Author Interviews, JAMA, Pediatrics, Surgical Research / 16.12.2015

MedicalResearch.com Interview with: Dr. Peter C. Minneci, M.D., MHSc Center for Innovation in Pediatric Practice Assistant Professor, Pediatric Surgery The Ohio State's Wexner Medical Center Medical Research: What is the background for this study? What are the main findings? Dr. Minneci: Non-operative management of uncomplicated appendicitis has been shown to safe and effective studied in several international adult trials. To be a reasonable treatment alternative to urgent appendectomy, non-operative management of appendicitis in children must have a clinically acceptable success rate with minimal harm in patients that fail and subsequently undergo appendectomy. We performed a prospective single-institution patient choice trial allowing the families of children with acute uncomplicated appendicitis to choose between urgent appendectomy or non-operative management with antibiotics alone. We enrolled 102 patients, with 65 choosing surgery and 37 choosing non-operative management with antibiotics alone. Non-operative management had an in-hospital success rate of 94%, a 30-day success rate of 89%, and a 1-year success rate of 76%. Compared to the surgery group, patients managed non-operatively reported higher quality of life scores at 30 days and had significantly fewer disability days and lower costs, with no differences in the rates of complicated appendicitis or treatment-related complications at 1 year of follow-up. With this being said, there are some cases that I have read about where doctors have failed to diagnose patients for Appendicitis even after they have complained about having a number of the symptoms associated with it. Following this, some patients have even contacted companies like Negligence Claimline to get back what they deserve. You go to doctors as they are the ones who can help you get your health back in order, but when something like this happens, it is understandable as to why some people lose faith in this system. (more…)
Author Interviews, BMJ, Mental Health Research / 16.12.2015

MedicalResearch.com Interview with: Dr. Rashmi Patel MA (Cantab) MA BM BCh PGDip (Oxon) MRCPsych Psychiatry King's College London, London  Medical Research: What is the background for this study? What are the main findings? Dr. Patel: Antidepressants are a safe and effective treatment for depression. However, in a minority of cases, people who take antidepressants can also develop symptoms of elevated mood and mania as part of a bipolar disorder. This is important because although bipolar disorder is uncommon, people who are affected often first present with symptoms of depression and, if left untreated, bipolar disorder can be very distressing and significantly affect social and occupational functioning. In our study we investigated the association of antidepressants with mania in people with depression receiving care from the South London and Maudsley NHS Foundation Trust, a large provider of specialist mental healthcare in South London (UK). We found that antidepressants were widely prescribed and associated with a small increased risk in developing mania. However, we did not demonstrate a causal association between antidepressants and mania. Instead, it is likely that people who developed symptoms of mania with antidepressants already had a propensity towards developing mania prior to antidepressant treatment. (more…)
Author Interviews, Gastrointestinal Disease, JAMA, Stem Cells / 16.12.2015

MedicalResearch.com Interview with: Dr. Chris J. Hawkey, DM, FRCP, FMedSci. University of Nottingham and Nottingham University Hospital England Medical Research: What is the background for this study?  Dr. Hawkey: ASTIC (The Autologous Stem Cell Transplantation International Crohn's Disease) systematically investigated the effect of immunoablation and autologous haemopoietic stem cell transplantation (HSCT) on objective signs of disease, symptoms and need for treatment and is the only controlled trial to have done so. The body’s immune system normally protects us from infections but in Crohn’s disease it turns on itself.  The treatment involves wiping out the body’s immune system (immunoablation) and replacing it with the patient’s own (autologous haemopoietic stem cell transplantation) innocent stem cells, a sort of immunological spring clean. Patients were randomly assigned to undergo transplantation (n=23) or just continue on best conventional treatment (n=22). ASTIC was stimulated by reports which suggested that long-term regression of disease amounting to potential cure could be achieved. But the treatment is hazardous with major potentially lethal risks, so recruitment to the trial was cautious and only the most resistant cases were studied. And we used the most stringent criteria ever developed for the trial’s primary endpoint. Medical Research: What are the main findings?  Dr. Hawkey: In fact the criteria we used for success were so stringent (no symptoms, no signs of disease on total bowel examination and no need for treatment) that few patients achieved them. Nevertheless, there were improvements in the individual measures underlying this composite endpoint. Objective signs of disease disappeared so that the gut looked normal from mouth to anus in about a quarter of actively treated patients vs no controls. Eight vs two patients were adjudicated free of active disease on endoscopy and radiology at final assessment (p=0.054). Patients were able to come off drug treatments: by the end of a year 61% of HSCT patients off immunosuppressive drugs for >3 months vs 23% of controls (p=0.012). Ten vs two patients had lost symptoms of active disease, eight vs two for of them for > 3 months (p=0.052). But treatment was challenging: there were 76 serious adverse events in HSCT patients (particularly infections) vs 38 in controls. One HSCT patient died. (more…)
Author Interviews, Brain Cancer - Brain Tumors, Cancer Research, JAMA / 16.12.2015

MedicalResearch.com Interview with: Roger Stupp, MD Professor & Chairman Department of Oncology & Cancer Center University of Zurich & University Hospital Zurich (USZ) Zürich / Switzerland Medical Research: What is the background for this study? Dr. Stupp: Tumor Treating Fields are an entirely novel modality in cancer treatment. Over 10 years ago researchers demonstrated that alternating electrical fields will block cell growth, interfere with organelle assembly, in particular perturb the spindle apparatus and cell division, all leading to mitotic arrest and ultimately apoptosis. This was shown in vitro, but importantly also in vivo animal models including not only mice and rats, but also hamsters and rabbits with deep seated solid tumours. So the question was whether we can demonstrate such an effect also in the clinic. Glioblastoma are locally invasive and aggressive tumours in the brain. They usually do not metastasise however they grow diffusely within the CNS and despite the best possible surgery, radiation and chemotherapy virtually always recur. We thus applied alternating electrical fields therapy, so called Tumor Treating Fields to the scalp of patients with newly diagnosed glioblastoma. After the end of standard chemoradiotherapy (TMZ/RT), patients were randomized to receive either standard maintenance TMZ-chemotherapy alone or in combination with TTFields. Almost 700 patients were randomized, here we report on a preplanned interim analysis looking at the first 315 patients included once they were followed for at least 18 months. The data on the first 315 patients are mature and allowed the IDMC to conclude that the trial should be stopped and the results made available. Medical Research: What are the main findings? Dr. Stupp: The study demonstrated a consistent prolongation of both progression-free and also of overall survival for patients who have been treated with TTFields in addition to standard therapy. The median progression-free survival and overall survival were prolonged by 3 months, translating to an absolute increase in overall survival at 2 years of 14%, from 29% to 43%. Or a hazard ratio of 0.74 for overall survival and of 0.62 for progression-free survival. (more…)
Allergies, Author Interviews / 16.12.2015

MedicalResearch.com Interview with: Meghan Jeffres, PharmD Assistant Professor | Dept of Clinical Pharmacy Skaggs School of Pharmacy and Pharmaceutical Science University of Colorado Anschutz Medical Campus Aurora, CO 80045  Medical Research: What is the background for this study? What are the main findings? Dr. Jeffres: There are over 500,000 hospitalizations annually in the U.S. in which patients will have a reported allergy against first line antibiotics. Beta-lactams are the largest group of antibiotics which include penicillins, cephalosporins, and carbapenems. These antibiotics are the first line treatment against most serious bacterial infections; however, they are also the class of antibiotics to which patients are most commonly allergic. Patients labeled as allergic to one of these antibiotics are often prescribed second line antibiotics. Previous studies have shown that the use of second line antibiotics are more expensive, result in more adverse events, and longer hospital stays. We theorized that patients labeled as penicillin, cephalosporin, or carbapenem allergic treated with non-beta-lactams would have higher rates of clinical failure, but lower rates of allergic reactions, than patients treated with beta-lactams. Analysis of the data revealed that patients treated with non-beta-lactams did indeed have higher rates of clinical failure. Unexpected findings of the study were the low number of new allergic reactions which occurred in 16 patients, less than 3% of the study population. (more…)
Author Interviews, Genetic Research, Methamphetamine, PLoS / 16.12.2015

MedicalResearch.com Interview with: Camron D. Bryant, Ph.D. Assistant Professor Laboratory of Addiction Genetics Department of Pharmacology and Experimental Therapeutics & Psychiatry Boston University School of Medicine Boston, MA 02118  Medical Research: What is the background for this study? What are the main findings? Dr. Bryant: The addictions, including addiction to psychostimulants such as methamphetamine and cocaine, are heritable neuropsychiatric disorders. However, the genetic factors underlying these disorders are almost completely unknown. We used an unbiased, discovery-based genetic approach to fine map a novel candidate genetic factor influencing the acute stimulant response to methamphetamine in mice. We then directly validated the causal genetic factor using a gene editing approach. The gene - Hnrnph1 (heterogeneous nuclear ribonucleoprotein H1) - codes for an RNA binding protein that is involved in alternative splicing of hundreds of genes in the brain. Based on a genome-wide transcriptome analysis of differentially expressed genes within the striatum -  a crucial brain region involved in the stimulant properties of amphetamines - we predict that Hnrnph1 is essential for proper neural development of the dopamine circuitry in the brain. These findings could have implications for understanding not only the addictions but also other neuropsychiatric disordersthat involve perturbations in the dopaminergic circuitry. (e.g., ADHD and schizophrenia) as well as neurodegenerative disorders such as Parkinson's disease. (more…)
Aging, Author Interviews, Breast Cancer / 16.12.2015

MedicalResearch.com Interview with: Susan K. Boolbol, MD, FACS Chief, Division of Breast Surgery Chief, Appel-Venet Comprehensive Breast Service Co-Director, Breast Surgery Fellowship Mount Sinai Beth Israel Associate Professor of Surgery Icahn School of Medicine at Mount Sinai New York, NY 10003  Medical Research: What is the background for this study? What are the main findings? Dr.Boolbol:  The background for this study is predicated on the USPSTF's recommendations that there is insufficient evidence to continue the use of screening mammography in women over the age of 75. According to the American College of Radiology, cancer detection rates via screening mammography should be at least 2.5 per 1000 mammograms at an institution, with reported rates as high as 4.7 cases per 1000. We reviewed 2057 screening mammograms in women aged 75 and older. We found 10 cases of breast cancer in this group. Of these cancers, 60% were invasive breast cancer. The breast cancer detection rate in this cohort was 4.9 per 1000 screening mammograms. (more…)
Author Interviews, Dermatology, Pediatrics / 16.12.2015

MedicalResearch.com Interview with: Dr Alison Cooke PhD, MRes, BMidwif (Hons), RM Lecturer in Midwifery (Teaching and Research) School of Nursing, Midwifery & Social Work The University of Manchester Oxford Road Manchester  Medical Research: What is the background for this study? What are the main findings? Dr. Cooke: The use of topical oils for the management of newborn dry skin or for massage is a common practice across the globe. In the UK, olive oil and sunflower oil are commonly recommended by maternity service health professionals for baby dry skin, yet there is no evidence to support this practice. The OBSeRvE study was conducted to investigate the effect of these two oils on healthy term newborn baby skin barrier function. The study found that both oils impeded the development of the skin barrier function from birth. (more…)
Author Interviews, Cognitive Issues, Weight Research / 16.12.2015

MedicalResearch.com Interview with: Dr Anne Martin PhD Research Associate/Research Fellow Physical Activity for Health Research Centre (PAHRC) Institute for Sport, PE & Health Sciences University of Edinburgh TeleScot Research Group Usher Institute for Population Health Sciences and Informatics Edinburgh Medical Research: What is the background for this study? What are the main findings? Dr. Martin: Impairments in cognitive development during childhood can have detrimental effects on health behaviour, educational attainment, and socio-economic status later in life. Epidemiological evidence indicates an association between childhood obesity and cognition and educational attainment. Knowledge of when obesity related deficits in cognition and attainment emerge, and how large the deficits are at various ages, may be useful to support arguments for school-based obesity prevention initiatives and in translating evidence on this topic into policy aimed at preventing obesity. In this study we explored whether the adverse association between obesity and cognition emerges in early childhood. Measures of cognitive abilities included visuo-spatial skills, expressive language skills and reasoning skills. Our findings indicated that obesity in the pre-school years may be weakly associated with some poorer cognitive outcomes at age 5 years in boys, independently of socioeconomic status. Stronger relationships between obesity and cognition or educational attainment may emerge later in childhood. Evidence from an English cohort study suggested an adverse association between obesity in teenage girls and lower academic attainment in Mathmatics, Science and English. (more…)
Allergies, Author Interviews, BMJ, Gastrointestinal Disease / 16.12.2015

MedicalResearch.com Interview with: Meri K Tulic PhD Université de Nice Sophia-Antipolis Immune Tolerance Nice, France The International Inflammation 'in-FLAME' Network Worldwide Universities Network  Medical Research: What is the background for this study? What are the main findings? Dr. Tulic: We know that damaged epithelial gut barrier is a hallmark of gut inflammatory diseases including inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). It has been long known that respiratory allergens such as house-dust mites (HDM) are the main causes of epithelial destruction in the lungs and initiation of allergic airway disease such as asthma. We set out to test whether  house-dust mites may also be present in the human gut and may contribute to intestinal barrier dysfunction. In this paper, we have shown that  house-dust mites is found in the gastrointestinal system of ~50% of all healthy subjects tested and it has detrimental effect on gut barrier function. The mechanisms include its direct destruction of tight-junction proteins which normally hold adjoining epithelial cells together, resulting in increased gut permeability. This process is driven by cysteine-proteases contained within the mite. In healthy individuals this effect is likely to be regulated by increased production of regulatory IL-10 (an anti-inflammatory mediator); our preliminary data indicate that a defect in regulatory responses may exist in IBS patients. (more…)
Author Interviews, Heart Disease, Hospital Readmissions / 15.12.2015

MedicalResearch.com Interview with: Javed Butler MD MPH Chief, Division of Cardiology Stony Brook University Health Sciences Center SUNY at Stony Brook, NY Medical Research: What is the background for this study? What are the main findings? Dr. Butler: There is a lot of emphasis on reducing the risk of readmission after heart failure hospitalization. The main focus is on early readmissions as the risk for readmission is highest earlier post discharge. In this study, we described the fact that certainly there is some increased risk post discharge, the majority of the risk is actually dependent on the patient and disease characteristics at the time of discharge as opposed to true reduction in risk over time, which is partially related to differential attrition of high risk patients earlier post discharge. (more…)
Author Interviews, Sexual Health / 15.12.2015

MedicalResearch.com Interview with: Lee Ellis PhD Department of Anthropology University of Malaya Kuala Lumpur Malaysia Medical Research: What is the background for this study? What are the main findings? Dr. Ellis: Sexual orientation appears to be highly influenced by prenatal neurohormonal factors (as opposed to social experiences throughout life).  However, the specifics continue to elude scientific comprehension.  Over the past two decades, researchers began to explore the possibility that a putative measure of prenatal testosterone exposure, called the 2D:4D finger length ratio, might be predictive of variations in sexual orientation.  The results have been mixed.  In the present study, colleagues and I obtained multiple measures of prenatal testosterone exposure (including a 2D:4D measure) from large samples of college students in two countries and factor analyzed these measures.  Analyses revealed two apparent prenatal testosterone exposure variables, one largely pertaining to bone growth (that included our 2D:4D measure), and the other mainly pertaining to muscular growth and coordination.  It was this second factor, not the first one, that appeared to be mainly responsible for variations in sexual orientation. (more…)
Antioxidants, Author Interviews, Exercise - Fitness, Nutrition / 14.12.2015

MedicalResearch.com Interview with: Néstor Vicente Salar, PhD. Profesor Asociado UMH/ UMH Part-time Assistant Professor Doctor en Biología Diplomado en Nutrición Humana y Dietética (CV00195) Miembro del GE-NuDAFD (AEDN)  Medical Research: What is the background for this study? What are the main findings? Response: Nowadays, the practising of endurance sport is increasing, running being the sport chosen by many people who decide to start doing exercise. Distances and time are important factors to take in account in amateur as well as in professional runners. Among others, these factors are directly related to the risk of oxidative damage. In fact, oxidative stress has two faces: beneficial and deleterious. Helpful effects include the defence against infectious agents or the function as intracellular signaling molecules in many processes. On the other hand, high and persistent levels of oxidative stress can produce harmful effects if the antioxidant defences are overwhelmed, resulting in structural damage. Antioxidants from diet, for example pomegranate juice, seem to control oxidative stress disorders. However, the studies about the role of pomegranate juice in oxidative stress modulation in athletes are scarce. We have demonstrated that the intake of this kind of juice during 22 days in endurance athletes is capable to modulate the structural damage in macromolecules as proteins and lipids. (more…)
Author Interviews, Brigham & Women's - Harvard, JCEM, Thyroid, Thyroid Disease / 14.12.2015

MedicalResearch.com Interview with: Dr. Erik K. Alexander, MD FACP Chief, Thyroid Section, Division of Endocrinology Brigham & Women's Hospital Associate Professor of Medicine, Harvard Medical School Medical Research: What is the background for this study? What are the main findings? Dr. Alexander: Thyroid nodular disease has become an increasingly common medical illness, with prevalence reported to range between 26-67% in the adult.  Though advancing age is known to influence the formation of thyroid nodules, their precise relationship remains unclear.  Furthermore, it is uncertain whether age influences the risk that any thyroid nodule may prove cancerous.  Thus we conducted a study to determine the impact of patient age on nodule formation, the number of thyroid nodules, and risk of thyroid malignancy. Medical Research:  What are the main findings? Dr. Alexander: Our study is a prospective cohort analysis of consecutive adults who presented for evaluation of nodular disease from 1995-2011 at Brigham and Women’s Hospital, Boston, MA.  6,391 patients underwent thyroid ultrasound and fine needle aspiration that resulted in 12,115 thyroid nodules ≥1 cm.  Patients were stratified into six age groups and compared using sonographic, cytologic, and histologic endpoints. We found that the prevalence of thyroid nodular disease increases with advancing age.  The mean number of nodules at presentation increased from 1.5 in the youngest cohort (ages 20–30) to 2.2 in the oldest cohort (>70 years).  In contrast, the risk for malignancy in a newly identified nodule declined with advancing age.  Thyroid cancer incidence per patient was 22.9% in the youngest cohort, but 12.6% in the oldest cohort.  Despite a lower likelihood of malignancy, identified cancers in older patients demonstrated a more aggressive cancer subtype.  While nearly all malignancies in younger patients were well-differentiated, older patients were more likely to have higher risk papillary thyroid cancer variants, poorly differentiated cancer, or anaplastic carcinoma. (more…)
Author Interviews, Cost of Health Care, Health Care Systems, Pediatrics / 14.12.2015

MedicalResearch.com Interview with: Dr. Eric W. Christensen, PhD Health Economist Children’s Hospitals and Clinics of Minnesota Minneapolis, MN Medical Research: What is the background for this study? Dr. Christensen: National healthcare expenditures are up from 5.0% of gross domestic product in 1960 to 17.4% in 2013. We must find ways to control cost while maintaining quality. Accountable care organizations (ACOs) were designed to control a population’s health care cost while maintaining or improving quality. This study was an examination of one ACO exclusively covering a pediatric Medicaid population. Medical Research: What are the main findings? Dr. Christensen: We found that health care utilization and cost patterns were associated with the length of time patients were attributed to this ACO, where attribution length can be thought of as a proxy for consistent primary care from ACO providers. Specifically, attribution length of 2 or more years was associated with a 40.6% decrease in inpatient days. This decrease was partially offset by increases in outpatient visits (as one would expect with a primary care focus), emergency department visits, and use of pharmaceuticals. Combined these utilization changes resulted in a cost reduction 15.7% for those attributed 2 or more years. These changes were achieved while meeting quality benchmarks. (more…)
Author Interviews, Cancer Research / 14.12.2015

MedicalResearch.com Interview with: Lindsey Torre, MSPH  Epidemiologist, Surveillance Research Surveillance Research group at the American Cancer Society Medical Research: What is the background for this study? What are the main findings? Response: This study updates a previous study published in 2010 using the latest available data on cancer incidence and mortality from cancer and vital registration around the world. We found that while high-income countries still have the highest cancer rates in the world, some low- and middle-income countries now also have elevated cancer rates. Also, mortality rates for common cancers such as lung, breast, and colorectum are declining in high-income countries, while they are increasing in low-income countries. At the same time, low-income countries still have a disproportionate burden of infection-related cancers, such as stomach, liver, and cervix. (more…)
Author Interviews, Leukemia, Race/Ethnic Diversity, Stanford / 14.12.2015

MedicalResearch.com Interview with: Manali Patel, MD, MPH Instructor in the Division of Oncology Department of Medicine Stanford University School of Medicine Researcher at the Clinical Excellence Research Center and the Primary Care and Outcomes Research Group at Stanford Staff oncologist at the Veterans Administration and a researcher in the Palo Alto Veterans Administration Health Services & Research Development group.  Medical Research: What is the background for this study? Dr. Patel: Racial and ethnic disparities in Acute Leukemia are well documented in the literature but the reasons underlying the disparities remain largely unknown. In our previous work, we demonstrated mortality disparities for minorities with Acute Myeloid Leukemia despite favorable prognostic demographic and molecular factors. We have also shown that differences in receipt of treatment may partially explain a large component of these disparities. The purpose of this study is to determine how socioeconomic status factors influence  mortality from Acute Leukemia using a population-based novel linked dataset of the Surveillance Epidemiology and End Results Database and the National Longitudinal Mortality Study. Medical Research: What are the main findings? Dr. Patel:  We found a total of 121 patients with Acute Lymphoid Leukemia and 438 patients with Acute Myeloid Leukemia in the linked dataset.  After adjusting for socioeconomic status factors, there were increased risk of mortality among Hispanic and decreased risk of mortality among Asian Pacific Islander patients as compared with non-Hispanic white patients in Acute Lymphocytic Leukemia.  Among patients with Acute Myeloid Leukemia, we found no associations of mortality by race/ethnicity and socioeconomic status. (more…)
Author Interviews, Cancer Research, Cost of Health Care, Medicare / 14.12.2015

MedicalResearch.com Interview with: Dr. Stacie B. Dusetzina, PhD Assistant professor in the Division of Pharmaceutical Outcomes and Policy Eshelman School of Pharmacy University of North Carolina  Medical Research: What is the background for this study? What are the main findings? Dr. Dusetzina: As part of the Affordable Care Act the Medicare Part D “doughnut hole” is closing – reducing Medicare beneficiaries out-of-pocket expenses during this phase of coverage from 100% of drug costs to 25% between 2010 and 2020.  In this study we analyzed 3,344 Medicare formularies that spell out how insurers cover prescription drugs. We found that in 2010, a typical course of oral chemotherapy drugs costs patients on average up to $8,100 per year. When the doughnut hole closes in 2020, patients will still have to pay on average $5,600 out of pocket per year, more than what the average Medicare beneficiary’s household spends on food each year. Even after the doughnut hold is closed oral chemotherapy drugs will still be out of reach for millions of Americans. (more…)
Author Interviews, Breast Cancer, Chemotherapy, University Texas / 14.12.2015

MedicalResearch.com Interview with: Mariana Chavez Mac Gregor, MD, MSC Assistant Professor Breast Medical Oncology Department Health Services Research Department The University of Texas MD Anderson Cancer Center Medical Research: What is the background for this study? What are the main findings? Dr. Chavez Mac Gregor: Adjuvant chemotherapy has proven to significantly decrease the risk of recurrence among breast cancer patients, however the optimal time to start adjuvant chemotherpay remains unknown. There are biological resasons to believe that a delay in the initiation of systemic therapy can be associated with adverse outcomes. In this large study we evaluated the impact of a delay in the initiation of time to chemotherapy (TTC).  We analyzed data from 24,843 patients with invasive breast cancer (stages I to III) from the California Cancer Registry and observed that compared with patients who received chemotherapy within 31 days of surgery,  no adverse outcomes were associated with time to chemotherapy of 31 to 90 days of surgery. However, there was  a 34 % increase in the risk of death and a 27% increase in the risk of breast cancer specific death  among patients who started  chemotherapy 91 or more days after surgery. In a stratified analysis according to breast cancer subtype, patients with triple-negative breast cancer, a TTC greater than 91 days  was  significantly  associated with worse overall and breast cancer-specific survival. In addition we evaluated factors associated with delays in  time to chemotherapy (defined as > or = 91 days) and observed that many of the factors are sociodemographic in nature including low socioeconomic status, non-private insurance, and being Hispanic or African American. (more…)
Annals Internal Medicine, Author Interviews, Diabetes, Pharmacology / 13.12.2015

MedicalResearch.com Interview with: Francesco Zaccardi, MD Diabetes Research Centre Leicester General Hospital, Leicester, United Kingdom Medical Research: What is the background for this study? Dr. Zaccardi: Nowadays there are different classes of drugs for the treatment of hyperglycaemia in patients with type 2 diabetes and, within the same class, multiple drugs are available.Glucagon-like peptide-1 receptors (GLP-1RAs) are a relatively new class of treatments that improve glucose control and reduce body weight, without an increased risk for hypoglycaemia. To date, however, no direct comparisons between once-weekly GLP-1RAs have been reported. In this view, the aim was to assess the comparative efficacy and safety profile of GLP-1RAs using a network meta-analysis, a methodology that allows the estimation of the comparative effectiveness of multiple treatments in the absence of direct evidence. Medical Research: What are the main findings? Dr. Zaccardi: There are several differences in the efficacy and safety profiles of once-weekly glucagon-like peptide-1 receptor agonists (GLP-1RAs). Some of these drugs evidenced a better glucose control or body weight reduction, while other had an increased risk of side effects, such as nausea. Compared to other once-weekly GLP-1RAs, dulaglutide 1.5mg, once weekly exenatide, and taspoglutide 20mg showed a greater reduction of HbA1c, fasting plasma glucose, and body weight. Marginal or no differences were found for blood pressure and blood lipid levels. While taspoglutide 20mg had the highest risk of nausea, the risk of hypoglycaemia among once-weekly GLP-1RAs was comparable. (more…)
Author Interviews, CDC, Tobacco / 13.12.2015

MedicalResearch.com Interview with: Ralph S. Caraballo, PhD MPH Branch Chief, Epidemiology Branch Office on Smoking and Health National Center for Chronic Disease Prevention and Health Promotion CDC Atlanta GA Medical Research: What is the background for this study? What are the main findings? Dr. Caraballo: Electronic nicotine delivery system (ENDS) use has increased rapidly in the U.S. in recent years. The availability and use of ENDS raise new issues for public health practice and tobacco regulation, as it is unknown whether patterns of ENDS use enhance, deter, or have no impact on combustible tobacco product use. This study assessed past-month, lifetime, and frequency of ENDS use among current, former, and never adult cigarette smokers. In 2014, overall lifetime and past-month ENDS use was 14.1% and 4.8%, respectively. By smoking status, 49.5% of current, 14.7% of former, and 4.1% of never cigarette smokers had used ENDS in their lifetime, whereas 20.6% of current, 4.0% of former, and 0.8% of never smokers used ENDS in the past month. Among current and former cigarette smokers who ever used ENDS, 44.1% and 44.7% reported using ENDS >10 days in their lifetime, respectively. (more…)
Author Interviews, BMJ, Colon Cancer, Gastrointestinal Disease / 13.12.2015

MedicalResearch.com Interview with: Dr Franco Radaelli Division of Digestive Endoscopy and Gastroenterology Valduce Hospital Como, Italy  Medical Research: What is the background for this study? Dr. Radaelli: Split regimens of bowel preparation are strongly recommended by European and American Guidelines as they have been associated with a higher level of colon cleansing. However, there is still uncertainty on whether the higher level of cleansing associated with a split regimen also results in a higher proportion of subjects with at least one adenoma (adenoma detection rate, ADR), that represents by far a more relevant quality indicator than the level of cleansing itself. On this background, we designed a randomized investigator-blinded controlled trial to evaluate whether a “split regimen” of low-volume 2-L PEG-ascorbate solution was superior to the traditional “full dose, the day before regimen” in terms of ADR. Differently from other studies on bowel preparation, we considered adenoma detection rate  instead of the level of colon cleansing, the primary study end-point, and we designed the sample size accordingly. A precise estimation of the sample size was facilitated by including an homogeneous population of asymptomatic subjects undergoing first colonoscopy after positive-FIT within CRC organized screening program. Besides, ADR represents a very solid end-point due to the very low inter-pathology variability in the differential diagnosis between neoplastic and non-neoplastic lesions, while the assessment of the level of cleansing is hampered by unavoidable degree of subjectivity and higher degree of inter-operator variability. (more…)
Author Interviews, Race/Ethnic Diversity, University of Michigan / 13.12.2015

MedicalResearch.com Interview with: Shervin Assari, MD, MPH Faculty, research investigator Department of Psychiatry and Center for Research on Ethnicity, Culture, and Health University of Michigan School of Public Health University of Michigan Ann Arbor, MI  Medical Research: What is the background for this study? What are the main findings? Dr. Assari: Literature has consistently shown that a single question that asks individuals to rate their health strongly predicts risk of mortality net of traditional risk factors. Our study shows that self rated health that very well predicts risk of death over a 25 year for Whites does not have any predictive value for Blacks. The results are important because Blacks have a worse self rated health and also shorter life expectancy in the United States, but those 2 health problems have weaker link among Blacks as Whites. (more…)
Author Interviews, Cancer Research, Radiation Therapy / 12.12.2015

MedicalResearch.com Interview with Dr. Ajay Bhatnagar MD Radiation Oncologist Medical director of 21st Century Oncology of Arizona MedicalResearch.com: What is the background for this report? What are the main findings? Dr. Bhatnagar: I recently presented updated data regarding my research at the American Society for Radiation Oncology (ASTRO) annual meeting in a poster titled “Electronic brachytherapy for the treatment of Non-Melanoma Skin Cancer: Results up to 5 years.” For this clinical study, I have been using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® which is FDA cleared, CE marked and licensed in Canada for the treatment of cancer anywhere in the body, including early-stage breast cancer, gynecological cancers, and nonmelanoma skin cancer (NMSC) including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). For the treatment of nonmelanoma skin cancer, the Xoft System uses a proprietary, miniaturized x-ray source to deliver a precise dose of targeted radiation directly to the surface lesion. This treatment uses electronic brachytherapy (eBx) to target cancerous cells while sparing healthy tissue. It is painless, non-invasive and offers a number of patient benefits, including fewer treatments than traditional radiation therapy. According to my findings, the Xoft System is safe and effective for the treatment of nonmelanoma skin cancer, with low rates of recurrence and excellent clinical outcomes. (more…)
Author Interviews, JAMA, Mental Health Research, MRI, Neurological Disorders / 12.12.2015

MedicalResearch.com Interview with: Stephane De Brito, PhD Birmingham Fellow School of Psychology Robert Aitken Building, Room 337a University of Birmingham  UK Medical Research: What is the background for this study? What are the main findings? Dr. De Brito: In the last decade, an increasing number of neuroimaging studies have used structural magnetic resonance imaging (sMRI) to examine the brains of youths who show behavioural problems that include antisocial and aggressive behaviour. Those studies have mostly relied on a method called voxel-based morphometry (or VBM), which is a whole-brain and automated technique that allows researchers to objectively assess the local composition of brain tissue, such as grey matter volume. The main problem is that the findings from those sMRI studies have been quite disparate and few have been replicated, partly due to differences in sample sizes and characteristics across studies. Therefore, we set out to carry out a meta-analysis of the available data to provide a clearer account of the literature on this topic. A particular strength of our meta-analysis is that we used the original brain imaging maps (also referred to as statistical parametric maps) from 11 of the 13 studies, which makes our analysis more accurate and reliable. The final sample comprised of 394 youths with behavioural problems and 350 typically developing youths, making it the largest study on this topic to date. Our results showed that, compared to typically developing youths, those with behavioural problems show reduced grey matter volume in the amygdala, the insula, and the prefrontal cortex. These brain areas have been shown to be important for decision-making, empathic responses, processing facial expressions and emotion regulation; key cognitive and affective processes that are shown to be deficient in youths with behavioural problems. (more…)
Author Interviews, Lancet, Leukemia / 12.12.2015

MedicalResearch.com Interview with: Dr. Christoph Röllig Medizinische Klinik und Poliklinik I Universitätsklinikum der Technischen Universitä Dresden, Germany Medical Research: What is the background for this study? What are the main findings? Dr. Röllig: When this trial began in 2009, standard treatment for Acute Myelogenous Leukemia (AML) consisted of a combination of cytarabine plus anthracyclin/anthracendion and the need for improvement was obvious in the light of only around 50% long-term survivors even amongst younger patients. Although a promising approach, the use of kinase inhibitors in AML had not been shown to be beneficial and was not widely used. Sorafenib had been shown to be tolerable as single agent and in combination with commonly used chemotherapeutic agents. The results of the trial show that the addition of sorafenib to standard chemotherapy for newly diagnosed AML patients up to the age of 60 years is associated with significant prolongation of event-free survival and relapse-free survival compared to placebo plus standard chemotherapy. That means that patient who took sorafenib had less AML relapses. To our knowledge, this is the first randomized-controlled showing that integrating a kinase inhibitor into standard intensive chemotherapy of younger patients with AML is associated with significant improvement of relapse-free survival, with no increase in treatment-related mortality. After a decade of evaluating the potential of kinase inhibitors in AML, their use in combination with standard treatment is becoming an important option for newly diagnosed younger patients. (more…)
Author Interviews, Immunotherapy, Lymphoma, NYU / 11.12.2015

MedicalResearch.com Interview with: Dr. Catherine S. M. Diefenbach MD Assistant Professor of Medicine NYU Langone Laura and Isaac Perlmutter Cancer Center New York, NY 10016  Medical Research: What is the background for this study? What are the main findings? Dr. Diefenbach: The background of the study is that through an understanding of the unique immunobiology of Hodgkin lymphoma we can derive rational treatment strategies which may heighten the efficacy of existing therapies, and improve the outcomes for patients with relapsed disease.  In E4412 which is a national study sponsored by the Eastern Cooperative Oncology Group (ECOG-ACRIN) we explore the safety and efficacy of combination of the antibody drug conjugate brentuximab vedotin which targets CD30 on the surface of the Hodgkin lymphoma tumor cells, and immune stimulation of the T cells in the tumor microenvironment using checkpoint inhibitors.  We reported the data from the first arm of the study Brentuximab Vedotin and Ipilimumab.  To date 23 patients with relapsed Hodgkin lymphoma have been treated; the combination of brentuximab and ipilimumab was safe and well tolerated with primarily grade 1 and 2 toxicities.  In 18 patients evaluable for response the ORR was 72% with a complete response rate of 50%. (more…)
Author Interviews, NYU, Tobacco, Tobacco Research / 11.12.2015

MedicalResearch.com Interview with: Michael L. Weitzman MD Professor, Departments of Pediatrics and Environmental Medicine NYU Langone Medical Center. Medical Research: What is the background for this study? What are the main findings? Dr. Weitzman: While the prevalence of cigarette smoking in the United States has recently seen a steady decline, more and more individuals report hookah (water pipe) usage. Researchers have shown that web queries for ‘hookah’ and ‘hookah bars’ have increased dramatically, but it is unclear whether this interest has led to an increase in the number of hookah bars in a given area.  We first tested the website Yelp.com to see whether it could reliably provide us with information – such as the date of establishment of a hookah bar – by comparing the date of the first review written on Yelp.com with the actual opening date. We found that, for 2014 onwards, the first review posting on Yelp.com, on average, occurred within the first month of a hookah bar’s opening date. Additionally, we found a dramatic increase in the number of hookah bars in New York City over the past 5 years. These hookah bars tend to be not randomly distributed, but instead clustered near universities and specific ethnic neighborhoods. (more…)
Author Interviews, Cancer Research, Depression, MD Anderson, Tobacco / 11.12.2015

MedicalResearch.com Interview with: Dr. Eileen H. Shinn PhD Assistant Professor, Department of Behavioral Science Cancer Prevention and Population Sciences MD Anderson Cancer Center The University of Texas Houston, TX  Medical Research: What is the background for this study? What are the main findings? Dr. Shinn: Recent studies with leukemia, breast, lung, renal and liver cancer patients have shown that patients with depression have worsened survival.  These effect sizes are small, but independent of any of the traditional factors that are known to impact survival, such as extent of cancer, types of treatment administered and baseline health and age of the patient.  The current thinking is that cancer patients who are depressed have chronically heightened responses to stress; the constant release of stress hormones trigger changes in the tumor itself (such as noradrenergically-driven tumor angiogenesis) or may weakens the body’s immune function and ability to resist tumor growth. When we measured depression in newly diagnosed patients with oropharyngeal cancer (cancer of the base of tongue and tonsil), we found that those patients who scored as depressed were 3.5 times more likely to have died within the five year period after their diagnosis, compared to nondepressed patients.  We also found that patients who were depressed were also 3.8 times more likely to have their cancer recur within the first five years after diagnosis.  We also found that patients who continued to smoke after diagnosis were more likely to recur within the first five years. These effect sizes were larger than those typically found in recent studies.  We believe that the larger effect size may be due to the tight eligibility criteria ( e.g., we did not include patients who already had recurrent disease, we only included patients with one specific type of head and neck cancer, oropharyngeal) and also due to controlling other known factors (all patients completed individualized treatment regimens of radiation/ chemoradiation at a comprehensive cancer center and patients with more advanced disease stage were more likely to have received treatment intensification compared to patients with early stage disease).  In all, we had 130 patients, one of the largest prospective studies with oropharyngeal cancer to examine the effect of depression on cancer outcome. (more…)
Author Interviews, Breast Cancer, Surgical Research, Yale / 11.12.2015

MedicalResearch.com Interview with: Anees B. Chagpar, MD, MSc, MPH, MA, MBA, FRCS(C), FACS Associate Professor, Department of Surgery Director, The Breast Center Smilow Cancer Hospital at Yale-New Haven Assistant Director -- Global Oncology Yale Comprehensive Cancer Center Yale University School of Medicine Medical Research: What is the background for this study? Dr. Chagpar: Up to 40% of women undergoing breast conserving surgery for breast cancer will have to return to the operating room due to positive margins (or cancer cells being found at the edge of what was removed at the initial surgery).  We recently reported the results of a randomized controlled trial, published in the New England Journal of Medicine, in which we found that taking a little more tissue circumferentially around the cavity (called shave margins) at the time of the initial surgery could cut the need for re-excisions (or return trips to the operating room) in half.  In this analysis, we evaluate the implications of this technique on costs. Medical Research: What are the main findings? Dr. Chagpar: We found that taking additional tissue added 10 minutes to the initial operative time.  While taking cavity shave margins resulted in higher costs associated with the initial surgery due to increased OR time and additional tissue requiring pathologic evaluation, this is offset by the significant reduction in the need for re-excisions.  From a payer perspective, costs including facility and provider fees for the index surgery as well as any breast surgery care in the ensuing 90 days was roughly $750 less for patients who had shave margins taken than for those who did not, although this did not reach statistical significance. (more…)