Alzheimer's - Dementia, Author Interviews, BMJ, Hormone Therapy / 07.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47814" align="alignleft" width="142"]Tomi Mikkola MDAssociate ProfessorHelsinki University HospitalDepartment of Obstetrics and GynecologyHelsinki, Finland Dr. Mikkola[/caption] Tomi Mikkola MD Associate Professor Helsinki University Hospital Department of Obstetrics and Gynecology Helsinki, Finland MedicalResearch.com: What is the background for this study? What are the main findings? Response: In Finland we have perhaps the most comprehensive and reliable medical registers in the world. Thus, with my research group I have conducted various large studies evaluating association of postmenopausal hormone therapy use and various major diseases (see e.g. the references in the B;MJ paper). There has been various smaller studies indicating that hormone therapy might be protective for all kinds of dementias, also Alzheimer’s disease. However, we have quite recently shown that hormone therapy seems to lower the mortality risk of vascular dementia but not Alzheimer’s disease (Mikkola TS et al. J Clin Endocrinol Metab 2017;102:870-7). Now in this upcoming BMJ-paper we report in a very large case-control study (83 688 women with Alzheimer’s disease and same number of control women without the disease) that systemic hormone therapy was associated with a 9-17% increased risk of Alzheimer’s disease. Furthermore, this risk increase is particularly in women using hormone therapy long, for more than 10 years. This was somewhat surprising finding, but it underlines the fact that mechanisms behind Alzheimer’s disease are likely quite different than in vascular dementia, where the risk factors are similar as in cardiovascular disease. We have also shown how hormone therapy protects against cardiovascular disease, particularly in women who initiate hormone therapy soon after menopause.
Author Interviews, Education, Health Care Systems, Outcomes & Safety, University of Pennsylvania / 07.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47812" align="alignleft" width="179"]Jeffrey H. Silber, MD, PhDDirector, Center for Outcomes ResearchNancy Abramson Wolfson Endowed Chair in Health Services ResearchChildren's Hospital of PhiladelphiaProfessor of Pediatrics, Anesthesiology and Critical CarePerelman School of Medicine, University of PennsylvaniaProfessor of Health Care ManagementWharton School, University of Pennsylvania Dr. Silber[/caption] Jeffrey H. Silber, MD, PhD Director, Center for Outcomes Research Nancy Abramson Wolfson Endowed Chair Health Services Research Children's Hospital of Philadelphia Professor of Pediatrics, Anesthesiology and Critical Care Perelman School of Medicine, University of Pennsylvania Professor of Health Care Management Wharton School, University of Pennsylvania  MedicalResearch.com: What is the background for this study? Response: This was a year-long randomized trial that involved 63 internal medicine residency programs from around the US.  In 2015-2016, about half of the programs were randomized to follow the existing rules about resident duty hours that included restrictions on the lengths of shifts and the rest time required between shifts (the standard arm of the trial) and the other half of the programs didn’t have those shift length or rest period rules (the flexible arm of the trial).  We measured what happened to the patients cared for in those programs (the safety study), and other studies examined how much sleep the residents received, and how alert they were at the end of shifts (the sleep study), and previously we published on the educational outcomes of the interns. To measure the impact on patient outcomes when allowing program directors the ability to use a flexible shift length for their interns, we compared patient outcomes after the flexible regimen went into place to outcomes the year before in the same program. We did the same comparison for the standard arm. Then we compared the difference between these comparisons. Comparing before and after the implementation of the trial within the same program allowed us to be more confident that a particularly strong or weak program, or a program with especially sick or healthy patients, would not throw off the results of the study. The trial was designed to determine, with 95% confidence, if the flexible arm did not do more than 1% worse than the standard arm. If this were true for the flexible arm, we could say the flexible regimen was “non-inferior” to the standard regimen.
Author Interviews, FDA, JAMA / 06.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47817" align="alignleft" width="200"]Craig Alexander Garmendia, PhDOffice of Bioresearch Monitoring Operations, Office of Regulatory AffairUS Food and Drug AdministrationMiami, Florida Dr. Garmendia[/caption] Craig Alexander Garmendia, PhD Office of Bioresearch Monitoring Operations Office of Regulatory Affairs US Food and Drug Administration Miami, Florida MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Clinical trials under the U.S. Food and Drug Administration’s (FDA) purview have been shown to suffer from falsified data. While the FDA warns researchers when falsified data are discovered, these data still make their way into medical literature. In this novel study, Dr. Garmendia and colleagues conducted a systematic review to examine the effects of publications containing falsified data on meta-analyses using sensitivity analyses. Almost half of all meta-analyses had conclusions altered by publications containing falsified data, while nearly one-third of all analyses had considerable changes in outcomes.
Author Interviews, Depression, OBGYNE, Weight Research / 05.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47752" align="alignleft" width="150"]Jun Ma, MD, PhD, FAHA, FABMRProfessor and Associate Head of Research, Department of MedicineDirector, Center for Health Behavior ResearchThe University of Illinois at Chicago Dr. Jun Ma[/caption] Jun Ma, MD, PhD, FAHA, FABMR Professor and Associate Head of Research Department of Medicine Director, Center for Health Behavior Research The University of Illinois at Chicago MedicalResearch.com: What is the background for this study? What are the main findings? Response: Obesity and depression are major public health problems. Obesity affects 40% of United States (US) adults. About 20% in US women and 13% in men experience major depressive disorder at some point in their lifetime and, additionally, many adults have elevated depressive symptoms that do not meet clinical diagnostic criteria but can nevertheless negatively affect their health and quality of life. Obesity and depression share common risk factors, such as poor diet and lack of exercise, and cause other health problems, such as diabetes and cardiovascular disease. People with obesity are at increased risk of being depressed and, likewise, people with depression are at increased risk of being obese. Consequently, obesity and depression often co-occur. To date, there has been no integrated therapy to effectively treat patients affected by both conditions at the same time. The RAINBOW randomized clinical trial addressed this gap. The main finding from the trial is that, among adult patients with obesity and depression, a collaborative care intervention integrating behavioral weight loss treatment, problem-solving therapy, and as-needed antidepressant medications significantly improve weight loss and depressive symptoms over one year compared with usual care, which patients received through their primary care physicians. 
Author Interviews, Dermatology, Pharmaceutical Companies / 05.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47805" align="alignleft" width="155"]Dr. James Q. Del Rosso, D.O., FAOCD, DermatologistResearch Director and Principal InvestigatorDel Rosso Dermatology Research Center, Las Vegas, NVGalderma Consultant Dr. Del Rosso[/caption] Dr. James Q. Del Rosso, D.O., FAOCD, Dermatologist Research Director and Principal Investigator Del Rosso Dermatology Research Center, Las Vegas, NV Galderma Consultant MedicalResearch.com: What is the background for this study? What are the main findings?
  • The ANSWER study, a 12-week, randomized, multicenter, Phase 4, Phase 3b in Canada and Europe clinical trial, is the first study of its kind to compare the efficacy and safety of combination therapy with Oracea® (doxycycline, USP) 40 mg Capsules + Soolantra® (ivermectin) Cream, 1% versus Soolantra® (ivermectin) Cream, 1% monotherapy in 273 adults with severe papulopustular rosacea (IGA 4) at clinical trial sites in the United States, Canada and Europe (Czech Republic, Poland, Hungary and Germany).
  • Results showed the combination therapy with Oracea Capsules + Soolantra Cream was well tolerated and effective with a faster onset of action than Soolantra Cream given as monotherapy. Key highlights of the study include:
  • The mean reduction in percentage of inflammatory lesions from baseline to Week 12 was significant with combination therapy compared to monotherapy (80.29% vs. 73.56%, respectively; p=0.032).
  • 5 times as many patients taking combination therapy achieved 100% clearance of inflammatory lesions by Week 12 compared with monotherapy (17.8% vs. 7.2%, respectively; p=0.006).
  • Over 2 times as many patients taking combination therapy achieved 100% clear (IGA 0) by Week 12 compared with monotherapy (11.9% vs. 5.1%, respectively; p=0.043).
  • Combination therapy was generally well tolerated and no discontinuation of treatments due to side effects.
Author Interviews, Diabetes, Exercise - Fitness, JAMA, Lifestyle & Health, Weight Research / 05.03.2019

MedicalResearch.com Interview with: Giuseppe Pugliese, MD, PhD for the Italian Diabetes and Exercise Study 2 (IDES_2) Investigators Department of Clinical and Molecular Medicine ‘‘La Sapienza’’ University Diabetes Unit, Sant’Andrea University Hospital Rome, Italy MedicalResearch.com: What is the background for this study? Response: There is a growing epidemic of obesity and type 2 diabetes worldwide, which are causally related to the increasing prevalence of “physical inactivity”, i.e., an insufficient amount of moderate-to-vigorous physical activity according to current guidelines, and “sedentariness”, i.e., too many hours, especially if uninterrupted, spent in a sitting or reclined position.  These two unhealthy behaviors exert their detrimental effects independently of each other and are very common among people suffering from type 2 diabetes, who would therefore benefit from increasing physical activity and reducing sedentary time, as recommended by current guidelines. However, such a behavior change is generally difficult for a number of internal and external barriers and requires behavioral interventions targeting both physical activity and sedentary habits.  Unfortunately, there is no definitive evidence that this is indeed feasible and, particularly, that, if adopted, change in behavior can be maintained in the long term. 
Author Interviews, Lung Cancer, Nature, Technology / 05.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47795" align="alignleft" width="200"]Saeed Hassanpour, PhDAssistant ProfessorDepartments of Biomedical Data Science,Computer Science, and EpidemiologyGeisel School of Medicine at DartmouthLebanon, NH 03756 Dr. Hassanpour[/caption] Saeed Hassanpour, PhD Assistant Professor Departments of Biomedical Data Science, Computer Science, and Epidemiology Geisel School of Medicine at Dartmouth Lebanon, NH 03756 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Lung cancer is the deadliest cancer for both men and women in the western world. The most common form, lung adenocarcinoma, requires pathologist’s visual examination of resection slides to determine grade and treatment. However, this is a hard and tedious task. Using new technologies in artificial intelligence and deep learning, we trained a deep neural network to classify lung adenocarcinoma subtypes on histopathology slides and found that it performed on par with three practicing pathologists.
Annals Internal Medicine, Author Interviews, Cancer Research, Prostate Cancer / 05.03.2019

MedicalResearch.com Interview with: Charlotte Skriver, PhD student, MSc Danish Cancer Society Research Center Statistics & Pharmacoepidemiology Danish Cancer Society Copenhagen  MedicalResearch.com: What is the background for this study?   Response: The drug aspirin is widely used due to its established protection against cardiovascular diseases. Increasing evidence also supports an effect of aspirin use on reducing the risk of and mortality from colorectal cancer and possibly other cancer types. Recent studies have suggested that aspirin use after a diagnosis of prostate cancer may improve the prognosis. We examined whether use of low-dose aspirin was associated with survival after prostate cancer in a nationwide study of prostate cancer patients in Denmark.
Author Interviews, Clots - Coagulation, Heart Disease, JAMA / 05.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47707" align="alignleft" width="144"]Geoffrey Barnes, MD, MScAssistant ProfessorVascular and Cardiovascular MedicineUniversity of Michigan Dr. Barnes[/caption] Geoffrey Barnes, MD, MSc Assistant Professor Vascular and Cardiovascular Medicine University of Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: Both aspirin and warfarin are commonly used medications meant to prevent thrombotic complications, but might increase rates of bleeding complications. We used a multi-center anticoagulation collaborative to explore how often patients being treated with warfarin were also taking aspirin but without a clear indication. We found that more than one-third (37.5%) of warfarin-treated patients without a clear reason for aspirin therapy were receiving aspirin. And these patients on both warfarin and aspirin experienced higher rates of bleeding and emergency department visits for bleeding than the patients taking warfarin alone. There were no differences in the rate of thrombotic events between the patients taking warfarin alone or those taking warfarin plus aspirin. 
Author Interviews, Dermatology, Surgical Research / 05.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47406" align="alignleft" width="130"]Hooman Khorasani, M.D. Cosmetic Surgeon & Mohs Skin Cancer Surgeon Icahn School of Medicine at Mt. Sinai Dr. Khorasani[/caption] Hooman Khorasani, M.D. Cosmetic Surgeon & Mohs Skin Cancer Surgeon Icahn School of Medicine at Mt. Sinai MedicalResearch.com: What is the background for this study? Response: Lipomas are tumors composed of mature fat cells located just beneath the skin surface. They are the most common soft tissue tumor and are estimated to occur in 1% of the population. These benign tumors are more common in overweight individuals, diabetics, patients with elevated serum cholesterol, and those suffering from familial multiple lipomatosis. Most of these tumors are treated for cosmetic reasons; however, large lipomas can also cause significant functional impairment. Traditional treatment includes surgical removal and / or liposuction. Deoxycholic acid is a member of the bile acid family that assists in the breakdown of fat. We investigated the use of deoxycholic acid injections to reduce the size of large lipomas prior to surgical removal.
AACR, Author Interviews, Biomarkers, MD Anderson / 05.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47785" align="alignleft" width="200"]Vassiliki Papadimitrakopoulou, MDProfessor of MedicineDepartment of Thoracic/Head and Neck Medical OncologyMD Anderson Cancer Center in Houston Dr. Papadimitrakopoulou[/caption] Vassiliki Papadimitrakopoulou, MD Professor of Medicine Department of Thoracic/Head and Neck Medical Oncology MD Anderson Cancer Center in Houston MedicalResearch.com: What is the background for this study? What are the main findings? Response: 30% of patients with newly diagnosed advanced NSCLC can be treated successfully with targeted therapies, often yielding higher response rates than chemotherapy or immune checkpoint inhibitors. Selecting first-line therapy for patients with NSCLC requires assessment of an expanding list of guideline-recommended genomic biomarkers (EGFR, ALK, ROS1, BRAF, RET, MET amplification and exon 14 skipping, and ERBB2, with NTRK newly added) Standard-of-care (SOC) testing relies on tissue, which is limited by biopsy-related risks, specimen insufficiency, and lab processing duration, which hamper timely optimal treatment selection -          NILE is a large, prospective, multicenter, head-to-head study of SOC tissue-based genomic testing to plasma-based comprehensive cfDNA genomic testing (Guardant360®). For the four biomarkers with FDA approved therapies, up to 34% of patients were tested by SOC tissue testing versus 95% with cfDNA testing. NILE met its primary endpoint - cfDNA performed similar to tissue in the detection of guideline-recommended biomarkers and cfDNA results were delivered significantly faster than SOC tissue testing (median 9 days vs. 15 days).Using cfDNA testing first, 87% of patients with a guideline-recommended biomarker would have been detected, compared to 67% if SOC tissue testing was first.
Author Interviews, Dermatology, Heart Disease, JAMA, Race/Ethnic Diversity / 04.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47582" align="alignleft" width="150"]Francis Alenghat, MD, PhD Assistant Professor of Medicine Section of Cardiology University of Chicago Dr. Alenghat[/caption] Francis Alenghat, MD, PhD Assistant Professor of Medicine Section of Cardiology University of Chicago MedicalResearch.com: What is the background for this study? What are the main findings? Response: Psoriasis has been associated with higher rates of atherosclerotic cardiovascular disease (ASCVD), potentially due to higher-than-normal levels of systemic inflammation. Whether this association varies by race was unknown. Also, it was unclear whether patients with psoriasis have more frequent ASCVD because of higher rates of traditional cardiovascular risk factors (smoking, diabetes, hypertension, hyperlipidemia) or because of components intrinsic to psoriasis itself. We found that, amongst a large population of patients with psoriasis, patients of both sexes and most ages had elevated ASCVD rates compared to those without psoriasis. Overall, African American patients with psoriasis had a 15% ASCVD prevalence, whereas it was 10% in white patients with psoriasis. Increased ASCVD associated with psoriasis occurred at earlier ages in African American patients compared to white patients. Traditional cardiovascular risk factors were common in patients with psoriasis and appeared to play a large role in the driving the higher rates of ASCVD in these patients, but even in patients with psoriasis but without any documented traditional risk factors, ASCVD rates were elevated compared to patients without psoriasis. 
Author Interviews, Columbia, Nutrition / 04.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47779" align="alignleft" width="200"]Sonia Y. Angell, MD MPHDivision of General MedicineDepartment of Medicine, Columbia University Irving Medical CenterNew York, NY   Dr. Angell[/caption] Sonia Y. Angell, MD MPH Division of General Medicine Department of Medicine, Columbia University Irving Medical Center New York, NY   MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Trans fatty acid in the diet increases the incidence of coronary heart disease in the population. In 2006, a policy restricting restaurant use of trans fat went into effect in NYC. This study measured the change in trans fatty acid serum concentration among a representative sample of the NYC population between 2004 and 2013-2014, and whether the change varied by frequency of restaurant food dining. Overall, blood trans fatty acid serum concentration went down by 57%. Among people who dined out less than one time a week, it went down 51% and in those who dined out 4 or more times a week, it went down 61.6%.  In fact, in 2013-2014 there was no longer a significant increase in the serum trans fatty acid concentrations among those who ate restaurant foods frequently compared with those who ate out rarely. 
Author Interviews, Brigham & Women's - Harvard, Health Care Systems, JAMA, Mental Health Research / 04.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47775" align="alignleft" width="125"]Mark S. Bauer, M.D.Professor of Psychiatry, EmeritusHarvard Medical SchoolCenter for Healthcare Organization and Implementation Research (CHOIR)VA Boston Healthcare System-152MBoston, MA 02130 Dr. Bauer[/caption] Mark S. Bauer, M.D. Professor of Psychiatry, Emeritus Harvard Medical School Center for Healthcare Organization and Implementation Research VA Boston Healthcare System-152M Boston, MA 02130 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Collaborative Chronic Care Models (CCMs) have extensive evidence for their effectiveness in a wide variety of mental health conditions.  CCMs are frameworks of care that include several or all of the following six elements:  work role redesign for anticipatory, continuous care; self-management support for individuals in treatment; provider decision support; information system support for population-based and measurement-guided care; linkage to community resources; and organization and leadership support. However, evidence for Collaborative Chronic Care Model effectiveness comes almost exclusively from highly structured clinical trials.  Little is known about whether CCMs can be implemented in general clinical practice settings, and the implementation evidence that does exist derives primarily from studies of the CCM used in primary care settings to treat depression. We conducted a randomized, stepped wedge implementation trial using implementation facilitation to establish CCMs in general mental health teams in nine US Department of Veterans Affairs medical centers. We found that establishing Collaborative Chronic Care Models was associated with reduced mental health hospitalization rates and, for individuals with complex clinical presentations, improvements in mental health status.  Additionally, standardized assessment of team clinicians indicated that facilitation improved clinician role clarity and increased focus on team goals.
AACR, Author Interviews, Colon Cancer / 04.03.2019

MedicalResearch.com Interview with: Ronit Yarden, PhD, MHSA Director of Medical Affairs Colorectal Cancer Alliance, a patient advocacy organization Washington, D.C.  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The colorectal Cancer Alliance is a patient advocacy group (the largest advocacy group for colorectal cancer) and its mission is to provide support to patients, survivors, their caregivers and family members as well as advocate on their behalf for.  The organization is also committed to raise awareness for screening and early detection of colorectal cancer to help save lives and to provide funding for innovative colorectal cancer research. As part of our support we sought to identify some of the clinical, emotional and financial experiences and unmet needs of patients under 50 years old.  We conducted an online survey that was promoted through social media and 1195 patients and survivors completed our survey. 
Author Interviews, Cognitive Issues, Education, Social Issues / 04.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47767" align="alignleft" width="128"]Marja Aartsen, PhDResearch professor at NOVA - Norwegian Social Research / OsloMetOslo Metropolitan University Dr. Aartsen[/caption] Marja Aartsen, PhD Research professor at NOVA Norwegian Social Research / OsloMet Oslo Metropolitan University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our study is part of a larger project “Life course influences on health trajectories at older age” conducted at the University of Geneva, of which dr. Stéphane Cullati is the principle investigator (see for more information on the project https://cigev.unige.ch/index.php?cID=887). The aim of that research project is to examine in what way retrospective life course precursors from childhood to late adulthood have long-term impacts on current health trajectories at older age. A number of studies in this project are now published among which our study on childhood conditions and cognitive functioning and cognitive decline in later life. In our research, we were particularly interested in the origins of cognitive decline in later life.  Studies among children show that the childhood is an important phase in the development of the brain. Growing up in environments in which people are cognitively stimulated stimulates the brain to develop more complex neuronal networks and larger brain reserves, which may compensate for the neuronal losses that occur when people get older. This effect is long visible, even at old age as a number of important studies recently provided quite solid evidence for the beneficial effect of advantaged childhood conditions on level of cognitive functioning in later life. However, not many studies investigated the relation between childhood conditions and the speed of cognitive decline in later life. Those that did found inconsistent results. We reasoned that part of the inconsistencies in study findings might stem from differences in the analytical approach (not sensitive enough), too little cognitive change because of a short follow-up, too young people, or too small sample (all causing too little power to find statistically significant effects) or differences in the measurement of the childhood conditions. To overcome these potential limitations, we used a large study sample with long follow-up, used a multidimensional measurement of childhood condition, and applied a powerful analytical technique. 
Author Interviews, Immunotherapy / 04.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47762" align="alignleft" width="200"]Edward Kim, MD MSAssistant Professor of MedicineDivision of Rheumatology, Allergy and ImmunologyDirector, UNC Allergy and Immunology ClinicUniversity of North Carolina at Chapel HillChapel Hill, NC Dr. Kim[/caption] Edwin Kim, MD MS Assistant Professor of Medicine Division of Rheumatology, Allergy and Immunology Director, UNC Allergy and Immunology Clinic University of North Carolina at Chapel Hill Chapel Hill, NC  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background is that egg allergy remains one of the most common food allergies in childhood and although most patients will outgrow the allergy, it seems that many will carry into their teen years. As a result patients still have many years of risk of anaphylaxis, poor quality of life and potential nutritional deficits. The ability to introduce some amount of egg into the diet could have profound benefit to allergy patients. The main findings are that after completing up to 4 years of egg oral immunotherapy (OIT), most patients are able to introduce at least baked egg products into the diet. The subset of patients who showed a lasting benefit by passing a food challenge 4-6 weeks after stopping the OIT, generally did even better by being able to introduce lightly cooked egg like scrambled, boiled, or fried in addition to baked egg products. This benefit to the diet seemed to last up to 5 years after stopping egg oral immunotherapy. In addition to the safety, quality of life and nutrition benefits, recent data suggesting that bringing baked egg into the diet can speed up outgrowing the allergy provides a further benefit.
Allergies, Author Interviews, Pediatrics / 04.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47726" align="alignleft" width="200"]Todd Green MD Vice President, Medical Affairs North AmericaDBV TechnologiesAssociate Professor of PediatricsUniversity of Pittsburgh School of Medicine Dr. Green[/caption] Todd Green MD  Vice President, Medical Affairs North America DBV Technologies Associate Professor of Pediatrics University of Pittsburgh School of Medicine MedicalResearch.com: What is the background for this announcement? What is Viaskin Peanut? Response: Peanut allergy is one of the most common food allergies and can cause severe, potentially life-threatening allergic reactions, including anaphylaxis. Unfortunately, there are no FDA-approved treatment options for peanut or other food allergies – leaving patients with avoidance and readiness to manage reactions to accidental exposures as their only option. Viaskin Peanut uses epicutaneous immunotherapy or EPIT, a method of delivering biologically active compounds to the immune system through the skin. Patients receive about 1/1,000th of a peanut with each daily dose of peanut protein – the equivalent of one peanut every three years – which activates the immune system with very minimal exposure. In February 2019, DBV announced that its planned resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin Peanut in the treatment of peanut-allergic children 4 to 11 years of age is anticipated in the third quarter of 2019. DBV is working diligently on its resubmission package, bringing us one step closer to providing an FDA-approved treatment for peanut-allergic children and their families. Viaskin Peanut previously received Breakthrough and Fast Track designations for the treatment of peanut-allergic children from the FDA in 2015 and 2012, respectively. 
Author Interviews, Cognitive Issues, Heart Disease, JAMA, Stroke / 04.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47709" align="alignleft" width="200"]Sarah Parish, MSc, DPhil Professor of Medical Statistics and Epidemiology MRC Population Health Research Unit Nuffield Department of Population Health University of Oxford Dr. Parish[/caption] Sarah Parish, MSc, DPhil Professor of Medical Statistics and Epidemiology MRC Population Health Research Unit Nuffield Department of Population Health University of Oxford MedicalResearch.com: What is the background for this study? Response: Acquiring reliable randomized evidence of the effects of cardiovascular interventions on cognitive decline is a priority. In this secondary analysis of 3 randomized intervention trials of cardiovascular event prevention, including 45 029 participants undergoing cognitive testing, we estimated the association of the avoidance of vascular events with differences in cognitive function in order to understand whether reports of non-significant results exclude worthwhile benefit. 
Author Interviews, Endocrinology, Pediatrics / 03.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47745" align="alignleft" width="200"]Yehuda Limony, MD, MScPediatric Endocrinology UnitFaculty of Health SciencesBen-Gurion University of the NegevClalit Health ServicesBeer-Sheva, Israel  Dr. Limony[/caption] Yehuda Limony, MD, MSc Pediatric Endocrinology Unit Faculty of Health Sciences Ben-Gurion University of the Negev Clalit Health Services Beer-Sheva, Israel  MedicalResearch.com: What is the background for this study? Response: The variability of the onset age of puberty is the subject of many studies in numerous disciplines; nonetheless, the timing of puberty remains an enigma. The conventional paradigm is that the time of onset of puberty is genetically determined even though genome-wide association studies explain only a very low percentage of the physiologic variability. It is commonly believed, therefore, that many environmental factors interfere with the genetics of timing of puberty. On the other hand, children grow toward an adult height that is the standardized average of parents' height called "target height". That is why children are usually similar in height to parents. This targeted growth process is evident especially in children whose height percentile in childhood is different from their target height percentile (we called this difference the "height gap"). It is known that the timing of puberty is associated with adult height: earlier puberty causes shorter adult height and vice versa. We hypothesized that the targeted process of growth involves adaptation of the age of onset of puberty in accordance with the height gap.
Alzheimer's - Dementia, Author Interviews, JAMA, Pharmacology, University of Pittsburgh / 01.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47508" align="alignleft" width="150"]Alvaro San-Juan-Rodriguez Alvaro San-Juan-Rodriguez[/caption] Alvaro San-Juan-Rodriguez, PharmD Pharmacoeconomics, Outcomes and Pharmacoanalytics Research Fellow Pharmacy and Therapeutics School of Pharmacy University of Pittsburgh MedicalResearch.com: What are the main findings? Response: Currently, there are 4 antidementia drugs approved by the FDA for the treatment of Alzheimer’s disease, including 3 acetylcholinesterase inhibitors (AChEIs)—donepezil, rivastigmine, and galantamine—and the N-methyl-D-aspartic receptor antagonist memantine. On the one hand, evidence about the effect of these drugs at delaying nursing home admission is still sparse and conflicting. On the other, all these antidementia medications have been associated with several cardiovascular side effects, such as bradycardia, ventricular tachycardia, syncope, QT interval prolongation, atrioventricular block or even myocardial infarction. In this study, we aimed to compare time to nursing home admission and time to cardiovascular side effects across all drug therapies available for the treatment of Alzheimer’s disease. In doing so, we used 2006-2014 medical and pharmacy claims data from Medicare Part D beneficiaries with a new diagnosis Alzheimer’s disease who initiated antidementia drug therapy.
Author Interviews, Biomarkers, CT Scanning, JAMA, Lung Cancer, Medical Imaging / 01.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47730" align="alignleft" width="200"]Martin C. Tammemägi   PhDSenior Scientist | Cancer Care Ontario | Prevention & Cancer Control | Scientific Lead | Lung Cancer Screening Pilot for People at High RiskProfessor (Epidemiology) | Brock University | Department of Health SciencesOntario  Canada Dr. Tammemägi[/caption] Martin C. Tammemägi PhD Senior Scientist Cancer Care Ontario | Prevention & Cancer Control Scientific Lead Lung Cancer Screening Pilot for People at High Risk Professor (Epidemiology) | Brock University Department of Health Sciences Ontario, Canada MedicalResearch.com: What is the background for this study? Response: Some prediction models can accurately predict lung cancer risk (probability of developing lung cancer during a specified time). Good model predictors include sociodemographic, medical and exposure variables. In recent years, low dose computed tomography (LDCT) lung cancer screening has become widespread in trials, pilots, demonstration studies, and public health practice. It appears that screening results provides added valuable, independent predictive information regarding future lung cancer risk, aside from the lung cancers directly detected from the diagnostic investigations resulting from positive screens.
Author Interviews, Cost of Health Care, JAMA, Outcomes & Safety / 01.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47659" align="alignleft" width="150"]Mr. Tim Badgery-Parker ELS, BSc(Hons), MBiostatResearch Fellow,Value in Health Care Division,Menzies Centre for Health Policy Mr. Badgery-Parker[/caption] Mr. Tim Badgery-Parker ELS, BSc(Hons), MBiostat Research Fellow,Value in Health Care Division Menzies Centre for Health Policy MedicalResearch.com: What is the background for this study? Response: This is part of a large program of work at the Menzies Centre for Health Policy on low-value care in the Australian health system. We have previously published rates of low-value care in public hospitals in Australia’s most populous state, New South Wales, and a report on rates in the Australian private health insurance population is due for publication shortly. We have also done similar analyses for other Australian state health systems. This particular paper extends the basic measurement work to focus on what we call the ‘cascade’ effects. That is, looking beyond how much low-value care occurs to examine the consequence for patients and the health system of providing these low-value procedures.
Allergies, Author Interviews, Immunotherapy, JAMA, Pediatrics / 01.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47721" align="alignleft" width="200"]Dr. Matthew GreenhawtDirector, Food Challenge and Research UnitChildren’s Hospital Colorado Dr. Greenhawt[/caption] Dr. Matthew Greenhawt Director, Food Challenge and Research Unit Children’s Hospital Colorado MedicalResearch.com: What is the background for this study? Response: In the US, nearly one million children suffer from a peanut allergy and severe reactions to food allergens are not uncommon – yet there is significant unmet need in the food allergy immunotherapy space, as there are no currently approved treatment options. That being said, we are encouraged by the efficacy and safety data, which support Viaskin Peanut as a convenient and well-tolerated potential treatment option for the peanut allergy. In the pivotal Phase III clinical trial (PEPITES) just published in The Journal of the American Medical Association (JAMA), Viaskin Peanut – the first epicutaneous immunotherapy (EPIT) in development that leverages the skin to activate the immune system – provided statistically significant desensitization in peanut-allergic children ages 4-11 years old. Patients who were treated with active therapy were more likely to have increased their eliciting dose to peanut (the amount of peanut protein ingested before an objective allergic reaction was seen during a double-blind, placebo-controlled food challenge) by a required amount as compared to patients treated with a placebo patch. The improvement suggests a reduced risk of allergic reaction to accidental peanut ingestion in the group treated with Viaskin Peanut, with no change seen in the placebo group.
Author Interviews, JAMA, Mental Health Research, Pharmacology / 01.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47717" align="alignleft" width="125"]Kuan-Pin Su, MD, PhDChina Medical UniversityTaichung, Taiwan Dr. Kuan-Pin Su[/caption] Kuan-Pin Su, MD, PhD China Medical University Taichung, Taiwan MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Delirium, also known as acute confusional state, is a serious disturbance in mental abilities that results in confused thinking and reduced awareness of the environment. Delirium can often be traced to one or more contributing factors, such as a severe or chronic illness, changes in metabolic balance (such as low sodium), medication, infection, surgery, or alcohol or drug intoxication or withdrawal. It’s critically important to identify and treat delirium because some of the contributing factors could be life-threatening. However, there is no sufficient evidence for choice of medication to treat or prevent the symptoms of delirium. A recent paper, Association of Delirium Response and Safety of Pharmacological Interventions for the Management and Prevention of Delirium A Network Meta-analysis, published in JAMA Psychiatry provides important findings of this missing piece in that important clinical uncertainty. The leading author, Professor Kuan-Pin Su, at the China Medical University in Taichung, Taiwan, concludes the main finding about treatment/prevention of delirium: “In this report, we found that the combination of haloperidol and lorazepam demonstrated the best option for treatment of delirium, while ramelteon for prevention against delirium. 
Author Interviews, Pediatrics, Sleep Disorders / 01.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47714" align="alignleft" width="200"]"Baby K - Mother's Kiss" by D.Clow - Maryland is licensed under CC BY-NC-ND 2.0. To view a copy of this license, visit: https://creativecommons.org/licenses/by-nc-nd/2.0 "Baby K - Mother's Kiss" by D.Clow[/caption] Dr. Sakari Lemola Associate Professor Department of Psychology University of Warwick Coventry, UK  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Sufficient sleep of good quality is important for physical and mental health. Therefore, we are studying factors in people’s lives that may affect their sleep. In the present study we examined in particular how the birth of a child affects parents’ sleep. In detail, we used data on sleep of more than 4,600 parents in Germany who had a child between 2008 and 2015. During these years parents reported on their sleep in yearly interviews. We found that the birth of a child had quite drastic short-term effects on new mothers’ sleep, particularly during the first three months after birth. This is not a new finding; previous studies reported similar effects. What is new in the current study is that we compared sleep before pregnancy with sleep until up to 6 years after birth. We were surprised to see that sleep duration and sleep satisfaction were still decreased up to six years after birth. Six years after birth mothers and father still slept around 15-20 minutes less.
Author Interviews, Health Care Systems, Opiods / 28.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47704" align="alignleft" width="200"]Cory E. Cronin PhDDepartment of Social and Public HealthOhio University College of Health Sciences and ProfessionsAthens, Ohio Dr. Cronin[/caption] Cory E. Cronin PhD Department of Social and Public Health Ohio University College of Health Sciences and Professions Athens, Ohio MedicalResearch.com: What is the background for this study? What are the main findings?  Response: One of my primary areas of research is exploring how hospitals interact with their local communities. My own background is in health administration and sociology, and I have been working with colleagues in the Heritage College of Osteopathic Medicine here at Ohio University (Berkeley Franz, Dan Skinner and Zelalem Haile) to conduct a series of studies looking at questions related to these hospital-community interactions. This particular question occurred to us because of the timeliness of the opioid epidemic. In analyzing data collected from the American Hospital Association and other sources, we identified that the number of hospitals offering in-patient and out-patient substance use disorder services actually dropped in recent years, in spite of the rising number of overdoses due to opioid use. Other factors seemed to matter more in regard to whether a hospital offered these services or not.
Author Interviews, Infections, Nature / 28.02.2019

MedicalResearch.com Interview with: bats-mattaeMatae Ahn,MD-PhD candidate Emerging Infectious Diseases (EID) Programme Duke-NUS Medical School MedicalResearch.com: What is the background for this study? What are the main findings? Response: Bats, as the only flying mammals, are ‘special’ in their ability to host many highprofile viruses without suffering from disease. Such viruses including Ebola virus, Nipah virus and SARS or MERS coronaviruses, are highly pathogenic and often lethal to humans or animals, but yet cause no or minimal disease in bats. In addition, they also live very long relative to their small body size, despite elevated metabolic rates. However, what makes them special is still unclear. In this study, we discovered dampened NLRP3-mediated inflammation in bats in response to both ‘sterile’ stressors and infection with three different types of zoonotic RNA viruses. We identified multiple molecular mechanisms of altered bat NLRP3, a critical regulator of virus-induced and age-related inflammation, as the cause. Importantly, the reduced inflammation had no effect on the viral loads, which suggests enhanced immune tolerance to infection in bats. Bats’ natural ability to dampen stress-related and virusinduced inflammation may be a key mechanism underlying their long lifespans and unique viral reservoir status. 
Author Interviews, Orthopedics, Pharmacology, Rheumatology / 28.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47695" align="alignleft" width="143"]Dr. Andrew Spitzer MDCo-director Joint Replacement ProgramCedars-Sinai Orthopedic CenterLos Angeles, CA Dr. Spitzer[/caption] Dr. Andrew Spitzer MD Co-director Joint Replacement Program Cedars-Sinai Orthopedic Center Los Angeles, CA MedicalResearch.com: What is the background for this study? How does this product differ from other steroid injections for inflammatory arthritis? Dr. Spitzer: Many patients receive repeat injections of intra-articular corticosteroids to manage recurrent osteoarthritis pain and other symptoms. However, in most clinical trials to date, patients only received a single corticosteroid injection, and patients were only followed for 12 to 24 weeks after treatment. For trials that have evaluated repeated injections of corticosteroids over a longer period of time—2 years, for example—injections were administered every 3 months, regardless of the timing of the return of OA symptoms. This is not reflective of what is done in clinical practice, where corticosteroids are administered again in response to the return of pain or a flare of inflammation in the knee. In this study, we used a flexible dosing schedule based on the patients’ symptoms, meaning that patients received the second injection of a recently approved extended-release corticosteroid only when their pain and/or symptoms returned, not before. Safety was monitored for 52 weeks—this length of time should be sufficient to identify any associated side effects, including any potential impact on the knee tissue. Triamcinolone acetonide extended-release (TA-ER; Zilretta®) was approved in late 2017 as an intra-articular injection for the management of osteoarthritis pain of the knee. The formulation utilizes microspheres which enable a slow release of the active agent (triamcinolone acetonide) into the synovial fluid for 12 weeks following injection. Previously, a Phase 3 study demonstrated safety and efficacy of a single injection of TA-ER (Conaghan PG, et al. J Bone Joint Surg Am. 2018;100:666-77). This is the first study evaluating the safety and patient response to repeat administration of TA-ER. This study also included patients that were more typical of who we see in the clinic—those who have higher body mass index, more severe disease, and received prior treatments for their osteoarthritis pain.
Addiction, Author Interviews, JAMA, Surgical Research / 27.02.2019

MedicalResearch.com Interview with: [caption id="attachment_43721" align="alignleft" width="144"]Calista Harbaugh, MD House Officer, General Surgery Clinician Scholar, National Clinician Scholars Program Research Fellow, Michigan Opioid Prescribing Engagement Network University of Michigan  Dr. Harbaugh[/caption] Calista Harbaugh, MD House Officer, General Surgery Clinician Scholar, National Clinician Scholars Program Research Fellow Michigan Opioid Prescribing Engagement Network University of Michigan  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Nonmedical prescription opioid use and prescription opioid-related overdose remain significant concerns among adolescents and young adults. Among adolescents and young adults prescribed an opioid after surgery, prior work found that 4.8% of opioid-naïve patients develop new persistent use, filling additional opioid prescriptions at 3-6 months after surgery. This work found associations of persistent use with diagnoses such as chronic pain disorders, depression, anxiety, and prior substance use disorder. It is likely that for young patients, family members may also play an important role in development of new persistent use, but this has not previously been explored. We performed this study to evaluate whether long-term opioid use among family members was associated with prescription opioid fills among adolescents and young adults perioperatively – and we found that opioid-naïve adolescents and young adults who have 1 or more family members with long-term opioid use are more likely to fill at the time of surgery, during recovery, and in the long-term with a near-doubling of rates of new persistent use.