Author Interviews, Health Care Systems / 25.10.2016

MedicalResearch.com Interview with: Julie M. Kapp, MPH, PhD, FACE Associate Professor 2014 Baldrige Executive Fellow University of Missouri School of Medicine Department of Health Management and Informatics Columbia, MO 65212 MedicalResearch.com: What is the background for this study? What are the main findings? Response: The United States lags behind its high-income peer countries on a number of critical health outcomes, including life expectancy, and this gap has been widening for the last several decades. The 2010 Patient Protection and Affordable Care Act (ACA) created a number of provisions to try to address this, including an emphasis on a systems-engineering approach to health care services. In addition to the ACA, there is a growing movement toward collective impact among community-based organizations. However, despite this focus, U.S. health and health care activities are often uncoordinated and fragmented. We applied a systems-thinking approach to U.S. population health. We used the Malcolm Baldrige Framework for Performance Excellence as the unifying conceptual systems-thinking approach. In addition to this proposed framework, we make two critical recommendations: 1) the need to drive a strategic outcomes-oriented, rather than action-oriented, approach by creating an evidence-based national reporting dashboard; and 2) improve the operational effectiveness of the workforce. (more…)
Author Interviews, Cancer Research, JAMA, Smoking / 24.10.2016

MedicalResearch.com Interview with: Joannie Lortet-Tieulent MSc Senior Epidemiologist American Cancer Society, Inc. Atlanta, GA 30303 MedicalResearch.com: What is the background for this study? Response: Many tobacco control policies are decided at state level. We have known for some times that some states have pioneered tobacco control, or have implemented strong tobacco control or programs. Meanwhile, in other states, tobacco control and programs can be weaker. Also, some states have large populations with low socioeconomic status, among which smoking prevalence is higher. We were interested in how those state-level differences impact people’s health. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, JAMA / 24.10.2016

MedicalResearch.com Interview with: Anna D. Sinaiko, PhD, MPP Research Scientist Department of Health Policy & Management Harvard T.H. Chan School of Public Health Boston, MA 02115 MedicalResearch.com: What is the background for this study? What are the main findings? Response: One strategy for reducing health care spending in the U.S. is to increase transparency in health care pricing for patients. The idea is that patients can learn about and anticipate the prices they would pay for health care before they receive care, and incorporate that information into their choices about whether and where to receive care. When patients incorporate price information into their decisions, it gives providers an incentive to compete on price and quality. There has been a dramatic increase in the availability of health care price information over the last few years for patients who have commercial health insurance, primarily through web-based tools. In this study, we examined the impact of this information on patient choice of health care facility. We find that a small number of enrollees with commercial health insurance through Aetna, 3% overall, accessed price information through their transparency tool. Among users of the tool, patients who viewed price information for imaging services and for sleep studies before they had the service chose facilities with lower prices, and incurred lower spending (of 12%) for imaging services. We found no effect on patient choices for patients who viewed price information for 6 other health care services (carpal tunnel release, cataract/lens procedures, colonoscopy, echocardiogram, mammograms, and upper gastrointestinal endoscopy). (more…)
Author Interviews, Brain Injury, JAMA, Pediatrics / 24.10.2016

MedicalResearch.com Interview with: Roger Zemek, MD, FRCPC Associate Professor, Dept of Pediatrics and Emergency Medicine, Clinical Research Chair in Pediatric Concussion University of Ottawa Director, Clinical Research Unit Children’s Hospital of Eastern Ontario Ottawa, ON MedicalResearch.com: What is the background for this study? Response: Concussion remains a major public health concern in children. Approximately 30% of affected children experience persistent post-concussive symptoms (PPCS) for at least one month post-injury. These symptoms may negatively impact their health related quality of life. Examples may include cognition, memory and attention affecting school attendance and performance, mood and social engagement, as well as physical performance. Prior to this study, there was little evidence that examined the relationship between PPCS and quality of life following concussion. This was important to better understand in order to provide appropriate interventions, expectation management and ultimately a better standard of care to affected patients and their families. (more…)
Author Interviews, Columbia, JAMA, OBGYNE, Stroke / 24.10.2016

MedicalResearch.com Interview with: Eliza Miller, M.D. Vascular Neurology Fellow New York-Presbyterian Hospital/Columbia University Medical Center We collaborated with researchers at the Massachusetts General Hospital and with the New York State Department of Health. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prior research has found that older women of childbearing age are at higher risk of stroke during pregnancy and postpartum than younger women. We hypothesized that their increased stroke risk might not be due to pregnancy-related factors, but just due to the fact that stroke risk increases with age for all people. We used billing data from New York State hospitals to calculate incidence risk ratios for four age groups: 12-24, 25-34, 35-44 and 45-55. In each age group, we compared the incidence of stroke in women who were pregnant or postpartum to the incidence of stroke in women of the same age who were not pregnant. As in prior studies, we found that the incidence of pregnancy-associated stroke was higher in older women compared to younger women (about 47/100,000 deliveries in the oldest group, versus 14/100,000 deliveries in the youngest group). However, the incidence ratios showed that pregnancy increased stroke risk significantly in women under 35, but did not appear to increase stroke risk in women over 35. In the youngest group (age 12-24), pregnancy more than doubled the risk of stroke, and in the 25-34 age group, pregnancy increased stroke risk by 60%. In women aged 35 and older, pregnancy did not increase stroke risk. Women who had pregnancy-related strokes tended to have fewer traditional vascular risk factors like hypertension and diabetes, compared to same-aged women with non-pregnancy related strokes. (more…)
Author Interviews, Neurological Disorders, Pulmonary Disease / 24.10.2016

MedicalResearch.com Interview with: Paolo Prandoni, M.D., Ph.D. and Department of Cardiovascular Sciences Vascular Medicine Unit University of Padua, Padua Sofia Barbar, M.D Department of Internal and Emergency Medicine Civic Hospital of Camposampiero Camposampiero MedicalResearch.com: WhaWhat are the main findings? Response: Syncope is defined as a sudden loss of consciousness due to transient global cerebral hypoperfusion characterized by rapid onset, short duration, and spontaneous complete recovery. According to the most recent guidelines, syncope can be classified as neurally-mediated, due to orthostatic hypotension and cardiovascular. Syncope is frequent in general population and represents up to 2% of all attendances in Emergency Department in Europe. The initial approach is unable to identify a plausible cause for syncope in 25-30% of cases and approximately 40% of syncope referred to an Emergency Department is then admitted to the hospital. Pulmonary embolism (PE) is an obstruction in the pulmonary arteries interfering with both blood circulation and gas exchange and therefore representing a potentially life-threatening event. Clinical features of PE are extremely variable. Available guidelines on syncope management consider PE as an infrequent cardiovascular cause of syncope. However, the true prevalence of pulmonary embolism in syncope-patients it is actually unknown. Moreover a workup for PE diagnosis in these patients is not suggested in the current guidelines. (more…)
Author Interviews, Gastrointestinal Disease / 22.10.2016

MedicalResearch.com Interview with: Christopher V. Almario, MD, MSHPM Assistant Professor of Medicine Division of Digestive and Liver Diseases, Cedars-Sinai Medical Center Cedars-Sinai Center for Outcomes Research and Education Los Angeles, CA MedicalResearch.com: What is the background for this study? Response: Recent drug approvals have increased the availability of biologic therapies for inflammatory bowel disease (IBD). However, the growing number of biologics has also made it more difficult for both patients and healthcare providers to navigate treatment options and to ultimately choose the most appropriate therapy. In this study, we wanted to examine patient decision-making surrounding IBD biologic therapies using conjoint analysis, which is a form of tradeoff analysis that determines how respondents make complex decisions by presenting them with competing product profiles. Here, we quantified the relative importance of 9 biologic therapy attributes (e.g., how the medicine works, how the medicine is received, long-term effectiveness, side-effect profile, etc.) in the decision-making process. (more…)
Author Interviews, Bipolar Disorder, Mental Health Research, Pediatrics, Schizophrenia / 21.10.2016

MedicalResearch.com Interview with: Merete Nordentoft DrMSc Professor, chief Psychiatrist University of Copenhagen Mental Health Centre Copenhagen MedicalResearch.com: What is the background for this study? Response: We knew that children born to parents with mental illness had an increased risk for developing a mental disorder them selves, either the same disorder as their parent or another menal disorder. We also knew that some of these children would have pootrt motor function and other difficulties in functioning. However previous studies were smaller, they were not based on a representative sample, and children were at different age. That is the background for The Danish High Risk and Resilience Study-VIA 7, in which a large group of 522 children and their families were thoroughly assessed. The children were seven year old, and 202 had a parent who had schizophrenia, 120 had a parent with bipolar disorder and 200 had parent with neither of these disorders. (more…)
Author Interviews, NEJM, Prostate Cancer / 21.10.2016

MedicalResearch.com Interview with: Professor Jenny Donovan OBE FMedSci NIHR-SI AcSS FFPHM Director, NIHR CLAHRC West (National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West) at University Hospitals Bristol NHS Trust Lewins Mead, Bristol Professor of Social Medicine School of Social and Community Medicine University of Bristol  MedicalResearch.com: What is the background for this study? What are the main findings? Response: PSA testing identifies many men with prostate cancer, but they do not all benefit from treatment. Surgery, radiation therapy and various programs of active monitoring/surveillance can be given as treatments for fit men with clinically localized prostate cancer. Previous studies have not compared the most commonly used treatments in terms of mortality, disease progression and patient-reported outcomes. In the ProtecT study, we used a comprehensive set of validated measures, completed by the men at baseline (before diagnosis), at six and 12 months and then annually for six years. The main finding is that each treatment has a particular pattern of side-effects and recovery which needs to be balanced against the findings from the paper reporting the clinical outcomes (Hamdy et al). (more…)
Author Interviews, Genetic Research, Menopause / 21.10.2016

MedicalResearch.com Interview with: Carolyn J. Crandall, MD, MS, FACP Professor of Medicine David Geffen School of Medicine at University of California, Los Angeles UCLA Medicine/GIM Los Angeles, California MedicalResearch.com: What is the background for this study? What are the main findings? Response: Scientists have suspected that genes may contribute to the risk of getting hot flashes and night sweats, but studies so far have been few in number and only focused on small parts of the human gene code (for example, the gene coding for estrogen receptors). No study has ever comprehensively sampled gene variations that span the entire human genome to look for associations between genetic variation and risk of hot flashes and night sweats. This was the first study of its kind, performed in more than 17.000 postmenopausal women participating in the Women’s Health Initiative Study. We examined 11,078,977 single-nucleotide polymorphisms, or SNPs, which are gene variants, in a genome-wide association study. Our main results were that 14 gene variants (SNPs) that were significantly associated with increased risk of having hot flashes. All of these variants were located in chromosome 4, in the gene that codes for the tachykinin receptor 3. (more…)
Author Interviews / 21.10.2016

MedicalResearch.com Interview with: Richard Eugene Frye MD Child Neurologist and Director of Autism Research Arkansas Children's Hospital Research Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: The study is a 12-week double-blind placebo-control clinical trial of folinic acid on improve core and associated symptoms of autism. We found that children that received folinic acid demonstrated significantly more improvement in verbal communication and behavior as compared to those children that received the placebo. In addition we found that a specific blood biomarker called the folate receptor alpha autoantibody predict response to the treatment. (more…)
Author Interviews, ESMO, Immunotherapy, Lung Cancer / 21.10.2016

MedicalResearch.com Interview with: Shirish Gadgeel, MD Leader of the Thoracic Oncology Multidisciplinary team Professor at Karmanos Cancer Institute Detroit MedicalResearch.com: What is the background for this study? What are the main findings? Response: LUX-Lung 7 is the first global, head-to-head trial comparing second- and first-generation EGFR-directed therapies (afatinib and gefitinib respectively) for patients with EGFR mutation-positiveNon-Small Cell Lung Cancer NSCLC who received no prior treatment. The Phase IIb trial included 319 patients with advanced stage NSCLC harboring common EGFR mutations (del19 or L858R). The trial's co-primary endpoints were progression-free survival (PFS) by independent review, time to treatment failure and overall survival (OS); and the secondary endpoints included ORR, disease control rate, tumor shrinkage, patient-reported outcomes and safety. (more…)
Author Interviews, JAMA, Surgical Research / 21.10.2016

MedicalResearch.com Interview with: Thue Bisgaard, M.D., D.M.Sc Professor of Surgery, Hvidovre Hospital Hvidovre Denmark MedicalResearch.com: What is the background for this study? What are the main findings? Response: The complete spectrum for the benefits and risks of mesh used to reinforce hernia repair is not known because there are very few clinical trial data reporting hernia outcomes as they pertain to mesh utilization. Generally, there is evidence that mesh is beneficial in terms of less risk of reoperation for recurrence after incisional hernia repair compared with sutured repair. The present study confirmed this for the first time in nationwide analysis with a long-term follow-up of 5 years up. From earlier studies from our group (Ann Surg 2012) it is known that reoperation rate for recurrence severely underestimates overall (clinical) risk of recurrence making differences between mesh vs. sutured repair even much bigger. Although rare (5%) the incidence of mesh-related complications was progressively increasing throughout the study period suggesting that mesh-related complications rate may continue to accrue with even longer follow-up. (more…)
Author Interviews, Endocrinology, Fertility, OBGYNE / 21.10.2016

MedicalResearch.com Interview with: Kavita Vedhara FAcSS Professor of Health Psychology Division of Primary Care School of Medicine University Park,Nottingham MedicalResearch.com: What is the background for this study? What are the main findings? Response: There has been a longstanding interest in the role of the hormone cortisol in fertility, because of its potential to affect the functioning of the biological systems that influence both conception and pregnancy. This interest has extended to IVF, with researchers exploring the relationship between levels of the hormone and pregnancy since the advent of the treatment in the late 1970s. However, a recent review showed that the relationship between cortisol and pregnancy in IVF was unclear. A number of reasons were highlighted for this, including that all of the studies to date had relied on short-term measures of the hormone measured in blood, saliva, urine and sometimes follicular fluid. Such measures can only capture hormone levels over a matter of minutes and hours. Such ‘snapshots’ are unable to give us an accurate picture of the levels of hormone over longer periods of time. This is important because any clinically relevant effects of cortisol on fertility are only likely to occur in the context of long-term changes in the hormone. In recent years it has become possible to measure long-term levels of cortisol in hair. Cortisol is deposited in the hair shaft and because human hair grows, on average, 1cm per month, a 3cm sample of hair closest to the scalp can tell us about levels of cortisol in the previous 3 months. We used the development of this technique to examine whether long term levels of cortisol (as measured in hair), or short term levels of cortisol (as measured in saliva) could predict whether or not women going through IVF would become pregnant. If you are trying to obtain a perfect cortisol balance, I use this product that helps to do just that. (more…)
Author Interviews, Lancet, Orthopedics, Stem Cells / 21.10.2016

MedicalResearch.com Interview with: Professor Ivan Martin, PhD Department of Surgery and Department of Biomedicine University Hospital Basel University of Basel Basel, Switzerland MedicalResearch.com: What is the background for this study and new use of autologous nasal chondrocytes? Response: We previously demonstrated that nasal chondrocytes, harvested from the nasal septum, have a larger and more reproducible capacity to form new cartilage than articular chondrocytes, harvested from the knee joint. We further established that the cartilage tissue generated by nasal chondrocytes can respond to physical forces (mechanical loads) similar to articular cartilage and has the ‘plasticity’ to adapt to a joint environment, since it efficiently integrated with surrounding articular cartilage when implanted in goat joints. This was the rationale for using nasal chondrocytes for articular cartilage repair. (more…)
Author Interviews, Biomarkers, Immunotherapy, Pancreatic / 21.10.2016

MedicalResearch.com Interview with Dr. Ashton A. Connor, MD PanCuRx Translational Research Initiative, Ontario Institute for Cancer Research Dr. Steven Gallinger MD, MSC Division of General Surgery Toronto General Hospital Toronto, ON MedicalResearch.com: What is the background for this study? What are the main findings? Response: The etiology of pancreatic ductal adenocarcinoma (i.e. "pancreatic cancer") and the relationship between the tumour and its characteristic dense, encroaching stroma are still poorly understood. Using whole genome sequencing in two large cohorts, we show that there are four fundamental mutational processes that give rise to pancreatic cancer. With expression data, we also show that the interaction between the tumour and the surrounding stroma varies with the type of mutational process found in the tumour. Specifically, tumours with defective DNA repair, either homologous recombination or mismatch repair deficiency, elicited strong anti-tumour immune responses, likely due to the relatively high numbers of neoantigens in these tumours. Individually, these concepts have been studied in other cancer types, but we are first to apply either of these to pancreatic cancer, and we also the first to integrate these two aspects of cancer biology for any tumour, to our knowledge. (more…)
Author Interviews, Hearing Loss / 20.10.2016

MedicalResearch.com Interview with: Samira Anderson, AuD., Ph.D. Assistant Professor Department of Hearing and Speech Sciences Faculty, Program in Neuroscience and Cognitive Sciences Faculty, Maryland Language Science Center Director, The Hearing Brain Lab www.hearingbrainlab.umd.edu University of Maryland – College Park MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is known that older adults ability to understand speech in background noise is enhanced by factors other than hearing. Older adults draw on cognitive resources to improve their understanding of what is said more so than do younger adults. Specifically, they can use the context of the conversation to fill in the gaps of what they might have missed due to background noise. They also benefit when the distracting noise or talker is speaking in a language that is unintelligible to them. So  someone who speaks English will understand the conversation better when the distracting talker is speaking a language other than English. If the background talker is speaking a different language, then that background talker is easier to ignore. In this study we were motivated to find out what is happening in the brain when older and younger adults are listening to a story spoken in English and ignoring a background talker who is speaking either in English or in Dutch. We found that overall the neural responses of older adults were degraded by noise to a greater extent than in younger adults, despite that fact that they had normal hearing. However, the neural response in older adults improved when the background talker was speaking Dutch compared to English, and this same improvement was not seen in younger adults. The older adults also reported that it was easier for them to focus on the English talker when the background talker was speaking Dutch, but the young adults said it didn't make any difference. (more…)
Alzheimer's - Dementia, Author Interviews, JAMA, Neurological Disorders / 20.10.2016

MedicalResearch.com Interview with: Dr David Lynch MB, MRCPI Leonard Wolfson Clinical Fellow UCL Institute of Neurology Queen Square, London MedicalResearch.com: What is the background for this study? What are the main findings? Response: In 2011 it was discovered that mutations in a gene called CSF1R cause a rare syndrome of early onset dementia often accompanied by movement disorders, spasticity and seizures, which is named adult onset leukoencephalopathy with axonal spheroids (ALSP). The hallmarks of ALSP are a characteristic appearance on MRI imaging and findings in brain pathological specimens - axonal swellings or 'spheroids'. We manage a multidisciplinary group with expertise in leukoencephalopathies and have previously identified patients with mutations in CSF1R. However, we also found patients with a syndrome typical of ALSP who did not carry mutations in CSF1R. In this study, we showed that some of these patients carry recessive mutations in a different gene, AARS2. This included a patient with characteristic axonal spheroids in brain tissue and typical ALSP clinical and imaging features. (more…)
AHA Journals, Author Interviews, Heart Disease / 20.10.2016

MedicalResearch.com Interview with: Joseph A. Ladapo, MD, PhD Division of General Internal Medicine and Health Services Research David Geffen School of Medicine UCLA Los Angeles, CA 90024 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Four million adults in the U.S. undergo stress testing or coronary computed tomographic angiography (CTA) each year because of suspected coronary disease. These patients are high risk for adverse cardiovascular events, but they are often not treated with the right medications after testing. Little is known about how CTA or stress testing affect physician and patient decisions about cardiovascular medications and preventive lifestyle choices like exercise and weight loss. Using data from patients in the PROMISE trial (PROspective Multicenter Imaging Study for Evaluation of chest pain), we found that patients who underwent CTA for suspected coronary artery disease were more likely to start a statin and aspirin and more likely to eat better and lose weight. (more…)
Author Interviews, Biomarkers, Infections, Technology / 19.10.2016

MedicalResearch.com Interview with: Ying Kong Ph.D. Assistant Professor University of Tennessee Health Science Center Department of Microbiology, Immunology, and Biochemistry Memphis, TN 38163 MedicalResearch.com: What is the background for this study? Response: Tuberculosis (TB) is a public health concern worldwide, with high morbidity and mortality. The causative agent of TB, M. tuberculosis, grows very slowly in culture. For research of TB, we need to quantitate bacterial numbers in order to evaluate drug and vaccine efficacy or to identify bacterial genes that are critical for survival in hosts or causing disease. M. tuberculosis divides every ~20 hours, which is much slower than other bacteria such as E. coli and Salmonella typhimurium, which divide every 20 minutes. Conventionally, quantitation of M. tuberculosis needs to spread M. tuberculosis on agar plates and wait for four weeks to obtain visible colonies, and then to count colony forming units. For the fast-growing bacteria, it takes only 18 hours to obtain visible colonies on agar plates. We and other groups have developed fluorescent protein labeled M. tuberculosis strains in order to quantitate M. tuberculosis in real time by measuring fluorescence. In this way, we are able to estimate bacterial number right after fluorescence measurement, which only takes a few minutes. However, this technology is not a diagnostic tool for clinical use, because the M. tuberculosis strains that we used were recombinant strains transformed with fluorescent protein genes. Another imaging technology that we have developed, REF, is for diagnosis purpose, which has been described in details in our other papers (Xie H, et al. Rapid point-of-care detection of the tuberculosis pathogen using a BlaC-specific fluorogenic probe. Nat Chem. 2012 Oct;4(10):802-9. Cheng Y, et al. Fluorogenic probes with substitutions at the 2 and 7 positions of cephalosporin are highly BlaC-specific for rapid Mycobacterium tuberculosis detection. Angew Chem Int Ed Engl. 2014 Aug 25;53(35):9360-4.). (more…)
Author Interviews, Endocrinology, OBGYNE, Pharmacology / 19.10.2016

MedicalResearch.com Interview with: Hugh S. Taylor, MD Anita O'Keeffe Young Professor of Obstetrics, Gynecology, and Reproductive Sciences and Professor of Molecular, Cellular, and Developmental Biology; Chair of Obstetrics Gynecology, and Reproductive Sciences, Yale School of Medicine Chief of Obstetrics and Gynecology Yale-New Haven Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: The abstract presented at ASRM featured results from two replicate pivotal Phase 3 clinical trials evaluating the efficacy and safety of Elagolix in premenopausal women who suffer from endometriosis. Elagolix is an investigational, orally administered, gonadotropin-releasing hormone (GnRH) receptor antagonist that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone and follicle-stimulating hormone secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, while on therapy. The data demonstrated dose-dependent superiority in reducing daily menstrual and non-menstrual pelvic pain associated with endometriosis compared to placebo. At month three and month six, patients treated with Elagolix reported statistically significant reductions in scores for menstrual pain (dysmenorrhea) and non-menstrual pelvic pain associated with endometriosis as measured by the Daily Assessment of Endometriosis Pain scale. The safety profile of Elagolix was consistent across both Phase 3 trials and also consistent with prior Elagolix studies. (more…)
AHA Journals, Author Interviews, Cost of Health Care, Gender Differences, Heart Disease, Social Issues / 19.10.2016

MedicalResearch.com Interview with: Adam L. Beckman Yale College, New Haven, CT (at the time this work was completed) Erica S Spatz MD MHS Assistant Professor, Section of Cardiovascular Medicine Center for Outcomes Research and Evaluation Yale-New Haven Hospital Yale University School of Medicine MedicalResearch.com: What is the background for this study? Beckman: Despite the expansion of insurance coverage, young adults face major challenges to obtaining affordable healthcare. We suspected women may experience greater challenges than men — they often have lower income and less complete medical coverage than men, and care for multiple generations of family, and that this may in part explain why young women have worse outcomes following a heart attack as compared with similarly-aged men. (more…)
Author Interviews, Breast Cancer, Cancer Research, Chemotherapy, ESMO / 18.10.2016

MedicalResearch.com Interview with: Corey Pelletier PhD Director, Health Economics & Outcomes Research Celgene Corporation Summit, NJ MedicalResearch.com: What is the background for this study? What are the main findings? Response: In a phase III clinical trial, ABRAXANE demonstrated significant improvement in ORR vs paclitaxel in patients with metastatic breast cancer. Celgene initiated this study because limited data exist on the comparative effectiveness of ABRAXANE vs paclitaxel for patients with metastatic breast cancer, including HR+/HER2- and triple negative (TN) metastatic breast cancer (MBC), in a real-world setting. This study used a U.S. based electronic medical record (EMR) dataset to evaluate the real-world comparative effectiveness of second-line ABRAXANE vs paclitaxel in patients with MBC and included patients with HR+/HER2- or TN MBC. This study also assessed adverse events and use of supportive care in this patient population. The median time to treatment discontinuation (TTD) for ABRAXANE vs paclitaxel was 4.50 vs 2.83 months (adjusted P<0.0001*) in all patients. Patients with HR+/HER2- or TN MBC had similar TTD. The median time to next treatment (TTNT) in all patients was 5.9 vs 4.2 months (adjusted P=0.2140*) for ABRAXANE vs paclitaxel, respectively. Patients receiving ABRAXANE had less fatigue, neuropathy, and anemia compared to patients receiving paclitaxel. Patients treated with ABRAXANE also used less antiemetics, and had fewer treatments for hydration or allergic reaction compared to those treated with paclitaxel. Patients treated with paclitaxel used less GCSF and had fewer treatments for bone loss compared to those treated with ABRAXANE. *TTD and TTNT were adjusted for age, number of metastases, targeted agent use, adjunctive chemotherapy, HER2 status, TN status, and CCI score without age. (more…)
Author Interviews, Biomarkers, Heart Disease / 18.10.2016

MedicalResearch.com Interview with: Susan Stienen, MD Department of Cardiology Academic Medical Center University of Amsterdam Amsterdam, the Netherland MedicalResearch.com: What is the background for this study? Response: Prognosis of patients admitted for and discharged after acute decompensated heart failure (ADHF) is poor, with a readmission and mortality rate of up to 50% of patients at 6 months. Previous studies demonstrated that a ≤30% NT-proBNP reduction from admission to discharge for ADHF is a strong predictor of HF readmissions and mortality, while those patients with a > 30% reduction in NT-proBNP had a far better prognosis. We conducted a randomized clinical trial in ADHF patients to study the effect of NT-proBNP-guided treatment with a target of NT-proBNP reduction of >30% from admission to discharge, versus conventional treatment. The guided arm used a therapy algorithm that included HF medication, review of rhythm problems and possible ischemia, and had a reminder of a possible indication for CRT-D. A total of 405 patients were randomized after an initial period of clinical stabilization, to receive NT-proBNP-guided or conventional therapy. Intention-to-treat analyses were performed in 404 patients. (more…)
AHA Journals, Author Interviews, Beth Israel Deaconess, Brigham & Women's - Harvard, Clots - Coagulation, Heart Disease / 18.10.2016

MedicalResearch.com Interview with: Eric A. Secemsky, MD MSc Interventional Cardiology Fellow Massachusetts General Hospital Harvard Medical School Fellow, Smith Center for Outcomes Research in Cardiology Beth Israel Deaconess Medical Center MedicalResearch.com: What is the background for this study? Response: Use of oral anticoagulant (OAC) therapy prior to coronary stenting is a significant predictor of post-procedural bleeding events. Previous studies have estimated that the frequency of chronic OAC use among patients undergoing percutaneous coronary intervention (PCI) is between 3% to 7%. Yet many of these analyses examined select patient populations, such as those admitted with acute myocardial infarction or atrial fibrillation, and preceded the market approval of non-vitamin K antagonist oral anticoagulants (NOACs). As such, the contemporary prevalence of OAC use among all-comers undergoing PCI, as well as associated risks of adverse events, are currently unknown. Therefore, we used PCI data from a large, integrated healthcare system to determine current use of  oral anticoagulant use among all-comers undergoing coronary stenting and the related short- and long-term risks of therapy. (more…)
Author Interviews, Endocrinology, Lancet, Toxin Research / 18.10.2016

MedicalResearch.com Interview with: Teresa Attina, MD, PhD Research Scientist NYU Langone School of Medicine Department of Pediatrics New York, NY 10016 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Endocrine-disrupting chemicals (EDCs) have been recently documented to contribute substantially to disease and dysfunction in the European Union (EU), with an annual estimated cost of €163 billion, corresponding to 1.28% of EU Gross Domestic Product. Our current study documents even greater annual costs in the US, $340 billion, corresponding to 2.33% of US GDP. These findings speak to the large health and economic benefits to regulating EDCs, which should be weighed against the cost of safer alternatives. The different costs between the EU and the US are due to different exposure levels to EDCs, and policy predicts exposure. US costs are higher mainly because of the widespread use of brominated flame retardants in furniture, whereas Europe restricted its use in 2008. Americans have much higher levels, such that the average American has a serum level of these chemicals that would be in the top 5% of Europeans. As a result, children born to pregnant women have lower IQs, such that more children suffer from intellectual disability. On the other hand, in Americans, levels of certain pesticides in foods are much lower due to the Food Quality Protection Act, which requires additional safety thresholds to protect pregnant women and children from exposure. The costs of pesticide exposures in the US were much lower ($12.6 billion) compared to Europe ($121 billion) because fewer children suffer loss of IQ as a result. (more…)
Anesthesiology, Author Interviews, Opiods, Pain Research, Surgical Research / 18.10.2016

MedicalResearch.com Interview with: Bryan Sakamoto MD, PhD Department of Anesthesia Richard L. Roudebush, Veterans Affairs Medical Center Department of Anesthesia Indiana University School of Medicine Indianapolis, Indiana MedicalResearch.com: What is the background for this study? Response: Liposomal bupivacaine is a novel extended-duration anesthetic that has recently become a popular option in total knee arthroplasty (TKA) for post-operative pain management. Although liposomal bupivacaine is widely used, it is unknown if the benefits justify the cost in the veteran population at our institution. The main purpose of this medication use study was to evaluate the cost verses benefit of using this agent in our veteran patient population. (more…)
Author Interviews, Diabetes, Diabetologia, Exercise - Fitness, Nutrition / 18.10.2016

MedicalResearch.com Interview with: Andrew Reynolds Department of Human NutritionUniversity Otago Dunedin New Zealand MedicalResearch.com: What is the background for this study? What are the main findings? Response: Current guidelines for people with type 2 diabetes are to undertake activities such as walking for at least 150 minutes a week, or 30 minutes a day. When to walk in the day is not specified. We thought it reasonable that walking after meals would improve blood sugars more so than a walk where the timing was unspecified. Our randomised controlled trial considered exactly this, a prescription to walk as per the guideline of 30 minutes a day and a prescription to walk for 10 minutes after each meal. Our participants were free-living, but wore accelerometers to record their movement, and continuous glucose monitoring systems to observe their blood glucose levels. We found that post-meal blood sugar levels dropped 12 per cent on average when the participants followed the walking after meals advice compared to walking at any time of the day. Most of this effect came from the highly significant 22 per cent reduction in blood sugar when walking after evening meals, which were the most carbohydrate heavy, and were followed by the most sedentary time. (more…)
Author Interviews, Outcomes & Safety, Surgical Research / 18.10.2016

MedicalResearch.com Interview with: Vishal Sarwahi, MD, senior author Associate Surgeon-in-Chief Chief, Spinal Deformity and Pediatric Orthopaedics Billie and George Ross center for Advanced Pediatric Orthopaedics and Minimally Invasive Spinal Surgery Cohen's Children Medical Center Northwell Hofstra School of Medicine and Stephen F. Wendolowski Research Assistant Pediatric Orthopaedics Cohen Children’s Medical Center New Hyde Park, NY, 11040 MedicalResearch.com: What is LEAN? Response: LEAN is a management principle that supports the concept of continuous improvement through small incremental changes to not only improve efficiency, but also quality. Particularly, we took interest in the 5S’s – Sort, Simplify, Sweep, Standardize, and Self-Discipline. We felt that Sort, Simplify, and Standardize were the most relevant to surgery. (more…)
Author Interviews, Dermatology, Immunotherapy / 17.10.2016

MedicalResearch.com Interview with: Dr. Alan Menter MD Texas Dermatology Associates MedicalResearch.com: What is the background for this study? Response: Psoriasis on the palms and soles of the feet—also known as palmoplantar psoriasis of which there are 2 variants, plaque type or pustular, —can significantly affect a person’s quality of life and is often difficult-to-treat with available treatments. Researchers in this study set out to determine the efficacy and safety of Taltz (ixekizumab) through 60 weeks among patients with moderate-to-severe plaque psoriasis with significant palmoplantar involvement. Plaque psoriasis is the most common form of psoriasis appearing as raised, red patches covered with a silvery white buildup of dead skin cells which are often painful or itchy. This study was an analysis of UNCOVER-3, a Phase 3, multicenter, double-blind, placebo-controlled trial. In the first 12 weeks of this study, patients were randomized to receive placebo, etanercept (50 mg, twice-weekly) or 80 mg of Taltz every two weeks or every four weeks, following an initial starting dose of 160 mg. At 12 weeks, all patients received open-label Taltz every four weeks through 60 weeks. (more…)