Author Interviews, NEJM, OBGYNE, Yale / 21.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34696" align="alignleft" width="143"]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 Dr. Taylor[/caption] 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.
Author Interviews, Heart Disease, JACC / 20.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34719" align="alignleft" width="166"]Kristie Harris, M.S. Doctoral Candidate, Department of Psychology Psychology Trainee, OSUWMC Department of Psychiatry Columbus, OH 43210 Ms. Harris[/caption] 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.
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.
Author Interviews, Biomarkers, Genetic Research, Prostate Cancer / 19.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34708" align="alignleft" width="194"]Bela S. Denes, MD, FACS Senior Director Medical Affairs UROLOGY Genomic Health Inc. Redwood City, CA. 94063 Dr. Bela S. Denes[/caption] 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.
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.
Author Interviews, JCEM, Surgical Research, Thyroid, University of Michigan / 18.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34701" align="alignleft" width="125"]Megan Rist Haymart MD Assistant Professor University of Michigan Dr. Haymart[/caption] 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.
Author Interviews, Psychological Science, Social Issues / 18.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34692" align="alignleft" width="160"]Carlota Batres PhD Postdoctoral fellow at Gettysburg College Dr. Batres[/caption] 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.
Author Interviews, Lancet, Macular Degeneration, Ophthalmology / 18.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34685" align="alignleft" width="101"]Prof Peter A Campochiaro MD Director, Retinal Cell and Molecular Laboratory Professor of Ophthalmology Johns Hopkins University School of Medicine Baltimore, MD Dr. Campochiaro[/caption] Prof Peter A Campochiaro MD Director, Retinal Cell and Molecular Laboratory Professor of Ophthalmology Johns Hopkins University School of Medicine Baltimore, MD MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients with wet age-related macular degeneration (AMD) have increased levels of vascular endothelial growth factor (VEGF) in their eyes resulting in growth of abnormal blood vessels that leak fluid into the retina and reduce vision. The current treatment is to inject proteins that block VEGF which initially provides a very good effect, but repeated injections are needed. Patients sometimes are unable to keep up the frequency of visits and injections needed to keep the disease quiet and over time there is often gradual loss of vision. The aim of this study was to test a new approach through which a viral vector is injected into the eye resulting in production of a protein that block VEGF in the eye reducing the need for repeated injections. These are the major findings: 1) Intravitreous injection of an AAV2 vector expressing a protein that blocks vascular endothelial growth factor (VEGF) was safe and well-tolerated. (2) 5 of 10 patients injected with the highest dose (2 × 10¹⁰ vector genomes) had measurable levels of the therapeutic protein in samples removed from the front of the eye- all of these patients had no or very low levels of anti-AAV2 serum antibodies and 4 of the 5 patients who did not show expression had high anti-AAV2 serum antibodies (3) Eleven patients had fluid in or under the retina before vector injection and 6 of them showed substantial reduction of the fluid which is the desired outcome.
Alzheimer's - Dementia, Author Interviews, Biomarkers / 18.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34808" align="alignleft" width="142"]Ali Yilmaz, PhD Beaumont Research Institute Beaumont Health, Royal Oak, MI Dr. Yilmaz[/caption] Ali Yilmaz, PhD Beaumont Research Institute Beaumont Health, Royal Oak, MI MedicalResearch.com: What is the background for this study? What are the main findings? Response: Alzheimer's disease (AD) is a neurodegenerative disorder that is characterized by the accumulation of β-amyloid plaques and tau tangles. Mild cognitive impairment (MCI) is progressive degree of impairment that is greater than might be attributed to normal age-related cognitive decline, but is not so severe as to merit a diagnosis of dementia. MCI is thought to be a transitional state between normal aging and AD sufferers phenotypically converting to AD at a rate of 10% per year. Currently there is no cure and few reliable diagnostic biomarkers for AD. As we live longer there is an ever increasing demand for valid and reliable biomarkers of Alzheimer's disease; not only because it will help clinicians recognize the disease in its earliest symptomatic stages but will also be important for developing novel treatment of AD. Using 1D H NMR metabolomics, we biochemically profiled saliva samples collected from healthy-controls (n = 12), mild cognitive impairment (MCI) sufferers (n = 8), and Alzheimer’s disease (AD) patients (n = 9). We accurately identified significant concentration changes in 22 metabolites in the saliva of MCI and AD patients compared to controls.
ASCO, Author Interviews, Cancer Research, Genetic Research / 18.05.2017

MedicalResearch.com Interview with: Roy Mano, MD and David Margel, MD, PhD Department of Urology, Rabin Medical Center Petach Tikva, Israel MedicalResearch.com: What is the background for this study? Response: According to previous reports, male BRCA mutation carriers have a higher risk of developing malignancies of the prostate, pancreas, breast, colon and melanoma. While malignancy screening protocols for female BRCA carriers are well established and widely implemented, little is known about the optimal screening protocol for male BRCA carriers, and current screening protocols focus on malignancies of the breast and prostate rather than offer a comprehensive screening protocol for all BRCA associated malignancies.
Author Interviews, Prostate, Urology / 18.05.2017

MedicalResearch.com Interview with: Dr. Nikhil K. Gupta and Kevin McVary, MD, FACS Professor, Department of Surgery Chair, Division of Urology Southern Illinois University School of Medicine MedicalResearch.com: What is the background for this study? [caption id="attachment_34679" align="alignleft" width="300"]Pre Treatment.jpg: Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland, affecting 12 million men in the U.S., with nearly 800,000 newly diagnosed each year. An enlarged prostate squeezes down on the urethra causing lower urinary tract symptoms. Pre Treatment.jpg: Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland, affecting 12 million men in the U.S., with nearly 800,000 newly diagnosed each year. An enlarged prostate squeezes down on the urethra causing lower urinary tract symptoms.[/caption] Response: Male lower urinary tract symptoms due to benign prostatic hyperplasia, or LUTS due to BPH, have most commonly been treated with a combination of medication, such as alpha-blockers and 5-alpha reductase inhibitors, and surgery, such as transurethral resection of prostate (TURP) and Greenlight photovaporization of prostate (PVP). These treatments, however, have potentially serious adverse and sexual side effects. Minimally invasive surgical therapies (MIST) for LUTS due to BPH have tried to thread the needle between medications and invasive surgery, giving effective relief of symptoms with minimal anesthetic need while preserving sexual function. Previously developed MISTs have been unable to provide durable relief of symptoms, causing patients to undergo multiple treatments in a short period of time, and have been limited by prostate size and conformation, e.g. the inability to treat a middle lobe or median bar. LUTS due to BPH is also very strongly and likely causally linked with obesity, and obesity seems to have an effect on the efficacy of treatment as well, as obesity affects response to medication and tends to dampen the treatment effect of TURP. Convective Radiofrequency Water Vapor Energy ablation of the prostate, named Rezūm®, is a new MIST that uses radiofrequency to generate energy in the form of water vapor. The water vapor acts as a convective energy source and, once injected into the treatment area, distributes itself evenly within the treated tissue, causing uniform necrosis througout the treated area. This mechanism using convection is in contrast to previous technologies using conductive heat energy, which created a heat gradient with tissue closest to the heat source receiving the largest amount of energy and tissue farthest from the heat source receiving almost no energy. Thus conductive energy has a different effect on different parts of the treated area. With Rezūm, MRI studies have shown that the water vapor creates a uniform treatment effect while staying within collagen barriers, obeying natural tissue planes and affecting only the intended treatment areas. The purpose of this study was to determine the efficacy of Rezūm in treatment of LUTS due to BPH, examine the treatment's effect on sexual function, and to determine whether obesity affected treatment efficacy.
Abuse and Neglect, JAMA, Surgical Research, Weight Research / 18.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34617" align="alignleft" width="148"]Andrew Ibrahim, M.D., M.Sc</strong> Institute for HealthCare Policy and Innovation University of Michigan Dr. Ibrahim[/caption] Andrew Ibrahim, M.D., M.Sc Institute for HealthCare Policy and Innovation University of Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: The laparoscopic gastric band was approved by the FDA in 2001 and widely adopted for the surgical treatment of morbid obesity. Reported rates of reoperation to revise or remove the device ranged from 4 to 60 percent in small scale studies, but no population estimates in the United States existed. In a review of Medicare Claims data between 2006 and 2013, we observed that reoperation was common with 18% of patients requiring at least one reoperation. More over, we found that on average, patients who did need a reoperation often underwent an average of 3.8 additional procedures. Taken together, nearly half (47%) of the $470 million paid by Medicare for device related procedures was for reoperations.
AHRQ, Author Interviews, JAMA, Outcomes & Safety / 18.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34664" align="alignleft" width="200"]John Oliver DeLancey, MD, MPH Resident, Department of Urology Research Fellow, Surgical Outcomes and Quality Improvement Center Northwestern University Feinberg School of Medicine Dr. John Oliver DeLancey[/caption] John Oliver DeLancey, MD, MPH Resident, Department of Urology Research Fellow, Surgical Outcomes and Quality Improvement Center Northwestern University Feinberg School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: We initially looked at the star ratings for hospitals that we considered to provide excellent care, and it did not seem that this was reflected in the star ratings. Therefore, we sought to examine which factors were associated with the likelihood of receiving a high or low star rating. When we examined these associations, we found that academic and community hospitals, who reported nearly all of the measures included, had disproportionally lower star ratings than Critical Access or Specialty hospitals, who reported on average about half of the measures used to generate the star ratings.
Author Interviews, Emergency Care, JAMA, Stroke / 18.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34409" align="alignleft" width="200"]Ryan A. McTaggart M.D. Assistant Professor of Diagnostic Imaging, Neurology, and Neurosurgery @mobilestroke4U Warren Alpert School of Medicine at Brown University Rhode Island Hospital Dr. Ryan  McTaggart[/caption] Ryan A. McTaggart M.D. Assistant Professor of Diagnostic Imaging, Neurology, and Neurosurgery @mobilestroke4U Warren Alpert School of Medicine Brown University Rhode Island Hospital MedicalResearch.com: What is the background for this study? Response: Stroke is the #1 cause of disability and 5th leading cause of death. Mechanical thrombectomy (direct mechanical removal of the obstructing blood clot) is a dramatically effective treatment for the most devastating of all acute ischemic strokes – emergency large vessel occlusion (ELVO). Access to this treatment can be optimized with the use of 1) mobile stroke unit technology, 2) changing our Emergency medical services triage algorithms so that stroke matches that of trauma (using field severity to transport the right patient, to the right hospital, the first time, whenever possible), and 3) improving in-hospital processes at Primary Stroke Centers (PSCs) so that patients with suspected ELVO who present to a PSC (a hospital that does not offer mechanical thrombectomy) do not get left behind and untreated. This study reflects an effort to address and improve the third item.
Author Interviews, Sexual Health, Urology / 18.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34656" align="alignleft" width="200"]Dr. Michael Krychman, MD Executive Director: The Southern California Center for Sexual Health and Survivorship, Medical Director: Sexual Medicine at Hoag Hospital Newport Beach CA Clinical faculty member University of Southern California Los Angeles, CA Dr. Krychman[/caption] Dr. Michael Krychman, MD Executive Director: The Southern California Center for Sexual Health and Survivorship, Medical Director: Sexual Medicine at Hoag Hospital Newport Beach CA Clinical faculty member University of Southern California Los Angeles, CA MedicalResearch.com: What is the background for this study? What are the main findings? Response: This post hoc analysis pooled data from three 24-week, double-blind, placebo-controlled studies (VIOLET, DAISY, and BEGONIA) of flibanserin in premenopausal women with acquired, generalized HSDD5-7. Patients who received flibanserin 100 mg once daily at bedtime (qhs) or placebo were included in the analysis. The Female Sexual Function Index (FSFI) consists of 19 items across 6 domains. Scores range from 2 to 36. Higher scores indicate better sexual functioning. Scores under 26 indicate sexual dysfunction. Analysis of covariance was used to evaluate changes from the first week to week 24 in the FSFI domain and total scores were compared for flibanserin 100 mg qhs versus placebo. For patients who discontinued study participation prior to week 24, the last postbaseline observation was carried forward (LOCF). Results found that treatment with flibanserin 100 mg qhs produced statistically significant improvement, relative to placebo, on all domains of the FSFI (desire, arousal, lubrication, orgasm, satisfaction and pain) in premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).
Alzheimer's - Dementia, Author Interviews, Depression, JAMA / 18.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34653" align="alignleft" width="130"]Archana Singh-Manoux, PhD Research Professor (Directeur de Recherche) Epidemiology of ageing & age-related diseases INSERM U1018, France Honorary Professor University College London, UK Dr. Archana Singh-Manoux[/caption] Archana Singh-Manoux, PhD Research Professor (Directeur de Recherche) Epidemiology of ageing & age-related diseases INSERM  France Honorary Professor University College London, UK  MedicalResearch.com: What is the background for this study? Response: Depressive symptoms are common in dementia patients. Previous studies, based on older adults, show depressive symptoms in late life to be associated with an increased risk of dementia. These studies do not allow conclusions to be drawn on the causal nature of the association between depressive symptoms and dementia.
Author Interviews, Exercise - Fitness, Geriatrics, NEJM, Weight Research / 17.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34649" align="alignleft" width="199"]Dennis T. Villareal, MD Professor of Medicine Division of Endocrinology, Diabetes & Metabolism Baylor College of Medicine Staff Physician, Michael E DeBakey VA Medical Center Dr. Villareal[/caption] Dennis T. Villareal, MD Professor of Medicine Division of Endocrinology, Diabetes & Metabolism Baylor College of Medicine Staff Physician, Michael E DeBakey VA Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: The prevalence of obesity in the elderly is rapidly increasing, given that the baby boomers are becoming senior citizens, but we do not know how best to manage obesity in the elderly population. Weight loss is the cornerstone of management for obesity but weight loss in the elderly is controversial because weight loss could cause not only fat loss but also muscle mass and bone mass losses, that could worsen rather than improve frailty. We tested the hypothesis that weight loss plus exercise training, especially resistance training, would improve physical function the most compared to other types of exercise (aerobic training or combined aerobic and resistance training added to diet-induced weight loss). Previous studies especially in younger adults have shown that combining aerobic with resistance exercise could lead to interference to the specific adaptations to each exercise, and thus less gain in strength with combined exercise compared to resistance training alone. On the other hand, contrary to our hypothesis, we found that there was no interference between aerobic and resistance exercise, and the most effective mode to improve physical function and thus reverse frailty was in fact weight loss plus the combination of aerobic and resistance exercise, which was also associated with some preservation of muscle and bone mass.
Author Interviews, Macular Degeneration, Ophthalmology, Technology / 17.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34646" align="alignleft" width="180"]Dr Felicity de Cogan PhD</strong> Institute of Inflammation and Ageing University of Birmingham Dr Felicity de Cogan[/caption] Dr Felicity de Cogan PhD Institute of Inflammation and Ageing University of Birmingham MedicalResearch.com: What is the background for this study? Response: The University of Birmingham has a unique approach to developing technologies. By locating chemists, engineers, biologists and clinicians in the same department it revolutionised the way research problems are solved. Initially, Felicity de Cogan was researching cell penetrating peptides (CPP) and their uses in microbiology. However, after joining forces with Neuroscientists, Dr Lisa Hill and Professor Ann Logan at the National Institute for Health Research Surgical Reconstruction and Microbiology Research Centre (NIHR SRMRC) together with the clinicians and Vision Scientists, Dr Mei Chen and Professor Heping Xu at the Queen’s University Belfast it became evident that there was huge potential to deliver drugs in the eye. This was the start of the project and it developed rapidly from there.
AHA Journals, Author Interviews, Heart Disease / 17.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34642" align="alignleft" width="117"]Elsayed Z. Soliman MD, MSc, MS, FAHA, FACC Director, Epidemiological Cardiology Research Center (EPICARE) Professor, Department of Epidemiology and Prevention Professor, Department of Internal Medicine, Cardiology Section Wake Forest School of Medicine Medical Center Blvd, Winston Salem, NC 27157 Dr. Soliman[/caption] Elsayed Z. Soliman MD, MSc, MS, FAHA, FACC Director, Epidemiological Cardiology Research Center (EPICARE) Professor, Department of Epidemiology and Prevention Professor, Department of Internal Medicine, Cardiology Section Wake Forest School of Medicine Medical Center Blvd, Winston Salem, NC 27157 MedicalResearch.com: What is the background for this study? Response: We already know that left ventricular hypertrophy (LVH, which is the most common complication of high blood pressure, is associated with an increased risk of cardiovascular disease (CVD). We also know that successful management of high blood pressure (BP) leads to regression of LVH and improved CVD outcomes in patients with hypertension. However, it is unknown whether intensive BP lowering beyond that recommended would reduce the risk of LVH in patients with hypertension, and whether reducing the risk of LVH explains the reported CVD benefits of intensive BP lowering in this population. Therefore, we examined the differential impact of intensive BP lowering (target systolic BP (SBP).
Author Interviews, Cancer Research, NYU/NYMC, Smoking / 17.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34281" align="alignleft" width="120"]Moon-shong Tang, Ph</strong>D Professor of Environmental Medicine, Pathology and Medicine New York University School of Medicine Tuxedo Park, New York 10987 Dr. Moon-shong Tang[/caption] Moon-shong Tang, PhD Professor of Environmental Medicine, Pathology and Medicine New York University Langone School of Medicine Tuxedo Park, New York 10987 MedicalResearch.com: What is the background for this study? Response: E-cigarettes (E-cigs) are designed to deliver the stimulant nicotine through aerosols, commonly referred as vapors. Nicotine is dissolved in organic solvents such as glycerin and propylene glycol. The nicotine is then aerosolized by controlled electric heating. E-cigs do not use tobacco leaves and E-cig smoke does not involve the burning process. Hence, E-cig smoke (ECS) contains only nicotine and the gas phase of the solvent. Because ECS contains neither carcinogens nor allergens or odors from the tobacco burning process, E-cigs have been promoted as an invention that can deliver a TS ‘high’ without TS negative effects. The population of E-cig users is rapidly rising, particularly in young adults. It has been estimated that 16% of high school students are E-cig smokers. Therefore, the health effects of E-cig smoke, particularly its carcinogenicity, deserve careful scrutiny.
Accidents & Violence, Author Interviews, JAMA, Surgical Research / 17.05.2017

MedicalResearch.com Interview with: Alan Cook, MD, FACS Director, Trauma Research Program Chandler Regional Medical Center Clinical Assistant Professor, Department of Surgery University of Arizona College of Medicine - Phoenix Chandler, AZ 85224 and Frederick B. Rogers MD, MS, FACS Trauma Surgeon Lancaster General Health/Penn Medicine Adjunct Professor of Surgery University of Pennsylvania College of Medicine Department of Surgery MedicalResearch.com: What is the background for this study? What are the main findings? Response: The morbidity and mortality from pulmonary emboli (PE) are considerable. They range in severity from a problem amenable to outpatient medical management to fatal. Trauma patients are often ineligible for chemoprophylaxis due to the risk for life-threatening bleeding. Yet traumatic injury can increase a person’s likelihood of having a pulmonary embolus via an array of mechanical and humoral pathways. The vena cava filter (VCF) offered the possibility of PE prophylaxis for patients otherwise vulnerable to PE risk. Use of VCF grew and the rate of use increased even more after the introduction of the retrievable VCF. Our study sought to determine if any temporal variation in VCF use has occurred and investigate if an contemporaneous change in the diagnosis of PE has taken place. We used three databases to allow a telescoping window of observation from a single state, Pennsylvania (PTOS), to a convenience of sample of trauma centers across the country (NTDB), and finally a national, population-based sample of all hospital discharges in the US (NIS). A temporal trend was observed in all three datasets with differing magnitudes and time points of change. The variation of vena cava filter use was most pronounced in the PTOS and least dramatic in the NIS, The rate of PE was essentially unchanged during the same period.
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care / 17.05.2017

MedicalResearch.com Interview with: Eric Roberts, PhD Post-doctoral fellow Department of Health Care Policy Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Increasing consolidation of health care providers has raised regulatory concerns that less competition will lead to higher health care prices and possibly lower quality care for patients. On the other hand, some industry observers have contended that larger and higher-priced practices are better able invest in systems to support care management, and ultimately, better patient care. In this study, we examined whether larger and higher-priced physician practices provided better and more efficient care to their patients. Higher-priced physician groups were paid an average of 36% more by commercial insurers, and were substantially larger than lower-priced practices located within the same geographic areas. Despite large differences in practices’ prices and size, we found few differences in their patients’ quality and efficiency of care. For example, when we compared patients who received care in high-priced versus low-priced practices, we found no differences in patients’ overall care ratings, physician ratings, access to care, physician communication, and use of preventive services. We also found no differences in patients’ hospital admissions or total spending, suggesting that higher-priced practices were not managing their patients’ care more efficiently than their lower-priced counterparts. We did find that patients in higher-priced practices were more likely to receive recommended vaccinations, review of their medications, and results of medical tests, and that they spent less time in the waiting room for a scheduled doctor’s appointment. However, once practice prices exceeded the average for their geographic area, we observed no further gains in quality on most of these measures.
Author Interviews, Prostate Cancer, Urology / 17.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34624" align="alignleft" width="180"]Keyan Salari, MD, PhD Resident in Urologic Surgery Keyan Salari is currently completing his residency in the Harvard Program in Urologic Surgery at the Massachusetts General Hospital, and is conducting post-doctoral research in cancer genomics in the Garraway Lab at the Dana-Farber Cancer Institute and the Broad Institute of Harvard and MI Dr. Keyan Salari[/caption] Keyan Salari, MD, PhD Resident in Urologic Surgery Keyan Salari is currently completing his residency in the Harvard Program in Urologic Surgery at the Massachusetts General Hospital, and is conducting post-doctoral research in cancer genomics in the Garraway Lab at the Dana-Farber Cancer Institute and the Broad Institute of Harvard and MIT MedicalResearch.com: What is the background for this study? Response: Active surveillance is an effective strategy addressing the problem of over treatment of clinically indolent prostate cancer, but data on the role of active surveillance in younger men is limited. Younger men diagnosed with prostate cancer are typically counseled to undergo treatment as opposed to surveillance of their prostate cancer. To potentially expand the role of active surveillance to younger patient populations, we undertook this study evaluating the outcomes of younger men under 60 years of age who elected to pursue active surveillance of their prostate cancer.
Author Interviews, Biomarkers, Prostate Cancer, Urology / 17.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34627" align="alignleft" width="159"]Eric A. Klein, MD</strong> Chairman, Glickman Urological and Kidney Institute Cleveland Clinic Dr. Klein[/caption] Eric A. Klein, MD Chairman, Glickman Urological and Kidney Institute Cleveland Clinic MedicalResearch.com: Which of these results did you find most interesting or surprising? Response: What’s most interesting is that the IsoPSA assay redefines how PSA is measured, which links it more closely to the underlying biology of cancer. Current assays measure only the concentration of PSA, which can be affected by conditions other than cancer – BPH most commonly, but also infection and inflammation – which limits its diagnostic accuracy for finding cancer. Its been known for several decades that PSA exists in multiple different forms in the bloodstream in patients with prostate cancer. These novel molecules arise because cancer cells have deranged cellular metabolism that result in the generation of new species of PSA, making their measurement more tightly linked to the presence or absence of cancer and even the presence of high grade cancer (where cellular metabolism is even more disordered). The IsoPSA assay is the first assay to measure all of these isoforms and thus has better diagnostic accuracy for cancer.
Author Interviews, Dermatology, OBGYNE / 16.05.2017

MedicalResearch.com Interview with: [caption id="attachment_21019" align="alignleft" width="200"]Alexander Egeberg, MD PhD National Allergy Research Centre, Departments of Dermato-Allergology and Cardiology Herlev and Gentofte University Hospital, University of Copenhagen Hellerup, Denmark Dr. Alexander Egeberg[/caption] Alexander Egeberg, MD PhD Gentofte Hospital Department of Dermatology and Allergy Denmark MedicalResearch.com: What is the background for this study? What are the main findings? Response: An issue that frequently arise in clinical practice is the question from patients whether they should discontinue their therapy if they want to have children. Since immunosuppressant agents are frequently used for a number of conditions, and discontinuation could lead to disease flaring, assessment of the potential impact of such drugs on birth outcomes is important. In our study, we examined birth outcomes in children whose father had received treatment with methotrexate, azathioprine, cyclosporine, and mycophenolate mofetil in the time leading up to conception. Importantly, we found no increased risk of congenital abnormalities, low birth weight, or preterm birth associated with paternal treatment with these drugs.
Author Interviews / 16.05.2017

MedicalResearch.com Interview with: ACCCMark S. Soberman, MD MBA FACS President, Association of Community Cancer Centers Medical Director, Oncology Service Line Chief Physician Executive, Monocacy Health Partners Frederick Regional Health System MedicalResearch.com: How will the online program prepare health care providers and patient advocates to help patients navigate the financial implications of cancer? Response: The Association of Community Cancer Centers (ACCC) Financial Advocacy Boot Camp is a dynamic online curriculum.  The interactive learning modules are easy to navigate and contain helpful features to support learning, including quizzes and supplemental resources. Each module is less than a half-hour long, so participants can work at their own pace while accessing the on-demand courses 24-7. The Financial Advocacy Boot Camp has 14 learning modules. Topics include:
  1. Financial Advocacy Fundamentals. Review the basics of financial advocacy and gain an understanding of public and private health insurance coverage options.
  2. Enhancing Communication. Develop strategies to improve communication among the care team, engage patients on financial concerns, and find various distress screening tools.
  3. Improving Insurance Coverage. Learn how to help cancer patients get better health insurance coverage to reduce the out-of-pocket burden and tap into resources to reduce financial toxicity.
  4. Maximizing External Assistance. Delve into external assistance programs and other sources of assistance available for patients with public health insurance, private insurance, or no insurance.
  5. Improving Financial Advocacy Services. Learn to track cost savings for patients and your facility. Apply different tracking methods and reporting tools to evaluate your financial advocacy program and identify opportunities for continuous improvement.
Author Interviews, Infections, Vaccine Studies / 15.05.2017

MedicalResearch.com Interview with: AbivaxJean-Marc Steens, M.D. Chief Medical Officer of Abivax MedicalResearch.com: What is the background for this study? What are the main findings? Response: Antiretroviral therapy (ART) has had an enormous impact on the HIV pandemic since its introduction almost 20 years ago. Most patients treated with ART achieve undetectable or near undetectable plasma levels of the virus. This means that although HIV is controlled, it is not completely eliminated. The virus remains in the body, usually contained in dormant cells (known as the HIV reservoir) that are widely distributed, including to the central nervous system, the gut mucosa, the lymph nodes and other sites. If ART is stopped, the virus rebounds. The goal of any curative therapy would be to eliminate the virus or ensure there is sustained remission in the absence of ART, which until now have been unsuccessful. Abivax’s Phase 2 clinical study with ABX464 demonstrated, for the first time, a reduction in HIV reservoirs in chronically infected HIV patients as measured by total HIV DNA detected in peripheral blood mononuclear cells (PBMCs). In the ABX464-004 trial, 30 HIV patients received either ABX464 or matching placebo in addition to their current antiretroviral treatment over 28 days. The viral load at the start of the study was well controlled with boosted darunavir. After the 28-day treatment period, all treatments were interrupted until viral load rebound. Baseline and day 28 blood samples were taken to assess the potential effect of ABX464 on the HIV reservoir in PBMCs. Safety was the primary endpoint in the trial. ABX464 was well tolerated, with no severe adverse events in the treatment group. Amongst evaluable patients (4 placebo and 14 ABX464-treated patients), a reduction in viral DNA copies/mPBMCs was observed in 7/14 treated patients (mean change of -40%, ranging from -27% to -67%) and no responders were observed in the placebo group. Responders were defined as patients who had a decrease greater than 25% in total HIV DNA in PBMCs and a reduction of at least 50 copies. Total HIV DNA in PBMC has been validated as a widely accepted biomarker for measuring the HIV reservoir. Specifically, in untreated patients, total HIV DNA load influences the course of the infection and is therefore clinically relevant. In addition, a correlation exists between the pool of HIV-1 DNA and the replication-competent reservoir.
Author Interviews, Biomarkers, Genetic Research, Personalized Medicine / 15.05.2017

MedicalResearch.com Interview with: 3D SignaturesJason Flowerday, CEO Director of 3D Signatures  MedicalResearch.com: What is the background for 3D Signatures? Response: 3D Signatures, and its clinical lab tests, which incorporate its proprietary TeloViewTM software analytics, is the culmination of over 20 years of ground-breaking research conducted by Dr. Sabine Mai and her colleagues. It is the only technology in the world that quantifies genomic instability, which is the hallmark of cancer and other proliferative diseases at the whole-cell level. By measuring the degree of genomic instability from different tissues, TeloViewTM has produced clinically actionable distinctions in the stage of disease, rate of progression of disease, drug efficacy, and drug toxicity. The technology is well developed and supported by 22 clinical studies on over 2,000 patients on 13 different cancers including Alzheimer’s disease. The results have been exceptional and represent a universal biomarker platform across all disease areas that the company has investigated to date.
Author Interviews, CMAJ, Diabetes, OBGYNE / 15.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34593" align="alignleft" width="200"]Dr. Gillian Booth PhD Researcher at St. Michael's and the Institute for Clinical Evaluative Sciences (ICES) Dr.Gillian Booth[/caption] Dr. Gillian Booth PhD Researcher at St. Michael's and the Institute for Clinical Evaluative Sciences (ICES) MedicalResearch.com: What is the background for this study? What are the main findings? Response: The impact of climate change on health is becoming increasingly relevant given the rise in global air temperature, and there is growing evidence supporting a link between air temperature, metabolic function, and energy expenditure. We know from animal models and small studies in humans that cold exposure and activate a type of fat known as brown fat and it appears that this process can improve sensitivity to insulin. However no studies have yet looked at air temperature and the development of diabetes. So we decided to examine the relationship between outdoor air temperature and gestational diabetes – a temporary form of diabetes that arises in the second trimester of pregnancy.
Author Interviews, JAMA, Thyroid / 15.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34585" align="alignleft" width="142"]Dr. C. Seth Landefeld MD U.S. Preventive Services Task Force and Chairman of the department of Medicine and Spencer Chair in Medical Science Leadership University of Alabama at Birmingham (UAB) School of Medicine Dr. Landefeld[/caption] Dr. C. Seth Landefeld MD U.S. Preventive Services Task Force and Chairman of the department of Medicine and Spencer Chair in Medical Science Leadership University of Alabama at Birmingham (UAB) School of Medicine  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Thyroid cancer is rare in the United States, and the evidence shows that screening for it leads to an increase in new diagnoses without affecting the number of people who die from it. This is because screening people without signs or symptoms for thyroid cancer often identifies small or slow-growing tumors that might never affect a person during their lifetime. After reviewing the evidence, the Task Force found little evidence on the benefits of screening for thyroid cancer and considerable evidence that treatment, which is often unnecessary, can cause significant harms. Additionally, in places where universal screening has been implemented, it hasn’t helped people live longer, healthier lives.