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…)
Author Interviews, Dermatology, Telemedicine / 09.12.2015

MedicalResearch.com Interview with: Mirna Becevic, PhD, MHA Assistant Research Professor of Telemedicine University of Missouri - Department of Dermatology Missouri Telehealth Network  Medical Research: What is the background for this study? What are the main findings? Dr. Becevic: The Missouri Telehealth Network (MTN) at the University of Missouri has been providing outpatient clinical services to rural Missourians since 1995.  Over 29 specialties and subspecialties have been utilized to assist patients in 69 counties. We have learned a lot along the way, what works well and what does not, in terms of telehealth protocols, trainings, best practices, etc. The MTN holds bi-annual two day training conference for new sites to share these experiences and provide hands-on training in telemedicine.  Our main goal with this study was to reach all telehealth users on the Missouri Telehealth Network (patients, providers, and telehealth coordinators-patient presenters) and learn about their perceptions of and opinions regarding this form of health care delivery.  We also wanted to evaluate the overall accessibility and discernment of the MTN by telehealth coordinators, since we felt that they might need to have continuous support in order to successfully manage their telehealth programs. Our main findings indicated that all three surveyed groups had high satisfaction with telemedicine.  Patients were confident in their doctors’ medical skills, and lack of physical contact was not viewed as a barrier. Telehealth providers thought telehealth was an effective tool for providing care at a distance, but indicated that they did not prefer telehealth over in-person visits. (more…)
Anesthesiology, Author Interviews, Emergency Care, Pain Research / 09.12.2015

MedicalResearch.com Interview with: Michael D. April, MD, DPhil Department of Emergency Medicine San Antonio Uniformed Services Health Education Consortium San Antonio, TX  Medical Research: What is the background for this study? What are the main findings? Dr. April: Anesthesia research studies have found that nasal inhalation of isopropyl alcohol has efficacy in treating nausea among post-operative patients. We sought to study this agent among Emergency Department patients with nausea or vomiting. We found that patients randomized to inhale isopropyl alcohol had improved self-reported nausea scores compared to patients randomized to inhale saline (placebo). MedicalEditor's note:  Do Not Do This Without Medical Supervision! (more…)
Author Interviews, Lifestyle & Health, Nutrition, UCSF / 09.12.2015

MedicalResearch.com Interview with: Maria T. Chao, DrPH, MPA Assistant Professor of Medicine Osher Center for Integrative Medicine & Division of General Internal Medicine - SFGH UCSF San Francisco, CA 94143-1726 Medical Research: What is the background for this study? What are the main findings? Dr. Chao: Many Americans use complementary and integrative health (CIH) approaches to help them manage the symptoms of chronic diseases. To date, most of these treatments are only available in outpatient clinics. In this study, we asked oncology inpatients which of 12 different CIH approaches they currently use or have tried in the past, and also which approaches they would like to be available in the hospital. We found that 95% of patients had tried at least one  complementary and integrative health approach in the past, and that a similarly high number were interested in accessing these services as an inpatient. More than three quarters of our sample expressed interest in receiving nutritional counseling and massage during their hospital stay, and approximately half were interested in acupuncture, biofeedback, and mindfulness meditation. (more…)
Author Interviews, BMJ, Cost of Health Care, Diabetes, Mayo Clinic / 09.12.2015

MedicalResearch.com Interview with: Rozalina G. McCoy, M.D. Senior Associate Consultant Division of Primary Care Internal Medicine Assistant Professor of Medicine Mayo Clinic Medical Research: What is the background for this study? What are the main findings? Dr. McCoy: Blood glucose monitoring is an integral component of managing diabetes.  Glycosylated hemoglobin (HbA1c) is a measure of average glycemia over approximately 3 months, and is used in routine clinical practice to monitor and adjust treatment with glucose-lowering medications.  However, monitoring and treatment protocols are not well defined by professional societies and regulatory bodies; while lower thresholds of testing frequencies are often discussed, the upper boundaries are rarely mentioned.  Most agree that for adult patients who are not using insulin, have stable glycemic control within the recommended targets, and have no history of severe hypoglycemia or hyperglycemia, checking once or twice a year should suffice. Yet in practice, there is a much higher prevalence of excess testing.  We believe that such over-testing results in redundancy and waste, adding unnecessary costs and burdens for patients and the health care system. We therefore conducted a large retrospective study among 31,545 adults across the U.S. with stable and controlled type 2 diabetes who had HbA1c less than 7% without use of insulin and without documented severe hypoglycemia or hyperglycemia.  We found that 55% of patients had their HbA1c checked 3-4 times per year, and 6% had it checked 5 times a year or more.  Such excessive testing had additional harms as well – we found that excessive testing was associated with greater risk of treatment intensification despite the fact that all patients in the study already met glycemic targets by having HbA1c under 7%.  Indeed, treatment was intensified by addition of more glucose lowering drugs or insulin in 8.4% of patients (comprising 13%, 9%, and 7% of those tested 5 or more times per year; 3-4 times per year; and 1-2 times per year, respectively). (more…)
Author Interviews, Breast Cancer, Chemotherapy, Immunotherapy / 09.12.2015

MedicalResearch.com Interview with: Professor Michael Gnant, M.D., FASC Director and Chairman Department of Surgery President, Austrian Breast&Colorectal Cancer Study Group Head, Breast Health Center Vienna Comprehensive Cancer Center Vienna Medical University of Vienna - Department of Surgery Austria Medical Research: What is the background for this study? What are the main findings? Response: The background of this presentation is as follows: For many years, we have seen intriguing - but also sometimes conflicting - results of trials using adjuvant bone-targeted therapy. ABCSG-18 is a placebo-controlled trial of adjuvant denosumab 60mg twice yearly, and I have been able to present to you at this year’s ASCO meeting the dramatic reduction in clinical fractures which was the primary end point of the trial. We have also showed that twice yearly denosumab can be administered without added toxicity in this double-blind placebo-controlled trial. These results were as well published in the Lancet earlier this year. The obvious question remaining now is whether adjuvant treatment with the anti-RANK ligand antibody also improves outcomes in a way similar to what bisphosphonates do. Main findings of ABCSG-18: disease-free survival results of the intention-to-treat analysis: In the placebo group, we observed 203 DFS events. In the denosumab group, there were 167 DFS events, resulting in a hazard ratio of 0.816, indicating an 18% relative DFS improvement by denosumab. In terms of absolute differences, the benefit was 1.2% at 3 years, 2.1% at 5 years, and 3.1% at 7 years. (more…)
Annals Internal Medicine, Author Interviews, Dermatology, Gastrointestinal Disease, Immunotherapy / 09.12.2015

MedicalResearch.com Interview with: Isabelle Cleynen  PhD University of Leuven  Medical Research: What is the background for this study? What are the main findings? Dr. Cleynen : Ulcerative colitis and Crohn’s disease, together inflammatory bowel disease (IBD), are characterized by chronic inflammation of the gastrointestinal tract. Treatment for IBD usually involves drug therapy including anti-inflammatory drugs and immune system repressors, amongst which biologics as the anti-TNF antibodies used for patients with moderate to severe IBD. Although these TNF-blocking drugs are effective in many patients with immune-mediated disorders like psoriasis, rheumatoid arthritis and spondylarthropathies, and IBD, several case reports and series showed that some patients developed troubling skin problems (including psoriasis and eczema), causing them to stop the anti-TNF treatment. It is however not clear how often these skin problems develop in IBD patients treated with anti-TNF, and what could be the predisposing factors. In a retrospective cohort of 917 IBD patients initiated on anti-TNF therapy in a single center, we have studied which patients did and did not develop skin problems, what type of skin problems, how they were treated, and whether the lesions resolved upon treatment. We found that about one third of the patients developed skin problems while being treated with anti-TNF drugs. The most common type was psoriasiform eczema, often occurring in flexural regions, the scalp, and genitalia. The time between starting the TNF-blocking drug and the appearance of the skin problem varied from less than half a year to more than 4 years. Quite surprisingly, we found that the cumulative dose of the treatment, or drug serum levels were not different in skin and non-skin lesion patients. Skin lesion patients however seemed to be younger when diagnosed with IBD and when started on anti-TNF agents, more often had anti-nuclear and dsDNA antibodies (both auto-immune factors), and a higher number of skin-disease related genetic risk variants. Most patients had a good response to treatment of their skin problem. About 10% of the patients who developed skin problems, however, stopped the TNF-blocking treatment because of this issue. (more…)
Author Interviews, Depression, Education, JAMA / 09.12.2015

MedicalResearch.com Interview with: Douglas A. Mata, M.D., M.P.H. Anatomic and Clinical Pathology Resident Physician, Brigham & Women’s Hospital Clinical Fellow, Harvard Medical School Boston, MA 02115 Marco A. Ramos, M.Phil., M.S.Ed. History of Science and Medicine M.D./Ph.D. Candidate, Yale School of Medicine New Haven, CT 06511 Medical Research: What is the background for your study? Dr. Mata: Training to be a doctor is clearly stressful, but the prevalence of depression among trainees is not well known. They may get especially depressed during their grueling years of residency, when young physicians are learning their craft by working long hours and taking care of critically ill patients. Coming up with a reliable estimate of the prevalence of depression among graduate medical trainees would help us identify causes of resident depression and begin to treat or prevent it. We thus aimed to find answers to two questions:
  • First, what percentage of new doctors might be depressed?
  • Second, how much has that changed over time?
Medical Research: What are the main findings? Dr. Mata: We set out to find every study ever published on this subject. We analyzed 50 years of research on depression in resident physicians. We collected and combined data from 54 studies conducted around the world, and found that a startling 29% of physicians in training have signs of depression. We also detected a small but significant increase in the prevalence of depression over the five decades the study covered. Mr. Ramos: Twenty-nine percent is a concrete number you can hang your hat on, so to speak. But this number alone doesn’t capture the extent of the problem. We conducted additional studies that revealed that up to 43% of residents have depressive symptoms. (more…)
Author Interviews, Education, JAMA / 09.12.2015

MedicalResearch.com Interview with: Henry Sondheimer, MD Senior director of student affairs American Association of Medical Colleges Medical Research: What is the background for this study? What are the main findings? Dr. Sondheimer: The background for this study in JAMA's Med Ed issue of December 8th is that a group of the medical schools' deans asked us (AAMC staff) in 2014 whether there was a differential in placement of African-American, Hispanic, and Native American graduates into Graduate Medical Education at the time of their graduation from medical school. In fact, as shown in this short paper, there is a difference with more current graduates from the under-represented in medicine graduates not beginning their GME immediately post-graduation. However, over time this difference diminishes substantially but does not disappear completely. (more…)
Author Interviews, Cancer Research, Chemotherapy, Hematology, Immunotherapy / 09.12.2015

MedicalResearch.com Interview with: Dr. Ajai Chari MD Associate Professor Medicine, Hematology and Medical Oncology Tisch Cancer Institute Mount Sinai School of Medicine New York, NY Medical Research: What is the background for this study? Dr. Chari: This is a heavily pretreated population where the median progression free survival (PFS) of the pomalidomide dexamethasone is only 4 months and ORR is only 31%. While the anti CD38 monoclonal antibody daratumumab has single agent has activity in this setting, patients with rapidly progressive disease need combination therapy to achieve rapid and deep responses. Pomalidomide also upregulates CD38 on MM cells and like daratumumab, increases the effector cell activity against myeloma. Thus, there is a strong preclinical and clinical rationale for combining daratumumab with pomalidomide and dexamethasone. (more…)
Author Interviews, Flu - Influenza, Pharmacology, Pulmonary Disease / 09.12.2015

MedicalResearch.com Interview with: Dr. Irene Braithwaite Deputy Director Medical Research Institute of New Zealand Wellington NZ Medical Research: What is the background for this study? What are the main findings? Dr. Braithwaite: We know from animal models that the reduction of fever is associated with an increased risk of dying from influenza. We also know that some influenza viruses cannot replicate well in the human febrile range (38 to 40 Celsius). Yet, guidelines on the management of community acquired influenza infection in humans is to rest, maintain hydration and to take antipyretics such as paracetamol on the basis that this may help and is unlikely to cause harm. We undertook this study to see whether using regular paracetamol during influenza infection might be harmful, as it may allow the influenza virus to replicate more readily, and increase and/or prolong symptoms. To the best of our knowledge, this is the first randomised controlled trial comparing the effects of regular paracetamol (1gram four times daily for five days) versus placebo in human adults infected with influenza. We found that there was no difference in influenza viral loads, temperature or influenza symptoms between the regular paracetamol group and placebo group. (more…)
Author Interviews, BMJ, Depression / 08.12.2015

MedicalResearch.com Interview with: Halle Amick, research associate Sheps Center for Health Services Research University of North Carolina at Chapel Hill Chapel Hill, NC Medical Research: What is the background for this study? What are the main findings? Response: Major depressive disorder (MDD) affects more than 32 million Americans and millions more worldwide. Many patients first seek care from a primary care provider, and the most common treatment initiated in that setting is medication. Although there is an evidence base that shows certain psychotherapies to be effective treatments, primary care providers may not be familiar enough with psychotherapy to present it as a treatment option. We conducted a full review of clinical trials that compared antidepressant medication—specifically second-generation antidepressants (SGAs)—with cognitive behavioral therapy (CBT). We found that symptom improvement and rate of remission were similar between SGAs and CBT, whether they were used alone or in combination with each other. We also found no difference in the rates of withdrawal from the clinical trials either overall or due to adverse events. (more…)
Author Interviews, Chemotherapy, Leukemia / 08.12.2015

MedicalResearch.com Interview with: Jeffrey Tyner, Ph.D. Assistant Professor in Cell, Developmental and Cancer Biology at the Oregon Health & Science University School of Medicine and researcher and OHSU Knight Cancer Institute Stephen Kurtz, Ph.D. Research Assistant Professor at the Oregon Health & Science University School of Medicine Leukemia Center and researcher OHSU Knight Cancer Institute What is the background for this study? What are the main findings?  Dr. Tyner: This study was one of many resulting from the ‘Beat AML’ initiative. Acute myeloid leukemia (AML) is a complex form of leukemia; less than 25 percent of newly diagnosed AML patients survive beyond five years. Led by the Knight Cancer Institute at Oregon Health & Science University and The Leukemia & Lymphoma Society (LLS), Beat AML brings together academic health centers and biopharmaceutical companies to accelerate discoveries to improve outcomes for patients with acute myeloid leukemia. In this study, by using a unique method to test drugs used together, we identified drug combinations that are active against leukemia cells in a patient-specific manner. (more…)
Author Interviews, Education, Electronic Records, JAMA / 08.12.2015

MedicalResearch.com Interview with: David Ouyang MD Department of Internal Medicine Stanford University School of Medicine Stanford, California Medical Research: What is the background for this study? What are the main findings? Dr. Ouyang: In American teaching hospitals, trainee resident physicians are an integral part of the medical team in performing procedures, writing notes, and coordinating care. As more care is being facilitated by electronic medical record (EMR) systems, we are just now finally able to understand how much residents work and how residents spend their time. In our study, we examined the types and timing of electronic actions performed on the EMR system by residents and found that residents spend about a third (36%) of their day in front of the computer and frequently perform many simultaneous tasks across the charts of multiple patients. Additionally, residents often do work long hours, with a median of 69.2 hours per week when on the inpatient medicine service. (more…)
Author Interviews, Duke, Heart Disease, JACC, Kidney Disease / 08.12.2015

MedicalResearch.com Interview with: Daniel Friedman, MD Cardiology Fellow Duke University Hospital Durham, North Carolina MedicalResearch: What is the background for this study? What are the main findings? Dr. Friedman: Cardiac resynchronization therapy (CRT) has been demonstrated to reduce heart failure hospitalizations, heart failure symptoms, and mortality in randomized clinical trials. However, these well-known trials either formally excluded or did not report enrollment of patients with more advanced chronic kidney disease (CKD), which we defined as a glomerular filtration rate of <45ml/minute. Since advanced CKD has been associated with an increased risk of adverse outcomes among patients with a variety of pacemakers and defibrillators, many have questioned whether the risks of CRT may outweigh the benefits in this population. Furthermore, many have hypothesized that the competing causes of morbidity and mortality among advanced CKD patients who meet criteria for CRT may mitigate clinical response and net benefit. Our study assessed the comparative effectiveness of CRT with defibrillator (CRT-D) versus defibrillator alone in CRT eligible patients with a glomerular filtration rate of <60ml/minute (Stage III-V CKD, including those on dialysis). We demonstrated that CRT-D use was associated with a significant reduction in heart failure hospitalization or death in the overall population and across the spectrum of CKD. The lower rates of heart failure hospitalization or death was apparent in all subgroups we tested except for those without a left bundle branch block. Importantly, we also demonstrated that complication rates did not increase with increasing severity of CKD. (more…)
Author Interviews, Cleveland Clinic, Emergency Care, JAMA, Stroke, Telemedicine / 08.12.2015

MedicalResearch.com Interview with: Ken Uchino, MD FAHA FANA Director, Vascular Neurology Fellowship Research Director, Cerebrovascular Center, Cleveland Clinic Associate Professor of Medicine (Neurology) Cleveland Clinic Lerner College of Medicine of CWRU Cleveland, OH 44195 Medical Research: What is the background for this study? What are the main findings? Dr. Uchino: Treatment for acute ischemic stroke is time dependent. Multiple studies have reported strategies to improve time to treatment after arrival in the hospital. Mimicking pre-hospital thrombolysis of acute myocardial infarction pioneered 30 years ago, two groups in Germany have implemented pre-hospital ischemic stroke thrombolysis using mobile stroke unit (“stroke ambulance”) that includes CT scan and laboratory capabilities. These units have been demonstrated to provide stroke treatment earlier than bringing patients to the emergency departments. Our report extends the concept mobile stroke unit further by using telemedicine for remote physician presence. The other mobile stroke units were designed to have at least one physician on board. This allows potential multiple or geographically distant units to be supported by stroke specialists. The study demonstrates that after patient arrival in the ambulance, the time to evaluation (CT scanning and blood testing) and to thrombolytic treatment is as quick or better as patient arrival in emergency department door. We are reporting the overall time efficiency after emergency medical service notification (911 call) in a separate paper. (more…)
Author Interviews, Melanoma, Pharmacology / 07.12.2015

MedicalResearch.com Interview with: Jeff Legos Senior Vice President Global Program Head Novartis Oncology Medical Research: What is the background for this study? What are the main findings? Response: Melanoma is the most serious form of skin cancer, and in recent years, research has discovered that melanoma is a diverse disease. In metastatic melanoma, approximately half of all patients have a mutation in the BRAF gene, and genetic testing can identify whether BRAF mutations are present in a tumor. Identifying a mutation can help doctors determine the appropriate treatment to treat BRAF-positive melanoma. Since January 2014, the combination of Tafinlar + Mekinist has been approved for use in the US in patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma as detected by an FDA-approved test. The combination was initially approved based on Phase II data through the FDA’s Accelerated Approval program and reviewed under a priority review designation. The approval was contingent on the results of the Phase III COMBI-d study, which was designed to evaluate the clinical benefit of the combination in patients with unresectable or metastatic melanoma with a BRAF V600E/K mutation. The regular approval is based on survival data from two Phase III studies: COMBI-d and COMBI-v. These studies showed that Tafinlar + Mekinist demonstrated statistically significant overall survival (OS) and progression-free survival (PFS) compared with dabrafenib or vemurafenib, in patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma. In addition, combination use of Tafinlar + Mekinist in patients with unresectable or metastatic melanoma who have a BRAF V600 mutation is approved in the EU, Australia, Canada and additional countries. (more…)