Dr. Chase Spurlock[/caption]
Dr. Chase Spurlock, PhD
CEO, IQuity, Specialty Diagnostic Technologies
Faculty, Vanderbilt University Medical Center
Dr. Spurlock discusses IQuity's release of IsolateFibromyalgia, the first RNA-based blood test to detect fibromyalgia.
MedicalResearch.com: What is the background for this test? Would you briefly explain what fibromyalgia is, whom it affects and why it has been difficult to definitely diagnosis?
Dr. Spurlock: We developed the IsolateFibromyalgia™ test using our established RNA assay platform, IQIsolate™, to help clinicians receive timely and accurate information. This technology has evolved from over a decade of research at Vanderbilt University and continues at IQuity funded by both the National Institutes of Health (NIH) as well as private investors. We discovered that differences in RNA expression patterns could be detected in patients with a variety of human conditions spanning infection to more complex inflammatory diseases. With our focus on autoimmune disease, we identified and validated RNAs capable of distinguishing multiple sclerosis, IBS, Crohn’s, ulcerative colitis and fibromyalgia syndrome. In the case of fibromyalgia, our research involved almost 600 subjects including healthy individuals, patients with endocrine conditions, dermatologic conditions and rheumatologic diseases — rheumatoid arthritis, Sjogren’s syndrome and systemic lupus erythematosus. Reported sensitivity and specificity of this assay is 92 percent and 96 percent, respectively.
Fibromyalgia syndrome is characterized by widespread musculoskeletal pain often initially localized to the neck and shoulders. Patients typically describe pain throughout the muscles but may also report pain in the joints. Furthermore, fibromyalgia is usually accompanied by fatigue as well as cognitive disturbance. Patients most afflicted are women between ages 20 and 55. Fibromyalgia affects approximately as many as 6-10 million people in the U.S.
The difficulty in reaching a definitive diagnosis lies in two important issues. First, the cause of the syndrome is unknown, and the way the condition presents and progresses can vary among patients. Secondarily, fibromyalgia syndrome mimics many other conditions due to the multiple nonspecific symptoms associated with fibromyalgia. Patients look well, there are no obvious abnormalities on physical examination other than tenderness, and laboratory and radiologic studies are normal. With no discernable abnormalities in routine clinical laboratory testing or imaging, the diagnosis is based on subjective reporting of symptoms.
The difficulties and complex nature of receiving a correct fibromyalgia diagnosis are apparent. Despite improved awareness among primary care clinicians, many continue to be uncomfortable with making this diagnosis. Fibromyalgia patients on average wait almost a year after experiencing symptoms before seeing a physician and end up visiting on average 3.7 different physicians before a diagnosis. The diagnostic journey can take years. IsolateFibromyalgia provides the clinician and patient actionable information with 94 percent accuracy.
Dr. Christopher Abeare[/caption]
Christopher Abeare, Ph.D.
Associate Professor
Clinical Neuropsychology
Department of Psychology
University of Windsor
Windsor, Ontario
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In this study, we examined the prevalence of invalid performance on baseline neurocognitive testing in sport concussion. Baseline testing is a commonly employed practice in which the cognitive abilities of athletes are assessed pre-season. These baseline test results are then used as a point of comparison against which post-injury neurocognitive test results can be compared, thereby creating a more individualized approach to the assessment of neurocognitive functioning.
However, there has been growing concern about the validity of baseline test results, meaning that there is concern over the degree to which the scores on these baseline tests actually reflect an athlete’s true cognitive ability. There are many reasons why their test scores might not reflect their actual ability, ranging from inattentiveness during testing and lack of appreciation of the importance of doing their best on testing to intentional underperformance (aka “sandbagging” or malingering).
As a result of these concerns, 4 different validity measures have been developed. We compared these 4 validity measures, head to head, in a sample of 7897 athletes aged 10 to 21 years.
We found that 56% of athletes failed at least 1 of these validity measures, suggesting that as many as 56% of athletes have scores that may not reflect their true ability level. We then tested the hypothesis that age would be related to the proportion of athletes with invalid performance. Our findings supported this hypothesis in that nearly 84% of 10-year-olds failed at least one validity measure and 29% of 21-year-olds failed at least one.
Dr. Cho[/caption]
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.
Dr. Kaye[/caption]
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.
Dr. Vaduganathan[/caption]
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.
Dr. Durkin[/caption]
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.
Dr. Easwaran[/caption]
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.
Superficial spreading melanoma arising from a dysplastic nevus
Prof. Hausforff[/caption]
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.
Dr. Khan[/caption]
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.
Dr. Fanaroff[/caption]
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.
Herpes Zoster or Shingles of chest
Dr. Sanghvi[/caption]
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.
Dr. Kishan[/caption]
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.
Dr. Chih-Chi Andrew Hu[/caption]
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).
Timothy 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%
Dr. Popkin[/caption]
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.
Dr. Bullitt[/caption]
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.
Dr. Morrow[/caption]
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.
Dr. Williams[/caption]
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.
Patricia Louie[/caption]
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.
Dr. Cather[/caption]
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:
Dr. Renato Lopes[/caption]
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.
Prof. Martin[/caption]
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%).
Dr. Paessler[/caption]
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.
Trine 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).