Author Interviews / 11.12.2018

MedicalResearch.comInterview with:
Lisa M. Lines, PhD, MPH
University ofMassachusetts Medical School
Worcester
RTI International,Waltham, MA

MedicalResearch.com:  What is the background for this study?  What are the main findings?

Response: The problem of potentially avoidable emergency department (ED) visits has been linked to barriers in access to high-quality, timely primary care. In Massachusetts ,about half of all ED visits were considered potentially avoidable, or primary-care sensitive (PCS), in the mid-2000s. Indeed, improving access to primary care was a prime motive for the state’s – and the nation’s – first universal coverage health insurance program in 2006. Now, the state has the highest coverage rate in the country.

We used Massachusetts All-Payer Claims Data to study characteristics of insured Massachusetts residents associated with primary-care sensitive ED use and compared such use among people under age 65 with public (Medicaid[MassHealth]) versus private insurance. We studied more than 2.2 million individuals in 2011-12; about 40% had public insurance in 2011, and the rest had private insurance. Our PCS ED measure included nonurgent, urgent but primary care treatable, and urgent but potentially avoidable ED visits.

We found that primary-care sensitive ED use was more than 4 times higher among the publicly insured (public insurees: 36.5 PCS ED visits per 100 person-years; private insurees: 9.0). After adjusting for a range of potential confounders, such as the vastly different morbidity burden of the two groups, public insurance in2011 was associated with about 150% more primary-care sensitive ED use. We also found that 70% of people with public insurance had at least 1 primary care visit, compared with 80% of those with private insurance. The public group also had fewer visits to their PCP of record, even though nearly all of them had an officially designated PCP.

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Author Interviews / 11.12.2018

MedicalResearch.com Interview with:

Kenneth H. Kraemer,M.D.
Chief DNA Repair Section
Laboratory of Cancer Biology and Genetics, Center for Cancer Research
National Cancer Institute

MedicalResearch.com:  What is the background for this study?

Response: At the National Cancer Institute, we have been examining patients with xeroderma pigmentosum (XP), a rare, recessively inherited, cancer-prone disease for many years. Therefore, with the increasing use of exome sequencing, we decided to see how closely"big data" corresponded with our clinical observations.  

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Author Interviews, Brigham & Women's - Harvard, Heart Disease, JAMA, Mediterranean Diet, Women's Heart Health / 10.12.2018

MedicalResearch.com Interview with: Samia Mora, MD, MHS Associate Professor of Medicine Harvard Medical School Director, Center for Lipid Metabolomics Brigham and Women’s Hospital Boston, MA MedicalResearch.com: What is the background for this study? What are the main findings? Response: The Mediterranean diet is rich in plants (nuts, seeds, fruits, vegetables, whole grains, legumes) and olive oil, and includes moderate intake of fish, poultry, dairy, and eggs, and alcohol, and rare use of meats and sweets.The Mediterranean diet has been associated with lower risk of cardiovascular disease (CVD) events but the precise mechanisms through which Mediterranean diet intake may reduce long-term risk of CVD are not well understood. We aimed to investigate the biological mechanisms that may mediate this cardiovascular benefit. Using a prospective study of 25,994 initially healthy women enrolled in the Women’s Health Study who were followed up to 12-years, we evaluated potential mediating effects of a panel of biomarkers (in total 40 biomarkers) that represent different CVD pathways and clinical factors. Higher baseline intake of a Mediterranean-type diet was associated with approximately one quarter lower risk of CVD events during the 12 year follow up. For the MED-CVD risk reduction, biomarkers of inflammation, glucose-metabolism/insulin-resistance, and adiposity contributed most to explaining the association, with additional contributions from pathways related to blood pressure, lipids – in particular HDL or triglyceride-rich lipoprotein metabolism, and to a lesser extent LDL cholesterol, branched chain amino acids, and small molecule metabolites.  (more…)
ADHD, Author Interviews, Autism, JAMA, Pediatrics, UC Davis / 10.12.2018

MedicalResearch.com Interview with: Meghan Miller, Ph.D. Assistant Professor Department of Psychiatry & Behavioral Sciences UC Davis MIND Institute Sacramento, CA 95817 MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study evaluated within-diagnosis sibling recurrence and sibling cross-aggregation of ADHD and autism spectrum disorder among later-born siblings of diagnosed children. We specifically chose to include only families who had at least one subsequent child after the diagnosis of an older child because failing to do so could bias recurrence risk estimates. We found that, compared to later-born siblings of non-diagnosed children, later-born siblings of children with autism were more likely to be diagnosed with autism or with ADHD. Likewise, compared to later-born siblings of non-diagnosed children, later-born siblings of children with ADHD were more likely to be diagnosed with ADHD or with autism. (more…)
Author Interviews / 10.12.2018

MedicalResearch.com Interview with:

Ira Kalfus, M.D., 
Medical Director
RedHill BioPharma

Immunohistochemical staining of H. pylori from a gastric biopsy  - Wikipedia  image

MedicalResearch.com: What is the background for this announcement? Would you briefly explain the significance of H. pylori infections?  What are the potential complications of infection with this bacteria?

Response: Heliobacter pylori is one of the most prevalent human pathogens. H. pylori bacterial infection affects over 50% of the adult population worldwide1 and 30-40% of the U.S. population2, with an estimated 2.5 million patients treated annually in the U.S.3 People infected with H. pylori may suffer from gastritis and have an increased risk of developing ulcers and gastric cancers. In fact, H. pylori is classified as a group I carcinogen by the International Agency for Research on Cancer in part because it is the strongest risk factor for the development of gastric cancer.4

Eradication of H. pylori is becoming more difficult. Current standard-of-care therapies fail in approximately 30-40% of patients, who remain H. pylori positive. This is due to increasing resistance of H. pylori to antibiotics commonly used in standard combination therapies5. Clarithromycin-resistant H. pylori was formally categorized by the World Health Organization as a pathogen for which there is a high priority need to develop new treatments.6

The pervasive nature of H. pylori, the great health risks that it poses and the rapid development of resistance to currently available therapies speak to the great unmet medical need for new treatments that are effective at eradicating H. pylori infections. We set out to develop TALICIA®(RHB-105) as an answer to this growing public health concern with the hopes that it could someday be adopted as a new first-line therapy for all people affected by H. pylori infection.

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Author Interviews / 10.12.2018

Prof. John McGrath
Prof. McGrath

MedicalResearch.comInterview with:
Professor John McGrath
Niels Bohr Professor
National Centre for Register-based Research
Aarhus University
Queensland Brain Institute
University of Queensland
Brisbane AustraliaQueensland Centre for Mental Health Research
The Park Centre for Mental Health Australia

MedicalResearch.com:  What is the background for this study? 
What are the main findings?

Response: We know that people born in winter and spring have an increased risk of later developing schizophrenia. But, we were not sure why. We know that vitaminD, the sunshine hormone, is more likely to be low in winter and spring, so wedeveloped a way to test for vitamin D in stored neonatal blood sample.

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Author Interviews, Electronic Records / 06.12.2018

MedicalResearch.com Interview with: Rebekah L Gardner MD Associate Professor of Medicine Warren Alpert Medical School Brown University Providence, Rhode Island MedicalResearch.com: What is the background for this study? What are the main findings? Response: Burnout profoundly affects physicians, their patients, and the health care system.The role of technology in physician burnout, specifically health information technology (HIT), is not as well characterized as some of the other factors. We sought to understand how stress related to HIT use predicts burnout among physicians. Our main findings are that 70% of electronic health record (EHR) users reported HIT-related stress, with the highest prevalence in primary care-oriented specialties. We found that experiencing HIT-related stress independently predicted burnout in these physicians, even accounting for other characteristics like age, gender, and practice type. In particular, those with time pressures for documentation or those doing excessive “work after work” on their EHR at home had approximately twice the odds of burnout compared to physicians without these challenges. We found that physicians in different specialties had different rates of stress and burnout. (more…)
Author Interviews, Memory, OBGYNE / 06.12.2018

MedicalResearch.com Interview with: Heather A. Bimonte-Nelson, Ph.D. Professor, Barrett Honors Faculty Department of Psychology Arizona State University MedicalResearch.com: What is the background for this study? What are the main findings? Response: The dogma in the field is that the nonpregnant uterus is dormant, and therefore it has not necessarily been of interest to study. Textbooks have described the nonpregnant uterus as “quiescent,” “dormant,” and “useless.” When I was in graduate school studying endocrinology, I read statements in books saying that the sole purpose of the uterus is for gestation. However, all women aging into midlife will experience some type of menopause, and some of these women will undergo surgical menopause via removal of all, or a part of, their reproductive tracts. Research evaluating reproductive tract-brain connections has grown quite a bit in the last few decades. For example, the ovary-brain connection has been focused on quite a bit, and we now know that hormones coming from the ovaries (such as estrogens and progesterone) can affect more than reproduction, and can impact brain functioning. While the uterus-brain connection is not well understood, there is research indicating that the uterus and autonomic nervous system communicate directly. We also know that hormones released from the ovaries impact the uterus. Therefore, there is a uterus-ovary-brain triad system. This uterus-ovary-brain triad has undergone little scientific investigation for functions outside of reproduction. Given that by age 60 one in three women experience hysterectomy, thereby interrupting this uterus-ovary-brain triad system, we believe it is important to understand the effects of variants of surgical menopause including hysterectomy. This led to our current evaluation testing multiple variations in surgical menopause using a rat model, where we tested the effects of uterus removal alone (hysterectomy), ovarian removal alone, or uterus plus ovarian removal. (more…)
Author Interviews, Depression, Hip Fractures, Lancet / 06.12.2018

MedicalResearch.com Interview with: Prof. Gillian Mead Chair of Stroke and Elderly Care Medicine Prof. Martin Dennis Chair of Stroke Medicine Centre for Clinical Brain Sciences The University of Edinburgh   MedicalResearch.com: What is the background for this study? Response: We are both practicing stroke physicians as well as clinical trialists. Therefore our interest in this area was triggered by the exciting results of the FLAME trial in 2011. This appeared to indicate that fluoxetine might boost the recovery of stroke patients. Potentially this was very important given the increasing numbers of people having disability due to stroke, and the fact that fluoxetine is inexpensive and could be introduced very easily into clinical practice. We were further encouraged by the large numbers of small RCTs we identified when we carried out a Cochrane systematic review on the topic. These trials provided more evidence of potential benefit but there was evidence that trials of greater quality showed less benefit, and benefits were greater in patients who were depressed. We felt there was a need for more evidence derived from much larger numbers of patients. (more…)
Author Interviews, Breast Cancer, JAMA, Weight Research / 06.12.2018

MedicalResearch.com Interview with: Neil M. Iyengar, MD Breast Medicine Service Department of Medicine Memorial Sloan Kettering Cancer Center Evelyn H. Lauder Breast And Imaging Center New York, NY  MedicalResearch.com: What is the background for this study? Response: Obesity is one of the leading modifiable risk factors for the development of hormone receptor positive breast cancer in postmenopausal women. Traditionally, physicians use a person's body mass index (weight in kilograms divided by height in squared meters, kg/m2) to estimate body fat levels. A BMI of 30 or greater is considered to be obese, and this level of BMI increases the risk of at least 13 different cancers. However, BMI is a crude measure of body fat and can be inaccurate. For example, some normal weight individuals (BMI less than 25) have obesity-related problems like diabetes and high blood pressure. Before our study, it was unknown whether high body fat levels in normal weight women contributes to obesity-related cancers such as breast cancer. (more…)
Author Interviews, Environmental Risks, Heart Disease, Nutrition / 05.12.2018

MedicalResearch.com Interview with: Dr. Lowell H. Steen, Jr., M.D. Interventional Cardiologist Loyola University Medical Center Dr. Steen discusses how holiday treats & stress can increase the risk of heart attack. MedicalResearch.com: What are the main factors that are linked to an increase in heart related adverse events during the Christmas holiday season? Who is most at risk?  Response: The increase in holiday season heart-related hospitalizations and deaths are due to a variety of behaviors such as putting off seeking medical help until after the holidays, overeating rich foods, strenuous travel, excessive alcohol consumption and stressful family interactions. These factors can all trigger heart issues. Factors such as age, diabetes, high cholesterol and smoking all increase heart risk. Additionally, those with high blood pressure, which is a leading risk factor for heart disease and stroke, are exceptionally at risk and should celebrate the hectic holiday season with caution.  (more…)
Author Interviews, Brigham & Women's - Harvard, Social Issues / 05.12.2018

MedicalResearch.com Interview with: Dr. Rishi Wadhera, MD  Cardiology Fellow Brigham and Women's Hospital Harvard Medical School. MedicalResearch.com: What is the background for this study? What are the main findings?  Response: In the United States, an estimated half a million people are homeless on any given night. In recent years, policy efforts to improve the health of homeless individuals have intensified, but there is little large-scale, contemporary data on how these efforts have impacted patterns of acute illness in this vulnerable population. In this study, we examined trends, causes, and outcomes of hospitalizations among homeless individuals in three states – Massachusetts, Florida, and California – from 2007 to 2013. We found that hospitalization rates among homeless adults increased over this period of time. Strikingly, over one-half of these hospitalizations were for mental illness and substance use disorder. More broadly, homeless adults were hospitalized for a very different set of reasons compared with demographically similar non-homeless adults. In addition, homeless individuals had longer lengths of hospitalization but lower total costs per hospitalization. (more…)
Author Interviews, Clots - Coagulation, J&J-Janssen / 05.12.2018

MedicalResearch.com Interview with: Paul Burton MD, PhD, FACC Vice President, Medical Affairs Internal Medicine Janssen Scientific Affairs, LLC. MedicalResearch.com: What is the background for this study? What are the main findings? Response: More than 900,000 Americans experience a venous thromboembolism (VTE) each year, with about one-third of these occurrences being fatal. Once a person experiences a VTE, they are at increased risk of a repeat occurrence. Guidelines currently recommend standard anticoagulant therapy with a Factor Xa inhibitor, like XARELTO® (rivaroxaban), for three months or longer. For those people who have had a VTE and stop anticoagulant therapy, as many as 10 percent of them will experience another VTE within one year and 20 percent within three years. This study examined extended use of XARELTO® after the recommended three-month treatment period in patients who experienced an initial VTE, showing XARELTO® was associated with a decreased risk of recurrent VTE with no increase in major bleeding during this time period.  (more…)
Author Interviews, Hematology, Leukemia, Pediatrics / 05.12.2018

MedicalResearch.com Interview with: Charles G. Mullighan, MBBS (Hons), MSc, MD Member, St. Jude Faculty Co-Leader, Hematological Malignancies Program Medical Director, St. Jude Biorepository William E. Evans Endowed Chair St. Judes Children’s Research Hospital Memphis, TN MedicalResearch.com: What is the background for this study?   Response: B-lineage acute lymphoblastic leukemia (B-ALL) is the commonest form of ALL, and the commonest childhood tumor. It is a leading cause of childhood cancer death. It consists of multiple subtypes defined by genetic alterations. These are often chromosomal translocations that deregulate oncogenes or form fusion proteins. These alterations are disease initiating events and are associated with distinct patterns of leukemic cell gene expression. Most subtypes also have additional mutations that are important for cells to become fully leukemic. Identifying these initiating genetic changes is very important to identify patients that are likely to respond or do poorly with conventional therapy (multiagent chemotherapy). Also, some identify new opportunities for targeted therapy. However, using standard genetic testing approaches such as chromosomal cytogenetics, about 30% of B-ALL patients don’t have a subtype classifying alteration. (more…)
Author Interviews, Blood Pressure - Hypertension, Duke, Heart Disease, JAMA / 05.12.2018

MedicalResearch.com Interview with: Taku Inohara MD, PhD Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina Department of Cardiology Keio University School of Medicine, Tokyo, Japan MedicalResearch.com: What is the background for this study? What are the main findings? Response: Transcatheter aortic valve replacement (TAVR) has been increasingly used for treating patients with severe aortic stenosis. Owing to the advancement of TAVR technology, the mortality and heart failure (HF) readmission after TAVR is decreasing over time, but 4.3% experienced readmission due to HF and 23.7% died within 1 year after TAVR. Inhibition of the renin-angiotensin system (RAS) with angiotensin-converting enzyme inhibitors (ACE-Is) or angiotensin-receptor blockers (ARBs) is known to improve clinical outcomes in patients with heart failure, but there remains unknown whether a RAS inhibitor is associated with a reduction in mortality and heart failure readmission after TAVR. Using the STS/ACC TVT Registry, a nationwide TAVR Registry in the US, we analyzed 15896 propensity-matched patients who underwent TAVR and found that receiving a prescription for a RAS inhibitor at discharge, compared with no prescription, was associated with a reduced risk for mortality ( 12.5% vs 14.9%) and HF readmission (12.0% vs 13.8%). (more…)
Author Interviews, Brigham & Women's - Harvard, Social Issues / 05.12.2018

MedicalResearch.com Interview with: Professor Tyler VanderWeele Ph.D John L. Loeb and Frances Lehman Loeb Professor of Epidemiology Harvard University MedicalResearch.com: What is the background for this study? What are the key points of the paper?   Response: Several prior studies have suggested that religious service attendance is associated with lower rates of divorce. However, many of these studies have been with small samples and have not had rigorous study designs. In addition, most studies have focused on women earlier in life and there has been little research on the effects of religious service attendance on divorce later in life. While divorce rates in the United States in general has been falling, it has in fact been increasing for middle-aged groups, doubling between 1990 and 2010. In our study we found that among women in mid- to late- life, regular religious service attendance was subsequently associated with 50% lower divorce rates over the following 14 years of the study. We also found that among those who were widowed, religious service attendance was associated with a 49% increase in the likelihood of remarrying over the 14 years of the study. (more…)
Author Interviews, Infections, NIH, Ophthalmology / 05.12.2018

MedicalResearch.com Interview with: Top, retina of a control patient. Bottom, retina from a patient with CJD. Arrowheads point to abnormal prions in the outer plexiform layer (opl), and the asterisk (*) marks more diffuse prions in the inner plexiform layer (ipl).Orrù et al., mBioByron Caughey, Ph.D. Senior Investigator Chief, TSE/prion Biochemistry Section Laboratory of Persistent Viral Diseases NIH/NIAID Rocky Mountain Laboratories Hamilton, MT 59840 USA  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Corneal transplants have caused the transmission of Creutzfeldt-Jakob disease (CJD) in at least two cases, and pathological prion protein has been detected in the retinas of the eyes of sporadic CJD cases. To build on these previous indications of prions in eye tissue, we tested the distribution of prions in various components of eyes from 11 sCJD decedents. We applied a highly sensitive surrogate test for prions (RT-QuIC) that indicated that all of the sCJD cases had prions in multiple parts of their eye, including the cornea and sclera, which is the white outer surface of the eye. Retinas were usually contained the highest levels, in some cases approaching levels in the brain. Some other parts such as the cornea, lens and vitreous had much lower, but detectable, levels.  (more…)
ADHD, Author Interviews, Pediatrics, Race/Ethnic Diversity / 05.12.2018

MedicalResearch.com Interview with: George J. DuPaul, PhD Department of Education and Human Services Lehigh University   Charles Barrett. Ph.D. School Psychologist Loudon County Virginia Public Schools   MedicalResearch.com: What is the background for this study? What are the main findings? Response: Numerous studies have shown that Black children are more likely to receive ratings that are more indicative of displaying externalizing behavior difficulties, including Attention Deficit Hyperactivity Disorder (ADHD).  However, many of these studies included teachers as the informants. Consistent with most teachers in the United States, raters have typically been White females.  For this reason, it is unclear if these outcomes would exist if the rater and child shared the same racial/ethnic background. Additionally, most research in the United States that involved cross-cultural comparisons has used White and Hispanic boys.  Few empirical studies have examined differences between Black and White boys. The present study sought to address several limitations in the field.  Most notably, cross-cultural comparisons between Black and White boys were included instead of Hispanic and White children.  Next, maternal figures, rather than teachers, were included as the informants. The present study was developed using a similar methodology that examined Hispanic and White boys’ behavior from the perspective of Hispanic and White teachers (Dominguez de Ramirez & Shapiro, 2005). In sum, we sought to determine if there were differences in how Black and White maternal figures rated Black and White boys who were demonstrating the same level/type of behavior (i.e., sub-clinical levels of ADHD).  Notably, although the boys’ behaviors were the same, maternal ratings were not identical. Specifically, using the ADHD Rating Scale, Fourth Edition (ARS-4), Black mothers assigned higher ratings to both Black and White boys. (more…)
Author Interviews, Autism, Pediatrics / 05.12.2018

MedicalResearch.com Interview with: Michael Kogan, Ph.D. Director of the office of Epidemiology and Research Health Resources and Services Administration’s Maternal and Child Health Bureau MedicalResearch.com: What is the background for this study? What are the main findings? Response: This was a study led by the Health Resources and Services Administration’s Maternal and Child Health Bureau, along with researchers from the Centers from Disease Control and Prevention, Harvard, Drexel, and George Washington Universities.  We used the 2016 National Survey of Children’s Health, a nationally representative survey of over 50,000 children that examines the health and well-being of US children, to examine the prevalence, treatment, and health care experiences of children with Autism Spectrum Disorder (ASD). We found that 1 out of 40 children in the US were reported by their parents to have been diagnosed with Autism Spectrum Disorder.  We also found that children with ASD were significantly less likely to receive services like needed care coordination, referrals to other services, and mental health counseling – even compared to children with other emotional, behavioral or developmental disorders (EBDs).  Parents of children with ASD were also significantly more likely to report being usually or always frustrated in their attempts to get services, again compared to families of children with other EBDs. Finally, we looked at treatment patterns for children with ASD and found that 64% had received behavioral therapy in the year before the interview, and 27% had received medications to treat symptoms of irritability.  (more…)
Author Interviews, OBGYNE, Science / 05.12.2018

MedicalResearch.com Interview with: "38 week fetus" by Zappys Technology Solutions is licensed under CC BY 2.0Kimberley Whitehead Neuroscience, Physiology & Pharmacology University College London MedicalResearch.com: What is the background for this study? Response: Fetuses move a lot! Very similar movement patterns are seen in both pre-term and full-term newborn infants, but their function is unclear. In animals such as rats, spontaneous movement and consequent feedback from the environment during the early developmental period trigger specific patterns of electrical activity in the brain that are necessary for proper brain mapping. (more…)
Author Interviews, Education, Sleep Disorders / 04.12.2018

MedicalResearch.com Interview with: Michael K. Scullin, Ph.D. Assistant Professor of Psychology and Neuroscience Director, Sleep Neuroscience and Cognition Laboratory Baylor University Waco, TX 76798  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: There is a gap between what health behaviors individuals know they should adopt, and what those individuals actually end up doing. For example, a growing literature shows that simply educating students on the importance of sleep does not change their sleep behaviors. Thus, we need to think outside of the box for solutions. In three classes, we have now investigated a motivational solution: if students can earn extra credit on their final exam for sleeping better, will they do so even during finals week? (more…)
Author Interviews, Cost of Health Care, Hematology, J&J-Janssen, Thromboembolism / 04.12.2018

MedicalResearch.com Interview with: Paul Burton MD, PhD, FACC Vice President, Medical Affairs Internal Medicine Janssen Scientific Affairs, LLC. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Despite being largely preventable, venous thromboembolism (VTE) is the second leading cause of death in people with cancer. The risk of VTE is five times greater in people with cancer than those without cancer, and that risk is magnified in those receiving certain types of chemotherapy, in the newly diagnosed and in those with more advanced, metastatic disease. This 6,194-patient study examined economic burden associated with VTE, and found patients newly diagnosed with cancer who are at a higher risk of a VTE had significantly higher all-cause and VTE-related health care costs compared to patients with a lower risk of VTE. (more…)
Author Interviews, Clots - Coagulation, Hematology, J&J-Janssen / 04.12.2018

MedicalResearch.com Interview with: Paul Burton MD, PhD, FACC Vice President, Medical Affairs Internal Medicine Janssen Scientific Affairs, LLC. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Treatment of venous thromboembolism (VTE) is complicated among morbidly obese patients. Current guidelines do not recommend use of Factor Xa inhibitors in these patients due to limited clinical data available. That's why Janssen undertook this study to examine XARELTO® (rivaroxaban) in these patients. In this 5,780-patient retrospective study, results found patients treated with XARELTO® had a similar risk of recurrent VTE and major bleeding compared to those taking warfarin. However, treatment with XARELTO® was associated with less all-cause health care resource utilization (HCRU) (e.g., inpatient hospitalizations and outpatient visits) and reduced total medical costs compared to warfarin. Of note, patients taking XARELTO® had an average $2,829 lower total medical costs per patient per year (PPPY) than those taking warfarin, which was mainly driven by lower hospitalization costs. (more…)
Author Interviews, FDA, JAMA, Medical Imaging / 04.12.2018

MedicalResearch.com Interview with: Aldo Badano, Ph.D. Deputy Director, Division of Imaging, Diagnostics, and Software Reliability Office of Science and Engineering Laboratories Center for Devices and Radiological Health Silver Spring, MD 20993 Aldo Badano, Ph.D. Deputy Director, Division of Imaging, Diagnostics, and Software Reliability Office of Science and Engineering Laboratories Center for Devices and Radiological Health Silver Spring, MD 20993  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Expensive and lengthy clinical trials can delay regulatory evaluation of innovative technologies, affecting patient access to high-quality medical products. Although computational modeling is increasingly being used in product development, it is rarely at the center of regulatory applications. Within this context, the VICTRE project attempted to replicate a previously conducted imaging clinical trial using only computational models. The VICTRE trial involved no human subjects and no clinicians. All trial steps were conducted in silico. The fundamental question the article addresses is whether in silico imaging trials are at a mature development stage to play a significant role in the regulatory evaluation of new medical imaging systems. The VICTRE trial consisted of in silico imaging of 2986 virtual patients comparing digital mammography (DM) and digital breast tomosynthesis (DBT) systems. The improved lesion detection performance favoring DBT for all breast sizes and lesion types was consistent with results from a comparative trial using human patients and radiologists.  (more…)
Annals Internal Medicine, Author Interviews, Heart Disease, Infections, Opiods / 04.12.2018

MedicalResearch.com Interview with: Asher Schranz, MD Division of Infectious Disease Department of Medicine UNC School of Medicine MedicalResearch.com: What is the background for this study? Response: The opioid crisis has led to several major infectious diseases concerns, including HIV and Hepatitis C. Drug use-associated infective endocarditis (DUA-IE) is a less commonly discussed consequence of the opioid epidemic. DUA-IE is an infection of one or more heart valves that occurs from injecting drugs. It can be a severe, life-threatening infection and requires a long course of intravenous antibiotics as well as, in some cases, open heart surgery to replace an infected heart valve. Several studies over the past few years have shown that DUA-IE has been increasing. Our study examined hospital discharges in North Carolina statewide from 2007 to 2017. We sought to update trends in DUA-IE and describe how much heart valve surgery was being performed for DUA-IE. We also aimed to report the demographics of persons who are undergoing heart valve surgery for DUA-IE and the charges, lengths of stay and outcomes of these hospitalizations.  (more…)
Author Interviews, Cancer Research, Hematology, J&J-Janssen / 04.12.2018

MedicalResearch.com Interview with: Caroline McKay, PhD Real World Value & Evidence, Oncology Janssen Scientific Affairs MedicalResearch.com: What is the background for this study? What are the main findings? Response: Considering patient preferences in treatment decision-making in oncology is growing in importance. While recent introduction of new treatments for multiple myeloma have improved survival and the possibility of sustaining longer remission periods, regimen options still vary with respect to efficacy, safety, and dosing. Therefore, patients and providers must consider tradeoffs inherent in making treatment decisions that are growing in complexity. Despite this, there is a lack of research describing patient preferences within the context of currently available treatment regimens. To address this gap, this study examined how multiple myeloma patients evaluate, or weigh, treatment options. Key findings from the research are that treatment preferences do not appear to be static, but instead suggest that the relative importance of treatment attributes may change over time and treatment history. Further, patients place higher importance on overall survival and progression-free survival than other treatment attributes, and may be willing to accept an increase in the risk of serious side effects and reduced convenience in exchange for greater efficacy; however, when efficacy is comparable, patients appear to place greater weight on dosing frequency than on the duration of treatment administration, i.e., more frequent dosing appears to be less preferable to patients than longer administration/infusion time.  (more…)
Annals Internal Medicine, Author Interviews, Lipids, Pharmacology / 04.12.2018

MedicalResearch.com Interview with: Prof. Dr. Milo Puhan Epidemiology, Biostatistics and Prevention Institute University of Zurich MedicalResearch.com: What is the background for this study? What are the main findings? Response: The use of statins for primary cardiovascular prevention is controversial and there is a debate at what risks statins provide more benefits than harms. Current guidelines recommend statins if the 10 year risk for cardiovascular events is above 7.5 to 10% and they do not distinguish between men and women, different age groups and different statins. We found in our study that the benefits of statins exceeds the harms if the 10 year risk for cardiovascular events is above 14% for middle aged mean (40-44 years) but even higher for older age groups, and women. In addition, the benefit harm balance varies substantially between different statins with atorvastatin providing the best benefit harm balance. (more…)
Author Interviews, Dermatology, Lipids / 04.12.2018

MedicalResearch.com Interview with: Wendy Bollag, PhD, FAHA Professor of Physiology VA Research Career Scientist Augusta University, Georgia MedicalResearch.com: What is the background for this study? Response: We have previously shown that the lipid (fat) phosphatidylglycerol (PG) is able to inhibit rapidly growing keratinocytes (skin cells) and promote their maturation. We also found that PG can suppress skin inflammation. Since the common skin disease psoriasis is characterized by inflammation and excessive growth and abnormal maturation of skin cells, we believed that PG might be useful as a treatment. However, the mechanism of its anti-inflammatory effect was unknown. PG in the lung has been found to inhibit inflammation induced by microbes or their components, which work by activating the innate immune system via binding to proteins called toll-like receptors (TLRs); however, psoriasis is not considered to be an infectious disease. We hypothesized that PG would also inhibit inflammation induced by anti-microbial peptides that activate TLRs. Anti-microbial peptides, produced normally by the skin to protect against infection, are known to be excessively up-regulated in psoriatic skin.  (more…)