Addiction, Author Interviews, Brigham & Women's - Harvard, Gender Differences, JAMA, Sexual Health / 27.03.2016 Interview with: Dr. Sari L. Reisner PhD Research Fellow in the Department of Epidemiology Harvard T.H. Chan School of Public Health Associate Scientific Researcher in the Division of General Pediatrics Boston Children’s Hospital/ Harvard Medical School What are the main findings? Dr. Reisner: Transgender youth—including adolescent and young adult transgender women assigned a male sex at birth who identify as girls, women, transgender women, transfemale, male-to-female, or another diverse gender identity on the transfeminine spectrum—represent a vulnerable population at-risk for negative mental health and substance use/abuse outcomes. Although community surveys of transgender people in the United States have found a high prevalence of depression, anxiety, and substance use relative to the general adult U.S. population, studies typically utilize screening instruments or sub-threshold symptom questions and do not use diagnostic interviews. Diagnostic interview data are scarce among young transgender women; such data are important to establish guidelines for diagnosis and treatment for this youth group given their complex life experiences. The aim of this study was to report the prevalence of mental health, substance dependence, and co-morbid psychiatric disorders assessed via a diagnostic interview in an at-risk community-recruited sample of young transgender women. This observational study reported baseline finding from a diverse sample of 298 sexually active, young transgender women ages 16-29 years (mean age 23.4; 49.0% Black, 12.4% Latina, 25.5% White, 13.1% other minority race/ethnicity) enrolled in Project LifeSkills, an ongoing randomized controlled HIV prevention intervention efficacy trial in Chicago and Boston, between 2012-2015 (NIMH-funded, multiple PIs: Rob Garofalo, MD, MPH & Matthew Mimiaga, ScD, MPH). (more…)
Author Interviews, Genetic Research, JAMA, Schizophrenia / 26.03.2016 Interview with: S. Hong Lee, PhD Queensland Brain Institute, The University of Queensland, Brisbane School of Environmental and Rural Science, University of New England, Armidale Australia What is the background for this study? What are the main findings? Response: Previous studies reported increased risk of schizophrenia (SCZ) in offspring associated with both early and delayed parental age. However, it remains unclear if the risk to the child is due to psychosocial factors associated with parental age or if those at higher risk for schizophrenia tend to have children at an earlier or later age. We found evidence for a significant overlap between genetic factors associated with risk of schizophrenia and genetic factors associated with Age at First Birth (AFB). We observed a U-shaped relationship between schizophrenia risk and maternal AFB, consistent with the previously reported relationship between schizophrenia risk in offspring and maternal age when not adjusted for age of the father. (more…)
Author Interviews, Cancer Research, JAMA, Pediatrics / 25.03.2016 Interview with: Lee J. Helman, MD Senior Investigator Pediatric Oncology Branch Head, Molecular Oncology Section Acting Director, Center for Cancer Research and CCR Scientific Director for Clinical Research National Cancer Institute Bethesda, Maryland What is the background for this study? What are the main findings? Dr. Helman: It was known that most gastrointestinal stromal tumors (GISTS) that occur in children and young adults do not contain cKIT or PDGFRA mutations that drive more than 90% of adult GIST tumors.  Since GISTs are quite rare in the pediatric and young adult population, we decided to establish a clinic at NIH that would allow us to study the most patients to try to define these tumors both clinically and molecularly. We were able to bring both patients and physicians interested in pediatric GIST from around the country to the NIH to begin to collect and study these patients. Of the 95 patients in this cohort study that lacked cKIT or PDGFRAmutations, 84 were found to have succinate dehydrogenase (SDH) deficient (SDH-deficient) GIST (75% due to SDH A, B, C, or mutations, and 25% due to SDHC promoter hypermethylation. Since these tumors are driven by SDH loss and not due to KIT or PDGFR mutations, they do not generally respond to standard treatments for GIST that target these kinases. The mechanism of SDH-deficiency is important, since SDH mutations are commonly germ line and therefore require genetic counseling and family testing, while the SDHC promoter methylation is not a germ line alteration and therefore does not require genetic counseling.  Finally, any patient with SDH-deficient GIST is also at risk for development of paraganglioma and should be screened on a regular basis for these tumors.  (more…)
Author Interviews, HPV, JAMA, OBGYNE, Sexual Health, UCSD / 24.03.2016 Interview with: Ryan K. Orosco, MD Division of Head and Neck Surgery Department of Surgery University of California, San Diego What is the background for this study? What are the main findings? Dr. Orosco: Our group at UC San Diego is interested in HPV as it relates to diseases of the head and neck.  HPV is a well-publicized cause of cervical cancer, and awareness about its link to throat (oropharynx) cancer is rapidly increasing. Less well-known, is the relationship between HPV and benign (non-cancerous) diseases such as genital warts and papilloma of the throat.  As we strive to understand how to best care for patients with HPV-related disorders, it is important to understand the entire process of disease progression, which begins with HPV infection. Our group wanted to explore the relationship between HPV infection in the two most commonly infected body sites: oral and vaginal. (more…)
Author Interviews, JAMA, Nutrition, Supplements / 23.03.2016 Interview with: Judy Jou, MA PhD Candidate PhD Candidate in Health Services Research, Policy, & Administration Division of Health Policy and Management University of Minnesota, Twin Cities Minneapolis, MN What is the background for this study? What are the main findings? Response:  Use of complementary and alternative medicine (CAM) is rising among U.S. adults, but CAM is often poorly integrated into patients’ treatment and self-care routines. We analyzed nearly 7,500 responses from the 2012 National Health Interview Survey (NHIS) and found that over two-fifths of U.S. adults who used CAM during the past year did not disclose their complementary and alternative medicine use to their primary health care providers, with rates of disclosure varying by the type of CAM used. We also examined reasons for non-disclosure and found that, in contrast to prior studies, lack of provider-initiated conversation about  complementary and alternative medicine was the most commonly cited reason, rather than patients’ concerns about negative reactions from their providers regarding their complementary and alternative medicine use. (more…)
Author Interviews, End of Life Care, Heart Disease, JAMA / 22.03.2016 Interview with: Colleen K. McIlvennan, DNP, ANP-BC Assistant Professor of Medicine Division of Cardiology Section of Advanced Heart Failure and Transplantation What is the background for this study? What are the main findings? Response: As technology continues to advance, more people are becoming eligible for advanced therapies for end-stage illness. One such therapy, the left ventricular assist device (LVAD) is an option for carefully selected individuals suffering from end-stage heart failure. Use of this innovative technology has expanded from its original indication as a bridge to transplantation to also include destination therapy, in which patients live with the device for the remainder of their lives. Significant focus has been placed on developing and expanding LVAD programs, with less thought about the eventual end-of-life process awaiting patients whose LVAD is indicated for destination therapy. We performed semi-structured interviews about experiences surrounding end of life with 8 caregivers of patients who died with an LVAD. There was a wide range of case histories represented by these patients; however, three main themes emerged that coalesced around feelings of confusion: 1) the process of death with an LVAD, 2) the legal and ethically permissible care of patients approaching death with an LVAD, and 3) the fragmented integration of palliative and hospice care. (more…)
Author Interviews, Dermatology, JAMA, Parkinson's / 21.03.2016 Interview with: Alexander Egeberg, MD PhD National Allergy Research Centre, Departments of Dermato-Allergology and Cardiology Herlev and Gentofte University Hospital University of Copenhagen Hellerup, Denmark What is the background for this study? What are the main findings? Dr. Egeberg: Rosacea skin shows an up-regulation of various cytokines (small proteins that are important in cell signalling), and displays increased activation and expression of matrix metalloproteinases (MMPs). Both rosacea and Parkinson’s disease have been associated with small intestinal bacterial overgrowth and Helicobacter pylori infection, and MMPs. MMPs are enzymes that are involved in tissue remodeling, organ development, and regulation of inflammatory processes. Parkinson’s is a progressive neurological disease that results from the gradual loss of brain cells that produce dopamine, a chemical that sends messages to the part of the brain that controls movement and coordination. Importantly, MMPs have also been implicated in the pathogenesis of Parkinson’s disease and other neurodegenerative disorders, and MMPs contribute to loss of dopamine producing brain cells. Rosacea is often characterized by flare-ups and remissions and typically presents as a redness on the cheeks, nose, chin or forehead. In our study, we found a significantly (approximately two-fold) increased risk of developing Parkinson's disease, a chronic and progressive movement disorder, among patients with rosacea. Also, we found that treatment with tetracycline, an oral antibiotic, was associated with a slightly decreased risk of Parkinson's disease. (more…)
Author Interviews, Heart Disease, JAMA / 18.03.2016 Interview with: Ruut Laitio, MD, PhD Department of Anaesthesiology and Intensive Care Division of Perioperative Services, Intensive Care Medicine and Pain Management Turku University Hospital, Turku, Finland What is the background for this study? Dr. Laitio: Numerous animal studies with different types of brain injury (hypoxic, toxic,stroke, traumatic brain injury) have established the neuroprotective effect of xenon during the last 15 years. We designed a proof-of-concept study to find out whether xenon has neuroprotective effect in humans. An important finding from animal studies was that xenon has at least additive or even synergistic neuroprotective interaction with hypothermia and the results were based on histopathological and functional outcomes. These putative neuroprotective properties had not been reported in humans until now. (more…)
Alzheimer's - Dementia, Author Interviews, Depression, JAMA, UCSF / 18.03.2016 Interview with: Allison R. Kaup, PhD Assistant Adjunct Professor, UCSF Department of Psychiatry Clinical Research Psychologist / Clinical Neuropsychologist and Kristine Yaffe MD Professor of Psychiatry, Neurology and Epidemiology Chief of Geriatric Psychiatry and Director of the Memory Evaluation Clinic San Francisco VA Medical Center What is the background for this study? Response: Previous research has shown that older adults with depression are more likely to develop dementia.  But, most studies have only examined an older adult’s depressive symptoms at one point in time.  This is an important limitation because we know that depressive symptoms change over time and that older adults show different patterns of depressive symptoms over time.  For the present study, older adults were followed for several years.  We assessed what patterns of depressive symptoms they tended to have during the early years of the study, and then investigated whether these different patterns were associated with who developed dementia during the later years of the study. What are the main findings? Response: Older adults in this study tended to show one of 3 different patterns of depressive symptoms.  Most tended to have few, if any, symptoms over time.  Some tended to have a moderate level of depressive symptoms at the beginning of the study, which increased over time.  And others tended to have a high level of depressive symptoms at the beginning of the study, which increased over time. We found that older adults with the high-and-increasing depressive symptoms pattern were almost twice as likely to develop dementia than those with minimal symptoms, even when accounting for other important factors.  While older adults with the moderate-and-increasing depressive symptom pattern were also somewhat more likely to develop dementia, this association was not as strong and did not hold up in our statistical models when we accounted for what individuals’ cognitive functioning was like during the early years of the study. (more…)
Author Interviews, Blood Pressure - Hypertension, Diabetes, JAMA, Weight Research / 18.03.2016 Interview with: Debbie Lawlor PhD School of Social and Community Medicine University of Bristol, Oakfield House, Oakfield Grove Medical Research Council Integrative Epidemiology Unit University of Bristol, UK and Rachel Freathy PhD, University of Exeter, Institute of Biomedical and Clinical Science, Royal Devon and Exeter Hospital,  Exeter  UK What is the background for this study? What are the main findings? Response: A healthy birth weight is important for babies’ health and wellbeing in the first year of their life. It reflects how well the baby has grown and developed in the womb. The experience of fetuses in the womb and how well they grow and develop might also determine their future health, even into adulthood. Both being too light or too heavy at birth is not good for the baby. Lots of studies have shown that mothers who are fatter at the start of their pregnancy have babies who are more likely to be heavier. But is it not clear whether the mother being fatter causes their baby to be bigger at birth. If mothers’ fatness does cause their baby to be heavier at birth, why this happens is not clear. We used genes to find out whether being fatter in pregnancy causes babies to be born heavier. We also tested whether risk factors in the mother that are affected by her fatness, such as her blood pressure, and the level of glucose (sugar) and lipids (fats) in her blood stream affect how heavy her baby is. Our results showed that being fatter during pregnancy did cause a mothers’ baby to be born heavier. We also showed that having higher blood levels of glucose in pregnancy also caused a mothers’ baby to be heavier. But we did not find any effect of mothers’ blood levels of lipids in pregnancy on their baby’s weight. Whilst mothers who are heavier in pregnancy will tend to have higher blood pressure in pregnancy we found that higher blood pressure caused the women’s babies to be lighter. (more…)
Author Interviews, Electronic Records, JAMA, Primary Care / 16.03.2016 Interview with: Daniel R. Murphy MD MBA Assistant Professor - Interim Director of GIM at Baylor Clinic Department of Medicine Health Svc Research & General Internal Medicine Baylor College of Medicine Houston, TX, US What is the background for this study? What are the main findings? Dr. Murphy: Electronic health records (EHRs) have enabled a large number of messages to be transmitted to physicians each day, including new types of messages that were not present in the pre-EHR era. Lack of support and policies to assist physicians with this workload creates opportunities for important information, such as abnormal tests results, to be missed among the vast amount of other information. We found that primary care physicians (PCPs) at three clinics using commercial EHRs received an average of 77 messages per day, of which only about 20% were test results. Specialists received an average of 29 total messages per day. Extrapolating time needed to process these messages from prior work suggests that PCPs would require an average of 67 minutes per day to process these messages. (more…)
Author Interviews, JAMA, Johns Hopkins, Surgical Research / 15.03.2016 Interview with: Shaun C. Desai, MD Assistant Professor Facial Plastic and Reconstructive Surgery Department of Otolaryngology - Head & Neck Surgery Johns Hopkins University School of Medicine What is the background for this study? What are the main findings? Dr. Desai: Estimates of the rate of revision septorhinoplasty and the risk factors associated with revision are unknown because the current published literature is limited to small, retrospective, single-surgeon studies with limited follow-up time. The purpose of this study is to determine the overall revision rates of patients undergoing a septorhinoplasty procedure (for functional or cosmetic reasons) and to determine risk factors for the revision. We found that the overall revision rate was 3.3% (5,775 patients of a total of 175,842 patients undergoing the procedure) with an average time to revision at 1 year. Risk factors for revision surgery included female gender, younger age, a history of anxiety or autoimmune disease, cosmetic indications, and more complicated initial surgery (i.e. cleft rhinoplasty). (more…)
Author Interviews, Hand Washing, Hospital Acquired, JAMA, University of Michigan / 15.03.2016 Interview with: Lona Mody, MD, MS Veterans Affairs Healthcare System, Geriatric Research, Education, and Clinical Center Division of Geriatric and Palliative Medicine, University of Michigan Medical School, School of Public Health University of Michigan, Ann Arbor What is the background for this study? Dr. Mody: Hand hygiene is considered to be the most important strategy to prevent infections and spread of drug resistant organisms. Surprisingly, all strategies and efforts have predominantly involved healthcare workers and that too mainly in acute care hospitals.  We are now facing a tsunami of an aging population in our hospitals, post-acute care facilities and long-term care facilities.  Hand hygiene falls off when patients are hospitalized compared to when they are at home.  So, we were very interested, first, in hand colonization in older patients who have recently been transferred from the acute care hospital to a post-acute care (PAC) facility for rehabilitation or other medical care before fully returning home. We were also interested in evaluating whether these organisms persisted. What are the main findings? Dr. Mody: We recruited and followed 357 patients (54.9 percent female with an average age of 76 years). The dominant hands of patients were swabbed at baseline when they were first enrolled in a post-acute care facility, at day 14 and then monthly for up to 180 days or until discharge. The study found:
  • To our surprise, nearly one-quarter (86 of 357) of patients had at least one multi-drug resistant organism on their hands when they were transferred from the hospital to the post-acute care facility
  • During follow-up, 34.2 percent of patients’ hands (122 of 357) were colonized with a resistant organism and 10.1 percent of patients (36 of 357) newly acquired one or more resistant organisms.
  • Overall, 67.2 percent of colonized patients (82 of 122) remained colonized at discharge from PAC.
Author Interviews, Blood Pressure - Hypertension, Heart Disease, JAMA, OBGYNE / 14.03.2016 Interview with: Ida Behrens, MD and Heather Boyd PhD Department of Epidemiology Research Statens Serum Institut Copenhagen, Denmark What is the background for this study? Response: Over the past decade, we have begun to realize that a woman’s pregnancy experiences can be a predictor of her future health. Miscarriages, stillbirths and preterm deliveries have all been linked with an increased risk of later cardiovascular disease, as have hypertensive disorders of pregnancy (preeclampsia and gestational hypertension). Women with preeclampsia also have an increased risk of peripartum cardiomyopathy, a rare but serious condition that severely compromises heart function at the end of pregnancy or shortly after delivery. We were interested to find out whether women with preeclampsia or gestational hypertension during one or more pregnancies also had an increased risk of cardiomyopathy later in life. What are the main findings? Response: Using Danish national registers, we followed more than 1 million women with pregnancies between 1978 and 2011 – with an average follow-up of almost 18 years per woman – to see whether women with hypertensive disorders of pregnancy had increased rates of cardiomyopathy later in life, compared with women who only had normotensive pregnancies. We found that the women with hypertensive disorders of pregnancy had a two-fold increased risk of cardiomyopathy later in life. Interestingly, only half of this increase in risk could be linked to chronic hypertension, which is common among women who have previously had a hypertensive disorder of pregnancy. The remaining 50% was not associated with hypertension and could potentially be directly attributable to the woman’s pregnancy experience (or to an underlying cause common to both hypertensive disorders of pregnancy and cardiomyopathy).  (more…)
Author Interviews, JAMA, Ophthalmology / 14.03.2016 Interview with: Fanny Raguideau Evaluateur en pharmaco-épidémiologie Direction Scientifique et de la Stratégie Européenne Pôle Epidémiologie des produits de santé What is the background for this study? What are the main findings? Response: Retinal detachment (RD), including both exudative types often associated with systemic diseases that might be receiving antibiotics for related conditions as well as rhegmatogenous which require prompt surgical intervention to reduce the chance of irreversible severe vision loss, has an annual incidence rate of 1 per 10,000 in the general population. Rhegmatogenous is the most common type. Fluoroquinolones are one of the most commonly prescribed classes of antibiotics. Thanks to their broad-spectrum antibacterial coverage, they are effective in the treatment of a wide variety of community-acquired infections. What is the background for this study? What are the main findings? Response: Several studies have suggested that oral fluoroquinolone use increased the risk of Retinal detachment, however this association remains controversial. We conducted a nationwide self-matched design study to overcome limitations of previous studies. Our finding of a significant increased risk of  Retinal detachment, including both rhegmatogenous and exudative types, following use of oral fluoroquinolone strongly supports the existence of this association. (more…)
Author Interviews, Hospital Readmissions, JAMA, Orthopedics, Surgical Research / 11.03.2016 Interview with: Ronald S. Chamberlain, MD, MPA, FACS Chairman and Surgeon-in-Chief Department of Surgery Saint Barnabas Medical Center Professor of Surgery New Jersey Medical School Rutgers University What is the background for this study? Dr. Chamberlain:  With the rapidly growing arthritic, aging, and obese population, total hip replacement (THR) has become the most commonly performed orthopedic procedure in the United States (US).  The Affordable Care Act signed by President Barack Obama imposed financial penalties for excess readmissions following certain procedures and diagnoses. While the initial program aimed to reduce readmissions for heart failure, pneumonia, and acute myocardial infarction (AMI), the program expanded to include THR in 2015. With current research estimating a 10%, 30-day readmission rate following a total or partial hip replacement, this study sought to identify factors associated with readmission and to create a scale which could reliably stratify preoperative readmission risk. (more…)
Author Interviews, Cancer Research, JAMA / 11.03.2016 Interview with: Joseph Unger, PhD, MS SWOG Statistical Center Assistant Member, Public Health Sciences Division, Fred Hutchinson Cancer Research Center Affiliate Assistant Professor, Health Services Research, University of Washington Seattle, WA  98109-1024 What is the background for this study? Dr. Unger: The rate at which trials are positive has previously been examined, and the relationship between trial results and publication rates in the context of publication bias has also been studied. But the comparative scientific impact of positive vs negative clinical trials using citation data has not been investigated We used the phase III trial database of SWOG, a major national cooperative clinical trials group, in combination with its trial publication database and citation data from Google Scholar, to compare the scientific impact of positive vs negative phase III cancer clinical treatment trials. (more…)
Author Interviews, Diabetes, JAMA, Multiple Sclerosis / 10.03.2016 Interview with: Jorge Correale MD Department of Neurology, Institute for Neurological Research Dr Raúl Carrea Buenos Aires, Argentina What is the background for this study? What are the main findings? Dr. Correale: First it is now well known that in parallel to the specific treatment of Multiple Sclerosis, those comorbidities that worsen the course of the disease should be treated. For example, cardiovascular diseases. Moreover there are in vitro and in animal models evidence of an anti-inflammatory role of compounds investigated in this publication evidence. (more…)
Author Interviews, JAMA, Rheumatology, Vitamin D / 10.03.2016 Interview with: Changhai Ding, MBBS, MMED, MD Australian Research Council Future Fellow Associate Director (International), Menzies Institute for Medical Research Professor,  University of Tasmania, Australia Honorary Professor, University of Sydney, Australia What is the background for this study? What are the main findings? Dr. Ding: Vitamin D can reduce bone turnover and cartilage degradation, thus potentially preventing the development and progression of knee osteoarthritis. Observational studies suggest that vitamin D supplementation is associated with benefits for knee osteoarthritis, but current evidence from clinical trials is contradictory. We  conducted a randomised clinical trial in Hobart, Tasmania and Melbourne, Victoria in Australia. We randomly assigned 413 patients with symptomatic knee osteoarthritis and low 25-hydroxyvitamin D to receive monthly treatment with oral vitamin D3 (50,000 IU; n = 209) or an identical placebo (n = 204) for 2 years. Of 413 enrolled participants (average age, 63 years; 50 percent women), 340 (82 percent) completed the study. Vitamin D supplementation significantly increased blood 25-hydroxyvitamin D levels over 2 years compared with placebo treatment; however, vitamin D supplementation, compared with placebo, did not result in significant differences in change in MRI-measured tibial cartilage volume or a measure of knee pain over 2 years. There were also no significant differences in change of tibiofemoral cartilage defects or change in tibiofemoral bone marrow lesions. Post-hoc analyses indicated that vitamin D supplementation might improve knee physical function and reduce another measure of knee pain and increases in bone marrow lesion. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Vitamin D / 08.03.2016 Interview with: Kassandra Munger, Sc.D. Harvard T.H. Chan School of Public Health What is the background for this study? Dr. Munger: Previous work has shown that adequate vitamin D nutrition is associated with a lower risk of multiple sclerosis (MS).  Results from studies examining whether adequate vitamin D exposure during early-life are also associated with a lower risk of MS have been mixed.  One study reported that daughters of mothers with high dietary vitamin D intake during their pregnancy had a reduced risk of multiple sclerosis, while two studies measuring 25-hydroxy vitamin D either in a blood sample from the pregnant mother or from a sample taken from the neonate, were not associated with future multiple sclerosis risk in the child. (more…)
Accidents & Violence, Author Interviews, JAMA, Pediatrics / 08.03.2016 Interview with: Alison Culyba, MD MPH Adolescent Medicine Advanced Research Fellow Craig-Dalsimer Division of Adolescent Medicine Children’s Hospital of Philadelphia PhD Candidate, Epidemiology Department of Epidemiology and Biostatistics Perelman School of Medicine at the University of Pennsylvania What is the background for this study? What are the main findings? Dr. Culyba: Youth violence is a major public health problem. Homicide is the second leading cause of death among all adolescents in the U.S., and the number one cause of death among African American adolescents. Prom prior research, we know that where you live and where you spend time has a major impact on health, and that making changes to environments, such as greening vacant lots and remediating abandoned buildings, can significantly reduce crime. However, much less is known about the relationship between adolescent’s immediate surroundings and the risk of homicide. The goal of this study was to examine associations between neighborhood environmental features, such as streets, buildings, and natural surroundings and adolescent homicide. We conducted a population-based case control study of 143 adolescents, ages 13 to 20, who were victims of homicides in Philadelphia and 155 matched controls in the same range, who were outdoors in Philadelphia at the same time that the homicides occurred. To assess features in the immediate environments of homicide victims and control individuals, trained field staff stood on the street corner of each homicide and control location and took a series of photographs that we stitched together into 360-degree high resolution panoramas, which we assessed for environmental features. After accounting for many individual and neighborhood contextual factors, we found that the odds of homicide was significantly lower in locations with street lighting, pedestrian infrastructure, public transportation, parks, and maintained vacant lots. (more…)
Author Interviews, JAMA / 07.03.2016 Interview with: DrAgnes Dechartres MD, PhD Centre de Recherche Epidémiologie et Statistique Paris, France What is the background for this study? What are the main findings? Dr. Dechartres: In general, the availability of trial results is not optimal, with about half of the results from clinical trials, especially those with negative results, not being published in journals. To improve the availability of results, the FDA Amendment Act (FDAAA) requires results to be posted at for all trials evaluating FDA-approved drugs, devices, or biologics within one year of trial completion. However, some previous methodological studies showed poor compliance with this law1-3. Rare diseases are defined by a prevalence of fewer than 200,000 people, but overall, they may affect up to 25 million people in North America. The limited number of patients affected by each rare disease makes this research particularly challenging, and the access to information on all trials conducted and their results is even more necessary. In this study, we aimed to describe the characteristics of completed phase 3 or 4 trials of rare diseases registered at and assess whether their results were publicly available. We found a substantial proportion of single-group trials and trials not randomized. Many trials were also conducted in a single-center. Concerning the availability of results, 36 months after trial completion, results were posted at for 35% of trials, published in journals for 47%, and publicly available (ie, posted at or published in journals) for 63%. Among the trials likely subject to the FDAAA, 68% had results posted at 4% had results posted at 12 months and 57% at 36 months. We also found that 21% of studies not concerned by the FDAAA had results posted. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Hand Washing, Health Care Systems, JAMA, UCSF / 07.03.2016 Interview with: Dr. Andrew Auerbach MD Professor of Medicine in Residence Director of Research Division of Hospital Medicine UCSF and Jeffrey L. Schnipper, MD, MPH Associate Physician, Brigham and Women's Hospital Associate Professor of Medicine, Harvard Medical School Department of Medicine Brigham and Women's Hospital What is the background for this study? Response: The Affordable Care Act required the Department of Health and Human Services to establish a program to reduce what has been dubbed a “revolving door of re-hospitalizations.” Effective October 2012, 1 percent of every Medicare payment was deducted for a hospital that was determined to have excessive readmissions. This percentage has subsequently increased to up to 3 percent. Penalties apply to readmitted Medicare patients with some heart conditions, pneumonia, chronic lung disease, and hip and knee replacements. Unfortunately, few data exist to guide us in determining how many readmissions are preventable, and in those cases how they might have been prevented. What are the main findings? Response: Our main findings were that 27 percent of readmissions were preventable, and that the most common contributors to readmission were being discharged too soon, poor coordination between inpatient and outpatient care providers, particularly in the Emergency Departments and in arranging post acute care. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Stroke / 04.03.2016 Interview with: Hakan Ay MD, FAHA Associate Professor of Neurology and Radiology Stroke Service, Department of Neurology Director of Stroke Research, A.A. Martinos Center, Department of Radiology Massachusetts General Hospital Harvard Medical School Boston MA, USA Medical Research: What is the background for this study? What are the main findings? Dr. Ay: Recurrent stroke is an important public health problem. One quarter of all strokes are recurrent strokes. Approximately one out of every 10 patients with stroke develops a second stroke within the next 2 years. The most critical period for recurrence after stroke is the first 90 days; approximately half of recurrent strokes that occur within 2 years occur within the first 90 days. The RRE tool was developed at the Massachusetts General Hospital in 2010 to assess the 90-day risk of recurrent stroke. The RRE was subsequently tested in a separate cohort of patients with transient stroke symptoms (mini strokes) admitted to the Massachusetts General Hospital in 2011. The current study expands upon prior two studies by showing that the RRE tool provides reliable risk estimates when tested in cohorts of patients recruited from different academic centers in various parts of the world. The study reports that the RRE can stratify approximately one-half of patients with stroke either at high-risk or at low-risk with a reasonable accuracy. (more…)
Author Interviews, Global Health, Heart Disease, Infections, JAMA / 04.03.2016 Interview with: Thomas Pilgrim, Prof. Dr. med. Oberarzt, Invasive Kardiologie Universitätsspital Bern Bern Switzerland What is the background for this study? Dr. Pilgrim: Three quarters of all children worldwide grow up in regions endemic for rheumatic heart disease. Clinically manifest rheumatic heart disease represents only the tip of the iceberg: only one in in 5 to 8 children with valvular lesions consistent with rheumatic heart disease have a heart murmur or clinical symptoms; the remaining children have clinically silent disease that goes undetected unless echocardiography is performed. An understanding of incidence, prevalence, and progression of disease is an important prerequisite to guide active surveillance and secondary prevention. We therefore performed a school-based cross-sectional study among more than 5000 children from 26 schools in Nepal. The objective of the study was to assess prevalence of clinically silent and manifest rheumatic heart disease as a function of age, gender and socioeconomic status and to estimate the age-specific incidence from available prevalence data. What are the main findings? Dr. Pilgrim: In our population-based observational cross-sectional study, the prevalence of borderline or definite rheumatic heart disease among schoolchildren in Eastern Nepal amounted to 10.2 (95% CI 7.5-13.0) per 1000 children between the ages of 5 and 15 years, and was more common in girls as compared to boys. The prevalence increased across age categories in a nearly linear fashion from 5.5 (95% CI 3.5-7.5) per 1000 in children 5 years of age to 16.0 (95% CI 14.9-17.0) in children 15 years of age, while the average incidence remained stable at 1.1 per 1000 children per year. The prevalence of clinically silent rheumatic heart disease was 5 times higher compared to manifest disease and the ratio of manifest to subclinical disease increased with increasing age. (more…)
Author Interviews, Depression, JAMA, Johns Hopkins / 04.03.2016 Interview with: Katherine L. Musliner, PhD National Centre for Register-Based Research, Department of Economics and Business Economics, Aarhus University, Aarhus, Denmark The Lundbeck Foundation Initiative for Integrative Psychiatric Research Department of Mental Health The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland What is the background for this study? What are the main findings? Response: There is great variation among patients with depression in terms of long-term illness course. This variation may be indicative of underlying differences in the cause of the illness, and from a practical perspective, it also has implications for treatment and allocation of public health resources. Our goal was to identify different trajectories of depression course by examining inpatient and outpatient contacts for depression at psychiatric treatment facilities in Denmark (where healthcare is free) during the 10-year period following patients’ initial depression diagnosis. We found that the majority of patients (77% in our sample) followed a trajectory characterized by a brief period of contact with the psychiatric treatment system and no contact for depression during the remainder of the 10-year follow up period. Patients with more prolonged contact either had a drawn out initial period of contact lasting as long as five years (13%), left depression treatment for several years only to return with a depression diagnosis years later (7%) or exhibited a chronic course (3%). (more…)
Author Interviews, Geriatrics, JAMA, Ophthalmology, Primary Care / 03.03.2016 Interview with: Dr. Albert Siu M.D., M.S.P.H. Chair of the U.S. Preventive Services Task Force Chairman and professor of the Brookdale Department of Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai Director of the Geriatric Research, Education, and Clinical Center James J. Peters Veterans Affairs Medical Center What is the background for this study? What are the main findings? Dr. Siu: Impaired vision is a serious and common problem facing older adults and can affect their independence, ability to function, and quality of life. When the Task Force reviewed the research around screening older adults for vision impairment in a primary care setting, we concluded that the current evidence is insufficient to assess the balance of benefits and harms. As a result, we issued an I statement, which is consistent with the 2009 final and 2015 draft recommendations. What should clinicians and patients take away from your report? Dr. Siu: Older adults who are having problems seeing should talk to their primary care doctor or an eye specialist. Primary care doctors can explore the various causes of vision problems and do an eye exam to check for refractive error. An eye specialist can do a full eye exam to look for and treat refractive errors and other eye conditions that affect vision, such as cataracts and age-related macular degeneration (AMD). With regards to clinicians, in the absence of clear evidence, they should use their clinical judgment when deciding whether to screen patients who have not reported any concerns about their vision. (more…)
Author Interviews, Diabetes, JAMA, Pharmacology / 01.03.2016 Interview with: Dr. John Buse MD Ph.D Professor, Medicine Director, Diabetes Care Center Chief, Division of Endocrinology Executive Associate Dean, Clinical Research University of North Carolina School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Buse: Degludec is an longer acting basal insulin analog recently approved in the US.  Liraglutide is a once-daily GLP-1 receptor agonist.  Both are among the most powerful glucose lowering drugs available in the setting of type 2 diabetes.  They have very different properties.  Degludec is best at lowering fasting glucose. Liraglutide has effects on postprandial glucose as well.  The major side effects of degludec are hypoglycemia and weight gain. Liraglutide on the other hand has not an inherent effect to cause hypoglycemia and does promote weight loss.  Liraglutide does cause nausea and in fewer patients vomiting in a dose dependent manner. In developing the fixed dose combination the idea was to amplify glucose lowering efficacy and minimize the adverse effects of both components.  Prior studies have basically shown that this has been accomplished.  In this study we looked at the very common clinical scenario of the patient with type 2 diabetes inadequately controlled on basal insulin glargine and asked the question of whether switching from glargine to IDegLira (the combination product) would do better than continued titration of glargine. (more…)