Dr. Aaron Kesselheim[/caption]
Aaron S. Kesselheim, M.D., J.D., M.P.H.
Associate Professor of Medicine at Harvard Medical School
Director, Program On Regulation, Therapeutics, And Law (PORTAL)
Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham and Women's Hospital
Boston MA 02120
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: It has been previously reported that the number of new cardiovascular drugs approved by the U.S. Food and Drug Administration (FDA) has declined in recent years. So we sought to empirically assess trends in the development of new cardiovascular therapeutics.
Dr. Audun Aase[/caption]
Audun Aase, PhD
Department Director, Infectious Disease Immunology
Norwegian Institute of Public Health
Oslo, Norway
MedicalResearch.com: What is the background for this study?
Response: Controversies related to Lyme disease and tick transmitted diseases have gained much attention in the public media in Norway, both regarding treatment regimens and diagnostics. People with long-lasting disease may relate their symptoms to previous tick bite and/or suboptimal-treated Lyme disease and have adopted the diagnosis chronic Lyme disease. As many of these patients lack objective proof of Lyme disease, they look for alternative test to signify their suspicion.
A modified microscopy method for detection of the Borrelia burgdorferi s.l. (the causative agent of Lyme disease) in human blood was published in 2013. The authors behind the method examined blood from suspected chronic Lyme disease patients, and the results showed presence of Borrelia spirochetes in most of the specimens. Using the same method, they also claimed to detect the Babesia parasites in many of the samples. The method gained much publicity and the patients advocated strongly for this method as most other laboratory tests had failed to prove their diagnosis.
Prof. Lars Wallentin[/caption]
Prof Lars Wallentin, MD PHD
Senior Professor Cardiology
Uppsala Clinical Research Center,
Uppsala University
MedicalResearch.com: What is the background for this study?
Response: The FRISC2 study was performed 1996 – 1998 and reported 1999 for the first time a significant reduction in death and myocardial infarction by early invasive compared to non-invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). The results at 6 months, 1, 2 and 5 years were published in The Lancet and pivotal in changing the treatment guidelines and thereby improving outcomes in patients with NSTE-ACS. These findings were within the next few years verified in the TACTICS-TIMI18 and RITA3 trials. However the later performed ICTUS trial, starting after these results were published and accordingly with a substantial early crossover to the invasive arm, showed neutral results. Recently the reduction in event rates by an early invasive strategy was again validated in patients above 80 years of age, which were less well represented in the initial trials. These benefits of an early invasive strategy have previously been shown sustained for at least five years based on results from the FRISC2, RITA3, and ICTUS trials. The FRISC2 and TACTICS-TIMI18 trials also showed that the benefits with an early invasive strategy seemed confined to patients with signs of myocardial necrosis as indicated by elevated troponin level at entry. In addition the FRISC2 trial found that the benefits were larger in patients with signs of inflammatory activity as indicated by a high level of growth differentiation factor 15 (GDF-15) at entry. These pivotal results have been the basis for the current international treatment guidelines recommending an early invasive treatment strategy in patients with NSTE-ACS and elevated troponin and/or other indicators of a raised risk.
Dr. Kai Ling Kong[/caption]
Kai Ling Kong, PhD, MS
Assistant Professor
Division of Behavioral Medicine
Department of Pediatrics
School of Medicine and Biomedical Sciences
State University of New York at Buffalo
MedicalResearch.com: What is the background for this study?
Response: Infant temperament, or individual behavior styles, can be reliably measured and is related to weight status. However, we know very little about the association of infants’ temperament and their motivation to eat versus engage in other activities (relative food reinforcement). Examining such associations is an important step given the need to use behavioral strategies in obesity prevention in early life. The purpose of our study was to determine if infant temperament, specifically the factors that have been linked with obesity risk, are associated with infant relative food reinforcement.
Dr. Seth Weinberg[/caption]
Seth M. Weinberg, PhD
Assistant Professor, Department of Oral Biology
Assistant Professor, Department of Anthropology
Director, CCDG Imaging and Morphometrics Lab
MedicalResearch.com: What is the background for this study?
Response: Scientists have long recognized that aspects of facial appearance have a genetic basis. This is most obvious when we look at the faces of people in the same family. It is also well known that mutations in certain genes can result in syndromes where the face is affected. However, very little is known about how specific genes influence the size and shape of normal human facial features. To date, only a handful of studies have looked at this question, and while these studies have reported several interesting results, only a small number of genes have so far been linked to normal variation in facial features. The primary goal of our study was to test for evidence of association between detailed facial measures derived from 3D images and common genetic variants spread across the entire genome. We also attempted to independently replicate some of the findings from previous studies.
Dr. Jason Wasfy[/caption]
Jason H. Wasfy, MD, MPhil
Assistant Medical Director, Massachusetts General Physicians Organization
Director of Quality and Analytics
Massachusetts General Hospital Heart Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Reducing preventable readmissions after PCI is a way to both improve the quality of care for our patients and improve value for patients with coronary artery disease. Through a variety of tactics, we were able to reduce the 30 day readmission rate for patients after PCI by nearly half. Keep in mind that this is only the readmission rate to our hospital, so we will need to confirm these results with data including patients who may have been readmitted to other hospitals after a PCI at Mass General.
Dr. Daniel Morgan[/caption]
Daniel J. Morgan M.D., M.S
Associate Professor
Epidemiology & Public Health
University of Maryland School of Medicine
MedicalResearch.com: What is the background for this study?
Response: Physicians are generally taught if a treatment is indicated, not how well the treatment works. Although this has been part of evidence based medical training, doctors still perform poorly with ability to understand risk and how treatment limits risk (Bayesian reasoning). Many publications focus on relative risk reduction which inflates the perception of an effect over the more accurate absolute risk reduction.
Alexis B. Peterson, PhD[/caption]
Alexis B. Peterson, PhD
(Epidemic Intelligence Service Officer)
[caption id="attachment_27435" align="alignleft" width="125"]
Dr. R. Mathew Gladden[/caption]
R. Matthew Gladden, PhD (Behavioral Scientist)
MedicalResearch.com What is the background for this study?
Response: In March and October 2015, the Drug Enforcement Administration and the Centers for Disease Control and Prevention (CDC) issued nationwide alerts identifying fentanyl, particularly illicitly manufactured fentanyl, as a threat to public health and safety. During 2013-2014, Ohio and Florida reported significant increases in fentanyl-involved overdose deaths (fentanyl deaths) and fentanyl submissions (drug products obtained by law enforcement that tested positive for fentanyl).
Fentanyl is a synthetic opioid 50-100 times more potent than morphine. The University of Florida and the Ohio Department of Public Health with CDC assistance compared trends in fentanyl deaths, fentanyl submissions, and fentanyl prescribing during January 2013–June 2015.
In-depth review of medical examiner and coroner reports of fentanyl deaths occurring in Ohio’s 14 high-burden counties were performed to identify circumstances surrounding fentanyl overdose death.
Dr. Deborah Blacker[/caption]
Deborah Blacker MD, ScD
Director of the Gerontology Research Unit
Department of Psychiatry
Massachusetts General Hospital
MedicalResearch.com: What is the background for this study? What are the main findings
Response: Many observational studies have found that those who are cognitively active have a lower risk of developing Alzheimer's disease or any type of
dementia.
However, we and others have been concerned that these findings
might be spurious due to two potential biases:
Elizabeth Burns MPH[/caption]
Elizabeth Burns, MPH
Health Scientist, Division of Unintentional Injury Prevention
National Center for Injury Prevention and Control
CDC
MedicalResearch.com: What is the background for this study?
Response: Falls are the leading cause of both fatal and non-fatal injuries among Americans aged 65 and older. In 2000, the direct cost of falls were estimated to be $179 million for fatal falls and $19 billion for non-fatal falls. Fall injuries and deaths are expected to rise as more than 10,000 Americans turn 65 each day. Within the next 15 years, the U. S. population of older Americans is anticipated to increase more than 50%, with the total number of older adults rising to 74 million by 2030.
Dr. Jolanta Weaver[/caption]
Jolanta U Weaver, FRCP MRCS PhD CTLHE
Senior Lecturer in Diabetes Medicine
Honorary Consultant Diabetologist
Newcastle
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Vascular stem cells, which are associated with an improvement of heart disease, are improved in type 1 diabetes by repurposing metformin, known to reduce heart disease in type 2 diabetes.
We treated patients with type 1 diabetes with metformin for 8 weeks. The metformin dose varied between 500 mg a day to 2000 mg a day, depending on what patients were happy to take. Subjects were requested to keep diabetic control unchanged to study the direct effect of metformin on heart disease. Circulating endothelial progenitor cells (vascular stem cells) count, Hill’s colonies and pro angiogenic cells function (in test tube) improved in comparison to patients, who did not take metformin but remained on standard therapy.
Endothelial cells associated with vascular damage, on the other hand, were reduced following metformin therapy confirming improved vascular health. The glycaemic control remained unchanged (as planned at the onset of the study) to allow us to examine the effect of metformin ALONE on vascular health. Patients did not suffer any serious side effects.
Dr. Laith Alshawabkeh[/caption]
Dr. Laith Alshawabkeh MD
Senior Fellow
Brigham & Women's and Boston Childrens Hospitals / Harvard Medical School
MedicalResearch.com: What is the background for this study?
Response: As the number of adults living with congenital heart disease continues to increase, there is paucity of evidence on the trajectories and patterns of their comorbidities. In all, heart failure is the leading cause of death in this group of patients. Unfortunately, landmark trials and advances in medical therapy which promoted increase survival in patients with the usual heart failure (non-congenital) has not been translated into those with congenital heart disease. Heart transplantation remains one of the (if not the only) sustainable option for many patients with congenital heart disease at the end stage of heart failure. Recent studies have shown that adults with congenital heart disease who underwent transplantation experienced higher risk of postoperative mortality compared to their non-congenital counterparts; however, patients with congenital heart disease who survived the first year post-transplantation enjoyed significantly better long-term survival, indicating that with careful selection those patients might benefit tremendously from transplantation. Much less is known about the outcome of these patients while they are waiting for an organ. As such, this study sought to examine the outcomes of patients with congenital heart disease while listed for heart transplantation and to investigate correlates of adverse outcomes (mortality and delisting due to clinical worsening).
Dr. Javed Butler[/caption]
Javed Butler, M.D., MPH, FACC, FAHA
Chief of the Cardiology Division and Co-Director of the Heart Institute at Stony Brook University
Stony Brook Heart Institute
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: It was previously assumed that stem cells must be delivered directly to the myocardium to improve patient outcomes. However, this delivery mechanism – either in the coronary artery or the myocardium – may not be feasible for millions of patients and for repeat injections. This study represents the first clinical trial to observe the effects of intravenous (IV) administration of ischemia-tolerant mesenchymal stem cells (itMSCs) in patients with chronic heart failure. Results show that an IV injection strategy is safe and well-tolerated.In addition, the data illustrate statistically significant improvement in 6-minute walk test, quality-of-life scores as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) and favorable immune modulatory benefits.
Dr. Gennaro Giustino[/caption]
Gennaro Giustino MD
Resident Physician - Department of Medicine
The Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study?
Response: A period of dual antiplatelet therapy (DAPT) is required after percutaneous coronary intervention (PCI) with drug-eluting stents (DES). The pathophysiological rationale for DAPT after DES-PCI is predicated on the need to prevent stent-related thrombotic complications while vascular healing and platform endothelialization are ongoing, a process that seems to last between 1 and 6 months with new-generation DES. Whether to extend DAPT after this mandatory period in order to provide a broader atherothrombotic risk protection (for stent-related and non-stent-related atherothrombotic events) is currently a matter of debate. Current guidelines recommend at least 6 months of DAPT after PCI in patients with stable coronary artery disease (CAD) and at least 12 months of DAPT in patients presenting with acute coronary syndrome (ACS). While, several risk scores have been developed to guide clinical decision making for DAPT intensity and duration (namely the DAPT score and the PARIS risk scores) little attention has been payed so far to PCI complexity and the extent of CAD to guide duration of DAPT. In fact irrespective of clinical presentation, patients undergoing more complex PCI procedure (likely due to greater coronary atherosclerotic burden) may remain at greater risk for ischemic events and therefore may benefit of prolonged, or more intense, DAPT.
Dr. Tara Moriarty Ph.D.[/caption]
Senior Author: Tara Moriarty, Ph.D.
University of Toronto, Canada
Faculty of Dentistry, Matrix Dynamics Group
Faculty of Medicine, Department of Laboratory Medicine and Pathobiology
[caption id="attachment_27454" align="alignleft" width="125"]
Rhodaba Ebady, Ph.D. student[/caption]
Lead Author: Rhodaba Ebady, Ph.D. student
University of Toronto, Canada
Faculty of Dentistry, Matrix Dynamics Group
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The spread of microbes via the bloodstream (dissemination) is responsible for most of the mortality associated with bacterial infection. Even though this is a clinically important step of many infectious diseases, and likely an important target for disease treatment, we don’t know how most microbes disseminate. One of the key steps in this process is adhesion of bacteria to the inner surfaces of blood vessels. This allows bacteria to slow down enough to grab onto vessel surfaces, then escape from the blood stream into tissues where it’s easier for them to live. It’s a bit like the problem faced by a person being carried down a fast-flowing river who needs to grab onto something on the banks to get out onto dry land. A big problem for bacteria, and any other cells which must stick to blood vessel walls (like white blood cells travelling to a site of infection or inflammation), is that they have to be able to stick to vessel walls without being ripped off by the flow of blood. They have to have adhesion mechanisms strong enough to overcome forces due to flow. It’s also really helpful to be able to hang on but keep moving along walls until they reach a good spot to get out. This is important for white blood cells too, which have to “sample” their environment to get to the right place to get out of blood flow.
Even though the problem of how bacteria stick to blood vessel walls is so important clinically, the mechanisms bacteria use to do this are not widely understood. Part of this gap in our knowledge arises because we haven’t had good tools to study this process as it happens, and to understand how force affects bacterial interaction with vessel walls. The process of bacteria sticking to blood vessel walls is very fast, and hard to observe. The methods to observe this have already been developed, but the major technical innovations of our paper were to figure out how to identify and track the movement of the individual bacteria which stuck to vessel walls among millions flowing past, and to figure out how to set up a flow chamber system which replicated certain conditions in human blood vessels. Figuring out how to do this allowed us to figure out a lot about how the bacteria moved, and the forces and mechanisms involved in adhesion. It took a couple of years just to figure out the common patterns in the thousands of tracks of bacteria interacting with blood vessels, after the initial technical innovation.
Ellizabeth Wood[/caption]
Elizabeth Geneva Wood, MHPA
Department of Health Policy and Administration
College of Nursing
Washington State University
Spokane
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Many people don’t fill prescriptions because they can’t afford them, which is risky for their health. The problem of cost-related nonadherence to prescriptions (CRN) was increasing in prevalence over time until several major policy changes in the 2000s that were intended to help prescription affordability and/or access to health insurance. We observed that each of these major policy changes corresponded with a decrease in CRN among the policy’s target population.
For seniors, CRN dropped in 2006, when Medicare Part D came into effect. For younger adults (19-25), CRN dropped in 2010, when the Affordable Care Act began allowing them to stay on their parents’ insurance. Cost-related nonadherence rates also dropped for all non-elderly adults (including the younger ones) in 2014 and 2015, when the Medicaid expansion and the introduction of the health insurance marketplaces offered coverage to many previously-uninsured adults.
Dr. R. Mathew Gladden[/caption]
R. Matthew Gladden, PhD
Surveillance and Epidemiology Team, Division of Unintentional Injury Prevention, Centers for Disease Control and Prevention
MedicalResearch.com: What is the background for this study?
Response: In March and October 2015, the Drug Enforcement Administration (DEA) and CDC, respectively, issued nationwide alerts identifying illicitly manufactured fentanyl (IMF) as a threat to public health and safety.IMF is unlawfully produced fentanyl, obtained through illicit drug markets, includes fentanyl analogs, and is commonly mixed with or sold as heroin. Starting in 2013, the production and distribution of IMF increased to unprecedented levels, fueled by increases in the global supply, processing, and distribution of fentanyl and fentanyl-precursor chemicals by criminal organizations.
Fentanyl is a synthetic opioid 50?100 times more potent than morphine. Multiple states have reported increases in fentanyl-involved overdose (poisoning) deaths (fentanyl deaths). This report examined the number of drug products obtained by law enforcement that tested positive for fentanyl (fentanyl submissions) and synthetic opioid-involved deaths other than methadone (synthetic opioid deaths), which include fentanyl deaths and deaths involving other synthetic opioids (e.g., tramadol).
Dr. Manel Esteller[/caption]
Dr. Manel Esteller
Director of the Epigenetics and Cancer Biology Program (PEBC)
Bellvitge Biomedical Research Institute
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Cancer of Unknown Primary (CUP) occurs when the patient is diagnosed with a metastasis but the primary tumor is not found. It accounts for around 5-10% of tumors around the world and the survival is very poor. Until now, only in 25% of cases the primary site was identified after diagnosis pipeline. We are showing herein that the use of epigenetic profiling, based in the determination of the chemical marks occurring in DNA that are tumor-type specific, reaches a diagnoses of 87% of cases.
Dr. Cohen Regev[/caption]
Dr. Cohen Regev, M.D
Head of the infectious diseases and infection control units
Sanz Medical Center, Laniado hospital
Netanya, Israel
MedicalResearch.com: What is the background for this study?
Response: During 3 months in 2012 we had a number of clinical isolates of Pseudomonas aeruginosa (PA) in our neonatal intensive care unit (NICU) and a high incidence of colonization among ventilated patients in our medical-surgical intensive care unit (MSICU). The origin of PA may be from various environmental sources (‘exogenous’), from the patients’ own microbiome (‘endogenous’), or from both. Since in NICUs the origin is usually exogenous, we investigated the sources of the bacteria, focusing on the faucets of these units, as they were previously incriminated as causes of outbreaks in ICUs.
The study was conducted in Sanz medical center, a 400-bed community hospital located in central Israel. In the NICU we obtained several environmental cultures from faucets using a bacterial swab by rubbing the tip into the distal part of the faucet. Aerators were dismantled from all faucets, cultured from their inner part using a swab and were not repositioned. Contaminated faucets were occasionally replaced or treated with enzymatic fluid and sterilization by Ethylene Oxide. During the intervention and since, neonates were bathed only with warmed sterile water, and tap water was allowed only for hand hygiene practices.
In the MSICU tap water was used only for bathing the patients. All other uses of tap water, such as drinking, moistening and mouth treatments, were allowed using only sterile water. The units' faucets were sampled on two different days concurrently with surveillance cultures of pharyngeal, sputum and urine from the patients.
Bacteria were identified with VITEK 2 (Biomerieux®) and typing was done by Enterobacterial Repetitive Intergenic Consensus (ERIC) PCR.
Dr. Mary Estes[/caption]
Mary K. Estes, Ph.D.
Distinguished Service Professor
Cullen Endowed Chair of Human and Molecular Virology
Department of Molecular Virology and Microbiology
Baylor College of Medicine
Houston, TX 77030
MedicalResearch.com: What is the background for this study?
Response: Noroviruses are the most common cause of acute gastroenteritis (vomiting and diarrhea) worldwide and the leading cause of food-borne gastroenteritis. They also can cause chronic (long-lasting) illness in immunocompromised patients. These viruses are highly contagious and spread rapidly among people. The first report of an outbreak caused by a norovirus was in an elementary school in Norwalk, Ohio in 1968. Since that time, it became known that the virus damaged cells in the small intestine of infected people but attempts by many research groups to grow human noroviruses in the laboratory in a variety of intestinal cancer cells lines failed. This inability to grow human norovirus has been considered the single greatest barrier to norovirus research because it limited studies to understand how the virus makes people sick and how to inactivate the virus to prevent infection.
Dr. Katrine Owe[/caption]
Katrine M. Owe, PhD
Domain for Mental and Physical Health
Norwegian Institute of Public Health
OSLO, Norway
Norwegian National Advisory Unit on Women's Health
Oslo University Hospital, Rikshospitalet
Oso, Norway
MedicalResearch.com: What is the background for this study?
Response: The rising cesarean delivery rates in developed countries are of great concern. Given the many adverse consequences of repeated cesarean deliveries for both mother and child, identifying factors associated with the decision to perform the first cesarean is important.
Growing evidence show that regular exercise during pregnancy is associated with a lower risk of gestational diabetes, preeclampsia and excessive birth weight, all of which are highly correlated with having a cesarean delivery.
Results from previous studies examining the relationship between pregnancy exercise and mode of delivery, are inconsistent. Small sample size, not population-based, reporting crude estimates, and not powered to study cesarean delivery, are common methodological limitations in previous studies.