Author Interviews, Infections, Multiple Sclerosis / 20.01.2015

Allan G Kermode MBBS MD FRACP FRCP Clinical Professor of Neuroimmunology, Murdoch University Clinical Professor of Neurology, University of Western Australia Head, Department of Neurology and Clinical Neurophysiology SCGH Centre for Neuromuscular and Neurological Disorders Australian Neuromuscular Research Institute Sir Charles Gairdner Hospital Perth WA Australia Institute of Immunology and Infectious Diseases Murdoch University, Western AustraliaMedicalResearch.com Interview with: Allan G Kermode MBBS MD FRACP FRCP Clinical Professor of Neuroimmunology, Murdoch University Clinical Professor of Neurology, University of Western Australia Head, Department of Neurology and Clinical Neurophysiology SCGH Centre for Neuromuscular and Neurological Disorders Australian Neuromuscular Research Institute  Sir Charles Gairdner Hospital Perth WA Australia Institute of Immunology and Infectious Diseases Murdoch University, Western Australia MedicalResearch: You found that H. pylori sero-positivity was significantly lower in female patients with MS than in female healthy controls, but you didn’t find such a trend in men with Multiple Sclerosis… Briefly, what might explain this association between H. pylori and Multiple Sclerosis in women? (i.e the hygiene hypothesis I suppose?). Prof. Kemode: There are a number of possible explanations, but we believe that the most likely is that helicobacter colonisation is a surrogate marker for the baseline levels of exposure to environmental pathogens and organisms during childhood. We have argued this point of view in our manuscript. It should be emphasised that perhaps not all exposure to infectious agents need necessarily be pathogenic, and the concept of the protobiome is an important one. Every healthy (and unhealthy) individual is host to very many organisms, with the gut having the widest diversity. Other explanations for the association might include that there is some specific antigenic interaction occurring promoting specific immune tolerance to CNS antigens, but I believe that this conclusion would be drawing a very long bow with our current stage of knowledge regarding Multiple Sclerosis. MedicalResearch: Why does this relationship exist in women but not in men? (presumably, they are exposed to the same sanitation, hygiene etc.) Prof. Kemode: This is arguably one of the most fascinating observations of our study. Historically the sex ratio in Multiple Sclerosis was equal, yet in the last 100 years the prevalence of Multiple Sclerosis has increased markedly and the majority of this increase has occurred in women such that in Australia the sex ratio F:M approximates 3:1. The fact that over the same period prevalence of helicobacter in Western countries has declined markedly is a tantalising observation. At this stage scientific knowledge has not explained the changing sex ratios in Multiple Sclerosis nor can we yet explain the strong helicobacter association in females but not males in our study, but our study provides useful navigation to direct further research. (more…)
Author Interviews, CDC, JAMA, OBGYNE / 20.01.2015

Sheree L. Boulet, DrPH, MPH Division of Reproductive Health Centers for Disease Control and Prevention, Atlanta, GeorgiaMedicalResearch.com Interview with: Sheree L. Boulet, DrPH, MPH Division of Reproductive Health Centers for Disease Control and Prevention, Atlanta, Georgia Medical Research: What is the background for this study? What are the main findings? Dr. Boulet:  Intracytoplasmic Sperm Injection is generally considered a safe and effective treatment for male factor infertility; however, some studies have shown that ICSI is increasingly used in patients without male factor infertility without clear evidence of a benefit over conventional in vitro fertilization (IVF). In addition to increasing the cost of an IVF cycle, use of  Intracytoplasmic Sperm Injection has been found to increase the risk for adverse infant outcomes such as birth defects, chromosomal abnormalities and autism. Using data from CDC’s National Assisted Reproductive Technology Surveillance System, we found that use of ICSI increased by fourfold from 1996 through 2012 (from 15.4% to 66.9%). Furthermore, we found that use of  Intracytoplasmic Sperm Injection did not improve reproductive outcomes such as rates of pregnancy, miscarriage and live birth, when compared with conventional IVF, regardless of whether male factor infertility was present. (more…)
Author Interviews, Lancet, Stroke / 20.01.2015

MedicalResearch.com Interview with: Prof. dr. Diederik van de Beek Department of Neurology, Academic Medical Center, University of Amsterdam The Netherlands MedicalResearch.com: What is the background for this study? What are the main findings? Dr. van de Beek: In adults with acute stroke, infections occur commonly and are associated with an unfavourable functional outcome. In the Preventive Antibiotics in Stroke Study (PASS) we aimed to establish whether or not preventive antimicrobial therapy with a third-generation cephalosporin, ceftriaxone, improves functional outcome in patients with acute stroke. PASS is an investigator-initiated, randomised, open-label, masked-endpoint trial that was undertaken between 2010 and 2014 in 30 Dutch centres and enrolled 2550 patients with ischaemic or haemorrhagic stroke. Randomly assigned in a 1:1 ratio to either preventive antibiotic therapy or a control group, all patients received standard stroke unit care. Starting within 24 h after stroke onset, patients in the preventive antibiotic group were given additional treatment with ceftriaxone administered intravenously at a dose of 2 g every 24 h for 4 days. The main findings were that preventive ceftriaxone did not improve 3-month functional outcome on the modified Rankin Scale (adjusted common odds ratio 0·95 [95% CI 0·82–1·09]); however, clinically diagnosed post-stroke infections were significantly reduced (adjusted odds ratio 0·55 [0·44–0·70]). Preventive antibiotic therapy with ceftriaxone is a safe treatment. (more…)
Author Interviews, Mental Health Research, Pediatrics, Social Issues / 20.01.2015

Ji Su Hong, MD Department of Psychiatry Washington University School of Medicine St. Louis, MOMedicalResearch.com Interview with: Ji Su Hong, MD  Department of Psychiatry Washington University School of Medicine St. Louis, MO   Medical Research: What is the background for this study? What are the main findings? Dr. Ji Su Hong: The estimated prevalence of preschool conduct disorder is 3.9%-6.6%. Approximately 1 out of 20 preschoolers has conduct disorder. Disruptive behaviors are common in the preschool period of development. However, to date we have not had scientific data to help guide clinicians to distinguish  between normal disruptive behaviors in preschoolers and behaviors that are markers of later Conduct disorder at school age. There were common misbehaviors which were found in preschoolers with mental health problems as well as healthy preschoolers. Those were losing temper, low intensity destruction of property and deceitfulness/stealing. Preschoolers who exhibited high-intensity defiant behavior, aggression toward people or animals, high-intensity destruction of property, peer problems and deceitfulness, including stealing, were more likely to have preschool conduct disorder and they were more likely to be diagnosed with a conduct disorder at school-age. (more…)
Addiction / 20.01.2015

Katharine A. Neill PhD Alfred C. Glassell III Postdoctoral Fellow in Drug Policy Baker Institute, Rice University Houston, TX 77005MedicalResearch.com Interview with: Katharine A. Neill  PhD Alfred C. Glassell III Postdoctoral Fellow in Drug Policy Baker Institute, Rice University Houston, TX 77005 Medical Research: What is the background for this study? What are the main findings? Dr. Neill: This study is a historical review of drug policy in 20th century United States. It examines drug policy decisions and consequences through a socio-political lens and argues that the prominence of the law-and-order approach to dealing with drug offenders--that emphasizes punishment and incarceration over prevention and treatment--is a result of the construction of drug offenders as social deviants that threaten society. This punitive model has been especially harmful because it has occurred to the detriment of harm reduction approaches to drug use that have greater potential to negate the negative individual and public health consequences of drug use. (more…)
Alcohol, Author Interviews, Circadian Rhythm / 20.01.2015

Timo Partonen MD, Research Professor National Institute for Health and Welfare Helsinki, FinlandMedicalResearch.com Interview with: Timo Partonen MD, Research Professor National Institute for Health and Welfare Helsinki, Finland Medical Research: What is the background for this study? What are the main findings? Response: Alcohol-use disorders are often comorbid conditions with mood and anxiety disorders. Clinical studies have demonstrated that there are abnormalities in circadian rhythms and intrinsic clocks in patients with alcohol-use disorders. Circadian clock gene variants are therefore a fruitful target of interest. The main findings are that variants of key clock genes, namely those of ARNTL, ARNTL2, PER1 and PER2, have association with alcohol consumption, with alcohol abuse, or with alcohol dependence. It is of interest that variants of a fifth clock gene of key importance, that is those of CLOCK, are associated with alcohol-use disorders only if comorbid with depressive disorders. (more…)
Author Interviews, Heart Disease, JACC, Statins / 20.01.2015

Dr. Robert S. Rosenson, MD Professor, Cardiology Icahn School of Medicine at Mount Sinai Cardiovascular Institute New York, New York 10029MedicalResearch.com Interview with: Dr. Robert S. Rosenson, MD Professor, Cardiology Icahn School of Medicine at Mount Sinai Cardiovascular Institute New York, New York 10029 Medical Research: What is the background for this study? What are the main findings? Dr. Rosenson: High intensity statin therapy is evidence-based and guideline directed for patients with acute coronary syndromes.  In a 5 percent random sample of Medicare patients, we investigated the utilization of high vs low-moderate dosage statin in older adjusts who were admitted with an acute myocardial infarction of severe myocardial ischemia requiring hospitalization for a revascularization procedure (PCI or CABG). We report that only 27 percent of hospitalized patients received high-intensity statin therapy based on their first outpatient fill for a statin medication.  The most important determinant for the utilization of statin therapy is the dosage of the statin previously prescribed as an outpatient.  When patients were started on a high-intensity statin, the continued use diminished in the ensuing year (more…)
Annals Internal Medicine, Author Interviews, Exercise - Fitness, Lifestyle & Health / 20.01.2015

David Alter, MD, PhD FRCPC Senior Scientist Toronto Rehabilitation Institute-University Health Network and Institute for Clinical Evaluative Sciences Research Director, Cardiac Rehabilitation and Secondary Prevention Program Toronto Rehabilitation InstituteMedicalResearch.com Interview with: David Alter, MD, PhD FRCPC Senior Scientist Toronto Rehabilitation Institute-University Health Network and Institute for Clinical Evaluative Sciences Research Director, Cardiac Rehabilitation and Secondary Prevention Program Toronto Rehabilitation Institute   Medical Research: What is the background for this study? What are the main findings? Dr. Alter: We knew going into the study that exercise was an important lifestyle factor that improved health. We also knew from studies that sedentary time was associated with deleterious health-effects. What we didn’t know was whether the health-outcome effects of sedentary time and exercise were really one and the same (i.e., albeit opposite ends of the same spectrum) or alternatively, whether the health effects of each were independent of one another.  We explored over 9000 published studies to quantify the health-outcome effects associated with sedentary behaviour and extracted only those which took into account both sedentary time and exercise. We found a consistent association between sedentary time and a host of health outcomes independent of exercise. Specifically, after controlling for an individual’s exercising behaviour, sitting-time was associated with a 15-20% higher risk of death, heart-disease, death from heart disease, cancer-incidence, and death from cancer. Sitting time was also independently  associated with a marked (i.e., 90% increase) in the risk for diabetes after controlling for exercise. In short, sedentary times and exercise are each independently associated with health outcomes. We hypothesize that the two may have different mechanism, and may require different therapeutic strategies. But, the health-outcome implications of both are each important in their own right. (more…)
Author Interviews, Cost of Health Care, Heart Disease, JACC, Outcomes & Safety / 19.01.2015

Dr. P. Michael Ho, MD PhD Denver Veteran Affairs Medical Center, University of Colorado, Denver, Section of Cardiology Denver, Colorado 80220.MedicalResearch.com Interview with: Dr. P. Michael Ho, MD PhD Denver Veteran Affairs Medical Center, University of Colorado, Denver, Section of Cardiology Denver, Colorado 80220. Medical Research: What is the background for this study? What are the main findings? Dr. Ho: There is increasing interest in measuring health care value, particularly as the healthcare system moves towards accountable care. Value in health care focuses on measuring outcomes achieved relative to costs for a cycle of care. Attaining high value care - good clinical outcomes at low costs - is of interest to patients, providers, health systems, and payers. To date, value assessments have not been operationalized and applied to specific patient populations. We focused on percutaneous coronary intervention (PCI) because it is an important aspect of care for patients with ischemic heart disease, is commonly performed and is a costly procedure. In this study, we evaluated 1-year risk-adjusted mortality and 1-year risk-standardized costs of care for all patients who underwent PCI in the VA healthcare system from 2008 to 2010. We found that median one-year unadjusted hospital mortality rate was 6.13% (interquartile range 4.51% to 7.34% across hospitals). Four hospitals were significantly above the one-year risk standardized median mortality rate, with median mortality ratios ranging from 1.23 to 1.28; no hospitals were significantly below median mortality. Median 1-year total unadjusted hospital costs were $46,302 (IQR of $37,291 to $57,886) per patient. There were 16 hospitals above and 19 hospitals below the risk standardized average cost, with risk standardized ratios ranging from 0.45 to 2.09 reflecting much larger magnitude of variability in costs compared to mortality. These findings suggest that there are opportunities to improve PCI healthcare by reducing costs without compromising outcomes. This approach of evaluating outcomes and costs together may be a model for other health systems and accountable care organizations interested in operationalizing value measurement. (more…)
Aging, Author Interviews, Heart Disease, JAMA, Salt-Sodium / 19.01.2015

Andreas Kalogeropoulos, MD MPH PhD Assistant Professor of Medicine (Cardiology) Emory University School of Medicine Emory Clinical Cardiovascular Research Institute Atlanta GA 30322MedicalResearch.com Interview with: Andreas Kalogeropoulos, MD MPH PhD Assistant Professor of Medicine (Cardiology) Emory University School of Medicine Emory Clinical Cardiovascular Research Institute Atlanta GA 30322 Medical Research: What is the background for this study? What are the main findings? Dr. Kalogeropoulos: There is ongoing debate on how low should we go when it comes to dietary sodium (salt) restriction recommendations. In this study, we examined the association between self-reported dietary sodium intake and 10-year risk for death, cardiovascular disease, and heart failure in approximately 2,600 adults 71-80 years old. The subjects (women: 51.2%; white: 61.7%; black: 38.3%) were participants of the community-based Health, Aging, and Body Composition Study, which is sponsored by NIH and focuses on aging processes, i.e. was not specifically designed to address the issue of dietary salt intake. Also, it is important to note that salt intake was self-reported (not objectively measured) using a food frequency questionnaire, which underestimates salt intake. Keeping these limitations in mind, we did not observe a significant association between self-reported sodium intake and 10-year mortality, cardiovascular disease, and heart failure. Ten-year mortality was lower in the group reporting 1500–2300 mg daily sodium intake (30.7%) compared to those reporting daily intake less than 1500 mg (33.8%) or over 2300 mg (35.2%); however, this difference was not statistically significant. The 10-year event rates for cardiovascular disease (28.5%, 28.2%, and 29.7%) and heart failure (15.7%, 14.3%, and 15.5%) were also comparable across the <1500-mg, 1500-2300-mg, and >2300-mg dietary sodium intake groups. (more…)
Author Interviews, Columbia, JAMA, Neurological Disorders / 19.01.2015

Jose Gutierrez MD, MPH Assistant Professor of Neurology Division of Stroke and Cerebrovascular Disease Columbia University Medical Center NY, NYMedicalResearch.com Interview with: Jose Gutierrez MD, MPH Assistant Professor of Neurology Division of Stroke and Cerebrovascular Disease Columbia University Medical Center NY, NY Medical Research: What is the background for this study? What are the main findings? Dr. Gutierrez: There is growing interest in the effects of vascular health in cognition. The prevailing thought is that vascular disease leads to worse cognition due to direct structural damage of the brain, as in the case of brain infarcts, microhemorrhages or white matter hyperintensities, which are themselves associated with traditional cardiovascular risk factors such as hypertension, diabetes, smoking etc. Arterial stiffness, particularly of the aorta, has gained interest among researchers as predictors of vascular disease and worse cognition, but it is not clear whether arterial stiffness in the absence of traditional definition of vascular disease may be associated with worse cognition. We investigated in a representative sample of the US among adults 60 years or older who underwent cognitive testing with the Digit Symbol Subtraction test and who also had other measures of vascular disease, including blood workup, blood pressure measurement and Pulse pressure. We hypothesized that indirect measures of arterial stiffness such as ABI > 1.3 or pulse pressure would be associated with worse cognition, even among those without any clinical vascular disease or traditional vascular risk factors. We Included 2573 US adults in the sample, segregated those with any self-reported vascular disease or vascular risk factors and we found that among those without vascular disease or risk factors, an ABI > 1.3 and increased intra-visit blood pressure variability were predictors of worse cognitive performance compared with those without these indicators. Among participants with both indirect markers of arterial stiffness, their cognitive performance was worse that having only one of them suggesting additive effects of these two variables. (more…)
Aging, Author Interviews, JAMA, Lifestyle & Health / 19.01.2015

Jane Wardle University College London MedicalResearch.com Interview with: Jane Wardle University College London Medical Research: What is the background for this study? What are the main findings? Dr. Wardle: Previous studies have shown that couples tend to have similar health behaviours to one another, but no studies had compared having a partner who takes up a healthy behaviour (e.g. quits smoking) with having one whose behaviour is consistently healthy (e.g. never smoked). Nor have there been other studies in the older age group – our participants were over 60 on average.  We used data from 3722 couples participating in the English Longitudinal Study of Ageing (ELSA) to explore this issue for three behaviours: smoking, physical activity, and weight loss. For each behaviour, we found that when one partner changed their behaviour, the other partner was more likely to make a positive change, and the effect was stronger than having a partner whose behaviour was consistently healthy (i.e. never smoked/always exercised). (more…)
Author Interviews, Brigham & Women's - Harvard, Diabetes, Diabetes Care, Nutrition / 19.01.2015

Jinnie J. Rhee Department of Epidemiology, Harvard School of Public Health, Boston, MAMedicalResearch.com Interview with: Jinnie J. Rhee MSc, ScD Department of Medicine, Stanford University School of Medicine Palo Alto, CA Medical Research: What is the background for this study? What are the main findings? Response: The goal of this study was to see if the dietary determinants of type 2 diabetes observed in predominantly white populations were similar to those in other racial and ethnic groups.  We created a dietary diabetes risk reduction score using eight different dietary factors found to be associated with risk of type 2 diabetes, where a higher score indicates a healthier overall diet (A higher score included low intakes trans fat, sugar-sweetened beverages, and red and processed meats; lower glycemic index; and higher intakes of cereal fiber, nuts, and coffee; and higher polyunsaturated to saturated fat ratio).  We found a protective association of similar magnitude between a healthy overall diet and type 2 diabetes risk in all racial and ethnic groups.  However, in terms of the actual number of preventable cases, a healthier diet conferred even greater benefit for minority women because they were initially at higher risk than white women. This study is significant because diabetes is a rapidly growing epidemic in most parts of the world, but most previous studies of diet and diabetes have been conducted in populations of European origin.  This analysis was very powerful because it combined two large populations with a total of 156,030 women who were followed for up to 28 years with many repeated assessments of diet.  This allowed us to conduct detailed analyses within specific racial and ethnic groups. (more…)
Author Interviews, Breast Cancer, Nutrition / 19.01.2015

Cecilia Cesa Schiavon Department of Nutrition, Federal University of Santa Catarina Florianópolis, Santa Catarina, BrazilMedicalResearch.com Interview with: Cecilia Cesa Schiavon Department of Nutrition, Federal University of Santa Catarina Florianópolis, Santa Catarina, Brazil Medical Research: What is the background for this study? What are the main findings? Response: The study was based on a nutritional intervention for patients undergoing treatment for breast cancer. The intervention took place right after the surgical procedure and lasted about a year, until the end of chemotherapy. The patients were submitted to a special methodology of intervention, aimed at increasing fruit and vegetable intake and reducing red and processed meat, following the World Cancer Research Fund and the American Institute for Cancer Research in the document entitled Food, Nutrition, Physical Activity and the prevention of Cancer: A Global Perspective”. The main findings show that women undergoing breast cancer treatment may benefit from immediate, individualized, and detailed nutrition monitoring through appropriate nutrition education. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Science / 19.01.2015

Lee Zou, Ph.D. Professor of Pathology, Harvard Medical School The Jim & Ann Orr MGH Research Scholar Associate Scientific Director, MGH Cancer CenterMedicalResearch.com Interview with: Lee Zou, Ph.D. Professor of Pathology, Harvard Medical School The Jim & Ann Orr MGH Research Scholar Associate Scientific Director, MGH Cancer Center Medical Research: What is the background for this study? What are the main findings? Dr. Lee Zou: Cancer cells must rely on telomerase or the alternative lengthening of telomere (ALT) pathway to maintain telomeres and bypass replicative senescence. The ALT pathway is active in about 10-15% of human cancers, and it is particularly prevalent in specific cancer types, such as osteosarcoma, glioblastoma, and neuroendocrine pancreatic tumors. ALT is a recombination-mediated process. Whether the reliance of cancer cells on  alternative lengthening of telomere can be exploited therapeutically was not known. In our study, we discovered that the ATR kinase is a key regulator of alternative lengthening of telomere. We found that ATR inhibitors disrupt ALT effectively. Furthermore, we found that ATR inhibitors selectively kill ALT-positive cancer cells in a panel of caner cell lines. These findings have suggested the first rational therapeutic strategy for the treatment of ALT-positive cancer. (more…)
Author Interviews, Kidney Disease, NEJM / 19.01.2015

MedicalResearch.com Interview with: David K. Packham, M.B., B.S., M.D Royal Melbourne Hospital Melbourne Renal Research Group VIC 3073, Australia, Medical Research: What is the background for this study? What are the main findings? Dr. Packham:  ZS-9 represents a new mechanism of action for addressing hyperkalemia. Unlike traditional nonspecific organic polymer cationexchangers, ZS-9 is a non-absorbed, inorganic crystalline potassium-selective cation exchanger that traps excess potassium in the gastrointestinal tract. It has been evaluated in three prospective, randomized, double-blind, placebo-controlled studies with over 1100 patients to date, representing the largest ever clinical development program for hyperkalemia. ZS-003 was the first of two pivotal Phase 3 studies that evaluated the safety and efficacy of ZS-9 in patients with hyperkalemia. In ZS-003, treatment of patients with an oral suspension of ZS-9 (2.5, 5, or 10 grams, three times a day) resulted in statistically significant and clinically meaningful reductions in serum potassium, compared with placebo, during the “acute phase” (first 48 hours), with 99 percent of patients achieving normal potassium levels with the highest 10 gram dose. During the next 12 days of the trial (the “maintenance phase”), ZS-9 (5 or 10 grams) given once daily could maintain the corrected potassium levels achieved during the acute phase. In contrast, patients who were randomized back to placebo after achieving normal potassium reverted back to hyperkalemia. The tolerability profile has been favorable, with adverse event rates from ZS-9 similar to that of placebo. (more…)
Author Interviews, Dental Research, Heart Disease / 19.01.2015

Dr. Francisco Mesa Department of Periodontics, School of Dentistry, University of Granada, Spain MedicalResearch.com Interview with: Dr. Francisco Mesa Department of Periodontics, School of Dentistry, University of Granada, Spain Medical Research: What is the background for this study? What are the main findings? Dr. Mesa: The size of an acute myocardial infarct (AMI) is one of the determinants of its severity, i.e., the degree of myocardial necrosis. This necrosis is indicated by peak troponin I levels in the blood. Among the acute myocardial infarct patients in our study, mediated regression analysis demonstrated that troponin I levels were higher, i.e., the infarct size was larger, in those with chronic periodontitis. (more…)
Erasmus, General Medicine, Heart Disease, JACC / 18.01.2015

MedicalResearch.com Interview Invitation Dr. Eric Boersma Associate Professor of Clinical Cardiovascular Epidemiology Thoraxcenter, Erasmus Medical Center and Cardiovascular Research Institute COEUR, Rotterdam, the Netherlands MedicalResearch: What is the background for this study? What are the main findings? Dr. Boersma: Near-infrared spectroscopy (NIRS) is a novel intracoronary imaging technique. The NIRS-derived lipid core burden index (LCBI) quantifies the lipid content within the coronary artery wall. This study was designed to evaluate the prognostic value of LCBI in patients with coronary artery disease (CAD) undergoing coronary catheterization (CAG). We learned that patients with high (above the median) LCBI values had 4 times higher risk of coronary events during 1 year follow-up than those with low values. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Surgical Research / 18.01.2015

Soko Setoguchi, MD DrPH Assistant Professor of Medicine Harvard Medical School and Harvard School of Public Health Director of Safety and Outcome Research in Cardiology Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s HospitalMedicalResearch.com Interview with: Soko Setoguchi, MD DrPH Assistant Professor of Medicine Harvard Medical School and Harvard School of Public Health Director of Safety and Outcome Research in Cardiology Associate Physician in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s Hospital 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 (CAS) vs Carotid endarterectomy (CEA) 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 peforming stenting in trial setting vs. real world practice setting. SAPPHIRE and CREST physicians were enrolled only after having demonstrated CAS 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 a 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. (more…)
Author Interviews, PLoS, Sexual Health / 18.01.2015

MedicalResearch.com Interview with: Matthew Golden MD, MPH Director, PHSKC HIV/STD Program Professor of Medicine, University of Washington Harborview Medical Center Medical Research: What is the background for this study? What are the main findings? Dr. Golden: Gonorrhea and chlamydial infection are the most common reportable infections in the United States and, in women, are associated with pelvic inflammatory disease, ectopic pregnancy, infertility and chronic pelvic pain. One way to decrease the number of cases of gonorrhea and chlamydia is to increase our success in treating the sex partners of persons diagnosed with these infections. Expedited partner therapy (EPT) - treating partners without requiring them to first undergo a medical evaluation - is one way to increase partner treatment. This usually involves giving people medication to give to their partners. Prior randomized trials have found that EPT decreases patients' risk of becoming reinfected. We conducted a community-level randomized trial to evaluate whether making free Expedited partner therapy available to medical providers would increase the use of Expedited Partner Therapy and decrease gonorrhea and chlamydial infections at the population level. We found that a public health program that made Expedited partner therapy widely available could dramatically increase medical providers use of EPT. Although our final result was not statistically significant, our findings suggest that the program likely decreased both gonorrhea and chlamydial infection by about 10% at the population-level. (more…)
Author Interviews, Dermatology, Heart Disease / 18.01.2015

Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology, Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, IllinoisMedicalResearch.com Interview with: Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology, Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, Illinois Medical Research: What is the background for this study? What are the main findings? Dr. Silverberg: There is a growing body of literature supporting an association between psoriasis and increased cardiovascular risk. We hypothesized that these associations are not specific to psoriasis. Rather, they likely occur in other chronic inflammatory skin disorders, namely eczema. We studied two large-scale US population-based studies and found that adults with eczema were more likely to smoke cigarettes, drink alcohol and were less physically active. In turn, they also have higher rates of obesity, high blood pressure, prediabetes and type 2 diabetes and high cholesterol. Of note, eczema was associated with these disorders even after controlling for smoking, alcohol consumption and physical activity. This suggests that chronic inflammation and/or other factors related to eczema may also drive increased cardiovascular risk. (more…)
Author Interviews, Weight Research / 17.01.2015

Sue Shapses, PhD Professor, Department of Nutritional Sciences Acting Chair, Department of Exercise Sciences and Sports Studies Rutgers, The State University New Brunswick, NJ 08901-8525MedicalResearch.com Interview with: Sue Shapses, PhD Professor, Department of Nutritional Sciences Acting Chair, Department of Exercise Sciences and Sports Studies Rutgers, The State University New Brunswick, NJ 08901-8525 MedicalResearch: What is the background for this study? Dr. Shapses: Improving health outcomes through dieting and weight loss is encouraged for the majority of Americans who are either overweight or obese. However, while most studies show that a moderate reduction in body weight decreases obesity related comorbidities, there may also be loss of bone and muscle in older individuals. Specifically in postmenopausal women, intentional moderate weight loss results in a 1-2.5% bone loss when compared to a weight stable group. Studies in men, designed to address the effect of weight reduction at multiple bone sites, compartments and geometry, are currently lacking. In addition, while a higher body weight is associated with higher bone mass, evidence indicates that bone quality, a predictor of fracture risk, is compromised in the obese. It is possible that frequent dieting or weight cycling in these obese individuals may have deleterious effects on bone. Therefore, understanding whether bone quality changes with weight loss, is important to better predict osteoporosis risk in this population. In this controlled trial, the effect of dietary restriction on bone mineral density (BMD), geometry and strength were examined in middle aged and older obese/overweight men. In addition, we addressed whether endocrine changes associated with weight loss explain bone changes. (more…)
Aging, Author Interviews, Frailty / 17.01.2015

MedicalResearch.com Interview with: Alexander Voukelatos BSc, BA, MA(psych), PhD Healthy Populations Program Manager Health Promotion Sydney Local Health District and Conjoint Lecturer School of Public Health and Community Medicine University of NSW Medical Research: What is the background for this study? Response:Falls in older people has been a significant public health issue in high income countries for several decades now. We know that if current trends continue, given that more people will be living for longer, falls will be an even bigger issue in the not too distant. Falls are not an inevitable part of ageing, and in fact many falls can be prevented relatively simply by increasing physical activity. For over 15 years we've known that physical activity is one of the most effective ways of reducing the risk of falls in older people living in the community; since the publication of the first Cochrane review on Interventions for preventing falls in the elderly by Gillespie and colleagues. [1]  I know that Health Departments here, in Australia, and in New Zealand - as I suspect has been the case in many high income countries - have invested a lot of resources over the past few decades into reducing falls-related hospital admissions in older people. Much of this going into promoting and funding physical activity programs for older people. However, this investment has had very little if any impact on falls-related hospital admissions in older people. There may be several reasons we haven't seen any difference in these rates. In New South Wales - Australia's most populous state -  we know that physical activity rates amongst older people have actually risen by about 15% between 1998 and 2005,[2] the most popular activity by far being walking,[3] yet we haven't see any corresponding change in falls-related hospitalization rates. Perhaps there has not been enough time for these programs to have made an impact on hospitalization rates, or perhaps the change in physical activity levels is insufficient to make an impact on these rates. Another possibility could be that while we've seen an increase in physical activity in older people perhaps its not the kind of physical activity that results in a reduction in falls. Sherrington and colleagues [4] reviewed effective physical activity interventions for preventing falls in older people and found they had several elements in common: a) the physical activity included balance challenging exercise i.e. exercises taking participants to the limits of their stability, b) at least 50 hours of accumulated activity was needed, and c) no walking was included in the exercises. So we know not all types of physical activity will be equally effective in reducing the risk of falling. There is some disagreement in the literature about walking. There are several studies that included walking as part of the intervention and showed a reduction in falls in older people. Other studies supported the conclusions made by Sherrington that walking is not associated with a reduction in falls. All of these studies included walking as a component of an intervention which makes it difficult to figure out what effect walking specifically has on falls rates. This is were our study comes in. We wanted to investigate the effectiveness of a walking program on falls in older people, specifically sedentary older people, who we presumed would get the most benefit from becoming more physically active. We developed a walking program specifically for sedentary older people, that they could do themselves in their own time, at their preferred locale. The aim of the program was to get participants walking for at least 150 minutes per week at a brisk pace. The program comprised of four parts: the first part focused on increasing the frequency of walks, the second part focused on getting participants to walk for at least 150 minutes per week, followed by walking for 150 minutes at a brisk pace, while the final part focused on supporting participants in maintaining their walking levels and incorporating walking as part of their daily activities. (more…)
AHA Journals, Author Interviews, Heart Disease, Stroke / 17.01.2015

Jonathan Thigpen, PharmD Assistant Professor Clinical and Administrative Sciences Notre Dame of Maryland University School of PharmacyMedicalResearch.com Interview with: Jonathan Thigpen, PharmD Assistant Professor Clinical and Administrative Sciences Notre Dame of Maryland University School of Pharmacy Medical Research: What is the background for this study? What are the main findings? Dr. Thigpen: This effort assessed the accuracy of International Classification of Disease 9th Edition (ICD-9) stroke codes in identifying valid stroke events in a cohort of atrial fibrillation (AF) patients. The initial electronic search yielded 1,812 events across three stroke centers (Boston Medical Center, Geisinger Health System, and University of Alabama). All ICD-9 identified stroke events were vetted through manual chart review with final adjudication by a stroke neurologist. Atrial fibrillation was verified by evidence via electrocardiogram at stroke admission, 6 months prior to, or 90 days after stroke admission. In addition to assessing the accuracy of the stroke codes alone, we also assessed the accuracy of stroke and Atrial fibrillation codes combined as well as the accuracy of stroke codes when seeking for stroke associated with Atrial fibrillation. These additional steps give readers insight as to the accuracy and reliability of using ICD-9 codes alone to create a stroke plus AF cohort. We feel that this effort is extremely important given the increasing reliance on ICD-9 codes as a means of identifying stroke events and covariates in research, especially research using administrative data. The positive predictive value (PPV) of stroke codes alone was 94.2%. PPVs did not differ across clinical site or by type of event (ischemic vs. intracranial hemorrhage). PPV of stroke codes did differ by event coding position (primary vs. other; 97.2% vs. 83.7%) and by ischemic stroke code (433 vs. 434; 85.2% vs. 94.4%). When combined with validation of Atrial fibrillation codes, the PPV of stroke codes decreased to 82.2%. After excluding ischemic stroke due to a different mechanism (eg, vascular procedure, tumor, sepsis) the PPV dropped further to 72.8%. As a separate exercise, manual review confirmed 33 (7.2%) ischemic strokes in 458 events coded as "without infarction". (more…)
Author Interviews, Endocrinology, Weight Research / 16.01.2015

Caroline M. Apovian, MD Chair of the Endocrine Society task force that developed “Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline” Boston University School of Medicine Boston Medical CenterMedicalResearch.com interview with: Caroline M. Apovian, MD Chair of the Endocrine Society task force that developed “Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline” Boston University School of Medicine Boston Medical Center MedicalResearch: What is the background for this report? Dr. Apovian: The Food and Drug Administration has approved four new anti-obesity drugs – lorcaserin, phentermine/topiramate, naltrexone/bupropion and liraglutide – in the past two years. To help clinicians navigate this changing landscape, the Endocrine Society developed its Clinical Practice Guideline to provide strategies for prescribing drugs to manage obesity and promote weight loss. MedicalResearch: What are the main findings? Dr. Apovian: In the Clinical Practice Guideline, the Endocrine Society recommends that diet, exercise and behavioral modifications be part of all obesity management approaches. Other tools such as weight loss medications and bariatric surgery can be combined with behavioral changes to reduce food intake and increase physical activity, in appropriate patients. Patients who have been unable to successfully lose weight and maintain a goal weight may be candidates for prescription medication if they meet the criteria on the drug’s label as well as BMI criteria (BMI greater than or equal to 30 or greater than or equal to 27 with at least one comorbidity). Other recommendations from the CPG include:
  • If a patient responds well to a weight loss medication and loses 5 percent or more of their body weight after three months, the medication can be continued. If the medication is ineffective or the patient experiences side effects, the prescription should be stopped and an alternative medication or approach considered.
  • Since some diabetes medications are associated with weight gain, people with diabetes who are obese or overweight should be given medications that promote weight loss or have no effect on weight as first- and second-line treatments. Doctors should discuss medications’ potential effects on weight with patients.
  • Certain types of medication – angiotensin converting enzyme inhibitors, angiotensin receptor blockers and calcium channel blockers – should be used as a first-line treatment for high blood pressure in obese people. These are effective blood pressure treatments that are less likely to contribute to weight gain than an alternative medication, beta-adrenergic blockers.
  • When patients need medications that can have an impact on weight such as antidepressants, antipsychotic drugs and medications for treating epilepsy, they should be fully informed and provided with estimates of each option’s anticipated effect on weight. Doctors and patients should engage in a shared-decision making process to evaluate the options.
  • In patients with uncontrolled high blood pressure or a history of heart disease, the medications phentermine and diethylpropion should not be used.
(more…)
Author Interviews, Technology / 16.01.2015

Moe Alsumidaie MBA MSF President & Chief Scientific Officer Annex ClinicalMedicalResearch.com Interview with: Moe Alsumidaie MBA MSF President & Chief Scientific Officer Annex Clinical   MedicalResearch: What is the background for this study? Response: SUMMARY: A real-world case study measuring the impact of Short Messaging System (SMS) or “Text Messaging” on clinical trial patient recruitment using an interactive two-way patient engagement platform by Mosio, Inc., which provides clinical research services designed to increase patient recruitment, engagement and retention, found that use of text messaging alone can be an effective means of patient engagement that results in clinical trial patient enrollment. Patient recruitment, retention and medication adherence continue to be challenges in conducting effective clinical trials. While clinical trials often rely on email recruitment, recent studies suggest that only 22% of emails are read.1 Alternatively, 98% of text messages are read1 and 90% of text messages are read within the first three minutes of receipt.2 Recent research has evaluated the impact of Short Messaging System (SMS) or “Text Messaging” in healthcare settings, such as appointment reminders and medication adherence. Results have demonstrated that SMS intervention significantly improved patient behavioral outcomes: patients who received SMS reminders were more likely to show up to appointments on time,3 and patients who received SMS reminders were more adherent to medications.4 However, only limited research is available on the effect of SMS on clinical trial subject enrollment. Johnson County Clin-Trials (JCCT), a clinical research facility that specializes in executing 10-15 vaccine clinical trials per year, was facing issues with enrolling patients rapidly in a tight time frame using email. To access a more effective strategy to better engage patients, JCCT employed two-way SMS/text messaging solutions, and this study assessed the impact of SMS/text messaging on patient recruitment and enrollment. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, JAMA, Medicare, Mental Health Research, Pharmacology / 16.01.2015

Dr. Jeanne Madden PhD Instructor, Department of Population Medicine Harvard Medical SchoolMedicalResearch.com Interview with: Dr. Jeanne Madden PhD Instructor, Department of Population Medicine Harvard Medical School   Medical Research: What is the background for this study? What are the main findings? Dr. Madden: When Medicare Prescription Drug Coverage started in 2006, many experts voiced concerns about disabled patients with serious mental illness making the transition from state Medicaid coverage to Medicare.  Our study is one of the first to examine the impact of the transition in mentally ill populations.  People living with schizophrenia and bipolar disorder are at high risk of relapse and hospitalization and are especially vulnerable to disruptions in access to their treatments. We found that the effects of transitioning from Medicaid to Medicare Part D depended on where patients lived.  Transition to Part D in states that put limits on Medicaid drug coverage resulted in fewer patients going without treatment. By contrast, in states with more generous drug coverage, we saw reductions in use, of antipsychotics in particular, after patients shifted to Medicare Part D.  This may have been due to new cost controls used within many private Medicare drug plans.  Given that most states in the US are in this latter category, with the relatively generous Medicaid drug coverage, we also found reductions in antipsychotic use nation-wide. Although a very large group of people made that transition from Medicaid to Medicare in 2006, thousands more still transition every year because when disabled people qualify for Medicare, they must wait 2 years for their benefits kick in.  Also, many other disabled patients are on Medicaid only and don’t qualify for Medicare.  They are of course affected by restrictions on Medicaid coverage, which vary from state to state. (more…)
Author Interviews, Dengue, Infections, PLoS / 16.01.2015

MedicalResearch.com Interview with: Jose R. Loaiza Smithsonian Tropical Research Institute, Panama City, Panama, Instituto de Investigaciones Científicas y Servicios de Alta Tecnología,  Universidad de Panamá, Ciudad de Panamá, Panamá   Medical Research: What is the background for this study? Response: The mosquito Aedes albopictus is a worldwide vector of both Dengue and Chikungunya viruses. This species invaded Panama in 2002, and it expanded across much of the country since that time. Our main goal was to determine the factors (e.g., ecological and non-ecological) associated with its expansion, and to comment on the implications for vector and disease control programs elsewhere in the American tropics. Medical Research: What are the main findings? Response: We found that road networks alone best predicted the distribution of Ae. albopictus in Panama over other variables such as population density and climate. Our data explain the invasion mode of this mosquito species on a local level and demonstrate a remarkable population expansion velocity across the country. Ae. albopictus is likely moving across the landscape as immature stages (i.e., larvae and pupae) in open water, such as used tires. (more…)
Author Interviews, Breast Cancer, Inflammation / 16.01.2015

Dr. Jorge Morales-Montor Departamento de Inmunología Instituto de Investigaciones Biomédicas Universidad Nacional Autónoma de México México City MéxicoMedicalResearch.com Interview with: Dr. Jorge Morales-Montor Departamento de Inmunología Instituto de Investigaciones Biomédicas Universidad Nacional Autónoma de México México City México MedicalResearch: What is the background for this study? Dr. Morales-Montor: Cytokines are highly inducible, secretory proteins that mediate intercellular communication in the immune system. They are grouped in several protein families referred as tumour necrosis factors, interleukins, interferons and colony stimulating factors. In recent years, it has become clear that some of these proteins as well as their receptors are produced in the organisms under physiological and pathological conditions. The exact initiation process of breast cancer is unknown, although several hypotheses have emerged. Inflammation has been proposed as an important player in tumor initiation, promotion, angiogenesis and metastasis, all phenomena in which cytokines are prominent players. The data we have hitherto let us suggest that cytokines play an important role in the regulation of both induction and protection in breast cancer. This knowledge could be fundamental for the proposal of new therapeutic approaches to particularly breast cancer and other cancer related disorders. (more…)