Author Interviews, Breast Cancer, Brigham & Women's - Harvard, JAMA, Mammograms / 03.05.2018

MedicalResearch.com Interview with: Anne Marie McCarthy, PhD Department of Medicine Massachusetts General Hospital and Harvard Medical School Boston MedicalResearch.com: What is the background for this study? What are the main findings? Response: Mammography is effective in reducing breast cancer mortality. However, it is not perfect, and approximately 15% of breast cancers are diagnosed despite a negative mammogram before the next recommended screening. MedicalResearch.com: What should clinicians and patients take away from your report? Response: Using data from the NCI funded PROSPR (Population-Based Research Optimizing Screening through Personalized Regimens) Consortium, we determined the rates of cancer diagnosis within one year following a negative or positive screening mammogram. The rate of cancer diagnosis within one year of a negative mammogram was small (5.9 per 10,000 screenings), but those cancers were more likely to have poor prognosis than cancers diagnosed after a positive mammogram (43.8% vs. 26.9%). As expected, women with dense breasts were more likely to have cancer diagnosed within 1 year of a negative mammogram. However, breast density was not a good predictor of poor prognosis among women diagnosed with cancer after a negative mammogram. Younger women were more likely to be diagnosed with poor prognosis breast cancer after a negative screening mammogram. (more…)
Author Interviews, JAMA, Outcomes & Safety, Race/Ethnic Diversity, Surgical Research / 03.05.2018

MedicalResearch.com Interview with: Dr-Hillary-J-Mull Hillary J. Mull, PhD, MPP Center for Healthcare Organization and Implementation Research Veterans Affairs (VA) Boston Healthcare System Department of Surgery, Boston University School of Medicine Boston, Massachusetts MedicalResearch.com: What is the background for this study? What are the main findings? Response: Little is known about outpatient procedures that can be considered invasive but are not conducted in a surgical operating room. These procedures are largely neglected by quality or patient safety surveillance programs, yet they are increasingly performed as technology improves and the U.S. population gets older. We assessed the rate of invasive procedures across five specialties, urology, podiatry, cardiology, interventional radiology and gastroenterology in the Veterans Health Administration between fiscal years 2012 and 2015. Our analysis included examining the rates of post procedure emergency department visits and hospitalizations within 14 days and the key patient, procedure or facility characteristics associated with these outcomes. We found varying rates of post procedure ED visits and hospitalizations across the specialties with podiatry accounting for a high volume of invasive outpatient care but the lowest rate of postoperative utilization (1.8%); in contrast, few of the procedures were in interventional radiology, but the postoperative utilization rate was the highest at 4.7%. In a series of logistic regression models predicting post procedure healthcare utilization for each specialty, we observed significantly higher odds of post procedural outcomes for African American patients compared to white patients. (more…)
Author Interviews, Cost of Health Care, End of Life Care, JAMA / 01.05.2018

MedicalResearch.com Interview with: R. Sean Morrison, MD Ellen and Howard C. Katz Professor and Chair Brookdale Department of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai New York, NY 10029 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Palliative care is team based care that is focused on improving quality of life and reducing suffering for persons with serious illness and their families.  It can be provided at any age and in concert with all other appropriate medical treatments.  Palliative care has been shown to improve patient quality of life, patient and family satisfaction, and in diseases like cancer and heart failure, improve survival.  A number of individual studies have shown that palliative care can reduce costs by providing the right care to the right people at the right time. This study pooled data from six existing studies to quantify the magnitude of savings that high quality palliative care provides. (more…)
Author Interviews, Emory, Hematology, JAMA, Neurological Disorders, Stroke / 23.04.2018

MedicalResearch.com Interview with : Dr. Hyacinth I Hyacinth MD Aflac Cancer and Blood Disorder Center, Emory Children’s Center, Department of Pediatrics, Emory University School of Medicine Atlanta, GA 30322 MedicalResearch.com: What is the background for this study? This study was conducted against the backdrop of a significantly higher risk for stroke among African Americans compared to non-Hispanic Whites, despite adjusting for traditional risk factors. Also, sickle cell disease is a well-known genetic risk factor for stroke and recent studies show that sickle cell trait is a risk factor for chronic kidney disease, venous thromboembolism and pulmonary embolism, all of which are potential risk factors for stroke. (more…)
Author Interviews, Education, JAMA, Pediatrics / 20.04.2018

MedicalResearch.com Interview with: “Children Playing at Swyalana Lagoon” by Doug Hay is licensed under CC BY 2.0Dr Anuja Pandey Population, Policy and Practice Programme, UCL Great Ormond Street Institute of Child Health London UK  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Evidence from longitudinal studies suggests that self-regulation skills can be a powerful predictor of positive health, educational, financial and social outcomes. Hence, self-regulation has received interest as an intervention target and a number of interventions have been evaluated in children and adolescents. Our study summarised the evidence from 50 rigorously evaluated self-regulation interventions in children and adolescents including 23098 participants. We found that while most interventions were successful in improving self-regulation (66%), some of them did not produce a noticeable change (34%).Curriculum based approach was most commonly used to deliver interventions, and this involved training teachers, who implemented these interventions.  (more…)
Author Interviews, Cancer Research, Dermatology, JAMA, Melanoma, Primary Care, University of Pittsburgh / 18.04.2018

MedicalResearch.com Interview with: Laura K. Ferris MD, PhD Associate Professor, University of Pittsburgh Clinical and Translational Science Institute Director of Clinical Trials, UPMC Department of Dermatology University of Pittsburgh MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Dermatology is one of the greatest utilizers of physician extenders, including physician assistants (PAs) in medicine. The scope of practice of PAs has also expanded over time from a role in assisting the dermatologist to taking a more independent role and many PAs now do skin cancer screening examinations and make independent decisions about which lesions are suspicious for skin cancer and need to be biopsied. Our main findings were that, overall, in comparison to board-certified dermatologists, PAs were more likely to perform biopsies of benign lesions. For every melanoma that they found, PAs biopsied 39 benign lesions whereas dermatologists biopsied 25. In addition, PAs were less likely than dermatologists to diagnose melanoma in situ, the earliest and most curable, but also hardest to identify and diagnose, form of melanoma. However, PAs had a similar rate of diagnosing the more clinically-obvious forms of skin cancer, including invasive melanoma, basal cell carcinoma, and squamous cell carcinoma. (more…)
Author Interviews, Heart Disease, JAMA, Lipids / 17.04.2018

MedicalResearch.com Interview with: Dr. Jennifer Robinson, MD MPH Professor, Departments of Epidemiology & Medicine Director, Prevention Intervention Center Department of Epidemiology University of Iowa MedicalResearch.com: What is the background for this study? Response: Compared to previous placebo-controlled statin trials, the FOURIER trial where all patients were on high or moderate intensity statin, had no reduction in cardiovascular or total mortality and the reduction in cardiovascular events was less than expected.  However, other PCSK9 inhibitor trials performed in populations with higher baseline low density lipoprotein cholesterol (LDL-C) had cardiovascular risk reductions similar to that in the statin trails. (more…)
Author Interviews, Blood Pressure - Hypertension, JAMA, Primary Care / 16.04.2018

MedicalResearch.com Interview with: “Doctors” by Tele Jane is licensed under CC BY 2.0Doug Einstadter, MD, MPH Center for Health Care Research and Policy MetroHealth System and Case Western Reserve University  MedicalResearch.com: What is the background for this study?   Response: Despite the recognized importance of blood pressure (BP) control for those with hypertension, based on national surveys only 54% of patients with hypertension seen in primary care have their BP controlled to less than 140/90 mm Hg. Blood pressure measurement error is a major cause of poor BP control. Reducing measurement error has the potential to avoid overtreatment, including side effects from medications which would be intensified or started due to a falsely elevated blood pressure. One way to reduce measurement error is to repeat the BP measurement during an office visit. The American Heart Association recommends repeating a blood pressure at the same clinic visit with at least 1 minute separating BP readings, but due to time constraints or lack of evidence for the value of repeat measurement, busy primary care practices often measure BP only once. Repeating the BP at the same office visit when the initial blood pressure measurement is high has the potential to improve clinical decision-making regarding BP treatment. Several studies have described the effect of a repeat BP measurement in the inpatient setting, but there are little data available to characterize the effect of repeating blood pressure measurement in an outpatient primary care setting. (more…)
Author Interviews, Cancer Research, JAMA / 16.04.2018

MedicalResearch.com Interview with: Lindor Qunaj BSc MD'19 Medical student, Warren Alpert Medical School of Brown University Brown Center for Biomedical Informatics Providence, Rhode Island MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our study was motivated by growing concerns that incomplete or delayed release of clinical trial data may put patients at risk of harm or suboptimal treatment and slow the pace of biomedical innovation. Especially in a field as rapidly evolving as oncology, complete and timely dissemination of clinical trial results is critical to the advancement of both patient care and scientific discovery. In an analysis of press releases from eight large pharmaceutical companies, we found that the median delay from presumed availability of Phase 3 trial data to peer-reviewed publication or public posting of results was 300 days. Studies reporting positive findings were published more rapidly than those with negative results. (more…)
Author Interviews, Blood Pressure - Hypertension, Brigham & Women's - Harvard, JAMA, Stroke / 16.04.2018

MedicalResearch.com Interview with: Dr. Joshua Goldstein MD, PhD J. Philip Kistler Stroke Research Center Division of Neurocritical Care and Emergency Neurology, Department of Neurology MGH Harvard Medical School, Boston Department of Emergency Medicine Massachusetts General Hospital for the Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 (ATACH-2) and the Neurological Emergencies Treatment Trials (NETT) Network Investigators   MedicalResearch.com: What is the background for this study? What are the main findings?  Response: It’s hard to know how aggressively to lower blood pressure in acute intracerebral hemorrhage (ICH).  Randomized controlled trials have been conflicting. We thought that we could use the presence of severe small vessel disease (SVD) - manifested by microbleeds seen on brain magnetic resonance imaging (MRI) – to guide treatment decisions.  On the one hand, those with severe SVD may be most vulnerable to continued bleeding, and specifically need more intensive blood pressure lowering.  On the other hand, if they have impaired regulation of cerebral blood flow, they might be harmed by rapid drops in blood pressure, and maybe we have to be more careful with them. To answer this, we performed a subgroup analysis of the multi-centre ATACH-2 clinical trial of intensive blood pressure lowering. This was the first study to assess the effect of randomized acute stroke treatment on patients with more severe SVD, manifested by microbleeds.  We found that no matter what your small vessel disease burden on MRI, you’ll respond the same to early blood pressure management. (more…)
Author Interviews, Depression, Eating Disorders, JAMA, Mental Health Research, Pediatrics / 13.04.2018

MedicalResearch.com Interview with: Tracy Vaillancourt, Ph.D. Full Professor and Canada Research Chair Children’s Mental Health and Violence Prevention Counselling Psychology, Faculty of Education School of Psychology, Faculty of Social Sciences University of Ottawa MedicalResearch.com: What is the background for this study? Response: Although there have been a few studies that have looked at the relation between being bullied and disordered eating, most studies have looked at it from the perspective of does being bullied lead to disordered eating and does depressive symptoms mediate (i.e., explain) the link. We wanted to look more closely at how bullying, disordered eating, and depression were related over time among teenagers by examining all possible pathways. Another novel aspect of our study was the focus on disordered eating behaviour only (e.g., vomiting, using diet pills, binge eating). Most previous work has examined behaviour and thoughts together, but because disordered eating thoughts are so common (termed normative discontent; e.g., fear of fat, dissatisfaction with body shape or size), particularly among girls and women, we wanted to focus on behaviour, which is more problematic in terms of physical and psychiatric health. (more…)
Author Interviews, JAMA, Mental Health Research, OBGYNE, Pediatrics / 11.04.2018

MedicalResearch.com Interview with: Jiook Cha, PhD Assistant Professor Division of Child and Adolescent Psychiatry Columbia University Medical Center New York, NY 10032 MedicalResearch.com: What did we already know about the connection between maternal SSRI use during pregnancy and infant brain development, and how do the current study findings add to our understanding? What’s new/surprising here and why does it matter for mothers and babies? Response: Prior studies have shown mixed results in terms of the associations between maternal SRI use during pregnancy and offspring’s brain and cognitive development. Neurobiological studies with animal models suggest that SSRI use perturbs serotonin signaling and that this has important effects on cognitive development (a study conducted an author of this paper, Jay Gingrich, MD, PhD: Ansorge et al., 2004, Science). The human literature has been more mixed in terms of the associations of prenatal exposure to SSRI with brain and cognitive development. In our study, we used neonatal brain imaging because this is a direct, non-invasive method to test associations between SSRI use and brain development at an early developmental stage, limiting the effects of the post-natal environment. In our study, we had two different control groups, that is, a non-depressed SSRI-free group (healthy controls), and depressed but SSRI-free (SSRI controls) group. Also, in our study we used rigorous imaging analytics that significantly improve the quantitative nature of MR-derived signals from the brain structure using two of the nation’s fastest supercomputers (Argonne National Laboratory and Texas Advanced Computing Center) and allows robust reconstruction of brain’s grey and white matter structure in the infants’ brains. We report a significant association of prenatal exposure to SSRI with a volume increases within many brain areas, including the amygdala and insula cortex, and an increase in white matter connection strength between the amygdala and insular cortex. We were surprised by the magnitude of the effects (or the statistical effect size), compared with other brain imaging studies in psychiatry with children or adults’ brains. Importantly, it should be noted that our estimates of brain structure are still experimental and for research-purpose only. This means that our data need to be replicated and rigorously tested against confounders in order to make a firm conclusion. While our study suggests a “potential” association between prenatal exposure to SSRI and a change in fetal or infant brain development, we still need more research.  tracts_in_the_brain (more…)
Author Interviews, Epilepsy, JAMA / 10.04.2018

MedicalResearch.com Interview with: Dr Hayley Gorton PhD MPharm MRPharmS FHEA Research Associate Centre for Pharmacoepidemiology and Drug Safety Research Division of Pharmacy & Optometry| Faculty of Biology, Medicine & Health University of Manchester MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is already known that people with epilepsy are at a higher risk of death than those without epilepsy but we didn’t know much about the risks of different types of death. Unnatural death (mainly accident and suicide) accounts for a very small number of all deaths but, compared to people without epilepsy, people with epilepsy are three times more likely to die by accident and twice as likely to die by suicide. Within these broad categories, persons with epilepsy are five times more likely to die specifically by accidental poisoning with medication, and three times more likely to die by intentionally poisoning themselves with medication. Opioid painkillers and medicines for mental illness were the ones most commonly used in poisoning deaths among people with epilepsy and those without epilepsy. Antiepileptic drugs were taken relatively infrequently-they were involved in about 10% of poisoning deaths in people with epilepsy.  (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA, Pharmaceutical Companies / 09.04.2018

MedicalResearch.com Interview with: Aaron Mitchell, MD Division of Hematology/Oncology, Department of Medicine, Lineberger Comprehensive Cancer Center The Cecil G. Sheps Center for Health Services Research The University of North Carolina at Chapel Hill MedicalResearch.com: What is the background for this study? What are the main findings? Response: Financial relationships between physicians and the pharmaceutical industry are very common. However, we are just beginning to figure out whether these relationships may lead to potentially concerning changes in physician behavior - whether physicians tend to prescribe more of the drugs made by a company that has given them money. We decided to ask whether oncologists who receive money from drugmakers are more likely to use the cancer drugs made by companies that have given them money in the past. In studying two specific groups of cancer drugs, one for kidney cancer and one for chronic myeloid leukemia (CML), we found that oncologists who had received payments such as meals, consulting fees, travel & lodging expenses from the manufacturer of one of these drugs tended to use that drug more. When looking at oncologists who received payments for research, we found increased prescribing among the kidney cancer drugs but not the CML drugs. (more…)
Author Interviews, JAMA, Mental Health Research, OBGYNE, Pediatrics / 09.04.2018

MedicalResearch.com Interview with: Claudia I. Lugo-Candelas, PhD Postdoctoral Research Fellow Columbia University Medical Center/ New York State Psychiatric Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: We have seen, in the last decade, an increase in the amount of mothers being prescribed SSRIs during pregnancy. While we know that untreated prenatal maternal depression has adverse consequences for both the mother and child, it’s not really clear what, if any, are the consequences of prenatal SSRI exposure on infant’s brain development. There have been some studies finding increased depression and anxiety in children prenatally exposed to SSRIs, but not all studies find these associations. We thus looked at 2-4 week old infants’ brains, using neuroimaging.  We found increased gray matter volume within the amygdala and insula, and increased white matter connectivity between these two structures in infants prenatally exposed to SSRIs. Of note, the statistical significance and the size of the effects we detected are quite large, even greater than the brain changes that we usually observe in our studies of children and adults with psychiatric disorders. Further, because these structures are involved in emotion processing, and alterations in volume and connectivity are sometimes seen in clinical populations, or in people at risk for anxiety, it important to learn more about what these volume and connectivity differences could mean for these infants. (more…)
ALS, Alzheimer's - Dementia, Author Interviews, JAMA / 09.04.2018

MedicalResearch.com Interview with: Celeste Karch, PhD Assistant Professor of Psychiatry Molecular mechanisms underlying tauopathies Washington University School of Medicine St Louis MedicalResearch.com: What is the background for this study? What are the main findings? Response: Nearly half of all patients with amyotrophic lateral sclerosis (ALS), a fatal neuromuscular disorder, develop cognitive problems that affect memory and thinking. Why a disease that primarily affects movement also disrupts thinking has been unclear. Our findings suggest that genetic connections between the two disorders may explain why they share some of the same features and suggest that some drugs developed to treat ALS also may work against frontotemporal dementia and vice versa. We used a statistical method in almost 125,000 individuals with ALS, frontotemporal dementia (FTD), progressive supranuclear palsy, corticobasal degeneration, Alzheimer’s disease and Parkinson’s disease to determine whether there are common genetic variants that increase risk for multiple neurodegenerative diseases. We found that common variants near the MAPT gene, which makes the tau protein, increases risk for ALS. MAPT has previously had been associated with diseases including frontotemporal dementia and Alzheimer’s disease. But the gene hadn’t been linked to ALS. We also identified variations in a second gene, BNIP1, which normally plays an important role in protecting against cell death, increased the risk of both ALS and frontotemporal dementia. ImportantlyBNIP1 mRNA levels were altered in people who had ALS and in patients with frontotemporal dementia, suggesting the BNIP1 may be a potential therapeutic target for both disorders. (more…)
Author Interviews, JAMA, Mental Health Research / 07.04.2018

MedicalResearch.com Interview with: Dr. Aideen Maguire Centre of Excellence for Public Health Queen's University Belfast Institute of Clinical Sciences B Royal Hospitals Site, Belfast MedicalResearch.com: What is the background for this study?   Response: Consanguineous Marriage is the marriage between second or first cousins. Although not common practice in the Western world approximately 1 in 10 children worldwide are born to consanguineous parents. It is legal in all countries worldwide except the United States of America, North Korea and China. Cousin-marriage is associated with an increased risk of autosomal recessive genetic disorders in offspring but the association between cousin-marriage and the mental health of offspring has not been extensively studied. MedicalResearch.com: What are the main findings? Response: Children of consanguineous parents are over 3 times more likley to be in receipt of medications for common mood disorders (antidepressant and/or anxioltyic medication) compared to children of non-related parents and over twice as likley to be in receipt of antipsychotic medication compared to children of non-related parents.  (more…)
Author Interviews, Brigham & Women's - Harvard, Heart Disease, JAMA / 06.04.2018

MedicalResearch.com Interview with: Dr. Alvin Chandra  MD first author  and Dr. Scott David Solomon M.D. Director, Noninvasive Cardiology Professor, Harvard Medical School Cardiovascular Medicine Brigham and Women’s Hospital Boston, Massachusetts MedicalResearch.com: What is the background for this study? What are the main findings? Response: In general, the quality of life of heart failure with reduced ejection fraction patients is quite impaired, and  similar to that of patients on dialysis. PARADIGM-HF was the largest trial of heart failure patients and showed that sacubitril/valsartan was superior to the gold-standard enalapril in reducing cardiovascular death, heart failure hospitalization and all-cause mortality. In addition, patients on sacubitril/valsartan, when compared to enalapril, showed significant improvement in overall quality of life. In this study we looked in more detail at the individual components of “quality of life” and found that in virtually all domains and activities, patients who were randomized to sacubitril/valsartan reported improvement in their limitations  compared to those who were randomized to enalapril. These activities included jogging, doing hobbies, and household chores, with the largest improvement seen in  sexual activities limitations. (more…)
Author Interviews, Genetic Research, Heart Disease, JAMA / 06.04.2018

MedicalResearch.com Interview with: Stella Aslibekyan, PhD Associate Professor PhD Program Director Department of Epidemiology University of Alabama at Birmingham MedicalResearch.com: What is the background for this study? What are the main findings? Response: When the human genome was sequenced in 2003, there were somewhat unrestrained expectations of unraveling all etiologic mysteries and discovering breakthrough treatments. Needless to say, that did not happen, in part because individual genetic variants can only account for a small fraction of trait variability. Since then, epigenetics-- the study of mitotically heritable changes in gene expression-- has emerged as another promising avenue for understanding disease risk. The best studied epigenetic process in humans is DNA methylation, and earlier studies (including some from our group) have shown interesting associations between changes in methylation in specific genomic regions and cardiovascular disease traits, e.g. plasma cholesterol levels. In this project, we have combined DNA methylation data on thousands of individuals from multiple international cohorts and interrogated epigenetic contributions to circulating tumor necrosis factor alpha (TNFa), a marker of systemic inflammation. We identified and replicated several epigenomic markers of TNFa, linked them to variation in gene expression, and showed that these methylation changes (which were located in interferon pathway genes) were predictive of coronary heart disease later in life. Interestingly, the variants we discovered were not sequence-dependent (in other words, they were not associated with any genetic mutations), highlighting the role of the environment. (more…)
Author Interviews, Colon Cancer, Genetic Research, JAMA / 03.04.2018

MedicalResearch.com Interview with: Heather Hampel, MS, LGC Associate Director, Division of Human Genetics Associate Director, Biospecimen Research Professor, Internal Medicine Licensed Genetic Counselor The Ohio State University Comprehensive Cancer Center Columbus, OH  4322 MedicalResearch.com:  What is the background for this study?  What are the main findings? Response: The background is that we had recently shown that some colorectal cancer patients who underwent traditional screening for Lynch syndrome were eventually found to have double somatic (two acquired) mutations in the MMR genes and they did not have Lynch syndrome at all. This was discovered after their tumor had already had MSI and/or IHC screening test, followed by MLH1 methylation and/or BRAF testing, followed by germline DNA testing on a blood sample from the patient for MMR gene mutations, then finally by sequencing their tumor. This gave us the idea to reverse the sequence and start with tumor sequencing since it might streamline testing, save time, and prevent several other tests. In addition, we knew that all stage IV colorectal cancer are already supposed to have tumor sequencing of the KRAS, NRAS, and BRAF genes and MSI testing for treatment purposes. Our hypothesis was that an upfront tumor sequencing test could replace all these separate tests with similar sensitivity and specificity. (more…)
Author Interviews, Cannabis, JAMA, Opiods / 02.04.2018

MedicalResearch.com Interview with: Hefei Wen, PhD Assistant Professor, Department of Health Management & Policy University of Kentucky College of Public Health  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Marijuana is one of the potential, non-opioid alternatives that can relieve pain at a relatively lower risk of addiction and virtually no risk of overdose. Medical and adult-use marijuana laws, has made marijuana available to more Americans. Yet no study to date has focused on the effect of medical and adult-use marijuana laws on opioid prescribing in particular. Our study provides some of the first empirical evidence that the implementation of medical and adult-use marijuana laws between 2011 and 2016 was associated with lower opioid prescribing rates and spending among Medicaid enrollees.   (more…)
Author Interviews, Gender Differences, JAMA, Surgical Research / 02.04.2018

MedicalResearch.com Interview with: Neel Mansukhani, MD Department of Surgery Northwestern University and Melina R. Kibbe, MD, FACS, FAHA Colin G. Thomas Jr. Distinguished Professor and Chair Department of Surgery Professor, Department of Biomedical Engineering The University of North Carolina at Chapel Hill Chapel Hill, NC 27599-7050 Editor in Chief, JAMA Surgery  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: This study is a follow-up to our previous work that examined sex bias in surgical research. Previously, we examined sex bias in basic and translational science surgical research, as well as in clinical surgical research. We discovered previously that sex bias exists in basic and translational surgical research in the unequal inclusion of male and female research subjects. In clinical research, we found sex bias in the degree of sex matching of included subjects, and in the frequency of sex-based reporting, analysis, and discussion of the data. In this current work, we sought to understand the effect of author gender on sex bias in surgical research. In this work, we found that most authors are male, most authors work with other authors of the same gender, and sex bias is prevalent regardless of author gender. Most importantly, we found that sex inclusive research receives more citations after publication compared to sex-biased research.  (more…)
Author Interviews, Cannabis, JAMA, Opiods / 02.04.2018

MedicalResearch.com Interview with “Cannabis sativa” by Manuel is licensed under CC BY 2.0 David Bradford, Ph.D. Busbee Chair in Public Policy Department of Public Administration and Policy University of Georgia Athens, GA 30602 MedicalResearch.com: What is the background for this study? Response: To give you some background, in 2016, part of our research team (Bradford and Bradford) published the first study to directly examine the impact that medical cannabis laws (MCLs) may be having on prescription use. We used yearly physician-level Medicare Part D data, looked at nearly all prescription drugs used to treat 9 broad categories of illness/diagnoses, and found substantial reductions in prescriptions. We published a follow-up study in 2017, this time using data from Medicaid Fee-for-Service. Again, we found significant substitution away from prescription medications. In both of these studies, pain was included in the list of conditions for which cannabis may be used in patients, and in both studies, pain prescriptions fell. One of the unanswered questions from both of those studies, though, was what *type* of pain medications were being reduced.  From a public health standpoint, when we're worried about opioid overdose, it matters whether the substitution away from pain medications is coming from substitutions away from things like NSAIDs or whether there is substitution away from opioids. (more…)
Author Interviews, JAMA, Schizophrenia / 29.03.2018

MedicalResearch.com Interview with: Silvana Galderisi MD President of the European Psychiatric Association Professor of Psychiatry University of Campania "Luigi Vanvitelli" Italy MedicalResearch.com: What is the background for this study? Response: The goal of schizophrenia treatment has gradually shifted from reduction of symptoms and prevention of relapse to improvement of real-life functioning. In fact, these outcomes not always coincide and, in spite of progress in treatments reducing symptoms and preventing relapses, people with schizophrenia live 15-20 years less than the general population, are often unemployed, and show severe disabilities. Enhanced understanding of factors associated with real-life functioning is instrumental to design effective integrated and personalized treatment plans for persons with schizophrenia. To this aim, the Italian Network for Research on Psychoses, including 26 twenty-six Italian university psychiatric clinics and/or mental health departments, has focused on the identification of variables influencing real-life functioning, in particular on the interrelationships among illness-related variables, personal resources, context-related variables and real-life functioning. The number of variables and subjects included in the study was larger than in any other study on this topic, and for the first time the network analysis was used to model the interplay among cognitive, psychopathological and psychosocial variables in a large sample of community dwelling subjects with schizophrenia. The network analysis is a data-driven approach; it does not rely on an a priori model of relationships among variables, provides quantitative measures of variable centrality within the network, thus indicating which variables play a key role in the network, and which ones are instead more peripheral. In addition, by inspecting the network, it is possible to understand the extent to which variables belonging to the same construct are connected, and how different constructs are mutually interacting and reinforcing each other.  (more…)
Alzheimer's - Dementia, Author Interviews, JAMA, Parkinson's / 27.03.2018

MedicalResearch.com Interview with: Benjamin Dawson, B.Sc. MD Candidate 2020 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Dementia in Parkinson’s Disease is one of its most feared complications, and may happen eventually to most patients if they reached advanced age. Identifying those at especially high risk of dementia has important potential implications - it would facilitate clinical counselling, it has treatment implications (e.g. knowing a person is likely to get dementia in the near future would probably steer you away from certain medications and towards others).  Most critically, it can help select patients for trials to prevent dementia. While several factors that show high risk for dementia in Parkinson’s disease have previously been described, these have yet to shape patient-care, either because they are not very strong predictors, or they are not user-friendly.  So, we designed a very simple clinical screening tool, called the Montreal Parkinson’s Risk of Dementia Scale (MoPaRDS).  It took predictors of dementia that were established from large-scale studies and boiled them down into a simple 8-point scale that uses information that you can get in a simple office visit.  The 8 predictors were being over 70, being male, having a blood pressure drop with standing, showing early mild cognitive changes, having a symmetric bilateral disease (that is, one side not clearly worse than the other), experiencing falls or freezing, having experienced hallucinations, and having symptoms of REM sleep behavior disorder ('acting out' the dreams at night). When we tested the scale in a combined cohort of 607 patients with Parkinson’s (of whom 70 developed dementia over mean follow-up of 4.4-years) a positive MoPaRDS screen (≥4 out of 8 items) identified 14-fold increased risk of dementia compared to a negative screen. We recommend dividing the scale into three categories; low-, intermediate- and high-risk. Those in the highest score group (MoPaRDS, 6-8) had a 14.9% risk of developing dementia each year, while those with the lowest scores (MoPaRDS, 0-3) had only 0.6% annual risk.  So, these simple measures can be pretty powerful predictors of dementia. (more…)
Author Interviews, Breast Cancer, Chemotherapy, JAMA, Novartis / 26.03.2018

MedicalResearch.com Interview with: Melanie E. Royce, MD, PhD Division of Hematology/Oncology University of New Mexico Comprehensive Cancer Center Albuquerque MedicalResearch.com: What is the background for this study? What are the main findings? Response: BOLERO-4 is an open label, single-arm, Phase II study that evaluates the combination of everolimus plus letrozole as a first-line treatment for hormone receptor (HR)-positive/human epidermal growth factor receptor (HER2)-negative advanced breast cancer patients, as well as the use of everolimus plus exemestane beyond initial progression. Results of the BOLERO-4 trial published in JAMA Oncology showed that everolimus in combination with endocrine therapy is an effective first-line treatment option for postmenopausal women with HR+/HER2- advanced breast cancer. A total of 202 patients received everolimus in combination with letrozole as first-line treatment between March 7, 2013 and December 17, 2014. Median progression-free survival (PFS) in the first-line setting was 22.0 months (95% CI 18.1-25.1) with an overall response rate of 45% (95% CI 38.1-52.2) and clinical benefit rate of 74% (95% CI 67.7-80.1). A total of 152 (75%) discontinued treatment, primarily due to disease progression (51%) or adverse events (16%). Data from a smaller number of patients in BOLERO-4 also show limited efficacy with continued everolimus, combined with exemestane, following disease progression. Second-line treatment was ongoing in 16 (32%) patients, while 34 (68%) had discontinued. The most frequent reason for second-line treatment discontinuation was disease progression (56%). In the second-line setting, median PFS was 3.7 months (95% CI 1.9-7.4) with an overall response of 6% (95% CI 1.3-16.5) and clinical benefit rate of 28% (95% CI 16.2-42.5). Safety findings from BOLERO-4 are consistent with previous studies of Afinitor in advanced breast cancer. The most common (≥ 20% incidence) first-line all-grade adverse events were stomatitis (69%), weight loss (44%), nausea (37%) and anemia (35%). Most were ‘low grade’ in severity (grade 1 or 2) and generally well managed. Safety findings show the most common (≥ 10% incidence) second-line adverse events were stomatitis (20%) and weight loss (20%). Lower rates of stomatitis in second-line were noted.  (more…)
Author Interviews, CDC, Infections, JAMA / 26.03.2018

MedicalResearch.com Interview with: Dr. Katherine Fleming-Dutra, MD, senior author Deputy Director Office of Antibiotic Stewardship CDC MedicalResearch.com: What is the background for this study? What are the main findings? Response: As noted in a previous study, antibiotics are prescribed more for sinus infections than any other illness in the United States. We found that almost 70% of antibiotic prescriptions were for 10 days or longer, whereas 5-7 days is recommended for most patients when antibiotics are needed. In addition, more than 20% of antibiotic prescriptions for sinus infections were for 5 days of azithromycin, even though guidelines recommend against prescribing azithromycin for sinus infections. (more…)