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…)
Author Interviews, Hematology / 11.12.2015

MedicalResearch.com Interview with: Dr. Elena Santagostino, MD PhD Angelo Bianchi Bonomi Hemophilia and Thrombosis Center Ca' Granda Foundation Maggiore Hospital Policlinico, Milan, Italy Medical Research: What is the background for this study? What are the main findings? Dr. Santagostino: Two of our abstracts presented at the 57th ASH Annual Meeting are part of the PROLONG-9FP clinical program evaluating the efficacy and safety of CSL Behring’s investigational long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP).  The first is an oral presentation on results from two Phase III studies and an ongoing extension study of rIX-FP for routine prophylaxis in previously-treated people with hemophilia B. The two Phase III studies included adolescents and adults (ages 12 to 61) treated with dosing intervals of up to 14 days for 12 to 18 months, and children (ages 1 to 11) who received seven-day prophylaxis treatment for approximately 12 months. Overall, the median annualized spontaneous bleeding rate (AsBR) was 0.00 for all treatment intervals. The extension study is examining longer treatment intervals, including 10- and 14-day intervals in patients younger than 12 and more prolonged treatment intervals in patients older than 18, and so far has reported favorable long-term tolerability with no serious adverse reactions such as the development of inhibitors to factor IX or antibodies to rIX-FP. A second abstract reported on a surgical sub-study in these trials found that a single pre-operative dose of rIX-FP maintained hemostasis during surgery with responses rated by investigators as “excellent” or “good.” Oven a 14-day perioperative period, patients needed six or seven infusions, and none developed inhibitors to factor IX or antibodies to rIX-FP. (more…)
Accidents & Violence, Author Interviews, CDC, Exercise - Fitness, Orthopedics, Pediatrics / 11.12.2015

MedicalResearch.com Interview with: Zachary Y. Kerr, PhD, MPH Sports Injury Epidemiologist Director, NCAA Injury Surveillance Program Datalys Center for Sports Injury Research and Prevention Indianapolis, IN 46202  Medical Research: What is the background for this study? What are the main findings? Dr. Kerr: The NCAA Injury Surveillance Program has been ongoing since 1982, but the Datalys Center for Sports Injury Research and Prevention began management in 2009.  We provide the NCAA sports and medical committees with evidence-based data they can use to make rule and policy decisions aimed at student-athlete health and safety.  However, among the research community, there lacks current injury incidence data across the collegiate student-athlete population. The main findings of this study is that the rate of injury was higher in competitions than in practices.  However, the total number of injuries estimated in practices exceeds that of competition, which suggests that interventions should be aimed at reducing injury incidence in both practices and competitions. (more…)
Alcohol, Alzheimer's - Dementia, Author Interviews, BMJ / 11.12.2015

MedicalResearch.com Interview with:

Professor, Frans Boch Waldorff General Practitioner Research Unit of General Practice Denmark

MedicalResearch: What is the background for this study? What are the main findings? Prof. Waldorff: While there are numerous studies focusing on alcohol as a risk factor for dementia and mortality in healthy subjects, virtually no attention has been paid to the effect of alcohol consumption in patients with Alzheimer’s disease (AD). Considering that AD is a neurodegenerative disorder and that alcohol has known neurotoxic effects, one could easily jump to the conclusion that alcohol is damaging for patients with AD. The aim of this study was to investigate whether the positive association between moderate alcohol intake and mortality shown in population-based studies on healthy subjects can be transferred to patients with mild AD. In our study we found that patients with mild  Alzheimer’s disease , moderate alcohol consumption (two to three units per day) was associated with a significantly lower risk of death compared with those who only had alcohol occasionally (one or less than one unit per day), and with those who had high alcohol intake (more than 3 units per day). Abstinence or high alcohol intake did not significantly raise mortality compared with those drinking only occasionally. (more…)
Author Interviews, Cancer Research, Chemotherapy, Dermatology, JAMA / 11.12.2015

MedicalResearch.com Interview with: Chia-Yu Chu, MD, PhD Associate Professor, Department of Dermatology National Taiwan University Hospital Medical Research: What is the background for this study? What are the main findings? Dr. Chia-Yu Chu: It has been well known that EGFR TKIs could cause skin toxicities (acneiform eruptions, pruritus, xerosis and paronychia). However, incidences of these skin toxicities have varied according to the different clinical trials, some of which even simply use “skin rash” instead of specific cutaneous findings in the reports. Afatinib, in contrast to first generation EGFR TKIs like gefitinib and erlotinib, is a second generation EGFR TKI with irreversible inhibition to not only EGFR, but also HER2 and ErbB4. Whether afatinib cause more skin toxicities remained unknown. Many of our patients received 2 or even 3 different EGFR TKIs with adequate drug exposure and washout period. Therefore, we had an opportunity to compare skin toxicities in “same patients” receiving different EGFR TKIs, and we found that around 30% of patients receiving afatinib developed paronychia whereas only 10% in gefetinib or erlotinib. This was the only significant difference between the 3 drugs. We also found afatinib treated patients needed significantly more dermatologic visits within 180 days of treatments and the reason was due to higher incidence of afatinib-related paronychia. Interestingly, regardless of causative agents, once skin toxicities developed they could be managed effectively in the same manners. (more…)
Author Interviews, Epilepsy, Technology / 11.12.2015

MedicalResearch.com Interview with: Dr. Frances Hutchings Interdisciplinary Computing and Complex BioSystems School of Computing Science, Newcastle University Newcastle upon Tyne, United Kingdom Medical Research: What is the background for this study? Response: Temporal lobe epilepsy is a prevalent and disruptive disorder, which is often treated with surgical removal of epileptic tissue when medication fails to repress seizures. In around a third of cases surgery is unsuccessful at preventing seizures. The aim of this study is to seek ways to improve surgery success rates by giving a better prediction of where seizures are starting and spreading on an individual patient basis, using an individual’s brain imaging data. Surgery is simulated in the model to provide a prediction of a procedures effectiveness at reducing seizures. Medical Research: What are the main findings? Response: Using patient Diffusion Tensor Imaging data to reconstruct the brain as a network, locations commonly implicated in temporal lobe epilepsy were found by the model to be most vulnerable to seizures. Simulations of surgery (following a commonly used surgery procedure) in patient models predicted a surgery success rate close to 70%, matching clinical observations. Subject specific surgery simulations were also tried, following individual predictions from the model of which regions to remove for which person. These showed far greater improvements in seizure likelihood than regular surgery. This is a preliminary study and there is much to be done to improve the predictive success, and also to ensure that model predicted subject specific surgery regions are safe to remove. Nonetheless it is a significant move towards computer aided patient specific surgery planning to improve outcomes. (more…)
Author Interviews, Breast Cancer, Chemotherapy / 10.12.2015

MedicalResearch.com Interview with: Sam Smith, PhD CPsychol Cancer Research UK Postdoctoral Fellow Centre for Cancer Prevention Queen Mary University of London Wolfson Institute of Preventive Medicine London Medical Research: What is the background for this study? What are the main findings? Dr. Smith:  Several trials have demonstrated that agents (e.g. ) can be used to prevent breast cancer among women at increased risk. However, their effectiveness is dependent upon their appropriate use by this patient group. Several studies have suggested that uptake is low, and that women are not taking the medications for the full 5 year course. We attempted to synthesize the evidence investigating these topics, as well as identify the factors affecting these behaviours. The main findings are that only 1 in 6 women (16.3%) were willing to start taking oral medications to prevent breast cancer. Furthermore, uptake rates were lower in routine clinical practice (9%) compared with trial enrollment rates (25%), suggesting that there may be problems with implementing chemoprevention within routine clinical care. We noted that day to day adherence and persistence over a short period (e.g. 1 year) was adequate, but when looking at the longer term studies only 1 in 10 reported that >80% of women were still taking their medications at the 5 year end point. Women may not be experiencing the full preventive effect of these medications. (more…)
Author Interviews, Exercise - Fitness, Heart Disease, Women's Heart Health / 10.12.2015

MedicalResearch.com Interview with: Sherry L. Grace, PhD Professor, York University Senior Scientist, University Health Network University of Toronto MedicalResearch: What is the background for this study? What are the main findings? Dr. Grace: Cardiovascular disease (CVD) is the leading cause of morbidity and mortality for women world-wide. Cardiac rehabilitation (CR) is an outpatient secondary prevention program composed of structured exercise and comprehensive education and counseling.Cardiac rehabilitation participation results in lower morbidity and mortality, among other benefits. Unfortunately, women are significantly less likely to adhere to these programs than men. While the traditional model of Cardiac rehabilitation care is a hospital-based mixed-sex program, women are the minority in such programs, and state that these programs do not meet their care preferences. Two other models of CR care have been developed: hospital-based women-only (sex-specific) and monitored home-based programs. Women’s adherence to these program models is not well known. Cardiac Rehabilitation for her Heart Event Recovery (CR4HER) was a 3 parallel arm pragmatic randomized controlled trial‎ (RCT) designed to compare women’s program adherence to traditional hospital-based CR with males and females attending (mixed-sex), home-based CR (bi-weekly phone calls), and women-only hospital-based CR. The primary outcome was program adherence operationalized as  Cardiac rehabilitation site-reported percentage of prescribed sessions completed by phone or on-site, as reported by a staff member who was blind to study objectives. The secondary outcomes included functional capacity. It was hoped that by identifying the CR program model which resulted in the greatest adherence for women, their participation and potentially their cardiac outcomes could be optimized. MedicalResearch: What are the main findings? Dr. Grace: Similar to previous research, we found that women did not adhere very highly to the  Cardiac rehabilitation programs. Half of the women dropped out of CR, and this occurred regardless of the type of program they went to. Some women did not even start Cardiac rehabilitation at all, even though we had referred them. On average, the women went to just over half the sessions (at the CR centre or on the phone; they were prescribed a median of 24 sessions). If we consider only the women who actually started CR, they attended almost 2/3rds of prescribed CR sessions. Women experienced gains in their exercise capacity over the course of CR participation. Attending the traditional co-ed program was associated with the greatest exercise capacity. This could be due to the fact that the staff push them to exercise at their target levels when they are in a supervised program. (more…)
Author Interviews, Biomarkers, Emergency Care, Heart Disease / 10.12.2015

MedicalResearch.com Interview with: Justin A. Ezekowitz, MBBCh MSc Associate Professor, University of Alberta Co-Director, Canadian VIGOUR Centre Cardiologist  and Director, Heart Function Clinic Nariman Sepehrvand, MD Research Fellow & Graduate Student Mazankowski Alberta Heart Institute University of Alberta Edmonton, Canada  Medical Research: What is the background for this study? Dr. Ezekowitz: Major practice guidelines recommend the use of natriuretic peptide (NP) testing for diagnosing acute heart failure (HF) in emergency departments (ED). Despite these guidelines, the majority of healthcare regions all around the world (except for the United States and New Zealand) have restricted access to NP testing due to concerns over cost to healthcare systems. In the province of Alberta, Canada, however, a province-wide access to NP testing was provided for all EDs in 2012. This study investigates the factors that are related to the utilization of NP testing in EDs. Medical Research: What are the main findings? Dr. Ezekowitz: There was a substantial geographic variation in testing for NPs, despite having a single payer system and the universal availability of NP testing in Alberta. Several factors (including male sex, some comorbidities like prior heart failure, urban residence, type of care provider and ED clinical volume) influenced the utilization of testing for NPs in routine ED practice. Interestingly, patients with heart failure who were tested for NPs at ED, had a higher rate of hospital admission and lower 7 day and 90 day repeat ED visit rates compared to those who were not tested. (more…)
Alzheimer's - Dementia, Author Interviews, Journal Clinical Oncology, Prostate Cancer, Testosterone, University of Pennsylvania / 10.12.2015

MedicalResearch.com Interview with: Kevin T. Nead, MD, MPhil Dept. of Radiation Oncology Perelman School of Medicine University of Pennsylvania MedicalResearch: What is the background for this study? What are the main findings? Dr. Nead: There are a growing number of studies suggesting that the use of  Androgen Deprivation Therapy (ADT)  may be associated with cognitive changes and some of these changes overlap with characteristic features of Alzheimer’s disease. In addition, low testosterone levels have been associated with Alzheimer’s disease risk and ADT lowers testosterone levels. Despite these findings, we could not identify any studies examining the association between ADT and Alzheimer’s disease risk. We therefore felt this study could make an important contribution in guiding future research to fully understand the relative risks and benefits of ADT. We examined electronic medical record data from Stanford University and Mt. Sinai hospitals to identify a cohort of 16,888 patients with prostate cancer. We found that men with prostate cancer who received Androgen Deprivation Therapy were more likely to develop Alzheimer’s disease than men who did not receive  Androgen Deprivation Therapy. We also found that this risk increased with a longer duration of ADT. These results were consistent using multiple statistical approaches and separately at both Stanford and Mr. Sinai. (more…)
Author Interviews, Lancet, Psychological Science / 10.12.2015

MedicalResearch.com Interview with: Dr Bette Liu MD PhD University of New South Wales Sydney, NSW Medical Research: What is the background for this study? What are the main findings? Dr. Liu: There is a generally held belief that being happier makes you live longer. We wanted to look at this question. We examined over 700,000 women enrolled in the UK Million Women Study. We found that being in poor health was associated with being unhappy but after accounting for an individuals poor health, unhappiness in itself was not associated with an increased risk of death. This finding was true for overall deaths, for deaths from heart disease and from cancer and it was true for stress as well as for unhappiness.  (more…)
Author Interviews, Biomarkers, Infections, PLoS, Technology / 10.12.2015

MedicalResearch.com Interview with: Leo McHugh, Ph.D. Director, Bioinformatics Immunexpress Seattle, Washington  Medical Research: What is the background for this study? What are the main findings? Dr. McHugh: Sepsis is the leading cause of child mortality in the world, and in developing countries kills more adults than breast cancer, prostate cancer and HIV combined. Approximately 30% of people admitted to ICU have sepsis, and up to 50% of these patients die. It’s a major cost burden also, costing the US health system $17 billion per year. The best way to reduce costs and improve patient outcomes is to detect sepsis early and with confidence, so that appropriate treatments can be applied. Each hour delay in the detection of sepsis has been reported to correspond to an 8% increase in mortality. So the need for a rapid and accurate diagnostic is recognized. Traditional methods rely on detection of the specific pathogen causing the infection, and these methods often take more than 24 hours, and find a pathogen in only 30% of clinically confirmed cases because they’re trying to detect a minuscule amount of pathogen or pathogenic product in the blood. Our approach was to use the host’s own immune system, which is highly tuned to respond to the presence of pathogens. Around 30% of all genes are dysregulated in sepsis, so there is a huge signal base to draw from. The trick with using multi marker host response is to pick out the specific combination of gene expression patterns that cover the broad range of patients that present with sepsis and who may present either early or late in the episode, thus with different gene activation patterns. This paper describes a simple combination of such genes that can be used to detect sepsis and performs over the full range of patients irrespective of stage of infection or severity of infection. In it’s current format, the test is manual and takes 4-6 hours, and is a great advance on the current tools, however the methods we’ve used are specifically designed to meet requirements to port this assay onto a fully automated Point of Care platform that could deliver a result in under 90 minutes. (more…)
Author Interviews, Dermatology, Genetic Research, JAMA, Melanoma / 10.12.2015

MedicalResearch.com Interview with: Susana Puig MD PhD Chief Dermatology Service Research Director "Melanoma: Imaging, genetics and immunology" at IDIBAPS Consultant & Assistant Professor Melanoma Unit, Dermatology Department Hospital Clinic, University of Barcelona Barcelona Spain  Medical Research: What is the background for this study? What are the main findings? Dr. Puig: CDKN2A is the main high-penetrance melanoma susceptibility gene. A rare functional variant in MITF, p.E318K (rs149617956), has been identified as a moderate risk allele in melanoma susceptibility and also predisposes to renal cell carcinoma. In this study MITF p.E318K was associated with an increased melanoma risk (OR=3.3, p<0.01), especially in patients with multiple primary melanoma (OR=4.5, p<0.01) and high nevi count (>200 nevi) (OR=8.4, p<0.01). Interestingly, two fast growing melanomas were detected among two MITF p.E318K carriers during dermatologic digital follow-up. Furthermore, we have detected a similar prevalence of MITF p.E318K in CDKN2A wild-type and mutated individuals. (more…)
Author Interviews, Diabetes, JAMA, Pediatrics / 10.12.2015

MedicalResearch.com Interview with: Maria C. Magnus PhD Norwegian Institute of Public Health Department of Chronic Diseases Nydalen Norway Medical Research: What is the background for this study? What are the main findings? Dr. Magnus: Type 1 diabetes mellitus is one of the most common chronic diseases with onset in childhood, but environmental risk factors have not been convincingly established. A few previous studies report that childhood weight increase might influence the development of type 1 diabetes. This study combined information from two Scandinavian birth cohorts, including more than 99,000 children. The results showed that a higher weight increase during the first year of life increased the risk of type 1 diabetes. The same was not seen for height increase during the first year of life. (more…)
Aging, Author Interviews, Disability Research, Lancet / 09.12.2015

MedicalResearch.com Interview with: Prof. Carol Jagger AXA Professor of Epidemiology of Ageing and Deputy Director of the Newcastle University Institute for Ageing (NUIA) Institute of Health & Society Campus for Ageing and Vitality Newcastle upon Tyne  Medical Research: What is the background for this study? Prof. Jagger: Although we know that life expectancy at older ages is increasing, there is still uncertainty about whether the extra years are healthy ones. Our results are based on data from the Cognitive Function and Ageing Studies (CFASI and II), two cohorts of people aged 65 years and over in three centres in England (Cambridgeshire, Newcastle and Nottingham) who were interviewed in 1991 and 2011. The participants, over 7000 people in each study, were recruited from general practices in the area and included those living in care homes to ensure our results reflect the total older population. Medical Research: What are the main findings? Prof. Jagger: We used three health measures to calculate the health expectancies at age 65: cognitive impairment, self-perceived health and disability (mild and moderate/severe). Over the 20 year period women’s life expectancy at age 65 increased by 3.6 years whilst they gained 4.4 years free of cognitive impairment, 3.1 years in good self-perceived health but only 0.5 years free of disability. Men on the other hand lived an extra 4.5 years in total with gains of 4.2 years free of disability, 3.8 years in good self-perceived health and 2.6 years free of disability. So all the extra years of life were free of cognitive impairment for women but most were spent with disability, although the gains were in mild rather than more severe disability. (more…)