Author Interviews, Biomarkers, Heart Disease, JACC / 09.08.2018

MedicalResearch.com Interview with: John D Horowitz, MBBS, PhD. Director of Cardiology/Clinical Pharmacology Queen Elizabeth Hospital University of Adelaide Australia  MedicalResearch.com: What is the background for this study? What are the main findings? Response:  Atrial fibrillation (AF) describes intermittent or permanent episodes of irregular pulse, due to rapid electrical activity within the atria (filling chambers) of the heart. During AF, the atria quiver, rather than contract, and the response of the ventricles is often rapid, resulting in palpitations and an increased risk of development of heart failure. AF may occur at any age, but is most common in ageing patients (typically over 75 years). The primary importance of AF is that it markedly increases the risk of thrombus formation in the atrium, with the resultant problem that these thrombi may dislodge (embolise), and commonly block arteries in the brain, causing strokes. Hence patients with AF are usually treated with anticoagulants. Although AF often occurs in patients with prior damage to their hearts and atrial distension, there has been evidence for about the past 8 years that AF also is caused, at least in part, by inflammatory changes: two components have been identified as possible causes for this inflammation: lack of nitric oxide (NO) effect[ NO is  an anti-inflammatory chemical formed by all tissues in the body],  and excess activity of the pro-inflammatory enzyme myeloperoxidase (MPO).  High concentrations of ADMA, which inhibits NO formation, may result from effects of MPO on tissues. SDMA, which is closely related to ADMA, also exerts pro-inflammatory effects and tends to suppress NO formation. The currently reported study began with the design of the ARISTOTLE trial, an investigation of the (then) novel anticoagulant apixaban as an alternative to warfarin therapy, as a means of preventing strokes in patients with AF. It was elected to perform a substudy to investigate the potential role of ADMA and SDMA as modulators of risk in patients with atrial fibrillation. This substudy, performed in just over 5000 patients from the ARISTOTLE trial, essentially asked two questions: (1) There are several indices of stroke risk in patients with atrial fibrillation, such as the CHADS2 score. These all rely on patient characteristics (eg age, presence of diabetes) rather than chemical changes. We postulated that there would be a direct relationship between clinically based risk scores and ADMA/SDMA concentrations. (2) More ambitiously, we postulated that ADMA and SDMA concentrations would represent INDEPENDENT risk markers for major adverse effects in atrial fibrillation patients on anticoagulant treatment, namely stroke, major bleeding and risk of mortality.  ADMA/SDMA concentrations were determined in Adelaide, Australia, while statistical analyses were performed in Uppsala, Sweden. (more…)
Author Interviews, Columbia, JAMA, Mental Health Research / 09.08.2018

MedicalResearch.com Interview with: Priya Wickramaratne PhD Associate Professor of Clinical Biostatistics (in Psychiatry) Department of Psychiatry, College of Physicians and Surgeons Columbia University New York State Psychiatric Institute New York MedicalResearch.com: What is the background for this study? Response: Approximately 12% of adolescents in the United States report having thoughts about attempting suicide. Moreover, suicide is a primary cause of death among females 15 to 19 years of age. Religious and spiritual beliefs have received little attention in previous research examining risk and protective factors of child and adolescent suicide. This study used data from a three-generation study of 214 children and adolescents from 112 nuclear families whose parents were at high or low risk for major depressive disorder to study the association of children and parent’s religious beliefs with risk of suicidal behavior in the children. (more…)
Author Interviews, Brigham & Women's - Harvard, Education, Gender Differences, JAMA, Surgical Research / 09.08.2018

MedicalResearch.com Interview with: Erika L. Rangel, MD,MS Instructor, Harvard Medical School Trauma, Burn and Surgical Critical Care Department of Surgery, Center for Surgery and Public Health Brigham and Women’s Hospital Harvard T. H. Chan School of Public Health Boston, Massachusetts MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Although women make up half of medical student graduates in 2018, they only comprise a third of applicants to general surgery. Studies suggest that lifestyle concerns and perceptions of conflict between career and family obligations dissuade students from the field. After entering surgical residencies, women residents have higher rates of attrition (25% vs 15%) and cite uncontrollable lifestyle as a predominant factor in leaving the field. Surgeons face reproductive challenges including stigma against pregnancy during training, higher rates of infertility, need for assisted reproduction, and increased rates of pregnancy complications. However, until recently, studies capturing the viewpoints of women who begin families during training have been limited. Single-institution experiences have described mixed experiences surrounding maternity leave duration, call responsibilities, attitudes of coworkers and faculty, and the presence of postpartum support. Earlier this year, our group presented findings of the first national study of perspectives of surgical residents who had undergone pregnancy during training. A 2017 survey was distributed to women surgical residents and surgeons through the Association of Program Directors in Surgery, the Association of Women Surgeons and through social media via twitter and Facebook. Responses were solicited from those who had at least one pregnancy during their surgical training. 39% of respondents had seriously considered leaving surgical residency, and 30% reported they would discourage a female medical student from a surgical career, specifically because of the difficulties of balancing pregnancy and motherhood with training (JAMA Surg 2018; July 1; 153(7):644-652). These findings suggested the challenges surrounding pregnancy and childrearing during training may have a significant impact on the decision to pursue or maintain a career in surgery. The current study provides an in-depth analysis of cultural and structural factors within residency programs that influence professional dissatisfaction. We found that women who faced stigma related to their pregnancies, who had no formal maternity leave at their programs, and who altered subspecialty training plans due to perceived challenges balancing motherhood with the originally chosen subspecialty were most likely to be unhappy with their career or residency. (more…)
Author Interviews / 09.08.2018

MedicalResearch.com Interview with: Kwangsik Nho, PhD Assistant Professor of Radiology & Imaging Sciences Indiana University School of Medicine Indianapolis, IN MedicalResearch.com: What is the ADNI (Alzheimer’s Disease Neuroimaging Initiative)? Response: The initial phase (ADNI-1) was launched in 2003 to test whether serial magnetic resonance imaging (MRI), position emission tomography (PET), other biological markers, and clinical and neuropsychological assessment could be combined to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's Disease (AD). ADNI-1 was extended to subsequent phases (ADNI-GO, ADNI-2, and ADNI-3) for follow-up for existing participants and additional new enrollments. To our knowledge, the ADNI cohort (370 cognitively normal older adults, 98 patients with significant memory concern, 284 early MCI, 505 late MCI, and 305 patients with AD) uniquely has multi-omics data sets including metabolomics and structural and functional neuroimaging data (MRI, PET) as well as rich clinical and fluid biomarker data on the same participants. (more…)
Author Interviews, Mental Health Research, Nature, University of Pennsylvania / 08.08.2018

MedicalResearch.com Interview with: MedicalResearch.com Interview with: Dr. Theodore Satterthwaite MD Assistant professor in the department of Psychiatry, and Cedric Xia, a MD-PhD candidate Perelman School of Medicine at the University of Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: Unlike other branches of modern medicine, psychiatry still solely replies on patient reports and physician observations for clinical decision-making. Without biologically-based tests, the diagnostic categories for mental health do not carve nature at its joint. This is evident in the high levels of co-morbidity across disorders and heterogeneity within disorders. Through this research, we studied a large sample of adolescents who completed MRI-based functional imaging, and used recently-developed machine learning techniques to uncover specific abnormalities that are highly predictive of a wide variety of psychiatric symptoms. Essentially, we tried to find brain patterns that were predictive of different types of psychiatric symptoms. We discovered four such brain-guided dimensions of psychopathology: mood, psychosis, fear, and disruptive behavior. While each of these dimensions exhibits a unique pattern of brain connectivity, a common feature of brain anomaly is shared across the dimensions. Notably, in all linked dimensions, the default mode network and fronto-parietal network, two brain regions that usually become increasingly distinct as the brain matures, were abnormally connected. This loss of normal brain network segregation supports the hypothesis that many psychiatric illnesses may be disorders of brain development. MedicalResearch.com: What should readers take away from your report? Response: This study shows that we can start to use the brain to guide our understanding of psychiatric disorders in a way that’s fundamentally different than grouping symptoms into clinical diagnostic categories. By moving away from clinical labels developed decades ago, we can begin to let the biology speak for itself. Our ultimate hope is that understanding the biology of mental illnesses will allow us to develop better treatments for our patients. MedicalResearch.com: What recommendations do you have for future research as a result of this work? Response: This study demonstrates the importance of incorporating vast amounts of biological data to study mental illness across clinical diagnostic boundaries. Moving forward, we hope to integrate genomic data in order to describe pathways from genes to brain to symptoms, which could ultimately be the basis for novel treatments for mental illness. MedicalResearch.com: Is there anything else you would like to add? Response: Future breakthroughs in brain science to understand mental illness requires large amount of data. While the current study takes advantage of one of the largest samples of youth, the size (n=999) remains dwarfed by the complexity of the brain. The neuroscience community is actively working towards collecting higher quality data in even larger samples, so we can validate and build upon the findings. Citation: Cedric Huchuan Xia, Zongming Ma, Rastko Ciric, Shi Gu, Richard F. Betzel, Antonia N. Kaczkurkin, Monica E. Calkins, Philip A. Cook, Angel García de la Garza, Simon N. Vandekar, Zaixu Cui, Tyler M. Moore, David R. Roalf, Kosha Ruparel, Daniel H. Wolf, Christos Davatzikos, Ruben C. Gur, Raquel E. Gur, Russell T. Shinohara, Danielle S. Bassett, Theodore D. Satterthwaite. Linked dimensions of psychopathology and connectivity in functional brain networks. Nature Communications, 2018; 9 (1) DOI: 10.1038/s41467-018-05317-y [wysija_form id="3"] [last-modified] The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.Dr. Theodore Satterthwaite MD Assistant professor in the department of Psychiatry, and Cedric Xia, a MD-PhD candidate Perelman School of Medicine at the University of Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Unlike other branches of modern medicine, psychiatry still solely replies on patient reports and physician observations for clinical decision-making. Without biologically-based tests, the diagnostic categories for mental health do not carve nature at its joint. This is evident in the high levels of co-morbidity across disorders and heterogeneity within disorders. Through this research, we studied a large sample of adolescents who completed MRI-based functional imaging, and used recently-developed machine learning techniques to uncover specific abnormalities that are highly predictive of a wide variety of psychiatric symptoms. Essentially, we tried to find brain patterns that were predictive of different types of psychiatric symptoms. We discovered four such brain-guided dimensions of psychopathology: mood, psychosis, fear, and disruptive behavior. While each of these dimensions exhibits a unique pattern of brain connectivity, a common feature of brain anomaly is shared across the dimensions. Notably, in all linked dimensions, the default mode network and fronto-parietal network, two brain regions that usually become increasingly distinct as the brain matures, were abnormally connected. This loss of normal brain network segregation supports the hypothesis that many psychiatric illnesses may be disorders of brain development. (more…)
Author Interviews, JAMA, Pediatrics, Weight Research / 08.08.2018

MedicalResearch.com Interview with: Shari Barkin, MD, MSHS William K. Warren Foundation Endowed Chair Professor of Pediatrics Division Chief of Academic General Pediatrics Director of Pediatric Obesity Research Vanderbilt University Medical Center MedicalResearch.com: What is the background for this study? Response: Obesity often begins in childhood and disproportionately affects some populations, including underserved children. Given the challenges associated with achieving effective obesity treatment, the focus needs to be on prevention and needs to start early. Barkin et al conducted the longest behavioral intervention obesity prevention trial with 610 underserved parent-preschool child pairs, testing a three-year pragmatic approach that focused on families based in the communities in which they lived, and partnering with both Metro Parks and Recreation and the Nashville Public Library Foundation. Eligible children were high normal weight or overweight but not obese and lived in neighborhoods with access to neighborhood built environments that included parks and recreation and library branches.  (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Exercise - Fitness, JAMA / 08.08.2018

MedicalResearch.com Interview with: “cycling” by Urs Steiner is licensed under CC BY 2.0Guillaume Fossat, Physiotherapist and Thierry Boulain, M.D. Médecine Intensive Réanimation Centre Hospitalier Régional Orléans, France MedicalResearch.com: What is the background for this study? Response: Critically ill patients may suffer terrific muscle wasting during their intensive care unit stay. In most patients, particularly those with sepsis or other high inflammatory states, this is due to proteolytic pathways runaway that may persist as long as the cause of inflammation has not been eliminated. What is more, forced rest, as the one imposed to severely ill patients who need sedation to tolerate artificial respiratory support also induces muscle deconditioning and mass loss. In short, the more you are severely and acutely ill, the more you breakdown your muscle proteins and use the catabolic byproducts to fuel the rest of your organism. As a result of this sort of autophagy, intensive care unit survivors may have lost tens of muscle mass kilograms at discharge, to the point that they have lost all or parts of their functional autonomy. The personal and social burden is considerable as muscle weakness may persist several years after hospital discharge. In the 2000’s, physiotherapy and early rehabilitation during intensive care have emerged as a way to counteract the autophagic muscle wasting and help patients to speed up their return to functional autonomy. Therefore, a standardized early rehabilitation that consists in early muscle exercises, systematic lowering or interruption of sedative drugs dosages to allow prompt patient’s awaking, early transfer to chair and early first walk try, has become the standard of care. However, to what extent, when and how muscles should be exercised during the intensive care unit stay in order to optimize the positive effects of rehabilitation remains a nearly blank clinical research area. In-bed leg cycling and electrical muscle stimulation, each for their part, have shown encouraging results. In our study, we sought to know if the very early combination of both could improve global muscle strength in survivors at intensive care unit discharge. (more…)
Addiction, Author Interviews, Cocaine / 08.08.2018

MedicalResearch.com Interview with: Ana-Clara Bobadilla, Ph.D. Postdoctoral scholar in the laboratory of Peter Kalivas, Ph.D MUSC  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The Brain-derived neurotrophic factor (BDNF) is a growth factor that has well-described effects in the survival, growth and differentiation of neurons during development of the central nervous system, but it also maintains a role during adulthood in learning, memory and various disorders such as addiction. Several clinical studies show increased BDNF levels in the serum of cocaine- or alcohol-dependent patients compared to controls (D’Sa et al., 2011; D’Sa et al., 2012). In preclinical research, a wealth of studies shows that chronic exposure to drugs of abuse impacts BDNF expression in different parts of the brain, including the main regions comprised in the reward circuitry, the cortex and the nucleus accumbens (for a comprehensive review, see Li & Wolf, 2015). Conversely, altering BDNF expression or transmission has profound effects on the response of the brain to drugs (see McGinty et al., 2010). Importantly, BDNF effects are often region-specific, meaning that an increase in BDNF expression in one region can decrease the effects of drug exposure in the brain while the same increase in another region can have opposite effects (Li et al., 2013). Because BDNF transmission can modify the expression of a wide range of genes leading to long-term modifications, numerous studies administer BDNF early in the drug exposure protocol and focus on the long-term changes induced by the growth factor. In this study, we microinjected BDNF directly in the nucleus accumbens minutes before measuring cocaine craving in a well-known rodent model of relapse. We found that BDNF induces a robust decrease in craving that lasts for at least 3 days post-treatment. The inhibitory effect of BDNF is not seen when animals are tested for sucrose, a very strong reward for rats, suggesting that this effect is specific to cocaine. Moreover, cocaine craving is only decreased when BDNF is microinjected before the craving test, but has no effect when injected a day before the craving test or in the home cage, indicating a time-specificity in addition to the region-specificity previously described.  (more…)
Accidents & Violence, Author Interviews, Environmental Risks, JAMA / 06.08.2018

MedicalResearch.com Interview with: Dr. Alexis R. Santos-Lozada Director, Graduate Program in Applied Demography Assistant Teaching Professor, Department of Sociology and Criminology Research Affiliate, Population Research Institute College of Liberal Arts Penn State University MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Dr. Howard and I have been working on the topic of deaths attributable to Hurricane Maria since November, and provided rapid-response estimates by the end of November about the humanitarian crisis experienced by Puerto Ricans following the Hurricane. Our main findings are that there are approximately 1,139 deaths in excess of historical patterns between September, October and November in Puerto Rico. (more…)
Addiction, Author Interviews, Opiods, Pharmacology / 06.08.2018

MedicalResearch.com Interview with: Mark Pirner, MD, PhD Senior Medical Director Clinical Research and Medical Affairs US WorldMeds MedicalResearch.com: What is the background for this announcement? How does lofexidine differ from other opioid withdrawal medications? Response: LUCEMYRA™ (lofexidine) was FDA-approved on May 16 as the first and only non-opioid, non-addictive medication for the management of opioid withdrawal in adults. LUCEMYRA mitigates the acute and painful symptoms of opioid withdrawal by suppressing the neurochemical surge in the brain that occurs when opioids are abruptly discontinued. In clinical studies, patients receiving treatment with LUCEMYRA experienced greater symptom relief and were significantly more likely to complete their withdrawal. LUCEMYRA is not an opioid drug and is not a treatment for opioid use disorder; it should be used as part of a longer-term treatment plan. (more…)
Author Interviews, Compliance, Cost of Health Care, University of Michigan / 05.08.2018

MedicalResearch.com Interview with: A. Mark Fendrick, M.D. Professor, Division of General Medicine, Department of Internal Medicine and Department of Health Management and Policy Director, University of Michigan Center for Value-Based Insurance Design Ann Arbor, Michigan 48109-2800 MedicalResearch.com: What is the background for this study? What are the main findings? Response: As Americans are being asked to pay more for the medical care, in terms of copayments and deductibles, one in four Americans reports having difficulty paying for their prescription drugs. One potential solution is “value-based insurance design,” or V-BID. V-BID, is built on the principle of lowering or removing financial barriers to essential, high-value clinical services. V-BID plans align patients’ out-of-pocket costs, such as copayments and deductibles, with the value of services to the patient. They are designed with the tenet of “clinical nuance” in mind— in that the clinical benefit derived from a specific service depends on the consumer using it, as well as when, where, and by whom the service is provided. According to a literature review published in the July 2018 issue of Health Affairs,  The researchers found that value-based insurance design programs which reduced consumer cost-sharing for clinically indicated medications resulted in increased adherence at no change in total spending. In other words, decreasing consumer cost-sharing meant better medication adherence for the same total cost to the insurer. (more…)
Author Interviews, Cancer Research, Gastrointestinal Disease, HIV, JAMA / 05.08.2018

MedicalResearch.com Interview with: Shan Rajendra MBBCh, MSc , MD, FRCP, FRACP Professor of Medicine University of New South Wales Director of Medicine & Clinical Executive Director Bankstown-Lidcombe Hospital Director Gastro-Intestinal Viral Oncology Group Ingham Institute for Applied Medical Research Sydney  MedicalResearch.com: What is the background for this study?   Response: High-risk human papillomavirus(HPV)  infection has been strongly associated with a subset of Barrett’s dysplasia and oesophageal adenocarcinoma. The research question was; Does HPV status of Barrett’s high-grade dysplasia and esophageal adenocarcinoma influence survival as in viral positive head and neck cancers? We therefore sought to determine the prognostic significance of esophageal tumor HPV status and associated viral transcriptional markers (E6/E7 mRNA and p16INK4A) and TP53. (more…)
Author Interviews, Cognitive Issues, Memory / 05.08.2018

MedicalResearch.com Interview with: Dr Antonina Pereira - CPsychol, PhD, FHEA, AFBPsS Head of Department of Psychology & Counselling University of Chichester Chichester, West Sussex UK MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Prospective memory (PM) is the ability to remember to perform future activities, such as remembering to take medication or remembering to attend an appointment. Prospective memory tasks pervade our daily lives, and PM failures, although sometimes merely annoying (e.g., forgetting an umbrella at home on a rainy day), can have serious and even life-threatening consequences (e.g., forgetting to turn off the stove). The fulfilment of such delayed intended actions can indeed be an early indicator of Alzheimer’s disease, with prospective memory failures representing one of the most prominent memory concerns in older adulthood and a fundamental requirement for independent living across the lifespan. We aimed to address this issue by exploring the potential benefits of a purposefully designed technique, encoded enactment, where participants were encouraged to act through the activity they must remember to do. This particular study was the fruit of an international research collaboration led by the University of Chichester and including members from Radboud University Nijmegen, Sussex Partnership NHS Foundation Trust and the Faculty of Medicine of the University of Lisbon. Our team has explored the potential benefits of this specific encoding strategy for healthy younger adults, healthy older adults as well as for patients with mild cognitive impairment. Results were very encouraging: All age groups reported improvement in prospective memory, but this was particularly evident in older patients with mild cognitive impairment, that is, potentially in the early stages of Alzheimer’s disease. The study suggests that encouraging people in this category to adopt enactment as a means to enhance prospective memory could result in them leading independent, autonomous lives for longer. (more…)
Author Interviews, Dermatology, Environmental Risks / 04.08.2018

MedicalResearch.com Interview with: sunscreen creative commonsAdela J. Li, PhD Research Affiliate Wadsworth Center, Rm. D597 New York State Dept. of Health Empire State Plaza Albany, NY, 12201-0509 On the behalf of Dr. Kelvin Leung  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Most people love the beach. In order to block the sun’s damaging UV radiation, people generally slather on a thick layer of sunscreen against sunburn and skin cancer. Sunscreen is suggested to be re-applied every few hours regarding its effectiveness as well as being washed off into the water. These UV filters have been detected in the environment but most studies concluded that individual sunscreen chemicals pose no/low risk to animals or human. However, UV filters constitute a heterogeneous group of chemicals in sunscreens. We are wondering if combination of UV filters would induce higher toxicity than individual compounds, and whether these chemical interactions would develop over time, becoming increasingly dangerous to the living systems. Our study found seven of the nine UV filters in Shenzhen waters, China --- a rapidly urbanized city with over 20 popular recreational beaches, surprisingly, a reservoir and tap water. After exposing artemia to three dominant UV filters and then feeding these artemia to zebrafish adults, concentrations in both were up to 4 times higher when exposed to the mixtures than when exposed to only a single UV filter. A short-term of 25-day dietary exposure to the zebrafish adults did not appear to significantly influence early life stage development of the second generation; however, relatively long exposure over 47 days had significant adverse effects on embryo development. (more…)
Accidents & Violence, Author Interviews, JAMA / 03.08.2018

MedicalResearch.com Interview with: Dr. Angela Sauaia, MD, PhD Professor of Public Health and Surgery University of Colorado Denver Statistical Editor, Journal of Trauma and Acute Care Surgery Statistical Consultant, Department of Surgery Denver Health Medical Center  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: As injury researchers we monitor national trends in injury. The CDC WISQARS (Web-based Injury Statistics Query and Reporting System) is one of the few available open sources of injury data we can use. During the 1980’s and 1990’s, we saw much improvement in deaths due to most injury mechanisms, such as car accidents fatalities. Our study shows, however, that recent trends seem to be eroding these promising survival gains. Both violent and unintentional injuries alike seem to be increasing, especially since 2014. We are unclear about the causes of this recent increase in trauma-related deaths, but it is an alarming trend. (more…)
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JAMA, Lipids / 03.08.2018

MedicalResearch.com Interview with: Marc S. Sabatine, MD, MPH Chairman | TIMI Study Group Lewis Dexter, MD, Distinguished Chair in Cardiovascular Medicine Brigham and Women's Hospital Professor of Medicine | Harvard Medical School MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Low-density lipoprotein cholesterol (LDL-C) is a well-established risk factor for cardiovascular disease. The initial statin trials studied patients with high levels of LDL-C, and showed a benefit by lowering LDL-C. We and others did studies in patients with so-called “average” levels of LDL-C (120-130 mg/dL), and also showed clinical benefit with lowering. (more…)
Author Interviews, HIV, Merck / 02.08.2018

MedicalResearch.com Interview with: merck Kathleen Squires MD Director, Division of Infectious Diseases Jefferson University Hospitals and Ming-Tai Lai, PhD Senior Principal Scientist, Biology Discover Merck   MedicalResearch.com: What is the background for this study? What are the main findings?  Dr. Squires: The DRIVE-FORWARD study is a pivotal, randomized, double-blind, Phase 3 study that evaluated the safety and efficacy of doravirine (DOR), a non-nucleoside reverse transcriptase inhibitor (NNRTI) in treatment-naïve adults with HIV-1 infection. Data from week 48 of this trial have previously been presented demonstrating that doravirine met its primary endpoint of non-inferior efficacy compared to ritonavir-boosted darunavir (DRV+r). In addition, at 48 weeks, a secondary endpoint showed that the doravirine-treated group had statistically significant lower levels of fasting LDL-C and non-HDL-C versus the DRV+r group. The data presented at AIDS 2018 are week 96 data from the DRIVE-FORWARD trial. At week 96, the doravirine group demonstrated efficacy of 73.1% compared with 66.0% in the DRV+r group, a treatment difference of 7.1% (95% CI: 0.5, 13.7)  Two participants in the DOR treatment group developed genotypic and phenotypic resistance to DOR through 96 weeks of treatment. The rate of discontinuation of therapy due to adverse events was 1.6 percent in the DOR group and 3.4 percent in the DRV+r group. Doravirine is a late-stage investigational NNRTI for the treatment of HIV-1 infection in treatment-naïve adults and is being evaluated both as a once-daily single-entity tablet in combination with other antiretroviral agents, and as a once-daily fixed-dose combination regimen with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF). Earlier this year, Merck announced that the FDA accepted for review two New Drug Applications (NDAs) for doravirine for the treatment of HIV-1 infection in treatment-naïve adults. The NDAs are based upon the findings at week 48 of two ongoing Phase 3 trials, DRIVE-FORWARD and DRIVE-AHEAD, evaluating the efficacy and safety of doravirine and the fixed-dose combination regimen of DOR/3TC/TDF, respectively. The FDA has set a target action date of October 23, 2018 for both applications. Dr. Lai: This study aimed to characterize the mutant viruses selected in treatment-naïve participants through week 48 from DRIVE-FORWARD and DRIVE-AHEAD, and to assess the impact of selected mutations on non-nucleoside reverse transcriptase inhibitor (NNRTI) susceptibility and viral fitness. All of the seven doravirine (DOR)-resistant mutants are either partially susceptible or susceptible to etravirine. Mutants containing the F227C substitution were shown to be hypersusceptible to some nucleoside reverse transcriptase inhibitors (NRTIs) such as azidothymidine (AZT), tenofovir (TFV), lamivudine (3TC), and MK-8591. Among the 12 participants who developed efavirenz (EFV) resistance, 9 of the EFV-resistant clinical mutants were susceptible to DOR with fold-change <2.5. The majority of DOR-selected viruses identified in the treatment-naïve participants in clinical trials to date retain susceptibility to etravirine and hypersensitivity to some NRTIs, with low replication capacity. In addition, the majority of EFV-selected viruses retain susceptibility to DOR.  (more…)
Author Interviews, Lung Cancer, Race/Ethnic Diversity, Social Issues / 02.08.2018

MedicalResearch.com Interview with: Mary Pasquinelli, MS, APRN Doctor of Nursing Practice Candidate (2018) Lung Cancer Screening Program Director Advanced Practice Nurse Pulmonary and Medical Oncology Department of Medicine Chicago, Il 60612  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: We performed a retrospective analysis of our lung cancer-screening program. Our program included individuals from a predominantly minority inner city population including Federal Qualified Health Centers. The main findings were that our screening program found a higher rate of positive screens and lung cancer in our initial screens than that compared to the National Lung Screening Trial. (more…)
Author Interviews, Depression, Gender Differences, Occupational Health / 02.08.2018

MedicalResearch.com Interview with: “Professional waitress” by Shih-Chi Chiang is licensed under CC BY 2.0Sarah Andrea, MPH School of Public Health OHSU-PSU MedicalResearch.com: What is the background for this study? Response: We spend one-third of our adult lives at work, and our work-related experiences and exposures affect our health. 14 million people work in the leisure and hospitality industry, a subset of the service industry that includes food service and personal care workers. This industry is simultaneously one of the fastest growing and lowest paid. In addition, work in this industry is frequently characterized by lack of control over hours and shifts worked, as well as insufficient access to health care and other benefits. Studies have previously found the highest burden of depression and sleep problems for workers in this industry compared to others. Individuals working in the service industry who earn the bulk for their income from tips from customers face additional vulnerabilities. In many states, tipped workers are paid as little as $2.13 an hour and rely on customers to make up the difference in tips, which are inequitable and unpredictable. Prior to this study, the potential health implications of tipped work were minimally assessed. (more…)
Author Interviews, Heart Disease, JACC / 02.08.2018

MedicalResearch.com Interview with: Stephen J. Greene, MD Fellow, Division of Cardiology Duke University Medical Center Durham, NC, USA Gregg C. Fonarow, MD, FACC, FAHA, FHFSA Eliot Corday Professor of Cardiovascular Medicine and Science UCLA   MedicalResearch.com: What is the background for this study? Response: Heart failure is a very common medical condition impacting roughly 6 million men and women in the United States, and associated with impaired quality of life, frequent hospitalizations, and high rates of death. There are over 300,000 deaths each year in the US among patients with heart failure. Half of heart failure patients have heart failure because of a weak heart muscle where the heart cannot eject a normal amount of blood with each heartbeat, a term called “reduced ejection fraction.” Fortunately, there are multiple medications proven in large clinical trials to make people with heart failure with reduced ejection fraction live longer and feel better. We also have target doses for these medications, which are the doses used in the trials where the medication proved its benefit. These medications and the target doses are strongly recommended in professional guidelines to improve patient outcomes. To make sure patients have the best outcomes possible, it is important that we work to get patients on these proven medications if at all possible. Unfortunately, prior research has suggested that many patients eligible for these medications in regular outpatient practice do not receive them. Most of this research is several years old, and there have been a lot of efforts to improve the quality of heart failure care in the meantime. In our study, we wanted to see if there have been improvements in the use and dosing of proven heart failure medications in modern-day practice. We also wanted to determine which patient factors were associated with not receiving a medication, or receiving the medication at a below target dose. (more…)
Author Interviews, Education, JAMA / 02.08.2018

MedicalResearch.com Interview with: “Doctors with patient, 1999” by Seattle Municipal Archives is licensed under CC BY 2.0Dr. Laura M. Mazer, MD Goodman Surgical Education Center Department of Surgery Stanford University School of Medicine Stanford, California MedicalResearch.com: What is the background for this study? What are the main findings?  Response: There are numerous articles that clearly document the high prevalence of mistreatment of medical trainees. We have all seen and experienced the results of an “I’ll do unto you like they did unto me” attitude towards medical education. Our motivation for this study was to go beyond just documenting the problem, and start looking at what people are doing to help fix it. Unfortunately, we found that there are comparatively few reports of programs dedicated to preventing or decreasing mistreatment of medical trainees. In those studies we did review, the study quality was generally poor. Most of the programs had no guiding conceptual framework, minimal literature review, and outcomes were almost exclusively learner-reported. (more…)
Author Interviews, Cost of Health Care / 02.08.2018

MedicalResearch.com Interview with: Jodi L. Liu, PhD Associate policy researcher RAND Corporation MedicalResearch.com: What is the background for this study? What are the main findings? Response: The New York Health Act (NYHA) would create a state-based single-payer plan called New York Health. The NYHA has been proposed in the New York State Assembly for many years. New York Health would provide all residents with comprehensive health benefits with no cost sharing and create new taxes to help fund the program. In this study, we used microsimulation modeling to analyze the impact of the NYHA on outcomes such as health care utilization and costs. We estimate that total health care spending could be similar or slightly lower if administrative costs and provider payment rates are reduced. The program would require substantial new taxes and would shift the types of payments people make for health care. After the presumed redirection of federal and state health care outlays to New York Health, we estimate that the new taxes revenue needed to finance the program in 2022 would be $139 billion. (more…)
Author Interviews, Endocrinology, NEJM / 01.08.2018

MedicalResearch.com Interview with: Prof. Dr. Mirjam Christ-Crain Professor of endocrinology, diabetes and metabolism Heads the Department of Clinical Research University and University Hospital of Basel   MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by Diabetes Insipidus? Response: Drinking more than three litres per day with the equivalent increase in urination is regarded as too much. This drinking by the liter – known as “polyuria polydipsia syndrome" – usually develops over time through habit, or can be a side effect of a mental illness. In rare cases, however, it may be caused by diabetes insipidus. This is when the pituitary gland lacks the hormone vasopressin, which regulates the water and salt content in our body. Patients have a decreased ability to concentrate the urine, therefore lose a lot of fluid and have to increase their fluid intake accordingly to prevent dehydration (= Diabetes insipidus). The distinction between what is considered a "harmless" primary polydipsia and a diabetes insipidus is crucial, as their therapy is fundamentally different. Diabetes insipidus must be treated with the hormone vasopressin, while patients with primary polydipsia require behavioural therapy to reduce their habitual drinking. A wrong therapy can have life-threatening consequences as treatment with vasopressin without indication can lead to water intoxication. (more…)
AACR, Author Interviews, Breast Cancer, Cancer Research, Lung Cancer / 01.08.2018

MedicalResearch.com Interview with: “smoking” by shira gal is licensed under CC BY 2.0Dr. Jose M. Martín-Sánchez IP of this study Grupo de Evaluación de Determinantes de Salud y Políticas Sanitarias Universitat Internacional de Catalunya Sant Cugat del Vallès Spain MedicalResearch.com: What is the background for this study? Response: Breast cancer has been the first cause of death from cancer among women. However, the mortality rates of breast cancer have been decreased in the last years. This downward trend can be attributed to treatment and screening programs. On the other hand, smoking has been increased among women during the last century and the main cause of lung cancer is smoking behavior. Based on this data, we hypothesized that the lung cancer mortality could outweigh the breast cancer mortality in the next years and the main purpose of this study was to project the mortality rates of lung cancer and breast cancer in women worldwide, based in previous data and using Bayesian methods, in order to identify potential strategies of public health to reduce the impact of lung cancer. Moreover, previous works described the lung and breast cancer mortality or projected one of them in a single country. For example, we have published two articles with data of Spain one of them with the description of lung cancer mortality trend in men and women and other with the projection of lung and breast cancer among women. The information of this study provides an overall point view around the word of this problem of public health. (more…)
Author Interviews, Education, Pharmaceutical Companies / 01.08.2018

MedicalResearch.com Interview with: Brian J. Piper, PhD, MS Department of Basic Sciences Geisinger Commonwealth School of Medicine Scranton, PA 18509 MedicalResearch.com: What is the background for this study? Response: The authors of this study are biomedical scientists, health care providers and educators who teach medical and pharmacy students. It is a standard practice in reputable medical journals like the New England Journal of Medicine to disclose conflicts of interest (CoI). Reputable sources like the Cochrane Library also disclose CoIs and analyze for their potential impact on the evidence base. Unfortunately, textbooks, which can be highly influential in the training of medical professionals, usually do not disclose their conflicts of interest. A prior study in this quantitative bioethics area found that more than one-quarter of a team-authored pharmacology textbook, Goodman and Gilman’s Pharmacological Basis of Therapeutics, had an undisclosed patent (PLoS One, 2015; 10: e0133261).  The goal of this investigation was to determine whether there were undisclosed CoIs in textbooks used in the training and as a reference for allopathic physicians, osteopathic physicians, dentists, pharmacists, nurses and other allied healthcare providers.  (more…)
Author Interviews, Cost of Health Care, JAMA, Medicare, UCSF / 01.08.2018

MedicalResearch.com Interview with: Andrew B. Bindman, MD Professor of Medicine PRL- Institute for Health Policy Studies University of California San Francisco MedicalResearch.com: What is the background for this study?   Response: The purpose of this study was to evaluate the use and impact of a payment code for transitional care management services which was implemented by Medicare in. The transition of patients from hospitals or skilled nursing facilities back to the community often involves a change in a patient’s health care provider and introduces risks in communication which can contribute to lapses in health care quality and safety. Transitional care management services include contacting the patient within 2 business days after discharge and seeing the patient in the office within 7-14 days. Medicare implemented payment for transitional care management services with the hope that this would increase the delivery of these services believing that they could reduce readmissions, reduce costs and improve health outcomes. (more…)
Author Interviews, Cancer Research, Cannabis, Pancreatic / 01.08.2018

MedicalResearch.com Interview with: Prof Marco Falasca Head Metabolic Signalling Group School of Pharmacy & Biomedical Sciences Faculty of Health Sciences Curtin University Western University MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Each year around 9,800 people in the UK are diagnosed with pancreatic cancer. The disease is particularly aggressive and has one of the lowest survival rates of all cancers. Indeed, the life expectancy for pancreatic cancer patients has barely changed in the last 40 years because there are very few, and mostly only palliative care, treatments available. Given the five-year survival rate for people with pancreatic cancer is less than seven per cent, the discovery of new treatments and therapeutic strategies is urgently needed. In this study, we decided to concentrate on a protein, named GPR55, found in high levels in pancreatic cancer. Our results show that GPR55 promotes pancreatic cancer progression. Consequently, we decided to use its inhibitor cannabidiol, a naturally occurring constituent of medicinal cannabis, as a pharmacological strategy to block GPR55 activity. Strikingly, mice with pancreatic cancer that were treated with cannabidiol alongside chemotherapy, survived almost three times longer than those treated with chemotherapy alone, our study reports.  (more…)