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Author Interviews, Duke, JAMA, Pharmacology, Stroke / 10.11.2015

MedicalResearch.com Interview with: Ying Xian, PhD Assistant Professor of Medicine. Member in the Duke Clinical Research Institute Medical Research: What is the background for this study? What are the main findings? Dr. Xian: Intravenous tissue plasminogen activator (tPA) is the only FDA approved medical therapy to reduce disability and improve outcomes for patients with acute ischemic stroke. But treatment with tPA also carries the risk of symptomatic intracranial hemorrhage (sICH), which is often fatal. Nearly half of ischemic stroke patients are taking antiplatelet drugs such as aspirin and/or clopidogrel prior to stroke. We found these patients had higher risk for sICH when treated with tPA. But the risk is relatively small. For every 147 patients on aspirin treated with tPA, only 1 more symptomatic intracranial hemorrhage as compared with those treated with tPA without prior antiplatelet therapy. The risk is slightly higher among those on dual antiplatelet therapy of aspirin and clopidogrel (number needed to harm 60). Despite the higher bleeding risk, patients treated with tPA on prior antiplatelet therapy appeared to have better functional outcomes in terms of ambulatory status and modified Rankin scale than those not on prior antiplatelet therapy. Therefore, overall the benefits of thrombolytic therapy may outweigh the risks. (more…)
Author Interviews, Diabetes, JAMA, Pediatrics, Probiotics / 10.11.2015

Dr. Ulla Uusitalo PhD University of South Florida, TampaMedicalResearch.com Interview with: Dr. Ulla Uusitalo PhD University of South Florida, Tampa Medical Research: What is the background for this study? What are the main findings? Dr. Uusitalo: The TEDDY Study is an international prospective cohort study with the primary goal to identify environmental causes of Type 1 Diabetes (T1D). It is carried out in six clinical research centers, in four countries: University of Colorado Health Science Center (US), Georgia Regents University (US), Pacific Northwest Diabetes Research Institute (US), Turku University Hospital (Finland), Institute of Diabetes Research (Germany), and Lund University (Sweden), since 2004. One possible environmental factor related to Type 1 Diabetes etiology is diet. Dietary supplements including probiotics as well as various types of infant formulas including probiotic fortified infant formula are studied. The microbial composition of gut has been shown to be associated with the development of  Type 1 Diabetes. Colonization of the infant gut starts already in utero and early microbial exposures have been found to be important in defining the trajectory of colonization. Probiotics have been demonstrated to induce favorable immunomodulation and it has been suggested that probiotic treatment could prevent T1D. Therefore we wanted to study the early exposures of probiotic and risk of islet autoimmunity, a condition often preceding Type 1 Diabetes. This study produced very interesting results. The main finding was that we found 60% decrease in the risk of islet autoimmunity among children with HLA genotype of DR3/4 (high risk), who were exposed to probiotics during the first 27 days of life. (more…)
Author Interviews, Diabetes, Heart Disease, JAMA, Mental Health Research / 10.11.2015

MedicalResearch.com Interview with: Dr. Christina Mangurian MD Associate Professor of Clinical Psychiatry UCSF School of Medicine and the UCSF Department of Psychiatry's first Director of Diversity Medical Research: What is the background for this study? What are the main findings? Dr. Mangurian: People with severe mental illness (SMI, e.g., schizophrenia and bipolar disorder) die 25 years earlier than the general population, often from cardiovascular disease.  The ADA and APA guidelines recommend annual diabetes screening of this population when taking certain antipsychotic medications.  Despite these guidelines, nearly 70% of this population remain unscreened.  This has huge public health implications and likely costs our public health system a tremendous amount in undiagnosed disease. (more…)
Author Interviews, Heart Disease, JAMA, PAD / 09.11.2015

MedicalResearch.com Interview with: Farzin Fakhry, MD PhD Candidate Depts. of Epidemiology & Radiology Erasmus MC Rotterdam, the Netherlands and Myriam Hunink MD, PhD Professor Professor of Radiology and Clinical Epidemiology Erasmus University Medical Center Rotterdam Adjunct Professor of Health Decision Science Harvard T.H. Chan School of Public Health, Boston Medical Research: What is the background for this study? What are the main findings? Response: Intermittent claudication is the classical symptomatic form of peripheral arterial disease (PAD) and affects approximately 20-40 million people worldwide. These patients experience significant functional disability resulting in a sedentary lifestyle and reduced quality of life. In the Endovascular Revascularization And Supervised Exercise (ERASE) study we compared a combination therapy of endovascular revascularization plus supervised exercise versus the recommended care of supervised exercise only as first-line treatment for patients with intermittent claudication. Results from the ERASE study showed that after one year follow up patients in both groups showed significant improvements in their treadmill walking distance and disease specific quality of life. Yet, patients receiving the combination therapy had more rapid and significantly greater improvement in their walking performance and disease specific quality of life compared to the patients following a supervised exercise program only. (more…)
Author Interviews, Gender Differences, Heart Disease, JAMA / 09.11.2015

MedicalResearch.com Interview with: Dr. David Bluemke MD, PhD, MsB Director of Radiology and Imaging Sciences NIH Clinical Center Bethesda, MD  Medical Research: What is the background for this study? What are the main findings? Dr. Bluemke: Heart disease is the most common reason for death and disability of adults in the United States and worldwide. This study evaluated 1,840 adults in six communities throughout the United States, ages 45-84. In normal adults, the heart is a muscle, but various injuries to the heart (the most severe being a myocardial infarction/ heart attack) occur over an individual’s lifetime. These injuries result in heart muscle being replaced by a scar composed of fibrous tissue. The main finding is that even in healthy, middle and older adults, about 1 in 12 adults in the U.S. have developed scars in the heart. Most of these (80%) are not detected by their doctor, or by other tests such as ECG. (more…)
Author Interviews, Cancer Research, JAMA, MD Anderson / 05.11.2015

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. (more…)
Author Interviews, Cancer Research, Dermatology, JAMA / 05.11.2015

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). (more…)
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. (more…)
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. (more…)
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. (more…)
Author Interviews, Columbia, Compliance, HIV, JAMA, Pediatrics / 04.11.2015

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. (more…)
Author Interviews, JAMA, Surgical Research / 29.10.2015

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. (more…)
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. (more…)
Author Interviews, Cancer Research, Education, JAMA / 29.10.2015

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. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Prostate Cancer, Race/Ethnic Diversity, Surgical Research / 23.10.2015

MedicalResearch.com Interview with: Dr. Quoc-Dien Trinh MD Assistant Professor of Surgery Harvard Medical School  Brigham and Women's Hospital Boston, MA 02115 Medical Research: What is the background for this study? What are the main findings? Dr. Trinh:  Blacks who undergo radical prostatectomy, e.g. surgical removal of the prostate for cancer, are more likely to experience complications, emergency room visits, readmissions compared to their non-hispanic White counterparts. As a result, the 1-year costs of care for Blacks is significantly higher than non-hispanic Whites. Interestingly, despite these quality of care concerns, the survival of elderly Blacks and Whites undergoing prostatectomy is the same. Medical Research: What should clinicians and patients take away from your report? Dr. Trinh: A possible interpretation of our findings is that the biological differences in tumor aggressiveness among Blacks  (e.g. Blacks have more aggressive prostate cancer than Whites) may have been exaggerated, and that the perceived gap in survival is a result of lack of access or cultural perceptions with regard to surgical care for prostate cancer or other factors that differentiate who makes it to the operating table. (more…)
Author Interviews, Cannabis, Columbia, JAMA / 21.10.2015

Deborah S. Hasin, Ph.D. Professor of Epidemiology Columbia University New York, New York 10032MedicalResearch.com Interview with: Deborah S. Hasin, Ph.D. Professor of Epidemiology Columbia University New York, New York 10032 Medical Research: What is the background for this study? What are the main findings? Dr. Hasin: This study is based on data from two large-scale national surveys conducted over an eleven-year period that are designed to provide information on many health-related conditions in U.S. adults, including use of marijuana and other substances, changes over time in the prevalence of marijuana users, changes over time in the prevalence of disorders such as marijuana abuse and dependence, and the correlates and predictors of those disorders. The main findings of the study are that between 2001-2002 and 2012-2013, the prevalence of marijuana users in the United States adult general population more than doubled, from 4.1% to 9.5%, while the prevalence of adults with marijuana use disorder (abuse or dependence) also increased substantially, from 1.5% to 2.9% of American adults. About three in ten adult marijuana users met criteria for a marijuana use disorder. The findings are consistent with other studies showing increases in rates of marijuana-related harms over the same general time period. This may be to do with how accessible marijuana has become, for example you can even find a purple lotus menu on various websites. This is perfectly safe and fun, but can develop into an addiction later in life. (more…)
Author Interviews, CDC, JAMA, OBGYNE, Vaccine Studies / 21.10.2015

MedicalResearch.com Interview with: Dr.Lakshmi Sukumaran MD, MPH Immunization Safety Office, Centers for Disease Control and Prevention Department of Pediatrics, Emory University School of Medicine Atlanta, Georgia Medical Research: What is the background for this study? What are the main findings? Dr. Sukumaran: Pertussis (whooping cough) is a vaccine-preventable disease that has been increasing in incidence over the past decade in the United States. Newborns and infants are at increased risk of pertussis-related hospitalization and death compared with older children and adults. The Advisory Committee on Immunization Practices (ACIP) recommends that pregnant women receive a tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) during each pregnancy to protect her infant from pertussis disease, regardless of prior immunization status. However, there is limited data on the safety of repeated Tdap vaccines in pregnant women. Our study evaluated medically attended (associated with doctor visit or hospitalization) adverse events in mothers, such as fever, allergy and local reactions, and adverse birth outcomes, such as prematurity and low birth weight in newborns, in women receiving Tdap in pregnancy who had received a prior tetanus-containing vaccine. We found no significant differences in rates of these adverse outcomes in women who received Tdap in pregnancy following a prior tetanus-containing vaccine less than 2 years before, 2 to 5 years before, and more than 5 years before. (more…)
Author Interviews, Breast Cancer, JAMA, Mammograms, UC Davis / 21.10.2015

MedicalResearch.com Interview with: Diana L. Miglioretti, PhD Dean's Professor in Biostatistics Department of Public Health Sciences UC Davis School of Medicine Davis, CA  95616 Medical Research: What is the background for this study? What are the main findings? Dr. Miglioretti: Screening mammography intervals remain under debate in the United States. The US Preventive Services Task Force recommends biennial (every other year) screening, whereas other organizations recommend annual screening. To help inform their updated screening guidelines, the American Cancer Society guideline development group requested that the US Breast Cancer Surveillance Consortium conduct a study comparing cancer outcomes among women screened annually vs. biennially. Prior studies conducted by the consortium used wide intervals for defining annual and biennial mammograms. We wanted to evaluate cancer outcomes for women who more closely adhere to screening intervals. Our goal was to determine if women diagnosed with cancer following biennial screening have tumors with less favorable prognostic characteristics compared to women diagnosed after annual screening. We evaluated outcomes separately by age and by menopausal status because evidence suggests that younger women and premenopausal women may have more aggressive tumors and thus may benefit from more frequent screening. We found from this study that premenopausal women diagnosed with invasive breast cancer following biennial versus annual screening mammography were more likely to have tumors with less-favorable prognostic characteristics (e.g., later stage, larger size). For example, women with an invasive breast cancer diagnosed after a biennial screen had a 28% increased risk of a stage IIB or higher tumor, a 21% increased risk of being diagnosed with a tumor >15 mm, and an 11% higher risk of being diagnosed with a tumor with any less-favorable prognostic characteristic compared women diagnosed with breast cancer following an annual mammogram. In contrast, we found postmenopausal women not using hormone therapy and women 50 years of age or older had similar proportions of tumors with less-favorable prognostic characteristics regardless of screening interval. Relative risk estimates were close to one with no significant differences between biennial and annual screeners. Among postmenopausal women using hormone therapy at the time of the mammogram and women age 40-49, results were less clear. Relative risk estimates for biennial versus annual screeners were consistently above one, but were not as large as for premenopausal women and were not statistically significant. (more…)
Author Interviews, Heart Disease, JAMA, OBGYNE, Pediatrics / 21.10.2015

Nathalie Auger MD MSc FRCPC Crémazie Est Montréal, Québec MedicalResearch.com Interview with: Nathalie Auger MD MSc FRCPC Crémazie Est Montréal, Québec  Medical Research: What is the background for this study? What are the main findings? Dr. Auger: Congenital heart defects are the most common defects found in infants, but the causes are for the most part unknown. Only about 15-20% can be linked to a clear cause, such as a genetics or maternal infection.  Recently, certain imbalances of angiogenic signaling proteins that control blood vessel development have been identified in individuals with congenital heart defects. Similar imbalances in the same biomarkers have been observed in women with preeclampsia, a serious complication of pregnancy that occurs in 3-5% of pregnant women. Because of this similarity, we sought to determine the relationship that preeclampsia has with the presence of congenital heart defects in infants. What we found was that there was a significant association between preeclampsia and congenital heart defects. In particular, preeclampsia that was diagnosed before 34 weeks of pregnancy was significantly associated with critical and noncritical heart defects and seemed to be the driving factor. There was increased risk for defects involving all general structures of the heart, although the absolute risk of congenital heart defects was low (16.8 per 1,000 infants). (more…)
Author Interviews, Brain Injury, JAMA / 21.10.2015

Dr-Davinia-Fernandez-Espejo.jpgMedicalResearch.com Interview with: Dr Davinia Fernández-Espejo PhD School of Psychology University of Birmingham Birmingham  Medical Research: What is the background for this study? What are the main findings? Dr. Fernández-Espejo: We have previously shown that a number of patients who appear to be in a vegetative state are actually aware of themselves and their surroundings, and simply unable to show it with their external behavior. In a prior study we demonstrated that a patient who had been repeatedly diagnosed as vegetative state for 12 years was not only fully aware but able to create memories. Notably, this patient was capable to modulate their brain activity in a functional magnetic resonance imaging (fMRI) scanner to answer questions about their condition and preferences for care. In the present study we identified the reason for the dissociation between these patients’ retained awareness and their inability to respond with intentional movement. First, we used fMRI to demonstrate that a functional connection between the thalamus and the motor cortex is essential for a successful execution of voluntary movements. Second, we used diffusion tensor tractography, a technique that allows reconstructing and assessing white matter pathways in the brain, to identify damage to such connection (i.e. thalamus and motor cortex) in a paradigmatic patient who produced repeated evidence of covert awareness across multiple examinations, despite clinically appearing as being in a vegetative state. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Health Care Systems, JAMA / 20.10.2015

MedicalResearch.com Interview with: Hannah Neprash PhD student Health Policy program Harvard University. Medical Research: What is the background for this study? Response: Hospitals are increasingly employing or purchasing physician practices. This trend started before the Affordable Care Act, as our study documents, but there is a concern that these trends may accelerate as providers reorganize to meet the challenges of new payment models that hold providers accountable for the entire spectrum of patient care, spanning inpatient and outpatient settings. It’s not clear how this change in provider market structure should affect spending. It could lead to lower spending, if care is better coordinated, reducing waste and unnecessary utilization. But, it could also lead to higher spending if larger provider groups have more market power and can negotiate higher prices with insurers. Medical Research: What are the main findings? Response: We used Medicare claims to quantify the share of physicians in major metropolitan markets that were owned or employed by a hospital. Most markets saw an increase in physician-hospital integration from 2008 to 2012. The average market saw a 3% increase in physician-hospital integration; the 75th percentile market saw a 5% increase; and the 95th percentile market saw a 15% increase. An increase in physician-hospital integration equivalent to the 75th percentile was associated with a $75 per person (or 3%) increase in annual outpatient spending among a non-elderly commercially insured population. This was driven by price increases – as we found no change in utilization. We did not find a similar association between physician-hospital integration and inpatient hospital spending. This is likely because hospital markets were already less competitive than physician markets at the beginning of our study period. When a hospital system buys a physician practice, the hospitals might not gain much bargaining power against an insurer in negotiating prices for inpatient care, but the hospital’s bargaining power could be used to negotiate higher fees for the outpatient physician practice.  That is, an insurer may not be persuaded by the threat of excluding the physician practice from its network, but the threat of excluding the entire hospital system from the insurer’s network is likely to carry more weight. (more…)
Author Interviews, Diabetes, JAMA, Surgical Research / 17.10.2015

MedicalResearch.com Interview with: Jan Peter Yska, PharmD Medical Centre Leeuwarden Department of Clinical Pharmacy & Clinical Pharmacology Leeuwarden The Netherlands Medical Research: What is the background for this study? Dr. Yska: Many patients with morbid obesity have known type 2 diabetes mellitus. Bariatric surgery effectively prevents and treats type 2 diabetes. A growing number of studies suggests that surgical treatment for obese patients may be considered an additional treatment option for the management of type 2 diabetes. However, an observational study on the remission of type 2 diabetes, using strict criteria for remisson of diabetes, after different types of bariatric surgery, based on data from general practice has not been carried out yet. Medical Research: What are the main findings? Dr. Yska: Our study included 569 obese patients with type 2 diabetes who had different types of weight-loss surgery and 1,881 similar diabetic patients who didn’t have surgery. This study confirms that bariatric surgery is successful in treating diabetes mellitus type 2. Per 1,000 person years 94.5 diabetes remissions were found in patients who underwent bariatric surgery, compared to 4.9 diabetes remissions in matched controls. A strict definition of remission of diabetes was used, much stricter than in other studies: patients should have stopped all diabetic medications with an HbA1c < 6.0% after at least 6 months of follow-up. Diabetic patients who underwent bariatric surgery had an 18-fold increased chance of diabetes remission, compared to diabetic patients who did not undergo surgery, with the greatest effect size observed for gastric bypass (adj. RR 43.1), followed by sleeve gastrectomy (adj. RR 16.6), and gastric banding (adj. 6.9). The largest decrease in  HbA1c and blood glucose levels was observed in the first two years after bariatric surgery. (more…)
Author Interviews, JAMA, Social Issues / 16.10.2015

Joseph M. Unger, PhD MS Assistant Member Fred Hutchinson Cancer Research Center Seattle, WAMedicalResearch.com Interview with: Joseph M. Unger, PhD MS Assistant Member Fred Hutchinson Cancer Research Center Seattle, WA Medical Research: What is the background for this study? What are the main findings? Response: In a prior study, we identified patient-level income as an important predictor of clinical trial participation. Because this was one of many demographic and socioeconomic factors that we examined, we sought to confirm the finding in this new study using prospective data. Again, we found that patient-level income predicted clinical trial participation. Patients with household income <$50,000/year had a 32% lower odds of participating in clinical trials than patients with household income >$50,000/year. This confirmed our previous observation and provided strong evidence that the observation of income disparities in clinical trial enrollment is valid. (more…)
Author Interviews, CDC, JAMA, Opiods, Pharmacology / 16.10.2015

MedicalResearch.com Interview with: Beth Han, MD, PhD, MPH Substance Abuse and Mental Health Services Administration U.S. Department of Health and Human Services Rockville, Maryland Medical Research: What is the background for this study? What are the main findings? Dr. Han: Since 1999, the United States has experienced increases in negative consequences and deaths associated with nonmedical use of prescription opioids. During this period, emergency department visits and drug overdose deaths involving these drugs have increased rapidly. To fully understand the current status of this public health crisis and who is currently most affected, we conducted this study based on nationally representative U.S. surveillance data. Our main study findings include:
  • Among adults age 18 through 64 years, the prevalence of nonmedical use of prescription opioids decreased from 5.4 percent in 2003 to 4.9 percent in 2013, but the prevalence of prescription opioid use disorders increased from 0.6 percent in 2003 to 0.9 percent in 2013. The 12-month prevalence of high-frequency use (200 days or more) also increased from 0.3 percent in 2003 to 0.4 percent in 2013.
  • Mortality assessed by drug overdose death rates involving prescription opioids increased from 4.5 per 100,000 in 2003 to 7.8 per 100,000 in 2013. The average number of days of nonmedical use of prescription opioids increased from 2.1 in 2003 to 2.6 in 2013. The prevalence of having prescription opioid use disorders among nonmedical users increased to 15.7 percent in 2010, 16.1 percent in 2011, 17 percent in 2012, and 16.9 percent in 2013, from 12.7 percent in 2003.
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Author Interviews, Cost of Health Care, JAMA, Surgical Research / 16.10.2015

Richard S. Hoehn, MD Division of Transplant Surgery Department of Surgery, University of Cincinnati School of Medicine Cincinnati, OHMedicalResearch.com Interview with: Richard S. Hoehn, MD Division of Transplant Surgery Department of Surgery University of Cincinnati School of Medicine Cincinnati, OH Medical Research: What is the background for this study? What are the main findings? Dr. Hoehn: Safety-net hospitals are hospitals that either have a stated purpose of maintaining an “open door policy” to all patients, regardless of their ability to pay, or simply have a significantly high burden of patients with Medicaid or no insurance. As healthcare policy and reimbursement change to focus on both “quality” metrics as well as cost containment, these hospitals may find themselves in a precarious situation. Current literature suggests that increased safety-net burden corresponds to inferior surgical outcomes. If this is true, safety-net hospitals will have inferior outcomes and suffer more financial penalties than other centers. This decrease in resources may adversely affect patient care, leading to even worse outcomes and further financial penalties, potentially creating a downward spiral that exacerbates disparities in surgical care that already exist in our country. Medical Research: What are the main findings? Dr. Hoehn: Our study analyzed 9 major surgical operations using the University HealthSystem Consortium clinical database, which represents 95% of academic medical centers in the United States. We sought to determine the effect of patient and hospital characteristics on the inferior outcomes at safety-net hospitals. As expected, we found that safety-net hospitals had higher rates of patients who were of black race, of lowest socioeconomic status, had government insurance, had extreme severity of illness, and needed emergent operations. They also had the highest rates of post-operative mortality, 30-day readmissions, and highest costs associated with care. Next we performed a multivariate analysis controlling for patient age, race, socioeconomic status, and severity of illness, as well as hospital procedure-specific volume. Using this model, we found that the increased mortality and readmission rates at safety-net hospitals were somewhat reduced, but the increased costs were not affected. Safety-net hospitals still provided surgical care that was 23-35% more expensive, despite controlling for patient characteristics. This suggests that intrinsic hospital characteristics may be responsible for the increased costs at safety-net hospitals. To further investigate this finding, we analyzed Medicare Hospital Compare data and found that safety-net hospitals performed worse on Surgical Care Improvement Project (SCIP) measures, had higher rates of reported surgical complications, and also had much slower measures of emergency department throughput (time from arrival to evaluation, treatment, admission, etc). This corresponded with our finding that hospital characteristics may be driving increased costs at safety-net hospitals. (more…)
Author Interviews, JAMA, Melanoma, Technology / 15.10.2015

Ashley K. Day, Ph.D., M. Psych (Hlth) Post-Doctoral Associate Rutgers Cancer Institute of New JerseyMedicalResearch.com Interview with: Ashley K. Day, Ph.D., M. Psych (Hlth) Post-Doctoral Associate Rutgers Cancer Institute of New Jersey Medical Research: What is the background for this study? What are the main findings? Dr. Day: Skin cancer is one of the most common cancers in the US, and it is estimated that more than 9,000 Americans will die of melanoma this year. Melanoma patients have a 9-times greater risk for a diagnosis of another melanoma compared to the general population. Because of this, it is important that melanoma patients practice regular sun protection and skin self-examination behaviors. There is potential opportunity to use the Internet to deliver information and interventions to help melanoma patients engage in these behaviors. However, it is important to understand patients’ preferences. Our research explored factors associated with the receptivity of patients with melanoma to such Internet-delivered behavioral interventions. We found that, in a sample of 176 melanoma patients, the vast majority (84.1%) had Internet access and had previously sought melanoma information online (77.7%). More than two-thirds of patients (68.4%) reported being at least moderately interested in participating in an Internet-based intervention to promote engagement in sun protection and skin self-examination behaviors. Receptivity to such an intervention was higher among patients who were younger, had greater knowledge of the ABCDE signs of melanoma (looking at the asymmetry, border irregularity, color, diameter, and evolution of the mole or affected area), and were more comfortable using the Internet. (more…)
Author Interviews, JAMA, Mental Health Research, Pediatrics / 15.10.2015

MedicalResearch.com Interview with: Christine Walrath, PhD Public Health Division ICF International New York, New York Medical Research: What is the background for this study? What are the main findings? Dr. Walrath: The study is part of a legislatively mandated evaluation of programs funded by the Garrett Lee Smith Memorial Act, signed into law in 2004 in recognition of the major public health problem of suicide and suicidal behavior in the US. The legislation set aside funding for campuses, states, tribes and US territories to develop, evaluate, and improve early intervention and suicide prevention programs. This is the most widely implemented group of suicide prevention programs in the United States, and allowed a unique opportunity, as reflected in the findings of this study and the study in the American Journal of Public Health in the spring (Walrath, C., Godoy Garraza, L., Reid, H., Goldston, D. B., & McKeon, R. (2015) to demonstrate that comprehensive community based suicide prevention programs appear to be effective in reducing suicide and suicide attempts. As mentioned, this is the second article on the impact of GLS suicide prevention program on youth suicide behavior. The previous one, published in APHA earlier this year, focused on suicide deaths, while this one focuses on suicide attempts. They use different sources for the outcome measures: vital records in one case and a large national survey in the other. In both cases, the county is the unit of analysis. They both take advantage of the availability of a large amount of information for relatively small areas to select counties that are essentially comparable. Making sure that the counties being compared are similar except for the GLS implementation is very important when randomized trials to assess impact of the prevention program are not feasible. The study found a reduction in the rate of suicide attempts among youth 16 to 23 following the implementation of the GLS program in counties exposed to these prevention activities when compared with similar counties that were not exposed to such intervention. The difference is significant and substantial: 4.9 less attempts per thousand youths. There is no evidence of a simultaneous change in the suicide attempt rate among adults, a group that was not targeted by GLS. The findings are consistent with those from the previous study, which found a substantial reduction in suicide mortality among youths 10-24 following GLS implementation: 1.3 fewer deaths per one hundred thousand youths. (more…)
Author Interviews, JAMA, Pain Research / 13.10.2015

MedicalResearch.com Interview with: Julie M. Fritz, PT, PhD, FAPTA Professor, Department of Physical Therapy Associate Dean for Research, College of Health University of Utah Salt Lake City, UT  84106 Medical Research: What is the background for this study? What are the main findings? Dr. Fritz: Low back pain affects up to 80% of adults at some point in their lives and back pain is among the most common reasons why someone visits their primary care provider.  Despite how common back pain is, the health care system does a surprisingly poor job of managing patients with the condition. There are many things that can happen at the initial primary care visit for back pain that are unhelpful or may even delay recovery such as ordering an MRI or prescribing opioids. Most practice guidelines recommend that primary care providers avoid ordering an MRI or opioid pain medication, reassure the patient that they will begin to feel better quickly and then wait a few weeks before considering referral to physical therapy.  Others have suggested that earlier use of physical therapy may be more beneficial to patients.  We conducted this study to compare early physical therapy with a wait-and-see approach. (more…)
Author Interviews, Cleveland Clinic, JAMA, Multiple Sclerosis / 13.10.2015

Dr. Jeffrey Cohen MD Director Mellen Center for Multiple Sclerosis Treatment and Research Director of the Experimental Therapeutics Program Cleveland Clinic Main CampusMedicalResearch.com Interview with: Dr. Jeffrey Cohen MD Director Mellen Center for Multiple Sclerosis Treatment and Research Director of the Experimental Therapeutics Program Cleveland Clinic Main Campus MedicalResearch: What is the background for this study? What are the main findings? Dr. Cohen: Medications are a major contributor to the high cost of Multiple Sclerosis (MS) care.  As medications go off patent, there is the opportunity to develop generic versions with lower cost.  This trial was conducted after extensive in vitro and animal studies supported the equivalence of a generic glatiramer acetate to the brand drug Copaxone. The trial showed that generic and brand glatiramer acetate have equivalent efficacy as measured by MRI and clinical endpoints, safety, and tolerability. (more…)