Author Interviews, Cost of Health Care / 12.03.2018

MedicalResearch.com Interview with: Dr. Samuel Cho, MD Associate Professor of Orthopaedics Icahn School of Medicine at Mount Sinai   MedicalResearch.com: What is the background for this study? What are the main findings? Response: Anterior cervical discectomy and fusion (ACDF), first implemented in 1957, has been considered the “gold standard” for decades for the treatment of cervical degenerative disc disease after conservative options have been exhausted. For patients presenting with neck and radiating arm pain, motor weakness, and sensory loss due to cervical disc herniation or compressive pathologies, ACDF has been shown to be generally well-tolerated and associated with a high clinical success rate. Despite the proven long-term radiographic and clinical success of ACDF, however, our literature has shown the procedure to be associated with certain drawbacks including neurological complications, rapid development of adjacent segment disease, and decreased range of motion owing to solid bony arthrodesis. More recently, cervical disc replacement (CDR) has also become an acceptable surgical option for similar cervical spine pathologies as ACDF. CDR was developed as a motion-sparing alternative to ACDF with purported advantages including minimization of adjacent segment disease and obviation of pseudoarthrosis. Multiple large investigational device exemption (IDE) studies showing the non-inferiority of cervical disc replacement, the cost-effectiveness of this procedure has increasingly become a topic of interest. For this reason, we sought to determine the seven-year cost-effectiveness of single level ACDF versus CDR for the treatment of cervical disc degeneration. (more…)
Author Interviews, JAMA, University of Michigan, Urinary Tract Infections / 12.03.2018

MedicalResearch.com Interview with: Keith S. Kaye, MD, MPH Professor of Medicine, Division of Infectious Diseases University of Michigan Medical School Ann Arbor MI  MedicalResearch.com: What is the background for this study? Response: Complicated complicated urinary tract infections (cUTI), including acute pyelonephritis, are a major cause of hospital admissions, and are associated with significant morbidity and mortality and can be difficult to treat. While the most common pathogen is Escherichia coli, the more problematic pathogens are multidrug-resistant (MDR) gram-negative organisms including other Enterobacteriaceae species. The prevalence of cUTI due to MDR gram-negative bacteria has risen. In some instances, MDR gram-negative bacteria isolated from the urinary tract can cause bacteremia. Vabomere was approved by the U.S. Food and Drug Administration (FDA) in August 2017 for the treatment of adult patients with cUTI, including pyelonephritis, caused by designated susceptible Enterobacteriaceae: Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae species complex.   Vabomere is a fixed-dose (2g/2g) combination product of a carbapenem and a β-lactamase inhibitor with potent in vitro activity against Klebsiella pneumoniae carbapenemase (KPC)-producing carbapenem-resistant Enterobacteriaceae (CRE), an important MDR organism associated with serious infections. The Targeting Antibiotic Non-susceptible Gram-negative Organisms (TANGO I) trial was the pivotal Phase 3 study that compared the efficacy and safety of Vabomere to piperacillin-tazobactam in the treatment of patients with cUTI and acute pyelonephritis. (more…)
Author Interviews, Brigham & Women's - Harvard, Diabetes, Heart Disease / 12.03.2018

MedicalResearch.com Interview with: Muthiah Vaduganathan, MD MPH Heart and Vascular Center Brigham and Women's Hospital  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The prevalence of heart failure with preserved ejection fraction (HFpEF) is rising globally, yet no medical therapies are currently available to alter its natural history and its progression remains incompletely understood. Sudden death may represent a target for therapy in this disease entity. In 1,767 patients with HFpEF enrolled in the Americas region of the TOPCAT trial, we found that sudden death accounts for ~20% of all deaths. Male sex and insulin-treated diabetes mellitus identify patients at higher risk for sudden death. Sudden death was numerically lower but not statistically reduced in those randomized to spironolactone. (more…)
Author Interviews, Infections / 12.03.2018

MedicalResearch.com Interview with: Michael Durkin, MD MPH Washington University School of Medicine St. Louis MedicalResearch.com: What is the background for this study? What are the main findings? Response: The aim of this study was to evaluate overall national outpatient antibiotic prescribing trends using a pharmacy benefits manager (Express Scripts). We wanted to evaluate if antibiotic prescribing had decreased as a result of increase physician awareness of antibiotic prescribing. Specifically, the ABIM choosing wisely campaign overlapped with our study period. We did not see any significant reductions in antibiotic prescribing during the 3-year study period. This is a little disappointing given that the CDC estimates that 30% of outpatient antibiotic prescriptions are inappropriate. We also saw some seasonal variation in antibiotic prescribing. This isn’t particularly novel. But it is important to note, as some of these prescriptions represent providers writing antibiotics for likely viral conditions. (more…)
Aging, Author Interviews, Cancer Research, Johns Hopkins / 12.03.2018

MedicalResearch.com Interview with: Hariharan Easwaran, PhD Assistant Professor of Oncology The Sidney Kimmel Comprehensive Cancer Center The Johns Hopkins University School of Medicine Bunting/Blaustein Cancer Research Building 1 Baltimore, MD 21287 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The interpretation of the information encoded in our DNA by the various cells in our body is mediated by a plethora of modifications of DNA and proteins that complex with DNA. DNA methylation is one such important modification, which is normally established in a very orchestrated fashion during development. All normal cells have a defined pattern of DNA methylation, which may vary by tissue type, but is consistent within tissues. This normal pattern is disrupted in all known cancers, and is considered a hallmark of cancers. (more…)
Author Interviews, Dermatology, JAMA, Melanoma / 11.03.2018

MedicalResearch.com Interview with: Aimilios Lallas, PhD First Department of Dermatology, School of Medicine Aristotle University Thessaloniki, Greece MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Our goal today is to recognize melanoma at the earliest stage, ideally before it invades the dermis and acquires metastatic potential. Melanoma-specific dermoscopic criteria have been tested mainly in the context of invasive melanoma. Although they were proven valid melanoma predictors, the question still remains if they are strong enough to diagnose melanoma in situ (MIS). Our aim was to investigate the diagnostic accuracy of dermoscopic criteria for the diagnosis of melanoma in situ. We identified 5 main positive dermoscopic indicators of MIS: atypical network, regression, irregular hyperpigmented areas, prominent skin markings and angulated lines.  (more…)
Author Interviews, Parkinson's / 11.03.2018

MedicalResearch.com Interview with: Prof. Jeffrey Hausdorff PhD Director of the Center for the Study of Movement, Cognition and Mobility Full Professor in the Sackler School of Medicine and Sagol School of Neuroscience Tel Aviv Medical Center MedicalResearch.com: What is the background for this study?  Response: Many people with Parkinson’s disease suffer from a disturbing symptom referred to as “freezing of gait”. When freezing occurs, the person’s feet inexplicably become stuck to the floor and he or she is unable to move forward, despite efforts to walk. Initially, the problem can last just a few seconds and occur very infrequently. As the problem progresses, however, freezing can last many seconds, occurring frequently throughout the day. This can lead to a very frustrating situation that may also be dangerous. People with freezing of gait have an increased risk of falls and reduced health-related quality of life. The behavioral manifestation of freezing of gait is a problem with walking, i.e., it is a “motor” symptom. However, there is also evidence that deficits in specific aspects of cognitive function (i.e., executive function) may also contribute to freezing of gait. The goals of the present work were to use non-invasive brain stimulation to better understand if these cognitive deficits are indeed in the causal chain and if non-invasive brain stimulation that simultaneously targets both motor and cognitive brain areas that are believed to involved with freezing have a better impact on freezing and related symptoms than stimulation that targets only motor brain areas or sham stimulation. (more…)
Author Interviews, Heart Disease, Weight Research / 11.03.2018

MedicalResearch.com Interview with: Dr. Sadiya S. Khan, MD MS Division of Cardiology, Department of Medicine Department of Preventive Medicine Northwestern University Feinberg School of Medicine Chicago, Illinois MedicalResearch.com: What is the background for this study? What are the main findings?  Response: In recent years, controversy has grown regarding findings termed the "obesity paradox" whereby individuals with cardiovascular disease who are obese have "better" outcomes. These findings have led to confusion for patients who are obese. The main findings of our study help clarify the adverse cardiovascular risks for obese individuals with a shorter overall health span and lifespan. Obese participants in our study lived shorter and sicker with more years lived with cardiovascular diseases and greater lifetime risk of developing cardiovascular disease.  (more…)
Author Interviews, Heart Disease, Psychological Science / 11.03.2018

MedicalResearch.com Interview with: Dr. Alexander Fanaroff MD Duke University School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Among patients with chronic angina, there are strong associations between depression and clinical outcomes, which illustrates the important interplay between psychosocial symptoms and physical symptoms in this condition. But depressive symptoms are distinct from expectations and optimism regarding recovery and returning to a one’s normal lifestyle. Patients with chronic angina may not be optimistic about their outlook for a number of reasons, including uncertainty about their prognosis or lack of medical knowledge, but for many patients with chronic angina, the outlook is actually quite good. We examined data from RIVER-PCI, a clinical trial that randomized patients with chronic angina and incomplete revascularization to ranolazine or placebo, and were followed for the primary outcome of ischemia-driven hospitalization or revascularization. Patients were asked at baseline, 1 month, 6 months, and 12 months how much they agreed with the phrase, “I am optimistic about my future and returning to a normal lifestyle.” We categorized patients by their responses at baseline – we coded “strongly agree” as very optimistic, “agree” as optimistic, “neutral” as neutral, and “disagree” and “strongly disagree” as not optimistic – and evaluated the association between baseline optimism and the primary outcome over long-term follow-up. We found that most patients were optimistic at baseline – 33% were very optimistic, 42% were optimistic, 19% were neutral, and 5% were not optimistic – and the majority remained optimistic over long-term follow-up. The most optimistic patients had a lower prevalence of prior myocardial infarction, heart failure, diabetes, and chronic kidney disease and less severe angina at baseline than less optimistic patients. The rate of the ischemia-driven hospitalization or revascularization was higher in neutral (32.8%) and not optimistic (35.0%) patients compared with the most optimistic patients (24.4%). Even after adjusting for baseline comorbidities and angina frequency, the most optimistic patients had a 30% lower risk of ischemia-driven hospitalization or revascularization compared with neutral or not optimistic patients. (more…)
Author Interviews, GSK, Herpes Viruses, Infections, Vaccine Studies / 10.03.2018

MedicalResearch.com Interview with: Anthony. L. Cunningham, MD The Westmead Institute for Medical Research Westmead, NSW University of Sydney, Sydney,   MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study examines the reasons why the HZ subunit vaccine candidate (HZ/su vaccine) consisting of a single viral protein, varicella-zoster glycoprotein E, and and adjuvant (immunostimulant) combination AS01B is so effective as a vaccine to prevent shingles (>90%), especially in those over the age of 70 years and 80 years, as published in recent trials i.e. it combats the declining immunity in the aging which usually restricts vaccine efficacy to under 60% in these age groups.  (more…)
Author Interviews, Heart Disease, Lancet, Menopause, Women's Heart Health / 10.03.2018

MedicalResearch.com Interview with: Mihir Sanghvi Academic Junior Doctor Barts Health NHS Trust MedicalResearch.com: What is the background for this study? What are the main findings? Response: The effect of menopausal hormone therapy (MHT), previously known as hormone replacement therapy, on cardiovascular health in post-menopausal women remains controversial and unclear. Extensive observational data had suggested MHT to be cardioprotective, leading to MHT being routinely prescribed for both primary and secondary prevention of coronary heart disease (CHD). However, subsequent data from the Women’s Health Initiative (WHI) and Heart and Estrogen/Progestin Replacement Study (HERS) studies cast doubt on the beneficial cardiovascular effects of MHT; this was reflected in learned societies’ clinical guidance concerning MHT’s role in CHD prevention. The most recent randomised trial data on the subject arose from the Danish Osteoporosis Prevention Study, which indicated that women taking menopausal hormone therapy had a reduced risk of the composite endpoint of mortality, heart failure and myocardial infarction but the study has been subject to criticism [10]. In more recent work, again from the WHI, there was no difference in cardiovascular mortality in MHT users compared to placebo, although the authors themselves state that cause-specific mortality data should be interpreted “cautiously”. The UK Biobank is an ongoing, large-scale, population-based study designed to examine determinants of health in middle and old age. Besides extensive collection of health questionnaire data, biological samples and physical measurements, it has incorporated cardiovascular magnetic resonance (CMR) imaging – the gold standard for analysis of cardiac structure and function – to provide detailed imaging phenotypes. At present, there is a paucity of data on the effects of  menopausal hormone therapy on left ventricular (LV) and left atrial (LA) volumes and function, alterations in which are markers of subclinical cardiovascular disease and have prognostic implications. We found that in a large, population-based cohort of post-menopausal women free of cardiovascular disease, use of menopausal hormone therapy is not associated with adverse, subclinical changes in cardiac structure and function. Indeed, we demonstrate significantly smaller LV and LA chamber volumes which have been linked to favorable cardiovascular outcomes in other settings. (more…)
Author Interviews, JAMA, Prostate Cancer / 10.03.2018

MedicalResearch.com Interview with: Amar U. Kishan, MD Assistant Professor Department of Radiation Oncology University of California, Los Angeles MedicalResearch.com: What is the background for this study? Response: Patients with high risk prostate cancer have several curative treatment options: radical prostatectomy, external beam radiotherapy with androgen deprivation therapy, and external beam radiotherapy with a brachytherapy boost, also with androgen deprivation therapy (so-called extremely dose-escalated radiotherapy). Prior attempts at comparing long-term clinical outcomes between these treatment options have been hampered by the fact that standards of care have changed significantly with respect to the appropriate dose of radiation and the usage of androgen deprivation therapy. Therefore, many comparative effectiveness reports are in essence comparing apples with rotten oranges. Further, not all high risk prostate cancers are the same. Gleason score 9-10 disease is a particularly aggressive form of prostate cancer that is much more likely to metastasize and potentially cause death. Thankfully, this is a rarer type of prostate cancer -- but this also means that not much data are available specifically for this type of disease. Therefore, we launched a multi-institutional study of men with Gleason score 9-10 disease, including 1809 men treated across 12 institutions. All men were treated between 2000 and 2013 and therefore were more likely to have treatments that would be commensurate with modern standards.  (more…)
Author Interviews, Infections / 09.03.2018

MedicalResearch.com Interview with: Chih-Chi Andrew Hu, Ph.D. Associate professor in Microenvironment & Metastasis Program Wistar Institute  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: To help our body fight infections, B cells need to differentiate into plasma cells so that they can produce abundant antibodies against pathogens. Antibodies are folded and assembled in the endoplasmic reticulum (ER). Only those perfectly manufactured antibodies are allowed to be released from the ER and delivered to the outside of B cells to fight against the pathogens. IRE1 is a sensor protein that sits on the membrane of the ER, and can respond to B cell differentiation by activating the transcription factor called XBP1s. Activation of XBP1s allows B cells to expand the size of the ER and produce necessary chaperone proteins to help B cells manufacture perfect antibodies. By studying B cells that lack XBP1s, we discovered that these B cells produced dramatically increased levels of IRE1, and such IRE1 acquired phosphorylation at its serine 729 (S729).  (more…)
Asthma, Author Interviews, NEJM, Pulmonary Disease / 09.03.2018

MedicalResearch.com Interview with: “Asthma Inhaler” by NIAID is licensed under CC BY 2.0Timothy Harrison, MBBS, BSc, FRCP, MD, MSc Professor and Honorary Consultant Faculty of Medicine & Health Sciences University of Nottingham MedicalResearch.com: What is the background for this study? What are the main findings? Response: Self management plans are recommend for patients with asthma but previous studies have shown that doubling the dose of inhaled steroids when asthma starts deteriorating is ineffective at preventing the development of an exacerbation. This study shows that quadrupling the dose is effective and in a real-life setting can reduce severe exacerbations by about 20% (more…)
Author Interviews, Orthopedics / 08.03.2018

MedicalResearch.com Interview with: Dr. Charles A. Popkin, MD Orthopedic Surgeon NewYork-Presbyterian/Columbia University Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? CAP: Sports participation offers multiple benefits for children and adolescents, but there is growing concern about the rise of early sports specialization (ESS). ESS is defined as intense, sport specific training for greater than 8 months a year at the exclusion of other sports and activities in children younger than 12 years of age (pre-pubescent). ESS has been linked with decreased enjoyment, burnout, injury risk and the impact of specialization on long term athletic success is unknown. The extent to which parents exert influence, both directly and indirectly on the phenomenon of ESS was the major focus of the study. (more…)
Author Interviews, Gastrointestinal Disease, Infections / 08.03.2018

MedicalResearch.com Interview with: Esther Bullitt, Ph.D. Associate Professor Dept. of Physiology & Biophysics Boston University School of Medicine Boston, MA  02118-2526  MedicalResearch.com: What is the background for this study? Response:      We know that saliva has properties that allow us to swallow easily, and to help prevent gum disease and infections in the mouth. But is that really the only use for the 1-2 liters (1-2 quarts) of saliva we produce every day?  We decided to test whether a component of saliva, Histatin-5, can help prevent diarrheal disease (Traveler’s Diarrhea by Enterotoxigenic Escherichia coli (ETEC)) that is caused by bacteria commonly found in contaminated food and water. ETEC are bacteria that have hundreds of thin hair-like fibers on their surface, called pili. These bacteria bind specifically to the surface of the gut using these pili, and the bacteria need to stay bound long enough to initiate disease. Studies by Mike Levine’s group in the 1970’s showed that pili are necessary for enterotoxigenic Escherichia coli (ETEC) to cause disease. No adhesion, no disease. One aid to remaining bound is the unwinding and rewinding of the pili. These helical fibers can unwind up to 8 times their original length, acting as shock absorbers during fluid flow.   (more…)
Author Interviews, Multiple Sclerosis, Ophthalmology, Pharmaceutical Companies / 08.03.2018

MedicalResearch.com Interview with: Sarah A. Morrow MD, MS, FRCPC Associate Professor of Neurology Department of Clinical Neurological Sciences University of Western Ontario (Western) MedicalResearch.com: What is the background for this study? Response: Acute demyelinating optic neuritis, which presents with loss of vision and painful eye movements, is common in multiple sclerosis (MS) occurring 50% of persons with MS. High dose (≥ 1g) corticosteroids administered through an IV became the standard of practice after the landmark Optic Neuritis Treatment Trial as IV administration. However, in that study the IV dose of corticosteroids was much higher (1 gram daily) than the oral dose (1 mg/kg). Thus, it is not clear if IV administration is still better if equivalent doses are used orally. Oral administration is much more convenient for patients and less expensive, and previous studies showed that it is preferred by patients. In this study, we asked the following question: are high dose (≥ 1000mg) IV corticosteroids superior to equivalent doses of oral corticosteroids for the acute treatment of optic neuritis? We randomly assigned fifty-five cases of acute optic neuritis to 1000mg IV methylprednisolone or 1250mg oral prednisone daily for three days and compared recovery of their vision over the next 6 months.  (more…)
Abuse and Neglect, Hematology, Lancet, Medical Imaging, Transplantation / 07.03.2018

MedicalResearch.com Interview with: Kirsten Williams, M.D. Blood and marrow transplant specialist Children’s National Health System  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: This study addressed a life-threatening complication of bone marrow transplantation called bone marrow failure. Bone marrow transplantation has provided a cure for patients with aggressive leukemias or acquired or genetic marrow dysfunction. The process of bone marrow transplantation involves giving chemotherapy and/or radiation, which removes the diseased blood cells from the bone marrow. After this, new bone marrow stem cells are infused from a healthy individual. They travel to the bone marrow and start the slow process of remaking the blood system. Because these new cells start from infancy, it takes upwards of four to five weeks for new mature healthy cells to emerge into the blood, where they can be identified. Historically, there has been no timely way to determine if the new cells have successfully repopulated unless they can be seen in the blood compartment. This condition of bone marrow failure is life-threatening, because patients don't have white blood cells to protect them from infection. Once bone marrow failure is diagnosed, a second new set of stem cells are infused, often after more chemotherapy is given. However, for many individuals this re-transplantation is too late, because severe infections can be fatal while waiting cells to recover. We were the first group to use a new imaging test to understand how the newly infused bone marrow cells develop inside the patient. We have recently published a way to detect the new bone marrow cell growth as early as five days after the cells are given. We used an investigational nuclear medicine test to reveal this early cell growth, which could be detected weeks before the cells appear in the blood. This radiology test is safe, does not cause any problems and is not invasive. It is called FLT (18F-fluorothymidine) and the contrast is taken up by dividing hematopoietic stem cells. The patients could even see the growth of their new cells inside the bone marrow (which they very much enjoyed while waiting to see recovery of the cells in their blood). We could use the brightness of the image (called SUV) to determine approximately how many weeks remained before the cells were visible in the blood. Finally, we actually could see where the new cells went after they were infused, tracking their settling in various organs and bones. Through this, we could see that cells did not travel directly to all of the bones right away as was previously thought, but rather first went to the liver and spleen, then to the mid-spine (thorax), then to the remainder of the spine and breastplate, and finally to the arms and legs. This pattern of bone marrow development is seen in healthy developing fetuses. In this case, it occurs in a similar pattern in adults undergoing bone marrow transplant. (more…)
Allergies, Author Interviews, Dermatology, Inflammation, Pediatrics / 07.03.2018

MedicalResearch.com Interview with: elstarNidhi Malhotra PhD Boston Children's Hospital Division of Allergy and Immunology Senior Scientist at Elstar Therapeutics Inc. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Allergies such as Atopic Dermatitis (AD) are rampant in the industrialized nations. Why are we more predisposed to developing hypersensitive reactions to innocuous proteins (allergens) is not well understood. To gain better understanding and to develop better therapies, we need to first delve deeper into how our immune system regulates homeostasis in tissues such as skin. The main cell types that thwart inflammatory reactions are known as regulatory T cells. These cells are generated in thymus and reside in secondary lymphoid tissues but they are also prominent at tissue sites such as in dermal layer of skin. In this study, I focused on understanding how Tregs resident in skin are distinct from the Tregs in secondary lymphoid organs such as lymph nodes (LNs). I uncovered that functioning of Tregs in skin is underpinned by a distinct set of genes. One main gene that I found to be highly expressed in skin Tregs but not in LN Tregs is Rora, which encodes for the transcription factor ROR alpha (RORa). This observation was intriguing as previous studies had elucidated the requirement of RORa in the development of inflammatory type-2 innate lymphoid cells (ILC2s) and it has been considered the antagonizing RORa functioning would curb allergic responses. However, I observed that Tregs require RORa to suppress allergic responses. In particular, RORa regulates the expression of a TNF receptor family member DR3, which binds to the cytokine TL1A. TL1A has a role in enhancing suppressive activity of Tregs while also enhancing type-2 cytokine production from ILC2s. Hence, in the absence of DR3 in Tregs, we believe more TL1A is available to ILC2s resulting in unrestrained allergic responses.  (more…)
Author Interviews, Education, Race/Ethnic Diversity, Social Issues / 07.03.2018

MedicalResearch.com Interview with: Patricia Louie, MA PhD Student, Department of Sociology University of Toronto Toronto, ON, Canada  MedicalResearch.com: What is the background for this study?   Response: While most physicians believe that they treat patients equally, research shows that racial inequality pervades the U.S. health care system (Feagin and Bennefield 2014; Williams 2012). Because these inequities persist even after demographic and other socio-economic differences are taken into consideration scholars have started to look at the representation of race in the medical curriculum. The idea is that medical curriculum creates both implicit and explicit connections between race and disease. We build on this body of work by investigating the representation of race (White, Black and Person of Color) and skin tone (light, medium and dark) in the images of four preclinical anatomy textbooks - Atlas of Human Anatomy, Bates’ Guide to Physical Examination & History Taking, Clinically Oriented Anatomy, and Gray’s Anatomy for Students.  Skin tone is important. The majority of medical imagery consists of decontextualized images of body parts where skin tone, which may be related to disease presentation, is the only phenotypical marker. If doctors associate light skin tones with White patients, this may also influence how doctors think about who is a “typical” patient, particularly for the type of disease that is shown in that image. (more…)
Author Interviews, Dermatology, Eli Lilly, Sexual Health / 07.03.2018

MedicalResearch.com Interview with: Dr. Jennifer Cather MD Medical Director at Modern Dermatology and Modern Research Associate Dallas, Texas  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Genital psoriasis can be an uncomfortable and burdensome condition that many people living with moderate-to-severe plaque psoriasis experience. Due to the significant impact, Lilly conducted a 12-week Phase 3b clinical trial with patients with moderate-to-severe genital psoriasis treated with ixekizumab, which found that patients had a greater decrease in the impact of their condition on sexual activity compared to placebo as early as one week. Specifically, trial patients were randomized to receive ixekizumab (80 mg every two weeks, following a 160-mg starting dose) or placebo and researchers measured pre-specified patient-reported outcomes, including the Genital Psoriasis Sexual Impact Scale (GPSIS), which is composed of the Sexual Activity Avoidance (Avoidance) and Impact of Sexual Activity on Genital Psoriasis Symptoms (Impact) subscales. Patient-reported outcomes were also measured by the Sexual Frequency Questionnaire (SFQ) item 2, evaluating the impact of genital psoriasis on the frequency of sexual activity, and the Dermatology Life Quality Index (DLQI) item 9, evaluating the impact of skin symptoms on sexual difficulties. At 12 weeks, patients reported the following outcomes:
  • DLQI Item 9 0/1: 92.0 percent of patients treated with ixekizumab compared to 56.8 percent of patients treated with placebo reported no (0) or little (1) sexual difficulties caused by skin symptoms.
  • SFQ Item 2 0/1:  78.4 percent of patients treated with ixekizumab compared to 21.4 percent of patients treated with placebo (reported the frequency of sexual activity was either never (0) or rarely (1) limited by genital psoriasis.
  • GPSIS-Avoidance 1/2:  76.7 percent of patients treated with ixekizumab compared to 25.7 percent of patients treated with placebo reported never (1) or rarely (2) avoiding sexual activity due to genital psoriasis.
  • GPSIS-Impact 1/2:  85.7 percent of patients treated with ixekizumab compared to 52.9 percent of patients treated with placebo reported worsening of genital psoriasis symptoms during or after sexual activity was very low/none at all (1) or low (2). 
(more…)
Allergies, Author Interviews / 07.03.2018

MedicalResearch.com Interview with: Emily Clarke McGowan, MD Assistant Professor, Allergy/Clinical Immunology Charlottesville, VA 22908-1355 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Folate (vitamin B9) is available in either the natural or synthetic forms and has been shown to reduce the risk of neural tube defects, like spina bifida, in newborns.  Folic acid, the synthetic form of folate, is widely consumed in the United States in infant formula, supplements, vitamins, and fortified grains.  When folic acid is consumed in high quantities, some of this folic acid does not undergo further metabolism and circulates in the blood as "unmetabolized folic acid" (UMFA). In this study, we measured total folate, UMFA, and 5-methyltetrahydrofolate (5-MTHF), the main folate metabolite involved in biochemical processes in the body, in a subset of children from the Boston Birth Cohort. While mean levels of total folate at birth were lower among those who developed food allergy, mean levels of the synthetic folic acid derivative, UMFA, were higher.  There was no association between total folate, 5-MTHF, or UMFA levels in early life and the development of food allergy.  (more…)
Author Interviews, Duke, Heart Disease, JACC / 07.03.2018

MedicalResearch.com Interview with: Renato D. Lopes MD, MHS, PhD Professor of Medicine, Division of Cardiology Duke University Medical Center Duke Clinical Research Institute Terrace Level, Durham, NC 27705 MedicalResearch.com: What is the background for this study? 1-      Digoxin is used in ≈ 30% of patients with atrial fibrillation (AF) worldwide, despite the lack of randomized clinical trials to assess its efficacy and safety in this setting. 2-      Current AF guidelines recommend digoxin for rate control in patients with AF with and without heart failure (HF). 3-      There are no specific recommendations about serum digoxin concentration monitoring in the atrial fibrillation guidelines. (more…)
Author Interviews, Biomarkers, Prostate Cancer / 07.03.2018

MedicalResearch.com Interview with: Richard Martin Professor of Clinical Epidemiology Head of Section, Clinical Epidemiology & Public Health Population Health Sciences Bristol Medical School  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Screening for prostate cancer using the PSA test aims to detect prostate cancer at an early stage, before symptoms develop, when treatment can be offered that may avoid the risks of advanced cancer or may extend life. Evidence from a large European trial suggests that PSA screening at 2 to 4 yearly intervals could reduce prostate-cancer deaths by 20%. after 13 years of follow-up. However, there are problems with the accuracy of the PSA test and potential harmful consequences. In particular, using the PSA test to screen for prostate cancer results in some tested men being diagnosed with low-risk, harmless cancers that are unlikely to progress or require treatment.  This problem may be particularly exacerbated when using repeated PSA testing as a screening strategy. The CAP trial offered a one-off PSA test to men aged 50-69 years in the UK. The goal of this low-intensity, one-off PSA testing was to avoid unnecessary screening while still identifying men with high risk, aggressive cancers for whom screening and early detection can reduce morbidity and mortality. However, we found that after an average 10-years of follow-up, the PSA test still detected too many low-risk prostate cancers, while also missing cancers that did need treatment. After an average 10-years of follow-up, the group who had been screened had the same percentage of men dying from prostate cancer as those who had not been screened (0.29%).  (more…)
Author Interviews, Biomarkers, Neurological Disorders, University Texas, Zika / 07.03.2018

MedicalResearch.com Interview with: Slobodan Paessler, D.V.M., Ph.D. Professor, Department of Pathology; Director, Galveston National Laboratory Preclinical Studies Core; Director, Animal Biosafety Level 3, Institute for Human Infections and Immunity; Member, Center for Biodefense & Emerging Infectious Diseases University of Texas Medical Branch Galveston, TX MedicalResearch.com: What is the background for this study? What are the main findings? Response: Zika virus infection is associated with various developmental issues for human embryos such as reduced head growth, reduced brain tissue growth, and damage to brain or eyes. We wanted to better understand if some of these birth defects are caused directly by the Zika virus or maybe by the host response to infection. In our study we demonstrate that the Zika virus infection induces autoimmune response against the C1q protein. This protein is a very important immune protein as well as one of the essential proteins for healthy brain development. Attacking the C1q protein upon exposure with the Zika virus could contribute to the development of autoimmune disorders and birth defects.  (more…)
Author Interviews, JACC, JAMA, Weight Research / 05.03.2018

MedicalResearch.com Interview with: “physical-activity-120112-M-2021D-019” by MilitaryHealth is licensed under CC BY 2.0Trine Moholdt, PhD Research Fellow Department of Circulation and Medical Imaging | Exercise, Cardiometabolic Health and Reproduction Norwegian University of Science and Technology MedicalResearch.com: What is the background for this study?   Response: Although obese individuals have an increased risk of cardiovascular disease, evidence from many observational studies shows that in those who already have cardiovascular disease, being overweight or obese is associated with lower risk of mortality compared to their normal weight counterparts. This phenomenon is often called the “obesity paradox”. Recently we observed that in individuals who have a high physical activity level, there is no such obesity paradox and body mass index did not associate with survival time in those who with high physical activity (Moholdt et al, American Journal of Medicine, 2017).  (more…)
Author Interviews, Boehringer Ingelheim, Dermatology, Pulmonary Disease, Rheumatology / 05.03.2018

MedicalResearch.com Interview with: Donald Zoz, MD Senior Associate Director Clinical Development & Medical Affairs IPF/ILD Boehringer Ingelheim Pharmaceuticals, Inc. MedicalResearch.com: What is the background for this platform? Would you briefly explain what is meant by scleroderma? How does it affect a person's skin and ability to function? Whom does this disease primarily affect? Response: “More Than Scleroderma™: The Inside Story” is Boehringer Ingelheim’s new global initiative highlighting real-life, inspirational stories of people living with the rare disease scleroderma. The new effort, created with support from the Scleroderma Foundation in the U.S., aims to raise awareness of the disease, dispel misperceptions and provide important resources to support and guide those on their journey with scleroderma. The initiative’s website http://www.morethanscleroderma.com/us/ features a powerful and inspiring collection of diverse photographs and video profiles of 10 people across the U.S. living with scleroderma and sharing their ‘inside story.’ Each tells their unique and moving experience with scleroderma through diagnosis to learning to live with the disease and manage it. Many less fortunate people in developing countries have to deal with this on a daily basis and only have the support of Orphan Drug Distributors and charities and I'm so thankful that people like this are available to support these people! Scleroderma, also known as systemic sclerosis, is a rare disease characterized by thickening and scarring of the skin, lungs and other organs. Scleroderma affects fewer than 200,000 people in the U.S. and typically affects women in the prime of their lives, between the ages of 25 and 55 taking a marked toll just as they are building their careers and bearing the responsibility of caring for their family. Nearly all people with scleroderma (more than 90%) will develop some skin symptoms including skin thickening, tightened skin around the joints, small red spots on the face and hands and hard lumps on pressure points and joints. Most people with the disease will also develop some degree of lung scarring, or interstitial lung disease (ILD). When the disease's signature thickening and scarring develops in vital organs, such as the lungs, there are potentially debilitating and life-threatening consequences. (more…)
Anesthesiology, Author Interviews, Critical Care - Intensive Care - ICUs, Mental Health Research / 04.03.2018

MedicalResearch.com Interview with: Yoanna Skrobik MD FRCP(c) MSc McGill University Health Centre Canada MedicalResearch.com: What is the background for this study? Response: My clinical research interests revolve around critical care analgesia, sedation, and delirium. I validated the first delirium screening tool in mechanically ventilated ICU patients (published in 2001), described ICU delirium risk factors, associated outcomes, compared treatment modalities and described pharmacological exposure for the disorder. I was invited to participate in the 2013 Society of Critical Care Medicine Pain, Anxiety, and Delirium management guidelines, and served as the vice-chair for the recently completed Pain, Agitation, Delirium, Early Mobility and Sleep upcoming guidelines. Until this study, no pharmacological prevention or intervention could convincingly be considered effective in ICU delirium. Although Haloperidol and other antipsychotics are frequently used in practice, their lack of efficacy and possible disadvantages are increasingly being understood. (more…)
Author Interviews, Frailty, Hospital Readmissions, Surgical Research / 04.03.2018

MedicalResearch.com Interview with: Rachel Khadaroo, MD, PhD, FRCSC Associate Professor of Surgery Department of Surgery & Division of Critical Care Medicine University of Alberta MedicalResearch.com: What is the background for this study? What are the main findings? Response: The elderly are the fastest growing population in North America. There are very few studies that have examined the impact of frailty and age on outcomes following abdominal surgery. Readmissions are expensive have been considered an important quality indicator for surgical care. This study examined 308 patients 65 years and older who were admitted for emergency abdominal surgery in two hospitals in Alberta and followed them for 6 months for readmission or death. Patients were classified into 3 categories: Well, pre-frail (no apparent disability), and frail. (more…)
Author Interviews, Dermatology, Surgical Research / 04.03.2018

MedicalResearch.com Interview with: Boris Paskhover, MD Associate Professor,Department of Otolaryngology-Head and Neck Surgery Rutgers New Jersey Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response:  Facial fillers include a wide range of cosmetic products used by physicians for augmenting the face. Some fillers are permanent, while others are temporary. Lip filler material is included in this category. Any physician is allowed to perform these procedures but patient’s need to be aware that these are not benign procedures and have some serious complications. It’s important to always go to an experienced facial plastic surgeon, general plastic surgeon or possibly dermatologist for your aesthetic fillers. Our study detailed a decade-long review of FDA reported complications with aesthetic fillers. (more…)