Author Interviews, Zika / 31.03.2017

MedicalResearch.com Interview with: Daihai He PhD Department of Applied Mathematics The Hong Kong Polytechnic University Hung Hom, Kowloon Hong Kong (SAR), China MedicalResearch.com: What is the background for this study? What are the main findings? Response: Zika virus disease has large outbreaks in many Pacific and American countries in 2016, and the outbreaks are still on-going. Our work is conducted against this background. We compared data from three localities: French Polynesia in 2013-2014, Colombia and Brazil in 2016. We found that in French Polynesia the infection attack rate (i.e. the proportion of the population who got infected) is about 3/4, which matched previous serological studies. We then make estimation for the other two place. We found that the infection attack rate in Colombia in 2016 was most likely less than 50%. For Bahia province of Brazil, we did not arrive at a very accurate estimation, as the confidence interval is wide, and our best estimate is 30%. The relatively low infection attack rate in Colombia and Brazil implies that future outbreaks of Zika virus diseases are still possible. Thus control and surveillance efforts should be continued. (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, HPV, NEJM, OBGYNE, Vaccine Studies / 30.03.2017

MedicalResearch.com Interview with: Anders Hviid Senior Investigator, M.Sc.,Dr.Med.Sci. Department of Epidemiology Research Division of National Health Surveillance & Research MedicalResearch.com: What is the background for this study? Response: HPV vaccination targeting girls and young women has been introduced in many countries throughout the world. HPV vaccines are not recommended for use in pregnancy, but given the target group, inadvertent exposure will occur in early unrecognized pregnancies. However, data on the safety of HPV vaccination in pregnancy is lacking. (more…)
Asthma, Author Interviews, Nursing / 30.03.2017

MedicalResearch.com Interview with: Catherine M. Pound MD The Ottawa Children’s Treatment Centre MedicalResearch.com: What is the background for this study? Response: Asthma is the most common chronic disease of childhood and contributes to a large portion of Canadian hospital pediatric admissions.  Once patients are admitted to hospitals, they receive salbutamol, a medication used for acute asthma exacerbations, at a pre-determined frequency.  In most hospitals, physicians are the ones to decide of the frequency of administration of the salbutamol, and they decide when to wean patients off it. However, children whose salbutamol treatment administration can be decreased are usually considered stable, and often do not require immediate medical attention, which may results in delays in reassessments as well as administration of unneeded salbutamol treatments, particularly if physicians are busy looking after other sicker patients.  Additionally, physicians’ assessments of children with asthma and their decisions to wean salbutamol frequency are not standardized, and vary among physicians. Therefore, in order to improve efficiency and standardize patient assessments, we developed a clinical pathway allowing nurses to wean salbutamol for children hospitalized with asthma based on a validated asthma scoring system. (more…)
Author Interviews, Medical Imaging, MRI, Stroke / 30.03.2017

MedicalResearch.com Interview with: Jalal B. Andre M.D., D.A.B.R.® Drector of neurological MRI and MRI safety officer at Harborview Medical Center University of Washington  MedicalResearch.com: What is the background for this study? Response: Acute ischemic stroke (AIS) patients with good collaterals have better clinical outcomes. AIS is characterized by an ischemic penumbra, a region of salvageable brain tissue, that surrounds a core of irreversible ischemic infarct. The penumbra is tenuously perfused by collateral blood vessels which, if extensive enough, can maintain penumbral perfusion, improving the odds that a larger volume of brain tissue will survive. Standard, first-line methods for evaluating collaterals in the acute setting include CT angiography, MR angiography, and (less commonly) digital subtraction angiography. Arterial spin labeling (ASL) is an emerging MRI technique that assesses cerebral perfusion. Its advantages include relatively short scan time (4-6 minutes), lack of ionizing radiation, and independence from an exogenous contrast agent (contraindicated in patients with impaired renal function or documented sensitivity). Collaterals can be identified within ASL images as foci of curvilinear hyperintensity bordering regions of hypoperfusion. We sought to explore a novel relationship between the presence of ASL collaterals (ASLc) and neurological outcome in acute ischemic stroke patients. (more…)
Author Interviews, Boehringer Ingelheim, Dermatology, Eli Lilly, Immunotherapy, J&J-Janssen, Merck / 30.03.2017

MedicalResearch.com Eric Hughes Global Development Franchise Head Immunology & Dermatology Novartis MedicalResearch.com: What is the background for this study? What are the main findings? Response: Psoriasis is a chronic immune-mediated inflammatory disease that negatively impacts patients’ quality of life (QOL); therefore QOL outcomes are increasingly recognized as an important measure of efficacy in psoriasis, complementing traditional measures of severity such as the Psoriasis Area and Severity Index (PASI). Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A (IL-17A), exhibits significant efficacy in the treatment of moderate-to-severe psoriasis, ankylosing spondylitis and psoriatic arthritis, demonstrating a rapid onset of action and a favorable safety profile. Biologic therapies for psoriasis have previously been associated with a fall-off in efficacy over time; accordingly, extended follow-up is required to adequately evaluate novel therapeutic strategies like IL-17A inhibition. Recently, results from the extension of the SCULPTURE secukinumab trial showed that high responses initially achieved with secukinumab at year 1 in the SCULPTURE study were sustained over time up to 3 years with no new or unexpected safety concerns. In this analysis, we examined whether the sustained efficacy observed in SCULPTURE up to 3 years was translated into sustained effect of secukinumab on patient’s QOL measured by the Dermatology Life Quality Index (DLQI) questionnaire. SCULPTURE, a multi-center extension study, was conducted with subjects who completed 52 weeks of treatment. Subjects were randomized into two maintenance dosing regimens; a fixed-interval schedule of secukinumab 300 mg every 4 weeks (Fixed interval dosing regimen (FI) cohort), and secukinumab retreatment-as-needed (Retreatment as needed (RAN) cohort), in which subjects received placebo until start of relapse, at which time secukinumab 300 mg every 4 weeks was re-initiated. The analysis using as-observed data showed that at Year 3, improvements in the total score on DLQI was well sustained in both FI and RAN cohorts. Approximately two-thirds of the subjects in the FI cohort reported no impact of skin disease on QOL (corresponding to a score of 0 or 1 on DLQI). The proportion of patients in the RAN cohort reporting no impact of the disease on their QOL was well sustained through 3 years but remained consistently lower than those observed in the FI cohort. The results for each subscale of the DLQI questionnaire were consistent with those with DLQI total score i.e. showing high and sustained proportions of patients reporting no impact of the disease on different domains of health-related QOL in the two secukinumab cohorts with greater effect in the FI cohort compared to the RAN cohort. (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…)
Author Interviews, Biomarkers, Breast Cancer, Genetic Research, Yale / 29.03.2017

MedicalResearch.com Interview with: Tara Sanft, MD Assistant Professor of Medicine (Medical Oncology) Medical Director of Adult Survivorship Yale Cancer Center Survivorship Clinic  MedicalResearch.com: What is the background for this study? Response: Previous studies have demonstrated the benefit of extended endocrine therapy (EET) for hormone receptor-positive (HR+) breast cancer in preventing late relapse, however that benefit is limited to 3-5% of women where late recurrence was prevented or staved off. However, EET has become common practice and as a result we are exposing many patients to risks of side effects and toxicities associated with anti-estrogen therapies when they may not be benefitting, and, conversely may not be treating the patients that might actually benefit. There is a real need to better identify the patients who are both at most risk of late distant recurrence, and most likely to benefit from EET. This prospective study included 141 patients with a mean age of 62. In the study, 83% of patients were postmenopausal, 73% were stage I. Breast Cancer Index (BCI) is a gene expression-based test and is the only currently available validated biomarker that is both prognostic for late distant recurrence and predictive for likelihood of benefit from EET. The purpose of this prospective study was to assess the impact of BCI on: physician EET recommendations; physician confidence; patient satisfaction, anxiety, and decision-conflict; and the cost impact of BCI. (more…)
Author Interviews, BMJ, Cost of Health Care, Orthopedics / 29.03.2017

MedicalResearch.com Interview with: Bart S Ferket, MD, PhD Assistant Professor, Population Health Science and Policy Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Response: The annual rate of total knee replacement in the US has doubled since 2000, and especially in those aged 45-65 utilization of this procedure has increased. The increase in practice cannot fully be explained by an increase in the prevalence of osteoarthritis and population growth, and has been partly attributed to expansion to people with less severe symptoms. The total number of procedures performed each year now exceeds 640,000. The evidence for the benefit of total knee replacement has been based on studies without a comparison group of no total knee replacement, and so far only one randomized clinical trial has been published. Although the published literature shows large improvements of pain, physical functioning and overall quality of life following the procedure, patients included in these studies generally had severe preoperative symptoms. A number of studies have suggested, however, that up to a third of recipients of total knee replacement show no benefit, and that those with poor physical functioning before surgery may show larger improvements. Therefore, the current US patient population undergoing total knee replacement might show less significant improvement in symptoms on average as compared with a hypothetical scenario in which eligibility is limited to those with more severe symptoms.   (more…)
Author Interviews, Cost of Health Care, Fertility, OBGYNE / 29.03.2017

MedicalResearch.com Interview with: Emily S. Jungheim, MD, MSCI Assistant Professor, Obstetrics and Gynecology Division of Reproductive Endocrinology and Infertility Washington University St. Louis, Missouri MedicalResearch.com: What is the background for this study? What are the main findings? Response: Many women with health insurance lack coverage for fertility treatment so they end up being self-pay for fertility treatments which can be expensive and limit access to care. 15 states have responded with mandates for employers to include fertility coverage in their employee insurance benefits, and 5 of these have comprehensive mandates that include IVF. Illinois is one of these states. Washington University is located on the border between Illinois and Missouri so our fertility center treats a number of women with coverage for fertility treatment and a large number of women who are self-pay for fertility treatment. We suspected that women requiring IVF to conceive were more likely to follow through with treatments if they had coverage so we decided to look at our data. Ultimately we confirmed our suspicions. Women with coverage were more likely to come back for additional cycles of IVF if they didn't conceive. Ultimately this ability to come back for additional treatment cycles led to a higher chance of live birth. (more…)
Author Interviews, Clots - Coagulation, Heart Disease, Thromboembolism / 29.03.2017

MedicalResearch.com Interview with: Paul Burton, MD, PhD, FACC Vice President, Medical Affairs Janssen MedicalResearch.com: What is the background for this study? What are the main findings? Response: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), affects more than 900,000 Americans each year; one-third of these occurrences are fatal. Once a person experiences a VTE, they are at risk of having another occurrence. Guidelines currently recommend anticoagulant therapy with a non-vitamin K antagonist oral anticoagulant (NOAC), like XARELTO® (rivaroxaban), for three months or longer. Once anticoagulant therapy is stopped, up to 10 percent of people will experience a recurrence during the first year and up to 20 percent within three years. In people who decide to stop anticoagulant therapy, guidelines currently suggest using aspirin for long-term prevention of recurrent VTE rather than no aspirin at all. The Phase 3 EINSTEIN CHOICE study was designed to compare the efficacy and safety of XARELTO® to aspirin for continued VTE management in people who experienced an initial VTE. The study met its primary endpoint, finding both XARELTO® doses (10 mg or 20 mg once daily) to be superior to aspirin 100 mg once daily in preventing recurrent VTE, with no significant impact on safety. Specifically, XARELTO® 10 mg reduced the risk of recurrent VTE by 74 percent and XARELTO® 20 mg by 66 percent. Rates of major bleeding were comparable and low across all treatment groups. These results were presented at the American College of Cardiology's 64th Annual Scientific Session (ACC.17) during a Joint ACC/Journal of American Medical Association Late-Breaking Clinical Trials session and published simultaneously in The New England Journal of Medicine. (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, Dermatology, Immunotherapy / 29.03.2017

MedicalResearch.com Interview with: Emma Guttman, MD, PhD Professor, Dermatology, Medicine and Clinical Immunology Vice Chair of Research in the Dermatology Department Director of the center for Excellence Eczema in the Occupational/Contact Dermatitis clinic Director of the Laboratory of Inflammatory Skin Diseases Icahn School of Medicine at Mount Sinai Medical Center New York MedicalResearch.com: Would you briefly explain what is meant by atopic dermatitis? How many people are affected by this disorder? Response: Atopic dermatitis or eczema as most people know it is an itchy red scaly skin disorder characterized by a very severe itch, that disrupts daily activities, and sleep and severely impairs the quality of life of patients. In the US 30 million people are affected by it, and 1/3 of these we expect to be moderate to severe. MedicalResearch.com: What is the background for Dupilumab therapy? How does it differ from emollients, steroids or topical immunomodulator treatments for eczema ie Protopic? Response: The background is that we currently do not have good treatments for long term use for our moderate to severe patients. The only approved drug by the FDA for atopic dermatitis in the US is oral prednisone, that has many long term side effects and causes disease rebound upon discontinuation. Other treatments with many side effects are broad immune suppressants--Cyclopsorin A, Mycophenolate mofetyl and phototherapy that is not feasible for most patients. Thus there is a large unmet need for safer and better treatments for moderate to severe atopic dermatitis patients. Dupilumab is different since it only targets one immune axis--Th2 axis, providing a safer alternative, with high efficacy, that is equal or even better than cyclosporin A, that is the current gold standard immune suppressant, and harbors many side effects including permanent effects on the kidneys after long term use. Topical treatments, while useful for mild patients, are often not adequate or sufficient to control moderate to severe patients that usually have more than 10% body surface area involved and need a systemic treatment. (more…)
Author Interviews, Boehringer Ingelheim, Dermatology, Immunotherapy / 29.03.2017

MedicalResearch.com Interview with: Eric Hughes, Global Head of Development, Immunology & Dermatology Novartis Pharma AG Basel, Switzerland MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is well established that psoriasis negatively affects quality of life and work productivity. However, how the treatments affect psoriasis severity (based on skin clearance, itch, pain and scaling symptoms), health-related quality of life (HRQOL), work productivity, and daily activity directly or indirectly (via other factors) are still largely unknown. Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A (IL-17A), exhibits significant efficacy in the treatment of moderate-to-severe psoriasis, ankylosing spondylitis, and psoriatic arthritis, demonstrating a rapid onset of action and a favorable safety profile. In CLEAR, a Phase 3b head-to-head study versus ustekinumab, secukinumab demonstrated sustained superior efficacy in clearing skin through Week 52, greater improvement in symptoms and HRQOL, greater relief of work and activity limitations, and a comparable safety profile. In this sub-analysis of the CLEAR study, Novartis was interested in examining the relationships among multiple variables that are thought to be important to patients with psoriasis. The direct and indirect (i.e. mediated) effects of treatment (secukinumab or ustekinumab) on psoriasis severity and patients’ HRQOL, work productivity, and daily activity were examined. The evaluation was conducted using structural equation modeling (or path analysis) and compared these relationships for secukinumab versus ustekinumab at 16 and 52 weeks. Structural equation modeling or path analysis is a statistical method that models the direct and indirect relationship between multiple patient-relevant outcomes simultaneously. Goodness-of-fit statistics for all models were excellent confirming the robustness of the results. Results at Week 16 and at Week 52 for different Psoriasis Area and Severity Index (PASI) response categories (e.g. PASI 75, PASI 90, PASI 100) indicated that psoriasis treatment indirectly affected HRQOL and work productivity and daily activity, measured with the Dermatology Life Quality Index (DLQI) and the Work Productivity and Activity Impairment (WPAI) questionnaires, respectively. Actually, greater effect of secukinumab over ustekinumab on DLQI was mediated by greater improvement of secukinumab in PASI response as well as by greater improvement in psoriasis-related symptoms (itch, pain and scaling). Greater effect of secukinumab over ustekinumab on work productivity and daily activity was mediated by greater improvement of secukinumab in psoriasis-related symptoms. (more…)
Author Interviews, Gastrointestinal Disease, Microbiome / 28.03.2017

MedicalResearch.com Interview with: Dr Pauline Scanlan Royal Society-Science Foundation Ireland University Research Fellow/APC Faculty, APC Microbiome Institute, Biosciences, University College Cork, Éire MedicalResearch.com: What is the background for this study? Response: The human gut is host to an incredible diversity of microbes collectively known as the gut microbiome. Each of us has a unique collection of bacterial strains that form part of the gut microbiome. This uniqueness is of potentially crucial importance with respect to host health as we know that differences in bacterial strain diversity within species could have a range of positive or negative consequences for the human host. For example, some strains of a given bacteria are harmless whilst another strain of the same bacterial species could kill you. A classic example of such a difference in strain functionality is exemplified by the gut bacterium Escherichia coli – one strain called E. coli Nissle 1917 is used as a probiotic and another, E. coli O157:H7, has been responsible for a number of deadly food-borne pathogen outbreaks. Therefore a better understanding of what drives bacterial strain diversity is not just fundamental to our understanding of the ecology and evolution of microbes but is also highly relevant for improvements in human health and disease prevention. (more…)
Author Interviews, Brigham & Women's - Harvard, HIV, Pediatrics / 28.03.2017

MedicalResearch.com Interview with: Anne M Neilan, MD,MPH Assistant in Medicine and Pediatrics Massachusetts General Hospital Instructor at Harvard Medical School Department: Medicine Service Division: Infectious Disease Department: Pediatric Service Massachusetts General Hospital Boston, MA 02114 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Adolescents infected with HIV – either at birth or later in life – experience poorer health outcomes compared to adults with HIV in nearly every respect. This study found that U.S. youth infected with HIV around the time of their birth are at higher risk throughout their adolescence and young adulthood for experiencing serious health problems, poor control of the HIV virus (having high levels of HIV virus in their bodies and fewer CD4 immune cells which protect the body from infection), or death. The study also found that among those with good HIV control, serious health problems are rare. By combining data from two large, long-term U.S. studies – the Pediatric HIV/AIDS Cohort Study (PHACS, www.phacsstudy.org) and the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT, www.impaactnetwork.org) Network – we were able to study the health of more than 1,400 perinatally HIV-infected children, adolescents and young adults ages 7 to 30 years between 2007 and 2015. The study found that youth ages 13 to 30 were most likely to have poor HIV control AIDS-related illnesses, and death compared to younger participants. Among 18 – 30 year-olds, the study found that poor control of the HIV virus – meaning higher levels of HIV virus and lower levels of CD4 immune cells which protect the body from infection –35 percent of the time, increasing the risk that these youth would stop responding to certain HIV medications and could transmit HIV to others. These findings are consistent with other U.S. and European reports. Despite being engaged in health care, the number of deaths among youth born with HIV in the U.S. is 6 to12 times higher than for youth without HIV of the same age, sex and race. Along with HIV-related health problems, the most commonly reported health conditions concerned mental health and brain and nervous system development. Many women in the study also had sexually transmitted infections, which was found to be associated with lower CD4 immune cell counts. This may suggest a biological mechanism or may reflect that patients who have difficulty with their medications are also engaging in more frequent risky sexual behaviors. (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, Dermatology, Environmental Risks, Melanoma / 27.03.2017

MedicalResearch.com Interview with: Matthew Reynolds Acting Team Lead, Office of Communication Division of Cancer Prevention and Control (DCPC) Centers for Disease Control and Prevention (CDC) Chamblee GA MedicalResearch.com: What is the background for this study? Response: Indoor tanning and sunburns, particularly during adolescence and young adulthood, increases the risk of developing skin cancer. Researchers examined trends in the prevalence of indoor tanning and the relationship between indoor tanning and sunburn among US high school students. Pooled cross-sectional data from the 2009, 2011, 2013, and 2015 national Youth Risk Behavior Surveys. The study included nationally representative samples of U.S. high school students. (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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Abuse and Neglect, Cancer Research, Fertility, Immunotherapy / 27.03.2017

MedicalResearch.com Interview with: Kenneth S. K. Tung, M.D. Professor of Pathology and Microbiology Director of UVA Research Histology Core Beirne B. Carter Center for Immunology Research University of Virginia MedicalResearch.com: What is the background for this study? Response: The immune system needs to see tissue antigens to avoid responding to them in order to prevent autoimmune disease development. The current dogma, stated in all Immunology and Reproductive Biology textbooks, considers the sperm antigens in the testis to be exempted from this process. They are considered totally hidden behind a tissue barrier, and are invisible to the immune system. Because sperm antigens are treated as foreign molecules, they should stimulate strong immune response when employed in cancer vaccines against antigens common to sperm and cancers. It is also believed that sperm molecules are protected by local factors that inhibit inflammation, whereas systemic mechanisms such as regulatory T cells would not exist. The paradigm has restrained ongoing research on systemic tolerance to sperm, and the need to understanding systemic regulation in infertility research.  (more…)
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, Sexual Health, Sleep Disorders / 27.03.2017

MedicalResearch.com Interview with: Jen-Hao Chen PhD Assistant Professor Department of Health Sciences and School of Public Affairs University of Missouri - Columbia MedicalResearch.com: What is the background for this study? Response: It has been well known that sexual minority adults in the US have worse health as compared with heterosexual peers. Queer folks are found to have poorer physical, mental and behavioral health outcomes because of their marginalized status and social environments. But we know very little about prevalence of sleep problems in the population of sexual minorities compared to heterosexual people. Do sexual minorities lose sleep? Do they wake up more often during the night? Do they sleep less? This study aims to address this important gap in the LGBT health literature. Using recent nationally representative data, we exam whether sexual minority adults have greater odds of having short sleep duration and poor sleep quality. In addition, we also investigate sexual minorities’ sleep in the context of gender and race/ethnicity  (more…)
Author Interviews, Rheumatology, Weight Research / 27.03.2017

MedicalResearch.com Interview with: Elizabeth Badley PhD Professor Emeritus Dalla Lana School of Public Health, University of Toronto Director: The Arthritis Community Research and Evaluation Unit and Head, Division of Health Care and Outcomes Research Krembil Research Institute Toronto Western Hospital Toronto, Ontario  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The aging of the baby boomer population is focusing attention on the health experience of this sector of the population.  Arthritis is one of the most frequent chronic health problems in the population.  Our research question was to investigate whether the prevalence of arthritis differs between generations (also called birth cohorts) and what might be associated with any differences. Using data collected in a longitudinal Canadian population health survey between 1994 and 2011, we looked at 4 generations: the World War II generation born 1935-1944, older baby boomers born 1945-1954, younger baby boomers born 1955-64, and Generation X born 1965-1974. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Dermatology, Pediatrics / 26.03.2017

MedicalResearch.com Interview with: Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, Illinois MedicalResearch.com: What is the background for this study? Response: Stevens-Johnson syndrome and Toxic Epidermal Necrolysis (SJS/TEN) are relatively rare and potentially life-threatening disorders. There have been some recent advances in our understanding of the epidemiology and risk factors of SJS/TEN in adults. However, little is known about the epidemiology of pediatric SJS/TEN. (more…)
Author Interviews, Dermatology, Orthopedics / 26.03.2017

MedicalResearch.com Interview with: Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, Illinois Response: Psoriasis is associated with a number of potential risk factors for developing osteoporosis and pathological fractures, including including low vitamin D, chronic inflammation, higher rates of cigarette smoking and systemic corticosteroid usage. We hypothesized that adults with psoriasis have higher rates of osteoporosis and pathological fractures. We examined data from the 2002-2012 National Inpatient Sample, which contains a representative 20% sample of all hospitalizations in the United States. We found that psoriasis was associated with higher odds of osteopenia, osteoporosis, osteomalacia, ankylosing spondylitis, and pathological fractures. In particular, psoriasis was associated with vertebral, pelvic, femoral and tibial/fibular fractures. The associations between psoriasis and pathological fractures were more pronounced in women than men. (more…)
Author Interviews, Cost of Health Care, Dermatology / 26.03.2017

MedicalResearch.com Interview with: Dr. Jonathan L. Silverberg MD PhD MPH Assistant Professor in Dermatology Medical Social Sciences and Preventive Medicine Northwestern University, Chicago, Illinois  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Atopic dermatitis (AD) is associated with considerable morbidity and quality of life impairment. AD patients may require hospitalization for acute treatment of serious flares and/or inadequately controlled chronic disease. We examined data from the 2002-2012 National Inpatient Sample, which contains a representative 20% sample of all hospitalizations in the United States. We found that there were substantial numbers of children and adults hospitalized in the United States for AD. Hospitalization rates for atopic dermatitis were highest in the northeast during the winter likely due to cold and dry weather and south during the summer likely due to heat and humidity. Further, hospitalization rates for AD significantly increased in adults between 2002 and 2012. The costs per individual hospitalization were lower in children and adults with AD compared to those without  atopic dermatitis. However, the high prevalence of hospitalization resulted in total inpatient costs of >$8 and >$3 million per-year for adults and children, respectively. (more…)
Abuse and Neglect, Cost of Health Care, Geriatrics / 25.03.2017

MedicalResearch.com Interview with: Sheila Eckenrode RN, CPHQ Quality Improvement Consultant The New England QIN-QIO Qualidigm, Wethersfield, Connecticut MedicalResearch.com: What is the background for this study? Response: Post-acute care has become a focus for improving quality and cost effectiveness of healthcare in the United States. Changes in Medicare payment systems such as bundled payments and the emergence of Affordable Healthcare Organizations will most likely lead to expansion of post-acute care services and decrease in acute care hospitalizations. Approximately 30% of hospitalized Medicare beneficiaries were referred to home health care at discharge in 2012. In 2013, home health agencies served 3.5 million beneficiaries with Medicare paying $18 billion for these services. Home health care has been emphasized under the Improving Medicare Post-Acute Care Transformation Act of 2014 to provide and improve care at individual patient and community levels. In anticipation of increasing utilization of home care services, our study aimed to demonstrate the overall growth in home care availability as well as identify geographical variation and potential gaps in service. (more…)