Author Interviews, Brigham & Women's - Harvard, Cancer Research, Immunotherapy, NEJM / 05.11.2015

[caption id="attachment_18967" align="alignleft" width="175"]Toni Choueiri, MD Clinical Director, Lank Center for Genitourinary Oncology Director, Kidney Cancer Center Senior Physician Dana Farber Cancer Institute Associate Professor of Medicine, Harvard Medical School Dr. Toni Choueiri[/caption] MedicalResearch.com Interview with: Toni Choueiri, MD Clinical Director, Lank Center for Genitourinary Oncology Director, Kidney Cancer Center Senior Physician Dana Farber Cancer Institute Associate Professor of Medicine Harvard Medical School Medical Research: What is the background for this study? What are the main findings? Dr. Choueiri: In the METEOR trial, we aimed to compare cabozantinib, a novel VEGFR, MET, AXL inhibitor to everolimus, a standard 2nd line option in advanced RCC. There is an unmet in this setting. Cabozantinib resulted in a median PFS of 7.4 months compared to 3.8 months with everolimus. Responses also were 4-times higher with cabozantinib-treated patients. At the interim OS analysis, there was a strong trend favoring cabozantinib. 
Author Interviews, Cancer Research, JAMA, MD Anderson / 05.11.2015

[caption id="attachment_19067" align="alignleft" width="114"]William N. William Jr., MD Associate Professor Chief, Head and Neck Section Department of Thoracic / Head and Neck Medical Oncology The University of Texas M. D. Anderson Cancer Center Houston, TX Dr. William[/caption] MedicalResearch.com Interview with: William N. William Jr., MD Associate Professor Chief, Head and Neck Section Department of Thoracic / Head and Neck Medical Oncology The University of Texas M. D. Anderson Cancer Center Houston, TX Medical Research: What is the background for this study? What are the main findings? Dr. William: Oral pre-malignant lesions are often characterized as white and/or red patches in the mouth and are considered risk factors for oral cancer. This is why it might be best for people to go get oral cancer screening done if they suspect that there might be a problem. However, not all oral pre-malignant lesions will turn into cancer, but when this happens, surgery is usually recommended, many times leading to serious speech and swallowing dysfunction. Chemoprevention is the use of compounds to prevent cancers from happening before they occur. One of the greatest challenges in developing chemopreventive agents is to identify the population at highest cancer risk. The Erlotinib Prevention of Oral Cancer (EPOC) trial involved 379 patients at five sites across the country. All had premalignant lesions in their mouths. Following study enrollment, participants were evaluated for LOH, a chromosomal abnormality characterized by the loss of chromosomal regions, which include tumor suppressor genes. Patients who tested positive for LOH were considered to be at high risk for oral cancer and were randomized to receive either erlotinib (an EGFR inhibitor drug) or a placebo for one year. The study’s primary endpoint was to determine if fewer patients treated with erlotinib would develop oral cancer, compared to those that received placebo. The EPOC study demonstrated that LOH predicted a higher oral cancer risk. LOH-negative patients had a three-year cancer-free survival rate of 87 percent compared to 74 percent for the LOH-positive group. However, patients who took erlotinib showed no statistical difference in terms of cancer-free survival rates after three years: 74 percent for participants given erlotinib compared to 70 percent for those taking placebo. Patients with both LOH and EGFR copy number gains had the highest incidence of cancer, but still did not benefit from erlotinib.
Author Interviews, Cancer Research, Dermatology, JAMA / 05.11.2015

[caption id="attachment_19105" align="alignleft" width="195"]Dr. Brad A. Bryan Ph.D Assistant Professor Biomedical Sciences Texas A&M University Health Science Center, Houston, TX Department of Biomedical Sciences Texas Tech University Health Sciences Center Dr. Bryan[/caption] MedicalResearch.com Interview with: Dr. Brad A. Bryan Ph.D Assistant Professor Biomedical Sciences Texas A&M University Health Science Center, Houston, TX Department of Biomedical Sciences Texas Tech University Health Sciences Center Medical Research: What is the background for this study? What are the main findings? Dr. Bryan: In 2008 it was serendipitously discovered that the beta blocker propranolol was effective in treating a common benign pediatric vascular tumor called infantile hemangioma.  Over the past few years, my lab has been working on elucidating the molecular mechanisms underlying this pediatric tumor and part of this research involved uncovering how propranolol selectively inhibited these tumors.  At the same time these studies were taking place, other members of my lab were working on pre-clinical drug development for a malignant vascular tumor called angiosarcoma.  Patients with angiosarcoma are faced with very few effective treatment options and abysmal survival rates, so we decided to see if the efficacy of beta blockade observed in infantile hemangiomas transferred to angiosarcomas.  Using preclinical in vitro and in vivo assays, we demonstrated that propranolol was very effective at inducing cell death, blocking migration, and inhibiting tumor growth in our angiosarcoma models.  This work was subsequently published in Plos One (Stiles et al., 2013).  I then collaborated with Dr. William Chow from San Francisco to test propranolol off-label (propranolol is FDA approved to treat high blood pressure, heart dysrhythmias, thyrotoxicosis, and essential tremors) in a patient suffering from a rapidly expanding angiosarcoma covering a large portion of his face.  In the window between diagnosis of the tumor and the start of chemotherapy, we placed the patient on oral propranolol.  The redness of the tumor very rapidly lessened and remarkably by only one week of treatment the tumor margins appeared to significantly shrink.  We examined biospies of the tumor before and after only one week of propranolol and found that the proliferation of the tumor cells was markedly decreased following beta blockade.  After a combination of propranolol, chemotherapy, and radiation that lasted several months, the patient had no detectable metabolically active tumor or distant metastases. We published these findings in JAMA Dermatology (Chow et al., 2015).
Author Interviews, Chemotherapy, Lymphoma, NEJM / 04.11.2015

Jia Ruan, M.D., Ph.D. Associate Professor of Clinical Medicine Weill Cornell Medicine Lymphoma Program Division of Hematology & Medical Oncology New York, NY 10021MedicalResearch.com Interview with: Jia Ruan, M.D., Ph.D. Associate Professor of Clinical Medicine Weill Cornell Medicine Lymphoma Program Division of Hematology & Medical Oncology New York, NY 10021   Medical Research: What is the background for this study? What are the main findings? Dr. Ruan: Mantle cell lymphoma is an uncommon subtype of non-Hodgkin lymphoma that primarily affects elderly populations. Conventional chemotherapy regimens are generally not curative, and may not be tolerated by many patients, underscoring the need for treatment alternatives.  Previous experience with immunomodulatory compound lenalidomide has shown favorable activity and was well tolerated in patients with relapsedMantle cell lymphoma.  We evaluated the efficacy and safety of the biologic combination with lenalidomide plus rituximab as initial treatment for mantle-cell lymphoma (MCL). The main findings of the study showed that the combination was effective and generally well tolerated when given as induction and maintenance treatment. The overall response rate was 92%, with complete response rate of 64% in the 36 evaluable patients. Median duration of response has not been reached at a median follow up of 30 months.   Treatment was outpatient-based and quality-of-life was preserved for most patients.
AHA Journals, Author Interviews, Duke, Outcomes & Safety, Stroke, Surgical Research / 04.11.2015

MedicalResearch.com Interview with: Soko Setoguchi-Iwata, M.D MPH Adjunct Associate Professor Department of Medicine Duke Clinical Research Institute Medical Research: What is the background for this study? What are the main findings? Dr. Setoguchi: Medicare made a decision to cover Carotid Artery Stenting (CAS) in 2005 after publication of SAPPHIRE, which demonstrated the efficacy of Carotid Artery Stenting vs Carotid Endarterectomy in high risk patients for CEA. Despite the data showing increased carotid artery stenting dissemination following the 2005 National Coverage Determination, peri-procedural and long-term outcomes have not been described among Medicare beneficiaries, who are quite different from trial patients, older and with more comorbidities in general population. Understanding the outcomes in these population is particularly important in the light of more recent study, the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), which established CAS as a safe and efficacious alternative to CEA among non-high-surgical risk patients that also expanded the clinical indication of carotid artery stenting. Another motivation to study ‘real world outcomes in the general population is expected differences in the proficiency of physicians performing stenting in trial setting vs. real world practice setting. SAPPHIRE and CREST physicians were enrolled only after having demonstrated  Carotid Artery Stenting proficiency with low complication rates whereas hands-on experience and patient outcomes among real-world physicians and hospitals is likely to be more diverse. We found that unadjusted mortality risks over study period of 5 years with an mean of 2 years of follow-up in our population was 32%.  Much higher mortality risks observed among certain subgroups with older age, symptomatic patients and non-elective hospitalizations.  
Author Interviews, JAMA, Stroke, Surgical Research / 04.11.2015

MedicalResearch.com Interview with: Saleh A Almenawer, MD Neurosurgeon, Hamilton Health Sciences McMaster University Hamilton, ON Canada  Medical Research: What is the background for this study? Dr. Almenawer: The current standard therapy for acute ischemic stroke is intravenous tissue plasminogen activator (tPA), which improves survival and functional outcomes when administered as early as possible after stroke. However, the use of intravenous tPA is limited by the narrow therapeutic time window (< 4.5 hours) and by important contraindications, including coagulopathy, recent surgery, or stroke or head injury within the past 3 months. This leaves as few as 10% of patients presenting with ischemic stroke eligible for treatment with tPA. Moreover, intravenous tPA is associated with long recanalization times and poor revascularization rates in proximal large vessel occlusion, and the prognosis of these patients remains poor. The limitations of intravenous tPA have spurred interest in endovascular thrombectomy for acute ischemic stroke, analogous to thrombolysis versus percutaneous coronary intervention for myocardial infarction. Several randomized clinical trials (RCTs) have compared clinical outcomes of mechanical thrombectomy to standard medical treatment with intravenous tPA. The current study was a meta-analysis of RCTs that aimed to answer the question of whether endovascular thrombectomy is associated with better clinical outcomes than intravenous tPA, and accordingly, whether endovascular thrombectomy should replace intravenous tPA as the new standard of care for ischemic stroke.
Author Interviews, Nutrition, PLoS, University Texas, Weight Research / 04.11.2015

Dr. Marcia C. de Oliveira Otto MD PhD Division of Epidemiology, Human Genetics and Environmental Sciences The University of Texas Health Science Center School of Public Health, Houston, TexasMedicalResearch.com Interview with: Dr.  Marcia C. de Oliveira Otto MD PhD Assistant professor  Division of Epidemiology, Human Genetics and Environmental Sciences The University of Texas Health Science Center School of Public Health, Houston, Texas  Medical Research: What is the background for this study? What are the main findings?  Dr. Otto: Eat a variety of foods, or food diversity, is a long standing public health recommendation because it is thought to ensure adequate intake of essential nutrients, to prevent excessive intakes of less healthy nutrients such as refined sugars and salt, thus promoting good health. However there hasn’t been empiric evidence from populational studies testing this hypothesis. In our study, we characterized three metrics of diet diversity and evaluated their association with metabolic health using data from 6,814 participants in the Multi-Ethnic Study of Atherosclerosis, including whites, blacks, Hispanic-Americans, and Chinese-Americans in the United States, including the total count (number of different foods eaten in a week), evenness (the distribution of calories across different foods consumed), and dissimilarity (the differences in food attributes relevant to metabolic health, such as fiber, sodium or trans-fat content). We then evaluated how diet diversity was associated with change in waist circumference five years after the beginning of the study and with onset of Type 2 diabetes ten years later. We also examined the relationship between diet quality and the same metabolic outcomes. Diet quality was measured using established scores such as the Dietary Approaches to Stop Hypertension (DASH) and the Alterative Healthy Eating (AHEI) score. When evaluating both food count and evenness, we found no associations with either increase in waist circumference or incidence of diabetes. In other words, more diversity in the diet was not linked to better metabolic outcomes. Participants with greater food dissimilarity actually experienced more central weight gain, with a 120 percent greater increase in waist circumference than participants with lower food dissimilarity. Contrary to what we expected, our results showed that participants with greater diversity in their diets, as measured by dissimilarity, had worse diet quality. They were eating less healthy foods, such as fruits and vegetables, and more unhealthy foods, such as processed meats, desserts and soda. When evaluating diet quality, we found about a 25 percent lower risk of developing Type 2 diabetes after 10 years of follow up in participants with higher diet quality. There was no association between diet quality scores and change in waist circumference. 
Author Interviews, Cost of Health Care, JAMA, Pharmacology, Sloan Kettering / 04.11.2015

MedicalResearch.com Interview with: Dr. Elizabeth D. Kantor PhD MPH Assistant Attending Epidemiologist Memorial Sloan Kettering Cancer Center

Medical Research: What is the background for this study? What are the main findings? Dr. Kantor: We know that use of prescription drugs represents a major expenditure in the United States and research suggests that use of prescriptions has increased. However, much of what we know is derived from information on expenditures, is outdated, or is limited to certain populations, such as older adults or those with a given clinical condition. For example, a number of studies have looked at things like use of drugs used to control condition x among persons with condition x, but that doesn't tell us about use of that class of drugs in the population. It’s important that we continue to monitor use of prescription drugs in the population, as practice patterns are continually evolving as the population ages, the health needs of the population change, drugs enter/exit the market, scientific knowledge advances, and policies change. We therefore sought to create an updated comprehensive reference on prescription drug use among US adults using nationally representative data from the National Health And Nutrition Examination Survey, a continuous survey conducted by the Centers for Disease Control and Prevention. We examined trends in use of prescription drugs over 7 cycles, ranging from 1999-2000 to 2011-2012 (the sample size per cycle ranged from 4,861 to 6,212).Participants were asked about use of prescription medications over the prior 30 days, from which we were able to estimate the prevalence of use within each survey cycle. We then looked at trends in prescription drug use, both overall and within drug classes. In our study, we observed that use of any prescription medications increased over the study period, with 51% of adults reporting any prescription medication use in 1999-2000 and 59% reporting any use in 2011-2012. We also observed an increase in polypharmacy (or use of 5 or more prescription drugs) over the study period, with approximately 8% of adults reporting use of 5 or more drugs in 1999-2000, as compared to 15% in 2011-2012. Polypharmacy was much more common among older adults: 24% of adults ages 65 and older reported use of 5 or more drugs in 1999-2000 and 39% reported use of 5 or more drugs in 2011-2012. At first glance, one might take a look at these results and think that this is probably because the US population is aging and people tend to take more drugs as they age. But we found that the increase in overall prescription drug use and polypharmacy persisted even after accounting for the aging of the US population. This means that something else is driving the observed increase in use of prescription drugs. We also found that use of the majority of drug classes increased over the study period. For example, among commonly used drug classes, we observed marked increases in use of drugs taken to control high cholesterol, high blood pressure, and diabetes. We also observed marked increases in some less commonly used drug classes, such as muscle relaxants. Interestingly, if we look at the ten most commonly used drugs in 2011-2012, we can see that most are taken for conditions associated with cardiometabolic disease This raises the question of how much of this increase in prescription drug use may be attributable to overweight/obesity, as we know that the prevalence of obesity has increased among US adults.
Author Interviews, Brigham & Women's - Harvard, JAMA, McGill, Pharmacology / 04.11.2015

MedicalResearch.com Interview with: Tewodros Eguale, MD, PhD Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada Research Fellow in Medicine Brigham and Women's Hospital Medical Research: What is the background for this study? Dr. Eguale: Off-label prescribing is common and has been identified as a potentially important contributor to preventable adverse drug events (ADE). Significant deleterious effects were reported with off-label use of some drugs. Moreover, studies in children, where drugs are often used without sufficient scientific investigation, have shown that off-label uses increase the risk of ADE.  In adults, there has been no systematic investigation of the effects of off-label use in real world situation. The lack of knowledge is related to the methodological challenges of measuring off-label use and its effects; specifically the lack of link between prescribed drugs and their indication for use. The Medical Office of the XXI Century (MOXXI) electronic health record (EHR), developed by team of researchers at McGill University, facilitates the documentation of treatment indications, reasons for discontinuation of drug orders and adverse drug event. These new features provided the first opportunity to systematically monitor and evaluate off-label use and the occurrence of adverse drug events.  This study took advantage of the use of this new generation of software in a network of primary care practices to systematicaly evaluate the effect of off-label use on ADEs.
Author Interviews, Columbia, Compliance, HIV, JAMA, Pediatrics / 04.11.2015

[caption id="attachment_18947" align="alignleft" width="165"]Dr. Louise Kuhn PhD Professor, Epidemiology Sergievsky Center Columbia University Dr. Kuhn[/caption] MedicalResearch.com Interview with: Dr. Louise Kuhn PhD Professor, Epidemiology Sergievsky Center Columbia University  Medical Research: What is the background for this study? What are the main findings? Dr. Kuhn: Ritonavir-boosted lopinavir-based antiretroviral therapy is recommended as first-line treatment for HIV-infected infants and young children while efavirenz is recommended for adults and older children. There are several advantages of transitioning HIV-infected children to efavirenz-based treatment as they get older.  These advantages include the possibility of once-daily dosing, simplification of co-treatment for tuberculosis, avoidance of some metabolic toxicities, preservation of ritonavir-boosted lopinavir for second-line treatment, and alignment of adult and pediatric treatment regimens. However, there have been concerns about possible reduced viral efficacy of efavirenz-based treatment in children exposed to nevirapine for prevention of mother-to-child transmission.  This is because efavirenz and nevirapine are in the same drug class and the majority of children who become infected despite exposure to nevirapine used for prevention have mutations in their virus that usually predict resistance to this drug class. In this study, we randomized HIV-infected children to two different treatment strategies: In the control strategy they remained on their initial ritonavir-boosted lopinavir regimen; in the alternative strategy they transitioned to an efavirenz-based regimen.  All children had been exposed to nevirapine used (unsuccessfully) to prevent mother to child HIV transmission and were virologically-suppressed (HIV in blood < 50 copies/ml) at the time of enrollment into the study.  We observed excellent virological control in both groups with fewer than 3% of children having levels of HIV in their blood greater than 1000 copies/ml.  Sustained suppression of virus in blood below 50 copies/ml throughout follow-up was achieved in 82% of the children transitioned to efavirenz-based treatment compared to 72% of children remaining on the control treatment.
Author Interviews, Cancer Research, Cognitive Issues, Journal Clinical Oncology, Memory / 03.11.2015

[caption id="attachment_19020" align="alignleft" width="141"]Dr Janette Vardy BMed (Hons), PhD, FRACP A.Prof of Cancer Medicine University of Sydney Medical Oncologist ,Concord Cancer Centre Concord Repatriation & General Hospital Concord, Australia Dr. Vardy[/caption] MedicalResearch.com Interview with: Dr Janette Vardy  BMed (Hons), PhD, FRACP A.Prof of Cancer Medicine University of Sydney Medical Oncologist ,Concord Cancer Centre Concord Repatriation & General Hospital Concord, Australia  Medical Research: What is the background for this study? Dr. Vardy: Many patients complain that their memory and concentration is not as good after chemotherapy.  Most of the studies have been in younger women with breast cancer, and are often limited by small sample sizes and short term follow up.    This is the largest longitudinal cohort study assessing impacts of cancer and its treatment on cognitive function. We evaluated changes in cognitive function in 289 men and women with localized colorectal cancer (CRC), comparing those who received chemotherapy to those who did not require chemotherapy, 73 with metastatic disease, and a group of 72 healthy controls.?The localized CRC patients were assessed at baseline (soon after diagnosis and prior to any chemotherapy), 6, 12 and 24 months.  The healthy controls and metastatic group were assessed at baseline, 6 and 12 months.  We also examined underlying mechanisms.
Author Interviews, Colon Cancer, Genetic Research, Journal Clinical Oncology / 03.11.2015

[caption id="attachment_19022" align="alignleft" width="201"]Hans F.A. Vasen, MD Department of Gastroenterology Leiden University Medical Center and Netherlands Foundation for the Detection of Hereditary Tumours Leiden, the Netherlands Dr. Vasen[/caption] MedicalResearch.com Interview with: Hans F.A. Vasen, MD Department of Gastroenterology Leiden University Medical Center and Netherlands Foundation for the Detection of Hereditary Tumours Leiden, the Netherlands Medical Research: What is the background for this study? Dr. Vasen: People with familial colorectal cancer (CRC) have a 3-6 fold increased risk of colorectal cancer. It has been estimated that about 2% of the population have familial CRC (about 2.7 million people in the US). Previous studies showed that colonoscopic surveillance reduces the CRC-mortality by >80%. In people with hereditary CRC, i.e., Lynch syndrome (10 fold increased risk of CRC), an intensive screening program with colonoscopy 1x/1-2 years, is recommended. In familialcolorectal cancer, the optimal screening program  is unknown. Medical Research: What are the main findings? Dr. Vasen: In this randomized trial with 528 individuals at risk for familial CRC, we compared screening intervals of 3 and 6 years. We found that patients had significant more high-risk adenomas (precursor lesions of CRC) at 6-years-follow-up compared to at 3-years-follow-up. However, because of the relatively low rate of high-risk adenomas at 6 years (7%) and the absence of colorectal cancer in the 6-years group, we consider a 6-year-interval safe.
Annals Internal Medicine, Author Interviews, Diabetes, Heart Disease / 30.10.2015

[caption id="attachment_18935" align="alignleft" width="157"]Dr. Yung-Tai Chen MD Division of Nephrology Department of Medicine Taipei City Hospital Heping Fuyou Branch Taipei, Taiwan Dr. Yung-Tai Chen[/caption] MedicalResearch.com Interview with: Dr. Yung-Tai Chen MD Division of Nephrology Department of Medicine Taipei City Hospital Heping Fuyou Branch Taipei, Taiwan Medical Research: What is the background for this study? What are the main findings? Dr. Chen: Recent studies concluded that dipeptidyl peptidase-4 (DPP-4) inhibitors can provide glycemic control but also raised concerns about the risk of heart failure in patients with Type 2 Diabetes Mellitus (T2DM). However, large-scale studies of the effects of DPP-4 inhibitors versus sulfonylureas (SUs) on cardiovascular outcomes when used as add-ons to metformin therapy remain scarce. Our study showed that compared to SUs, DPP-4 inhibitors were associated with a lower risk of all-cause mortality, stroke and hypoglycemia as an add-on to metformin. Besides, dipeptidyl peptidase-4 inhibitors had comparable risks of hospitalization for heart failure to sulfonylureas as add-ons to metformin.
AHA Journals, Author Interviews, Electronic Records, Heart Disease / 30.10.2015

[caption id="attachment_18882" align="alignleft" width="120"]Jonathan R. Enriquez, MD Assistant Professor of Medicine Division of Cardiology University of Missouri- Kansas City Director, Coronary Care Unit Truman Medical Center Dr. Enriquez[/caption] MedicalResearch.com Interview with: Jonathan R. Enriquez, MD Assistant Professor of Medicine Division of Cardiology University of Missouri- Kansas City Director, Coronary Care Unit Truman Medical Center  Medical Research: What is the background for this study? Dr. Enriquez:  
  • In 2009, U.S. legislation appropriated tens of billions of dollars to promote the use of electronic health records (EHRs).
  • Approximately 4 million hospitalizations for cardiovascular diagnoses occur annually in the U.S., which are more hospitalizations than for any other category of disease.  Therefore, evaluating the use of EHRs in these settings can help us understand how to best optimize the care and outcomes of a huge set of patients.
AHA Journals, Author Interviews, Health Care Systems, Outcomes & Safety, Stroke / 29.10.2015

[caption id="attachment_18912" align="alignleft" width="169"]Mathew J. Reeves BVSc, PhD, FAHA Professor, Department of Epidemiology and Biostatistics, Michigan State University East Lansing, MI 48824 Prof. Reeves[/caption] MedicalResearch.com Interview with: Mathew J. Reeves BVSc, PhD, FAHA Professor, Department of Epidemiology and Biostatistics, Michigan State University East Lansing, MI 48824  Medical Research: What is the background for this study? Dr. Reeves: The National Institutes of Health Stroke Scale (NIHSS) is the single most important prognostic factor in predicting outcomes of individual stroke patients. NIHSS data is obviously important at the patient level but also at a hospital level since the case mix of stroke patients are assumed to vary widely across different hospitals and referral centers. Measuring stroke outcomes at a hospital level is becoming increasingly important as work proceeds in the US to develop integrated stroke systems of care. But it is also very relevant to the new payment models being introduced by CMS which are based on hospital rankings that are developed from statistical risk adjustment models. One would expect that NIHSS would be a major contributor to these models but currently a major limitation is that NIHSS is incompletely documented in clinical registries such as GWTG-Stroke, and is completely absent from administrative data. The problem of missing NIHSS data plays havoc with the ability to risk adjust stroke outcomes across hospitals. Missing data results is a smaller number of stroke cases being included in the risk adjusted calculations for a given hospital which results in greater uncertainty over what the actual hospital outcomes are. Further there is concern that NIHSS data is not missing at random, and so the NIHSS data that is documented may represent a biased selection of all the cases that a hospital admits. This too could have important consequences for hospital rankings. To determine the degree of potential bias in the documentation of NIHSS data this study examined trends in and predictors of documentation of NIHSS across 10 years of data (2003-2012) in the GWTG-Stroke program.
Author Interviews, JAMA, Surgical Research / 29.10.2015

[caption id="attachment_18904" align="alignleft" width="300"]Luke Rudmik, MD Division of Otolaryngology–Head and Neck Surgery Department of Surgery University of Calgary Calgary, Alberta, Canada Dr. Luke  Rudmik[/caption] MedicalResearch.com Interview with: Luke Rudmik, MD Division of Otolaryngology–Head and Neck Surgery Department of Surgery University of Calgary Calgary, Alberta, Canada Medical Research: What is the background for this study? What are the main findings? Dr. Rudmik: The main findings were that patients with chronic sinusitis who have lower impairments in their quality of life can have their work productivity maintained with continuing medical therapy. Although there were no 'improvements' in the patients productivity with continuing medical therapy, it is important to note that patients in this study had better baseline quality of life and better baseline productivity compared to patients who chose to receive sinus surgery who had worse baseline quality of life and baseline productivity impairment.
Author Interviews, Cancer, Cancer Research, JAMA / 29.10.2015

Jiemin Ma, PhD, MHS Director of Surveillance and Health Services Research American Cancer SocietyMedicalResearch.com Interview with: Jiemin Ma, PhD, MHS Director of Surveillance and Health Services Research American Cancer Society Medical Research: What is the background for this study? What are the main findings? Dr. Ma: This study is an analysis of long-term trends in mortality for all causes combined and for 6 leading causes of death, including heart disease, cancer, stroke, chronic obstructive pulmonary disease (COPD), unintentional injuries, and diabetes, in the United States from 1969 through 2013. We found that death rates for all causes and for five of these 6 leading causes (except COPD) decreased during this time period, although the rate of decrease appears to have slowed for heart disease, stroke, and diabetes. COPD death rates doubled during this time period, although the rate began to decrease in men since 1999.
Author Interviews, Cancer Research, Education, JAMA / 29.10.2015

[caption id="attachment_18889" align="alignleft" width="142"]Vinay Prasad, MD MPH Assistant Professor of Medicine Division of Hematology Oncology in the Knight Cancer Institute Department of Public Health and Preventive Medicine Senior Scholar in the Center for Health Care Ethics Oregon Health and Sciences University Portland, Oregon 97239 Dr. Prasad[/caption] MedicalResearch.com Interview with: Vinay Prasad, MD MPH Assistant Professor of Medicine Division of Hematology Oncology in the Knight Cancer Institute Department of Public Health and Preventive Medicine Senior Scholar in the Center for Health Care Ethics Oregon Health and Sciences University Portland, Oregon 97239   Medical Research: What is the background for this study? What are the main findings? Dr. Prasad: We wanted to get some information about when and which cancer drugs were called "game changer" or "breakthrough" or "revolutionary".  What we found was surprising.  The use of these grandiose terms, or superlatives, was common in news articles.  They occurred across many classes of medication, were used for approved and unapproved drugs, and some of the use was questionable.
Annals Internal Medicine, Author Interviews, Cognitive Issues, Cost of Health Care, End of Life Care / 28.10.2015

[caption id="attachment_18871" align="alignleft" width="130"]Amy S. Kelley, MD, MSHS Department of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai New York, NY Dr. Kelley[/caption] MedicalResearch.com Interview with: Amy S. Kelley, MD, MSHS Department of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai New York, NY Medical Research: Why is it so important to understand the financial burdens families may face in providing end-of-life care for a loved one and why do you think the burdens may be greater for dementia than for other medical conditions? Dr. Kelley: Understanding the financial risks that older adults face in the last years of life is important for individuals and families, in order to plan and save, if possible. It is also important for our policy makers, in particular, to know about these costs so that this information can help shape health and social policy that will best serve our society. Households of those with dementia face the greatest burden of costs, on average, particularly with regard to out-of-pocket expenses and the costs of caregiving.  Many costs related to daily care for patients with dementia are not covered by health insurance, and these care needs, including everything from supervision, to bathing and feeding, may span several years.
Author Interviews, Diabetes, NEJM / 28.10.2015

Marcus Lind, M.D., Ph.D Department of Medicine, Uddevalla Hospital Uddevalla, Swede MedicalResearch.com Interview with: Marcus Lind, M.D., Ph.D Department of Medicine, Uddevalla Hospital Uddevalla, Swede Medical Research: What is the background for this study? Dr. Lind:  One of the main goals of the diabetes care is to reduce excess mortality in individuals with type 2 diabetes close to that of the general population. We want patients to have a similar life expectancy as individuals in the general population. Earlier studies have shown that targeting good glucose levels, blood lipid and blood pressure levels are beneficial with respect to decrease cardiovascular disease being the main cause for mortality. We wanted to evaluate the prognosis for individuals with type 2 diabetes today in Sweden. Further, earlier population-based studies have generally assessed mortality rates only on a group level whereas we believe the prognosis differs greatly depending on various factors such as how well risk factor control is obtained in clinical practice. The Swedish Diabetes Registry include more than 90% of all individuals with type 2 diabetes in Sweden and information of e.g. the glycaemic control, measured by a biomarker called A1c exists for most persons. There were 97% who had at least 1 measurement. Also most patients had information of other risk factors, among others renal complications which we believed were of special concern. 
AHA Journals, Author Interviews, Heart Disease, Nutrition, Pediatrics / 28.10.2015

[caption id="attachment_18607" align="alignleft" width="150"]Michael D. Miedema, MD, MPH Minneapolis Heart Institute Foundation Abbott Northwestern Hospital Minneapolis, MN Dr. Michael Miedema[/caption] MedicalResearch.com Interview with: Michael D. Miedema, MD, MPH Minneapolis Heart Institute Foundation Abbott Northwestern Hospital Minneapolis, MN Medical Research: What is the background for this study? Dr. Miedema: A healthy diet is an essential component in the prevention of cardiovascular disease. A dietary pattern high in fruits and vegetables has been associated with reduced rates of cardiovascular disease outcomes in multiple observation cohorts of middle-aged and older adults. However, the cardiovascular impact of fruit and vegetable intake in younger adults is less clear. Medical Research: What are the main findings? Dr. Miedema: To evaluate this relationship, we studied 2,506 young adults in the Coronary Artery Risk Development in Young Adults (CARDIA) study to determine the association between fruit and vegetable intake during young adulthood and subsequent development of coronary artery calcium 20 years later. After adjusting for age, gender, and lifestyle variables, including smoking and physical activity, we found an inverse relationship between fruit and vegetable and subsequent coronary artery calcium across tertiles of fruit and vegetable intake (p-value <0.001). Individuals in the top third of fruit and vegetable intake at baseline had 26% lower odds of developing calcified plaque 20 years later. This inverse linear relationship remained significant after adjusting for fruit and vegetable intake at year 20 as well as after adjustment for other dietary variables such as dairy, nuts, fish, salt, and refined grains.
Author Interviews, Nature, NYU/NYMC, Weight Research / 28.10.2015

[caption id="attachment_18828" align="alignleft" width="150"]Dr. Margaret E. Rice, PhD Professor, Department of Neuroscience and Physiology Neurosurgery NYU Langone Medical Center Dr. Margaret Rice[/caption] MedicalResearch.com Interview with: Dr. Margaret E. Rice, PhD Professor, Department of Neuroscience and Physiology Neurosurgery NYU Langone Medical Center Medical Research: What is the background for this study? What are the main findings? Dr. Rice: Insulin is released from the pancreas into the bloodstream in response to a rise in circulating glucose levels when we eat. In most cells in the body, including those of liver and muscle, insulin acts at insulin receptors to promote glucose transport and other metabolic functions. Insulin also enters the brain and acts at brain insulin receptors, particularly in the hypothalamus where insulin acts as a satiety signal to indicate that we are full and should stop eating. The rising incidence of obesity, in which circulating insulin levels are chronically elevated, suggests insulin may play a role in other brain regions, as well, including regions that regulate motivation and reward. Indeed, our new studies introduce a new role for insulin as a reward signal that acts in the dorsal striatum to enhance release of dopamine.  Dopamine is a key neurotransmitter in reward systems; most drugs of abuse enhance release of dopamine, which contributes to their addictive properties. We found that insulin, at levels found in the brain by the end of a meal, enhances dopamine release by activating insulin receptors on acetylcholine-containing striatal cells that boost dopamine release. Consistent with a role of insulin in signaling reward, companion behavioral studies in rodents indicate that insulin signaling in the striatum communicates the reward value of an ingested meal, and thereby influences food choices. These studies reveal the dual nature of insulin in the brain, which not only tells us when to stop eating, but also influences what we eat.
Author Interviews, Kidney Disease, Nature / 27.10.2015

[caption id="attachment_18851" align="alignleft" width="100"]Daniele Zink PhD Institute of Bioengineering and Nanotechnology Singapore Dr. Zink[/caption] MedicalResearch.com Interview with: Daniele Zink PhD Institute of Bioengineering and Nanotechnology Singapore  Medical Research: What is the background for this study? Dr. Zink: The kidney is one of the main target organs for toxic effects of drugs, environmental toxicants and other compounds. Renal proximal tubular cells (PTCs) are frequently affected due to their roles in compound transport and metabolism. Validated and accepted assays for the prediction of PTC toxicity in humans currently do not exist. Recently, we have developed the first and only pre-validated assays for the accurate prediction of PTC toxicity in humans 1, 2. This previous work was performed with human primary renal proximal tubular cells (HPTCs) or embryonic stem cell-derived HPTC-like cells. HPTCs are associated with a variety of issues that apply to all kinds of primary cells, such as cell sourcing problems, inter-donor variability and limited proliferative capacity. Embryonic stem cell-derived cells are associated with ethical and legal issues. These are the main reasons why induced pluripotent stem cell (iPSC)-derived cells are currently a favored cell source for in vitro toxicology and other applications. The problem was that stem cell-based approaches were not well-established with respect to the kidney. Recently, the group of IBN Executive Director Prof. Jackie Y. Ying developed the first protocol for differentiating embryonic stem cells into HPTC-like cells, and my group has contributed to characterizing these cells and publishing the results 3.  In the work published in Scientific Reports ,4we have applied a modified version of this protocol to iPSCs. In this way, we have established the simplest and fastest protocol ever for differentiating iPSCs into HPTC-like cells. The cells can be used for downstream applications after just 8 days of differentiation. These cells can also be applied directly without further purification due to their high purity of > 90%. By using these cells, we have developed the first and only iPSC-based model for the prediction of PTC toxicity in humans. This was achieved by combining our iPSC-based differentiation protocol with our previously developed assay based on interleukin (IL)6/IL8 induction 1, 2 and machine learning methods 5. Machine learning methods were used for data analysis and for determining the predictive performance of the assay. The test accuracy of the predictive iPSC-based model is 87%, and the assay is suitable for correctly identifying injury mechanisms and compound-induced cellular pathways.
AHA Journals, Author Interviews, Stroke / 26.10.2015

[caption id="attachment_18708" align="alignleft" width="125"]Shadi Yaghi, MD Assistant Professor of Neurology The Warren Alpert Medical School of Brown University Rhode Island Hospital Stroke Center, Staff Neurologist Dr. Shadi Yaghi[/caption] MedicalResearch.com Interview with: Shadi Yaghi, MD Assistant Professor of Neurology The Warren Alpert Medical School of Brown University Rhode Island Hospital Stroke Center, Staff Neurologist Medical Research: What is the background for this study? What are the main findings? Dr. Yaghi: In this study, we pooled data from 10 stroke centers across the country to investigate the treatment and outcome of post thrombolysis hemorrhage in acute ischemic stroke. This study included 128 patients and showed that the treatments used were not effective in improving the mortality related to this condition.
Author Interviews, Genetic Research, Kidney Disease, Nature, Stem Cells / 24.10.2015

[caption id="attachment_18772" align="alignleft" width="140"]Benjamin Freedman, Ph.D. Assistant Professor | University of Washington Department of Medicine | Division of Nephrology Member, Kidney Research Institute Member, Institute for Stem Cell and Regenerative Medicine Seattle WA 98109 Dr. Benjamin Freedman[/caption] MedicalResearch.com Interview with: Benjamin Freedman, Ph.D. Assistant Professor | University of Washington Department of Medicine | Division of Nephrology Member, Kidney Research Institute Member, Institute for Stem Cell and Regenerative Medicine Seattle WA 98109  Medical Research: What is the background for this study? What are the main findings? Dr. Freedman: We are born with a limited number of kidney tubular subunits called nephrons. There are many different types of kidney disease that affect different parts of the nephron. The common denominator between all of these diseases is the irreversible loss of nephrons, which causes chronic kidney disease in 730 million patients worldwide, and end stage renal disease in 2.5 million. Few treatments have been discovered that specifically treat kidney disease, and the therapeutic gold standards, dialysis and transplant, are of limited availability and efficacy. Pluripotent stem cells are a renewable source of patient-specific human tissues for regeneration and disease analysis. In our study, we investigated the potential of pluripotent cells to re-create functional kidney tissue and disease in the lab. Pluripotent cells treated with a simple chemical cocktail matured into mini-kidney 'organoids' that closely resembled nephrons. Using an advanced gene editing technique called CRISPR, we created stem cells with genetic mutations linked to two common kidney diseases, polycystic kidney disease (PKD) and glomerulonephritis. Mini-kidneys derived from these genetically engineered cells showed specific 'symptoms' of these two different diseases in the petri dish.
Author Interviews, Clots - Coagulation, Heart Disease, JACC / 24.10.2015

H.A. (Hendrika) van den Ham PharmD Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University The Netherlands.MedicalResearch.com Interview with: H.A. (Hendrika) van den Ham PharmD Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University The Netherlands. Medical Research: What is the background for this study? What are the main findings? Dr. van den Ham: Atrial fibrillation (AF) is associated with a substantial risk of ischemic stroke and thromboembolism. The CHADS2 and the CHA2DS2-VASc risk scores are developed to guide the decision to prescribe anticoagulants. Recently a new clinically-based risk score, the ATRIA study risk score, was developed. We compared the predictive ability of the ATRIA risk score with the CHADS2 and CHA2DS2-VASc risk scores in a large, independent, community-based cohort of Atrial fibrillation patients in the United Kingdom. We found that the ATRIA score more accurately identified low risk patients that the CHA2DS2-VASc score assigned to higher risk categories.  Such reclassification of stroke risk could prevent overuse of anticoagulants in very low stroke risk patients with Atrial fibrillation.
Author Interviews, Bipolar Disorder, Kidney Disease, Lancet, Mental Health Research, Pharmacology / 24.10.2015

MedicalResearch.com Interview with: Dr. Stefan Clos MSc Applied Health Statistics Psychiatrist Murray Royal Hospital Scotland UK Medical Research: What is the background for this study? Dr. Clos: For more than 40 years there has been a debate about the long-term effect of lithium maintenance therapy on renal function. There is a lack of good quality data from randomized clinical trials and two previous meta-analyses from 2010 and 2012 suggest that little evidence exists for a clinically significant reduction in renal function in most patients who are on lithium therapy. However, the two publications point out the poor quality of available study data, emphasising the need for large scale epidemiological studies that control for confounders. Several population-based studies have since attempted to address this problem, but had insufficient ability to adjust for confounders or had limitations because of inappropriate cross-sectional study design or did not include an appropriate comparator group. 
Anesthesiology, Author Interviews, CHEST, Critical Care - Intensive Care - ICUs, PTSD, Pulmonary Disease / 24.10.2015

[caption id="attachment_18766" align="alignleft" width="200"]Jad Kebbe, MD Jacobs School of Medicine and Biomedical Sciences Department of Medicine University of Buffalo Dr. Jad Kebbe[/caption] MedicalResearch.com Interview with: Jad Kebbe, MD Jacobs School of Medicine and Biomedical Sciences Department of Medicine University of Buffalo Medical Research: What is the background for this study? What are the main findings? Dr. Kebbe: This study proceeded after sensing that post-traumatic stress disorder (PTSD) was a major contributor to ill outcomes in Veterans who are hospitalized in general, and mechanically ventilated in the intensive care unit (ICU) in particular. There is plenty of data depicting the comorbid roles PTSD plays in other medical conditions, leading to an increase in the use of medical services. Furthermore, PTSD affects a Veteran’s adherence to both medical and psychiatric therapies. Having said this, the ICU course could itself negatively affect a pre-existing PTSD, or even lead to the inception of such a condition de novo. However, to date, there has been no study looking at the effect a pre-existing PTSD diagnosis may have on the ICU hospitalization and thereafter. Our study confirmed that PTSD led to an increase in sedative requirements (opiates and benzodiazepines) for Veterans who were mechanically ventilated for more than 24h between 2003 and 2013, and revealed a trend towards an increase in mortality when compared to Veterans not suffering from PTSD. This is why many veterans are trying to claim disability benefits using va benefits and disability lawyer Tennessee to help them fight their case.