Author Interviews, Epilepsy, FDA / 29.05.2019

MedicalResearch.com Interview with: Dr. Steven S. Chung, MD Executive Director and Program Chair Neuroscience Institute and Director of the Epilepsy Program Banner – University Medical Center MedicalResearch.com: What is the background for this study? How is Nayzilam different from other treatments for epilepsy? Who/How is it administered?  Response: NAYZILAM is the first medication and only FDA-approved nasal option for treating seizure clusters. NAYZILAM allows for administration by a non-healthcare professional to patients when a seizure cluster occurs, which could provide significant value to patients who currently have limited treatment options for SC. The effectiveness of NAYZILAM was established in a randomized, double-blind, placebo-controlled trial (Study 1; NCT 01390220). Study 1 was conducted in two phases: an open-label Test Dose Phase followed by a randomized, double-blind, placebo-controlled, Comparative Phase. In the Test Dose Phase, tolerability was assessed in 292 patients. Patients were excluded from participation in the Comparative Phase if they failed to meet pre-defined blood pressure, heart rate, sedation, electrocardiogram, and peripheral oxygen saturation criteria. In the Comparative Phase, 201 patients treated a single seizure cluster episode in an outpatient setting. Numerical differences in favor of NAYZILAM were observed on each of the components of the treatment success responder definition; termination of seizure(s) within 10 minutes after initial dose of study drug (80.6 versus 70.1%) and the absence of seizure recurrence between 10 minutes and 6 hours after the initial dose of study drug (58.2 versus 37.3%). Study 1 also evaluated the occurrence and time to next seizure after the initial blinded dose of study drug. A smaller proportion of NAYZILAM-treated patients experienced the next seizure within 24 hours after the initial blinded dose of study drug (37.3% versus 46.3%). NAYZILAM-treated patients experienced a statistically longer time-to-next-seizure than the placebo group.   (more…)
Author Interviews, Baylor University Medical Center Dallas, Gastrointestinal Disease / 28.05.2019

MedicalResearch.com Interview with: Dr. Rhonda Souza, MD Baylor University Medical Center Center for Esophageal Research Dallas, TX 75246  MedicalResearch.com: What is the background for this study?   Response: Eosinophilic esophagitis (EoE) is a modern disorder of the esophagus caused by an allergy to certain foods. EoE causes esophageal symptoms like difficulty swallowing and heartburn and is diagnosed when biopsies of the esophagus taken during endoscopy show numerous eosinophils, which are a type of inflammatory blood cell.  There are few established treatments for EoE. One such treatment is a diet that eliminates the offending food allergens, and another is to use steroids to reduce the number of eosinophils in the esophagus. However, the most common treatment for adults with eosinophilic esophagitis is to use proton pump inhibitors (PPIs), which block the proton pumps in stomach cells that make acid.  In earlier studies, we found that PPIs also can block proton pumps in esophageal cells.  Those proton pumps are activated by chemicals that the body produces in response to allergens including interleukin (IL)-13 or IL-4.  Il-13 and IL-4, which cause the esophagus to produce eotaxin-3, a molecule that attracts eosinophils. What remained unknown, however, was the mechanism whereby these interleukins activate proton pumps in the EoE esophagus. In our present study, we explored whether IL-4 works by increasing calcium levels in esophageal cells from EoE patients. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Lipids / 28.05.2019

MedicalResearch.com Interview with: Samia Mora, MD, MHS Associate Physician, Brigham and Women's Hospital Associate Professor of Medicine, Harvard Medical School Brigham and Women's Hospital Department of Medicine Preventive Medicine Boston, MA 02115  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Lipid testing plays a major role in cardiovascular disease (CVD) risk screening, prediction, and treatment. In the past decade, several pivotal studies (including the Women’s Health Study, the Copenhagen City Heart Study, and the Copenhagen General Population Study) compared populations of individuals who had fasting lipid testing with populations of individuals who had nonfasting lipid testing, and found that non-fasting lipids were at least as good as fasting lipids in cardiovascular risk screening and predicting CVD risk. To date, however, no study has examined the cardiovascular predictive value of lipids measured on the same individuals who had both fasting and nonfasting lipid testing. This is important because individual-level variability in fasting versus nonfasting lipids may not be captured when looking at population-level risk associations, and evidence from randomized studies is lacking. Furthermore, it is unclear whether substituting nonfasting lipids would misclassify cardiovascular risk for individuals who may be eligible for statin therapy. (more…)
Author Interviews, JAMA, Mental Health Research, Surgical Research, UCSF / 27.05.2019

MedicalResearch.com Interview with: Carter Lebares, MD Assistant Professor of Surgery Director, Center for Mindfulness in Surgery Department of Surgery, UCSF  MedicalResearch.com: What is the background for this study?  Response: This study was inspired by extensive evidence of the effectiveness of mindfulness-based interventions (MBIs) for mitigating stress and enhancing performance in other high-stress populations like police and the military.  We know that overwhelming stress is related to burnout and to cognitive errors - two critical issues within surgery, today. This prompted us to tailor and streamline an MBI specifically for surgeons, and to test it in our trainees. (more…)
Author Interviews, Frailty, Hospital Readmissions, JAMA, Stanford, Surgical Research / 27.05.2019

MedicalResearch.com Interview with: hospital-frailty-surgeryKara Anne Rothenberg.MD Postdoctoral Research Fellow, Vascular Surgery Shipra Arya, MD SM FACS Associate Professor of Surgery Stanford University School of Medicine MedicalResearch.com: What is the background for this study? Response: There is a growing body of literature showing that frailty, a syndrome where patients have increased vulnerability to a stressor (such as surgery), is associated with increased postoperative complications, failure to rescue, and hospital readmissions. The Risk Analysis Index (RAI), is an easy to use frailty measurement tool that better predicts postoperative mortality than age or comorbidities alone. As the rates of outpatient surgeries rise nationwide, we noted that most of the surgical frailty studies focus only on inpatient surgeries. Elective, outpatient surgery is generally considered low risk for complications and unplanned readmissions, however we hypothesized that for frail patients, it might not be. (more…)
Author Interviews, Heart Disease, JAMA, NIH, Stroke / 27.05.2019

MedicalResearch.com Interview with: Lenore J. Launer, PhD. Chief Neuroepidemiology Section Intramural Research Program National Institute on Aging MedicalResearch.com: What is the background for this study? What are the main findings? Response: The prevalence of cerebral infarction on MRI can be as high as 30% in community-based studies. These lesions detected on brain MRI, are often clinically silent, but are associated with impairments in cognitive and physical function and can increase the risk for clinical events. For a large number, the origin of these brain lesions is unknown. There is also a lack of population-based data on unrecognized myocardial infarction, which is associated with an increased for clinical coronary disease and mortality. Unrecognized MI was detected in 17% of participants using state-of-the-art cardia MRI, a more sensitive measure of the lesions, than the standard ECG. We investigated the contribution to these lesions of recognized and unrecognized myocardial infarction [MI] identified on cardiac MRI. We found both recognized and unrecognized myocardial infarction increased the risk for cerebral infarction, and that in particular unrecognized MI was associated with cerebral infarction of embolic origins of an unknown source. Given their prevalence, unrecognized MI may be an underestimated contributor to the risk for cerebral infarction in older persons.  (more…)
Addiction, Author Interviews, OBGYNE, Pediatrics, Tobacco Research, UCSD / 25.05.2019

MedicalResearch.com Interview with: Davide Dulcis, PhD Associate Professor Department of Psychiatry, UCSD School of Medicine University of California, San Diego La Jolla, CA 92093-0603 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Previous studies in humans have shown that pre-natal and early life exposure to nicotine can lead to altered children behavior and propensity for drug abuse, but the precise mechanisms involved are still unclear. In this pre-clinical study we showed how nicotine “primes” neurons of the mouse brain’s reward center for a fate they normally would not have taken, making them more susceptible to the effects of nicotine when the animals are again exposed to nicotine later in life, said Dr. Benedetto Romoli, first author of the research article.   (more…)
Author Interviews, Hearing Loss, JAMA, NIH, NYU / 24.05.2019

MedicalResearch.com Interview with: Jan Blustein, MD PhD Professor of Health Policy and Medicine Wagner Graduate School and School of Medicine New York University, New York MedicalResearch.com: What is the background for this study?   Response: The National Institutes of Health (NIH), the nation’s largest public funder of health research, provides annual reports about levels of funding for many diseases and conditions.  These reports, issued as part of the NIH’s Research, Condition and Disease Categorization (RCDC) process, allow members of the public to track funding across key conditions and across time. Hearing loss is not included among the reported conditions. This runs counter to two of the NIH’s stated goals, according to researcher Jan Blustein (M.D., Ph.D.), professor of health policy and medicine at New York University’s Robert F. Wagner Graduate School of Public Service, in a Research Letter in the May 15th issue of the Journal of the American Medical Association Otolaryngology and Head & Neck Surgery. “First, the NIH is committed to transparency about how it divides funds across diseases and conditions,” said Dr. Blustein.  “Second, it has said that it will prioritize its funding to those conditions that cause the greatest disease burden.”  Hearing loss causes great disease burden, ranking 10th in the U.S. among all conditions as a contributor to Disability Adjusted Life Years (a widely-used measure of disease burden), according to the World Health Organization. (more…)
Author Interviews, Hospital Readmissions, JAMA, Neurology, Outcomes & Safety, University of Pennsylvania / 20.05.2019

MedicalResearch.com Interview with: Sameed Khatana, MD Fellow, Cardiovascular Medicine, Perleman School of Medicine Associate Fellow, Leonard Davis Institute of Health Economics University of Pennsylvania MedicalResearch.com: What is the background for this study? Response: There has been a growing use of quality metrics and indices in the US healthcare system. Much attention has been paid to quality measurement programs used by public payors, however, the use of such programs by commercial payors is much less studied. "Centers of excellence" are one type of quality designation program that is growing in use by commercial payors where certain hospitals are determined to be "high quality" for a certain disease state or procedure based on meeting certain criteria. For some people, this is even impacting the choice of providers and hospitals they can use by payors. We evaluated centers of excellence programs from three large commercial payors, Aetna, Cigna and Blue Cross Blue Shield, targeted at cardiovascular diseases and interventions and examined publicly reported outcomes for all hospitals performing percutaneous coronary interventions (cardiac stenting) in New York State.  (more…)
Author Interviews, Emory, Heart Disease, JAMA, Pediatrics, Sugar / 19.05.2019

MedicalResearch.com Interview with: Jean A. Welsh, RN, MPH, PhD Departments of Epidemiology and Pediatrics Emory University Wellness Department, Children’s Healthcare of Atlanta Atlanta, Georgia MedicalResearch.com: What is the background for this study? Response: As the evidence has accumulated regarding the health risks associated with sugar-sweetened beverages, I’ve wondered about fruit juices.  Though they have a kind of healthy halo, their main ingredients are the same as sugar-sweetened beverages, sugar and water.  We know that young children drink a lot of fruit juice, and I’ve wondered if older children and adults might switch to drinking more as concern grows about soft drinks and other sugar-sweetened beverages. (more…)
Author Interviews, Education, Neurology, NYU / 17.05.2019

MedicalResearch.com Interview with: Dr. Rebecca Stainman Dr. Arielle Kurzweil MD Adult Neurology Program Director New York University School of Medicine NYU Langone Health MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Physician burnout is prevalent. Neurologists have among the highest burnout rates, ranked third among specialties in a 2011 study, and over half of US Neurologists report at least 1 symptom of burnout in a 2016 survey.  Efforts to address burnout in training programs have mostly been aimed at implementing wellness curricula and offering mental health resources. Training neurology residents to effectively identify, address, and help impaired colleagues is equally crucial in these efforts, yet there is a paucity of literature on this topic. We used simulation as a means of addressing this topic, via identifying and addressing an impaired colleague through an objective structured clinical examination (OSCE).  (more…)
Author Interviews, Brigham & Women's - Harvard, Opiods, Orthopedics, Pain Research, Surgical Research / 16.05.2019

MedicalResearch.com Interview with: Marilyn M. Heng, MD, MPH, FRCSC Orthopaedic Trauma Surgeon Assistant Professor of Orthopaedic Surgery Harvard Medical School  MedicalResearch.com: What is the background for this study?   Response: The ultimate background for this study does come from the larger context of the opioid epidemic that is seen worldwide but particularly in North America. Orthopaedic surgeons should take responsibility as being among the top prescribers of opioids. The more specific background that led to this specific study was the observation that several colleagues would insist that a drug like hydromorphone was so dangerous that they would not prescribe it but seemed okay prescribing large amounts of oxycodone.  It seemed like an urban myth that the type of opioid was what made it dangerous, so that led us to do the study to see if there was evidence for that.  (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Orthopedics, Osteoporosis, Surgical Research / 15.05.2019

MedicalResearch.com Interview with: Elaine W. Yu, MD, MMSc Assistant Professor,  Harvard Medical School Director, Bone Density Center Endocrine Unit, Massachusetts General Hospital MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Roux-en-Y gastric bypass (RYGB) is a popular surgical weight loss procedure.  We have previously shown that gastric bypass leads to rapid high-turnover bone loss. Bariatric procedures are being increasingly performed in older adults, and the clinical consequences of gastric bypass-associated skeletal changes in this vulnerable population have been unclear to date.  Thus, we used Medicare claims data to investigate fracture risk among older adults after gastric bypass, and in comparison to adults who received another bariatric procedure called adjustable gastric banding (AGB), which is thought to have fewer negative bone effects. In our analysis, we found that patients undergoing Roux-en-Y gastric bypass were 73% more likely to fracture than those undergoing AGB. Importantly, we found that hip fracture risk increased nearly 180% after RYGB, and that fracture rates in patients aged 65 or older were similar to the overall group.  (more…)
Annals Internal Medicine, Author Interviews, Critical Care - Intensive Care - ICUs, Infections, University of Pittsburgh / 15.05.2019

MedicalResearch.com Interview with: Minh-Hong Nguyen, MD Infectious Diseases Professor of Medicine Director, Transplant Infectious Diseases Director, Antimicrobial Management Program Department of Medicine University of Pittsburgh School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Blood cultures, the gold standard for diagnosing blood stream infections, are insensitive and limited by prolonged time to results. Early institution of appropriate antibiotics is a crucial determinant of improved outcomes in patients with sepsis and blood stream infections (BSI). For these reasons, development of rapid non-culture diagnostic tests for blood stream infections is a top priority. The T2Bacteria panel is the first direct from blood, non-culture test cleared by FDA for diagnosis of blood stream infections .  It detects within 4-6 hours the 5 most common ESKAPE bacteria that are frequent causes of hospital infection, and which are often multi-drug resistant.  This study shows that the T2Bacteria panel rapidly and accurately diagnosed and identified ESKAPE bacterial BSIs, and identified probable and possible BSIs that were missed by blood cultures (in particular among patients who were already receiving antibiotics). (more…)
Author Interviews, Cost of Health Care, Kidney Disease, UCLA / 14.05.2019

MedicalResearch.com Interview with: Chris Childers, MD, PhD Division of General Surgery David Geffen School of Medicine at UCLA Los Angeles, CA 90095 MedicalResearch.com: What is the background for this study? Response: Patients with end-stage renal disease – poorly functioning kidneys – often have to receive dialysis. This typically requires a patient to visit an outpatient clinic several times a week to have their blood filtered by a machine. Over the past few years, two for-profit companies have increased their control over the outpatient dialysis market – DaVita and Fresenius. Combined they control approximately ¾ of the market.  A number of concerns have been raised against these for-profit companies suggesting that the quality of care they deliver may be worse than the care delivered at not-for-profit companies. But, because they control so much of the market and because patients have to receive dialysis so frequently, patients may not have much choice in the clinic they visit. Medicare covers patients who are 65 years or older and also patients on dialysis regardless of age.  Medicare pays a fixed rate for dialysis which they believe is adequate to cover the clinics' costs. However, if a patient also has private insurance, the insurer is required to pay for dialysis instead of Medicare. Whereas Medicare rates are fixed by the federal government, private insurers have to negotiate the price they pay, and may pay much more as a result. (more…)
Author Interviews, Medical Imaging, Mental Health Research, UCSD / 13.05.2019

MedicalResearch.com Interview with: Dr. Mingxiong Huang, PhD Professor, Electrical and Computer Engineering University of California, San Diego MedicalResearch.com: What is the background for this study?   Response: Combat-related mild traumatic brain injury (mTBI) is a leading cause of sustained impairments in military service members and Veterans. Yet, conventional neuroimaging techniques such as magnetic resonance imaging (MRI) and computed tomography (CT) are typically insensitive to physiological alterations caused by mild and some moderate TBIs. With funding from the VA, we have pursued in developing sensitive imaging markers based on magnetoencephalography (MEG) for mTBI. This paper reflects the news MEG findings in this research field.  (more…)
Author Interviews, Biomarkers, Cancer Research, Colon Cancer, JAMA, Karolinski Institute / 13.05.2019

MedicalResearch.com Interview with: Louise Olsson MD PhD Senior researcher Department of Molecular Medicine and Surgery Colorectal Surgery Karolinski Institute Stockholm, Sweden  MedicalResearch.com: What is the background for this study? What are the main findings? Response: I read a very interesting paper back in 2006 “Detection and quantification of mutation in the plasma of patients with colorectal cancer”. Only some 60 % of patients with early colorectal cancer were detectable in this way whereas patients with stage IV disease all had a high concentration of APC mutations in their plasma. So the prospects of using the method for example, screening of primary colorectal cancer seemed limited but I thought wow, this is the test to detect recurrences and generalized disease during follow-up after surgery for colorectal cancer. After some discussion we started to collect plasma samples from patients at the hospital where I worked and that´s how my research began. (more…)
Author Interviews, JAMA, Opiods, Primary Care, University of Michigan / 11.05.2019

MedicalResearch.com Interview with: Kao-Ping Chua, M.D., Ph.D. Department of Pediatrics Susan B. Meister Child Health Evaluation and Research Center University of Michigan, Ann Arbor MedicalResearch.com: What is the background for this study?   Response: Doctor and pharmacy shopping is a high-risk behavior in which patients obtain opioid prescriptions from multiple prescribers and fill them at multiple pharmacies. Because this behavior is associated with a high risk of overdose death, there have been many efforts to help clinicians detect doctor and pharmacy shopping among patients prescribed opioids. For example, 49 states have a prescription drug monitoring program that provides information on patients’ prior controlled substance prescriptions. In contrast, there has been little attention to the possibility that patients prescribed opioids may have family members who are engaged in opioid doctor and pharmacy shopping. Such family members may divert opioids prescribed to patients because of their access to these opioids. (more…)
Author Interviews, C. difficile, Gastrointestinal Disease, Johns Hopkins, Lipids / 09.05.2019

MedicalResearch.com Interview with: Rajesh Kumar NV, Ph.D. Affiliation during the study: Senior Manager, Human Therapeutics Division, Intrexon Corporation, Germantown, MD, USA Current affiliation: Translational Research Program Manager, Oncology Drug Discovery, Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine Baltimore, MD,   MedicalResearch.com: What is the background for this study? Response: Clostridium difficile is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. Clostridium difficile infection is the most frequent form of colitis in hospitals and nursing homes and affects millions of patients in the United States and abroad. Clostridium difficile associated disease (CDAD) is a global public health challenge where even mild to moderate infections at times can quickly progress to a fatal disease if not treated promptly. OG253 is a novel lantibiotic in development for the treatment of CDAD. Lantibiotics are antimicrobial peptides whose chemical structure includes a bridge maintained by the non-canonical amino acid lanthionine. The primary objective of our study was to evaluate the repeated dose toxicokinetics and any possible side effects of OG253 as enteric-coated capsules following daily oral administrations of three different doses (6.75, 27 and 108 mg/day) for a single day or seven consecutive days in both genders of rats. An enteric-coated capsule of OG253 was formulated in an attempt to circumvent the proteolytic degradation of OG253 in the upper digestive tract and specifically deliver this lantibiotic to the distal portion of the small intestine. (more…)
Author Interviews, McGill, Multiple Sclerosis, Neurology / 09.05.2019

MedicalResearch.com Interview with: Douglas Arnold, MD The Montreal Neurological Institute & Hospital McGill University Montreal, QC, Canada MedicalResearch.com: What is the background for this study? Response: Diroximel fumarate (DRF) is a novel oral fumarate, with a distinct chemical structure that is being developed for relapsing forms of multiple sclerosis (MS). It is hypothesized that the distinct chemical structure of DRF may elicit less localized irritation in the gastrointestinal (GI) tract, potentially leading to improved GI tolerability. Diroximel fumarate is expected to have similar efficacy as dimethyl fumarate (marketed as TECFIDERA®), as both are converted to equivalent levels of monomethyl fumarate in the body. The EVOLVE-MS-1 study is primarily evaluating the safety of DRF and also exploring efficacy endpoints.   (more…)
Alzheimer's - Dementia, Author Interviews, Biomarkers, Neurological Disorders, Neurology, University of Pennsylvania / 08.05.2019

MedicalResearch.com Interview with: Lauren McCollum, MDCognitive and Behavioral Neurology FellowPenn Memory Center / Cognitive Neurology DivisionLauren McCollum, MD Cognitive and Behavioral Neurology Fellow Penn Memory Center / Cognitive Neurology Division MedicalResearch.com: What is the background for this study?   Response: Alzheimer’s Disease (AD) is a heterogenous condition, with considerable variability in cognitive symptoms and progression rates. One major reason for this heterogeneity is “mixed pathology,” – i.e., both AD- and non-AD pathology. Examples of non-AD pathology include cerebrovascular disease (CVD), Lewy Bodies, and TDP-43. Pathologically, Alzheimer’s Disease is defined by characteristic amyloid plaques and neurofibrillary tangles, which can be assessed for in living patients with CSF- or PET-based biomarkers for amyloid and tau, respectively. Classically, amyloid deposition begins years or even decades before pathologic tau accumulation, which is in turn associated with brain atrophy and cognitive decline. The recently developed NIA-AA “ATN” research framework allows for the classification of individuals with regard to 3 binary biomarkers: Amyloid (A), Tau (T), and Neurodegeneration (N). An individual’s ATN biomarker status indicates where along the “Alzheimer’s Disease continuum” they lie. Additionally, some ATN statuses are on the “typical AD” continuum, while others are not. Research has shown that 15-30% of cognitively normal older adults have elevated amyloid. It stands to reason that some portion of cognitively impaired individuals with elevated amyloid and neurodegeneration have something other than AD driving their neuronal injury. Within the context of the ATN research framework, this subset of people is the A+T-N+ group (i.e., people who have elevated amyloid and neurodegeneration, but are tau-negative), as amyloid alone (that is, amyloid without tau) is not thought to cause significant cognitive impairment or brain atrophy. Our hypothesis was that, compared to A+T+N+ (a set of typical-AD biomarkers), A+T-N+ have cognitive and neuroimaging profiles that deviate from a typical Alzheimer’s Disease pattern – i.e., with less memory loss and less atrophy in AD-signature regions – and may have biomarkers suggestive of alternate non-AD pathologies [e.g., white matter hyperintensities (WMHs), a marker of CVD]. (more…)
Author Interviews, Cancer Research, Environmental Risks, University Texas, Urology / 08.05.2019

MedicalResearch.com Interview with: Stephen B. Williams, MD, FACS Chief, Division of Urology Associate Professor, Urology and Radiology Robert Earl Cone Professorship Director of Urologic Oncology Director of Urologic Research Co-Director Department of Surgery Clinical Outcomes Research Program University of Texas Medical Branch at Galveston MedicalResearch.com: What is the background for this study? What are the main findings? Response: Despite prior studies evaluating cancer in those living near and working in oil refineries, there remains a gap in knowledge regarding proximity to oil refineries and risk of bladder cancer. Aromatic amines have been associated with increased risk of various cancers including bladder cancer. Texas is a home to the largest numbers of oil refineries in the US. Our goal was to evaluate if there was a link between bladder cancer and living in close proximity to an oil refinery in Texas. Our data did suggest that living within 10 miles of an oil refinery was associated with a small increase in risk of bladder cancer. These data support further research to validate these findings. (more…)
Author Interviews, Heart Disease, JAMA, Johns Hopkins, Pulmonary Disease / 07.05.2019

MedicalResearch.com Interview with: Robert A. Wise, M.D. Professor of Medicine Pulmonary and Critical Care Johns Hopkins University School of Medicine Baltimore, MD MedicalResearch.com: What is the background for this study? What are the main findings? Response: There has been a lingering controversy about the safety of long-acting anti-muscarinic agents (LAMA) as maintenance treatment for COPD in patients who have increased cardiovascular risk.  This study enrolled participants with COPD who also had increased cardiovascular risk or known cardiovascular disease.  Participants were randomly treated with either aclidinium bromide (Tudorza Pressair) or placebo. Over 3 years of follow up there was no increased risk of adverse cardiovascular events.  Moreover, the medication had a significant benefit in terms of reducing exacerbations and COPD hospitalizations. (more…)
Author Interviews, Dermatology, Environmental Risks, FDA, JAMA / 06.05.2019

MedicalResearch.com Interview with: David Strauss, MD, PhD Director, Division of Applied Regulatory Science U.S. Food and Drug Administration Center for Drug Evaluation and Research MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is unknown whether most active ingredients in sunscreens are absorbed. FDA has provided guidance that sunscreen active ingredients with systemic absorption greater than 0.5 ng/mL or with safety concerns should undergo nonclinical toxicology assessment including systemic carcinogenicity and additional developmental and reproductive studies. This randomized clinical trial demonstrated systemic exposure of 4 commonly used sunscreen active ingredients on application of sunscreen products under maximal use conditions consistent with current sunscreen labeling. All 4 sunscreen active ingredients tested resulted in exposures exceeding 0.5 ng/mL.  (more…)
Author Interviews, Brigham & Women's - Harvard, Education, JAMA / 06.05.2019

MedicalResearch.com Interview with: Arabella L. Simpkin,  MD, MMSc Associate Director, Center for Educational Innovation and Scholarship, MGH Associate Program Director, Education and Curriculum, Internal Medicine Residency, MGH Instructor in Medicine, Harvard Medical School Boston, MA 02114 MedicalResearch.com: What is the background for this study? Response: The academic health care environment has changed in unprecedented ways over several decades, with mounting evidence that faculty are becoming increasingly more unhappy, dissatisfied, and burnt out in their work. Concern for faculty wellbeing is high, with much speculation about causes of burnout. Comprehending what affects satisfaction at work in academic health care centers is critically important to stem this epidemic of discontent. For physicians, satisfaction has been reported to be associated with quality of care delivered, particularly as measured by patient satisfaction; faculty retention and job satisfaction are intricately linked, with dissatisfied physicians more likely to leave the profession and to discourage others from entering. Other industries that have suffered similar rises in employee discontent have found that demonstration of respect is the most important leadership behavior in improving employees satisfaction. To our knowledge this factor has not been looked at in healthcare professionals. To address this gap, we sought to determine key variables influencing satisfaction at work for faculty in a large academic medical center in the United States. (more…)
Author Interviews, Dermatology, Microbiome, Pediatrics, UCSD / 30.04.2019

MedicalResearch.com Interview with: Dr. Jusleen Ahluwalia MD Second-year Dermatology resident University of California, San Diego MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Preadolescence is an interesting stage during which changes in microbial diversity can coincide with the development of acne. This study is the largest assessment of preadolescent acne microbiome in the literature to date. In this study, we found that early acne in preadolescent females is characterized by an abundance of Streptococcus mitis, while later stages are characterized by a predominance of Cutibacterium acnes (formerly known as Propionibacterium acnes).   (more…)
Alzheimer's - Dementia, Author Interviews, End of Life Care, JAMA, University of Pennsylvania / 30.04.2019

MedicalResearch.com Interview with: Emily Largent, PhD, JD, RN Assistant ProfessorMedical Ethics and Health Policy Perelman School of Medicine Leonard Davis Institute of Health Economics University of Pennsylvania  MedicalResearch.com: What is the background for this study? What are the main findings?  Response:  Public support for aid in dying in the United States is rapidly growing.  As a result, we’re now seeing debates about whether to expand access to aid-in-dying to new populations – such as people with Alzheimer’s disease – who wouldn’t be eligible under current laws. With those debates in mind, we asked currently healthy people who recently learned about their risk for developing Alzheimer’s disease dementia (i.e., due to the presence of amyloid, an Alzheimer’s disease biomarker) whether they would be interested in aid-in-dying. Our findings suggest that about 20% of individuals with elevated amyloid may be interested in aid-in-dying if they become cognitively impaired.   (more…)
Author Interviews, Cancer Research, JAMA, MD Anderson, Radiation Therapy / 30.04.2019

MedicalResearch.com Interview with: Quynh-Nhu Nguyen, MD Department of Radiation Oncology The University of Texas MD Anderson Cancer Center Houston MedicalResearch.com: What is the background for this study? What are the main findings?  Response: This is the first non-spine bone metastases trial comparing higher dose single fraction radiotherapy vs multifraction standard fractionated radiotherapy for patients with painful bone metastases. The results of this trial demonstrated more durable pain relief and superior local control for patients treated in the higher dose(12 Gy-16 Gy)  single fraction RT compared to standard 30 Gy/10 fractions multifractionated regimen.  This trial supports the previous multiple randomized trials which recommend single fraction should be standard palliative radiotherapy regimen for bone metastases.  This trial is unique in that it addressed previous criticism that single fraction does not provide durable palliation with lower 8 gy single fraction and result in higher re-irradiation rates.  This trial on the contrary with the utilization of modern radiotherapy techniques, demonstrated we can safely and more effectively deliver a higher single fraction radiotherapy regimen for improvement in the quality of life for patients.  This higher dose should be the new standard single fraction regimen for patients who are functional and have a longer life expectancy.  (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Pediatrics, Weight Research / 26.04.2019

MedicalResearch.com Interview with: Vincent W. V. Jaddoe, MD, PhD Adjunct Professor of Epidemiology Department of Epidemiology MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Childhood body fat may be affected by patterns of fetal and infant weight change. Children born small for gestational age (SGA) tend to have infant growth acceleration, whereas those born large for gestational age (LGA) tend to have infant growth deceleration. Little is known about fetal and infant growth patterns affecting visceral, liver, and pericardial fat, which are strongly associated with cardiometabolic disease in later life. We assessed in a large population cohort study whether fetal and infant weight change was associated with not only general, but also organ fat at school age. We observed that fetal and infant weight change patterns were both associated with childhood body fat, but weight change patterns in infancy tended to have larger effects. Fetal growth restriction followed by infant growth acceleration was associated with increased visceral and liver fat.  (more…)