Author Interviews, JAMA, Smoking / 27.01.2016

MedicalResearch.com Interview with: Timothy Baker, PhD Professor of Medicine University of Wisconsin-Madison School of Medicine and Public Health Medical Research: What is the background for this study? What are the main findings? Dr. Baker: Previous research showed that combination nicotine replacement (the nicotine patch plus the nicotine lozenge or gum) and varenicline are the most effective smoking cessation treatments available, yet they had never been directly compared with one another. This study set out to do that, and compare them with the nicotine patch. The present study shows that three medications which were combined with coaching to quit smoking—a pill called varenicline (Chantix), the nicotine patch alone, and a combination of nicotine-replacement medications—all produced about the same abstinence rates among participants at 6- and 12-months after the quit attempt. We were surprised that the patch by itself produced about the same level of success as the other two more intensive medications. (more…)
Author Interviews, Brigham & Women's - Harvard, End of Life Care, JAMA / 27.01.2016

MedicalResearch.com Interview with: Joel Weissman, PhD, Deputy Director and Zara Cooper, MD, MSc Associate Surgeon Center for Surgery and Public Health Brigham and Women’s Hospital Boston, Massachusetts Medical Research: What is the background for this study? What are the main findings? Response: A major priority for providers of end-of-life care is balancing the intensity of a patient’s treatment with quality of life. Previous studies have looked at the intensity of end-of-life care for the general population, but not whether physicians, the group most familiar with end-of-life care, receive more or less intense end-of-life care compared to non-physicians. Research from the Center for Surgery and Public Health (CSPH) at Brigham and Women’s Hospital found that for 3 of 5 end-of-life care intensity measures, physicians received significantly less intensive end-of-life care than the general population.  The findings are published in the January 19, 2016 issue of JAMA, in a special themed issue focusing on end-of-life care. The analysis included non-health maintenance organization Medicare beneficiaries aged 65 years or older who died between 2004 and 2011 in Massachusetts, Michigan, Utah, and Vermont, and was based on availability of electronic death records and ability to link to Medicare. Researchers used data from these records to look at 5 validated measures of end-of-life care intensity during the last 6 months of life: surgery, hospice care, intensive care unit (ICU) admission, death in the hospital, and expenditures. They then compared these measures between physicians and the general population (excluding other health care workers and lawyers), physicians vs. lawyers, who are presumed to be socioeconomically and educationally similar, and lawyers vs. the general population. There were 2,396 deceased physicians, 2,081 lawyers, and 666,579 people included in the analysis. Overall, physicians were less likely to die in a hospital compared with the general population (27.9 percent vs. 32 percent, respectively), less likely to have surgery (25.1 percent vs. 27.4 percent), and less likely to be admitted to the ICU (25.8 percent vs. 27.6 percent). Physicians were less likely to die in a hospital compared to lawyers (27.9 percent vs. 32.7 percent, respectively), but did not differ significantly in other measures. (more…)
Asthma, Author Interviews, JAMA, OBGYNE, Vitamin D / 27.01.2016

More on Asthma on MedicalResearch.com MedicalResearch.com Interview with: Hans Bisgaard, MD, DMSc Professor of Pediatrics The Faculty of Health Sciences University of Copenhagen Head of the Copenhagen Prospective Studies on Asthma in Childhood University  of Copenhagen and Naestved Hospital MedicalResearch: What is the background for this study? What are the main findings? Dr. Bisgaard: Vitamin D deficiency has become a common health problem in westernized societies, possibly caused by a more sedentary indoor lifestyle and decreased intake of vitamin D containing foods. Vitamin D possesses a range of immune regulatory properties, and it has been speculated that vitamin D deficiency during pregnancy may affect fetal immune programming and contribute to asthma pathogenesis. Asthma often begins in early childhood and is the most common chronic childhood disorder. Observational studies have suggested that increased dietary vitamin D intake during pregnancy may protect against wheezing in the offspring, but the preventive effect of vitamin D supplementation to pregnant women is unknown. In our double-blind, single-center, randomized clinical trial conducted within the Copenhagen Prospective Studies on Asthma in Childhood 2010 cohort we supplemented 2800 IU/d of vitamin D3 during the third trimester of pregnancy compared with 400 IU/d in the control group. Although the maternal supplementation did not result in a statistically significant reduction of risk of persistent wheeze in the offspring through age 3 years, the interpretation of the study is limited by a wide confidence interval that includes a clinically important protective effect. (more…)
Asthma, Author Interviews, Brigham & Women's - Harvard, JAMA, Vitamin D / 26.01.2016

MedicalResearch.com Interview with: Augusto A. Litonjua, MD, MPH Associate Professor Channing Division of Network Medicine and Division of Pulmonary and Critical Care Medicine Department of Medicine Brigham and Women's Hospital Harvard Medical School Boston, MA 02115 USA  Medical Research: What is the background for this study? What are the main findings? Response: Vitamin D deficiency has been hypothesized to contribute to the asthma and allergy epidemic.  Vitamin D has been shown to affect lung development in utero. However, observational studies have shown mixed results when studying asthma development in young children. Since most asthma cases start out as wheezing illnesses in very young children, we hypothesized that vitamin D supplementation in pregnant mothers might prevent the development of asthma and wheezing illnesses in their offspring.  We randomly assigned 881 pregnant women at 10 to 18 weeks' gestation and at high risk of having children with asthma to receive daily 4,000 IU vitamin D plus a prenatal vitamin containing 400 IU vitamin D (n = 440), or a placebo plus a prenatal vitamin containing 400 IU vitamin D (n = 436). Eight hundred ten infants were born during the study period, and 806 were included in the analyses for the 3-year outcomes. The children born to mothers in the 4,400 IU group had a 20% reduction in the development of asthma or recurrent wheeze compared to the children born to mothers in the 400 IU group (24% vs 30%, respectively; an absolute reduction of 6%).  However, this reduction did not reach statistical significance (p=0.051). (more…)
Author Interviews, Breast Cancer, Cancer Research, JAMA, Prostate Cancer / 23.01.2016

More on Cancer Research on MedicalResearch.com MedicalResearch.com Interview with: Firas Abdollah, M.D., F.E.B.U. (Fellow of European Board of Urology) Urology Fellow with the Center for Outcomes Research, Analytics and Evaluation Vattikuti Urology Institute at Henry Ford Hospital in Detroit  MedicalResearch: What is the background for this study? What are the main findings? Dr. Abdollah: Cancer screening aims to detect tumors early, before they become symptomatic. Evidence suggests that detection and treatment of early-stage tumors may reduce cancer mortality among screened individuals. Despite this potential benefit, screening programs may also cause harm. Notably, screening may identify low-risk indolent tumors that would never become clinically evident in the absence of screening (overdiagnosis), subjecting patients to the harms of unnecessary treatment. Such considerations are central to screening for prostate and breast cancers, the most prevalent solid tumors in men and women, respectively. These tumors are often slow growing, and guidelines recommend against screening (non-recommended screening) for these tumors in individuals with limited life expectancy, i.e. those with a life expectancy less than 10 years. Unfortunately, our study found that this practice is not uncommon in the US. Using a nationwide representative survey conducted in 2012, we found that among 149,514 individuals 65 years or older, 76,419 (51.1%) received any prostate/breast screening. Among these, 23,532 (30.8%) individuals had a life expectancy of less than 10 years. These numbers imply that among the screened population over 65 years old, almost one in three individuals received a non-recommended screening. This corresponds to an overall rate of non-recommended screening of 15.7% (23,532 of 149,514 individuals). Another important finding of our study was that there were important variations in the rate of non-recommended screening from state to state; i.e. the chance of an individual older than 65 to receive a non-recommended screening varies based on his/her geographical location in United States. Finally, on a state-by-state level, there was a correlation (40%) between non-recommended screening for prostate and breast cancer, i.e. states that are more likely to offer non-recommended screening for prostate cancer are also more likely to offer non-recommended screening for breast cancer, and vice versa. (more…)
Accidents & Violence, Author Interviews, JAMA, Surgical Research, UCSF / 22.01.2016

MedicalResearch.com Interview with: Dr. Rachael Callcut M.D., M.S.P.H Assistant Professor of Surgery Division of General Surgery UCSF Medical Research: What is the background for this study? What are the main findings? Dr. Callcut: San Francisco General Hospital (SFGH) responded on July 6, 2013 to one of the larger multiple casualty events in the history of our institution.  Asiana Airlines flight 214 crashed on approach to San Francisco International Airport with 307 people on board.  192 patients were injured and SFGH received the highest total of number of patients of area hospitals. The majority of data that is available on disaster response focuses on initial scene triage or initial hospital resources required to respond to these types of major events.  Our paper focuses on some additional considerations for optimizing disaster response not typically included in literature on these events including nursing resources, blood bank needs, and radiology studies. As an example, over 370 hours of nursing overtime were needed just in the first 18 hours following the disaster to care for patients.  This type of information in traditionally not been included in disaster planning, but clearly was a critical element of providing optimum care to our patients. (more…)
Author Interviews, HPV, JAMA / 22.01.2016

More on HPV on MedicalResearch.com  MedicalResearch.com Interview with: Ilir Agalliu, M.D., Sc.D. Assistant Professor, Department of Epidemiology & Population Health and Department of Urology Albert Einstein College of Medicine Jack and Pearl Resnick Campus Bronx, NY Medical Research: What is the background for this study? Dr. Burk: We performed this study since we had previously detected an unusually high prevalence of HPV types found on the skin and skin cancers in the oral cavity in addition to HPV16 and other high-risk (HR) types (as defined by their association with cervix cancer) (see Journal of Infectious Diseases 204:787, 2011). We wished to determine if these types were associated with risk of head and neck cancers (HNSCCs). In addition, we wished to determine if HPV detection preceded the diagnosis of HNSCCs and might serve as a biomarker. Currently there are no good screening tests for HNSCC. Dr. Agalliu: To-date, there have been no prospective studies examining the temporal relationship between oral HPV detection and risk of head and neck squamous cell carcinoma (HNSCC). In this manuscript we examined prospectively associations between detection of a wide spectrum of oral HPVs (alpha, beta and gamma) with incident HNSCC in a nested case-control study among ~100,000 participants who provided mouthwash samples in the American Cancer Society-CPS II cohort and the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. Dr. Agalliu: Oral HPV16 detection, which preceded cancer development on average for 4 years, was associated with a 22-fold increased risk for incident oropharyngeal cancer. Detection of other oral HPVs (beta1 HPV5, and gamma11 and 12 species) were associated with a 3.3 to 5.5-fold higher risk of  head and neck squamous cell carcinoma after adjustment for smoking, alcohol and HPV16. Associations of beta and gamma HPVs, which have been identified in the skin, with risk of HNSCC suggest a broader role for HPVs in HNSCC etiology. (more…)
Author Interviews, JAMA, Nursing, Outcomes & Safety, Surgical Research, University of Pennsylvania / 20.01.2016

More on Nursing Research on MedicalResearch.com MedicalResearch.com Interview with: Jeffrey H. Silber, M.D., Ph.D. The Nancy Abramson Wolfson Professor of Health Services Research Professor of Pediatrics and Anesthesiology & Critical Care,  The University of Pennsylvania Perelman School of Medicine Professor of Health Care Management The Wharton School Director, Center for Outcomes Research The Children's Hospital of Philadelphia Philadelphia, PA 19104  Medical Research: What is the background for this study? Response: We wanted to test whether hospitals with better nursing work environments displayed better outcomes and value than those with worse nursing environments, and to determine whether these results depended on how sick patients were when first admitted to the hospital. Medical Research: What are the main findings? Response: Hospitals with better nursing work environments (defined by Magnet status), and staffing that was above average (a nurse-to-bed ratio greater than or equal to 1), had lower mortality than those hospitals with worse nursing environments and below average staffing levels. The mortality rate in Medicare patients undergoing general surgery was 4.8% in the hospitals with the better nursing environments versus 5.8% in those hospitals with worse nursing environments. Furthermore, cost per patient was similar. We found that better nursing environments were also associated with lower need to use the Intensive Care Unit. The greatest mortality benefit occurred in patients in the highest risk groups. (more…)
Anesthesiology, Author Interviews, Frailty, JAMA, Surgical Research / 20.01.2016

More on Frailty on MedicalResearch.com MedicalResearch.com Interview with: Dr. Daniel I McIsaac, MD, MPH, FRCPC Assistant Professor of Anesthesiology Department of Anesthesiology The Ottawa Hospital, Civic Campus Ottawa, ON Medical Research: What is the background for this study? Dr. McIsaac: Older age is a well-known risk factor for adverse outcomes after surgery, however, many older patients have positive surgical outcomes. Frailty is a syndrome that encompasses the negative health attributes and comorbidities that accumulate across the lifespan, and is a strong discriminating factor between high- and low-risk older surgical patients.  By definition, frail patients are “sicker” than non-frail patients, so their higher rates of morbidity and mortality after surgery aren’t surprising. However, frailty increases in prevalence with increasing age, so as our population ages we expect to see more frail people presenting for surgery.  Our goal was to evaluate the impact of frailty on postoperative mortality at a population-level, and over the first year after surgery to provide insights that aren’t available in the current literature, which largely consists of single center studies limited to in-hospital and 30-day outcome windows. (more…)
Author Interviews, JAMA, Neurological Disorders, Parkinson's / 20.01.2016

More Interviews on Neurological Disorders on MedicalResearch.com MedicalResearch.com Interview with: Professor Carl E Clarke Professor of Clinical Neurology and Honorary Consultant Neurologist Department of Neurology City Hospital Sandwell and West Birmingham Hospitals NHS Trust Birmingham UK Medical Research: What is the background for this study? Dr. Clarke: Parkinson's disease causes problems with activities of daily living that are only partially treated by medication and occasionally surgery. Physiotherapy and occupational therapy services like Ck Physio are traditionally used later in the disease, but it is unclear whether they are clinically and cost-effective in Parkinson's disease. Medical Research: What are the main findings? Dr. Clarke: We performed a large pragmatic randomised trial to evaluate the clinical and cost-effectiveness of individualized physiotherapy and occupational therapy in Parkinson's disease. The PD REHAB trial was a multicenter, open label, parallel group, controlled efficacy trial. 762 patients with mild-moderate Parkinson’s disease were recruited from 38 sites across the United Kingdom. For patients with mild to moderate Parkinson disease, there were no clinically meaningful benefits in activities of daily living or quality of life associated with physiotherapy and occupational therapy. (more…)
Author Interviews, Diabetes, JAMA, Mental Health Research, Pediatrics, Pharmacology / 20.01.2016

More on Mental Health on MedicalResearch.com MedicalResearch.com Interview with: Christoph U. Correll, MD Professor of Psychiatry and Molecular Medicine Hofstra Northwell School of Medicine Hempstead, New York, USA Investigator, Center for Psychiatric Neuroscience Feinstein Institute for Medical Research Manhasset, New York, Medical Director, Recognition and Prevention The Zucker Hillside Hospital, Department of Psychiatry  Medical Research: What is the background for this study? Dr. Correll: Antipsychotics have been used increasingly for psychotic, but also for many non-psychotic conditions, including for disorders and conditions for which they have not received regulatory approval. Moreover, antipsychotics have been associated with weight gain and abnormalities in blood fat and blood glucose levels. Although data in youth have been less available than in children and adolescents, youth appear to be more sensitive to the cardiometabolic adverse effects of antipsychotics than adults in whom significant weight gain might have already occurred due to long-term prior antipsychotic treatment. Nevertheless, type 2 diabetes, which is related to weight gain, overweight and obesity, seemed to be more common in adults than youth, likely due to the fact that it takes a long time for the body to develop diabetes. Recently, several individual epidemiologic or database studies with sufficient long-term follow-up durations suggested that the type 2 diabetes risk was higher in youth exposed to antipsychotics than healthy control youth and, possibly, even compared to psychiatrically ill patients treated with non-antipsychotic medications. However, a meta-analytic pooling of all available data has not been available to estimate the absolute and relative risk of type 2 diabetes in youth receiving antipsychotic treatment.  Medical Research: What are the main findings? Dr. Correll: The main findings of the study that meta-analyzed data from 13 studies with 185,105 youth exposed to antipsychotics (average age 14.1 and 59.5 percent male) are that the absolute rates of type 2 diabetes are fortunately still relatively low, i.e. a cumulative type 2 diabetes  risk of 5.7/1,000 patients and an exposure adjusted incidence rate of 3.1/1,000 patient-years. Nevertheless, the cumulative risk of type 2 diabetes and its exposure adjusted incidence rate per patient were 2.6 times and three times higher compared with 298,803 healthy controls. Furthermore, the cumulative risk of type 2 diabetes and its exposure adjusted incidence rate per patient were 2.1 times and 1.8 times higher compared with 1,342,121 psychiatric patients not exposed to antipsychotics. Main modifiable risk factors for type 2 diabetes development in antipsychotic-treated youth were treatment with the antipsychotic olanzapine and longer antipsychotic exposure time. (more…)
Author Interviews, Brigham & Women's - Harvard, Dermatology, JAMA, Melanoma, Transplantation / 20.01.2016

More on Dermatology from MedicalResearch.com  MedicalResearch.com Interview with: Pritesh S. Karia, MPH Manager-Dermatologic Oncology Research Program Mohs and Dermatologic Surgery Center Brigham and Women's Hospital Boston, MA 02130  Medical Research: What is the background for this study? Response: Several recent studies have shown a reduced incidence of skin cancer in organ transplant recipients (OTR) treated with sirolimus as first-time therapy and those converted from calcineurin inhibitors to sirolimus. Although cancer formation is one of the main reasons for conversion to sirolimus, studies examining the effect of sirolimus on the risk of subsequent cancer formation in organ transplant recipients who have already been diagnosed with a post-transplant cancer are limited. (more…)
Author Interviews, JAMA, NYU, Pediatrics, Weight Research / 20.01.2016

More on Obesity from MedicalResearch.com MedicalResearch.com Interview with: Brian Elbel, PhD, MPH, Associate Professor, Department of Population Health, NYU Langone Medical Center Amy Schwartz, PhD, Director, New York University Institute for Education and Social Policy, and the Daniel Patrick Moynihan Chair in Public Affairs, Syracuse University Michele Leardo, MA, Assistant Director New York University Institute for Education and Social Policy Medical Research: What is the background for this study? What are the main findings? Response: New York City, as well as other school districts, is making tap water available to students during lunch by placing water dispensers, called water jets, in schools. Surprisingly, drinking water was not always readily available in the lunchroom. Water jets are part of a larger effort to combat child obesity. We find small, but statistically significant, decreases in weight for students in schools with water jets compared to students in schools without water jets. We see a .025 reduction in standardized body mass index for boys and .022 for girls. We also see a .9 percentage point reduction in the likelihood of being overweight for boys and a .6 percentage point reduction for girls. In other words, the intervention is working. (more…)
Author Interviews, Heart Disease, JAMA, Wake Forest / 20.01.2016

More on Heart Disease on MedicalResearch.com MedicalResearch.com Interview with: Ajay Dharod, M.D. Coordinator of Medical Informatics Department of Internal Medicine Wake Forest School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Dharod: There is a relative paucity of data regarding asymptomatic bradycardia in adults free of clinical cardiovascular disease. Are individuals with low heart rates simply healthy individuals with a non-clinically significant finding or is there a subclinical disease process? That was the question that generated this study. Until now, there had not been any research to determine if a slow heart rate contributed to the development of cardiovascular disease. We found that a heart rate (HR) of less than 50 was not associated with an elevated risk of cardiovascular disease in participants regardless of whether they were taking Heart Rate-modifying drugs, such as beta blockers and calcium channel blockers. However, we did find a potential association between bradycardia and higher mortality rates in individuals taking HR-modifying drugs. (more…)
Author Interviews, Eating Disorders, JAMA, Karolinski Institute, Mental Health Research / 17.01.2016

More on Eating Disorders from MedicalResearch.com MedicalResearch.com Interview with: Shuyang Yao, MSc Department of Medical Epidemiology and Biostatistics Karolinska Institutet, Stockholm, Sweden Medical Research: What is the background for this study? Response: Suicide risk is much higher in individuals with eating disorders than individuals without the disorders. The mechanism underlying the high suicide risk in eating disorders (i.e., why?) is not clear. Large studies and genetically informative designs can help us understand the nature of the association between suicide attempts and eating disorders. Medical Research: What are the main findings? 1) Eating disorders are associated with increased risk of suicide attempts and death by suicide. 2) Increased risk of suicide attempts is also found in relatives of individuals with eating disorders. 3) Some, but not all of the increased risk for suicide in individuals with eating disorders is accounted for by the presence of comorbid major depressive, anxiety, and substance use disorders. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Nutrition, Ophthalmology / 16.01.2016

More on Ophthalmology on MedicalResearch.com MedicalResearch.com Interview with: Jae Hee Kang, MSc, SC Associate Epidemiologist, Brigham and Women's Hospital Assistant Professor of Medicine, Harvard Medical School Brigham and Women's Hospital Department of Medicine Channing Division of Network Medicine Boston, MA 02115 Medical Research: What is the background for this study? What are the main findings? Dr. Kang: Glaucoma is a leading cause of irreversible blindness worldwide, and primary open-angle glaucoma (POAG) is the most common form of the disease. Little is known on the causes of glaucoma but dysfunction in the regulation of blood flow to the optic nerve, which transmits visual information to the brain, may be involved. Nitric oxide is important for maintenance of blood flow and its signaling may be impaired in glaucoma. We were interested in whether dietary nitrates, an exogenous source of nitric oxide mostly found in green-leafy vegetables, may be related to lower risk of POAG. Medical Research: What is the background for this study? What are the main findings? Dr. Kang: We (Brigham and Women’s Hospital / Harvard Medical School and Massachusetts Eye and Ear researchers) used 25+ years of data from over 100,000 participants in the Nurses' Health Study (63,893 women) and the Health Professionals Follow-up Study (41,094 men). Participants were nurses or other health professionals and were aged 40 years or older and reported eye exams. We collected information on their diet and other health information every two years with questionnaires. During follow-up, 1,483 new cases of primary open-angle glaucoma with visual field loss were identified and confirmed with medical record review. Participants were divided into quintiles (one of five groups) of dietary nitrate intake (quintile 5, approximately 240 mg/day; quintile 1, approximately 80 mg/day) and of green leafy vegetables (quintile 5, approximately 1.5 servings/day; quintile 1, approximately one-third of a serving/day). We observed that greater intake of dietary nitrate and green leafy vegetables (e.g., romaine and iceberg lettuce and kale/chard/mustard greens) was associated with a 20 percent to 30 percent lower POAG risk; the association was particularly strong (40 percent-50 percent lower risk) for POAG with early paracentral visual field loss (a subtype of POAG most linked to dysfunction in blood flow autoregulation). (more…)
Author Interviews, Columbia, Cost of Health Care, JAMA, Ophthalmology / 15.01.2016

More on Health Care Costs on MedicalResearch.com MedicalResearch.com Interview with: Alisa Prager BS Bernard and Shirlee Brown Glaucoma Research Laboratory Department of Ophthalmology Edward S. Harkness Eye Institute Columbia University Medical Center, New York, New York MedicalResearch: What is the background for this study?  Response: The goal of this research was to better understand the impact of glaucoma on non-ophthalmic healthcare use and costs. While there have been other studies assessing costs associated with glaucoma, these studies were primarily derived from either claims data or chart review. Our study used the Medicare Current Beneficiary Survey, which is a dataset that links claims data with survey results. The advantage of this is that the survey data allowed us to assess patient reported outcomes that did not necessarily prompt an encounter with the health care system, such as recent falls or feelings of sadness. The MCBS also provides complete expenditure and source of payment data on health services, including those not covered by Medicare, which allowed us to look at a more full spectrum of both private and public healthcare use and costs among Medicare beneficiaries. MedicalResearch: What are the main findings? Response: We found that Medicare beneficiaries with glaucoma have 27% higher likelihood of inpatient hospitalizations and home health aide visits compared to those without glaucoma, even after adjusting for covariates and excluding individuals who were admitted to the hospital with a diagnosis of glaucoma. When we stratified glaucoma patients based on self-reported visual disability, we found that those with self-reported visual disability were more likely to complain of depression, falls and difficulty walking compared to those without. We also found that glaucoma patients incurred a predicted $2,903 higher mean annual total healthcare costs from all sources compared to those without glaucoma after adjusting for socioeconomic factors and comorbidities. Costs were higher among those who reported visual disability, and remained higher after excluding outpatient payments. (more…)
Author Interviews, Dermatology, JAMA / 15.01.2016

More interviews with researchers from JAMA on MedicalResearch.com MedicalResearch.com Interview with: Daniela Kroshinsky, MD, MPH Department of Dermatology Massachusetts General Hospital, Boston  and Suchismita Paul, MD Medical student at Harvard Medical School, Boston, Massachusetts, at the time of the study now with Department of Medicine and Department of Dermatology and Cutaneous Surgery Jackson Memorial Medical Research: What is the background for this study? Response: Calciphylaxis is a life-threatening disease and the diagnosis is challenging with clinicians mostly relying on the clinical findings along with an assessment of risk factors. Tissue biopsy is often falsely negative, requiring multiple tissue biopsies, possibly propagating new lesion formation, and delaying treatment initiation. Therefore, a non-invasive tool would be of significant value for the diagnosis of calciphylaxis. The use of bone scans for the diagnosis of calciphylaxis has been reported in several case reports, yet its use remains controversial because of the reported low sensitivity and specificity. Only one previous study from 2002 reported that in fact the sensitivity is very high (97%), however, only 4 of 36 calciphylaxis patients were biopsy-confirmed and the specificity was not addressed. We investigated the potential role of bone scintigraphy for the early diagnosis and treatment monitoring of calciphylaxis. We performed a retrospective case-control study involving 49 patients, 18 calciphylaxis cases (biopsy-confirmed in 14) and 31 controls with end-stage renal disease without calciphylaxis. (more…)
ALS, Alzheimer's - Dementia, Author Interviews, JAMA, Multiple Sclerosis, Neurological Disorders, Stem Cells / 12.01.2016

MedicalResearch.com Interview with: Prof. Dimitrios Karussis M.D., Ph.D. Professor of Neurology Head, Multiple Sclerosis Center Hadassah BrainLabs Medical Research: What is the background for this study? What are the main findings? Prof. Karussis: BrainStorm Cell Therapeutics is developing innovative, autologous stem cell therapies for highly debilitating neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), and Parkinson’s Disease (PD).  Our technology, NurOwn™ is a first-of-its-kind approach that induces autologous bone marrow-derived Mesenchymal Stem Cells (MSCs) to secrete Neurotrophic Growth Factors (NTFs).  These MSC-NTF cells have been shown to be protective in several animal models of neurodegenerative diseases. Data from the clinical trials described in the recent issue of the Journal of American Medicine – Neurology (JAMA Neurology), suggest that NurOwn can help patients with ALS.  The two trials featured in the article, a phase 1/2 and a phase 2a, studied the transplantation NurOwn cells in ALS patients.  These trials confirmed the excellent safety profile of NurOwn and suggest a clinically meaningful effect. The investigators used two well established clinical endpoints that measure disease activity in ALS, the Revised ALS Functional Rating Scale and Forced Vital Capacity, and were able demonstrate a slowing of disease activity in the period following treatment. (more…)
Author Interviews, Depression, JAMA, Surgical Research, UCLA, Weight Research / 12.01.2016

MedicalResearch.com Interview with: Aaron J. Dawes, MD Fellow, VA/RWJF Clinical Scholars Program Division of Health Services Research University of California Los Angeles Los Angeles, CA 90024 Medical Research: What is the background for this study? What are the main findings? Dr. Dawes: We reviewed the published literature to answer three basic questions about bariatric surgery and mental health conditions. First, how common are mental health conditions among patients being referred for or undergoing bariatric surgery?
  • Second, do patients who carry a diagnosis of one of these conditions lose less weight after surgery than patients without these conditions?
  • And, third, what happens to the clinical course of mental health conditions after patients undergo surgery? Do they get better, worse, or stay the same?
We found that mental health conditions are surprisingly common among bariatric patients, especially depression and binge eating disorder, which occur at almost twice the rate among bariatric patients than in the general U.S. population. We also found no strong evidence to suggest that patients with depression lose less weight after surgery and some evidence that the condition may actually improve after surgery. Eleven of the twelve studies on the topic found either lower rates or fewer symptoms of depression, at least during the first 3 years post-operatively. (more…)
Accidents & Violence, Author Interviews, Autism, JAMA / 12.01.2016

MedicalResearch.com Interview with: Diana Schendel, Professor MSO Department of Public Health Institute of Epidemiology and Social Medicine and Department of Economics and Business                             National Centre for Register-based Research Aarhus University Denmark Medical Research: What is the background for this study? What are the main findings? Dr. Schende: Elevated mortality has been reported in persons with autism spectrum disorder (ASD), especially with comorbid epilepsy and intellectual disability. The effect of comorbidity on the risk for mortality in ASD, however, has not been rigorously examined in large, population-based studies. Our study aim was to investigate ASD mortality patterns overall and to assess the specific effects of comorbid mental, behavioral, and neurologic disorders on ASD mortality into young adulthood. Our study comprised a nation-wide Danish cohort of 1.9 million children of whom 20,492 were diagnosed with ASD. We observed 68 deaths in persons with ASD; 83% of the persons with ASD who died had comorbid mental/behavioral or neurologic disorders. The risk for mortality was two-fold higher in persons with autism spectrum disorder overall. An elevated risk for mortality was also seen in persons who had ASD only, or had both ASD and other neurologic or mental/behavioral disorders, compared to persons without these other morbidities and no ASD. However, the co-occurrence of ASD in persons with neurologic, or with mental/behavioral disorders, added no additional mortality risk compared to persons with these disorders and no autism spectrum disorder. These results suggest that the mechanisms underlying mortality risk in ASD in part may be shared with these other disorders, although what might be the specific shared mechanisms cannot be determined with these data. (more…)
Author Interviews, Clots - Coagulation, FDA, Heart Disease, JAMA, Johns Hopkins / 12.01.2016

MedicalResearch.com Interview with:
Victor Serebruany, MD, PhD
HeartDrug Research, Towson, Maryland
Department of Neurology Johns Hopkins University Baltimore, Maryland Medical Research: What is the background for this study? What are the main findings?

Dr. Serebruany: Missing data are common challenges to the validity of trial results, yet it is unclear how to characterize the extent of missing data.  We compared the published lost-to-follow-up rates to incomplete follow-up rates determined from subject records submitted to the FDA for major oral antithrombotic trials.  The 21 trials having both sets of rates included 270,089 patients followed for a median duration of 20 months.  The mean published lost-to-follow-up rates is 0.4% (median 0.3%, range 0.005% to 2%), consistently much lower than the FDA incomplete follow-up rates: mean 12% (median 13%, range 2% to 23%).  There is no correlation between the publication and FDA-calculated  rates (R 0.07, p = 0.76).   The FDA rates exceed greatly the endpoint rate differences: mean 1.3% (median 1,0%, range 0.2% to 3.0%). Medical Research: What should clinicians and patients take away from your report? Dr. Serebruany: That the FDA incomplete follow-up rates greatly exceed the endpoint rate differences raises questions of whether the endpoint differences may be due to differential follow-up rather than drug effect.  That they greatly exceed the measures routinely reported for trials, i.e., lost-to-follow-up rates, suggests that current trial reporting is inadequate.  Completeness of follow-up and other indicators of trial data quality should be considered when interpreting trial results. (more…)
Author Interviews, JAMA, OBGYNE, Pediatrics / 11.01.2016

MedicalResearch.com Interview with: Annie Gatewood Hoen, PhD  Assistant Professor of Epidemiology and of Biomedical Data Science and Juliette Madan, MD, MS Associate Professor of Pediatrics The Geisel School of Medicine at Dartmouth Dartmouth-Hitchcock Medical Center Lebanon, NH 03756 Medical Research: What is the background for this study? What are the main findings? Response: When newborns are delivered they begin the process of acquiring vast numbers of bacteria that are critical for healthy nutrition and for immune training for a lifetime of health. Diseases such as obesity, heart disease, colitis, autism, and even cancer risk is associated with particular patterns in the gut microbiota; interestingly breast milk exposure is associated with decreased risk of many of these diseases. The intestinal microbiome plays a critical role in development, and delivery mode (cesarean section versus vaginal delivery) and feeding method (breast milk vs. formula) are important determinants of microbiome patterns.  We observed the intestinal microbiome in 6 week old infants and how it relates to delivery type and feeding. We were particularly interested in examining patterns in the microbiome in infants who received combination feeding of both breast milk and formula, an area that has been understudied. We prospectively studied 102 infants and, with gene sequencing of bacteria, identified important patterns in microbiome composition that differed greatly based upon delivery method and between feeding groups.  Babies who were combination fed (formula and breast milk) had an intestinal microbiome that was more similar to babies who were exclusively formula fed than breast fed babies. We identified individual bacteria that were differentially abundant between delivery mode and feeding groups. (more…)
Author Interviews, Cancer Research, JAMA, Transplantation / 11.01.2016

MedicalResearch.com Interview with: Sergio A. Acuna, MD Graduate Student at St. Michael's Hospital and IHPME University of Toronto Medical Research: What is the background for this study? Dr. Acuna: Solid organ transplant recipients are known to be at greater risk of developing cancers compared to the general population; however, because they are also at high increased risk of mortality from non-cancer causes, the risk of cancer morality in this population is unclear. As previous studies on this topic have reported disparate findings, the cancer mortality risk in this population remained uncertain. Medical Research: What are the main findings? Dr. Acuna: Our study provides conclusive evidence that solid organ transplant recipients are at increased risk of cancer mortality. Our findings demonstrate that solid organ transplant recipients are at increased risk of cancer death compared to the general population regardless of age, transplanted organ, and year of transplantation, and indicate cancer is a substantial cause of death in this population. (more…)
Author Interviews, Exercise - Fitness, JAMA, Orthopedics, Pain Research / 11.01.2016

Daniel Steffens, Ph.D. The George Institute for Global Health The University of SydneyMedicalResearch.com Interview with: Daniel Steffens, Ph.D. The George Institute for Global Health The University of Sydney Medical Research: What is the background for this study? Dr. Steffens: Back pain is a leading cause of disease burden globally. At present, a variety of interventions, such as getting a mattress that can help with back pain, exercise, education, back belts and shoe insoles, are commonly prescribed to prevent an episode of low back pain. Guidelines lack clear recommendations for prevention of low back pain and the effectiveness of the range of possible prevention strategies for low back pain is not clear. Our study aimed to investigate the effectiveness of these interventions for prevention of low back pain. (more…)
Author Interviews, JAMA, Surgical Research, Weight Research / 10.01.2016

MedicalResearch.com Interview with: Dr. Sigrid Bjerge Gribsholt MD, PhD Student Department of Endocrinology and Internal Medicine, Aarhus University Hospital 8000 Aarhus C Medical Research: What is the background for this study? What are the main findings? Response: Based on our clinical experiences we became aware that surgical, medical and nutritional symptoms were common in this group of patients. To enlighten the prevalence and severity we decided to undertake the study. Our main findings include that 88% of the patients felt better or much better than before surgery and 8% felt worse. Furthermore, we found that 68% of the patients had been in contact with the health care system. (more…)
Author Interviews, Cost of Health Care, JAMA, Stanford, Surgical Research / 08.01.2016

MedicalResearch.com Interview with: Sam P. Most, M.D., F.A.C.S. Professor, Departments of Otolaryngology-Head & Neck Surgery and Surgery (Division of Plastic Surgery, by courtesy) Chief, Division of Facial Plastic & Reconstructive Surgery Stanford University School of Medicine Stanford, CA  Medical Research: What is the background for this study? What are the main findings? Dr. Most: Insurance companies often require patients to try a 6 or more week treatment with nasal steroids prior to allowing nasal surgery to proceed. This is true even in cases of physician-documented severe or extreme anatomic nasal obstruction that we know will not respond to medical therapy. We sought to examine this from a cost and quality-of-life perspective. We found that while the up-front cost of surgery is obviously much higher than medical therapy, when viewed from an effect on improvement of quality of life (or lack thereof, in the case of medical therapy), the surgical therapy became more cost effective as years passed by. (more…)
Author Interviews, Dermatology, JAMA, Melanoma, Technology / 08.01.2016

MedicalResearch.com Interview with: Marc Haspeslagh, MD Dermpat, Ardooie, Belgium Department of Dermatology University Hospital, Ghent, Belgium Medical Research: What is the background for this study? Dr. Haspeslagh: In daily practice, most pathology laboratories process skin biopsy specimens without access to the clinical and /or dermoscopic images. In pigmented skin tumors, this information can be crucial to process and diagnose the lesion correctly. With increasingly smaller diameter lesions undergoing biopsy, these focal changes are only visible with dermoscopy; therefore, communication of this dermoscopic information to the pathologist is important. In many dermatopathology laboratories, this communication is often insufficient or totally absent, and one can presume that these suspicious areas are often missed with the standard random sectioning technique that examines less than 2% of the tissue. To overcome this diagnostic limitation we developed in 2013 a new method for processing skin biopsies, were we routinely take an ex vivo dermoscopic image of most tumoral skin lesions. In combination with marking specific and suspected areas seen on the ex vivo dermoscopy (EVD) with nail varnish, EVD with derm dotting is a simple and easy method that brings this crucial information to the pathologist and in the slides to be examined (Am J Dermatopathol 2013; 35(8),867-869). (more…)
Author Interviews, Depression, Hormone Therapy, JAMA, Menopause / 08.01.2016

MedicalResearch.com Interview with: Eleni Petridou, MD, MPH, PhD Marios K. Georgakis, MD Department of Hygiene, Epidemiology and Medical Statistics School of Medicine National and Kapodistrian University of Athens Athens, Greece Medical Research: What is the background for this study? Response: Previous epidemiologic studies have shown that women during their reproductive life are more vulnerable (by a factor of two) to depression than men; this has been particularly evident during peaks of intense fluctuations of ovarian hormones, like the premenstrual, perimenopausal and postpartum periods. Endogenous (natural) female sex hormones, however, have been shown in various experimental studies to possess neuroprotective and anti-depressive properties. Production of these hormones is diminished after menopause; therefore, age at menopause can be used as a proxy of the lifetime exposure to endogenous hormones. Our research hypothesis was whether longer exposure to endogenous sex hormones has a cumulative anti-depressive action, i.e., whether later age at menopause decreases the risk for postmenopausal depression. (more…)
Author Interviews, Exercise - Fitness, Heart Disease, JAMA, Nutrition / 08.01.2016

MedicalResearch.com Interview with: Dalane W. Kitzman, M.D. Professor, Cardiology Sticht Center on Aging Gerontology and Geriatric Medicine Translational Science Institute Wake-Forest Baptist Health Winston-Salem, NC Medical Research: What is the background of the research? Dr. Kitzman: Heart Failure With Preserved Ejection Fraction (HFPEF) is a relatively recently recognized disorder.  It used to be thought that it was rare.  However, we now realize that HFPEF is the dominant form of heart failure in America.  It is also the fastest growing cardiovascular disorder.  Interestingly, this disorder occurs almost exclusively among older persons, particularly women.  The need is great because outcomes in persons with HFPEF (death, rehospitalization, health care costs) are worsening.  This stands in contrast to most other cardiovascular disorders which are on the decline and / or are experiencing greatly improved outcomes.  Remarkably, all of the large studies that have used medications in HFPEF that seemed they should be ‘sure bets’ showed no benefit for their primary outcomes.  Thus, this is also the only major cardiovascular disorder where there is no proven medication treatment.  That means physicians take ‘educated guesses’ in choosing treatment for this large group of patients. The main symptom in patients with chronic HFPEF is shortness of breath and and fatigue with exertion.  We showed in 2002 in JAMA that when we objectively measured this symptom with expired gas analysis (Peak VO2), this was as severely decreased in HFPEF as in patients with HFREF (severely reduced EF), the classic, well accepted form of heart failure.  That and other studies helped lead to acceptance of HFPEF as a true Heart Failure disorder. We first showed 5 years ago that 4 months of exercise training improves peak VO2 and quality of life in patients with HFPEF.  In fact, exercise remains the only proven means to improve these patients’ chronic symptoms. The goal of our study was to determine if weight loss diet also improved peak VO2 and quality of life in HFPEF patients, alone and in combination with exercise training.  This was based on the under-recognized fact that over 80% of Heart Failure With Preserved Ejection Fraction patients are overweight or obese.  It was already known that weight loss diet in other groups of older persons improves peak VO2 and quality of life.  And small studies of weight loss surgery in the other form of HF (HFREF) suggested that weight loss can improves symptoms, peak VO2, and quality of life.  However, there had never been a study of weight loss, by diet or other means, in HFPEF.  In fact, it had been thought, based on observational data, that weight loss diet might be contraindicated in HFPEF. So we recruited 100 overweight / obese patients age 60 years and older with this disorder from our community; 80% were women.  The exercise was standard exercise training that we’d previously shown was effective.  The meals for the weight loss diet were prepared in our metabolic kitchen by a regisered dietition.  Patients made out menus selecting preferred foods.  Well balanced, healthy, nutritious, but very palatable.  The portions were controlled so that there was a 350 caloric deficit per day deficit, on average.  Pateints made their own breakfast with guidance, unlimited of certain fruits and vegetables, and occasional “free days”, such as for holidays.  Patients loved the meals and wanted to continue after the 5 month study. (more…)