for individuals with both periodontal disease and tooth loss.  (more…)
Author Interviews, Columbia, COVID -19 Coronavirus, Kidney Disease, Transplantation / 09.07.2020

MedicalResearch.com Interview with: Syed Ali Husain, MD, MPH Assistant Professor of Medicine Division of Nephrology, Department of Medicine Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital The Columbia University Renal Epidemiology Group New York, New York  MedicalResearch.com: What is the background for this study? Response: One group of patients thought to be at a high risk of severe COVID-19 manifestations is kidney transplant recipients, since they take medications that suppress their immune system and they often have other medical problems that have been associated with severe infection. We wanted to understand whether it is safe to manage kidney transplant recipients who develop COVID-19 as outpatients, without admitting them to the hospital. (more…)
Author Interviews, Brigham & Women's - Harvard, Geriatrics, Lipids / 08.07.2020

MedicalResearch.com Interview with: Ariela Orkaby, MD, MPH Geriatrics & Preventive Cardiology Associate Epidemiologist Division of Aging, Brigham and Women's Hospital Assistant Professor of Medicine, Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Statins are cholesterol lowering medications that have been proven to prevent heart attacks, strokes and death in middle-aged adults. Current guidelines for cholesterol lowering therapy are uncertain as to treatment for older adults due to a lack of available data, even though older adults are at the highest risk of heart disease and death. (more…)
Author Interviews, JAMA, Sleep Disorders, Stanford / 07.07.2020

MedicalResearch.com Interview with: Eileen B. Leary, Ph.D. Student Epidemiology and Clinical Research Stanford University MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by REM sleep? Response: Sleep is a regulated, reversible, and recurring loss of consciousness that is a critical requirement for a happy, healthy life. REM sleep is an important component of sleep defined by rapid eye movements and commonly associated with dreaming. We learned from previous studies that sleep duration is associated with mortality, however little was known about how the different sleep stages relate to timing or cause of death. (more…)
Author Interviews, Brigham & Women's - Harvard, Cognitive Issues, Sleep Disorders / 01.07.2020

MedicalResearch.com Interview with: Dr. Rebecca Robbins, PhD MS Fellow at Brigham & Women's Hospital and Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Sleep difficulties are common among older adults and are associated with cognitive decline. We used data collected over 10 years from a large, nationally representative longitudinal survey of adults over the age of 50 in the U.S. We examined the relationship between specific sleep difficulties and cognitive function over time. MedicalResearch.com: What are the main findings?  Response: Our results show that early difficulty falling asleep and early morning awakenings, when experienced "most nights" of the week, were each associated with worse cognitive function. Conversely, reports of waking feeling rested was associated with better cognitive function, over time.   (more…)
Author Interviews, Brigham & Women's - Harvard, Critical Care - Intensive Care - ICUs, NEJM, Pediatrics / 24.06.2020

MedicalResearch.com Interview with: Christopher P. Landrigan, MD, MPH Chief, Division of General Pediatrics, Boston Children’s Hospital Director, Sleep and Patient Safety Program, Brigham and Women's Hospital William Berenberg Professor of Pediatrics, Harvard Medical School Boston Children's Hospital Boston, MA 02115 MedicalResearch.com: What is the background for this study? Response: An enormous body of literature demonstrates that sleep deprivation adversely affects the safety and performance of resident physicians, as well as individuals across other occupations.  Resident physicians are at greatly increased risk of suffering motor vehicle crashes and needlestick injuries, and are at substantially increased risk of making medical errors, when working on traditional schedules that include 24-hour shifts. We previously conducted a randomized controlled trial in two intensive care units that found resident physicians made 36% fewer medical errors when a scheduling intervention was introduced that eliminated 24-hour shifts but held resident workload constant. The current study, ROSTERS, was a 6-center study that again introduced a scheduling intervention to eliminate 24-hour shifts in intensive care units.  Due to varying resources and unit organization across sites, each hospital developed its own staffing plan to accommodate the intervention​. (more…)
Accidents & Violence, Author Interviews, Cannabis, JAMA, NYU / 23.06.2020

MedicalResearch.com Interview with: Julian Santaella Tenorio, MSc DrPH Epidemiology Center for Opioid Epidemiology and Policy Division of Epidemiology, Department of Population Health New York University Langone School of Medicine, New York, New York MedicalResearch.com: What are the main findings? car-accident-traffic-accidentResponse: This study found that recreational cannabis laws were associated with increases in traffic fatalities in Colorado (mean of 75 excess fatalities per year) but not in Washington State.  These findings suggest that unintended effects of recreational cannabis laws can be heterogeneous and may be specific to variations in how these laws are implemented
(eg, density of recreational cannabis stores).   (more…)
Author Interviews, Heart Disease, JAMA, Opiods, Surgical Research, University of Pennsylvania / 20.06.2020

MedicalResearch.com Interview with: Chase Brown, MD Associate Fellow, Leonard Davis Institute of Health Economics Integrated Cardiac Surgery Resident Hospital of the University of Pennsylvania Nimesh D. Desai, MD, PhD Director, Thoracic Aortic Surgery Research Program Associate Professor of Surgery Hospital of the University of Pennsylvania MedicalResearch.com: What is the background for this study? Dr. Chase Brown:  Opioid use in the United States is a public health emergency. We know that opioids prescribed after general surgery operations to patients who never received them within the year prior to their surgery are at increased risk for continuing to take opioids months later. However, this has not been studied in patients undergoing cardiac surgery, who often times have more severe post-operative pain. Our goal in this study was to determine how many patients after cardiac surgery and are opioid naive are continuing to take opioids within 90-180 days after their surgery.   (more…)
Author Interviews, Diabetes, Duke, Telemedicine / 15.06.2020

MedicalResearch.com Interview with: Matthew J. Crowley, MD Core Investigator, Durham Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) Affiliated Investigator, VA Office of Rural Health Staff Physician, Endocrinology Section, Durham VA Health Care System Elizabeth Kobe, BS Medical Student Durham VA Health Care System Duke University School of Medicine MedicalResearch.com: What is the background for this study? With whom were the telehealth sessions performed? (MDs, PAs, Dieticians etc). Response: Diabetes management in rural populations is especially challenging due to limited access to specialty care and self-management programs. Telehealth is a potential strategy for extending high-quality diabetes care to rural areas. The Veterans Health Administration (VHA) has a robust Home Telehealth (HT) system that is currently used for telemonitoring patient blood glucose values. In order to address the challenges of managing diabetes in rural areas in a clinically feasible manner, we strategically designed an intensive diabetes management intervention – Advanced Comprehensive Diabetes Care (ACDC) – for delivery using existing VHA HT infrastructure and clinical staffing. ACDC is a 6-month telehealth intervention that combines telemonitoring with module-based self-management support and medication management. ACDC is delivered entirely by existing clinical staff (a clinical HT nurse and a medication manager (typically a PharmD)) through bimonthly, 30-minute calls. Our initial randomized controlled trial found that ACDC improved HbA1c by a clinically and statistically significant  -1.0% relative to usual care at 6 months, while also improving blood pressure and diabetes self-care. Our goal with the present work was to improve diabetes care in clinical practice for rural Veterans whose type 2 diabetes remained uncontrolled despite receiving available services. To this end, we partnered with the VA Office of Rural Health to implement ACDC into VA sites across the country with large rural populations.  (more…)
ASCO, AstraZeneca, Author Interviews, Cancer Research, Lung Cancer, Yale / 13.06.2020

MedicalResearch.com Interview with: Roy S. Herbst, MD, PhD Ensign Professor of Medicine (Medical Oncology) Professor of Pharmacology Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital; Associate Cancer Center Director for Translational Research Yale Cancer Center MedicalResearch.com: What is the background for this study? What are the main findings?
  • ADAURA is the first global trial for an EGFR tyrosine kinase inhibitor to show statistically significant and clinically meaningful benefit in adjuvant treatment of Stage IB, II, and IIIA EGFRm NSCLC. The results demonstrated unprecedented disease free survival (DFS) in the adjuvant treatment of these patients after complete tumor resection with curative intent. Osimertinib was assessed against placebo for a treatment duration of up to three years and then unblinded two years earlier than expected at the recommendation of the Independent Data Monitoring Committee (IDMC), based on its determination of overwhelming efficacy during a planned safety analysis.
  • In the primary endpoint of DFS in patients with Stage II and IIIA disease, adjuvant (after surgery) treatment with osimertinib reduced the risk of disease recurrence or death by 83% (based on a hazard ratio [HR] of 0.17; 95% confidence interval [CI] 0.12, 0.23; p<0.0001).
  • DFS results in the overall trial population, Stage IB through IIIA, a key secondary endpoint, demonstrated a reduction in the risk of disease recurrence or death of 79% (based on a HR of 0.21; 95% CI 0.16, 0.28; p<0.0001).
(more…)
ASCO, Author Interviews, Cancer Research, Leukemia, UC Davis / 28.05.2020

MedicalResearch.com Interview with: Brian A. Jonas, M.D., Ph.D. UC Davis Health System MedicalResearch.com: What is the background for this study? At this year’s American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) virtual meetings, we presented data on the rapidity and likelihood of response to venetoclax treatments, and its associated characteristics, in older patients with newly diagnosed acute myeloid leukemia (AML). We evaluated data from two clinical trials of venetoclax in combination with azacitidine, or decitabine (M14-358), or low-dose cytarabine (LDAC) (M14-387) in this patient population. (more…)
Author Interviews, Cancer Research, JAMA, Yale / 28.05.2020

MedicalResearch.com Interview with: Daniel J. Boffa, MD Associate Professor of Thoracic Surgery Yale School of Medicine MedicalResearch.com: What is the background for this study? Response: The study examined networks that formed around hospitals that had been previously ranked in the top-50 by US News and World Report.  These top-ranked hospitals have shared their brand with hospitals in their network, which leads some people to believe that the care is the same at top-ranked hospitals and their affiliate hospitals.  We wanted to determine if outcomes after complex surgical procedures were truly the same at affiliate hospitals and top-ranked hospitals.  (more…)
Author Interviews, Brigham & Women's - Harvard, Cognitive Issues, Heart Disease, JACC, Lipids / 23.05.2020

MedicalResearch.com Interview with: Robert P. Giugliano, MD, SM Senior Investigator, TIMI Study Group Cardiovascular Medicine Brigham and Women's Hospital Professor of Medicine Harvard Medical School Boston, MA  MedicalResearch.com: What is the background for this study? Response: Some prior studies had suggested that lipid lowering therapies were associated with impaired cognition.  We sought to explore this question in a prospectively designed substudy of the large FOURIER randomized, double-blind clinical trial utilizing patient self-surveys administered the end of the study to determine whether patients themselves noticed any changes in cognition over the duration of the trial. The survey tool was a shortened version of the Everyday Cognition Questionnaire (see attached) that asks patients 23 questions that assess memory and executive function (including subdomains of planning, organization, and divided attention). The questions are in the format of "Compared to the beginning of the study, has there been any change in .....", and are graded as 1=better/no change, 2=questionable/occasionally worse, 3=consistently a little worse, 4=consistently much worse. (more…)
AHA Journals, Author Interviews, COVID -19 Coronavirus, NYU / 21.05.2020

MedicalResearch.com Interview with: Shadi Yaghi, MD Assistant Professor Department of Neurology at NYU Grossman School of Medicine Director, Clinical Vascular Neurology Research, NYU Langone Health Director, Vascular Neurology, NYU Langone Hospital-Brooklyn  MedicalResearch.com: What is the background for this study? Response: Our aim was to determine the characteristics of imaging proven ischemic stroke in the setting of COVID-19 infection and compare them to those of ischemic stroke but without COVID-19 infection. (more…)
Author Interviews, Gender Differences, JAMA, Surgical Research, University of Pittsburgh / 21.05.2020

MedicalResearch.com Interview with: Sara P. Myers, M.D., Ph.D. University of Pittsburgh School of Medicine  MedicalResearch.com: What is the background for this study? Response: Compared to other fields, medicine, and especially academic surgery and its subspecialties, trail with respect to gender diversity. Considering that these fields were traditionally male-dominated, two issues that may present ongoing challenges to the retention and promotion of women are pro-male bias and negative stereotypes about women. Training specific to pursuing a surgical career begins in residency, so it is important to understand how these issues affect motivation and achievement during this formative period. In our study we first evaluated the association between pro-male bias and research-related career engagement using a survey methodology, and then looked at whether evoking negative stereotypes about women was associated with reduced performance on a simulated technical skill assessment called the Fundamentals of Laparoscopic Surgery (FLS) assessment.  (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Heart Disease, Race/Ethnic Diversity, Statins / 14.05.2020

MedicalResearch.com Interview with: Dr. Ankur Pandya, PhD Assistant Professor of Health Decision Science Department of Health Policy and Management Harvard T.H. Chan School of Public Health MedicalResearch.com: What is the background for this study? Response: The 2013 ACC-AHA cholesterol treatment guidelines greatly expanded statin medication eligibility for individuals between the ages of 40-75 years without known cardiovascular disease, and there was some concern that African Americans at "intermediate risk" per those guidelines could be (arguably) overtreated with statins. The 2018 ACC-AHA guidelines included coronary artery calcium assessment for individuals at intermediate cardiovascular disease risk; those with a "zero" calcium score and no other risk factors would now change the eligibility (from indicated statin to not indicated). (more…)
Author Interviews, Brigham & Women's - Harvard, Gender Differences, Genetic Research, Nature / 13.05.2020

MedicalResearch.com Interview with: Nolan Kamitaki PhD Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Previous work from our lab found that the strongest common genetic association to schizophrenia is driven in part by copy number variation of the C4 genes.  Given that lupus and Sjogren's syndrome, two autoimmune disorders, have association patterns that span the same region of the human genome, we wondered if part of the signal for these diseases may also arise from variation of C4 given that both have hypocomplementemia as a characterizing trait.   The other main finding is that these associations appear to be sex-biased, where the protection from each additional copy of the C4 gene was greater in men than in women.  When we went back to the data used in the previous study from our lab association C4 variation to schizophrenia, we found that the effect was stronger in men there as well.  Although the expression of C4 at the RNA level does not appear to differ between men and women, we saw that men had more C4 protein in both cerebrospinal fluid and blood plasma, suggesting that this may explain the greater genetic association in men. (more…)
AACR, Author Interviews, Biomarkers, Cancer Research, MD Anderson, Pharmaceutical Companies / 09.05.2020

MedicalResearch.com Interview with: David S Hong, M.D MD Anderson Department of Investigational Cancer Therapeutics Division of Cancer Medicine University of Texas MedicalResearch.com: What is the background for this study? Response: Larotrectinib is a first-in-class, CNS active, oral TRK inhibitor exclusively designed to treat tumors with an NTRK gene fusion and does not have secondary targets. In previous presentations and published in The Lancet Oncology, larotrectinib demonstrated robust tumor-agnostic efficacy in an integrated dataset of 159 adult and pediatric patients with TRK fusion cancer across three clinical trials (Feb 2019 data cut-off date). In these studies, the objective response rate (ORR), according to investigator assessment, was 79% (95% confidence interval [CI], 72 – 85%), with a complete response rate of 16%. In this analysis presented at AACR 2020, we sought to evaluate the outcomes in patients from the integrated data set based on different baseline characteristics, including prior lines of therapy and Eastern Cooperative Oncology Group (ECOG) performance status. ECOG measures how the disease impacts a patient. ECOG describes a patient’s level of functioning with a numbering scale (0-5) so physicians can uniformly describe a patient’s ability to care for themselves, daily activity and physical activity (selfcare, walking, working, etc). (more…)
Author Interviews, Brigham & Women's - Harvard, Nature, Weight Research / 05.05.2020

MedicalResearch.com Interview with: Ronald Kahn, MD Chief Academic Officer, Joslin Diabetes Center Mary K. Iacocca Professor of Medicine Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Adipose tissue is a heterogeneous organ and composed of several cell types, including mature adipocytes, preadipocytes, stem cells, endothelial cells, and various blood cells. Different adipose depots have distinct physiological functions associated with their anatomical location and cell composition. For example, accumulation of intra-abdominal (visceral) white adipose tissue is associated with insulin resistance and metabolic syndrome, whereas accumulation of subcutaneous adipose tissue is not metabolically detrimental and may be even associated with increased insulin sensitivity. Determining the mechanisms for these phenotypic differences could lead to development of novel therapies for diabetes, obesity, and their associated morbidities. A central challenging question in research of metabolic disease is whether disease risk for diabetes and metabolic syndrome is driven by a subset of fat cells that may interact with environmental stresses in disease pathogenesis in a way different from other fat cells. Indeed, previous studies from the Kahn lab have shown different fat cells in a single depot from the mouse may exhibit developmental heterogeneity. In this new study, we attempted to address this question for human white fat using a synergistic application of several methodologies: 1) single cell transcriptional profiling of human white fat during differentiation, 2) analysis of individual clones of white fat cells taken from humans at surgery, 3) novel computer based network analysis and 4) integration of the gene signatures across experimental models. Single-cell RNA sequencing is an ideal technique to profile gene expression of heterogeneous cell populations obtained from a single tissue, including fat tissue. (more…)
Author Interviews, Beth Israel Deaconess, COVID -19 Coronavirus, JAMA, Race/Ethnic Diversity / 01.05.2020

MedicalResearch.com Interview with: Rishi Wadhera, MD, MPP, MPhil Instructor in Medicine at Harvard Medical School Cardiologist,Beth Israel Deaconess Medical Center MedicalResearch.com: What is the background for this study? Response: With more than a million confirmed cases of COVID-19 in the United States, there is growing concern that low-income communities and racial/ethnic minorities may be disproportionately shouldering the burden of the pandemic. New York City, which is comprised of 5 boroughs (Bronx, Brooklyn, Manhattan, Queens, and Staten Island) with unique demographic and socioeconomic characteristics, has emerged as the epicenter of the COVID-19 outbreak. (more…)
Author Interviews, C. difficile, Gastrointestinal Disease, Imperial College, Infections, Transplantation / 30.04.2020

MedicalResearch.com Interview with: Prof. Julian Marchesi PhD Professor of Digestive Health Faculty of Medicine, Department of Metabolism, Digestion and Reproduction   Dr. Benjamin Mullish PhD Faculty of Medicine, Department of Metabolism, Digestion and Reproduction NIHR Clinical Lecturer Imperial College London       MedicalResearch.com: What is the background for this study? Response: Many patients are colonized with bacteria that are resistant to nearly all the antibiotics that we currently have. This antibiotic resistance is a huge public health problem, not least because it may lead to the scenario where a bacterial species moves from the gut and into the bloodstream, causes an infection, and cannot be treated. Such scenarios particularly occur in patients who are particularly prone to getting multiple and frequent courses of antibiotics; this may include patients with particular kidney conditions (who may be vulnerable to recurrent urinary tract infections (UTIs)), and patients with blood cancers (such as leukaemia, who have weak immune systems and are therefore prone to infections). Furthermore, in both sets of patients, to help treat their disease, they may be offered transplants, either a new kidney or new bone marrow. When this transplant happens, the clinician needs to ‘switch off’ their immune system to allow the transplant to work. When the immune system is dialled down, it can no longer stop any invading bacteria, increasing the chance of antibiotic resistance bacteria causing infections, which frequently leads to patient death.  (more…)
Author Interviews, Emergency Care, Heart Disease, JAMA, UT Southwestern / 22.04.2020

MedicalResearch.com Interview with: Rebecca Vigen, MD, MSCS Assistant Professor of Internal Medicine UT Southwestern MedicalResearch.com: What is the background for this study? Response: Emergency department overcrowding is an urgent health priority and chest pain is a common reason for emergency department visits.  We developed a new protocol that uses high sensitivity cardiac troponin testing with a risk assessment tool that guides decisions on discharge and stress testing for patients presenting with chest pain. The protocol allows us to rule out heart attacks more quickly than the protocols utilizing an older troponin assay. (more…)
COVID -19 Coronavirus, FDA / 21.04.2020

'The U.S. Food and Drug Administration authorized the first diagnostic test with a home collection option for COVID-19. Specifically, the FDA re-issued the emergency use authorization (EUA) for the Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test to permit testing of samples self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit. “Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers. Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.” (more…)
Author Interviews, Cognitive Issues, Mediterranean Diet, NIH / 21.04.2020

MedicalResearch.com Interview with: Emily Y. Chew, M.D. Director of the Division of Epidemiology and Clinical Applications Deputy Clinical Director at the National Eye Institute (NEI), National Institutes of Health  MedicalResearch.com: What is the background for this study? Response: Dementia is a common disorder that was estimated to have a worldwide prevalence of 44 million in 2016 and is projected to hit 115 million by 2050. Many phase 3 trials of various therapies have failed and we have no treatment currently available for the prevention or reduction of the course of dementia. A slow neurocognitive decline throughout life is part of the normal process of aging. However, there is a subset of individuals who may have accelerated aging and is at high risk of development dementia. If the course of such accelerated decline could be altered in any way, it would be important to evaluate. The role of diet with biologic aging has been studied and diet has been also found to be associated with age-related conditions linked to dementia, including cardiovascular disease and diabetes. We were interested in the cognitive function of our participants who had another neurodegenerative disease, age-related macular degeneration (AMD). We had conducted two randomized controlled clinical trials designed to evaluate the role of oral supplements for the treatment of AMD. We also studied cognitive function in both clinical trials of nearly 8,000 participants who were followed for 10 years. We also evaluated the dietary habits of the participants with food frequency questionnaires (FFQ) at baseline. Cognitive function testing was conducted in the first study, the Age-Related Eye Disease Study (AREDS) near the end of the clinical trial while the AREDS2, the second study, evaluated cognitive function testing at baseline and every 2 years until year 6. AREDS study evaluated cognitive function with in-clinic study visits while AREDS2 was conducted using telephone interviews. Our aim was to determine whether closer adherence to the alternative Mediterranean diet (aMED) was associated with impaired cognitive function these two studies. We were interested in the particular components of the Mediterranean diet that may be important. We also evaluated the interaction of genetics with the diet.    (more…)
Author Interviews, Blood Pressure - Hypertension, UT Southwestern / 15.04.2020

MedicalResearch.com Interview with: DaiWai Olson, PhD, RN Professor of Neurology and Neurotheraputics UT Southwestern Medical Center MedicalResearch.com: What is the background for this study? Response: This study resonates across nursing. Kat Siaron is a Neuroscience nurse who had questions about the ‘best’ location for checking blood pressure. Like so many studies this started with a clinical question: “does it make a difference where you check the blood pressure?” She applied for a nursing research fellowship and was one of 6 nurses selected. She spent about 3 months reading articles on blood pressure and looking to see if there are any similar studies. After confirming that this has not been done, she submitted her study for approval from the Institutional Review Board and started data collection. (more…)