01 Sep Long-Acting Beta-Agonists-Steroid Combination in Pediatric Asthma
MedicalResearch.com Interview with: David A Stempel, MD Medical Affairs Lead US Medical Affairs GlaxoSmithKline MedicalResearch.com: What is the background for this study? What are the main findings? Response: Long-acting beta-agonists (LABAs) have been shown to increase the risk of asthma-related death among adults and the risk of asthma-related hospitalization among children. It is unknown whether the concomitant use of inhaled glucocorticoids with LABAs mitigates those risks. This trial prospectively evaluated the safety of the LABA salmeterol, added to fluticasone propionate, in a fixed-dose combination in children.31 Aug Drug-Eluting Stents Reduce Need for Revascularization after PCI
MedicalResearch.com Interview with: Dr. Kaare Harald Bønaa Principal investigator University of Tromsø, Norway MedicalResearch.com: What is the background for this study? Response: The NORSTENT study was designed shortly after the “Barcelona fire storm” in 2006 that raised severe safety concerns against drug-eluting stents (DES). At that time there was evidence for increased risk of stent thrombosis with DES. How this could influence long term results compared to PCI with bare metal stents (MMS) was not known. Accordingly, we designed the NORSTENT study with the primary composite endpoint of all-cause mortality and non-fatal spontaneous myocardial infarction at a medial of 5 years of follow-up.30 Aug Study Finds CPAP Improved Quality of Life But Did Not Reduce Cardiovascular Risk
Posted at 18:23h
in Author Interviews, Heart Disease, NEJM, Obstructive Sleep Apnea, Sleep Disorders
MedicalResearch.com Interview with:
Prof. Craig Anderson, PhD
Professor of Stroke Medicine and Clinical Neuroscience
Medicine, The George Institute for Global Health
University of Sydney
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: We wished to prove whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP ) can modify the risk of cardiovascular disease. The is a lot of association data from epidemiological and clinical studies but no large scale international clinical trials assessing the effects of CPAP on the prevention of serious cardiovascular events like heart attack and stroke.
Our study in nearly 3000 adults with prior heart attack or stroke and moderate to severe obstructive sleep apnea showed that CPAP treatment did not prevent recurrent cardiovascular events or major cardiovascular risk factors. However CPAP did improve wearers' sense of wellbeing, mood and work productivity.
26 Aug 70-Gene Signature Can Help Identify Early-Stage Breast Cancer Patients Who Do Not Need Chemotherapy
MedicalResearch.com Interview with: [caption id="attachment_27366" align="alignleft" width="150"]
Dr. Laura Van't Leer[/caption]
Prof. Laura van ’t Veer, PhD
Leader, Breast Oncology Program, and Director, Applied Genomics, UCSF Helen Diller Family Comprehensive Cancer Center
Angela and Shu Kai Chan Endowed Chair in Cancer Research
UCSF Helen Diller Family Comprehensive Cancer Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: MINDACT was designed to involve only patients with node negative and 1 to 3 positive lymph node breast cancer. Node negative breast cancer is a cancer that has not spread to the surrounding lymph nodes and therefore has a lower risk of recurrence. Scientists have also demonstrated that breast cancer which has spread to 1 to 3 lymph nodes may behave like node negative breast cancer. Patients with either node negative cancer or with a cancer that involves 1-3 lymph nodes are often prescribed chemotherapy, although physicians believe that approximately 15% of them do not require such treatment.
MINDACT provides the highest level of evidence to show that using MammaPrint® can substantially reduce the use of chemotherapy in patients with node-negative and 1-to-3 node positive breast cancer – in other words, it can identify patients with these types of breast cancer who can safely be spared a treatment that may cause significant side effects, and will offer no to very little benefit.
19 Aug Closed-Loop Insulin Delivery During Pregnancy Improves Glucose Control
MedicalResearch.com Interview with: Professor Helen Murphy and Dr Zoe Stewart Institute of Metabolic Science University of Cambridge MedicalResearch.com: What is the background for this study? Response: Controlling blood glucose levels is a daily challenge for people with Type 1 diabetes and is particularly crucial during pregnancy. Previous research shows that women with type 1 diabetes spend only 12 hours per day within the recommended glucose target levels, leading to increased rates of complications including preterm delivery and large for gestational age infants. National surveys show that one in two babies suffer complications related to type 1 diabetes in the mother. The hormonal changes that occur in pregnancy make it difficult for women to predict the best insulin doses for every meal and overnight. Too much insulin causes low glucose levels harmful for the mother and too little causes problems for the developing baby. The artificial pancreas automates the insulin delivery giving better glucose control than we can achieve with currently available treatments. Previous studies show that the closed-loop system also known as artificial pancreas can be used safely in children and adults and our study aimed to investigate whether or not it was helpful for women with type1 diabetes during pregnancy.18 Aug No Difference In Asthma Exacerbations Between Acetaminophen and Ibuprofen in Young Children
MedicalResearch.com Interview with: [caption id="attachment_27010" align="alignleft" width="120"]
Dr. Wanda Phipatanakul[/caption]
Wanda Phipatanakul, MD, MS
Associate Professor of Pediatrics
Harvard Medical School
Director, Asthma Clinical Research Center
Boston Children's Hospital
Asthma, Allergy and Immunology
Boston, MA 02115
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Acetaminophen (e.g., Tylenol, Panadol) and ibuprofen (e.g., Advil, Motrin) are the only available treatments for pain and fever in toddlers and the most commonly utilized medications worldwide. Recently there has been controversy and even alarm with suggestive observational data that acetaminophen makes asthma worse. This has led some experts to recommend the avoidance of acetaminophen in children with asthma. We sought to find the answer to this burning question through the first prospective, double-blind, randomized clinical trial comparing acetaminophen versus ibuprofen head to head for use when clinically indicated for fever or pain. Is there a difference in asthma morbidity (exacerbations) in young children between the age of 12-59 months, who have asthma?
17 Aug POISE Data Support New Medication Ocaliva For Primary Biliary Cholangitis
MedicalResearch.com Interview with:
Prof. Dr. F. Nevens, MD, PhD
Professor of Medicine
Hepatology and liver transplantation
University Hospitals KU Leuven, Belgium
MedicalResearch.com: What is the background for this study?
Response: Primary biliary cholangitis (PBC) is a rare, autoimmune cholestatic liver disease that puts patients at risk for life-threatening complications. PBC is primarily a disease of women, affecting approximately one in 1,000 women over the age of 40. If left untreated, survival of PBC patients is significantly worse than the general population.
The POISE trial evaluated the safety and efficacy of once-daily treatment with Ocaliva® (obeticholic acid) in PBC patients with an inadequate therapeutic response to, or who are unable to tolerate, ursodeoxycholic acid (UDCA), the current standard of care. Ocaliva is the first PBC therapy that targets the farnesoid X receptor (FXR), a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways.
The trial’s primary endpoint was an alkaline phosphatase (ALP) level of less than 1.67 times the upper limit of the normal range, with a reduction of at least 15% from baseline, and a total bilirubin level at or below the upper limit of the normal range after 12 months of obeticholic acid therapy. These liver biomarkers have been shown to predict progression to liver failure and resulting liver transplant or premature death in patients with PBC.
12 Aug Thymectomy A Rational Choice For Some Patients With Myasthenia Gravis
MedicalResearch.com Interview with: [caption id="attachment_26807" align="alignleft" width="133"]
Dr. Gil Wolfe[/caption]
Gil I. Wolfe, MD, FAAN
Irvin and Rosemary Smith Professor and Chair
Dept. of Neurology/Jacobs Neurological Institute
Univ. at Buffalo Jacobs School of Medicine and Biomedical Sciences/SUNY
Buffalo General Medical Center
Buffalo, NY 14203-1126
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Thymectomy has been used in myasthenia gravis (MG), in particular those patients who do not have a tumor of the thymus gland, known as a thymoma, for over 75 years without randomized data to support its use. A practice parameter in 2000 on behalf of the American Academy of Neurology stated that the benefits of thymectomy in this population of non-thymomatou smyasthenia gravis patients remained uncertain, classified thymectomy as a treatment option in this group, and called for rigorous, randomized studies.
What we found is that compared to an identical prednisone protocol alone, that extended transsternal thymectomy confers significant benefits to non-thymomatous MG patients over a period of three years after the procedure. The benefits include better disease status, reduced prednisone requirements, fewer hospitalizations to manage myasthenia gravis worsenings, and a lower symptom profile related to side effects from medications used to control the disease state.
08 Aug Sickle Cell Trait Not Associated With Increased Mortality in Military Population
MedicalResearch.com Interview with: D. Alan Nelson, MPAS, PhD Postdoctoral research fellow Stanford Medicine MedicalResearch.com: What is the background for this study? Response: The study was inspired by the uncertainty surrounding sickle cell trait (SCT) and its association with serious exertional collapse events and mortality in active populations. I conducted initial, exploratory analyses on these topics in 2014-15 while examining a range of military readiness predictors and outcomes. The early work indicated that the risk of mortality, rhabdomyolysis and other exertional events arising from SCT might be substantially lower than that suggested by prior work in the research literature. Dr. Lianne Kurina and I decided to conduct further, focused study at the Stanford University School of Medicine to confirm or refute these findings. In considering best approaches, we noted that there was an absence of prior research in which the sickle cell trait status of an entire, large, physically-active study population was known. This limitation could introduce bias to inflate the apparent impact of a theorized predictive factor. Aside from the challenges in studying the impact of SCT on exertional outcomes, with respect to prevention, a further concern is that sickle cell trait is a non-modifiable trait. If it were a serious risk factor for rhabdomyolysis and/or mortality, despite careful exertional injury precautions such as those employed by the Army, this might present great challenges for prevention efforts. To maximize the potential for new research to provide actionable prevention information, our interests included examining a range of modifiable risk factors for rhabdomyolysis. Dr. Kurina and I have employed large, longitudinal military datasets for about five years to examine critical military health outcomes, making this study a natural progression of our joint work. The research proceeded with the support of the Uniformed Services University of the Health Sciences, and in cooperation with a distinguished group of experts who co-authored the paper and advised the project. The study was conducted using de-identified records of all SCT-tested African American US Army soldiers on active duty during 2011 - 2014 (N = 47,944).04 Aug Innate Immune Activation Protects Amish Children From Asthma
MedicalResearch.com Interview with: [caption id="attachment_26649" align="alignleft" width="100"]
Dr. Donata Vercelli[/caption]
Donata Vercelli, MD
Professor of Cellular and Molecular Medicine, University of Arizona
Director, Arizona Center for the Biology of Complex Diseases
Associate Director, Asthma and Airway Disease Research Center
The BIO5 Institute
Tucson, AZ 85721
MedicalResearch.com: What is the background for this study?
Response: By probing the differences between two farming communities—the Amish of Indiana and the Hutterites of South Dakota—our interdisciplinary team (which included, among others, Erika von Mutius from Ludwig-Maximilians University in Munich, Carole Ober and Anne Sperling from the University of Chicago, and myself) found that substances in the house dust from Amish, but not Hutterite, homes shape the innate immune system in ways that may prevent the development of allergic asthma.
Growing up in a microbe-rich farm environment has been known to protect against asthma. Our current study extends these findings by showing that in both humans and mice protection requires engagement of the innate immune system.
The Amish and Hutterite farming communities in the United States, founded by immigrants from Central Europe in the 18th and 19th centuries, provide textbook opportunities for comparative studies. The Amish and the Hutterites have similar genetic ancestry and share lifestyles (e.g., family size, diet, lack of exposure to indoor pets) known to affect asthma risk. However, their farming practices differ. The Amish have retained traditional methods, live on single-family dairy farms and rely on horses for fieldwork and transportation. In contrast, the Hutterites live on large communal farms and use modern, industrialized farm machinery. This distances young Hutterite children from the constant daily exposure to farm animals.
21 Jul Hormone Overcomes Genetic Cause of Morbid Obesity
MedicalResearch.com Interview with: Dr. Peter Kühnen MD Institute for Experimental Pediatric Endocrinology Charité–Universitätsmedizin Berlin Berlin, Germany MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Kühnen: The patients, which were included in this study, are suffering from a genetic defect in a gene called POMC. This gene is cleaved into different hormones as e.g. MSH (melanocyte stimulating hormone). MSH is very important for the regulation of satiety by activation of the MC-4 receptor. For this reason these patients are persistent hyperphagic due to the lack of MSH and they gain weight very fast in the first months of their life. Setmelanotide activates the MC-4 receptor, which is important for the activation of satiety. By restoring the lost function Setmelanotide leads to a reduction of hyperphagia and to a reduction of body weight in this POMC deficient patients.20 Jul Meningococcal B Vaccine Tested During University Outbreak of Meningitis
MedicalResearch.com Interview with: [caption id="attachment_26324" align="alignleft" width="133"]
Dr. Nicole Basta[/caption]
Nicole E. Basta, PhD MPhil
Assistant Professor
Division of Epidemiology and Community Health
School of Public Health
University of Minnesota
MedicalResearch.com: What is the background for this study?
Response: Meningococcal disease is a serious and often life-threatening condition.
In the past several years, multiple outbreaks caused by meningococcal serogroup B (MenB) have occurred on college campuses in the US. Recently, a new meningococcal B vaccine known as 4CMenB or Bexsero was developed. The FDA granted special approval to use the vaccine to control an outbreak at a University in New Jersey prior to its licensure.
We took advantage of this unique opportunity to investigate the impact of Bexsero during the outbreak. In doing so, we conducted the first clinical study of Bexsero among teens and young adults in the US.
09 Jul NEJM Study Calculates Cost Of Training Residents in Teaching Health Centers
MedicalResearch.com Interview with: [caption id="attachment_25942" align="alignleft" width="200"]
Prof. Marsha Regenstein[/caption]
Marsha Regenstein, Ph.D, Professor
From the Department of Health Policy and Management
Milken Institute School of Public Health
George Washington University
Washington, DC
MedicalResearch.com: What is the background for this study?
Response: Despite the billions of dollars in public spending on graduate medical education (GME) in the United States, little is known about the true cost of training a resident, with the few studies that exist showing wide variation in their methods and results. At the same time, the U.S. appears to be producing too few primary care physicians to meet the health care needs of the population, and especially those who live in underserved areas with high health care needs and shortages of health professionals. The Teaching Health Center (THC) Graduate Medical Education funding program was established under the Affordable Care Act to increase the number of medical and dental residents training in six primary care specialties in underserved areas. The Teaching Health Center funding supports community-based residency training in settings such as Federally-qualified health centers, rural clinics, mental health clinics and other non-profit community-based organizations. Hospitals commonly serve as training partners, but THC funding goes directly to the community-based partner, bringing funding and training closer to the communities where underserved patients live. The Health Resources and Services Administration (HRSA), which manages and funds the program, set an interim payment of $150,000 per resident; currently, 59 THCs are training 690 residents in 27 states and the District of Columbia. The interim payment rate was based on the best available information at the time and was meant to cover the full cost of training a resident.
29 Jun Multikinase Inhibitor Midostaurin Improved Symptoms and Survival in Most Advanced Forms of Blood Cancer Mastocytosis
MedicalResearch.com Interview with: [caption id="attachment_25621" align="alignleft" width="200"]
Dr. Jason R. Gotlib[/caption]
Jason R. Gotlib, MD
The Clinical Investigator Pathway
Hematology Division
Stanford University Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The background is that advanced forms of systemic mastocytosis, which are blood cancers characterized by accumulation of abnormal mast cells in the bone marrow and additional organs, represent a group of orphan diseases with a large unmet need. Approximately 90% of patients harbor the acquired KIT D816V mutation, a mutated receptor tyrosine kinase on the surface of mast cells which a primary driver of disease pathogenesis. Only 1 drug is approved for patients with one form of advanced systemic mastocytosis, termed ‘aggressive systemic mastocytosis, or ‘ASM’. This therapy is imatinib (Gleevec), but it is only approved for patients without the KIT D816V mutation, or with KIT mutation status unknown because the KIT D816V mutation is resistant to imatinib. Therefore, this drug may only be useful for approximately 10% of patients. Other drugs that have been used off-label for systemic mastocytosis (but are not approved for this indication) include interferon-alpha or cladribine, which show some activity, but their evaluation to date has been primarily limited to small case series which are usually retrospective in nature, and include mixed populations of systemic mastocytosis patients who have both early stage disease without organ damage (e.g. indolent systemic mastocytosis) and and advanced stage patients, as included in this trial, who have one or more findings of organ damage. Also, those trials employed differing response criteria and no central adjudication of eligibility and response assessments was undertaken.
Midostaurin is a multikinase inhibitor with activity against both wild-type KIT, but most importantly, KIT D816V (in contrast to imatinib). Prior work demonstrated that cell lines transformed with the KIT D816V mutation can be inhibited at relatively low concentrations of midostaurin. These concentrations could also be achieved in vivo (e.g. at concentrations achievable in the blood of patients). Cell lines transformed by KIT D816V could not be inhibited by imatinib.
29 Jun This Generation of Malaria Vaccine Not Perfect But Can Still Save Lives
MedicalResearch.com Interview with: [caption id="attachment_25691" align="alignleft" width="136"]
Dr. Philip Bejon[/caption]
Philip Bejon, Ph.D.
Professor of Tropical Medicine, Director of the Wellcome-KEMRI-Oxford Collaborative Research Programme, Group Head / PI, Consultant Physician and Unit Director
Kilifi, Kenya
MedicalResearch.com: What is the background for this study?
Response: According to the latest World Health Organisation (WHO) estimates more than 400,000 people died from malaria in 2015, with over 90% of these deaths occurring in sub-Saharan Africa. The vast majority who die are children under 5, and almost all cases are caused by the P. falciparum strain of malaria transmitted by female Anopheles mosquitoes.
RTS,S, which protects only against P. falciparum, was developed by GlaxoSmithKline with support from the PATH Malaria Vaccine Initiative (MVI) and with grant funds from the Bill & Melinda Gates Foundation to MVI. In July 2015, it received a positive opinion from the European Medicines Agency.
Earlier this year, the WHO recommended further evaluation of the four-dose regimen of RTS,S in a pilot implementation programme in sub-Saharan Africa, to address several knowledge gaps before the vaccine might be rolled out more widely.
26 Jun Requests for Abortions in South American Rise Dramatically Since Zika, Especially in Brazil
MedicalResearch.com Interview with: [caption id="attachment_25543" align="alignleft" width="129"]
Dr. Abigail Aiken[/caption]
Abigail R.A. Aiken, MD, MPH, PhD
Assistant Professor
LBJ School of Public Affairs
University of Texas at Austin
Austin, TX, 78713
MedicalResearch.com: What is the background for this study?
Response: As Zika began to emerge as an epidemic in Latin America and its links with microcephaly began to be realized, we were aware that women in the region who were already pregnant or who would become pregnant would have a very limited set of reproductive options. Research and media attention about the possible biological effects of Zika in pregnancy began to appear rapidly. But much less attention was been paid to the impacts of Zika on women. We followed the responses of governments and health organizations and when they began to issue advisories warning women to avoid pregnancy, we knew it would be important to investigate the impacts of those advisories. A country-wide policy that is impossible to follow if you are pregnant or cannot avoid pregnancy is an unusual and important public issue. Accurate data on abortion are very difficult to obtain in Latin America because in most countries, abortion is highly restricted. We wanted to provide a window on the issue of how women were responding to the risks of Zika and its associated advisories, so we worked with Women on Web (WoW), an online non-profit telemedicine initiative that provides safe medical abortion to women in countries where safe, legal abortion is not universally available.
24 Jun Opioid-Restricting Laws Have Not Reduced Overdoses in Disabled Workers
MedicalResearch.com Interview with: [caption id="attachment_25503" align="alignleft" width="125"]
Prof. Ellen Meara[/caption]
Professor Ellen Meara, PhD
Professor
The Dartmouth Institute for Health Policy and Clinical Practice
MedicalResearch.com: What is the background for this study?
Response: Responding to a fourfold rise in death rates, between 2006 and 2012, states collectively enacted 81 laws restricting prescribing and dispensing of prescription opioids. Jill Horwitz, PhD, JD, said “states hoped passing a range of laws might help. So they are enacting small fixes — forbidding patients from “doctor-shopping,” and requiring doctors to use tamper-resistant prescription forms. They are also implementing major efforts such as prescription drug monitoring programs (PDMPs) — online databases that allow law enforcement and clinicians to monitor prescriptions.”
23 Jun PET-CT Scan Can Guide Treatment in Advanced Hodgkin’s Lymphoma
MedicalResearch.com Interview with: [caption id="attachment_25380" align="alignleft" width="150"]
Prof. Peter Johnson[/caption]
Peter Johnson MA, MD, FRCP
Professor of Medical Oncology
Cancer Research UK Centre
Southampton General Hospital
Southampton
MedicalResearch.com: What is the background for this study? What are the main findings?
Prof. Johnson: Based upon retrospective series looking at the ability of interim PET to predict the outcomes of treatment, we aimed to test the idea of modulating treatment in response to an early assessment of the response to ABVD: could we safely reduce the amount of treatment by omitting bleomycin in the group who had responded well? Although the risk of severe toxicity from bleomycin is generally low, for the small number of patients who experience it, it can be life-changing or even fatal. We also wanted to test whether it might be possible to reduce the use of consolidation radiotherapy by comparison to our previous trials, and this seems to have worked too: we used radiotherapy in less than 10% of patients in RATHL, as compared to around half in our previous trials. We have seen better survival figures than in our previous studies with less treatment overall, so it feels as though we are on the right track.
23 Jun Over Half Sudden Cardiac Deaths in Young are Male; Over 25% Have Identifiable Genetic Cause
MedicalResearch.com Interview with: [caption id="attachment_25295" align="alignleft" width="180"]
Prof. Chris Semsarian[/caption]
Professor Chris Semsarian
MBBS PhD MPH FRACP FAHMS FAHA FHRS FCSANZ
Professor of Medicine, University of Sydney
Cardiologist, Royal Prince Alfred Hospital
NHMRC Practitioner Fellow
Head, Molecular Cardiology Program
Centenary Institute,
Newtown NSW Australia
MedicalResearch.com: What is the background for this study?
Response: Sudden cardiac death is a tragic and devastating event at all ages, and especially in the young (aged under 35 years). Understanding the causes and circumstances of SCD in the young is critical if we are to develop strategies to prevent SCD in the young. Our study represents the first prospective, population-based study of SCD in the young across two nations, Australia and New Zealand.
09 Jun No Clinical Benefit With Intensive Blood-Pressure Lowering in Acute Cerebral Hemorrhage
MedicalResearch.com Interview with: Adnan I. Qureshi, M.D Zeenat Qureshi Stroke Research Center University of Minnesota Minneapolis, MN MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Qureshi: An acute hypertensive response in patients with intracerebral hemorrhage is common and may be associated with hematoma expansion and increased mortality. The Antihypertensive Treatment of Acute Cerebral Hemorrhage II (ATACH-2) trial was designed to determine the efficacy of rapidly lowering systolic blood pressure in patients in an earlier time window after symptom onset than evaluated in previous trials. The trial was based on evidence that hematoma expansion and subsequent death or disability might be reduced with very early and more aggressive reduction in systolic blood pressure in those at higher risk due to presence of high systolic blood pressure at presentation. The trial randomized eligible subjects with intracerebral hemorrhage to test the superiority of intensive (goal 110-140 mmHg) over standard (goal 140-180 mmHg) systolic blood pressure reduction using intravenous nicardipine within 4.5 hours of symptom onset. Of a total of 1000 subjects that were recruited with a mean (standard deviation) baseline systolic blood pressure of 200.6 (27.0) mmHg, 500 were assigned to intensive-treatment and 500 to standard-treatment. Enrollment was stopped following a pre-specified interim analysis because of futility. The primary endpoint of death or disability at 3 months post-randomization was observed in 38.7% (186/481) of subjects receiving intensive treatment and 37.7% (181/480) subjects receiving standard treatment (relative risk: 1.03; 95% confidence interval: 0.85 to 1.27), adjusted for age, initial Glasgow Coma scale, and presence or absence of intraventricular hemorrhage. The rate of renal adverse events within 7 days of randomization was significantly higher among subjects randomized to intensive treatment. Compared to a target systolic blood pressure of 140-180 mmHg, treating subjects with intracerebral hemorrhage to a target systolic blood pressure of 110-140 mmHg did not lower the rate of death or disability.02 Jun Chewing Gum Test Unmasks Jaw Claudication of Giant Cell Arteritis
MedicalResearch.com Interview with: Chih-Hung Kuo, M.B., B.S. Peter McCluskey, M.D. Clare L. Fraser, M.B., B.S. University of Sydney Sydney, NSW, Australia MedicalResearch.com: What is the background for this study? What are the main findings? Response: Giant cell arteritis is a life and sight threatening systemic inflammatory condition, which remains difficult to diagnose. Jaw claudication (cramping of muscle from ischemia) is a highly specific symptom with significant diagnostic and prognostic (risk of permanent blindness) values. The reporting of jaw symptoms may be affected by many factors, such as diet. There remains no standardized clinical test available for clinicians. We study the use of chewing gum as a standardized test (like a stress test for angina pain) to better characterize this critical symptom. The pilot study of two cases with abnormal results were published in the New England Journal of Medicine. Chewing gum at a rate of 1 chew/second can reproduce the jaw claudication symptom around 2-3 minutes. In one case, the jaw claudication was unmasked by the test with a subsequent positive biopsy result. The test result became negative after corticosteroid treatment.02 Jun National Program Reduces Urinary Tract Infections in Hospitalized Patients
[caption id="attachment_24775" align="alignleft" width="200"]
Dr. Sanjay Saint[/caption]
MedicalResearch.com Interview with:
Sanjay Saint, MD, MPH
Chief of Medicine
VA Ann Arbor Healthcare System
George Dock Professor of Internal Medicine & Senior Associate Chair -
Department of Internal Medicine
University of Michigan Medical School
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Saint: Catheter-associated urinary tract infection (CAUTI) is a common, costly, and morbid complication of hospitalization. Urinary tract infection (UTI) is one of the most common device-related infections in the United States. CAUTI rates rose nationally between 2009 and 2013.
We put in place a national program to reduce CAUTI. Specifically, we enrolled 926 intensive care unit (ICU) and non-ICU hospital units in 603 hospitals spread over 32 states, the District of Columbia and Puerto Rico between March 2011 and November 2013.
By the end of the 18-month program, UTI rates among hospital patients in general wards had dropped by a third. Specifically:
• The rate of CAUTIs dropped from 2.40 per 1000 days of catheter use to 2.05 (a ~14 percent overall drop).
• Nearly all of the decrease in CAUTI rates was due to changes in infection rates in non-ICUs, which went from 2.28 to 1.54 infections per 1,000 catheter-days – a drop of 32 percent. In non-ICUs, the overall use of catheters decreased by 7%.
• ICUs didn’t see a substantial change in either CAUTI or catheter use, likely because the nature of patients treated in ICUs means more frequent urine output monitoring and culturing of urine, so UTIs are more likely to be spotted.
29 May Genome Sequencing Identifies Some Forms of Potentially Treatable Intellectual Disabilities
MedicalResearch.com Interview with: [caption id="attachment_24758" align="alignleft" width="156"]
Dr. Clara van Karnebeek[/caption]
Dr. Clara van Karnebeek PhD
Certified Pediatrician and Biochemical Geneticist at the BC Children’s Hospital
Principal Investigator, University of British Columbia
MedicalResearch.com: What is the background for this study?
Dr. van Karnebeek: The goal of the study was to diagnose patients with genetic conditions and discover and describe new diseases with potential for treatment. The study included patients with neurodevelopmental conditions that doctors suspected were genetic or metabolic in origin but had not been diagnosed using conventional methods. Our team tested the children and their parents using a combination of metabolomic (large scale chemical) analysis and a type of genomic sequencing called whole exome sequencing. With this state-of-the-art technique, experts analyze and interpret the portion of DNA called genes that hold the codes for proteins.
Some people’s intellectual disability is due to rare genetic conditions that interfere with the processes the body uses to break down food. Because of these metabolic dysfunctions, there is an energy deficit and build-up of toxic substances in the brain and body leading to symptoms such as developmental and cognitive delays, epilepsy, and organ dysfunction. Some of these rare diseases respond to treatments targeting the metabolic dysfunction at the cellular level and range from simple interventions like dietary modifications, vitamin supplements and medications to more invasive procedures like bone marrow transplants. Because the right treatment can improve cognitive functioning or slow or stop irreversible brain damage, early intervention can improve lifelong outcomes for affected children and their families.
24 May Many Caregivers Report High Levels of Depression and Loss of Control Over Their Lives
MedicalResearch.com Interview with: [caption id="attachment_24622" align="alignleft" width="200"]
Dr. Jill Cameron[/caption]
Jill Cameron, PhD
Canadian Institutes of Health Research New Investigator
Associate Professor,
Department of Occupational Science and Occupational Therapy
Rehabilitation Sciences Institute
Faculty of Medicine,
University of Toronto
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Cameron: In the world of critical illness, a lot of research has focused on helping people to survive – and now that more people are surviving, we need to ask ourselves, what does quality of life and wellbeing look like afterwards for both patients and caregivers? The aim of our research was to identify factors associated with family caregiver health and wellbeing during the first year after patients were discharged from the Intensive Care Unit. We examined factors related to the patient and their functional wellbeing, the caregiving situation including the impact it has on caregivers everyday lives, and caregiver including their sense of control over their lives and available social support. We used Pearlin’s Caregiving Stress Process model to guide this research.
From 2007-2014, caregivers of patients who received seven or more days of mechanical ventilation in an ICU across 10 Canadian university-affiliated hospitals were given self-administered questionnaires to assess caregiver and patient characteristics, caregiver depression symptoms, psychological wellbeing, and health-related quality of life. Assessments occurred seven days and three, six and 12-months after ICU discharge.
The study found that most caregivers reported high levels of depression symptoms, which commonly persisted up to one year and did not improve in some. Caregiver sense of control, impact on caregivers’ everyday lives, and social support had the largest relationships with the outcomes. Caregivers’ experienced better health outcomes when they were older, caring for a spouse, had higher income, better social support, sense of control, and caregiving had less of a negative impact on their everyday lives. No patient characteristics or indicators of illness severity were associated with caregiver outcomes.
Poor caregiver outcomes may compromise patients’ rehabilitation potential and sustainability of home care. Identifying risk factors for caregiver distress is an important first step to prevent more suffering and allow ICU survivors and caregivers to regain active and fulfilling lives.
18 May Persistent Childhood Asthma Linked to Long-Term Lung Function Deficits
MedicalResearch.com Interview with: [caption id="attachment_24442" align="alignleft" width="106"]
Dr. James Kiley[/caption]
Dr. James P. Kiley Ph.D
National Institutes of Health Bethesda
Maryland
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Kiley: While a higher proportion of children have asthma compared to adults, the disease is limited to childhood for many individuals who appear to be unaffected as adults. Regardless of whether asthma continues into adulthood or reoccurs during adulthood, the impact of childhood asthma on lung function later in life is unclear. This study demonstrated that in children with chronic persistent asthma at the age of 5-12 years who continued to be followed through their early twenties, 75% of them had some abnormality in the pattern of their lung growth. The study examined the trajectory of lung growth, and the decline from maximum growth, in a large cohort of persons who had persistent, mild-to-moderate asthma in childhood and determined the demographic and clinical factors associated with abnormal patterns of lung growth and decline.
15 May Children With Persistent Asthma At Risk For Future Lung Disease
Posted at 11:57h
in Asthma, Author Interviews, Brigham & Women's - Harvard, NEJM, Pediatrics, Pulmonary Disease
MedicalResearch.com Interview with:
[caption id="attachment_24191" align="alignleft" width="150"]
Dr. Michael McGeachie[/caption]
Michael McGeachie, PhD
Instructor in Medicine
Harvard Medical School
Channing Division of Network Medicine
Brigham and Women's Hospital
MedicalResearch.com: What is the background for this study?
Dr. McGeachie: In asthma, and in general but particularly in asthma, a person’s level of lung function has a big impact on his or her quality of life, level of respiratory symptoms and complications, and general morbidity. In asthma, low lung function leads to greater severity and frequency of asthma symptoms. Asthma is a common childhood illness, affecting 9-10% of children. Many children grow out of asthma as they become adults, but other asthmatics remain effected through adulthood, which can lead to a lifetime of respiratory symptoms and chronic airway obstruction, including chronic obstructive pulmonary disease (COPD).
If you consider lung function longitudinally, throughout development, plateau, and decline, different people and different asthmatics tend to exhibit different patterns of lung function. Healthy, non-asthmatic people tend to have a period of rapid lung function increase in adolescence, a plateau of lung function level in their late teens and early 20s, and starting around 25 or so a slow, gradual decline of lung function that continues throughout old age. We call this Normal Growth of lung function. However, some people exhibit Reduced Growth, where they don’t reach their expected maximum lung function for a person of the same age, sex, height, and race. Others can show Early Decline, who might reach a normal maximum but then begin to decline immediately without a plateau or with a truncated plateau. We hypothesized that these patterns, Reduced Growth and Early Decline, might have different baseline indicators, precursors, outcomes, and risk of developing COPD.
10 May Lower Dose of tPA Found Safer For Patients With Acute Ischemic Stroke
MedicalResearch.com Interview with: [caption id="attachment_24180" align="alignleft" width="64"]
Prof. Craig Anderson[/caption]
Professor Craig Anderson
Professor of Stroke Medicine and Clinical Neuroscience
Sydney Medical School at the University of Sydney
Institute of Neurosciences of Royal Prince Alfred Hospital
MedicalResearch.com: What is the background for this study?
Prof. Anderson: Intravenous use of the clot-busting drug, alteplase (or rtPA), at a dose of 0.9 mg/kg body weight is the only proven medical treatment of acute ischemic stroke. However, a major drawback to the treatment is an increased risk of major bleeding in the brain, or intracerebral hemorrhage (ICH), that occurs in about 5% of cases, and can be fatal. This balance of effectiveness (recovery from disability) and risks (ICH, and bleeding elsewhere and uncommon drug allergic reactions) has led to much of the controversy over the net benefit of the drug. The optimal dose of the drug has never been established, but the Japanese drug safety regulatory authority, has approved a lower dose (0.6mg/kg) on the basis of a small, non-randomized, open study which showed comparable outcomes and lower risk of ICH than historical controls. This ‘east-west’ divide over the approved dose of alteplase has led to much variation in the dose of alteplase used in clinical practice in Asia – according to a doctor’s perceived risk of ICH in individual patients and the affordability of this relatively expensive treatment in low resource settings. Data from the Get-with-the Guidelines Quality Registry in the United States suggests Asian patients are at higher risk of ICH after standard-dose alteplase than non-Asians.
Our research aimed to resolve this uncertainty over the optimal dose of alteplase, as an international, active-comparator, open-label, blinded outcome assessed, clinical trial of low-dose (0.6 mg/kg) versus standard-dose (0.9mg/kg) in 3310 patients recruited from over 100 hospitals in 13 countries between 2012 and 2015.
02 May Pembrolizumab Immunotherapy Benefits Some Merkel Cell Carcinoma Patients
MedicalResearch.com Interview with: [caption id="attachment_23947" align="alignleft" width="142"]
Dr. Paul Nghiem[/caption]
Paul Nghiem, MD, PhD
Professor & Head, University of Washington Dermatology
George F. Odland Endowed Chair
Affiliate Investigator, Fred Hutchinson Cancer Research Center
Professor, Adjunct, of Pathology and Oral Health Sciences
Clinical Director, Skin Oncology, Seattle Cancer Care Alliance
UW Medical Center at Lake Union
Seattle WA 98109
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Nghiem: Merkel cell carcinoma (MCC) is about 30 times less common than malignant melanoma, but about 3 times more likely to kill a patient than a melanoma. There is no FDA-approved therapy for this cancer & chemotherapy typically only provides about 90 days prior to the cancer progressing. Because of the strong links between MCC and the immune system, including the fact that most MCCs are caused by a virus, there was interest in trying to use immune checkpoint therapy to treat advanced Merkel cell carcinoma. The response to immune stimulation with anti-PD1 therapy was about as frequent as to chemotherapy (56% of patients responded) but importantly, among the responders, 86% remained in ongoing responses at a median of 7.6 months. While still early, this appears to be strikingly more durable than responses to chemotherapy.
14 Apr Adding Lumbar Fusion to Laminectomy Improves Long-Term Quality of Life
MedicalResearch.com Interview with: [caption id="attachment_23431" align="alignleft" width="138"]
Dr. Zoher Ghogawala[/caption]
Zoher Ghogawala MD FACS
Department of Neurosurgery
Lahey Hospital and Medical Center
Burlington, MA 01805
MedicalResearch.com: What is the background for this study?
Dr. Ghogawala: There is enormous practice variation around the utilization of lumbar spinal fusion in the United States and across the world. In the United States, lumbar spinal fusion utilization has increased to 465,000 hospital-based procedures in 2011 according to a report from the AHRQ (published in 2014). Spinal fusion accounts now for the highest aggregate hospital cost (12.8 billion dollars in 2011) of any surgical procedure performed in US hospitals. What is problematic is that there are no top tier studies that address the question of whether or not adding a lumbar spinal fusion when performing a simple decompression is necessary or helpful. The question is whether we perform too many fusions in the United States.
The SLIP study is the first class I study that demonstrates that the addition of a lumbar fusion when performing a lumbar laminectomy to decompress spinal nerves improves health-related quality of life for patients suffering from low back pain and sciatica from lumbar stenosis with spondylolisthesis - a very common cause of low back pain caused by nerve compression associated with one spinal bone being slightly out of alignment.
MedicalResearch.com: What are the main findings?
Dr. Ghogawala:
1) Adding a lumbar fusion when performing a lumbar laminectomy results in superior health-related quality of life at 2,3, and 4 years after surgery.
2) Patients with fusion obtained durable results but 14% required re-operation for problems adjacent to their fusion over the 4 year study period.
3) Lumbar laminectomy alone provided good results for 70% of patients. There was less blood loss and faster recovery for these patients. On the other hand, the outcomes were less durable. One in three patients who underwent a lumbar laminectomy alone required re-operation within 4 years because their back became unstable. These patients underwent fusion and their health-related quality of life improved.