Author Interviews, Biomarkers, BMJ, Heart Disease / 25.11.2016

MedicalResearch.com Interview with: Archana Singh-Manoux, PhD Research Professor (Directeur de Recherche) Epidemiology of ageing & age-related diseases INSERM,France MedicalResearch.com: What is the background for this study? What are the main findings? Response: A recent metabolomics study examined 106 biomarkers and found alpha-1-acid glycoprotein (AGP), an acute phase protein, to be the strongest predictor of five-year mortality. It is also unknown how well AGP compares with other sensitive, dynamic, and commonly measured markers of systemic inflammation, such as CRP and IL-6, as a predictor of mortality. We examined the association of these three inflammatory markers with short- and long-term mortality in a large sample of middle-aged adults, followed for 17 years. Our analysis of all-cause, cancer and cardiovascular mortality suggests that for all these outcomes IL-6 may be a better prognostic marker, both in the short and the long-term.
Author Interviews, HIV, NEJM, University of Pennsylvania / 24.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29950" align="alignleft" width="148"]Katharine J Bar, MD Assistant Professor of Medicine Attending Physician, Infectious Diseases, Hospital of the University of Pennsylvania Physician, International Travel Medicine, Perelman Center for Advanced Medicine Director, Penn CFAR Viral and Molecular Core Dr. Katharine J Bar[/caption] Katharine J Bar, MD Assistant Professor of Medicine Attending Physician, Infectious Diseases, Hospital of the University of Pennsylvania Physician, International Travel Medicine, Perelman Center for Advanced Medicine Director, Penn CFAR Viral and Molecular Core MedicalResearch.com: What is the background for this study? What are the main findings? Response: The passive administration of monoclonal antibodies has revolutionized many fields of medicine. Anti-HIV monoclonal antibodies are being explored as components of novel therapeutic and curative strategies, as they can both neutralize free virus and kill virus-infected cells. We sought to determine whether passive administration of an anti-HIV monoclonal antibody, VRC01, to chronically HIV-infected individuals on antiretroviral medications (ART) would be safe and well tolerated and could delay virus rebound after discontinuation of their ART.
Author Interviews, Heart Disease, JAMA / 22.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29970" align="alignleft" width="200"]Vinay Kini, MD, MS Division of Cardiovascular Medicine Hospital of the University of Pennsylvania The Leonard Davis Institute of Health Economics University of Pennsylvania Philadelphia Dr. Vinay Kini[/caption] Vinay Kini, MD, MS Division of Cardiovascular Medicine Hospital of the University of Pennsylvania The Leonard Davis Institute of Health Economics University of Pennsylvania Philadelphia MedicalResearch.com: What is the background for this study? What are the main findings? Response: Recent studies have shown that use of cardiac stress tests has declined by about 25% among Medicare beneficiaries and by about 50% in Kaiser Permanente over the last several years. However, the reasons for these declines is not well understood. Decreases in the use of stress testing could be due to dissemination of appropriate use criteria and other clinical practice guidelines, advances in preventive care, reductions in reimbursement for testing, or other health system organizational characteristics. Therefore, our goal was to determine whether similar declines in testing are observed among a nationally representative cohort of commercially insured patients. We identified over 2 million stress tests performed among 33 million members of the commercial insurance company, and found that there was a 3% increase in the overall use of stress testing in this cohort between 2005 and 2012. Declines in the use of nuclear SPECT tests were offset by increases in the use of stress echocardiography, exercise electrocardiography, and newer stress test modalities such as coronary computed tomography angiography. The largest increase in use of testing was seen among younger individuals - there was a 60% increase in use of testing among patients aged 25-34, and a 30% increase among individuals aged 35-44.
Author Interviews, BMJ, Pediatrics, Social Issues / 22.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29918" align="alignleft" width="200"]Charles Opondo, BPharm MSc PhD. Researcher in Statistics and Epidemiology National Perinatal Epidemiology Unit Nuffield Department of Population Health University of Oxford Oxford Dr. Charles Opondo[/caption] Charles Opondo, BPharm MSc PhD. Researcher in Statistics and Epidemiology National Perinatal Epidemiology Unit Nuffield Department of Population Health University of Oxford Oxford MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our study measured fathers’ involvement in their child’s upbringing in infancy by looking at their emotional response to their child (e.g. feeling confident with the child, making a strong bond with the child), how involved they were in childcare (e.g. changing nappies, playing, night feeding, and also general care tasks around the house such as meal preparation) and their feelings of being a secure in their role as a parent (e.g. feeling included by mother in childcare, not feeling inexperienced with children). We found that the children of fathers who scored highly in terms of their emotional response and feeling like a secure parent were less likely to have symptoms of behavioural problems when they were 9 or 11 years. However, fathers being more involved in direct childcare did not seem to affect the child’s risk of having later behavioural problems.
Author Interviews, Cancer Research, Dermatology, JAMA, UCLA / 22.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29923" align="alignleft" width="200"]Albert Yoon-Kyu Han, PhD Class of 2017 Medical Scientist Training Program David Geffen School of Medicine at UCLA Dr. Albert Han[/caption] Albert Yoon-Kyu Han, PhD Class of 2017 Medical Scientist Training Program David Geffen School of Medicine at UCLA MedicalResearch.com: What is the background for this study? What are the main findings? Response: Squamous cell carcinoma (SCC) of the lip makes up a large portion of oral cancers (25%). Most of the demographic and prognostic indicators for lip SCC are only available through retrospective case series. Thus, we used the national cancer database (Surveillance, Epidemiology, and End Results, or SEER) to examine the incidence, treatment, and survival of patients with lip SCC. The main findings of this study were that lip Squamous cell carcinoma predominantly affects white men in their mid-60s. We also found that the determinants of survival for lip SCC include age at diagnosis, primary site, T stage, and N stage. More specifically, on the primary site, SCC of the upper and lower lip had similar survival, whereas SCC of the oral commissure was associated with decreased survival.
Author Interviews, NEJM, Outcomes & Safety, Surgical Research / 22.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29912" align="alignleft" width="200"]Alan Karthikesalingam MD PhD, NIHR Academic Clinical Lecturer in Vascular Surgery St George's Vascular Institute London, UK Dr. Alan Karthikesalingam[/caption] Alan Karthikesalingam MD PhD, NIHR Academic Clinical Lecturer in Vascular Surgery St George's Vascular Institute London, UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background for this study was that the typical diameter at abdominal aortic aneurysm (AAA)  repair, and the population incidence of AAA repair, have been known to vary considerably between different countries. This study aimed to observe whether a discrepancy in the population incidence rate of AAA repair between England and the USA was seen alongside a discrepancy in population rates of AAA-related mortality or AAA rupture in those countries.
ADHD, Author Interviews, JAMA, Neurological Disorders, NIH / 22.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29904" align="alignleft" width="200"]Gustavo Sudre, PhD Section on Neurobehavioral Clinical Research, Social and Behavioral Research Branch National Human Genome Research Institute Bethesda, Maryland Dr. Gustavo Sudre[/caption] Gustavo Sudre, PhD Section on Neurobehavioral Clinical Research, Social and Behavioral Research Branch National Human Genome Research Institute Bethesda, Maryland MedicalResearch.com: What is the background for this study? What are the main findings? Response: ADHD is the most common childhood neuropsychiatric disorder, affecting 7-9% of school age children. It is highly heritable (h2=0.7), but few risk genes have been identified. In this study, we aimed to provide quantitative brain-based phenotypes to accelerate gene discovery and understanding. ADHD is increasingly viewed as resulting from anomalies of the brain’s connectome. The connectome is comprised of the structural connectome (white matter tracts joining different brain regions) and the functional connectome (networks of synchronized functional activity supporting cognition). Here, we identified features of the connectome that are both heritable and associated with ADHD symptoms.
Author Interviews, Blood Pressure - Hypertension, Bone Density, JAMA, Kaiser Permanente, Osteoporosis, Pharmacology / 22.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29895" align="alignleft" width="200"]Joshua I. Barzilay, MD Kaiser Permanente of Georgia Duluth, GA 30096 Dr. Joshua I. Barzilay[/caption] Joshua I. Barzilay, MD Kaiser Permanente of Georgia Duluth, GA 30096 MedicalResearch.com: What is the background for this study? Response: Hypertension (HTN) and osteoporosis (OP) are age-related disorders. Both increase rapidly in prevalence after age 65 years. Prior retrospective, post hoc studies have suggested that thiazide diuretics may decrease the risk of osteoporosis. These studies, by their nature, are open to bias. Moreover, these studies have not examined the effects of other anti HTN medications on osteoporosis. Here we used a prospective blood pressure study of ~5 years duration to examine the effects of a thiazide diuretic, a calcium channel blocker and an ACE inhibitor on hip and pelvic fractures. We chose these fractures since they are almost always associated with hospitalization and thus their occurrence can be verified. After the conclusion of the study we added another several years of follow up by querying medicare data sets for hip and pelvic fractures in those participants with medicare coverage after the study conclusion.
Author Interviews, JAMA, Neurological Disorders, Parkinson's / 21.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29406" align="alignleft" width="120"]Adolfo Ramirez Zamora, MD Associate Professor of Neurology and Phyllis E. Dake Endowed Chair in Movement Disorders Department of Neurology Albany Medical College Dr. Adolfo Ramirez Zamora[/caption] Adolfo Ramirez Zamora, MD Associate Professor of Neurology and Phyllis E. Dake Endowed Chair in Movement Disorders Department of Neurology Albany Medical College MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients with SPG 11 mutations can present with motor symptoms characterized by juvenile onset dystonia, Parkinsonism and lower extremity spasticity. Parkinsonism appears to be responsive to levodopa therapy early in the disease but treatment is complicated by the occurrence of motor fluctuations resembling parkinson disease. Patients have short duration of medication effects, unpredictable response to medications along with generalized, excessive involuntary movements known as dyskinesias. Deep Brain stimulation is a well-established treatment for movement disorders but it has never been used in this disease. We first report the clinical outcome obtained with globus pallidus internal deep brain stimulation in a patient with parkinsonism, dystonia, dyskinesias related to SPG 11. Additionally, we report for the first time the basal ganglia changes observed in the disease using intraoperative neuronal recordings. Patient had a sustained and remarkable response to stimulation over the next two years without side effects. Neurophysiologic changes revealed a unique pattern of neuronal firing despite of the resemblance to advance Parkinsons disease.
Author Interviews, BMJ, Fertility, OBGYNE / 21.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29707" align="alignleft" width="144"]David McLernon PhD MPhil BSc Research Fellow in Medical Statistics Medical Statistics Team Institute of Applied Health Sciences University of Aberdeen Foresterhill Aberdeen Dr. David McLernon[/caption] David McLernon PhD MPhil BSc Research Fellow in Medical Statistics Medical Statistics Team Institute of Applied Health Sciences University of Aberdeen Foresterhill Aberdeen MedicalResearch.com: What is the background for this study? Response: Normally when a couple attend a fertility clinic to begin IVF treatment they are only informed about their chances of having a baby for the first attempt of IVF. In actual fact the first treatment is often unsuccessful and many couples will go on to have several complete cycles of the treatment– each involving the transfer of one or two fresh embryos potentially followed by one or more frozen embryo transfers. We felt that a prediction model that could calculate the chances of having a baby over the complete package of treatment would provide better information for couples.
Author Interviews, Heart Disease, JAMA / 21.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29860" align="alignleft" width="200"]Dr. Doug Owens MD former USPSTF Task Force member Professor at Stanford University Henry J. Kaiser, Jr. Professor Director of the Center for Health Policy Freeman Spogli Institute for International Studies Center for Primary Care and Outcomes Research Department of Medicine and School of Medicine Stanford Dr. Doug Owens[/caption] Dr. Doug Owens MD former USPSTF Task Force member Professor at Stanford University Henry J. Kaiser, Jr. Professor Director of the Center for Health Policy Freeman Spogli Institute for International Studies Center for Primary Care and Outcomes Research Department of Medicine and School of Medicine Stanford MedicalResearch.com: What is the background for review and statement? Response: Cardiovascular disease is serious—it can lead to heart attacks and strokes, and is responsible for one in every three adult deaths in the U.S. People with no signs or symptoms and no past history of cardiovascular disease can still be at risk. Fortunately, some people can benefit from taking a medication called statins to reduce that risk.
Author Interviews, Autism, JAMA, Pediatrics / 20.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29602" align="alignleft" width="193"]Dr. Melanie Penner, MD FRCP (C) Clinician investigator and developmental pediatrician Holland Bloorview Kids Rehabilitation Hospital Dr. Melanie Penner[/caption] Dr. Melanie Penner, MD FRCP (C) Clinician investigator and developmental pediatrician Holland Bloorview Kids Rehabilitation Hospital  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Studies have shown that accessing intensive behavioral intervention (IBI) services at younger ages is associated with improved outcomes for children with autism spectrum disorder (ASD). In Ontario, Canada, children wait years to access publicly-funded IBI. This analysis estimated costs and projected adult independence for three IBI wait time scenarios: the current wait time, a wait time reduced by half, and an eliminated wait time. The model inputs came from published literature. The main findings showed that eliminating the wait time generated the most independence and cost the least amount of money to both the government and society. With no wait time for intensive behavioral intervention, the government would save $53,000 (2015 Canadian dollars per person) with autism spectrum disorder over their lifetime, and society would save $267,000 (2015 Canadian dollars).
Author Interviews, Endocrinology, Hormone Therapy, JCEM, Menopause, Osteoporosis / 20.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29927" align="alignleft" width="131"]Dr Georgios Papadakis FMH, Médecin InternenMédecin assistant Service d'endocrinologie, diabétologie et métabolisme Lausanne Dr Georgios Papadakis[/caption] Dr Georgios Papadakis FMH, Médecin InternenMédecin assistant Service d'endocrinologie, diabétologie et métabolisme Lausanne MedicalResearch.com: What is the background for this study? Response: This study was mainly motivated by the absence of available data on the effect of menopausal hormone therapy (MHT) on bone microarchitecture, as well as contradictory results of previous trials regarding the persistence of a residual effect after MHT withdrawal. We performed a cross-sectional analysis of 1279 postmenopausal women aged 50-80 years participating in OsteoLaus cohort of Lausanne University Hospital. Participants had bone mineral density (BMD) measurement by dual X-ray absorptiometry (DXA) at lumbar spine, femoral neck and total hip, as well as assessment of trabecular bone score (TBS), a textural index that evaluates pixel grey-level variations in the lumbar spine DXA image, providing an indirect index of trabecular microarchitecture.
Author Interviews, Breast Cancer, PNAS, Stem Cells / 20.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29824" align="alignleft" width="144"]Thomas Bartosh Jr, Ph.D. Assistant Professor Medical Physiology Texas A&M Health Science Center Dr. Thomas Bartosh Jr,[/caption] Thomas Bartosh Jr, Ph.D. Assistant Professor Medical Physiology Texas A&M Health Science Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: One mysterious and devastating aspect of breast cancer is that it can reemerge abruptly, often as metastatic disease, in patients many years after an apparent eradication of the primary tumor. The sudden reappearance of cancer has been termed relapse and is thought to occur because a minimal number of resilient tumor cells are able to evade frontline therapies and linger in an undetectable/dormant state somewhere in the body for an unpredictable amount of time. Then, for reasons that remain unclear, these same dormant cells awaken and rapidly grow, and produce almost invariably fatal cancerous lesions. The therapeutic challenges of tumor dormancy and need to decode the underlying mechanisms involved are apparent. Cancer cell behavior is strongly influenced by various non-malignant cell types that are found within the tumor mass itself and that help make up the tumor microenvironment (TME). In particular, bone marrow-derived mesenchymal stem/stromal cells (MSCs), which are actively recruited into the tumor stroma, directly interact with carcinoma cells and significantly impact cancer progression, although the role of MSCs in tumor dormancy remains ill-defined.
Author Interviews, JAMA, Mental Health Research / 19.11.2016

MedicalResearch.com Interview with: Guillermo Horga, MD, PhD Assistant Professor of Clinical Psychiatry Columbia University Medical Center MedicalResearch.com: What is the background for this study? Response: Some people who eventually develop schizophrenia or other psychotic disorders have early “prodromal” symptoms such as subtle perceptual abnormalities and unusual thoughts that precede the onset of these disorders by months or even years. These subtle symptoms are typically not fully formed or met with full conviction, which distinguishes them from full-blown symptoms of psychosis. The “prodromal” phase has been the subject of intense study as researchers believe it can provide an invaluable window into the neurobiological processes that cause psychotic disorders as well as an opportunity to develop early preventive interventions. Persons who experience “prodromal” symptoms (known as “clinical high-risk” individuals) tend to report a variety of relatively subtle perceptual abnormalities (e.g., heightened sensitivity to sounds, distortions in how objects are perceived, momentarily hearing voices of speakers who are not present), unusual thoughts, and disorganized speech, some of which have been shown to be particularly informative in distinguishing who among these persons will eventually develop a full-blown psychotic disorder, a prediction that is clinically important as it may indicate the need for close monitoring of individuals who are at the greatest risk. Even though subtle perceptual abnormalities are common in this population, the available research indicates that they are as a whole uninformative for clinical prediction purposes. However, previous research in this area had never examined in detail whether assessing perceptual abnormalities in different sensory domains (such as visual versus auditory abnormalities) separately could be more informative than assessing them as a whole.
Author Interviews, Critical Care - Intensive Care - ICUs, Diabetes, JCEM, Outcomes & Safety / 19.11.2016

MedicalResearch.com Interview with: Amit Akirov, MD Institute of Endocrinology Rabin Medical Center- Beilinson Hospital Petach Tikva, Israel MedicalResearch.com: What is the background for this study? Response: As hypoglycemia is common among hospitalized patients with and without diabetes mellitus, we aimed to investigate the association between spontaneous and insulin-related hypoglycemia including severe hypoglycemia and all-cause mortality among a large cohort of hospitalized patients.
ALS, Author Interviews, NEJM, Technology / 19.11.2016

MedicalResearch.com Interview with: Mariska Van Steensel PhD Nick F. Ramsey, Ph.D. Department of Neurology and Neurosurgery Brain Center Rudolf Magnus University Medical Center Utrecht Utrecht, the Netherlands MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patients who are severely paralyzed due to for example ALS or brain stem stroke are often unable to speak (also called ‘ Locked-in State'), and therefore need assistive devices, such as an eye tracker, for their communication. When these devices fail (e.g. due to environmental lighting or eye movement problems), people may indicate yes or no with eye blinks in response to closed questions. This leaves patients in a highly dependent position, since questions asked may or may not represent their actual wish or comment. In the current study, we used a technology called brain-computer interfacing (BCI), to allow a patient with late-stage amyotrophic lateral sclerosis (ALS) to control a communication device using her brain signals. The patient was implanted with subdural electrodes that covered the brain area that is normally responsible for hand movement. The electrodes were connected with wires, subcutaneously, to an amplifier/transmitter device that was placed subcutaneously under the clavicle. The patient was able to generate a signal equivalent to a mouse-click with this brain-computer interface by attempting to move her hand, and used it to make selections of letters or words on her communication device, with high accuracy and a speed of 2 letters per minute. She used the brain-computer interface system to communicate whenever she was outside, as her eye-tracker device does not function well in that situation.
Author Interviews, CMAJ, Pharmacology, Urology / 19.11.2016

MedicalResearch.com Interview with: Emma Maund, MSc PhD Nordic Cochrane Centre MedicalResearch.com: What is the background for this study? Response: Duloxetine has been approved in Europe for the treatment of stress urinary incontinence in women. It is not approved for this indication in the US and Canada. Currently, reasons why marketing authorization applications are withdrawn or denied are not published by either the Canadian or the US drug agency. However, the FDA has said that a higher-than-expected rate of suicide attempts - 2.6 timer higher - was observed in the open-label extensions of controlled trials of duloxetine for stress urinary incontinence. Given the FDA’s statement about the rate of suicide attempts, we wanted to determine whether duloxetine increased the risk of suicidality, violence or their possible precursors (drug induced akathisia, an extreme type of restlessness; activation, which consists of stimulating effects such as insomnia, anxiety and agitation; emotional disturbance, such as depersonalization and derealization; or psychotic events, such as delusions and hallucinations) in the randomized phases of the trials. We therefore assessed the benefits and harms of duloxetine in stress urinary incontinence using clinical study reports, including individual patient data, of the 4 main trials submitted by Eli Lilly to the European Medicines Agency.
Author Interviews, Cannabis, Nature, UT Southwestern, Weight Research / 19.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29787" align="alignleft" width="300"](l-r) Dr. Zhenhua Shao and Dr. Daniel Rosenbaum (l-r) Dr. Zhenhua Shao and Dr. Daniel Rosenbaum UT Southwestern[/caption] Dan Rosenbaum, Ph.D. Principal Investigator Department of Biophysics The University of Texas Southwestern Medical Center Dallas, Texas MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study focuses on the structure of the human CB1 cannabinoid receptor. The CB1 protein is a membrane-embedded G protein-coupled receptor (GPCR) in the brain and peripheral tissues that responds to a variety of different compounds, including endogenous lipid messengers (‘endocannabinoids’), plant natural products (such as THC from the Cannabis sativa plant i.e. marijuana), and synthetic antagonists (such as the taranabant ligand used for this study). The CB1 receptor is involved in regulating neurotransmission in vertebrates, and is a potential therapeutic target for numerous conditions including obesity, pain, and epilepsy. The main findings of this study entailed the solution of the high-resolution crystal structure of human CB1 receptor bound to the inhibitor taranabant. This structure revealed the precise shape of the inhibitor binding pocket, which is also responsible for binding THC and endocannabinoids. In addition to helping explain the mechanism of inhibitor and THC binding, our structure provides a framework for computational studies of binding to a large diversity of cannabinoid modulators of therapeutic importance.
Author Interviews, Gender Differences, JAMA, Stroke / 19.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29782" align="alignleft" width="180"]Catharina J. M. Klijn, MD Brain Center Rudolf Magnus, Department of Neurology and Neurosurgery University Medical Center Utrecht, Utrecht Donders Institute for Brain, Cognition and Behaviour, Centre for Neuroscience Department of Neurology Radboud University Nijmegen Medical Centre Nijmegen, the Netherlands Dr. Catharina J. M. Klijn[/caption] Catharina J. M. Klijn, MD Brain Center Rudolf Magnus, Department of Neurology and Neurosurgery University Medical Center Utrecht, Utrecht Donders Institute for Brain, Cognition and Behaviour, Centre for Neuroscience Department of Neurology Radboud University Nijmegen Medical Centre Nijmegen, the Netherlands MedicalResearch.com: What is the background for this study? Response: The incidence of stroke is higher in men than in women. This difference attenuates with increasing age. Established risk factors for stroke, such as hypertension, cigarette smoking and ischemic heart disease are more prevalent in men but only partly explain the difference in stroke incidence. The contribution of oral contraceptive use and hormone therapy to stroke risk has been previously reviewed. We aimed to evaluate what is known on other female- and male specific risk factors for ischemic and hemorrhagic stroke incidence and stroke mortality through a systematic review and meta-analysis of 78 studies including over 10 million participants.
Author Interviews, Critical Care - Intensive Care - ICUs, Kidney Disease, NEJM, Pediatrics / 18.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29776" align="alignleft" width="133"]Stuart L. Goldstein, MD, FAAP, FNKF</strong> Clark D. West Endowed Chair Professor of Pediatrics | University of Cincinnati College of Medicine Director, Center for Acute Care Nephrology | Associate Director, Division of Nephrology Medical Director, Pheresis Service | Co-Medical Director, Heart Institute Research Core Division of Nephrology and Hypertension | The Heart Institute Cincinnati Children’s Hospital Medical Center Cincinnati, OH 45229 Dr. Stuart L. Goldstein[/caption] Stuart L. Goldstein, MD, FAAP, FNKF Clark D. West Endowed Chair Professor of Pediatrics University of Cincinnati College of Medicine Director, Center for Acute Care Nephrology | Associate Director, Division of Nephrology Medical Director, Pheresis Service | Co-Medical Director, Heart Institute Research Core Division of Nephrology and Hypertension | The Heart Institute Cincinnati Children’s Hospital Medical Center Cincinnati, OH 45229 MedicalResearch.com: What is the background for this study? What are the main findings? Response: This was a prospective international multi-center assessment of the epidemiology of acute kidney injury in children in young adults. Over 5,000 children were enrolled from 32 pediatric ICUs in 9 countries on 4 continents. The main findings are: 1) Severe AKI, defined by either Stage 2 or 3 KDIGO serum creatinine and urine output criteria carried an incremental risk of death after adjusting for 16 co-variates. 2) Patients with AKI by low urine output would have been misclassified as not having AKI by serum creatinine criteria and patients with AKI by urine output criteria have worse outcomes than patients with AKI by creatinine crtieria. 3) Severe AKI was also associated with increased and prolonged mechanical ventilation use, increased receipt of dialysis or ECMO
Author Interviews, Brigham & Women's - Harvard, Heart Disease, NEJM, Surgical Research / 17.11.2016

MedicalResearch.com Interview with: Mandeep R. Mehra, MD, FACC, FESC, FHFSA, FRCP Medical Director, Brigham and Women’s Hospital Heart and Vascular Center Executive Director, Center for Advanced Heart Disease Professor of Medicine, Harvard Medical School Editor in Chief, The Journal of Heart and Lung Transplantation Brigham and Women's Hospital Boston, MA Mandeep R. Mehra, MD, FACC, FESC, FHFSA, FRCP Medical Director, Brigham and Women’s Hospital Heart and Vascular Center Executive Director, Center for Advanced Heart Disease Professor of Medicine, Harvard Medical School Editor in Chief, The Journal of Heart and Lung Transplantation Brigham and Women's Hospital Boston, MA MedicalResearch.com: What is the background for this study? Response: 10% of patients with heart failure and a reduced ejection fraction transition into Advanced Stages of disease where they become unresponsive to life prolonging traditional medications. Such patients typically require intravenous inotropic therapy to preserve cardiac function but most remain profoundly limited in their quality of life. In such cases a heart transplant is desirable but this is an option for only a few patients. Left Ventricular Assist Devices (LVADs) have become the mainstay for treating such patients either while they await a transplant or as a permanent option. However, there are challenges leading to infections, strokes, bleeding and most importantly pump malfunction due to thrombosis of the LVAD itself. The HeartMate 3 LVAD is a centrifugal pump that is designed to overcome the problem of pump thrombosis by virtue of 3 engineering attributes: (a) A frictionless rotor that is based on a fully magnetically levitated platform (b) wide blood flow passages that reduce red cell destruction and (c) an artificial intrinsic pulse that prevents stasis of blood within the pump.
Author Interviews, CT Scanning, Heart Disease, JAMA, Women's Heart Health / 16.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29717" align="alignleft" width="180"]Dr-Maryam-Kavousi Dr. Maryam Kavousi[/caption] Maryam Kavousi MD, PhD, FESC Assistant Professor Department of Epidemiology Erasmus University Medical Center Rotterdam The Netherlands  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The most recent American College of Cardiology/American Heart Association (ACC/AHA) cardiovascular disease (CVD) prevention guidelines recommend statins for a larger proportion of populations. Notably, a large group of women are categorized as low CVD risk by the guidelines and would therefore not typically qualify for intensive management of their standard risk factors. Coronary artery calcium (CAC) scanning allows for the detection of subclinical coronary atherosclerosis and is viewed as the vessel’s memory of lifetime exposure to risk factors. We therefore aimed to address the utility of CAC as a potential tool for refining CVD risk assessment in asymptomatic women at low CVD risk based on the new guidelines. This study involved data on 6,739 low-risk women from 5 population-based cohort studies across the United States and Europe. We found that CAC was present in 36% of low-risk women and was associated with increased risk of CVD.
Author Interviews, BMJ, Cost of Health Care, Nursing, Outcomes & Safety, University of Pennsylvania / 16.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29710" align="alignleft" width="200"]Dr Linda H Aiken PhD, FAAN, FRCN, RN Claire M. Fagin Leadership Professor in Nursing Professor of Sociology, School of Arts & Sciences Director, Center for Health Outcomes and Policy Research University of Pennsylvania School of Nursing Center for Health Outcomes and Policy Research Philadelphia, PA 19104 Dr Linda H Aiken[/caption] Dr Linda H Aiken PhD, FAAN, FRCN, RN Claire M. Fagin Leadership Professor in Nursing Professor of Sociology, School of Arts & Sciences Director, Center for Health Outcomes and Policy Research University of Pennsylvania School of Nursing Center for Health Outcomes and Policy Research Philadelphia, PA 19104 MedicalResearch.com: What is the background for this study? Response: The idea that adding lower skilled and lower wage caregivers to hospitals instead of increasing the number of professional nurses could save money without adversely affecting care outcomes is intuitively appealing to mangers and policymakers but evidence is lacking on whether this strategy is safe or saves money.
Author Interviews, Cost of Health Care, Heart Disease, JAMA, Pharmacology / 16.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29573" align="alignleft" width="149"]Paul J. Hauptman, MD</strong> Professor Internal Medicine, Division of Cardiology Health Management & Policy, School of Public Health Dr. Paul Hauptman[/caption] Paul J. Hauptman, MD Professor Internal Medicine, Division of Cardiology Health Management & Policy, School of Public Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: We decided to evaluate the cost of generic heart failure medications after an uninsured patient of ours reported that he could not fill a prescription for digoxin because of the cost for a one month's supply: $100. We called the pharmacy in question and confirmed the pricing. At that point we decided to explore this issue more closely. We called 200 retail pharmacies in the bi-state, St. Louis metropolitan area, 175 of which provided us with drug prices for three generic heart failure medications: digoxin, carvedilol and lisinopril. We found significant variability in the cash price for these medications. Combined prices for the three drugs ranged from $12-$400 for 30 day supply and $30-$1,100 for 90 day supply. The variability was completely random, not a function of pharmacy type, zip code, median annual income, region or state. In fact, pricing even varied among different retail stores of the same pharmacy chain.
Author Interviews, Immunotherapy, JAMA, Melanoma / 15.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29273" align="alignleft" width="150"]Feng Xie, Ph.D.</strong> Associate Professor Department of Clinical Epidemiology and Biostatistics Faculty of Health Sciences, McMaster University Dr. Feng Xie[/caption] Feng Xie, Ph.D. Associate Professor Department of Clinical Epidemiology and Biostatistics Faculty of Health Sciences McMaster University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Cutaneous melanoma, an aggressive and deadly form of skin cancer, in early stages is often cured with surgery alone. Most patients presenting with advanced-stage disease, however, are not candidates for surgery and drug therapy is the main course of treatment. Around 40-60% of melanomas have a mutation in the BRAF protein. Multiple effective first-line treatment options are available for patients with advanced BRAF-mutated melanoma, which fall under two established classes of drug therapies: targeted therapy and immunotherapy. Presently, it remains uncertain which is the optimal first-line treatment. In our network meta-analysis we evaluated 15 randomized controlled trials published between 2011 and 2015 assessing the benefits and harms of targeted or immune checkpoint inhibitors in 6662 treatment naïve patients with lymph node metastasis not amenable to surgery or distant metastatic melanoma. We found that combined BRAF and MEK targeted therapy and PD-1 immunotherapy were both equally effective in improving overall survival. Combined BRAF and MEK inhibition was most effective in improving progression-free survival. PD-1 inhibition was associated with the lowest risk of serious adverse events.
Author Interviews, JAMA, OBGYNE, Surgical Research, Weight Research / 15.11.2016

MedicalResearch.com Interview with: Brodie Parent, MD MS General Surgery R4 University of Washington MedicalResearch.com: What is the background for this study? What are the main findings? Response: We already knew that women with a history of bariatric surgery are a high risk group when it comes to childbirth. Our study has confirmed prior data which show that infants from these women are at a higher risk for being premature, low birth-weight, or requiring ICU admission. However, this is some of the first data which looks at their risk over time after recovery from the operation. Data from this study show that risks to the infant are highest in the first 3 years after an operation, and diminish over time. This suggests that women should wait a minimum of three years after an operation before attempting conception.
Author Interviews, JAMA, Prostate, Prostate Cancer, Surgical Research, Urology / 15.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29302" align="alignleft" width="134"]Jim C. Hu, M.D., M.P.H. Ronald P. Lynch Professor of Urologic Oncology Director of the LeFrak Center for Robotic Surgery Weill Cornell Medicine Urology New York Presbyterian/Weill Cornell New York, NY 10065 Dr. Jim Hu[/caption] Jim C. Hu, M.D., M.P.H. Ronald P. Lynch Professor of Urologic Oncology Director of the LeFrak Center for Robotic Surgery Weill Cornell Medicine Urology New York Presbyterian/Weill Cornell New York, NY 10065 MedicalResearch.com: What is the background for this study? What are the main findings? Response: The US Preventative Services Task Force (USPSTF) recommended against PSA testing in men older than 75 years in 2008 and more recently in all US men regardless of age in 2012. This was largely based on a faulty study, the prostate, lung, colo-rectal and ovarian screening study. We demonstrated in May 2016 that this randomized trial did not compare screening to no screening or apples to oranges, as it set out to do. It compared screening to screening. Although controversial, the guidelines were well-intentioned, as recognize that there is over-diagnosis and over-treatment of men with prostate cancer. Given this background, the goal of our study was to explore the downstream consequences of the recommendation against PSA screening. As such, we explored 3 separate databases to characterize national procedure volumes for prostate needle biopsy and radical prostatectomy, or surgery to cure prostate cancer. The main finding was that prostate biopsy numbers decreased by 29% and radical prostatectomy surgeries decreased by 16% when comparing before to after USPSTF recommendations against PSA screening. Therefore practice patterns followed policy. Prostate biopsies are usually performed due to an elevated, abnormal screening PSA. However, it is also performed to monitor low-risk, slow growing prostate cancers. We also found that while the overall number of prostate biopsies decreased, there was a 29% increase in the proportion or percentage of biopsies performed due to active surveillance, or monitoring of low risk prostate cancers which should be done periodically. Therefore we provide the first national study to demonstrate that there is less over-diagnosis and over-treatment of prostate cancer. However, the concern is that we also recently demonstrated that there is more aggressive prostate cancer on surgical pathology for men who go on to radical prostatectomy. They have high grade, higher stage cancers, which have a lower chance of cure. The link is: http://www.prostatecancerreports.org/fulltext/2016/_Hu_JC160708.pdf
Author Interviews, Heart Disease, JACC, Surgical Research / 15.11.2016

MedicalResearch.com Interview with: Opeyemi O. Fadahunsi, MBBS, MPH Department of Medicine Reading Health System West Reading, Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: Transcatheter aortic valve replacement (TAVR) is a minimally invasive approach to managing symptomatic severe aortic stenosis in patients who have a high surgical risk or are deemed to be inoperable. One of the most frequent complications is development of conduction abnormalities requiring permanent pacemaker placement. We compared clinical outcomes in patients requiring permanent pacemaker placement post-TAVR to those not requiring a pacemaker using a large US database called the STS/ACC TVT RegistryTM . We used real-world data of patients undergoing TAVR in the US at 229 sites between November 2011 and September 2014. The frequency of pacemaker placement within 30 days post-TAVR was 6.7% (651 of 9,785 patients). Those who needed a pacemaker within 30 days post-TAVR had longer hospital and intensive care unit stays compared to those who did not. Furthermore, those who needed a pacemaker had a higher risk of death from any cause at one year compared to those who did not get a pacemaker.
Author Interviews, Cancer Research, ENT, JAMA, Radiation Therapy, Stanford / 15.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29579" align="alignleft" width="188"]Michelle M. Chen, MD/MHS Department of Otolaryngology- Head and Neck Surgery Stanford University Dr. Michelle Chen[/caption] Michelle M. Chen, MD/MHS Department of Otolaryngology- Head and Neck Surgery Stanford University  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The benefit of post-operative radiotherapy (PORT) for patients with T1-T2 N1 oral cavity and oropharyngeal cancer without adverse pathologic features is unclear. Starting in 2014, the national guidelines no longer recommended consideration of post-operative radiotherapy for N1 oropharyngeal cancer patients, but left it as a consideration for N1 oral cavity cancer patients. We found that post-operative radiotherapy was associated with improved survival in both oral cavity and oropharyngeal cancers, particularly in patients younger than 70 years of age and those with T2 disease.