Author Interviews, Leukemia / 03.05.2017

MedicalResearch.com Interview with: Martin J.S. Dyer, D.Phil MA FRCP FRCPath Ernest and Helen Scott Haematological Research Institute University of Leicester, UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study follows on from a world-first clinical trial of a new drug to treat particular blood cancers. Results of that international clinical trial were published in the journal Blood in November 2015 and looked at the efficacy of a new inhibitor, ONO/GS-4059, in the treatment of CLL and Non-Hodgkin Lymphoma patients, refractory or resistant to current chemotherapies. ONO/GS-4059 targets BTK, a protein essential for the survival and proliferation of the tumour cells. The study opened in January 2012 and 90 patients were enrolled in different centres in the UK and in France, with 28 coming from Leicester. Patients with CLL showed the best response and most of them were still on the study after 3 years, and remarkably without notable toxicities. In the new paper, we are reporting the long-term follow-up results. This work, published in the journal Blood, was funded by the Ernest and Helen Scott Haematological Research Institute, ONO Pharmaceuticals, Gilead Pharmaceuticals and the Cancer Research UK Leicester Experimental Cancer Medicine Centre. Local charity Hope Against Cancer fund the Clinical Trials Facility based at the Leicester Royal Infirmary. This current paper describes the long term follow up and shows that in patients with CLL the remissions are durable and associated with no new toxicities. Furthermore, in collaboration with Sistemas Genomicos, a company in Valencia, we have shown that mutations associated with aggressive disease respond well to treatment with ONO/GS-4059. (more…)
Aging, Author Interviews, Cancer Research, CDC, OBGYNE / 03.05.2017

MedicalResearch.com Interview with: Mary C. White, ScD MedicalResearch.com: What is the background for this study? Response: For women between the ages of 21 to 65, Pap testing every three years, or Pap testing with HPV co-testing every five years, can prevent cervical cancers and deaths. Current recommendations state that women 65 and older and not otherwise at special risk can skip Pap tests, but only if they have had three consecutive negative Pap screening tests or two consecutive negative co-tests over the past 10 years, with the most recent done within the past five years. We used data from two federal cancer registry programs to examine how cervical cancer risk changes with age, after excluding women who have had a hysterectomy. We also examined data from a federal national health survey to examine the proportion of women who either had never been tested or had not been tested in the last 5 years. (more…)
Author Interviews, CMAJ, Infections, OBGYNE / 03.05.2017

MedicalResearch.com Interview with: Anick Bérard PhD FISPE Research chair FRQS on Medications and Pregnancy Director, Réseau Québécois de recherche sur le médicament (RQRM) Professor, Research Chair on Medications, Pregnancy and Lactation Faculty of Pharmacy, University of Montreal Director, Research Unit on Medications and Pregnancy Research Center, CHU Ste-Justine MedicalResearch.com: The Danish study you cite reported a connection between antibiotics and miscarriage – why was further research of this topic necessary? Response: Given that a single study will assess an association, repetition of findings are essential in order to assess causality. For example, we were able to conclude that smoking was causing lung cancer after 10 years of observational research on the topic showing concordant associations. In addition, antibiotic prescription patterns vary from country to country, hence the importance of studying the research question in various patient populations. Finally, our cohort has validated exposure status, gestational age (first day of pregnancy) and miscarriage cases - our study was also able to look at types of antibiotics. (more…)
Author Interviews, JAMA, Pharmacology, UCLA / 03.05.2017

MedicalResearch.com Interview with: Ian Larkin, PhD Assistant Professor of Strategy UCLA Anderson School of Management MedicalResearch.com: What is the background for this study? Response: The study examined whether restrictions put in by medical centers on salesperson visits to physicians, known as “detailing,” affected subsequent physician prescribing behavior. Detailing represents the most prominent form of pharmaceutical marketing. Detailing visits allow the sharing of scientific information, but they also often involve small gifts for physicians and their staff, such as meals. Pharmaceutical companies incur far greater expenditures on detailing visits than they do on direct-to-consumer marketing, or even on research and development of new drugs. Specifically, the study examined detailing restrictions put into place by 19 academic medical centers (AMCs) in five states in the U.S. It compared changes in prescribing by thousands of AMC physicians whose practices limited typical elements of detailing visits, such as provisions of meals and educational gifts, to a carefully matched control group of similar physicians practicing in the same geographic regions but not subject to such detailing restrictions. The study, which included more than 25,000 physicians and all 262 drugs in eight major drug classes — from statins to sleep aids to antidepressants, representing more than $60 billion in aggregate sales in the United States — was, to date, by far the most comprehensive to examine the impact of detailing restrictions. The comprehensive and quasi-experimental methodology, which compared prescribing behavior before and after implementation of policies, and which included a large matched control group of physicians not subject to policy changes, was an important innovation relative to prior research. The study used prescription data from CVS Caremark, one of the largest pharmacy benefit managers in the United States. (more…)
Author Interviews, Diabetes, Pediatrics / 03.05.2017

MedicalResearch.com Interview with: Tove Fall, PhD Department of Medical Sciences Molecular Epidemiology and Science for Life Laboratory, Uppsala University Uppsala, Sweden MedicalResearch.com: What is the background for this study? What are the main findings? Response: Type 1 diabetes is a severe chronic disease in children. There are few established risk factors, but it has been hypothesized that factors related to reduction of microbial exposure in childhood may increase the risk. We have previously shown that children in dog-owning families are at lower risk for asthma, and we now wanted to investigate the relationship of dog ownership and diabetes. We did this by studying the whole Swedish child population with record linkage across registers of health and dog ownership. We could not find evidence for an association of dog ownership and type 1 diabetes in the general population. (more…)
Author Interviews, Global Health, Heart Disease / 03.05.2017

MedicalResearch.com Interview with: Hisham Dokainish, M.D., FRCPC, FASE, FACC Associate Professor of Medicine, McMaster University Principal Investigator, Population Health Research Insitute Director of Heart Failure Services, Director of Medical Diagnostic Units & Echocardiography, Hamilton Health Sciences Hamilton, ON, Canada MedicalResearch.com: What is the background for this study? Response: Most data on mortality and prognostic factors in patients with heart failure come from North America and Europe, with little information from other regions of the world, particularly from low and middle income countries. MedicalResearch.com: What are the main findings? Response: We enrolled 5823 patients within 1 year (with 98% follow-up). Overall mortality was 16·5%: highest in Africa (34%) and India (23%), intermediate in southeast Asia (15%), and lowest in China (7%), South America (9%), and the Middle East (9%). These large regional differences in mortality persisted after multivariable adjustment for demographic, clinical, medication and socioeconomic variables. About half of the mortality risk was explained by multivariable modeling with these variables; however, the remainder was unexplained. (more…)
Author Interviews, JAMA, Opiods, Pain Research, Surgical Research / 03.05.2017

MedicalResearch.com Interview with: Chad M. Brummett, M.D. Associate Professor Director, Clinical Anesthesia Research Director, Pain Research Department of Anesthesiology Division of Pain Medicine University of Michigan Medical School Ann Arbor, MI  48109  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The opioid epidemic has received tremendous attention in recent years, but most of the focus has been on chronic pain, opioid abuse and overdose. Far less attention has been paid to the importance of acute care prescribing (e.g. surgical pain) in patients that are not chronic opioid users. We found that 5-6% of patients not using opioids prior to surgery continued to fill prescriptions for opioids long after what would be considered normal surgical recovery. Moreover, the rates of new chronic use did not differ between patients having major and minor surgeries, suggesting that patients continue to use these pain medications for something other than simply pain from surgery. Building on other work by our group, and the few additional studies done on the topic to date, these data suggest that pain medications written for surgery are a major cause of new chronic opioid use for millions of Americans each year. (more…)
Author Interviews, JACC, Stroke, Surgical Research / 03.05.2017

MedicalResearch.com Interview with: Jay S. Giri, MD, MPH Director, Peripheral Intervention Assistant Professor of Clinical Medicine Penn Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: We analyzed data from 6,526 patients in the 5 most recent randomized trials comparing carotid artery stenting to carotid endarterectomy.  These procedures are performed to prevent long-term stroke in patients with severe narrowings of their carotid arteries.  We learned that the procedures are equally effective in preventing stroke over the long-term.  However, the procedures have quite different safety profiles, defined as adverse events that the patients experienced within 30 days of their procedure. Carotid artery stenting was associated with a higher risk of stroke in the initial 30 days after the procedure.  Carotid endarterectomy was associated with greater risks of myocardial infarction (heart attack) and cranial nerve palsy, a variable condition that most often results in difficulty with swallowing or speaking, over this timeframe. (more…)
Author Interviews, Kidney Disease, Social Issues / 03.05.2017

MedicalResearch.com Interview with: Wendy Tan Senior Medical Social Worker Medical Social Work The National Kidney Foundation MedicalResearch.com: What is the background for this study? Response: End Stage Renal Disease (ESRD) patients experience significant changes to their daily routine and lifestyle. Their time and attention were often centred solely on their sickness whilst receiving treatment accentuating the employment isolation. This study determined the need for extra support to assist patients adjust (e.g. learning about their psychological wellbeing, change of role and mindset, suitable work conditions and employment support) in returning to work. It also sheds light on how individuals perceive the particular situations they are facing, how they are making sense of their health conditions and the society at large in relations to seeking continued employment. (more…)
Author Interviews, Environmental Risks, OBGYNE, Pediatrics / 03.05.2017

MedicalResearch.com Interview with: Laura Birks, MPH, Predoctoral Fellow ISGlobal Instituto de Salud Global de Barcelona - Campus MAR Barcelona Biomedical Research Park (PRBB) (office 183.01B) Barcelona, Spain MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previous studies in Denmark and the Netherlands have reported associations between prenatal cell phone use and child behavioral problems, but findings have been inconsistent and based on retrospective assessment of cell phone use. This study aimed to assess this association in a multi-national analysis, using data from three cohorts with prospective data on prenatal cell phone use, together with previously published data from two cohorts with retrospectively collected cell phone use data. We found that cell phone use during pregnancy was associated with increased risk for behavioral problems in offspring, specifically hyperactivity/inattention problems. This association was fairly consistent across cohorts and between cohorts with retrospectively and prospectively collected cell phone use data. While our models were adjusted for many confounders, it is possible that other factors could explain this association, such as hyperactivity in the mother or parenting styles (variables that were not collected in these cohorts). Furthermore, to date there is no known biological mechanism that could explain the association. (more…)
Alzheimer's - Dementia, Author Interviews / 02.05.2017

MedicalResearch.com Interview with: Dr. Petr Kocis PhD Vice President Preclinical Development Alzheon, Inc. University of Oxford MedicalResearch.com: What is the background for this study? What are the main findings? Response: Researchers widely accept that amyloid plaques are the hallmark of Alzheimer’s disease. However, for many years, drug development has focused on the solid amyloid plaque as a primary disease culprit. Recent advances show that it is more likely that early stage soluble beta amyloid oligomers play a key role in the pathogenic process of Alzheimer’s disease. A paper recently published by Alzheon, a company developing medicines for Alzheimer’s disease and other neurological disorders, suggests a new therapeutic mechanism for targeting toxic amyloid beta oligomers with a small molecule, tramiprosate, the active agent in the drug candidate, ALZ-801. ALZ-801 is a Phase 3-ready drug candidate that is an optimized prodrug of tramiprosate, with a substantially improved pharmacokinetic and safety profile compared to tramiprosate. Alzheon scientists discovered that tramiprosate acts to inhibit the production of neurotoxic beta amyloid oligomers by ‘enveloping’ the amyloid peptide to prevent its misfolding into soluble amyloid aggregates. Beta amyloid oligomers are believed to be key drivers of the pathogenic process in Alzheimer’s disease (AD). This novel enveloping mechanism of tramiprosate prevents the self-assembly of misfolded proteins into beta amyloid oligomers that lead to amyloid aggregation and, subsequently, cause neuronal toxicity and clinical progression in Alzheimer’s disease. These results were published in the medical journal, CNS Drugs, and the paper is available through Open Access here. [“Elucidating the Aß42 Anti-Aggregation Mechanism of Action of Tramiprosate in Alzheimer’s Disease: Integrating Molecular Analytical Methods, Pharmacokinetic and Clinical Data”] (more…)
Aging, AHA Journals, Author Interviews, Blood Pressure - Hypertension / 02.05.2017

MedicalResearch.com Interview with: Dr. Rathi Ravindrarajah PhD Division of Health and Social Care Research Faculty of Life Sciences & Medicine Guy’s Campus King’s College London MedicalResearch.com: What is the background for this study? What are the main findings? Response: Clinical trials show that it is beneficial to lower systolic blood pressure (SBP) in adults aged 80 and over, but non-randomized epidemiological studies suggest that lower systolic blood pressure may be associated with a higher risk of mortality. Our main findings were that there was a terminal decline in systolic blood pressure in the final 2 years of life suggesting that the higher mortality in those with a low SBP shown in non-randomized epidemiological studies might be due to reverse causation. (more…)
Author Interviews, Heart Disease, JAMA, Surgical Research / 02.05.2017

MedicalResearch.com Interview with: Dr. PJ Devereaux MD, PhD, FRCP(C) Director of the Division of Cardiolog Scientific Leader of the Anesthesiology, Perioperative Medicine and Surgical Research Group at the Population Health Research Institute Professor and University Scholar in the Departments of Health Research Methods, Evidence, and Impact and Medicine McMaster University MedicalResearch.com: What is the background for this study? Response: Although the majority of patients undergoing noncardiac surgery benefit from surgery and do well, even when a small proportion of these patients have a serious complication it represents a major population issue. A recent publication in JAMA Cardiology established that >5 million Americans age ≥45 years undergo major in-patient noncardiac surgery annually, and 1.3% of these patients die in the hospital. This means 65,000 of these patients die, and cardiovascular causes are a dominant cause. (more…)
Author Interviews, JAMA, Pain Research, Pharmacology, UT Southwestern / 01.05.2017

MedicalResearch.com Interview with: Una Makris MD, MSc Clinical Investigator at the VA North Texas Health System VA North Texas Health Care System Assistant Professor at UT Southwestern Medical Center Departments on Internal Medicine and Clinical Sciences Dr. Makris is a Rheumatologist, clinically, and spends the majority of time focused on clinical research investigating how to improve outcomes for adults with back pain. MedicalResearch.com: What is the background for this study? Response: Back pain is the most common type of musculoskeletal (MSK) pain. We know that expenditures for back pain exceed $100 billion each year (and this was in 2005). Back pain results in tremendous disability (including reduced mobility) and impaired quality of life (not exclusive to physical consequences, but also including important psychosocial repercussions). We also know that statins are prescribed very often, and frequently in younger populations who are active. Some reports suggest that statins may have a protective effect on  musculoskeletal conditions such as back pain. (more…)
Author Interviews, Blood Pressure - Hypertension, JAMA, OBGYNE / 01.05.2017

MedicalResearch.com Interview with: Dr. Maureen Phipps, USPTS Task Force member Department chair and Chace-Joukowsky professor of obstetrics and gynecology Assistant dean for teaching and research on women's health Warren Alpert Medical School of Brown University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Preeclampsia, which includes high blood pressure after 20 weeks of pregnancy, is one of the most serious health problems affecting pregnant women. After reviewing the evidence, the Task Force found the benefits of screening for preeclampsia outweighed the harms and recommended screening pregnant women for preeclampsia with blood pressure measurements throughout pregnancy. The evidence showed mothers and their babies are likely to benefit from screening, as screening leads to treatment that reduces their risk of severe complications, including death. (more…)
Author Interviews, Menopause, OBGYNE / 01.05.2017

MedicalResearch.com Interview with: Dr. James A. Simon, MD CCD, NCMP, FACOG Clinical professor of obstetrics and gynecology George Washington University, and Medical director, Women's Health & Research Consultants® Washington, D.C MedicalResearch.com: What is the background for this study? Response: The Phase 2b uterine fibroids study was a 24-week, multicenter, double-blind, randomized, placebo-controlled, parallel group clinical trial that evaluated the efficacy and safety of elagolix alone or in combination with add-back therapy (estradiol/norethindrone acetate) in women with heavy uterine bleeding associated with uterine fibroids. Elagolix is currently being investigated in diseases that are mediated by sex hormones, such as uterine fibroids and endometriosis. The study was conducted in 567 premenopausal women, age 18 to 51, at 100 sites in the United States, Canada, Puerto Rico, Chile and the United Kingdom. The two cohort design study evaluated the safety and efficacy of two elagolix treatment regimens (300mg BID and 600mg QD) alone and in combination with two different strengths of add-back therapy (estradiol/norethindrone acetate). The data presented were results from the 300mg cohort. Results from the 600mg cohort were similar and will be reported in a future publication. Current non-surgical treatments indicated for uterine fibroids are limited, and women suffering from heavy menstrual bleeding associated with uterine fibroids need more options. (more…)
ADHD, Author Interviews, Education, Gender Differences, JAMA, Pediatrics / 01.05.2017

MedicalResearch.com Interview with: Professor Jill Pell MD Director of Institute (Institute of Health and Wellbeing) Associate (School of Medicine, Dentistry and Nursing) University of Glasgow MedicalResearch.com: What is the background for this study? Response: The novelty of our study lies in its scale and scope. In terms of scope, it reported on six educational outcomes and three health outcomes in the same group of children. In terms of scale, it is the first study of a whole country to compare educational outcomes of children with treated ADHD with their unaffected peers and is more than 20 times larger than previous studies on similar educational outcomes. The only previous countrywide study on health outcomes, included only children with very severe ADHD who were in psychiatric hospitals. (more…)
AACR, Author Interviews, Biomarkers, Brigham & Women's - Harvard, Cancer Research, Immunotherapy, Neurology, Radiology / 01.05.2017

MedicalResearch.com Interview with: Ben Larimer, PhD research fellow in lab of Umar Mahmood, MD, PhD Massachusetts General Hospital Professor, Radiology, Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Although immunotherapies such as checkpoint inhibitors have revolutionized cancer treatment, unfortunately they only work in a minority of patients. This means that most people who are put on a checkpoint inhibitor will not benefit but still have the increased risk of side effects. They also lose time they could have spent on other therapies. The ability to differentiate early in the course of treatment patients who are likely to benefit from immunotherapy from those who will not greatly improves individual patient care and helps accelerate the development of new therapies. The main purpose of our study was to find a way to separate immunotherapy responders from non-responders at the earliest time point possible, and develop an imaging probe that would allow us to distinguish this non-invasively. Granzyme B is a protein that immune cells use to actually kill their target. They keep it locked up in special compartments until they get the right signal to kill, after which they release it along with another protein called perforin that allows it to go inside of tumor cells and kill them. We designed a probe that only binds to granzyme B after it is released from immune cells, so that we could directly measure immune cell killing. We then attached it to a radioactive atom that quickly decays, so we could use PET scanning to noninvasively image the entire body to see where immune cells were actively releasing tumor-killing granzyme B. We took genetically identical mice and gave them identical cancer and then treated every mouse with checkpoint inhibitors, which we knew would result in roughly half of the mice responding, but we wouldn’t know which ones until their tumors began to shrink. A little over a week after giving therapy to the mice, and before any of the tumors started to shrink, we injected our imaging probe and performed PET scans. When we looked at the mice by PET imaging, they fell into two groups. One group had high PET uptake, meaning high levels of granzyme B in the tumors, the other group had low levels of PET signal in the tumors. When we then followed out the two groups, all of the mice with high granzyme B PET uptake ended up responding to the therapy and their tumors subsequently disappeared, whereas those with low uptake had their tumors continue to grow. We were very excited about this and so we expanded our collaboration with co-authors Keith Flaherty and Genevieve Boland to get patient samples from patients who were on checkpoint inhibitor therapy to see if the same pattern held true in humans. When we looked at the human melanoma tumor samples we saw the same pattern, high secreted granzyme levels in responders and much lower levels in non-responders. (more…)
Author Interviews, JAMA, Macular Degeneration, Ophthalmology, Primary Care / 01.05.2017

MedicalResearch.com Interview with: David C Neely, MD The University of Alabama at Birmingham MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study examined the prevalence of eyes with age-related macular degeneration (AMD) in patients seen in primary eye care clinics who purportedly have normal macular health. Approximately 25.0% of eyes deemed to be normal based on dilated eye examination by primary eye care providers had macular characteristics that indicated age-related macular degeneration. (more…)
Author Interviews, CDC, OBGYNE, Pediatrics / 01.05.2017

MedicalResearch.com Interview with: Deborah L. Dee, PhD Division of Reproductive Health National Center for Chronic Disease Prevention and Health Promotion CDC MedicalResearch.com: What is the background for this study? Response: Although the national teen birth rate has dropped to a historic low (22.3 births per 1,000 females aged 15-19 years in 2015), many teens continue to have repeat births. Because repeat teen births are more likely than first teen births to be preterm and low birth weight, and giving birth more than once as a teenager can significantly limit a mother’s ability to attend school and obtain work experience, it’s important to assess patterns in repeat teen births and better understand contraceptive use within this population. (more…)
Author Interviews, Cleveland Clinic, Heart Disease, Kidney Disease / 01.05.2017

MedicalResearch.com Interview with: Mohamed Khayata, MD Internal Medicine Resident PGY-3 Cleveland Clinic Akron General Akron, Ohio MedicalResearch.com: What is the background for this study? What are the main findings? Response: Previous studies showed that patients with ST-elevation myocardial infarction (STEMI) who had elevated creatinine and/or impaired creatinine clearance on presentation had higher short- and long-term mortality independent of other cardiovascular risk factors. We used the National Cardiovascular Database Registry to investigate the impact of creatinine levels at the time of presentation on the cardiovascular outcomes in patients who presented with STEMI. Our study showed that elevated creatinine levels correlated with higher incidence of atrial fibrillation, bleeding, heart failure, and cardiogenic shock during hospital stay after the percutaneous intervention. (more…)
Author Interviews, Education, Technology / 01.05.2017

MedicalResearch.com Interview with: Frederick W. Kron, MD President and Founder of Medical Cyberworlds, Inc Department of Family Medicine,Ann Arbor, MI and Michael D. Fetters, M.D., M.P.H., M.A. Professor of Family Medicine University of Michigan MedicalResearch.com: What is the background for this technology and study? Dr. Kron: Communication is the most important component of the doctor-patient relationship. I know that through research, but also through personal experience. As a cancer survivor, I’ve seen first-hand the difference that outstanding communication skill can make to a vulnerable patient. At the beginning of the project, we asked medical educators about the challenges they had in assessing and training communication competency. They told us that technical skills are easy to teach and assess, but communication skills are mainly behavioral skills that involve verbal and nonverbal behaviors, facial expressions, and many other cues that pass between patient and provider. That’s hard to teach and assess. Activities like role play with standardized patients (SPs) have been widely used, but it’s impossible for SPs to accurately portray these behaviors, or for faculty to fully assess the nuanced behaviors of both learner and patient. Supporting this idea is a lack of evidence proving that SP encounters translate in behavioral changes or transfer into clinical settings. Developments in virtual reality provided us with a great opportunity for assessing and teaching of communication behaviors. Working with a national group of experts, we created computer-based Virtual Humans that interact with learners using the full range of behaviors you’d expect from two people talking together. They are so behaviorally realistic and compelling, that they trigger emotional responses in learners, and make learners want to learn so they can do their best. Dr. Fetters: Our team has particular interest in doctor-patient communication in the context of cancer. There are many critical aspects of cancer communication: breaking the bad news to the patient, negotiating sometimes conflicting family opinions about treatment, and communication among team members about the patient's care, just to name a few. We’ve begun building out those scenarios in the technological platform we developed, Mpathic-VR. (more…)
Accidents & Violence, Author Interviews, JAMA, Mental Health Research, Surgical Research / 30.04.2017

MedicalResearch.com Interview with: Elinore J. Kaufman, MD, MSHP Department of Surgery, New York Presbyterian Hospital Weill Cornell Medicine New York, New York MedicalResearch.com: What is the background for this study? What are the main findings? Response: Deaths of civilians in contact with police have recently gained national public and policy attention. However, we know very little about nonfatal injuries, which far outnumber deaths. MedicalResearch.com: What should readers take away from your report? Response: Nonfatal injuries are much more pervasive than law enforcement-associated deaths, and rates have remained stable over several years, at approximately 51,000 emergency department visits and hospitalizations each year. These injuries primarily affect young men, and mental illness is a common theme. As a physician, my goal is always to get to zero preventable injuries. (more…)
Author Interviews, Blood Pressure - Hypertension, Sleep Disorders, Stroke / 30.04.2017

MedicalResearch.com Interview with: Shyam Prabhakaran, MD, MS Department of Neurology Feinberg School of Medicine Northwestern University Chicago, IL MedicalResearch.com: What is the background for this study? What are the main findings? Response: Wake-up stroke, or stroke onset during sleep, accounts for one-quarter of stroke presentations. Yet, there are few studies exploring mechanisms or triggers of onset during sleep. We explored whether blood pressure variability which is known to have circadian patterns could trigger wake-up stroke. We found that in the first 24 hours after stroke, those with wake-up stroke had greater blood pressure variability than non-wake up stroke patients. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Kidney Disease / 29.04.2017

MedicalResearch.com Interview with: Sean Bagshaw MD MSc Director for Research for the Division of Critical Care Medicine School of Public Health University of Alberta, Canada MedicalResearch.com: What is the background for this study? What are the main findings? Response: The rationale for SPARK stemmed from two general observations. First, experimental and pre-clinical data have suggested the timely utilization of loop diuretics in early AKI could provide “kidney protection” largely mediated through reduction in medullary oxygen demand. Yet, this is in apparent paradox with clinical data (largely derived from older observational studies at some risk of bias) suggesting use of loop diuretics in AKI may be associated with increased risk for death and/or non-recovery of kidney function. Second, in AKI, loop diuretics are used exceedingly often. Surveys of healthcare practitioners and observational data suggest more than two-thirds to three-quarters of patients are exposed to diuretics at some point during their course. This represents a significant misalignment between evidence and clinical practice. This would suggest there is need to generate new evidence and knowledge that would ideally help inform best practice in the management of AKI. SPARK was designed as a pilot trial largely aimed at evaluating the feasibility of the approach to use of loop diuretics in early AKI. While SPARK did not find significant differences in risk of worsening AKI, utilization of RRT or mortality, we recognize the trial was underpowered to meaningfully inform about these and other patient-centered outcomes. We did see differences in secondary endpoints (i.e., fluid balance); however, use of loop diuretics in this setting was also associated with greater incidence of electrolyte abnormalities. (more…)
Author Interviews, Gastrointestinal Disease, Karolinski Institute, Parkinson's / 29.04.2017

MedicalResearch.com Interview with: Karin Wirdefeldt, MD, PhD Associate professor Karolinska Institutet Stockholm, Sweden MedicalResearch.com: What is the background for this study? What are the main findings? Response: It has been hypothesized that Parkinson's disease may start in the gut and spread to the brain via the vagal nerve. We found that people who had a truncal vagotomy (ie, the nerve trunk fully resected) at least 5 years earlier were less likely to develop Parkinson's disease compared to people without vagotomy or people who had a selective vagotomy (ie, only branches of the nerve resected). (more…)
Author Interviews, Microbiome, Nutrition, Weight Research / 28.04.2017

MedicalResearch.com Interview with: Krzysztof Czaja VBDI, D.V.M Associate professor of veterinary biosciences and diagnostic imaging College of Veterinary Medicine University of Georgia MedicalResearch.com: What is the background for this study? Response: The neural regulation of food intake and satiety in rodents and human are similar. Therefore, rodent model is well established in studying neural regulation in obesity in humans. MedicalResearch.com: What are the main findings? Response: We determined that diets rich in sugar, and many “diet products” contain high amount of sugar (sometimes under different names), increase efficiency of accumulation of body and liver fat. We also found that sugar-rich diets change the gut microflora toward overpopulation of enterotoxic bacteria, damaging neural gut-brain communication and disrupting neural regulation of food intake. The implications of our results on human health are very significant because they show that diets rich in sugar changes the brain circuits responsible for food intake and satiety, induces chronic inflammation and symptoms of non-alcoholic liver disease (NALD). (more…)
Author Interviews, Dermatology, JAMA, Melanoma, Technology / 27.04.2017

MedicalResearch.com Interview with: Laura Korb Ferris, MD, PhD Associate Professor, University of Pittsburgh Clinical and Translational Science Institute Director of Clinical Trials Department of Dermatology University of Pittsburgh Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: We found that a non-invasive adhesive patch applied to the skin over a pigmented skin lesion allowed us to capture enough genetic material from the lesion to analyze and predict if that lesion is likely to be melanoma, meaning a biopsy is warranted, or if it is likely benign, meaning the patient would not need a skin biopsy. In this study, we asked dermatologists to use their clinical judgement to decide if they would recommend biopsying a skin lesion based on photos and information about the lesion and the patients, such as the patient's age, personal and family history of skin cancer, and if the lesion was new or changing. We then provided them the read out of the gene test and asked them how this influence their decision. We found that with this test result, dermatologists were more accurate in their decision making, meaning they were more likely to recommend biopsy of melanomas and less likely to biopsy harmless moles than they were without the test. This is important as it means this test has the potential to reduce the number of unnecessary skin biopsies performed, saving patients from undergoing a procedure and having a scar as a result, without increasing the risk of missing a melanoma. (more…)
Addiction, Author Interviews, Cannabis, JAMA / 27.04.2017

MedicalResearch.com Interview with: Deborah S. Hasin, Ph.D. Professor of Epidemiology Columbia University New York, New York 10032 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Among adults, the prevalence of cannabis use and cannabis use disorders has increased in recent years. Concerns have been raised that for various reasons, medical marijuana laws would promote use of cannabis and consequently, cannabis-related consequences. Many studies show that this didn't happen among adolescents, but very little was known about the relationship between medical marijuana laws and adults. Using data from three surveys spanning the years 1991-2013, the study findings suggested that medical marijuana laws did play a role in increasing rates of cannabis use and cannabis use disorders. (more…)
Author Interviews, Boehringer Ingelheim, Immunotherapy, Pulmonary Disease / 27.04.2017

MedicalResearch.com Interview with: Thomas Leonard, Ph.D. Executive director, Clinical Development and Medical Affairs, Specialty Care Boehringer Ingelheim Pharmaceuticals, Inc. MedicalResearch.com: What is the background for this study? Would you tell us a little more about IPF? Response: Boehringer Ingelheim’s Phase III PF-ILD (progressive fibrosing interstitial lung disease) trial will investigate the safety and efficacy of nintedanib, in a range of progressive fibrosing lung conditions other than idiopathic pulmonary fibrosis, or IPF. The PF-ILD trial is the first time that patients with different fibrosing lung diseases will be included in one single clinical trial assessing the efficacy of nintedanib as a potential treatment, and the trial is the first in the field of fibrosing lung diseases to group patients based on the clinical characteristics of their disease, rather than the diagnosis. There are more than 200 conditions that affect the tissue and space around the air sacs of the lungs, or interstitium, and, collectively, these conditions are called interstitial lung diseases -- or ILDs. Based on clinical observations, there is a group of patients with ILD who, independent from the classification of the ILD, exhibit progressive fibrosis. The proposed terminology for describing this group of patients is PF-ILD. In these patients, the disease appears to follow a course similar to IPF with worsening of respiratory symptoms, lung function, quality of life and ability to perform daily activities, as well as early mortality despite treatment. There is currently no efficacious treatment available for PF-ILD. This trial is exploring how fibrosis in the lungs is treated and whether nintedanib is a potential treatment, based on the efficacy and safety of nintedanib in IPF, a rare and serious lung disease that causes permanent scarring of the lungs, making it difficult to breathe. IPF affects as many as 132,000 Americans, typically men over the age of 65. On average, people with IPF live only three to five years after diagnosis, and approximately 40,000 people die from this disease every year. (more…)