Author Interviews, Bone Density, Heart Disease / 21.03.2018

MedicalResearch.com Interview with: Dr. Joshua Lewis, PhD National Health and Medical Research Council Career Development Fellow, Edith Cowan University, School of Medical and Health Sciences / Centre for Kidney Research Children’s Hospital Westmead Honorary Senior Research Fellow, Sydney Medical School, School of Public Health University of Sydney  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Bone scans from bone density machines are widely used to predict future fracture risk. These scans can also be used to detect the presence and severity of abdominal aortic calcification (AAC), which is a marker of advanced atherosclerosis. We examined bone scans of over one thousand Australian women that were taken in the late 1990s using a method developed many years ago by one of the authors Dr. Kiel from the Institute for Aging Research at Hebrew SeniorLife and Harvard Medical School, and validated on scans from bone density machines by the joint first author Dr. Schousboe from the University of Minnesota. More than 2/3rd of these women had detectable AAC and women with more advanced calcification had increased likelihood of long-term cardiovascular hospitalizations and deaths as well as deaths from any cause. These finding remained significant even after adjusting for conventional cardiovascular risk factors. (more…)
Author Interviews, Cancer Research, MRI, Prostate Cancer / 21.03.2018

MedicalResearch.com Interview with: Veeru Kasivisvanathan MBBS BSc MRCS MSc PGCert Lead for CPD, Division of Surgery and Interventional Science, UCL Academic Section Committee, British Association of Urological Surgeons Twitter: @veerukasi PRECISION Study Coordinator https://clinicaltrials.gov/ct2/show/NCT02380027   MedicalResearch.com: What is the background for this study? What are the main findings? 
  • We knew that there were limitations in the standard of care pathway for the diagnosis of prostate cancer, TRUS biopsy which missed harmful cancers and over diagnosed harmless cancers.
  • Emerging reports in the literature showed that using an alternative diagnostic pathway, MRI and MRI-targeted biopsy, showed promising prostate cancer detection rates
  • In 2012 we set out in an international working group to design a study that could change clinical practice and replace the standard of care with a pathway involving MRI 
(more…)
AHA Journals, Author Interviews, Hospital Readmissions, JAMA / 21.03.2018

MedicalResearch.com Interview with: Dr. Sahil Agrawal, MBBS MD Division of Cardiology, St. Luke’s University Health Network, Bethlehem, PA Dr Lohit Garg MD Division of Cardiology Lehigh Valley Health Network, Allentown  MedicalResearch.com: What is the background for this study? Response: Readmissions among advanced heart failure patients are common and contribute significantly to heath care related costs. Rates and causes of readmissions, and their associated costs among patients after durable left ventricular assist device (LVAD) implantation have not been studied in a contemporary multi-institutional setting. We studied the incidence, predictors, causes, and costs of 30-day readmissions after LVAD implantation using Nationwide Readmissions Database (NRD) in our recently published study. (more…)
Author Interviews, PLoS, Weight Research / 21.03.2018

MedicalResearch.com Interview with: Robin Dando, PhD Assistant Professor Director, Cornell Sensory Evaluation Facility Department of Food Science Cornell University Ithaca, NY 14853 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: For many years, people have been interested in if gaining weight can change how we perceive foods, thus maybe encouraging less healthy food choices.  There is some evidence in previous work that if we become obese, we seem to perceive things as tasting less intense.  Now if this were the case, to make up for this we might eat more of whatever food it was we were eating, or conversely we might choose something that tasted more intense, to make up this difference.  More intense usually means higher calories, so if we took either of these approaches, we’re at risk for weight gain. In our study, we examined the taste buds of mice who were fed an unhealthy diet that induces obesity, versus sibling mice fed a more healthy diet that keeps them lean.  The mice gaining weight ended up after only 8 weeks with a lot fewer taste buds than the lean mice.  This loss of taste buds represents one explanation for foods tasting less intense to the obese. (more…)
Author Interviews, NYU, Rheumatology, Surgical Research, Weight Research / 20.03.2018

MedicalResearch.com Interview with: Jonathan Samuels, MD Associate Professor of Medicine Division of Rheumatology NYU Langone Health MedicalResearch.com: What is the background for this study?  Response: A high percentage of obese patients have painful knee osteoarthritis, and have difficulty losing weight as well as treating the knee pain with a self-perpetuating cycle.  MedicalResearch.com: What are the main findings? Response:  Patients who lost weight with their laparoscopic banding surgeries also experienced marked improvement of their knee pain. We found a significant correlation between the degree of improvement in the body mass index and reduction of knee pain in our cohort. In addition, the patients who experienced the most relief from weight loss surgeries had their procedures at earlier ages, as well as those who never had a traumatic knee injury nor developed osteoarthritis in other joints. (more…)
Author Interviews, Brigham & Women's - Harvard, Endocrinology, OBGYNE, Weight Research / 20.03.2018

MedicalResearch.com Interview with: Madhusmita Misra, MD, MPH Division Chief, Pediatric Endocrinology Fritz Bradley Talbot and Nathan Bill Talbot Professor of Pediatrics, Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Disordered eating behavior is common in conditions of functional hypothalamic amenorrhea, such as anorexia nervosa and exercise-induced amenorrhea, which are also associated with anxiety and depression. In hypoestrogenic rodents, estrogen replacement reduces anxiety-related behavior. Similarly, physiologic estrogen replacement in adolescents with anorexia nervosa reduces anxiety and prevents the increased body dissatisfaction observed with increasing weight. However, the impact of estrogen administration on disordered eating behavior and psychopathology in normal-weight young women with exercise-induced amenorrhea is unknown. Adolescent and young adult normal-weight athletes 14-25 years old with irregular periods were randomized to receive (i) physiologic estrogen replacement using a transdermal patch with cyclic progesterone, or (ii) an oral estrogen-progesterone containing pill (an oral contraceptive pill), or (iii) no estrogen for 12-months. The Eating Disorder Inventory-2 (EDI-2) and Three-Factor Eating Questionnaire (TFEQ) were administered ag the beginning and the end of the study to assess disordered eating behavior and psychopathology. We found that the group that did not receive estrogen had a worsening of disordered eating behavior and psychopathology over the 12-months duration of the study, but this was not observed in the group that received estrogen replacement. Further, body dissatisfaction scores improved over 12-months in the groups receiving estrogen replacement, with the transdermal estrogen group showing the strongest effect. (more…)
AACR, Author Interviews, Colon Cancer / 20.03.2018

MedicalResearch.com Interview with: Darren D. Browning, PhD | Professor Department of Biochemistry and Molecular Biology, Medical College of Georgia at Augusta University Georgia Cancer Center, Augusta, Georgia 30912-2100 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Cancer of the colon and rectum is one of the most commonly diagnosed and has a high mortality because it is often identified at an advanced stage. In the United States the average overall risk of having to deal with this disease at some point is around one in twenty-five, but the risk is much higher for people who have previously had polyps removed or if a close relative was diagnosed with colon cancer. The risk is even higher for patients with inflammatory bowel disease or heritable disorders such as familial adenomatous polyposis and lynch syndrome. While chemoprevention is clearly warranted, there are currently no drugs available that can reduce the risk for those predisposed to colorectal cancer. Previous work from our laboratory has shown that drugs like sildenafil that inhibit phosphodiesterase 5 (PDE5), have a profound effect on the epithelial lining of the intestine. Our recent work has shown that these drugs can prevent intestinal cancers in two different mouse models of human disease. While this class of drugs is best known for treating erectile dysfunction, due to a low side-effect profile they are also prescribed for long-term daily use to treat pulmonary arterial hypertension (PAH) and benign prostate hyperplasia (more…)
ADHD, Author Interviews, Brain Injury, JAMA, Pediatrics / 20.03.2018

MedicalResearch.com Interview with: Dr. Megan E. Narad, PhD Division of Behavioral Medicine and Clinical Psychology Cincinnati Children's Hospital Medical Center | CCHMC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previous research has shown that children with a history of traumatic brain injury (TBI) demonstrate difficulties with attention following injury; however, most studies only follow children 2-3 years after injury. Our study followed a group of children with a history of TBI 7-10 years after injury. The main finding is that those with severe TBI were at greater risk for developing secondary attention deficit hyperactivity disorder (SADHD) than those with orthopedic injury; however, it should also be noted that kids with less severe injuries were also at risk of developing SADHD. In addition to injury severity, environmental factors (maternal education and family functioning) also played a role in SADHD development. It should also be noted that a number of kids developed SADHD >3.5 years after injury suggesting that these difficulties may not surface until many years after injury. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Menopause, OBGYNE, Sexual Health / 20.03.2018

MedicalResearch.com Interview with: Caroline Mitchell, MD, MPH Vincent Center for Reproductive Biology Assistant Professor, Obstetrics, Gynecology & Reproductive Biology http://massgeneral.link/MitchellLab MedicalResearch.com: What is the background for this study? What are the main findings? Response: In this study we compared two commonly recommended treatments for menopausal vaginal discomfort - low dose vaginal estradiol tablets and a vaginal moisturizer - to placebo, and found no difference in reduction of symptom severity; all three groups improved over 12 weeks of treatment.  This is great news for women, as it means that using any treatment regularly is likely to have benefit, whether it costs $20 or $200. Symptoms of vaginal dryness, irritation and pain with sex, which occur in over half of postmenopausal women, cause a significant decrease in quality of life and negatively impact intimate relationships.  The significant impact of these symptoms is reflected in the fact that we enrolled all 302 participants in under a year, a faster enrollment than any of the four prior trials  conducted by the MsFlash research network that evaluated treatments for hot flashes.  Women were desperate for some kind of intervention for these symptoms. (more…)
Author Interviews, Opiods / 19.03.2018

MedicalResearch.com Interview with: Brian J. Piper, PhD, MS Assistant Professor of Neuroscience Department of Basic Sciences, Geisinger Commonwealth School of Medicine, Scranton PA 18509  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The US is experiencing an opioid crisis. There were 63,800 drug overdose deaths in 2016 which is three-fold higher than in 1999. Drug overdose deaths involving synthetic opioids like fentanyl increased 27-fold. Overdoses may even have contributed to decreases in the US lifespan. Emergency Room visits involving opioids have also shown recent increases, particularly in the Southwest and Western US. The US accounts for less than 5% of the world’s population but consumed over two-thirds (69.1%) of the world’s supply of six opioids (fentanyl: 30.1%, methadone: 48.1%, morphine: 51.2%, hydromorphone: 53.0%, oxycodone: 73.1% and hydrocodone: 99.7%) in 2014. The goal of this study was to examine changes in medical use of ten opioids within the United States, and US Territories, from 2006 to 2016 as reported to the Drug Enforcement Administration’s Automation of Reports and Consolidated Orders System (ARCOS). Prior estimates of the Morphine Mg Equivalent (MME), per person in the US (640), although much higher than most other developed countries, may be an underestimate because of a federal regulation (42 CFR Part 2) that prevents reporting methadone from narcotic treatment programs. We discovered that prescription opioid use peaked in 2011 (389.5 metric ton MMEs) and has been rapidly declining (346.5 in 2016). Relative to 2011, there were decreases in hydrocodone (–28.4%); oxymorphone (–28.0%); fentanyl (–21.4%); morphine (–18.9%); oxycodone (–13.8%); and meperidine (–58.0%). However, there was a pronounced increase in buprenorphine (75.2%). Similar changes were observed from 2015 to 2016 with a statistically significant reduction in all opioids except buprenorphine which was increased. There were substantial geographical variations in rates with a seven fold difference between the highest Morphine Milligram Equivalents in 2016 (Rhode Island = 2,624 mg/person) relative to Puerto Rico (351 mg/person). Two drugs used in treating an opioid use disorder (methadone and buprenorphine) accounted for over-half (52%) of the total MME in 2016.   (more…)
Author Interviews, Orthopedics, UCSF / 19.03.2018

MedicalResearch.com Interview with: Terence J. Gioe, MD American Joint Replacement Registry, Rosemont, IL UCSF School of Medicine, San Francisco VA Health Care System  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Hospital-based or regional registries are typically limited in their catchment area, making loss to follow-up a major concern when patients move out of the area or otherwise receive subsequent medical care outside of the original hospital network. The American Joint Replacement Registry (AJRR), a part of the American Academy of Orthopaedic Surgeons’ (AAOS) registries portfolio, has the goal of tracking total joint arthroplasty (TJA) patients nationally across the US, but currently captures only approximately 28% of annual TJA procedures. Until a nationwide network of reporting hospitals is established that covers at least 90% of all TJA procedures, loss to follow-up due to migration will be a key potential limitation of large-scale studies on implant performance in the US. Assessment of loss to follow-up can provide an essential understanding of the migration patterns of TJA patients, and help to improve recruitment and enrollment efforts of the AJRR. The magnitude and characteristics of patient migration following TJA have not previously been studied in the US.  (more…)
Author Interviews, Orthopedics, Pediatrics / 19.03.2018

MedicalResearch.com Interview with: Baron  Lonner, MD 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: 2-3% of adolescents have idiopathic scoliosis and 1 in 10 of these individuals will require surgery to correct severe scoliosis which if left untreated can lead to back pain and disability as well as pulmonary (breathing) problems later in life. For the adolescent with curvatures that require surgical treatment, body image and self esteem are big issues as they are for all adolescents going through their developmental stages. Scoliosis has an impact on body shape, which is seen by the affected individual looking in the mirror as well as by their peers and those around them. This can lead to self esteem and body image disturbance issues. We set out to explore the body shape distortions that occur with scoliosis, that are not depicted by x-rays that are standardly used to assess curvatures of the spine, and the improvements in parameters of body shape that occur with corrective surgery. We can assess body shape directly through surface topography imaging, that is light-based, thus, not involving x-ray exposure. This technology (Diers Formetrics) uses the same scientific methodology that is used to create modern topographical maps through satellite imagery. We found dramatic improvements in body shape asymmetry with surgery that correlated with some improvements in quality of life for the adolescent in this cohort of 23 patients as well as with the improvements in curvatures evaluated by x-rays.  (more…)
Author Interviews, Hematology, Surgical Research, Transfusions / 19.03.2018

MedicalResearch.com Interview with: Shawn Anthony, MD, MBA Assistant 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: Rates of total shoulder arthroplasty are increasing, especially with an aging population.  Blood loss requiring transfusion is less common than in total hip or knee replacements but still required in some patients.  Tranexamic acid (TXA) is increasingly used to reduce blood loss in lower extremity arthroplasty but limited data exists for its effectiveness and safety in patients undergoing shoulder arthroplasty. We aimed to utilize national data to assess frequency of use and effectiveness of TXA in shoulder arthroplasty patients. While utilization of TXA has become very common in total hip and knee arthroplasty, TXA is still used in less than 50% of patients undergoing shoulder arthroplasty as of 2016.  TXA use was associated with a 36% decrease in transfusion risk and a 35% decreased risk for combined complications. Moreover, TXA use was associated with 6.2% shorter hospital stay. (more…)
Author Interviews, Brigham & Women's - Harvard / 18.03.2018

MedicalResearch.com Interview with: Alexander Turchin, M.D., M.S. FACMI Associate Professor of Medicine ENDOCRINOLOGY, DIABETES AND HYPERTENSION BRIGHAM AND WOMEN'S HOSPITAL MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Statins are known to reduce the risk of cardiovascular events and death, and are some of the most commonly prescribed medications. However, many patients stop taking statins, most commonly because of adverse reactions. It has been shown previously that many individuals who discontinued statin therapy after an adverse reaction are ultimately able to tolerate statins, and that reattempting statin therapy after an adverse reaction is associated with reduced risk of cardiovascular events and death. However, optimal patient selection criteria and methods of reattempting treatment with statins are unknown. We therefore conducted this study to identify patient and treatment characteristics associated with an increased chances of successful reattempt of statin therapy after an adverse reaction. Through analysis of EMR data of over 6,000 patients we found that the following were associated with higher chances of successful statin therapy reattempt:
  • Reattempted treatment with a different statin
  • Patient at high cardiovascular risk (prior history of CAD, stroke or diabetes)
On the other hand, the following were associated with lower chances of success:
  • Adverse reaction was reported in the first year after starting statin therapy
  • Adverse reaction was myalgia or myopathy
  • Previous history of adverse reactions to other (non-statin) medications 
(more…)
Author Interviews, JAMA, Ophthalmology, University of Michigan / 16.03.2018

MedicalResearch.com Interview with: Maria A. Woodward, MD, MSc Department of Ophthalmology and Visual Sciences W. K. Kellogg Eye Center Institute for Healthcare Policy and Innovation University of Michigan Ann Arbor, MI MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Many people go to emergency departments seeking care for their eye problems. We wished to investigate which factors are associated with the involvement of ophthalmologist consultants in the care of these patients and whether any disparities exist.  (more…)
Author Interviews, Education, Outcomes & Safety / 16.03.2018

MedicalResearch.com Interview with: Dr. Furman S. McDonald MD MPH Lead author of the research and Senior Vice President for Academic and Medical Affairs American Board of Internal Medicine (ABIM) MedicalResearch.com: What is the background for this study? Would you briefly explain how the MOC examination works? Response: To earn Board Certification from the American Board of Internal Medicine (ABIM), doctors take an exam after completing a medical education training program accredited by the Accreditation Council for Graduate Medical Education to demonstrate they have the knowledge to practice in a specialty. Previously, ABIM conducted research that showed that physicians who passed a certification exam were five times less likely to be disciplined by a state licensing board than those who do not become certified. After becoming board certified, physicians can participate in ABIM’s Maintenance of Certification (MOC) program, which involves periodic assessments and learning activities to support doctors in staying current with medical knowledge through their careers. ABIM has been in conversations across the medical community and many people have expressed interest in whether performance on the MOC exams doctors take is also associated with important outcomes relevant to patients. For this study, my ABIM colleagues and I studied whether there was any association between Internal Medicine MOC exam performance and disciplinary actions by state licensing boards. We studied MOC exam results and any reported disciplinary actions for nearly 48,000 general internists who initially certified between 1990 and 2003.  (more…)
Author Interviews, Emergency Care, Heart Disease, Surgical Research / 16.03.2018

MedicalResearch.com Interview with: Dawn Abbott, MD, FACC, FSCAI Associate Chief, Faculty Development and Academic Advancement Director, Interventional Cardiology and Structural Fellowship Programs Associate Professor of Medicine Warren Alpert Medical School, Brown Providence, RI 02903  MedicalResearch.com: What is the background for this study? Response: Approximately 35,000 transcatheter aortic valve replacement (TAVR) procedures are now performed annually in the United States (US). TAVR is usually performed as an elective procedure in hemodynamically stable patients. Approximately 1 in 5 hospitalizations for severe aortic stenosis (AS) are emergent with acute decompensation. Balloon aortic valvuloplasty (BAV) is a therapeutic option in patients with acute decompensated AS; however, long-term survival after BAV remains poor with a high incidence of valvular re-stenosis. Data on the outcomes of urgent/emergent TAVR as a rescue therapy in patients with acute decompensated severe AS are extremely limited. (more…)
Author Interviews, Brain Cancer - Brain Tumors, Emory, PNAS, Technology / 16.03.2018

MedicalResearch.com Interview with: Lee Cooper, Ph.D. Assistant Professor of Biomedical Informatics Assistant Professor of Biomedical Engineering Emory University School of Medicine - Georgia Institute of Technology MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Gliomas are a form of brain tumor that are often ultimately fatal, but patients diagnosed with glioma may survive as few as 6 months to 10 or more years. Prognosis is an important determinant in selecting treatment, that can range from simply monitoring the disease to surgical removal followed by radiation treatment and chemotherapy. Recent genomic studies have significantly improved our ability to predict how rapidly a patient's disease will progress, however a significant part of this determination still relies on the visual microscopic evaluation of the tissues by a neuropathologist. The neuropathologist assigns a grade that is used to further refine the prognosis determined by genomic testing. We developed a predictive algorithm to perform accurate and repeatable microscopic evaluation of glioma brain tumors. This algorithm learns the relationships between visual patterns presented in the brain tumor tissue removed from a patient brain and the duration of that patient's survival beyond diagnosis. The algorithm was demonstrated to accurately predict survival, and when combining images of histology with genomics into a single predictive framework, the algorithm was slightly more accurate than models based on the predictions of human pathologists. We were also able to identify that the algorithm learns to recognize some of the same tissue features used by pathologists in evaluating brain tumors, and to appreciate their prognostic relevance. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Heart Disease, Medicare / 15.03.2018

MedicalResearch.com Interview with: Dr. Rishi K. Wadhera MD Clinical Fellow in Medicine Brigham and Women's Hospital  MedicalResearch.com: What is the background for this study?   Response: The Hospital Value Based Purchasing program, in which over 3,000 hospitals participate, is a Centers for Medicare and Medicaid Services (CMS) pay-for-performance program that links hospital fee per service reimbursement to performance, through measures like 30-day mortality rates after an acute myocardial infarction (a heart attack), and other measures such as average spending for an episode of care for Medicare beneficiaries. Hospitals that perform poorly on these measures are financially penalized by CMS. (more…)
Author Interviews, Dermatology, Global Health, NEJM, Zika / 15.03.2018

MedicalResearch.com Interview with: Professor Bruno Hoen, M.D., Ph.D Dept of Infectious Diseases, Dermatology, and Internal Medicine University Medical Center of Guadeloupe  MedicalResearch.com: What is the background for this study? Response: Zika virus (ZIKV) infection during pregnancy has been identified only recently to cause severe birth defects, including microcephaly, other brain defects, and the congenital Zika syndrome. However, the magnitude of this risk was not clearly defined, with discrepancies between observational data from Brazil and the U.S. Zika Pregnancy Registry. We implemented a cohort study of pregnant women who have been exposed to ZIKV throughout the outbreak that hit the Caribbean in 2016. (more…)
Author Interviews, CDC, Dermatology, Environmental Risks, JAMA / 15.03.2018

MedicalResearch.com Interview with: “Sunburn” by Beatrice Murch is licensed under CC BY 2.0Dawn Holman, MPH Behavioral Scientist Division of Cancer Prevention and Control CDC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Sunburn at any age increases a person’s chances of developing skin cancer in the future. Using a combination of strategies including staying in the shade, wearing clothing that covers the arms and legs, wearing a hat with a wide brim, and wearing sunscreen (SPF 15+) on exposed skin can protect skin from sun damage and reduce risk of sunburn. This study used national data to examine how often US adults used these sun protection strategies when outdoors in the sun for an hour or longer and how many US adults got sunburned in 2015. Among adult women, staying in the shade and using sunscreen were the most common sun protection methods. About 40% of women regularly used these strategies. Women were less likely to wear a wide-brimmed hat (14%) or wear clothing covering their arms (11%) and legs (23%). Among adult men, wearing pants or other clothing covering their legs and staying in the shade were the most common sun protection methods. Just over 30% of men regularly used these strategies. Men were less likely to use sunscreen (22%), wear a wide-brimmed hat (14%) or wear a shirt with long sleeves (13%). About one-third of US adults got sunburned in 2015. Sunburn was even more common among certain groups. For example, about half of individuals with sun-sensitive skin and about half of adults aged 18-29 got sunburned. Certain behaviors and health conditions were related to sunburn. For example, adults who used sunless tanning products to darken their skin, binge drank, engaged in aerobic activity, or were overweight or obese were more likely to get sunburned compared to other adults. Adults who regularly stayed in the shade when outdoors or avoided long periods of time in the sun were slightly less likely to get sunburned compared to other adults. Adults who regularly used sunscreen were slightly more likely to get sunburned. (more…)
Accidents & Violence, Annals Internal Medicine, Author Interviews / 15.03.2018

MedicalResearch.com Interview with: Simon Chapman AO PhD FASSA Hon FFPH (UK) Emeritus Professor in the School Public Health University of Sydney MedicalResearch.com: What is the background for this study? Response: Since major gun law reforms in 1996, Australian has seen zero mass shootings (five or more deaths, not including the perpetrator).The law reforms outlawed semi-automatic rifles, those often favored by mass killers. In the 18 years prior to the reforms, Australia experienced 13 mass shootings. The National Rifle Association and others have suggested that the 22 year absence of mass shootings may simply reflect that these events are rare and statistically unlikely to occur regardless of any policy. (more…)
Aging, Alcohol, Author Interviews, JAMA, Stanford / 15.03.2018

MedicalResearch.com Interview with: alcohol-cdc-imageEdith V. Sullivan, Ph.D. Professor Department of Psychiatry & Behavioral Sciences Stanford University School of Medicine Stanford, CA 94305-5723  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Alcohol misuse is a major public health problem worldwide with profound health consequences on the body, brain, and function. Our research group has conducted naturalistic yet controlled studies of alcohol dependence for several decades to further our understanding of when and how alcohol misuse affects specific parts of the brain.  In addition, we wanted to know how alcohol misuse interacts with the typical changes in the brain as we grow older.  The studies are controlled in that we recruit healthy, non-alcohol dependence men and women from the community to undergo the same screening and neuroimaging procedures as our alcoholic recruits.  The studies are quantitative because we use neuroimaging methods (Magnetic Resonance Imaging) that enable us to measure specific regions of brain structural volumes.  Consistent collection of such data over the years positioned us to ask whether age and alcohol dependence interact to produce regional brain volume loss beyond the loss that occurs in normal aging. A number of cross-sectional studies pointed to the likelihood that the effects of alcohol dependence on brain structure would be exacerbated by normal aging, which we do know from longitudinal neuroimaging studies results in shrinkage of cortical gray matter volume and thinning of the cortex. What was particularly striking about our longitudinal study of men and women with alcohol dependence was the acceleration of the aging of brain structure that was especially prominent in the frontal cortex.  Critically, even those who initiated dependent drinking at an older age showed accelerated loss. Because our study sample was large enough, we could also test whether our findings were attributable to conditions that commonly co-occur with alcohol dependence, namely, illicit drug use and hepatitis C.  Although both drug use and hepatitis C infection may have exacerbated brain volume loss, these factors did not fully account for the alcoholism-aging interaction we identified. (more…)
ASCO, Author Interviews, Prostate, Prostate Cancer, Urology / 15.03.2018

MedicalResearch.com Interview with: https://www.churchillpharma.com/ Paul Nemeth, Ph.D. Sr. Vice President, Regulatory Affairs, Clinical Development & Quality Assurance Churchill Pharmaceuticals LLC King of Prussia, PA 19406 MedicalResearch.com: What is the background for this study? Response: In the STAAR study, 53 patients with metastatic castration-resistant prostate cancer (mCRPC) were randomized to receive YONSA, an abiraterone acetate fine particle formulation 500 mg once daily in combination with 4 mg of methylpresnisolone twice daily or 1,000 mg daily of the originator abiraterone acetate (OAA) in combination with 5 mg of prednisone twice daily for a period of 84 days.  Previous studies in healthy volunteers under fasted conditions had shown that single oral doses of 500 mg of YONSA are bioequivalent to single oral doses of 1,000 mg OAA and that a background of 4 mg of methylprednisolone twice daily on a single oral dose of 500 mg of YONSA results in the same extent of absorption as a background of 5 mg of prednisone twice daily on a single oral dose of 1,000 mg of OAA.  (more…)
Author Interviews, Flu - Influenza, Infections, Mental Health Research, Primary Care, Roche / 14.03.2018

MedicalResearch.com Interview with: James W. Antoon, MD, PhD, FAAP Assistant Professor of Clinical Pediatrics University of Illinois at Chicago Associate Medical Director, Pediatric Inpatient Unit Children's Hospital, University of Illinois Hospital & Health Sciences System Chicago, IL 60612  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Oseltamivir, commonly known as Tamiflu, is the only commercially available medication FDA approved to treat the flu.  Since the 2009 H1N1 flu epidemic pediatric prescriptions for Tamiflu have soared.  In the United States, about 40% of Tamiflu prescriptions are given to children less than 16 years of age.  Following reports of abnormal behavior, such as hallucinations, self-injury and suicide attempts in adolescents on Tamiflu, the FDA placed a new warning about these neuropsychiatric symptoms on the drug label.  Whenever the FDA puts out label warning about a drug, doctors and the public take notice. Whether Tamiflu truly causes these side effects is unclear.  For this study we chose to focus on the most consequential of those reports: suicide. The potential link between a drug and suicide is a particularly difficult topic to study for a number of reasons. There are things that happen together or at the same time that can influence someone to attempt suicide and it is very difficult to know which thing is actually having an affect. In our study, other things that can influence suicide are socioeconomic status, mental health, trauma, abuse, among others.  Separating the effects of these confounders can be difficult. It is also possible that the disease itself, which in this case is the flu, causes the effect of suicide. Finally, and luckily, suicide is rare. Our database had 12 million children per year and over five year 21,000 attempted suicide. Of those, only 251 were taking Tamiflu. To get past these issues, we took advantage of a growing drug safety research collaboration between the Departments of Pediatrics and Pharmacy at our institution.  Previous studies have compared those on Tamiflu to those not on Tamiflu to see if there are more side effects in the Tamiflu group.  Our team utilized a novel study method called a case-crossover design. What’s different about this study is that we used each patient as their own comparison.  In other words, we compared each patient to themselves rather than a different group of people.  We essentially studied how patients behaved when the Tamiflu was in their system compared to other l periods where they were not on Tamiflu.  This allowed use to account for the personal differences noted above like mental health and socioeconomic status.   We also compared those children with flu who got Tamiflu and those with flu who did not get Tamiflu to see if the infection itself could be associated with increased suicide. After accounting for all these variables, we did not find any an association between Tamiflu exposure and suicide. Our findings suggest that Tamiflu does NOT increase the risk of suicide in children or teenagers. (more…)
Accidents & Violence, Addiction, Author Interviews, JAMA / 14.03.2018

MedicalResearch.com Interview with: Dr. Laura Dwyer-Lindgren PhD Assistant Professor at IHME Institute for Health Metrics and Evaluation  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: This study in the latest in a series of studies IHME has conducted on health and disease on the county level in the United States. We analyzed data provided by the National Center for Health Statistics, the U.S. Census Bureau, and other sources. Main findings include:
  • Nearly 550,000 deaths were attributed to drug use over the 35 years. Nationally, the age-standardized death date increased 238% between 1980 and 2000, and 112% between 2000 and 2014. The death rate from drug use disorders increased in every county, but some counties in Kentucky, West Virginia, Ohio, Indiana, and eastern Oklahoma has increases exceeding 5000%.
  • There were more than a quarter million deaths in the U.S. due to alcohol use; Western counties generally has higher levels than those in other parts of area of the nation, with especially high death rates in Wisconsin, North Dakota, South Dakota, Nebraska, Montana, New Mexico, Arizona, Utah, and Alaska.
  • Neatly 1.3 million suicides were recorded, with especially high rates in Alaska, Nevada, South Dakota, Utah, New Mexico, Arizona, Montana, North Dakota, Oregon, Wyoming and one county in Maryland. While the national death rate due to suicide decreased between 1980 and 2014, there was an increase in the death rate due to suicide in most counties.
  • More than three quarters of a million deaths by homicide occurred in the US between 1980 and 2015. Nationally, the age-standardized death rate due to homicide decreased by about 35% between 1980 and 2000, and by nearly 16% between 2000 and 2014. Counties with the largest decreases were found in Virginia, Florida, Texas, California and New York. 
(more…)
Abuse and Neglect, Neurology / 14.03.2018

MedicalResearch.com Interview with: Veljko Dubljević, Ph.D., D.Phil. Assistant Professor of Philosophy, Department of Philosophy and Religious Studies, and Science Technology and Society Program, North Carolina State University Raleigh, NC 27607  MedicalResearch.com: What is the background for this study? Response: There is considerable controversy about the interpretation of data of the neuroscientific studies done by Benjamin Libet. On the one hand, Libet claimed that his work disproves certain metaphysical conceptions of free will (Libertarianism), whereas it does not disprove others (e.g., Compatibilism). In a nutshell, the reason for these claims is that Libet found preparatory brain activity (Readiness Potentials or RPs) some 500ms before the conscious decision to act was felt by study participants. That seemed to exclude the possibility that mental causation was taking place. At the same time, the onset of movement left a time-window for a 'veto-decision'. This led Libet to conclude that there is no 'free will', but that there is a 'free won't'. On the other hand, there were many criticisms of the study - methodological or substantive. Most notably, Patrick Haggard argued that it is not RPs that are correlates of a decision to act, but Lateralized Readiness Potentials (LRPs). Haggard agreed with many critics of Libet in that RPs could be connected to a range of other phenomena, and that preparatory brain activity that is most important for a decision to act already has to be 'lateralized'. Namely, the decision to move the left or right arm is critical in this regard, and will lead to RP being focused in one or the other hemisphere, thus making LRPs the point of interest for any conscious decision to act. All in all, Haggard claimed to have replicated Libet's major findings, with the caveat that timing of LRPs excludes the time-frame for a 'veto-decision'. This Haggard claimed makes the evidence more in line with the metaphysical doctrine of 'hard determinism', which excludes agency and responsibility. Many other neuroscientists followed Libet's (and Haggard's) lead and these experiment became part of 'lore' in neuroscience education - many other labs performed similar experiments and claimed to basically replicate the findings. Our study was the first to review all available evidence. (more…)
Author Interviews, Diabetes, Duke, Heart Disease / 14.03.2018

MedicalResearch.com Interview with: Stephen J. Greene, MD Division of Cardiology Duke University Medical Center Durham, NC MedicalResearch.com: What is the background for this study? What are the main findings? Response: In 2008, the United States FDA issued an industry guidance specifying that diabetes drugs should routinely be tested in large cardiovascular outcome trials to confirm cardiovascular safety. The guidance specifically mentioned cardiovascular safety in terms of MACE, or major adverse cardiac events, including cardiovascular death, myocardial infarction, and stroke.  Largely because of this, these trials have traditionally had a focus on cardiovascular disease in terms of atherosclerotic events. Heart failure was not mentioned in the FDA document and these trials have had a lesser focus on it. As the years have gone by, we have learned more and more about the connection between diabetes and heart failure. There is tremendous overlap between the two patient populations. Also, as more and more of the large cardiovascular outcome trials have been completed, we have seen multiple examples of various glucose lowering therapies either increasing or decreasing risk of heart failure events. Given all these data on heart failure/ diabetes interactions, the goal of our research was to carefully examine all of the completed large cardiovascular outcome trials of diabetes therapies to systematically describe the type of heart failure-related data they capture. As an initial step in improving heart failure characterization in these trials, we wanted to first describe what trials have already been doing and where the gaps in understanding heart failure in these trials exist. Overall, we found major gaps in the amount and quality of the heart failure data capture in these trials. We looked at 21 large trials, including over 150,000 patients. Rates of patients with baseline heart failure were inconsistently provided, and among those trials that did provide it, heart failure patients tended to be underrepresented compared to the general population. Patients with baseline heart failure were also poorly characterized, with minimal data on functional status, ejection fraction, or heart failure medications. Only 6 trials reported rates of new-onset heart failure and the definitions used were non-specific. Most trials tended to report rates of heart failure hospitalization, but did not include data on fatal or other types of heart failure events. Only 2 trials included heart failure events within the primary study endpoint. More details are included in our full manuscript, which was published in the Journal of the American College of Cardiology to coincide with our presentation at the ACC conference. (more…)
Author Interviews, Primary Care, Prostate Cancer / 14.03.2018

MedicalResearch.com Interview with: Dr. Jason Profetto, MD, CCFP Family and Academic Medicine Chair, Clinical Skills Undergraduate Medical Education McMaster University MedicalResearch.com: What is the background for this study?  Response: The main reason that prompted me to investigate the issue of digital rectal exams in primary care for prostate screening was that it appeared to be rather dogmatic practice (continually practiced by many despite updated data suggesting a lack of benefit).  I was very curious to see if there was any data that suggested the digital rectal exams was indeed a useful indicator in primary practice (ie. Family Medicine) in detecting prostate cancer in asymptomatic men.  Intuitively, I didn’t believe the DRE was accurate mainly because in medical school it’s generally under-represented in clinical skills teaching and poorly taught and assessed (not just in Ontario, but also Canada).  As a result, it seemed bizarre to me that this specific clinical skills was being used as a routine measure in family medicine to screen for prostate cancer.  Also, for me this was a big issue as many men in my practice were used to having yearly “rectal exams” done and I thought it was time to really take a closer look at the research to see whether or not we can support this practice. MedicalResearch.com: What are the main findings? Response: The main findings suggest that the digital rectal exam is not helpful/accurate in detecting prostate cancer in asymptomatic men in family practice or primary care. (more…)
Author Interviews, Diabetes, Microbiome, Nutrition, Science / 13.03.2018

MedicalResearch.com Interview with: Liping Zhao PhD, Professor Department of Biochemistry and Microbiology School of Environmental and Biological Sciences Rutgers University-New Brunswick NJ MedicalResearch.com: What is the background for this study? Response: Microbes in the human gut (collectively known as the gut microbiota) provide many functions that are important for human health. A notable example is that some gut bacteria are able to ferment non-digestible carbohydrates in our diet, e.g. dietary fibers, to produce short-chain fatty acids (SCFAs). These SCFAs nourish our gut epithelial cells, reduce inflammation, and play a role in appetite control. Deficiency of SCFAs has been associated with many diseases including type 2 diabetes. Many gut bacteria have the genes (and therefore the capacity) to produce SCFAs from carbohydrate fermentation. However, we know little about how these bacteria, as individual strains and as a group, actually respond to an increased supply of carbohydrates. This is key to improve clinical efficacy of dietary fiber interventions to improve human health. (more…)