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…)
Anemia, Author Interviews, Brigham & Women's - Harvard, JAMA, Transfusions / 07.12.2015

MedicalResearch.com Interview with: Dr. Walter H. Dzik MD Associate Pathologist, Massachusetts General Hospital Associate Professor of Pathology Harvard Medical School Medical Research: What is the background for this study? What are the main findings? Dr. Dzik: Millions of Red Blood Cell transfusions are given each year.  To maintain adequate blood inventories worldwide, Red Blood Cell units are stored under refrigerated conditions.  Previous animal and laboratory research has highlighted the fact that red cells undergo biochemical, morphologic, and biophysical changes during prolonged refrigerated blood storage.    Researchers and clnicians have questioned whether the changes that occur during storage would impair the ability of transfused Red Cells to delivery oxygen to tissues. Our study was a randomized controlled trial conducted in patients with extreme anemia and insufficient global tissue oxygenation.    We randomly assigned children with severe anemia and lactic acidosis to receive Red Blood Cells stored 1-10 days versus Red Blood Cells stored 25-35 days.   We measured the recovery from lactic acidosis in response to transfusion in the two groups.   We also measured cerebral tissue oxygenation using a non-invasive tissue oximeter.    We found that the proportion of patients who achieved reversal of lactic acidosis was the same in the two RBC storage-duration groups.   The rate of decline of lactic acidosis was also equal.   There was also no difference in cerebral oxygenation, resolution of acidosis, correction of vital signs, clinical recovery, survival and 30-day followup.    (more…)
Author Interviews, Biomarkers, Kidney Disease, University of Michigan / 07.12.2015

MedicalResearch.com Interview with: Wenjun Ju, Ph.D., M.S. Research Assistant Professor, Internal Medicine Matthias Kretzler, M.D. Professor, Internal Medicine, Nephrology Research Professor, Computational Medicine and Biology University of Michigan Health System  Medical Research: What is the background for this study? What are the main findings? Response: Chronic kidney disease (CKD) is a global health issue that affects approximately 15% of the global population.. While not all patients with CKD will progress to end-stage kidney disease (ESKD), those that do tend to advance quickly and require dialysis or kidney transplant. They are also at an increased risk of death from cardiovascular disease. According to the International Society of Nephrology, treatment of CKD, including medical management, dialysis and kidney transplant, is very costly.  In the U.S. alone, therapy for CKD is likely to exceed $48 billion per year, and the ESKD program consumes 6.7 percent of the total Medicare budget to care for less than 1 percent of the covered population. In China, the disease will cost the economy the equivalent of $558 billion in the U.S. over the next decade. Early identification of patients that are more likely to experience end-stage kidney disease is an urgent, unmet clinical need. Currently, kidney biopsy is required to determine diagnosis and prognosis of kidney disease. This procedure is costly, carries a low, but significant health risk, and has limited ability to predict the future course of kidney disease. Together with the European Renal cDNA Bank and the Peking University Institute of Nephrology, the University of Michigan team identified epidermal growth factor (EGF) as a promising candidate for prediction of kidney function loss while analyzing transcriptomic data derived from kidney tissue biopsies of CKD patients across Europe and the U.S. We then validated the findings in urine samples from more than 940 patients in North America, Europe and China, and found that a decrease in urinary EGF protein concentration is an early sign of diminishing kidney function and pinpoints the at-risk patient population. (more…)
Author Interviews, Breast Cancer, Cancer, Genetic Research / 07.12.2015

MedicalResearch.com Interview with: Dr. Jane E. Churpek, MD Assistant Professor of Medicine Co-Director, Comprehensive Cancer Risk and Prevention Program The University of Chicago Medicine Chicago, IL 6063 Medical Research: What is the background for this study? What are the main findings? Dr. Churpek:   We designed this study to try to understand whether damaging, inherited changes in genes known to cause an increased risk of breast cancer are common in those who develop leukemia after getting chemotherapy and/or radiation for treatment of breast cancer. Leukemias that occur in this setting are called “therapy-related.” This means that chemotherapy or radiation, or both, may have been involved in causing the leukemia.  This is an uncommon but serious complication of cancer treatment, and the factors that put women at risk for this complication are not well understood. We looked at the clinical histories of 88 such women. We found that most of them have relatives who also had cancer, suggesting they may be cancer-prone to begin with. Because we did not have a group of women who had similar breast cancer treatment and who did not get a therapy-related leukemia, we cannot definitively prove that more women with therapy-related leukemia than expected had these mutations. However, this study gives us reason to further study the role of these genes in therapy-related leukemia. (more…)
Author Interviews, Multiple Sclerosis / 07.12.2015

MedicalResearch.com Interview with: Dr. Vittorio Gallo PhD Center for Neuroscience Research Children’s Research Institute Children’s National Medical Center Washington, DC 20010 Medical Research: What is the background for this study? What are the main findings? Dr. Gallo: Astrocytes are cells in the central nervous system (CNS) that provide nutrients, recycle neurotransmitters, and help maintain homeostasis. In many neurodegenerative disorders – including multiple sclerosis  (MS) –astrocytes undergo a cellular and biochemical transformation called reactive gliosis. This process significantly impacts – both positively and negatively – neural regeneration. Reactive astrocytes (RAs) synthesize and release a peptide called Endothelin-1 (ET-1). Gallo and his team previously demonstrated that ET-1 is expressed at high levels by RAs in multiple sclerosis (MS) lesions and that – in animal models of MS – this peptide inhibits repair by delaying oligodendrocyte maturation and remyelination.  The main finding of the study published in Cell Reports is the identification of the cellular and molecular pathway that mediates the inhibitory effects of ET-1 on oligodendrocyte regeneration and remyelinaton in demyelinated lesions. In particular - by using pharmacological and genetic approaches - the study demonstrates that the ET-1 acts selectively through the ET-receptor B (ENDRB) on astrocytes - and not oligodendrocytes - to indirectly inhibit remyelination. (more…)
Author Interviews, Lancet, Multiple Sclerosis, Pharmacology, UCLA / 07.12.2015

MedicalResearch.com Interview with: Professor Rhonda Voskuhl, M.D. Jack H. Skirball Chair in MS Research Director of the UCLA MS Program David Geffen School of Medicine University of California, Los Angeles Medical Research: What is the background for this study? What are the main findings? Dr. Voskuhl: It had been known for decades that relapses were reduced during pregnancy in women with Multiple Sclerosis (MS), psoriasis and rheumatoid arthritis. We viewed this as a major clue to help find new disease modifying treatments. Focusing on MS, we investigated treatment with estriol, an estrogen that is made by the fetus/placenta during pregnancy. Preclinical studies and a pilot clinical trial at UCLA showed good results leading to the current Phase 2 clinical trial at 16 sites across the U.S. It showed that treatment with estriol pills compared to placebo pills, each in combination with standard of care (glatirmar acetate) injections, reduced relapses by one third to one half over and above standard of care treatment. (more…)
Author Interviews, Rheumatology, UCSF, Weight Research / 07.12.2015

MedicalResearch.com Interview with: Alexandra S. Gersing, MD Department of Radiology and Biomedical Imaging University of California, San Francisco Medical Research: What is the background for this study? What are the main findings? Dr. Gersing:  This study is part of a larger NIH-funded project focusing on the effects of weight change in individuals at risk for and with osteoarthritis. Our group has previously shown that weight gain causes substantial worsening of knee joint degeneration in patients with risk factors for osteoarthritis and now we aimed to show that weight loss could protect the knee joint from degeneration and osteoarthritis. Osteoarthritis is one of the major causes of pain and disability worldwide; and cartilage plays a central role in the development of joint degeneration. Since cartilage loss is irreversible, we wanted to assess whether lifestyle interventions, such as weight loss, could make a difference at a very early, potentially reversible stage of cartilage degradation and whether a certain amount of weight loss is more beneficial to prevent cartilage deterioration. To measure these early changes we used a novel Magnetic Resonance Imaging (MRI) technique, called T2 mapping, which allows us to evaluate biochemical cartilage degradation in the patient on a molecular level. The most relevant finding of this study is that patients with more that 10% of weight loss benefited significantly more from losing weight compared to the obese controls that did not lose weight or only lost little weight. (more…)
Author Interviews, Genetic Research, Weight Research / 06.12.2015

MedicalResearch.com Interview with: Ida Donkin MD, PhD Postdoc, Medical Doctor, PhD University of Copenhagen Faculty Of Health Sciences Copenhagen, Denmark Medical Research: What is the background for this study? Dr. Donkin: We know that children of obese fathers are more prone to develop obesity themselves – regardless of the weight of the mother. We also know that obesity and diabetes are diseases with a very big inheritable components in their aetiology. If your parents are obese, you have a risk of about 75% percent of developing obesity yourself. But we do not know how the disease is inherited from one generation to the next. Despite exhaustive research trying to investigate genes potentially responsible for this, and more than 125 genetic mutations have been discovered to associate to the development of obesity, all the genetic mutations put together cannot explain more than about 10% of the actual inheritance. So how is obesity inherited from parents to children? One explanation could be the transfer of epigenetic information from one generation to the next. Epigenetic information is established in our body’s cells in response to our lifestyle and the environment around us. We discovered that the epigenetic factors of semen cells also responds to changes in our lifestyle, and we speculated whether these might be the key to understand how obesity in dads can lead to obesity in children. Medical Research: What are the main findings? Dr. Donkin: In this study we discovered that the information kept in our semen cells responds dynamically to changes in our lifestyle. If you are obese, your semen cells will contain a different epigenetic pattern than if you are lean. Weight loss induced by gastric bypass surgery will dynamically change these epigenetic patterns, meaning that by changing our lifestyle, we can actively change the epigenetic information we pass on to our children. Other research groups have created solid evidence showing us that most these epigenetic marks kept in the sperm cells will be passed on to the embryo at fertilization. The epigenetic information can affect the development of the embryo, and thereby change the health – and the risk of disease – of our children. Our study thus provides a likely explanation for the mechanism of the inheritance of acquired traits and diseases through generations, and gives us a likely explanation as to why children of obese fathers are more prone to develop obesity themselves. (more…)
Author Interviews, Colon Cancer, Cost of Health Care, Health Care Systems, Outcomes & Safety, Surgical Research / 06.12.2015

MedicalResearch.com Interview with: Johannes Govaert MD Department of Surgery Leiden University Medical Center Leiden, The Netherlands Medical Research: What is the background for this study? Dr. Govaert: The Value Based Health Care agenda ofPprof. Porter (Harvard Business School) suggests that focus in healthcare should shift from reducing costs to improving quality: where quality of healthcare improves, cost reduction will follow. One of the cornerstones of potential cost reduction, as mentioned by Porter, could be availability of key clinical data on processes and outcomes of care. Despite the important societal and economical role the healthcare system fulfils, it still lags behind when it comes to standardised reporting processes. With the introduction of the Dutch Surgical Colorectal Audit (DSCA) in 2009, robust quality information became available enabling monitoring, evaluation and improvement of surgical colorectal cancer care in the Netherlands. Since the introduction of the DSCA postoperative morbidity and mortality declined. Primary aim of this study was to investigate whether improving quality of surgical colorectal cancer care, by using a national quality improvement initiative, leads to a reduction of hospital costs. Detailed clinical data was obtained from the 2010-2012 population-based Dutch Surgical Colorectal Audit. Costs at patient-level were measured uniformly in all 29 participating hospitals and based on Time-Driven Activity-Based Costing. Medical Research: What are the main findings? Dr. Govaert: Over three consecutive years (2010-2012) severe complications and mortality after colorectal cancer surgery respectively declined with 20% and 29%. Simultaneously, costs during primary admission decreased with 9% without increase in costs within the first 90 days after discharge. Moreover, an inverse relationship (at hospital level) between severe complication rate and hospital costs was identified among the 29 participating hospitals. Hospitals with increasing severe complication rates (between 2010 and 2012) were associated with increasing costs whereas hospitals with declining severe complication rates were associated with cost reduction. (more…)
Accidents & Violence, Author Interviews / 06.12.2015

MedicalResearch.com Interview with: Professor Ajai Singh Department of Orthopaedic Surgery King George's Medical University India  Medical Research: What is the background for this study? Prof. Singh: Road traffic accidents (RTAs), in the current scenario, have taken the form of an epidemic. Developing countries are presently showing an increasing trend with respect to the number of vehicles and population. Personality characteristics are becoming a significant contributor in RTAs, owing to rising stress levels and varying circumstances. In developing countries, most of the RTAs occur in urban regions and pedestrians, passengers, and motorcyclists collectively constitute around 90% of deaths. We, therefore, conducted this study in order to evaluate the patterns of various personality characteristics in patients suffering from nonfatal orthopedic injuries as a result of Road traffic accidents and attending a tertiary care center, with special focus on motorcyclists. Medical Research: What are the main findings? Prof. Singh: Most of the accidental injuries are faced by motorized two wheeler drivers of younger age. This is probably due to the fact that we are a developing nation with a huge population having motorized two wheeler vehicles as a major means of private transport. Also, these motorized two wheelers have a low safety profile that makes their riders more prone to accident. Amongst all the motorcyclists encountering road traffic accidents, impulsive personality trait is found in 85.19% and histrionic trait was found in 82.72% of cases. (more…)
Author Interviews, Lifestyle & Health, PLoS / 06.12.2015

MedicalResearch.com Interview with: Ding Ding (Melody), Ph.D., MPH NHMRC Early Career Senior Research Fellow Sydney University Postdoctoral Research Fellow Prevention Research Collaboration Sydney School of Public Health The University of Sydney  Medical Research: What is the background for this study? What are the main findings? Response:  The study followed a large sample (around 200,000) of Australian adults aged 45 or older. Participants reported their lifestyle behaviours (smoking, excessive alcohol use, physical inactivity, unhealthy diet, prolonged sitting, short/long sleep duration) at baseline (2006-2009) and were followed up for around 6 years (up to June 2014). Based on linked administrative data (death records), we found a clear relationship between the total number of lifestyle risk behaviours and the risk of mortality---the more risk behaviours, the higher risk for mortality. This pattern of associations was consistent in men and women, participants in different age groups, of different socioeconomic status, and with and without major chronic disease. Certain behavioural risk factors have synergistic associations with mortality and appear more harmful together than individually. For example, if people only sit for long hours (defined as >7 hours a day), without having other co-occurring risk behaviours, the risk for mortality was only elevated by 15%, and if people are only physically inactive without having other co-occurring risk behaviours, the risk for mortality was elevated by 60%. However when the two risk factors were combined, say if one is not physically active AND sit for long hours, the combined risk has become much larger (increased by 140%, compared with those with zero risk behaviours).  Similarly, the combination of smoking and excessive alcohol use appeared a lot more “deadly” than the two risk factors alone. (more…)