Author Interviews, Heart Disease / 28.07.2017

MedicalResearch.com Interview with: Tom Marshall, MSc, PhD, MRGP, FFPH Professor of public health and primary care Institute of Applied Health Research University of Birmingham Birmingham UK  MedicalResearch.com: What is the background for this study? What are the main findings? Response: It is widely recognised that anticoagulants are underused in patients with atrial fibrillation (AF) although they are effective in reducing risk of stroke. We investigated whether this could be explained by the fact that many AF patients have conditions which are considered relative contraindications to their use. We analysed electronic medical records from 645 general practices from 2004 to 2015 and included over 1 million patients with AF. We found that about 6% of AF patients had are relative contraindications such as recent history of major bleeding. In each of the 12 years, similar numbers of patients with and without contraindications were prescribed anticoagulants. (more…)
Author Interviews, Electronic Records, General Medicine / 28.07.2017

MedicalResearch.com Interview with: Macda Gerard M.D. Candidate | Class of 2021 Wayne State University School of Medicine MedicalResearch.com: What is the background for this study? Response: As electronic health records proliferate, patients are increasingly asking for their health information but little is known about how patients use that information or whether they encounter errors in their records. This comes at a time when we’re learning that understanding the patient and family experience, especially what is most valued in exchanges between doctors and patients is important and has many benefits. To learn more, we developed a formal mechanism for patients to provide feedback on what they like about accessing the information in their health records and to inform their clinical team about things like inaccuracies and perceived errors. So that’s the gap we tried to fill. The patient feedback tool is linked to the visit note in the electronic health record (EHR), and it’s part of a quality improvement initiative aimed at improving safety and learning what motivates patients to engage with their health information on the patient portal. Over the 12-month pilot period, 260 patients and care partners provided feedback using the OpenNotes patient feedback tool. Nearly all respondents found the tool to be valuable and about 70 percent provided additional information regarding what they liked about their notes and the feedback process. (more…)
Addiction, Author Interviews, Gender Differences, Mental Health Research, Opiods / 28.07.2017

MedicalResearch.com Interview with: Andrea M. Tilstra Doctoral Student, Department of Sociology Population Program, Institute of Behavioral Science University of Colorado Boulder and Ryan K. Masters Assistant Professor, Department of Sociology Faculty Associate, Population Program and Health & Society Program Institute of Behavioral Science University of Colorado Boulder MedicalResearch.com: What is the background for this study? What are the main findings? Response:  “Despair” deaths – deaths from suicides, alcohol poisonings, and drug overdoses – have been a topic of interest in recent mortality research. For instance, existing findings suggest that mortality among white Americans has increased as a result of middle-aged whites experiencing elevated levels of despair and distress. These factors supposedly are driving white Americans to cope in unhealthy ways – excessive drinking, drug use, and suicides. However, there were two major problems with the existing research that supported this narrative. First, men and women were analyzed together, despite the knowledge that overall mortality levels and trends differ significantly by gender. Second, all three of the aforementioned causes of death were pooled together and analyzed as one group. This is highly problematic if deaths from suicides, alcohol use, and drug use are not, in fact, moving in conjunction with one another. We addressed these issues and expanded previous analyses by analyzing cause-specific death rates for men and women separately, for years 1980-2014, and decomposing the trends into period- and cohort- based analyses. We find that there are huge gender differences in U.S. white mortality rates and that trends in mortality from the three causes of death are quite distinct from one another. Recent increases in U.S. white mortality are largely driven by period-based increases in drug poisoning deaths and cohort-based increases in metabolic disease deaths. (more…)
Author Interviews, Blood Pressure - Hypertension, Brigham & Women's - Harvard, JAMA / 28.07.2017

MedicalResearch.com Interview with: Stephen P. Juraschek, MD, PhD Instructor of Medicine Beth Israel Deaconess Medical Center Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Many adults experience dizziness and light-headedness when they stand up. This is more common in older adults and is related to risk of falling, fractures, fainting, car crashes, and early death. These symptoms are thought to be caused by a drop in blood pressure after standing also called orthostatic hypotension. However, if measured at the wrong time it is possible to miss this important clinical sign. For over 2 decades (since 1996), it has been recommended that orthostatic hypotension be identified by measuring blood pressure within 3 minutes of standing. Furthermore, it was also thought that measurements immediately after standing be avoided because they might be inaccurate (based on fluctuation in blood pressure immediately after standing). As a result, a lot of clinical protocols instructing healthcare staff on measuring orthostatic blood pressure encourage measurement at 3 minutes, but this has not been scientifically evaluated. (more…)
Author Interviews, Gastrointestinal Disease, Microbiome / 28.07.2017

MedicalResearch.com Interview with: Eric I. Benchimol, MD, PhD, FRCPC Associate Professor of Pediatrics and Epidemiology, University of Ottawa Division of Gastroenterology, Hepatology and Nutrition Children's Hospital of Eastern Ontario Ottawa, ON Canada MedicalResearch.com: What is the background for this study? What are the main findings? Response: We found that living in a rural household (compared to urban households) was protective against developing inflammatory bowel disease (IBD). People living in a rural household were around 10% less likely to get IBD (Crohn’s disease and ulcerative colitis). While our finding that IBD was more common in people living in urban households was similar to other studies from around the world, there were a number of new, interesting findings:
  1. Living in a rural household was most protective against pediatric-onset IBD. In fact, it was not protective in IBD with onset between ages 18-39, 40-64, or 65 and older at diagnosis.
  2. Living in a rural household in the first 5 years of life was highly protective against IBD later in life.
These findings indicate the importance of early life environmental exposures in the subsequent development of IBD. This effect has been seen in the inflammatory bowel disease literature when examining other environmental risk factors, particularly early-life antibiotic use and air pollution. These risk factors seem to have the strongest effect of increasing the risk of childhood-onset IBD, and not adult-onset disease. (more…)
Author Interviews, Education, Heart Disease, JAMA, Lifestyle & Health, Primary Care, UCLA / 28.07.2017

MedicalResearch.com Interview with: Carol M. Mangione, MD, MSPH, FACP Barbara A. Levey, MD, and Gerald S. Levey, MD Endowed chair in medicine David Geffen School of Medicine University of California, Los Angeles Professor of public health at the UCLA Fielding School of Public Health MedicalResearch.com: What is the background for this study? Response: Americans can experience several health benefits from consuming healthy foods and engaging in physical activity. The Task Force recommends that primary care professionals work together with their patients when making the decision to offer or refer adults who are not obese and do not have hypertension, high cholesterol, high blood sugar, or diabetes to behavior counseling to promote healthful diet and physical activity. Our focus was on the impact of a healthful diet and physical activity on cardiovascular risk because this condition is the leading cause of premature morbidity and mortality. The Task Force evaluates what the science tells us surrounding the potential benefits and harms of a particular preventive service. In this case, the Task Force found high quality evidence focusing on the impact a healthful diet and physical activity can have on a patient’s risk of cardiovascular disease. Relying on this evidence, the Task Force was able to conclude that there is a positive but small benefit of behavioral counseling to prevent cardiovascular disease. (more…)
Accidents & Violence, Author Interviews, Opiods / 28.07.2017

MedicalResearch.com Interview with: Stanford Chihuri, MPH Staff Associate/Data Analyst Department of Anesthesiology, College of Physicians and Surgeons Columbia University Medical Center NY, NY 10032  MedicalResearch.com: What is the background for this study? What are the main findings? Response: In the past 2 decades, consumption of prescription opioids has substantially increased in the U.S. Prescription drugs may cause drowsiness and impaired cognition which may interfere with psychomotor functioning necessary during the operation of a motor vehicle. The current study assessed time trends in prescription opioids detected in drivers killed in motor vehicle crashes from 1995 to 2015 in 6 states in the U.S. Results of the study showed that the prevalence of prescription opioids detected in fatally injured drivers has increased 700% in the past 2 decades. (more…)
Author Interviews, Biomarkers, Critical Care - Intensive Care - ICUs, PLoS, Surgical Research / 27.07.2017

MedicalResearch.com Interview with: Dr. Joanna Shepherd Centre for Trauma Sciences Blizard Institute Queen Mary, University of London MedicalResearch.com: What is the background for this study? What are the main findings? Response: Recent advances in resuscitation and treatment of life-threatening critical injuries means that patients with previously unsurvivable injuries are now surviving to reach hospital.  However, many of these patients develop Multiple Organ Dysfunction Syndrome (MODS), which is a failure of several organs including the lung, heart, kidney, and liver. We studied immune cell genes in the blood of critically injured patients within the first few minutes to hours after injury, a period called the ‘hyperacute window’. We found a small and specific response to critical injury during this window that then evolved into a widespread immune reaction by 24 hours.  The development of MODS was linked to changes in the hyperacute window, with central roles for innate immune cells (including natural killer cells and neutrophils) and biological pathways associated with cell death and survival.  By 24 hours after injury, there was widespread immune activation present in all critically injured patients, but the MODS signal had either reversed or disappeared. (more…)
Author Interviews, Psychological Science, Sexual Health / 27.07.2017

MedicalResearch.com Interview with: Omri Gillath PhD Department of Psychology University of Kansas Angela Bahns, PhD Wellesley College MedicalResearch.com: What is the background for this study? What are the main findings? Response: We tracked the eye movements of 105 heterosexual participants while they viewed photos of strangers and answered questions about their interest in either becoming friends with or dating the person. We found that in looking at others, people scan the body differently depending on whether a person is judged as a potential friend or a potential romantic partner. Heterosexual men and women looked at the head or chest of an opposite-sex person longer and more often when evaluating dating potential compared to friendship potential. In contrast, both men and women looked at the legs or feet more for friendship judgments than for dating judgments (although overall legs and feet were looked at less than other body regions). (more…)
Annals Internal Medicine, Author Interviews, Brigham & Women's - Harvard, Hormone Therapy, Sexual Health, Testosterone / 27.07.2017

MedicalResearch.com Interview with: Carl G Streed Jr. M.D. Pronouns: he, him, his, himself Fellow, Division General Internal Medicine & Primary Care Brigham & Women’s Hospital  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Recent reports estimate that 0.6% of adults in the United States, or approximately 1.4 million persons, identify as transgender. Despite gains in rights and media attention, the reality is that transgender persons experience health disparities, and a dearth of research and evidence-based guidelines remains regarding their specific health needs. The lack of research to characterize cardiovascular disease (CVD) and CVD risk factors in transgender populations receiving cross-sex hormone therapy (CSHT) limits appropriate primary and specialty care. As with hormone therapy in cisgender persons (that is, those whose sex assigned at birth aligns with their gender identity), existing research in transgender populations suggests that CVD risk factors are altered by CSHT. (more…)
Author Interviews, JAMA, Pediatrics, Sleep Disorders / 26.07.2017

MedicalResearch.com Interview with: Rachel Y. Moon, M.D. Division Head, General Pediatrics Professor of Pediatrics University of Virginia School of Medicine Charlottesville, VA 22908 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Approximately 3500 babies die suddenly and unexpectedly during sleep in the US every year. Even though there are safe sleep recommendations, many parents do not follow them because of misinformation or misconceptions. Therefore we tested 2 complementary interventions to promote infant safe sleep practices. The first was a nursing quality improvement intervention aimed at ensuring that mothers would hear key messages and that there was appropriate role modeling of safe sleep practices by hospital personnel. The second was a mobile health intervention, in which mothers received videos and text messages or emails with safe sleep information during the baby's first two months of life. We randomized mothers to receive either the safe sleep interventions or breast-feeding interventions (the control interventions). Mothers who received the mobile health intervention reported statistically significantly higher rates of placing their babies on their back, room sharing without bed sharing, no soft bedding use, and pacifier use, compared with mothers who received a control intervention. Although the nursing quality improvement intervention did not influence infant safe sleep practices, there was an interaction such that mothers who received both the safe sleep nursing quality improvement intervention and the safe sleep mobile health intervention had the highest rates of placing their babies on the back. (more…)
Alzheimer's - Dementia, Author Interviews, Race/Ethnic Diversity / 26.07.2017

MedicalResearch.com Interview with: Amy Kind, M.D., Ph.D. Associate Professor, Division of Geriatrics Director, Department of Medicine Health Services and Care Research Program University of Wisconsin School of Medicine and Public Health and Associate Director- Clinical Geriatrics Research, Education and Clinical Center (GRECC) William S. Middleton Veteran’s Affairs Hospital MedicalResearch.com: What is the background for this study? What are the main findings? Background: Dementia due to Alzheimer’s Disease (AD) disproportionately impacts racial/ethnic minorities and the socioeconomically disadvantaged—populations often exposed to neighborhood disadvantage. Neighborhood disadvantage is associated with education, health behaviors and mortality. Health improves with moving to less disadvantaged neighborhoods (Ludwig, Science 2012). Although studies have linked neighborhood disadvantage to diseases like diabetes and cancer, little is known about its effect on development of dementia. Objective:  To examine the association between neighborhood disadvantage, baseline cognition, and CSF biomarkers of Alzheimer’s Disease among participants in the WRAP study, comprising a cohort of late-middle-aged adults enriched for parental family history of AD. Methods:  We created and validated neighborhood-level quantifications of socioeconomic contextual disadvantage for the full US—over 34 million Zip+4 codes—employing the latest American Community Survey and Census data. This metric--the Area Deprivation Index (ADI)--incorporates poverty, education, housing and employment indicators; predicts disparity-related health outcomes; and is employed by Maryland and Medicare through our provision. We used standard techniques to geocode all WRAP subjects with a documented address (N= 1479). WRAP participants were ranked into deciles of neighborhood disadvantage, by ADI. Baseline cognitive function (indexed by factor scores) and CSF biomarker outcomes for levels of Aβ42 and P-tau181 (n=153 with CSF samples) were examined by neighborhood disadvantage decile. (more…)
Author Interviews, Cognitive Issues, General Medicine, JAMA / 26.07.2017

MedicalResearch.com Interview with: Jochen René Thyrian, PhD German Center for Neurodegenerative Diseases (DZNE) Greifswald, Germany MedicalResearch.com: What is the background for this study? What are the main findings? Response: Dementia presents a challenge to the health care systems worldwide. People with dementia (PWD) need comprehensive medical, nursing, psychological and social support to delay the progression of disease and sustain autonomy and social inclusion. Evidence-based interventions alleviate the burden of disease for PwD and their caregivers, as no curative treatment is currently available. Involving caregivers is important because they provide the largest proportion of care for PwD. General physicians in residency have been identified as the first point of contact for PwD and is thus a promising setting for identification, comprehensive needs assessment and initiating dementia-specific treatment and care. In this study we tested the effectiveness and safety of a model of collaborative care, Dementia Care Management (DCM) on patient-oriented outcomes in n=634 people screened positive for dementia in primary care. DCM is provided by specifically trained nurses, supported by a computerized intervention management system, in close cooperation with the treating physician at the people´s homes. Recommendations for improving treatment and care were based on a comprehensive needs assessment, discussed interprofessionally and their implementation monitored/ adjusted over the course of 6-12 months (more…)
Author Interviews, Gender Differences, Mental Health Research / 26.07.2017

MedicalResearch.com Interview with: Areti Smaragdi, PhD University of Southampton Southampton, UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: Conduct Disorder is a psychiatric disorder that involves severe antisocial behavior – symptoms of the condition include behaviors like physical fighting, pathological lying, and serious theft. The disorder affects around 5% of school-aged children and adolescents, and is up to three times more common in boys than girls. Because of this, very little research has focused on the possible brain basis of the disorder in girls. We used MRI scanning methods to measure the brain structure of 48 boys and 48 girls with Conduct Disorder (14-18 years old) and 52 boys and 52 girls without severe antisocial behavior. We found that boys and girls with Conduct Disorder had reduced thickness and more folding in the prefrontal cortex, an area at the front of the brain which is responsible for reward and punishment processing and helping us to control our emotions and impulses. In contrast, in some other areas such as the superior frontal gyrus, which is involved in short-term memory, boys and girls with Conduct Disorder showed structural changes in opposite directions (e.g., more versus less folding) compared with controls. This suggests that there are common abnormalities in brain structure in boys and girls with Conduct Disorder, but also some sex differences that might indicate that the causes of the disorder are partly different in boys and girls. (more…)
ADHD, Author Interviews, JAMA, Pharmacology / 26.07.2017

MedicalResearch.com Interview with: Professor Ian Chi Kei Wong and Kenneth KC Man, Senior Research Assistant Department of Social Work and Social Administration, Faculty of Social Science Department of Pharmacology and Pharmacy, LKS Faculty of Medicine The University of Hong Kong MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients with attention-deficit/hyperactivity disorder (ADHD) are at higher risk of various mental health problems. Previous studies suggested that individuals with ADHD are having a higher chance of both attempted and completed suicide. Methylphenidate is a psychostimulant that is recommended for the treatment of ADHD. With the increasing usage of methylphenidate over the past decade, there are concerns about the safety of the medication, in particular, psychiatric adverse effects such as suicide attempt. The current study looked into over 25,000 patients aged 6 to 25 years in Hong Kong who were receiving methylphenidate in 2001 to 2015. Using the self-controlled case series design, in which the patients act as their own control, we found that the risk of suicide attempt was 6.5 fold higher during a 90-day period before methylphenidate was initiated, remained elevated 4-fold during the first 90 days of treatment, and returned to the normal level during ongoing treatment. (more…)
Alzheimer's - Dementia, Author Interviews, Obstructive Sleep Apnea / 26.07.2017

MedicalResearch.com Interview with: O. Michael Bubu, M.D., M.P.H., C.P.H Wheaton College MedicalResearch.com: What is the background for this study?
  • Obstructive Sleep Apnea (OSA) and Alzheimer’s disease (AD) are both chronic disease conditions that are highly prevalent, cause significant morbidity and mortality to those afflicted, and have an enormous socio-economic impact. Recent human and animal studies describe associations between Sleep Disordered Breathing (SDB) and Alzheimer's Disease (AD). However, whether OSA accelerates longitudinal increases in amyloid (Aβ) burden in MCI patients is presently unclear.
  • In this study, we examined the effect of Obstructive Sleep Apnea (OSA) on longitudinal changes in brain amyloid deposition, and Alzheimer’s disease (AD) Cerebrospinal fluid (CSF) biomarkers including CSF beta-amyloid 42 peptide (Aβ-42), CSF TAU protein, CSF phosphorylated TAU protein (PTAU) in Cognitive Normal (CN), Mild Cognitive Impairment (MCI) and AD elderly. Brain amyloid (Aβ) burden, CSF Abeta42 and tau proteins are biomarkers (measurable substances whose presence are indicative) of AD-associated pathologic changes in the brain.
  • Data from 1639 subjects (516 CN, 798 MCI and 325 AD, mean ages = 74.4 ± 5.8; 73.4 ± 7.4 and 75.1 ± 7.8 respectively), in the Alzheimer’s disease Neuroimaging Initiative (ADNI) database was used. OSA was self-reported and participants were labeled OSA positive, or OSA negative (mean ages = 72.3 ± 7.1; and 73.9 ± 7.3 respectively). Statistical analyses were conductedto examine whether OSA positive compared to OSA negative participants experienced significant differences in the rate of change of AD biomarkers over time (mean = 2.52 ± 0.51 years) in each group (CN, MCI and AD). Both OSA positives and negatives were similar in age, APOE e4 status, and history of cardiovascular disease. The final models controlled for sex, body mass index (BMI), and Continuous Pulmonary Airway Pressure (CPAP) use.
(more…)
Author Interviews, Cognitive Issues, PLoS / 26.07.2017

MedicalResearch.com Interview with: Carla Aimé PhD Institute of Evolutionary Sciences of Montpellier France MedicalResearch.com: What is the background for this study? What are the main findings? Response:  In all human populations, regardless of environmental and socioeconomic conditions, menopause occurs in women well before the end of their expected lifespan. Conversely, extensive post-reproductive life-span is rare in other species; except in some cetaceans. Evolutionary theory predicts that menopause and extensive post-reproductive lifespan should emerge and persist in populations only if it is advantageous for gene transmission. Identifying this advantage is a long-standing issue, and some hypotheses has already been suggested by other researchers. However, testing these hypotheses about the emergence of menopause is difficult, in particular because menopause exists today in all human populations. It is thus not possible to measure in real life the evolutionary advantage related to menopause by comparing gene transmission of women who stop reproduction and women who don't stop reproduction. Here, we used computer simulations to overcome this difficulty by modeling the emergence of menopause in simulated human populations. The main finding were the following : - Physiological constraints are not required for menopause to emerge. - The increasing cost of reproduction with age cannot explain menopause. - Grandmothering is part of the process leading to menopause : stopping reproduction allow reallocating resources to existing children and grand-children, thus leading to increase gene transmission via increased fertility of children and survival of grand children - Cognitive resources are also important. Indeed, cognitive abilities allow accumulation of skills and experience over the lifespan, thus providing an advantage for resource acquisition. These surplus resources can then be used to increase the number of offspring or be transmitted to existing offspring and grandoffspring. Stopping reproduction during aging allows allocating more resources to assist offspring and grandoffspring, thus increasing children’s fertility and grandchildren’s survival. (more…)
Author Interviews, General Medicine, Primary Care / 26.07.2017

MedicalResearch.com Interview with: Christine D. Jones, MD, MS Assistant professor Director of Care Transitions, Hospital Medicine Group University of Colorado School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background for this study is that referrals to home health care at hospital discharge have increased over recent years.  Yet, care coordination including information exchange and communication is often suboptimal between the hospital and home health care and may contribute to medication list discrepancies and even hospital readmissions. We spoke with focus groups of home health nurses and our main findings were that improvements in key areas could care coordination after hospital discharge. Specific solutions included: 1) Clearly defining the accountability for home health orders after discharge between hospitalists and primary care providers 2) Changes to insurance requirements that currently only allow physicians to write home health orders so that nurse practitioners and physician assistants can also write home health orders 3) Enhancing access for home health agencies to hospital electronic health records and direct phone lines 4) Encouraging liaisons from home health agencies to meet patients in the hospital to align clinician and patient expectations 5) Direct coordination between home health nurses and clinicians or pharmacists to resolve medication discrepancies 6) Ensuring that detailed information about cognitive and behavioral health is included in information provided to home health from referring hospitals (more…)
Author Interviews, JAMA, Mental Health Research / 26.07.2017

MedicalResearch.com Interview with: Robert J. Ursano, M.D. Professor of Psychiatry and Neuroscience Director, Center for the Study of Traumatic Stress Dept of Psychiatry Uniformed Services University of the Health Sciences Bethesda, MD  MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study is part of the STARRS study- a study to identify risk and protective factors for suicide in US Army. Originally funded by NIMH it is not funded by DoD. It has been called the "Framingham study" for suicide and has been highly productive. In this study we report that units with one suicide attempt are at increased risk of a second- indicating clustering of suicide attempts. (more…)
Author Interviews, Cognitive Issues, JAMA, Schizophrenia / 26.07.2017

MedicalResearch.com Interview with: Olav B. Smeland MD PhD Postdoctoral researcher SFF NORMENT, KG Jepsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital & Institute of Clinical Medicine University of Oslo Oslo, Norway MedicalResearch.com: What is the background for this study? What are the main findings? Response: Schizophrenia is a severe mental disorder associated with widespread cognitive impairments. The cognitive deficits are associated with disabilities in social, economic and occupational functioning and lower quality of life among individuals with schizophrenia. Despite this, current treatment strategies largely fail to ameliorate these cognitive impairments. To develop more efficient treatment strategies in schizophrenia, a better understanding of the disease mechanisms underlying cognitive deficits is needed. For a long time we have known that schizophrenia is heritable, and in recent years many schizophrenia risk genes have been identified. Moreover, several studies have indicated that genetic risk of schizophrenia may contribute to cognitive dysfunction. In this study, we aimed to identify schizophrenia risk genes that also influence cognitive function. In a large international collaboration of researchers, we combined genome-wide association studies on schizophrenia and the cognitive traits of verbal-numerical reasoning, reaction time and general cognitive function. In total, we analyzed genetic data from more than 250.000 participants. We were able to identify 21 genetic variants shared between schizophrenia and cognitive traits. For 18 of these genetic variants, schizophrenia risk was associated with poorer cognitive performance. (more…)
Author Interviews, HIV, J&J-Janssen, Merck, Pharmacology / 26.07.2017

MedicalResearch.com Interview with: Dr. Kathleen Squires MD Professor and Director of Infectious Diseases Thomas Jefferson University Philadelphia, PA  MedicalResearch.com: What is the background for this study? What are the main findings?
  • The pivotal Phase 3 DRIVE-AHEAD study evaluated the safety and efficacy of a once-daily, single tablet, fixed-dose combination containing doravirine, an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection, compared to a fixed-dose combination containing efavirenz.
    • After 48 weeks of treatment, 84 percent of the 364 treatment-naïve patients taking once-daily DOR/3TC/TDF achieved levels of HIV-1 RNA <50 copies/mL compared to 81 percent of the 364 patients taking once-daily EFV/FTC/TDF, with an estimated treatment difference of 3.5 percent.
    • Increases in mean CD4+ T-cell counts from baseline for the DOR/3TC/TDF and EFV/FTC/TDF groups were 198 and 188 cells/mm3, respectively, with an estimated treatment difference of 10.1.
    • In addition, comparable efficacy was observed across both treatment groups among individuals with high viral load (HIV-1 RNA >100,000 copies/mL) at baseline, which consisted of 69 patients in the DOR/3TC/TDF group and 73 patients in the EFV/FTC/TDF group (Observed Failure approach).
      • Of those patients with a high viral load (HIV-1 RNA >100,000 copies/mL) at baseline, 81 percent in the DOR/3TC/TDF group and 81 percent in the EFV/FTC/TDF group achieved the study’s primary endpoint of <50 copies/mL of HIV-1 RNA, with a treatment difference of 1.0 percent.
    • The study also met its primary safety endpoint, showing that treatment with DOR/3TC/TDF resulted in fewer patients reporting events of several pre-specified neuropsychiatric adverse events compared to EFV/FTC/TDF by Week 48, including dizziness (8.8 percent versus 37.1 percent); sleep disorders and disturbances (12.1 percent versus 25.5 percent); and inability to think clearly or concentrate (4.4 percent versus 8.2 percent).
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Author Interviews, HIV, Merck, Pharmacology / 25.07.2017

MedicalResearch.com Interview with: Dr. Pedro Cahn Chief of the infectious disease unit at Juan A. Fernandez Hospital Buenos Aires, Argentina, and ONCEMRK lead study investigator MedicalResearch.com: What is the background for this study? What are the main findings? The ONCEMRK Phase 3 study was conducted to evaluate the efficacy and safety of once-daily ISENTRESS (raltegravir) HD 1200 mg (given as two 600 mg oral tablets) compared to twice daily raltegravir 400 mg, each in combination therapy with emtricitabine plus tenofovir disoproxil fumarate in previously untreated adults with HIV-1 infection with levels of HIV-1 RNA ≥ 1,000 copies/mL.
  • Week 96 data showed:
    • 5 percent of the 531 patients taking once-daily raltegravir 1200 mg (2 x 600 mg) achieved viral suppression of less than 40 copies/mL of HIV-1 RNA, compared to 80.1 percent of the 266 patients taking twice-daily raltegravir 400 mg, both in combination therapy with emtricitabine plus tenofovir disoproxil fumarate, with a treatment difference of 1.4 percent.
    • Increases in CD4+T-cell counts from baseline were comparable for the two treatment regimens, with an average increase of 261.6 cells/mm3 for once-daily raltegravir (1200 mg) and 262.2 cells/mm3 for twice-daily raltegravir (400 mg).
    • Efficacy was consistent across a variety of patient populations, including those with high viral load at baseline (HIV-1 RNA >100,000 copies/mL).
    • Treatment-emergent viral mutations leading to any drug resistance were detected in less than 1 percent of patients in both treatment arms, with 4/531 (0.8 percent) in the once-daily raltegravir (1200 mg) treatment arm, and 2/266 (0.8 percent) in the twice-daily raltegravir (400 mg) treatment arm through 96 weeks.
    • The rate of discontinuation of therapy due to adverse events through 96 weeks was low (1.3 percent in patients receiving once-daily raltegravir (1200 mg) and 2.3 percent in patients receiving twice-daily raltegravir (400 mg).
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Author Interviews, Brain Injury, Exercise - Fitness, JAMA / 25.07.2017

MedicalResearch.com Interview with: Daniel H. Daneshvar, M.D., Ph.D. Chronic Traumatic Encephalopathy Center Team Up Against Concussions | Founder Boston University  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Chronic traumatic encephalopathy (CTE) is a neurodegenerative disease associated with repetitive head impacts. CTE was first described in JAMA in 1928. In the 99 years since, just over 100 cases of CTE have been described in the world’s literature. This study nearly doubles the number of reported cases of CTE, with 177 cases of CTE in football players. Of note, 110 of the 111 athletes who played in the NFL had CTE. This study represents the largest and the most methodologically rigorous description of a series of patients with CTE ever published. Such a richness of data regarding the clinical and pathological features of CTE has never been previously compiled. As such, this study represents an important advance to the medical literature and an enormous scientific advance in our understanding of  chronic traumatic encephalopathy. (more…)
Author Interviews, JAMA, Stem Cells / 25.07.2017

MedicalResearch.com Interview with: Dr. Paul J. Hauptman, MD Professor of Internal Medicine Division of Cardiology Assistant Dean, Clinical and Translational  Research Saint Louis University School of Medicine St. Louis MO 63110-0250  MedicalResearch.com: What is the background for this study? What are the main findings? Response: A publication in 2016 by Leigh Turner from the University of Minnesota in 2016 shed light on the proliferation of stem cell centers or "businesses" that offer non FDA approved treatments, described as "stem cell therapy" for a variety of conditions. We opted to evaluate sites that claimed to treat heart failure. We collected data on type of infusion, need for a medical evaluation, board certification status of the center physician, cost and other factors. Self reported patient volumes were very variable. Most centers/businesses claimed to use autologous stem cells; a number offered ancillary treatment (i.e. vitamin infusions and hyperbaric oxygen); only one appeared to have a board-certified cardiologist involved. The costs were high for single infusions (mean price of $7694, SD 2737 for autologous cells; slightly less for allogeneic cells). Efficacy claims made during telephone calls with the centers were highly positive. (more…)
Author Interviews, FDA, JAMA, Race/Ethnic Diversity / 25.07.2017

MedicalResearch.com Interview with: Sanket Dhruva, MD, MHS, FACC Cardiology, VA Connecticut Healthcare System Robert Wood Johnson Foundation Clinical Scholar Yale University MedicalResearch.com: What is the background for this study? What are the main findings? Response: In 2012, Congress passed the Food & Drug Administration (FDA) Safety and Innovation Act, with the goal of increasing enrollment and availability of data in important patient groups such as the elderly, women, and racial and ethnic minorities. In 2014, as mandated by the legislation, the FDA released an Action Plan to address these issues. This Action Plan included the goal of increasing the transparency by posting demographic information of pivotal (or key) clinical trials used to support approval decisions. We examined how often these data were available in 2015 for all studies used to support approval of all original high-risk medical devices approved in the calendar year following the FDA Action Plan. Examples of these medical devices include stents, bone grafts, heart valves, and spinal cord stimulators. We wanted to understand if age, sex, and race and ethnicity data were available and if the results of clinical studies supporting these medical devices were analyzed to assess if there were differences in safety and effectiveness by these important demographic factors. Our main findings are that FDA Summaries publicly reported age for 65% of study populations, sex for 66%, and race and/or ethnicity for 51%. Analyses to assess if demographic factors may have impacted device safety and effectiveness were only conducted by age for 9%, by sex for 17%, and by race for 4% of clinical studies. (more…)
Annals Internal Medicine, AstraZeneca, Author Interviews, Brigham & Women's - Harvard, Heart Disease, Merck, Pharmacology / 25.07.2017

MedicalResearch.com Interview with: Alexander Turchin, MD,MS Director of Quality in Diabetes Associate Professor, Harvard Medical School Brigham and Women's Hospital Boston, MA MedicalResearch.com: What is the background for this study? Response: Cardiovascular disease is the # 1 cause of death in the U.S. and worldwide. Statins are some of the most effective medications available for prevention of cardiovascular events. However, many patients stop statins, frequently because of adverse reactions. In our study we aimed to assess the risk-benefit balance of trying a statin again after experiencing an adverse reaction. (more…)
Author Interviews, Cancer Research, Dermatology, Ophthalmology / 24.07.2017

MedicalResearch.com Interview with: Dr.med.univ. Christoph Schwab Departement of Ophthalmology Medical University of Graz Graz, Austria  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Knowledge about risk factors and/or pathways involved in pathogenesis is from special importance in order of preventing diseases. The role of sunlight in several eye diseases is unclear. In our study we found a close relation between sun light exposure - evaluated by a full body skin examination and a personal questionnaire - and iris freckles. Therefore we suggest the presence of iris freckles as a novel biomarker indicating high ocular sun exposure. (more…)
Alzheimer's - Dementia, Author Interviews, Columbia, Nutrition / 24.07.2017

MedicalResearch.com Interview with: Yian Gu, PhD Assistant Professor of Neuropsychology (in Neurology and Taub Institute for Research on Alzheimer's Disease and the Aging Brain) Columbia University Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: We have previously shown that elderly individuals who consume healthier diet (certain foods, nutrients, and dietary patterns) have larger brain volume, better cognition, and lower risk of developing Alzheimer’s disease. The current study aimed to examine the biological mechanisms for the relationship between diet and brain/cognitive health.  (more…)
Author Interviews, Chemotherapy, Lung Cancer, Science / 24.07.2017

MedicalResearch.com Interview with: Prof. Gerhard Hamilton Department of Obstetrics and Gynecology Medical University of Vienna MedicalResearch.com: What is the background for this study? What are the main findings? Response: Small cell lung cancer (SCLC) is a highly aggressive tumor (15 % of all lung cancers) mainly of patients with high tobacco consumption which shows an extremely poor survival (< 5% 2-year survival rate). Unfortunately the low survival rates of advanced SCLC cases has not improved significantly during the last decades, with platinum drugs/etoposide and topotecan employed for first- and second-line chemotherapy, respectively. All kinds of new chemotherapeutics, targeted drugs and immunotherapies either failed or resulted in prolongation of survival of several months at best. SCLC responds well to first-line therapy but relapses within a short time as chemoradioresistant tumor. The failure of hundreds of registered studies seem to be linked to the lack of knowledge of the mechanism of resistance of SCLCs and proper ways to reverse the refractoriness. Small cell lung cancer is distinguished by excessive numbers of circulating tumor cells (CTCs) in advanced stages. CTCs contain the founder of metastasis and seem to constitute a highly chemoresistant cell population. Thus, we ware able to establish a panel of permanent CTC lines in vitro for the first time (8 SCLC lines so far from blood samples). Although CTCs were considered to be chemoresistant we detected that they are chemosensitive in vitro in form of single cell suspensions. However, all CTC lines developed spontaneously into large multicellular aggregates, termed tumorospheres, which grow up to 1-2 mm in size and exhibit high chemoradioresistance due to limited drug perfusion as well as content of quiescent and hypoxic cells. Resistance to irradiation seems to be caused by lack of oxygen, such limiting the generation of oxygen radicals. High resistance mediated by the occurrence of tumorospheres easily explains the failure of a large number of drugs - if one is not able to achieve a sufficient concentration of a drug in cancer cells and the cells are quiescent, the respective compounds will not be able to destroy the target cells, regardless of their chemical nature. (more…)
Author Interviews, Heart Disease / 24.07.2017

MedicalResearch.com Interview with: Abhishek Sharma MD and Division of Cardiovascular Medicine State University New York Downstate Medical Center Dr.Sahil Agarwal M.B.B.S., M.D. Division of Cardiology St. Luke's University Health Network Bethlehem, Pennsylvania MedicalResearch.com: What is the background for this study?  Response: Prior randomized control trials (RCTs) and meta-analysis of these trials which have attempted to compare differences in outcomes between strategies of short (S) (3-6 months) and longer (L) (12-30 months) durations of dual anti-platelet therapy (DAPT) after drug eluting stents (DES) implantation have reported conflicting results. In general, the events rates in these studies were small, affecting statistical power. To overcome this limitation, we conducted an updated meta-analysis to compare the efficacy and safety of strategies of S-DAPT versus L-DAPT strategy after DES implantation by restricting inclusion to randomized studies with follow-up durations of 24 months or longer. The current meta-analysis is the first to compare outcomes between S-DAPT and L-DAPT in a meta-analysis restricted to trials with patient follow-up of 24 months or longer. We found no significant difference in the rates of mortality or of stent thrombosis with S-DAPT or L-DAPT. S-DAPT was associated with significantly lower risk of major bleeding but slightly higher risk of future myocardial infarctions. (more…)