AstraZeneca, Author Interviews, Autism, Boehringer Ingelheim, Depression, Eli Lilly, J&J-Janssen, JAMA, Merck, OBGYNE / 17.04.2017

MedicalResearch.com Interview with: Florence Gressier MD PhD Insermk Department of psychiatry CHU de Bicêtrem Le Kremlin Bicêtre France MedicalResearch.com: What is the background for this study? What are the main findings? Response: Results from recent studies have suggested an increased risk for Autism Spectrum Disorders (ASDs) in children exposed to antidepressants in utero. We performed a systematic review of and a meta-analysis of published studies to assess the association between ASDs and fetal exposure to antidepressants during pregnancy for each trimester of pregnancy and preconception. Our systematic review and meta-analysis suggests a significant association between increased ASD risk and maternal use of antidepressants during pregnancy; however, it appears to be more consistent during the preconception period than during each trimester. In addition, the association was weaker when controlled for past maternal mental illness. Maternal psychiatric disorders in treatment before pregnancy rather than antenatal exposure to antidepressants could have a major role in the risk for Autism Spectrum Disorders. (more…)
Author Interviews, Hepatitis - Liver Disease, JAMA / 14.04.2017

MedicalResearch.com Interview with: Joshua Barocas, MD Clinical and Research Fellow Division of Infectious Diseases Massachusetts General Hospital and Brigham and Women's Hospital  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Boston Health Care for the Homeless Program began treating HCV-infected individuals with the new oral medications. Based on clinical experience and previous experience with medication adherence in the setting of HIV, there were no clinical reasons that homeless persons should be excluded. As a result, we began to track the experience of treated individuals including cure, side effects, and adherence. We found that in the initial group of treated individuals, 62 of 64 persons achieved SVR. There were minimal side effects and adherence was excellent.  (more…)
Author Interviews, Boehringer Ingelheim, Diabetes, JAMA, Ophthalmology / 13.04.2017

MedicalResearch.com Interview with: Marco A Zarbin, MD, PhD, FACS Alfonse Cinotti, MD/Lions Eye Research Professor and Chair Institute of Ophthalmology & Visual Science Rutgers-New Jersey Medical School Rutgers University Newark, NJ 0710  MedicalResearch.com: What is the background for this study? What are the main findings?
  1. Most large, randomized clinical trials are powered to assess the efficacy of drugs or interventions, but they usually do not enroll enough patients to accurately assess the frequency of uncommon, undesirable side effects.
  2. In order to compensate for this deficiency in trial design, investigators aggregate the results of numerous studies all of which address the same clinical question with the same (or similar) drugs/interventions to increase the power to detect uncommon side effects. These aggregate studies can be meta-analyses.
  3. Unfortunately, most meta-analyses do not have the ability to answer some critical questions such as the timing of an adverse event relative to the last exposure to the drug, nor can they compensate fully for differences among the aggregated studies in trial design, length of patient follow-up, or presence pre-existing risk factors for the side effects in question.
  4. A pooled analysis of combined clinical trials using patient level data, however, allows a more in depth analysis of side effects than study level data, which are usually used for most published meta-analyses, because patient level data allow one to incorporate the per-patient duration of exposure to treatment, adjust for imbalances in predefined baseline risk factors, and adjust for the effect of results of single studies on the overall result.
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Author Interviews, Heart Disease, JAMA, Vitamin D / 13.04.2017

MedicalResearch.com Interview with: Robert Scragg, MBBS, PhD School of Population Health The University of Auckland Auckland New Zealand MedicalResearch.com: What is the background for this study? What are the main findings? Response: Interest in a possible role for vitamin D deficiency as a risk factor for cardiovascular disease was stimulated by studies showing a seasonal variation in cardiovascular disease, which is much higher in winter, when body levels of vitamin D are low, than in summer. Main findings are that bolus monthly doses of vitamin D supplementation do not prevent against cardiovascular disease, even in people with low levels of vitamin D. (more…)
Author Interviews, Heart Disease, JAMA, Lipids, Nutrition, Stroke, Yale / 13.04.2017

MedicalResearch.com Interview with: Eric J. Brandt, MD Yale University Cardiovascular Disease Fellow MedicalResearch.com: What is the background for this study? What are the main findings? Response: From previous studies we know that industrial trans fatty acid (trans fat) consumption is linked to elevated risk for cardiovascular disease. Even small amounts of consumption can be deleterious to cardiovascular health. In New York state, there were 11 counties that restricted the use of trans fatty acids in eateries. We compared hospitalization for heart attacks and stroke from 2002 through 2013 in counties that did and did not have restrictions. Our study found that when comparing populations within New York state that restricted the use of trans fat, compared to those that did not, there was an associated additional decline beyond temporal trends for heart attacks and stroke events combined by 6.2%. (more…)
Author Interviews, End of Life Care, JAMA / 10.04.2017

MedicalResearch.com Interview with: Charles D. Blanke, M.D., F.A.C.P., F.A.S.C.O. CHAIR, SWOG Professor, OHSU Knight Cancer Institute Marquam II MedicalResearch.com: What is the background for this study? What are the main findings? Response: Oregon’s Death with Dignity Act as a voter initiative which law in 1997 – the first of its kind in the nation. Now, physician aid-in-dying is spreading quickly, with the states of Washington, Vermont, Colorado, and California passing similar legislation, as well as the District of Columbia, and Montana (through a court ruling). Millions of Americans lives in states where they would have the opportunity, if they were terminally ill, to take a lethal dose of medication with a doctor’s prescription. My team here at SWOG, a global cancer research community that designs and conducts publicly funded clinical trials, wanted to look at Oregon’s 18 years of aid-in-dying data and answer some simple questions: Who is using the law? Why? Are the drugs effective? What are the trends in actually taking the prescribed medications? We found that use of law has mostly increased over time – and substantially increased in 2014 and 2015. We found that predominantly white, older, well-educated people, take advantage of the law, and many of them – 77 percent – have underlying terminal cancer. The medication is also 99.4 percent effective. (more…)
Author Interviews, Autism, Environmental Risks, JAMA, Toxin Research / 10.04.2017

MedicalResearch.com Interview with: Keith Fluegge BS Institute of Health and Environmental Research (IHER) Cleveland Graduate School, The Ohio State University, Columbus Ohio MedicalResearch.com: What is the background for this study? What are the main findings? Response: The research letter discusses the possible link between rainfall precipitation and risk of autism. Earlier research suggested a link, although there remained quite a bit of skepticism surrounding the findings at the time. The purpose of the study was to briefly highlight the role of environmental exposure to the agricultural and combustion pollutant, nitrous oxide (N2O), as a possible etiological factor in neurodevelopmental disorders. We have published a series of epidemiological investigations, reviews, and correspondences discussing this possibility. In my continued research on this topic, I learned that rainfall and extreme weather-related events, like hurricanes, drive N2O emissions, especially from nitrogen amended soils. Exposure to this particular air pollutant may, therefore, plausibly undergird the relationship between rainfall precipitation and risk of autism. (more…)
Author Interviews, Cost of Health Care, JAMA, Primary Care, UCLA / 10.04.2017

MedicalResearch.com Interview with: John N. Mafi, MD, MPH Assistant Professor of Medicine Division of General Internal Medicine and Health Services Research UCLA David Geffen School of Medicine Los Angeles, CA 90024 Affiliated Natural Scientist in Health Policy RAND Corporation 1776 Main St, Santa Monica, CA 90401 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Between 10-30% of healthcare costs are due to low value care, or patient care that provides little to no benefit to patients, and can sometimes cause harm (e.g., radiation exposure from diagnostic imaging tests). In this study, we found that hospital-based primary care practice provide more low value care than community-based primary care practices across the United States. Understanding where and why low value care occurs is going to be essential if we want to get serious about eliminating it. (more…)
Author Interviews, CDC, JAMA, Stroke / 10.04.2017

MedicalResearch.com Interview with: Mary G. George, MD, MSPH Division for Heart Disease and Stroke Prevention National Center for Chronic Disease Prevention and Health Promotion Centers for Disease Control and Prevention Atlanta, Georgia MedicalResearch.com: What is the background for this study? Response: Stroke is the fifth leading cause of death in the United States, killing more than 130,000 Americans each year—that’s 1 of every 20 deaths—and costs the nation $33 billion annually, including the cost of health care services, medications, and lost productivity. And, stroke is leading cause of serious disability. An ischemic stroke, sometimes called a brain attack, is a stroke that occurs when there is a blockage of the blood supply to the brain. (more…)
Accidents & Violence, Author Interviews, JAMA, Karolinski Institute, Mental Health Research / 06.04.2017

MedicalResearch.com Interview with: Hanna Sahlin MSc, Lic psychologist, Lic psychotherapist Specialist in clinical psychology PhD-student Departement of Clinical Neuroscience Karolinska Institutet National Self-harm project Centre for Psychiatry Research, CPF Stockholm, Sweden What is the background for this study? What are the main findings? Response: This study is the result of wanting to find a more conclusive answer to whether individuals who engage in non-fatal deliberate self-harm are more prone to aggression towards others. There has long been a debate on whether aggression to oneself and aggression towards others co-occur, but the studies that have been conducted thus far have been on smaller samples or with clinical or forensic cohorts. Also, the studies have had great variability regarding the definition of both “deliberate self-harm” and “violence”. Thus, it has been difficult to establish an ”overall” effect size for this association, or to draw firmer conclusions on how and if this association plays out in the general population. We had the opportunity to study this association in several large nationwide population-based registries including all Swedish citizens, and with high specificity regarding the ingoing variables of interest – i.e., non-fatal deliberate self-harm (as registered in the National Patient Register) and violent crime convictions (as registered in the National Crime Register). We found a five times increased crude risk (hazard) of being convicted of a violent crime if one had received self-harm associated clinical care, and vice-versa, that there was an equally increased risk of self-harm if one had been convicted of a violent crime. After controlling for relevant psychiatric comorbidities and socio-economic status, an almost doubled risk of violent crime conviction remained among self-harming men and women compared to individuals not exposed to self-harm. It is important to notice that our study did not find any evidence suggesting that self-harm behaviours cause violent criminality. Therefore, we conclude that the engagement in violence towards oneself and towards others share an underlying vulnerability to impulsive and aggressive behaviours. (more…)
Author Interviews, Global Health, JAMA, Pediatrics / 06.04.2017

MedicalResearch.com Interview with: Dr. Nicholas Kassebaum, MD Assistant Professor Institute for Health Metrics and Evaluation University of Washington MedicalResearch.com: What is the background for this study? Response: Reducing deaths of young children has been an international priority over the past few decades, and much progress has been made in this regard. Comprehensive and timely measurement of death and disease burden among children and adolescents is essential for improving the health of young people. Analyzing the latest estimates from the Global Burden of Disease (GBD), the current study quantifies and describes levels and trends of mortality and disease burden among children and adolescents under the age of 19 from 1990 to 2015. (more…)
Author Interviews, Epilepsy, JAMA, Karolinski Institute, OBGYNE, Pediatrics, Weight Research / 06.04.2017

MedicalResearch.com Interview with: Neda Razaz-Vandyke, PhD, MPH Postdoctoral Fellow Reproductive Epidemiology Unit Karolinska Institutet   MedicalResearch.com: What is the background for this study? What are the main findings? Response:   There is a growing concern about long-term neurological effects of prenatal exposure to maternal overweight and obesity. The etiology of epilepsy is poorly understood and in more than 60% of cases no definitive cause can be determined. We found that maternal overweight and obesity increased the risks of childhood epilepsy in a dose-response pattern. (more…)
Author Interviews, Education, Electronic Records, JAMA, Johns Hopkins / 06.04.2017

MedicalResearch.com Interview with: Ge Bai, PhD, CPA Assistant Professor The Johns Hopkins Carey Business School Washington, DC 20036 MedicalResearch.com: What is the background for this study? What are the main findings? Response: We examined the hospital data breaches between 2009 and 2016 and found that larger hospitals and hospitals that have a major teaching mission have a higher risk of data breaches. (more…)
Author Interviews, Cost of Health Care, JAMA, Surgical Research, Thyroid / 05.04.2017

MedicalResearch.com Interview with: Benjamin James, MD MS Assistant Professor of Surgery Adjunct Assistant Professor of Otolaryngology Section of Endocrine Surgery IU Division of General Surgery Indiana University Hospital Indianapolis, IN 46202 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Over the few decades, there has been a substantial increase in the incidence of thyroid cancer. It is the fastest growing cancer and a recent study in JAMA found that the mortality rate has been rising. In 2006, Massachusetts passed healthcare reform, which expanded Medicaid, created new subsidized insurance programs for those ineligible for Medicaid and extended young adults eligibility on parental plans until the age of 26. The aim of our study was to evaluate the impact this has had on the treatment of thyroid cancer. To address this question, we used the Hospital Cost and Utilization Project State Inpatient Databases for Massachusetts, New Jersey, New York, and Florida, which included a cohort of 56,581 inpatient admissions from 2001 to 2011. We then compared these states before and after the healthcare reform in Massachusetts to evaluate the effect the healthcare reform had on the treatment of thyroid cancer. (more…)
Author Interviews, Gastrointestinal Disease, JAMA / 04.04.2017

MedicalResearch.com Interview with: Dr. Ann Kurth, Task Force member Dean of the Yale School of Nursing Adjunct professor New York University College of Nursing and the College of Global Public Health. MedicalResearch.com: What is the background for this study? Response: Celiac disease, an immune disorder where people should not eat food with gluten, is fairly prevalent. When people with celiac disease eat foods containing gluten, which is found in wheat, rye and barley, their body responds by inflaming or destroying villi—the tiny, fingerlike projections on the inner lining of the small intestine–which prevents the body from absorbing the necessary nutrients from food. (more…)
Author Interviews, Cost of Health Care, JAMA, Macular Degeneration, Ophthalmology, Telemedicine / 02.04.2017

MedicalResearch.com Interview with: John Wittenborn Senior research scientist NORC's Public Health Analytics University of Chicago MedicalResearch.com: What is the background for this study? What are the main findings? Response:The emergence of anti-VEGF treatment for wet-form AMD (choroidal neovascularization) has had a dramatic impact on preserving vision for many Americans. However, community-based studies show that most patients are not diagnosed with wet-form AMD until they have already lost a significant, and largely unrecoverable amount of their vision.  Early detection of wet-form AMD is key to effective treatment and the preservation of vision. The ForeseeHome telemonitoring technology provides patients with a means to check their own eyes on a daily basis to detect the earliest signs of vision loss from wet-form AMD. This is a novel technology that has the potential to improve visual health outcomes for AMD patients.  A prior clinical trial (the AREDS-2 HOME study) demonstrated that this technology can detect wet-form AMD earlier, and with less vision loss than standard care alone. However, that is exactly where that study ended as it reported no cost information nor follow-up. Since the end of this study, the device has been cleared by the FDA and approved for reimbursement by Medicare for certain higher risk patients, but no study has yet considered the long-term implications of adoption of this technology. In our analysis, we use a computer simulation model to essentially estimate what will come next, after patients realize earlier detection of wet-form AMD by utilizing home monitoring. Basically, we follow simulated patients from the time they begin monitoring for the rest of their lives, recording the likely impacts of home monitoring on patients’ long term outcomes including visual status, costs and quality of life. We find that home telemonitoring among the population indicated for reimbursement by Medicare would cost $35,663 per quality adjusted life year (QALY) gained.  Medicare would expect to incur $1,312 in net budgetary costs over 10 years for each patient who initiates monitoring.  However, Medicare patients may expect to achieve lifetime net savings when accounting for the chance of avoided vision loss and its associated costs later in life. (more…)
Author Interviews, Breast Cancer, Cancer Research, JAMA, Surgical Research / 31.03.2017

MedicalResearch.com Interview with: Rebecca Nash, MPH Rollins School of Public Health Emory University MedicalResearch.com: What is the background for this study? Response: Contralateral prophylactic mastectomy (CPM) in women with invasive early-stage unilateral breast cancer has significantly increased in the U.S. over the past decade, despite the lack of evidence for a survival benefit. This procedure is particularly common among patients younger than 45 years old. It is also more common in whites compared to blacks, and in privately insured patients compared to uninsured or Medicaid insured patients. However, the extent of regional variation across the United States was unknown. (more…)
Author Interviews, Biomarkers, Heart Disease, JAMA / 30.03.2017

MedicalResearch.com Interview with: Stefan Kiechl, MD and Karin Willeit, MD Department of Neurology Medical University Innsbruck Innsbruck, Austria  MedicalResearch.com: What is the background for this study? Response: Atrial fibrillation (AF) is the most common cardiac arrhythmia and a major contributor to thromboembolic stroke and population morbidity and mortality. Aside from well-established risk factors such as age, heart failure, and hypertension, inflammation has been suggested to play a significant role in the pathogenesis of AF. This is evidenced by histologic studies that found marked inflammatory infiltrates in atrial biopsies of AF patients and by epidemiological studies demonstrating an association of circulatory inflammation markers with incident AF. Of note, an increased endocardial expression of vascular intercellular adhesion molecule 1 (VCAM-1), a mediator of leukocyte trafficking, during rapid atrial pacing was demonstrated which was shown to contribute to an inflammatory and prothrombotic environment within atrial tissue. Because it is still unclear whether inflammation related to AF is primarily a systemic or localized phenomenon, we sought to examine the association of 13 baseline inflammation markers with incident atrial fibrillation in the prospective population-based Bruneck Study and to replicate key findings in a second cohort, the SAPHIR Study. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Dermatology, JAMA / 30.03.2017

MedicalResearch.com Interview with: Prof. Dr. Maja Mockenhaupt Dept. of Dermatology Medical Center - University of Freiburg Deutschland / Germany MedicalResearch.com: What is the background for this study? Response: Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN) are severe cutaneous adverse reactions that are associated with high morbidity and mortality. Primarily due to their rareness, therapeutic effects are often studied in observational settings. An evidence-based standardized treatment protocol for SJS/TEN is still missing. (more…)
Allergies, Author Interviews, JAMA, Pediatrics / 29.03.2017

MedicalResearch.com Interview with: Dr. Debra Palmer (BSc, BND, PhD) on behalf of my fellow co-authors on this publication Childhood Allergy and Immunology Research University of Western Australia MedicalResearch.com: What is the background for this study? What are the main findings? Response: We conducted a multicentre trial, Starting Time of Egg Protein (STEP) involving 820 infants, and found a 25% risk reduction in egg allergy with early regular egg intake from 4-6.5 months compared with egg avoidance to 10 months of age, although this did not achieve statistical significance. So we also investigated in exploratory analyses whether the effect of regular egg introduction in solid foods was modified by any maternal, family or infant characteristics. Our results found that infants from families of higher socioeconomic status and those families who consume few eggs per week could benefit by less egg allergy at 12 months of age from regular egg intake once they start eating solid foods. (more…)
Author Interviews, C. difficile, Gastrointestinal Disease, JAMA, Mayo Clinic / 29.03.2017

MedicalResearch.com Interview with: Sahil Khanna, M.B.B.S. MS Division of Gastroenterology and Hepatology Mayo Clinic, Rochester, Minnesota MedicalResearch.com: What is the background for this study? What are the main findings? Response: Clostridium difficile infection (CDI) is the most common cause of hospital-acquired diarrhea and has recently shown increasing incidence especially in the community. Novel risk factors for CDI development include the use of gastric acid suppression medication, presence of systemic comorbid conditions, C difficile carriage in water and food sources, amongst others. Gastric acid suppression medications such as proton-pump inhibitors (PPIs) and histamine-2 receptor blockers (H2Bs) are commonly prescribed and consumed over the counter for gastroesophageal reflux disease, peptic ulcer disease, or functional dyspepsia, but they are also sometimes prescribed for unnecessary indications, which leads to overuse of these medications. Recurrent CDI after a primary infection is a major problem, with the risk being as high as 50% to 60% after 3 or more Clostridium difficile infections. Data on the association between acid suppression and recurrent CDI are conflicting and therefore we performed a systematic review and meta-analysis to study the association between the use of gastric acid suppression medications and the risk of recurrent CDI. (more…)
Author Interviews, Cancer Research, JAMA, OBGYNE, Pediatrics / 27.03.2017

MedicalResearch.com Interview with: Hazel B. Nichols, PhD, UNC Assistant professor Lineberger Comprehensive Cancer Center member UNC Gillings School of Global Public Health. MedicalResearch.com: What is the background for this study? Response: Each year more than 45,000 adolescent and young adult women (AYA, ages 15-39 years) are diagnosed with cancer in the United States. While many of these women may wish to have children in the years following diagnosis, there is currently little information available to address their concerns about the impact of cancer diagnosis and treatment on future pregnancy. We identified >2,500 women who had a child after their cancer diagnosis using data from the North Carolina Central Cancer registry and statewide birth certificate files. We investigated whether adverse birth outcomes, such as preterm birth and low birth weight, were more common among AYA cancer survivors compared to women without cancer. We also looked at infant Apgar scores, which measure newborn health, and a calculation called small-for-gestational age, which can indicate restricted growth during pregnancy. (more…)
Author Interviews, Cancer Research, JAMA, Vitamin D / 27.03.2017

MedicalResearch.com Interview with: Joan M. Lappe, Ph.D., R.N., F.A.A.N. Associate Dean for Research, College of Nursing Criss/Beirne Professor of Nursing Professor of Medicine Creighton University Omaha NE 68131 MedicalResearch.com: What is the background for this study? What are the main findings?
  • Numerous observational studies show that higher vitamin D intake and serum 25, hydroxyvitamin D [25(OH)D], the functional indicator of vitamin D status, are associated with lower incidence of cancer.
  • However, the scientific fields consider randomized clinical trials (RCT) as a gold standard for testing new interventions for prevention and treatment of disease. In the only RCT of cancer and vitamin D to date with cancer as a primary outcome, the Women’s Health Initiative, postmenopausal women randomly assigned to vitamin D3400 IU/day and calcium 1000 mg/day showed no difference from those assigned to placebo in colorectal cancer incidence. One criticism of that study was that the vitamin D intervention was low, only 400 international units (IU) per day.
  • In our study we found that, in healthy women ages 55 and older with a mean baseline serum 25(OH)D of 33 ng/mL, supplementation with 2000 IU/day of vitamin D3and 1500 mg/day of calcium for four years, compared with placebo, decreased all-type cancer incidence by about 30%, but this did not reach statistical significance. (p value =0.057 and for statistical significance, the p value would need to be less than 0.05.)
  • In a secondary analysis, we re-analyzed the data excluding cancers that developed during the first year of study and were likely present but not diagnosed upon study enrollment. The findings here were that vitamin D and calcium did significantly decrease cancer risk by about 35%.
  • In another secondary analyses, we combined all of the serum 25(OH)D values to determine if higher levels were associated with lower cancer incidence. Here, higher serum 25(OH)D was significantly associated with lower cancer incidence. Persons with serum 25(OH)D of 55 ng/mL had a 35% lower risk of cancer than persons with serum 25(OH)D of 30 ng/mL.  This is especially interesting since current recommendations for sufficient serum 25(OH)D levels are 20 ng/mL (the National Academy of Medicine) and 30 ng/mL (the Endocrine Society).
  • Note that serum 25(OH)D is a better predictor of cancer development than assigning persons to supplement groups. Serum 25(OH)D takes into account poor compliance of the active supplement group with taking supplements, personal use of supplements by the placebo group, dietary vitamin D intake, sunlight exposure, and the variation among persons in absorption and metabolism of the vitamin D supplement.
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Author Interviews, Heart Disease, JAMA, Osteoporosis / 27.03.2017

MedicalResearch.com Interview with: Wallis CY Lau BSc Centre for Safe Medication Practice and Research Department of Pharmacology and Pharmacy Li Ka Shing Faculty of Medicine The University of Hong Kong MedicalResearch.com: What is the background for this study? What are the main findings? Response: Warfarin is a vitamin K antagonist (VKA) oral anticoagulant used for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF), a common heart rhythm disorder. It works by interfering with vitamin K-dependent reactions in the process of blood clot formation. As these reactions also play a role in bone mineralization, there is concern that warfarin use may be linked with osteoporotic fracture. Despite the concerns for fracture risk, warfarin had been an inevitable treatment choice for over 50 years as there were no other alternatives available. Dabigatran is the first non-VKA oral anticoagulant (NOAC) approved for use in patients with NVAF. Recently, an animal study reported that use of dabigatran is associated with a better bone safety profile compared to warfarin in rats, suggesting a potential for a lower risk of osteoporotic fractures over warfarin. However, the actual risk of osteoporotic fractures with dabigatran use in human remains unclear. Therefore, we conducted a population-based cohort study to compare the risk of osteoporotic fractures in patients with NVAF treated with dabigatran and warfarin. (more…)
Author Interviews, Cancer Research, Genetic Research, JAMA / 24.03.2017

MedicalResearch.com Interview with: Heikki Joensuu, MD Department of Oncology Helsinki University Hospital University of Helsinki Helsinki, Finland  MedicalResearch.com: What is the background for this study? Response: The randomized Scandinavian Sarcoma Group (SSG) XVIII trial compared three years of adjuvant imatinib to one year of adjuvant imatinib as adjuvant treatments of patients who had undergone macroscopically complete surgery for a GIST with a high risk for tumor recurrence. In this trial, patients treated with 3 years of imatinib had improved overall survival as compared to those who were allocated to one year of adjuvant imatinib. In 2 other randomized trials that compared either 1 year of adjuvant imatinib to one year or placebo, or 2 years of adjuvant imatinib to observation, no improvement in overall survival was found, although in all three trials adjuvant imatinib improved recurrence-free survival (RFS). The reasons for the discrepant findings with respect of overall survival in the 3 trials have been unclear. (more…)
Author Interviews, Clots - Coagulation, Electronic Records, JAMA, NYU, Surgical Research / 23.03.2017

MedicalResearch.com Interview with: Zachary Borabm, Research fellow Hansjörg Wyss Department of Plastic Surgery NYU Langone Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Recent studies have shown that health care providers perform poorly in risk stratifying their patients for venous thromboembolism (VTE) which leads to inadequate VTE prophylaxis delivery, especially in surgical patients. Computerized Clinical Decision Support Systems (CCDSSs) are programs integrated into an electronic health record that have the power to aid health care providers. Using a meta-analysis study technique we were able to pool data from 11 studies, including 156,366 patients that either had CCDSSs intervention or routine care without CCDSSs. Our main outcome measures were the rate of prophylaxis for VTE and the rate of actual VTE events. We found that CCDSSs increased the rate of VTE prophylaxis (odds ratio 2.35, p<0.001) and decreased the risk of VTE events (risk ratio 0.78, p<0.001). (more…)
Abuse and Neglect, Author Interviews, Diabetes, JAMA, Ophthalmology, Technology / 21.03.2017

MedicalResearch.com Interview with: José Cunha-Vaz, M.D., Ph.D. Emeritus Professor of Ophthalmology University of Coimbra, Portugal President of AIBILI Association for Innovation and Biomedical Research on Light and Image Editor-in-Chief of Ophthalmic Research Coordinator, Diabetic Retinopathy and Retinal Vascular Diseases, European Vision Institute Clinical Research Network (EVICR.net)  MedicalResearch.com: What is the background for this study? What are the main findings? Response: In this study, we evaluated the clinical utility of quantitative measures of microvasculature in optical coherence tomographic angiography (OCTA). Although several studies have demonstrated the potential value of measures of microvasculature in the management of diabetic retinopathy (DR), our study uses the ROC curve to compare the overall value of different approaches. In this age matched population with a range of disease, the mean vessel density measured in the SRL had the highest AUC, indicating that it is best among the methods tested at differentiating normal eyes from eyes with diabetic retinopathy. (more…)
Aging, Alzheimer's - Dementia, Author Interviews, JAMA, Supplements / 21.03.2017

MedicalResearch.com Interview with: Richard J. Kryscio, Ph.D. Statistics and Chair, Biostatistics and Sanders-Brown Center on Aging Sanders-Brown Center on Aging University of Kentucky  MedicalResearch.com: What is the background for this study? Response: At the time the trial was initiated (2002), there was ample evidence that oxidative stress is an important mechanism in brain aging. Research showed that protein oxidation is linked to the brain’s response to the abnormal proteins seen in Alzheimer disease (amyloid beta plaques in particular) leading to inflammation, DNA repair problems, reduced energy production, and other cellular changes that are identified mechanisms in the Alzheimer brain. Both vitamin E and selenium are antioxidants. Antioxidants, either through food or supplements, are believed to reduce oxidative stress throughout the body. In the brain, they may reduce the formation of amyloid beta plaques, reduce brain inflammation, and improve other brain processes. Studies in humans support these hypotheses. The Rotterdam study in the Netherlands, as an example, showed that initial blood levels of vitamin E could predict dementia risk. Those people with higher vitamin E levels were 25% less likely to develop dementia. Also, selenium deficiency results in cognitive difficulties and several population-based studies have shown an association between selenium level and cognitive decline (lower selenium levels are linked to thinking changes in the elderly). (more…)
Author Interviews, Heart Disease, JAMA / 21.03.2017

MedicalResearch.com Interview with: Eric A. Secemsky, MD, MSc Interventional Cardiology Fellow Massachusetts General Hospital Harvard Medical School Baim Institute for Clinical Research  MedicalResearch.com: What is the background for this study?  What are the main findings? Response: We know from previous trials that continuing dual antiplatelet therapy longer than 12 months after coronary stenting decreases ischemic events, including spontaneous myocardial infarction and stent thrombosis. However, extending dual antiplatelet therapy is also associated with some increase in bleeding risk. For instance, in the DAPT Study, more than 25,600 patients were enrolled and received both aspirin and a thienopyridine antiplatelet drug (clopidogrel or prasugrel) for one year after stenting. Of these patients, 11,648 participants who had followed the study protocol and had no serious cardiovascular or bleeding events during that first year were then randomized to either continue with dual therapy or to receive aspirin plus a placebo for another 18 months. The overall findings of the DAPT study were that, compared with switching to aspirin only after one year, continuing dual antiplatelet therapy for a total of 30 months led to a 1.6 percent reduction in major adverse cardiovascular and cerebrovascular events – a composite of death, myocardial infarction, stent thrombosis and ischemic stroke – and a 0.9 percent increase in moderate to severe bleeding events. The prognosis following early ischemic and bleeding events has previously been well described. However, data for events occurring beyond 1 year after PCI are limited. As such, we sought to assess the cumulative incidence of death following ischemic and bleeding events occurring among patients in the DAPT Study beyond 1 year after coronary stenting. (more…)
Author Interviews, JAMA, Mental Health Research, Urology / 21.03.2017

MedicalResearch.com Interview with: Blayne Welk, MD, FRCSC Assistant Professor of Surgery Western University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Concerns have been raised by regulatory agencies and patients about possible serious psychiatric side effects associated with the use of 5 alpha reductase inhibitors. These medications can be used for both enlarged prostates and alopecia. We used administrative data to assess for potential psychiatric side effects associated with finasteride and dutasteride usage in older men with benign prostatic enlargement. In our study we found that there was no increased risk of suicide associated with the use of these medications. However, there was a small increase in both self-harm and new onset depression associated with the use of 5 alpha reductase inhibitors. (more…)