AHA Journals, Author Interviews, Heart Disease, Testosterone / 24.05.2017

MedicalResearch.com Interview with: Rajat S. Barua, MD; PhD; FACC; FSCAI Associate Professor of Medicine (Cardiology), University of Kansas School of Medicine Director, Cardiovascular Research, Dept. of Cardiology, Kansas City VA Medical Center Director, Interventional Cardiology & Cardiac Catheterization Laboratory Kansas City VA Medical Center MedicalResearch.com: What is the background for this study? Response: Atrial fibrillation is the most common cardiac arrhythmia worldwide, with significant morbidity, mortality and financial burden. Atrial fibrillation is known to increase with age and is higher in men than in women. Although the underlying mechanisms of this sex difference are still unclear, one preclinical and several small clinical studies have suggested that testosterone deficiency may play a role in the development of atrial fibrillation. To date, no studies have investigated the effect of testosterone-level normalization on incidence of new atrial fibrillation in men after testosterone replacement therapy. In this study, we investigated the incidence of atrial fibrillation in hypogonadal men with documented low testosterone levels. We compared the incidence of atrial fibrillation among patients who did not receive any testosterone replacement therapy, those who received testosterone replacement therapy that resulted in normalization of total testosterone, and those who received testosterone replacement therapy but that did not result in normal total testosterone levels. (more…)
Author Interviews, Dental Research, Heart Disease, Infections, Mayo Clinic / 24.05.2017

MedicalResearch.com Interview with: Daniel C. DeSimone, M.D. Infectious Diseases Fellowship, Year 2 Mayo Clinic MedicalResearch.com: What is the background for this study? Response: For over 50 years, the American Heart Association (AHA) has recommended antibiotics to be given to patients with certain cardiac conditions prior to invasive dental procedures (dental cleanings, extractions, root canals) with the hope to prevent infective endocarditis--a potentially deadly infection of the heart valves. Prevention of this infection was preferred to treatment of an established infection due to its high morbidity and mortality rates. However, in 2007, experts found that there was very little, if any, evidence that showed antibiotics prophylaxis prevented infective endocarditis prior to invasive dental procedures. Given this, the AHA revised its guidelines, significant reducing the number of patients where antibiotic prophylaxis would be given--as routine daily activities such as chewing food, tooth brushing, and flossing were much more likely to cause infective endocarditis than a single dental procedure. For over 50 years, patients with cardiac conditions that placed them at "moderate risk" and/or "high risk" were to receive antibiotics prior to dental procedures. In 2007, the "moderate risk" group were to no longer receive antibiotic prophylaxis. This is a significantly large proportion of patients--approximately 90% of all patients who would have received antibiotic prophylaxis. Given the drastic changes made in 2007, there was concern among the medical and dental communities about whether we were leaving patients "unprotected" and at risk for infective endocarditis. Thankfully, several population based studies from our group and others across the United States have not shown an increase in the rate of infective endocarditis. However, the question remained, "Are providers following the 2007 AHA guidelines?" and "Are patients still receiving antibiotics prior to dental procedures when its no longer indicated by the guidelines?". This was the main focus of our paper. We were able to go into the local dental offices and at the same time, have full access to their medical records. Every dental visit between 2005 and 2015 at their dental office was reviewed; the type of dental visit, whether they received antibiotic prophylaxis or not. In addition, we could confirm their cardiac conditions that would place them at "moderate risk" or "high risk" compared to the general population. (more…)
Author Interviews, Cocaine, McGill / 24.05.2017

MedicalResearch.com Interview with: Marco Leyton, Ph.D. Professor, Department of Psychiatry McGill University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Drug-related cues are potent triggers for eliciting conscious and unconscious desire for the drug. In people with severe substance use disorders, these cues also activate dopamine release in the dorsal striatum, a brain region thought to be involved in hard-to-break habits and compulsions. In the present study we found evidence that drug cues also activate this same dopamine response in non-dependent ‘recreational’ cocaine users. (more…)
Annals Internal Medicine, Author Interviews, Cancer Research, Colon Cancer, Race/Ethnic Diversity / 24.05.2017

MedicalResearch.com Interview with: Stacey Fedewa PhD Strategic Director, Risk Factors & Screening Surveillance American Cancer Society, Inc. Atlanta, GA 30303 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Screening for colorectal cancer is effective in reducing incidence and mortality by detecting precancerous lesions or cancer at more curable stages. But colorectal cancers can still develop in screened populations, some are missed at the time of screening; others can develop between recommended screenings. Patterns of risk for interval colorectal cancer, defined as cancers that develop after a negative result on colonoscopy, by race/ethnicity are not well known. The risk for blacks was of interest to us because colorectal incidence and mortality rates in blacks are the highest among any race or ethnicity in the United States. We were also interested to see if quality of colonoscopy, measured by physician’s polyp detection rate, could account for differences. (more…)
Alzheimer's - Dementia, Author Interviews, Genetic Research, Mental Health Research / 23.05.2017

MedicalResearch.com Interview with: Auriel Willette, M.S., Ph.D. Assistant Professor Departments of Food Science and Human Nutrition and Psychology Iowa State University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Translocase of Outer Mitochondrial Membrane 40 (TOMM40) is a gene that regulates the width of the outer mitochondrial pore, facilitating the transport of ribosomal pre-proteins into the inner mitochondrial matrix for translational modification into functional proteins. In 2010, Dr. Allen Roses, who discovered the Apolipoprotein E (APOE) gene, Dr. Michael Lutz, and other colleagues found that a variation in poly-T length at locus rs10524523 ('523) within intron 6 predicted Alzheimer's disease onset. Specifically, a "long" versus "short" poly-T length was related to earlier age of onset by 8 years. However, several multi-cohort studies either failed to replicate the findings or found the opposite relationship, where a "long" or "very long" poly-T length was related to later age of onset. The literature has remained mixed to this day. We were interested in testing factors that might change the relationship between TOMM40 and both cognitive decline and risk for having Alzheimer's disease. It is known that a family history (FH) of Alzheimer's disease has been associated with mitochondrial dysfunction. We reasoned, then, that FH may interact with TOMM40 to modulate how it was related to our outcomes of interest. We investigated this hypothesis in two separate cohorts: the Wisconsin Registry for Alzheimer's Prevention (WRAP), a late middle-aged cohort, and the Alzheimer's Disease Neuroimaging Initiative (ADNI), a well-characterized sample of aged participants from across the Alzheimer's spectrum. (more…)
Author Interviews, Pulmonary Disease / 23.05.2017

MedicalResearch.com Interview with: Catherine Bonham MD Section of Pulmonary and Critical Care Medicine University of Chicago MedicalResearch.com: What is the background for this study? Response: Idiopathic pulmonary fibrosis (IPF) causes fibrosis, or scar tissue, to form in the lungs. People with IPF become more and more short of breath and need oxygen. It is progressive and we don’t have any cure. Prognosis is about 3 to 5 years, worse than many cancers. We don’t know what causes it. It is a leading indication for lung transplant. Many doctors and scientists are skeptical about the role of the immune system in IPF because some immune-directed treatments, like steroids, have been tried and failed. However, recent research shows that the expression of genes in patients who do well with IPF is different from patients who do poorly and die rapidly from IPF. The difference in survival was in genes expressed by their immune systems, specifically their T cells. We have known for decades that T cells are a type of white blood cell specialized for fighting infection. In the last several years, doctors and scientists made the amazing discovery that T cells also fight cancer within the body. Many new immune therapies have now been developed that can make some patients cancer-free. It was very exciting to think that T cells could also affect survival in pulmonary fibrosis. My study followed 59 patients with Idiopathic pulmonary fibrosis for up to 5 years, and examined whether we could measure two molecules on the surface of CD4 T cells, and use them to predict survival for patients with IPF. These molecules are called ICOS and CD28. They function to activate the T cells, which creates a chain reaction activating other parts of the immune system. A second part of my study looked at the lungs and lymph nodes from 9 IPF patients who generously donated their old lungs to research after they received lung transplant. The purpose of this was to find if what I see in blood samples reflected what the T cells really do in the lungs. (more…)
Author Interviews, OBGYNE / 23.05.2017

MedicalResearch.com Interview with: Hirohito Ichii, M.D, Ph.D, FACS Associate Professor of Clinical Surgery Division of Transplantation, Department of Surgery University of California, Irvine, Orange CA 92868 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Venous thromboembolism (VTE) is a critical complication after surgery. Although pregnancy is known to increase the risk of VTE 4- to 5-fold, there are scarce data on the risk of VTE among pregnant women who are undergoing surgery. In this study using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) data, we observed that pregnant women, compared to matched non-pregnant women, experienced 93% higher likelihood of developing VTE. Absolute incidence of VTE among pregnant vs. matched non-pregnant were 0.5% vs. 0.3%. (more…)
Author Interviews, BMJ, Osteoporosis / 23.05.2017

MedicalResearch.com Interview with: Jean-Yves Reginster M.D.,PH.D. Professor of Epidemiology, Public Health and Health Economics Head of the Bone and Cartilage Metabolism Unit University of Liège MedicalResearch.com: What is the background for this study? What are the main findings? Response: Whereas several recommendations, issued by scientific societies, recommend to use Symptom-Modifying Slow Acting Drugs (SYSADOAs) for the symptomatic and structural management of osteoarthritis, no medication is currently registered, in this particular indication, by the European Medicines Agency (EMA) or by the Food and Drug Administration (FDA). This study is the first study, conducted, with a SYSADOA which fully complies with the requirements of the EMA for the assessment of drugs to be used in the treatment of osteoarthritis, i.e. a six-month duration, two co-primary endpoints (pain and function) and a three-arm design, with a placebo and an active comparator. The main findings are that pharmaceutical grade chondroitin sulfate provides an improvement in pain and function, which is greater than placebo and not distinguishable from celecoxib, a non-steroidal anti-inflammatory drug currently licensed for the symptomatic management of osteoarthritis. (more…)
Author Interviews, JNCI, Lung Cancer, Smoking, Tobacco, Tobacco Research / 22.05.2017

MedicalResearch.com Interview with: Peter G. Shields, M.D. Deputy Director, Comprehensive Cancer Center James Cancer Hospital Professor, College of Medicine Julius F. Stone Chair in Cancer Research The Ohio State University Columbus, OH MedicalResearch.com: What do we know about the health effects of cigarette filters?  Response:  The issue is that the design of the filters makes a cigarette even more dangerous, which can be regulated by the FDA. The issue is not about having a filter, but how they are made. And now we are changing the dialogue to the design of virtually all cigarettes. The holes on the filter are likely one reason the cigarettes of today are more dangerous. (more…)
Author Interviews, Geriatrics, JAMA, NYU, Primary Care / 22.05.2017

MedicalResearch.com Interview with: Benjamin Han, MD, MPH Assistant professor Departments of Medicine-Division of Geriatric Medicine and Palliative Care, and Population Health NYU Langone Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: There are an increasing number of older adults being prescribed statins for primary prevention, but the evidence for the benefit for older adults is unclear. Our study finds that in the ALLHAT-LLT clinical trial, there were no benefits in either all-cause mortality or cardiovascular outcomes for older adults who did not have any evidence of cardiovascular disease at baseline. (more…)
Author Interviews, Infections, UCLA / 22.05.2017

MedicalResearch.com Interview with: Dr. James A. McKinnell, MD LA BioMed Assistant Professor of Medicine David Geffen School of Medicine at UCLA MedicalResearch.com: What is the background for this study? Response: Pneumonia is the leading cause of death from infectious disease in the United States. We conducted this study because current community-acquired pneumonia guidelines from the American Thoracic Society and the Infectious Disease Society America, published in 2007, provide some direction about prescribing antibiotics for community-acquired pneumonia. But large-scale, real-world data are needed to better understand and optimize antibiotic choices and to better define clinical risk factors that may be associated with treatment failure. Antibiotic failure for community-acquired pneumonia is associated with substantial morbidity and mortality and results in significant medical expenditures. We examined databases containing records for 251,947 adult patients who were treated between 2011 and 2015 with a single class of antibiotics (beta-lactam, macrolide, tetracycline, or fluoroquinolone) following a visit to their physician for treatment for community-acquired pneumonia. We defined treatment failure as either the need to refill antibiotic prescriptions, antibiotic switch, ER visit or hospitalization within 30 days of receipt of the initial antibiotic prescription. (more…)
Author Interviews, Blood Pressure - Hypertension, Cleveland Clinic, Critical Care - Intensive Care - ICUs, Infections, NEJM / 22.05.2017

MedicalResearch.com Interview with: Ashish Khanna, MD, FCCP Assistant Professor of Anesthesiology, Cleveland Clinic Lerner College of Medicine Staff Intensivist Center for Critical Care and Department of Outcomes Research Cleveland Clinic, Cleveland MedicalResearch.com: How did you become interested in this topic? Response: Anesthesia forms the basis of my training but I also completed a fellowship in critical care and, at the present time, I do more work in critical care than anesthesia. About 75% of my time is spent in the Cleveland Clinic critical care units, including the Medical and surgical ICUs (Intensive Care Units). (more…)
Author Interviews, JAMA, Tobacco / 22.05.2017

MedicalResearch.com Interview with: Reto Auer, MD, MAS Institute of Primary Health Care (BIHAM), University of Bern, Bern, Department of Ambulatory Care and Community Medicine University of Lausanne, Lausanne, Switzerland MedicalResearch.com: What is the background for this study? Response: When the tobacco industry began to promote new “heat-not-burn” (HNB) tobacco cigarettes as a “safer” alternative to traditional cigarettes, we wanted to find out if their claims were true. Philip Morris International (PMI) created an HBN called IQOS® (I-Quit-Ordinary-Smoking). IQOS® uses tobacco sticks soaked in propylene glycol, which are inserted into a holder and heated to a maximum of 350°C. PMI claims that because its HNBs don’t combust, they emit far fewer harmful chemicals than conventional cigarettes. We decided to test their claims. (more…)
Author Interviews, Gender Differences, UCLA, Weight Research / 22.05.2017

MedicalResearch.com Interview with: Arpana Gupta, Ph.D. Assistant Professor G. Oppenheimer Center for Neurobiology of Stress and Resilience Ingestive Behavior and Obesity Program Vatche and Tamar Manoukin Division of Digestive Diseases David Geffen School of Medicine, UCLA MedicalResearch.com: What is the background for this study? Response: Past studies have demonstrated how an imbalance in the processing of rewarding and salient stimuli results in maladaptive or excessive eating behaviors. However, stress and drug use are known to affect how sex and sex hormones modulate responses of the dopamine system involved in reward, and are thought to underlie sex differences in the pathophysiology of drug addiction and treatment response. These results suggest similar sex effects on the mesolimbic reward system may also be at play in obesity. (more…)
Author Interviews, Heart Disease, JACC / 21.05.2017

MedicalResearch.com Interview with: Dr. Ion S. Jovin, MD, ScD Associate Professor of Medicine at Virginia Commonwealth University Pauley Heart Center Director of the Cardiac Catheterization Laboratories and Site Director of the VCU Interventional Cardiology Fellowship Program at McGuire V.A. Medical Center Visiting Assistant Professor in the Department of Surgery/Cardiothoracic Surgery Yale University, New Haven, CT MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is still uncertainty regarding the best anticoagulant for patients with acute ST-segment elevation myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI) and especially PCI done via radial (as opposed to femoral) access. Our study compared outcomes of patients with STEMI treated with PCI done via radial access in the NCDR database who received one of the two main anticoagulants: bivalirudin and heparin. There is a large degree of variation in the use of the two anticoagulants in PCI and in primary PCI both within the United States but also in the world. We did not find a statistically significant difference between the outcomes of the two groups of patients, but we also found that a significant number of patients in both the heparin and in the bivalirudin group were also treated with additional medicines that inhibit platelet activation (glycoprotein IIb/IIIa inhibitors). (more…)
Author Interviews, BMJ, Brigham & Women's - Harvard, Outcomes & Safety / 21.05.2017

MedicalResearch.com Interview with: Yusuke Tsugawa, MD, MPH, PhD Harvard T. H. Chan School of Public Health Department of Health Policy and Management Cambridge, MA 02138 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Although evidence has suggested that older physicians may experience a decline in medical knowledge and are less likely to adhere to standard care, patients in general had a perception that older doctors are more experienced and therefore provide superior care. Using a nationally representative sample of Medicare beneficiaries who were hospitalized for medical conditions in 2011-2014, we found that patients treated by younger doctors have lower 30-day mortality compared to those cared for by older doctors, after adjusting for patient, physician, and hospital characteristics. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Emergency Care, Infections, NEJM, University of Pittsburgh / 21.05.2017

MedicalResearch.com Interview with: Christopher W. Seymour, M.D., M.Sc. Assistant professor of Critical Care Medicine and Emergency Medicine, and member of Clinical Research Investigation and Systems Modeling of Acute Illness University of Pittsburgh MedicalResearch.com: What is the background for this study? What are the main findings? Response: Following the tragic and widely publicized death of Rory Staunton, 12, from undiagnosed sepsis in 2012, New York became the first state to require that hospitals follow a protocol to quickly identify and treat the condition. The mandate led to widespread controversy in the medical community as to whether such steps would have saved Rory or anyone else’s life. Rory’s Regulations require hospitals to follow protocols for early identification and treatment of sepsis, and submit data on compliance and outcomes. The hospitals can tailor how they implement the protocols, but must include a blood culture to test for infection, measurement of blood lactate (a sign of tissue stress) and administration of antibiotics within three hours of diagnosis—collectively known as the “three-hour bundle.” We analyzed data from nearly 50,000 patients from 149 New York hospitals to scientifically determine if  Rory’s Regulations worked. We found that they did - 83 percent of the hospitals completed the bundle within the required three hours, overall averaging 1.3 hours for completion. For every hour that it took clinicians to complete the bundle, the odds of the patient dying increased by 4 percent. (more…)
Author Interviews, Education, Psychological Science, Technology, University of Pennsylvania / 21.05.2017

MedicalResearch.com Interview with: Jason Han, MD Resident, Cardiothoracic Surgery Hospital at the University of Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: The inspiration for this study comes from my personal experience as a medical student on clinical rotations. Despite having been a victim of a medical error while growing up myself, I found it extraordinarily difficult to admit to even some of my smallest errors to my patients and team. Perplexed by the psychological barriers that impeded error disclosure, I began to discuss this subject with my advisory Dean and mentor, Dr. Neha Vapiwala. We wanted to analyze the topic more robustly through an academic lens and researched cognitive biases that must be overcome in order to facilitate effective disclosure of error, and began to think about potential ways to implement these strategies into the medical school curriculum with the help of the director of the Standardized Patient program at the Perelman School of Medicine, Denise LaMarra. We ultimately contend that any educational strategy that aims to truly address and improve error disclosure must target the cognitive roots of this paradigm. And at this point in time, simulation-based learning seems to be the most direct way to do so, but also remain hopeful that emerging technologies such as virtual and augmented reality may offer ways for students as well as staff to rehearse difficult patient encounters and improve. (more…)
Abuse and Neglect, Blood Pressure - Hypertension, UT Southwestern / 21.05.2017

MedicalResearch.com Interview with: Wanpen Vongpatanasin, M.D. Professor of Medicine Norman & Audrey Kaplan Chair in Hypertension Fredric L. Coe Professorship in Nephrolithiasis and Mineral Metabolism Research Director, Hypertension Section, Cardiology Division, UT Southwestern Medical Center Dallas, TX 75390-8586 MedicalResearch.com: What is the background for this study? Response: It is well know that treatment of isolated systolic hypertension (ISH), a subtype of hypertension with elevated systolic BP 140 or above but normal diastolic BP of < 90 mmHg, improves cardiovascular outcomes in older adults after the sixth decade of life. However, it is controversial if ISH in young adults requires treatment because it was suggested that elevated systolic BP in these individuals are related to high stroke volume, rather than increased aortic stiffness. In earlier case series, ISH in young adults were particularly common in athletes with long arms and legs, suggesting that pulse wave amplification coupled with high stroke volume were responsible for elevated brachial systolic blood pressure but the true central BP was normal. Thus,  isolated systolic hypertension was proposed to be a spurious condition in young adults that can be ignored. However, previous studies used only indirect technique in assessing aortic structure and function. Furthermore, none of these studies were conducted in the U.S. Population. (more…)
Author Interviews, Cost of Health Care, MRI, Prostate, Prostate Cancer / 21.05.2017

MedicalResearch.com Interview with: Vikas Gulani, MD, PhD Director, MRI, UH Cleveland Medical Center Associate Professor, Radiology, CWRU School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: We wanted to learn if performing MR before prostate biopsy, followed by MR guided strategies for biopsy, are cost effective for the diagnosis of prostate cancer in men who have not previously undergone a biopsy and who have a suspicion of prostate cancer. The most significant findings are as follows: We found that all three MR guided strategies for lesion targeting (cognitive targeting, MR-ultrasound fusion targeting, and in-gantry targeting) are cost effective, as the increase in net health benefits as measured by addition of quality adjusted life years (QALY), outweigh the additional costs according to commonly accepted willingness to pay thresholds in the United States. Cognitive targeting was the most cost effective. In-gantry biopsy added the most health benefit, and this additional benefit was cost-effective as well. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Electronic Records, Infections / 21.05.2017

MedicalResearch.com Interview with: Faheem Guirgis MD Assistant Professor of Emergency Medicine Department of Emergency Medicine Division of Research UF Health Jacksonville MedicalResearch.com: What is the background for this study? What are the main findings? Response: Sepsis is quite prevalent among hospitals and the incidence is increasing. It is a life-threatening disease that can lead to poor outcomes if patients are not recognized and treated promptly. We recognized that our institution needed a strategic approach to the problem of sepsis, therefore the Sepsis Committee was created with the goal of creating a comprehensive sepsis program. We developed a system for sepsis recognition and rapid care delivery that would work in any area of the hospital. We found that we reduced overall mortality from sepsis, the number of patients requiring mechanical ventilation, intensive care unit length and overall hospital length of stay, and the charges to the patient by approximately $7000 per patient. (more…)
Author Interviews, PTSD / 21.05.2017

MedicalResearch.com Interview with: Jun-Hyeong Cho, M.D., Ph.D. Assistant Professor Department of Cell Biology & Neuroscience University of California, Riverside Riverside, CA 92521 MedicalResearch.com: What is the background for this study? What are the main findings? Response: In order to survive in a dynamic environment, animals develop adaptive fear responses to dangerous situations, which requires coordinated neural activity in the hippocampus, medial prefrontal cortex (mPFC), and amygdala. Dysregulation of this process leads to maladaptive generalized fear in post-traumatic stress disorder (PTSD), which affects 7 percent of the U.S. population. In this study, we found that a population of hippocampal neurons project to both amygdala and medical prefrontal cortex (mPFC). We also found neural mechanisms how these double-projecting neurons efficiently convey contextual information to the amygdala and mPFC to encode and retrieve fear memory for a context associated with an aversive event. (more…)
Author Interviews, Heart Disease, JAMA / 21.05.2017

MedicalResearch.com Interview with: Dr. Gregory Roth MD MPH Division of Cardiology, Department of Medicine Institute for Health Metrics and Evaluation University of Washington, Seattle MedicalResearch.com: What is the background for this study? Response: My colleagues and I at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, evaluated and analyzed mortality rates from cardiovascular diseases (CVD) on the county level from throughout the United States. We obtained the data from: The National Center for Health Statistics and population counts from the U.S. Census Bureau, the National Center for Health Statistics, and the Human Mortality Database. This data ranged from 1980 through 2014. (more…)
Author Interviews, NEJM, OBGYNE, Yale / 21.05.2017

MedicalResearch.com Interview with: Hugh S. Taylor, M.D. Anitta O’keeffe Young Professor and Chair Departemnt of Obstetrics, Gynecology and Reproductive Sciences Yale School of Medicine Chief of Obstetrics and Gynecology Yale-New Haven Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Response: Elagolix is an investigational, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that blocks endogenous GnRH signaling by binding competitively to GnRH receptors. Administration results in rapid, reversible, dose-dependent inhibition of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion, leading to reduced ovarian production of the sex hormones, estradiol and progesterone, while on therapy. Data from two replicate Phase 3 studies evaluating the efficacy and safety of elagolix were published in the New England Journal of Medicine. Elagolix demonstrated dose-dependent superiority in reducing daily menstrual and non-menstrual pelvic pain associated with endometriosis compared to placebo. At month three and month six, patients treated with elagolix reported statistically significant reductions in scores for menstrual pain (dysmenorrhea, DYS) and non-menstrual pelvic pain (NMPP) associated with endometriosis as measured by the Daily Assessment of Endometriosis Pain scale. The safety profile of elagolix was consistent across both Phase 3 trials and also consistent with prior elagolix studies. Ultimately, the studies showed that both elagolix doses (150 mg QD and 200 mg BID) were effective in improving dysmenorrhea, non-menstrual pelvic pain and quality of life over 6 months in women with endometriosis-associated pain. The elagolix safety/tolerability profile was consistent with the mechanism of action. (more…)
Author Interviews, Heart Disease, JACC / 20.05.2017

MedicalResearch.com Interview with: Kristie Harris, M.S. Doctoral Candidate, Department of Psychology Psychology Trainee, OSUWMC Department of Psychiatry Columbus, OH 43210 MedicalResearch.com: What is the background for this study? Response: In patients with chronic diseases such as heart failure, treatment strategies and medical management often rely on clinician’s assessment of symptoms and impairments in functional status. The six-minute walk test (6MWT) is a validated and commonly-used measure for assessing functional status in this patient population and has the advantage of being self-paced and easily administered. However, its clinical utility may be limited because it is time consuming, not suitable for patients with comorbidities that interfere with walking, and requires a long continuous hallway course. In this this study we report the development of an alternative measure of objective functional status, the sixty-foot walk test (60ftWT). For this task, patients are simply asked to walk four laps of 15 feet and the total time taken to walk the 60ft is recorded in seconds. (more…)
Author Interviews, OBGYNE, Telemedicine / 20.05.2017

MedicalResearch.com Interview with: Abigail R.A. Aiken, MD, MPH, PhD Assistant Professor LBJ School of Public Affairs Faculty Associate Population Research Center University of Texas at Austin Austin, TX, 78713Abigail R.A. Aiken, MD, MPH, PhD Assistant Professor LBJ School of Public Affairs Faculty Associate Population Research Center University of Texas at Austin Austin, TX, 78713 MedicalResearch.com: What is the background for this study? What are the main findings? Response: We've known for some time that women in Ireland and Northern Ireland self-source their own abortions using online telemedicine. In fact, this model has revolutionized abortion access for Irish women. Yet very little was previously known about the outcomes of those abortions. How safe and effective are they? We wanted to address that knowledge gap with this study. What this research shows is that self-sourced medication abortion, conducted entirely outside the formal healthcare setting, can have high rates of effectiveness and low rates of adverse outcomes. Women can successfully manage their own abortions and recognize the symptoms of potential complications. Among the small number who experienced such a symptom, virtually all sought in-person medical attention as advised. (more…)
Author Interviews, Biomarkers, Genetic Research, Prostate Cancer / 19.05.2017

MedicalResearch.com Interview with: Bela S. Denes, MD, FACS Senior Director Medical Affairs UROLOGY Genomic Health Inc. Redwood City, CA. 94063 MedicalResearch.com: What is the background for this study? Response: This is a prospective community based non-interventional study designed to provide information on the utility of Oncotype GPS in the management of men presenting with a new diagnosis of clinically localized low risk prostate cancer. We sought to understand the impact of incorporating a molecular marker into the shared treatment decision in practices already well versed in Active Surveillance (AS) as measured by persistence on surveillance at 2 years as well as a number of patient reported outcomes. The current publication reports on the results of a one year pre-specified interim analysis. (more…)
Author Interviews, Mental Health Research, Psychological Science / 19.05.2017

MedicalResearch.com Interview with: Justin M. Kim, Ph.D Dartmouth College Advisor: Paul J. Whalen MedicalResearch.com: What is the background for this study? What are the main findings? Response: Anxiety (and its co-conspirator ‘worry’) is an active, energy consuming process. You haven’t given up - you are still fighting back, trying to anticipate what might happen tomorrow. The problem of course is that there are an infinite number of ‘what if…’ scenarios you can come up with. For some individuals, the uncertainty of what ‘might happen’ tomorrow, is actually worse than the negative event itself actually happening. These individuals are intolerant of uncertainty. We were interested in how uncertainty and ambiguity of potential future threat contribute to the generation of anxiety and how they might be represented in our brain. In the psychology literature, how we deal with an uncertain future can be quantified as intolerance of uncertainty (IU). As is the case with any other personality characteristic, we all have varying degrees of IU. For example, individuals high in IU display difficulty accepting the possibility of potential negative events in the future. Importantly, psychiatric disorders such as generalized anxiety disorder (GAD) or obsessive-compulsive disorder (OCD), whose symptoms are marked with worrying/obsessing, are commonly associated elevated IU. We noticed that while much of the neuroimaging research on IU has been primarily focused on brain function, brain structural correlates of IU have received little attention so far. As such, we believed that it was an important endeavor to assess the relationship between IU and the structural properties of the brain, which can be done through the use of magnetic resonance imaging (MRI) techniques. (more…)
Author Interviews, JCEM, Surgical Research, Thyroid, University of Michigan / 18.05.2017

MedicalResearch.com Interview with: Megan Rist Haymart MD Assistant Professor University of Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: Thyroid cancer is typically treated with thyroid surgery. It is common practice for physicians to inform patients that the risk of vocal cord paralysis or hypoparathyroidism with thyroid surgery is 1-3%. However, most of these estimates are based on single institution studies with high volume surgeons. In our study we evaluated surgical risks in a population-based cohort. Using the Surveillance, Epidemiology, and End Results-Medicare database, we found that 6.5% of thyroid cancer patients developed general post-operative complications (fever, infection, hematoma, cardiopulmonary and thromboembolic events) and 12.3% developed thyroid surgery specific complications (hypoparathyroidism/hypocalcemia, vocal cord/fold paralysis). Older patient age, presence of comorbidities, and advanced stage disease were associated with the greatest risks of surgical complications. (more…)
Author Interviews, Psychological Science, Social Issues / 18.05.2017

MedicalResearch.com Interview with: Carlota Batres PhD Postdoctoral fellow at Gettysburg College MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background for this study is that previous research has found that individuals from rural areas prefer heavier women than individuals from urban areas. Several explanations have been proposed to explain these preference differences: media exposure, differing optimal weights for different environments, and urbanization. In this study, we investigated familiarity as a possible explanation by examining participants’ face preferences while also examining the facial characteristics of the actual participants. The main finding of this study is that familiarity appears to be contributing to our facial preferences. (more…)