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…)
Author Interviews, CDC, Salt-Sodium / 15.01.2016

Click Here for More on Salt/Sodium on MedicalResearch.com MedicalResearch.com Interview with: Sandra L Jackson PhD Epidemic Intelligence Service, CDC Division for Heart Disease and Stroke Prevention National Center for Chronic Disease Prevention and Health Promotion Atlanta, Georgia Medical Research: What is the background for this study? What are the main findings? Dr. Jackson: Sodium reduction is an important public health strategy to reduce cardiovascular disease, and this study was the latest in CDC’s ongoing effort to monitor U.S. sodium intake. These findings reveal that nearly all Americans – regardless of age, race and gender – consume more sodium than is recommended for a healthy diet. Specifically, over 90 percent of children (2 to 18) and 89 percent of adults (19 and up) eat more than the recommended limits in the 2015-2020 Dietary Guidelines for Americans, and that doesn’t even include salt added at the table. The newly released guidelines recommend limiting sodium to less than 2,300 mg per day for people over the age of 14, and less for those younger. The analysis also examined specific populations. Among adults, a larger proportion of men (98 percent) than women (80 percent) consume too much sodium. Among people at greater risk of developing heart disease or stroke – such as people age 51 and older, African Americans and individuals with high blood pressure or pre-hypertension (blood pressure higher than normal but not in the “high” range) – more than three out of four exceed 2,300 mg per day. Adults with hypertension consume slightly less sodium than other adults, and may be trying to follow physician’s advice to reduce sodium. However, 86 percent of adults with hypertension still consume too much. (more…)
Author Interviews, Cancer Research / 14.01.2016

More on Protein Kinases on MedicalResearch.com MedicalResearch.com Interview with: Dr Angus Cameron Kinase Biology Laboratory Barts Cancer Institute at Queen Mary University of London and Professor Peter Parker Protein Phosphorylation Laboratory The Francis Crick Institute Medical Research: What is the background for this study? What are the main findings? Response: A particular family of candidate targets for cancer therapies (the three members of the protein kinase, or PKN, family) have been largely overlooked in terms of our understanding of their roles in normal biology and also in disease. Since any programme to develop new treatments is well informed by understanding the normal roles of the drug targets in non-tumour settings, our research teams ‘knocked-out’ these genes in a model mammalian system, in mice, and observed the effect. A key finding is that whilst two of the protein kinases, PKN1 and PKN3, are not necessary for mammalian development or adulthood, for PKN2 there is an absolute requirement in embryo development, but evidence of little requirement in adulthood. Our teams then analysed in some detail the genetics and pathology of the developmental defects for PKN2 knock-outs. This established the importance of PKN2 in mesenchymal cell survival and proliferation during development. Mesenchymal cells are dynamic contractile cells which provide structure and shape to the developing embryo. This finding has profound effects on multiple developmental events. Mesenchymal cells are also important in many connective tissue conditions, including fibrosis of the lungs, and in cancer where mesenchymal cells can support invasion of cancer cells into tissues. (more…)
Author Interviews, Brigham & Women's - Harvard, Colon Cancer, Dermatology, Nature, Testosterone / 14.01.2016

More on Colon Cancer on MedicalResearch.com MedicalResearch.com Interview with: Dr. Nana Keum, PhD Department of Nutrition Harvard T.H. Chan School of Public Health Boston, MA Medical Research: What is the background for this study? What are the main findings? Dr. Keum: Male pattern baldness, the most common type of hair loss in men, is positively associated with androgens as well as IGF-1 and insulin, all of which are implicated in pathogenesis of colorectal neoplasia.  Therefore, it is biologically plausible that male pattern baldness, as a marker of underlying aberration in the regulation of the aforementioned hormones, may be associated with colorectal neoplasia.  In our study that examined the relationship between five male hair pattern at age 45 years (no-baldness, frontal-only-baldness, frontal-plus-mild-vertex-baldness, frontal-plus-moderate-vertex-baldness, and frontal-plus-severe-vertex-baldness) and the risk of colorectal adenoma and cancer, we found that frontal-only-baldness and frontal-plus-mild-vertex-baldness were associated with approximately 30% increased risk of colon cancer relative to no-baldness.  Frontal-only-baldness was also positively associated with colorectal adenoma. (more…)
Author Interviews, NEJM, NIH, Opiods / 14.01.2016

For more on Opioids on MedicalResearch.com please click here. MedicalResearch.com Interview with: Wilson M. Compton, M.D., M.P.E. Deputy Director National Institute on Drug Abuse Medical Research: What is the background for this study? What are the main findings? Dr. Compton: Deaths related to opioids (from both prescription pain killers and street drugs, like heroin) have dramatically increased in the past 15 years.  How these different types of opioids are related to each other is important because the pain killers ultimately are derived from prescriptions written by health care providers and street drugs, like heroin, are from illegal sources.  The different types of opioids vary in there source but are quite similar in their effects in the brain.  Given the different sources, interventions to reduce availability vary across the two categories. There is also a concern that interventions to reduce the availability of prescription opioids may be encouraging people to switch to heroin.  That’s the main question addressed in this review. (more…)
Author Interviews, NEJM, Surgical Research / 14.01.2016

MedicalResearch.com Interview with: Dr. Jenny Löfgren Surgery and Perioperative Sciences Faculty of Medicine, University Hospital of Umeå Umeå Sweden  Medical Research: What is the background for this study? What are the main findings? Response: There are an estimated 220 million groin hernia patients in the World. 20 million are operated on annually making it one of the worlds most commonly performed surgeries. The surgical repair rate in low income settings is very low. Also, the quality of the surgery is lower than in high income settings. The superior technique that uses a synthetic mesh to reinforce the abdominal wall at the site of the hernia is not affordable due to the high cost of that mesh. Mosquito mesh, which is very similar to the expensive mesh, is already used in several settings but its safety and effectiveness had not previously been investigated in a randomized trial of sufficient size with follow up for as long as one year.   Medical Research: What are the main findings? Response: The most important finding of the study is that it was not able to detect any differences in terms of safety, effectiveness and patient satisfaction when outcomes in the group receiving the low-cost (mosquito) mesh with the group receiving a commonly used commercial mesh. The study also shows that high quality surgery, on par with standards in high income settings, can be provided for an underserved population in rural Uganda, at an affordable cost. Finally, the study shows that it is possible to conduct high quality surgical (clinical) research with high follow up rates also in settings such as rural Uganda. This should encourage us and others to conduct other trials in the future.  (more…)
Annals Thoracic Surgery, Author Interviews, Heart Disease / 14.01.2016

MedicalResearch.com Interview with: Islam Elgendy, MD Clinical Pharmacology, Cardiology University of Florida Medical Research: What is the background for this study? What are the main findings? Dr. Elgendy: This study aimed to review the current evidence for the effect of statin therapy before and after bypass surgery on different outcomes. The evidence suggests that statins can help reduce cardiac complications, such as atrial fibrillation, following the surgery. Statin use also seemed to be associated with a reduced risk of death during and immediately after bypass surgery. (more…)
Author Interviews, Ophthalmology / 14.01.2016

MedicalResearch.com Interview with: Maria A. Woodward, MD Department of Ophthalmology and Visual Sciences University of Michigan Ann Arbor, MI 48105  Medical Research: What is the background for this study? What are the main findings? Dr. Woodward: The research was sparked by questions whether changes to the eye with keratoconus affect other parts of the body.  There is conflicting information from past research about connections between systemic diseases and keratoconus.  This creates confusion for patients and for doctors treating these patients. (more…)
Author Interviews, Heart Disease / 14.01.2016

Click Here for more Articles on Nutrition and Heart Disease MedicalResearch.com Interview with: James J. DiNicolantonio, PharmD Associate Editor BMJ Open Heart Cardiovascular Research Scientist Saint Luke's Mid America Heart Institute  Medical Research: What is the background for this study? What are the main findings? Dr. DiNicolantonio: We comprehensively reviewed the literature looking at the cardiovascular effects of saturated fat and compared them with refined sugars (sucrose and high-fructose corn syrup).  Our main finding is that saturated fat per se is not necessarily unhealthy.  Importantly, people eat foods, not saturated fat, and depending on what foods are consumed determines if saturated fat associates with health risk.  For example, the consumption of processed meat is associated with an increased risk of cardiovascular disease, whereas dairy is not.  Importantly, the replacement of saturated fat with refined sugars seems to increase the risk of myocardial infarction.  Hence, reducing added sugars should be the main focus rather than reducing saturated fat, as the latter could translate to reductions in healthy whole foods that just so happen to also be high in saturated fat (but also provide other healthy fats). (more…)
Author Interviews, Breast Cancer, Nature, University Texas / 13.01.2016

Click Here for More Articles Related To Breast Cancer on MedicalResearch.com. MedicalResearch.com Interview with: Dr. Chunru Lin PhD Assistant Professor, Department of Molecular and Cellular Oncology, Division of Basic Science Research and Graduate School of Biomedical Sciences The University of Texas MD Anderson Cancer Center, Houston, TX MedicalResearch: What is the background for this study? What are the main findings? Dr. Lin: Triple-Negative Breast Cancer (TNBC) continues to be a serious healthcare problem despite improvements in early detection and treatment; lncRNAs are one of the emerging elements that make the process of understanding breast cancer development and progression so complex yet thorough. Thus, it is imperative to include an examination of lncRNAs when studying breast cancer, especially when researching challenging questions related to relapses and recurrences of breast cancer that occur after targeted therapeutic treatments. A perspective that incorporates lncRNAs into the discussion of breast cancer biology could be the conceptual advance that is necessary to encourage further breakthroughs. Our research reveals the biological functional roles of cytoplasmic lncRNAs as signaling pathway mediators and catalysts that serve as indispensable components of signal transduction cascades and gene networks. This understanding could transform the prevailing dogma of the field of signal transduction. This study has identified a previously unknown mechanism for HIF stabilization and signal transduction, which is triggered by the HB-EGF bound EGFR/GPNMB heterodimer and is mediated by LINK-A-dependent recruitment of two kinases, BRK and LRRK2, to phosphorylate HIF1α at two new sites, leading to HIF1α stabilization and interaction with p300 for transcriptional activation; this further results in cancer glycolytic reprogramming under normoxic conditions. LINK-A is the first demonstrated lncRNA that acts as a key mediator of biological signaling pathways, which suggests the potential for the involvement of other lncRNAs as mediators of numerous signaling pathways. Importantly, expression of LINK-A and activation of the LINK-A mediated signaling pathway are both correlated with TNBC. Targeting LINK-A with LNAs (Locked Nucleic Acids) serves as an encouraging strategy to block reprogramming of glucose metabolism in TNBC with therapeutic potential.  (more…)
Author Interviews, Heart Disease, JACC / 13.01.2016

Tanush Gupta, MD MedicalResearch.com Interview with: Tanush Gupta, MD Chief Resident & Instructor of Medicine and Prakash Harikrishnan, MD Prakash Harikrishnan, MD Fellow in Cardiology New York Medical College at Westchester Medical Center Valhalla, NY   Medical Research: What is the background for this study? Response: Complete heart block (CHB) is a relatively frequent complication in patients hospitalized with ST-elevation myocardial infarction (STEMI). Patients who develop complete heart block in the setting of STEMI have a 3- to 5-fold increase in in-hospital mortality compared to those without CHB. However, most of the existing reports on CHB complicating STEMI are from the pre-thrombolytic and thrombolytic era in the 1980s and 1990s, before the widespread use of percutaneous coronary intervention (PCI) and advent of modern adjunctive medical therapies. Hence, the purpose of this investigation was to examine the association of complete heart block with in-hospital outcomes in patients hospitalized with STEMI and to examine the temporal trends in the incidence and outcomes of CHB complicating STEMI using the National Inpatient Sample (NIS) databases from 2003 to 2012. (more…)
Author Interviews, BMJ, Diabetes, NIH, OBGYNE / 13.01.2016

MedicalResearch.com Interview with: Cuilin Zhang MD, PhD Senior Investigator, Epidemiology Branch Division of Intramural Population Health Research NICHD/National Institutes of Health Rockville, MD 20852  Medical Research: What is the background for this study? What are the main findings? Dr. Zhang: Potatoes are the third most commonly consumed food crop in the world. In the United States, about 35% of women of reproductive age consume potatoes daily, accounting for 8% of daily total energy intake.  Gestational diabetes mellitus (GDM) is a common complication of pregnancy characterized by glucose intolerance with onset or first recognition during pregnancy. GDM is at the center of a vicious circle of 'diabetes begets diabetes' across generations. Potato foods are typically higher in glycemic index and glycemic load, but data are lacking regarding whether potato consumption is associated with the risk of Gestational diabetes mellitus. Medical Research: What is the background for this study? What are the main findings? Dr. Zhang: Women who eat more potatoes before pregnancy may have higher risk of gestational diabetes—the form of diabetes that occurs or first diagnosed during pregnancy—compared to women who consume fewer potatoes. Substituting potatoes with other vegetables, legumes or whole grains may help lower gestational diabetes risk. (more…)
Author Interviews, Lung Cancer, Pharmacology / 12.01.2016

MedicalResearch.com Interview with: Glen Weiss, MD, MBA Director of Clinical Research & Medical Oncologist and Dr. Zoltan Lohinai MD National Koranyi Institute of Pulmonology Budapest, Hungary Western Regional Medical Center Cancer Treatment Centers of America Goodyear, Arizona MedicalResearch: What is the background for this study? What are the main findings? Response: With nearly 1.4 million deaths each year, lung cancer is the world’s leading cause of cancer-related mortality. In the U.S., more than 162,000 die annually of this disease. One subtype of this cancer, small cell lung cancer (SCLC), is one of the most progressive tumor types. No new class of systemic treatment has been adopted as a new benchmark for standard therapy against SCLC for nearly three decades. Lung cancer researchers focus on SCLC not only because of its scientific challenge, but also because of their great desire to help patients suffering from this aggressive tumor. Drug repurposing bioinformatical analysis, a new research direction, has found that FDA-approved drugs in non-malignant diseases may have antitumor effects. Our study attempted to evaluate the recent laboratory findings in a clinical setting. Statins are a class of drugs primarily used to lower cholesterol in patients at risk for heart disease. They have been hypothesized by preclinical data to affect tumor cells through the extracellular signal-regulated kinase (ERK) pathway, which regulates many cellular functions. Our study of 876 metastatic-stage  small cell lung cancer patients, published Jan. 6, 2015, in the peer-reviewed scientific journal PLOS ONE, showed that statins appeared to provide an increase in overall survival for those cancer patients who were prescribed those medications. Patients prescribed other classes of drugs, including aspirin, antidepressants, and blood pressure-lowering agents, have reportedly shown anti-SCLC activity in previous preclinical studies. However, our study found no such survival benefits. All in all, our study is a good example of how to evaluate drug repurposing in oncology, and that statins might have clinical relevance in the treatment of SCLC. (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…)
AHA Journals, Author Interviews, Brigham & Women's - Harvard, NIH, Nutrition, Sugar, Weight Research / 12.01.2016

MedicalResearch.com Interview with: Dr. Caroline Fox, MD MPH National Heart, Lung, and Blood Institute Assistant Clinical Professor of Medicine Harvard Medical School Medical Research: What is the background for this study? What are the main findings? Dr. Fox: There is evidence linking sugar sweetened beverages with obesity and type 2 diabetes. There is also evidence suggesting that specific adipose tissue depots may play a role in the pathogenesis of these diseases. We found that higher levels of sugar sweetened beverage (SSB) intake was associated with more visceral fat (fat in the stomach cavity) over 6 years. (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…)
Author Interviews, Kidney Disease / 12.01.2016

MedicalResearch.com Interview with: Navdeep Tangri, MD, PhD FRCPC Department of Medicine Seven Oaks General Hospital University of Manitoba Winnipeg, Canada Medical Research: What is the background for this study? What are the main findings? Dr. Tangri: Chronic kidney disease is common and its end stage of kidney failure requiring dialysis can be devastating for patients and families. While 26 million North Americans are affected by CKD, the vast majority of them will not experience kidney failure during their lifetime. Predicting the risk of kidney failure for an individual patient can help doctors plan treatment, improve shared decision making, and provide patients with piece of mind. In 2011, we developed equations that accurately predict the risk of dialysis in more than 8,000 Canadian patients with CKD. While these equations are widely used, global implementation has been limited due to a lack of validation in other countries/health systems. The current study addresses all of these concerns by comprehensively validating the risk equations in more than 700,000 participants spanning 30+ countries, and demonstrating its accuracy in predicting the risk of dialysis. (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, Biomarkers, Mayo Clinic, Prostate, Prostate Cancer, Urology / 12.01.2016

MedicalResearch.com Interview with: R. Jeffrey Karnes MD Department of Urology, Mayo Clinic, Rochester, MN 55905   MedicalResearch: What is the background for this study? What are the main findings? Dr. Karnes: Cancer recurrence following radical prostatectomy is a concern for men undergoing definitive surgical treatment for prostate cancer. Approximately 20-35% of patients develop a rising prostate specific antigen following radical prostatectomy for clinically localized prostate cancer. PSA monitoring is an important tool for cancer surveillance; however, a standard PSA cutpoint to indicate biochemical recurrence has yet to be established. Over 60 different definitions have been described in literature. This variation creates confusion for the patients and clinicians. By studying a large group of patients who underwent radical prostatectomy at Mayo Clinic, we found that a PSA cutpoint of 0.4 ng/mL is the optimal definition for biochemical recurrence. (more…)
Annals Internal Medicine, Author Interviews, Breast Cancer, Mammograms / 12.01.2016

MedicalResearch.com Interview with: Susan K. Boolbol, MD, FACS Chief, Division of Breast Surgery Chief, Appel-Venet Comprehensive Breast Service Co-Director, Breast Surgery Fellowship Mount Sinai Beth Israel Associate Professor of Surgery Icahn School of Medicine at Mount Sinai New York, NY 10003 Medical Research: What is the background for these new recommendations? Dr. Boolbol: To make this final recommendation, the Task Force conducted a comprehensive review of the science since its 2009 recommendation and considered the public comments it received on its 2015 draft recommendation statement. Based on all of this, the task force issued their recommendations. Medical Research: What are the main changes from current guidelines? Dr. Boolbol: Presently, there are several different guidelines and recommendations regarding screening mammography. Depending on the group issuing the guidelines, the recommendations vary from annual mammography beginning at 40 years old to biennial mammograms from 50 to 74 years old. The Task Force continues to find that the benefit of mammography increases with age, and recommends biennial screening in women ages 50 to 74. (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, Cost of Health Care / 12.01.2016

MedicalResearch.com Interview with: Paul Barr MSc, PhD Assistant Professor of Health Policy and Clinical Practice The Dartmouth Institute for Health Policy & Clinical Practice  Medical Research: What is the background for this study? What are the main findings? Dr. Barr: I belong to the Preference Laboratory, a group of researchers in The Dartmouth Institute for Health Policy & Clinical Practice, who focus on research to improve patient engagement in their health care. One of our areas of interest is mental health, especially depression given the high and increasing prevalence of this condition in America and worldwide. Previous research has found that individuals with depression are not fully engaged in the treatment decision making process and may not be aware of their options. Decision aids are short tools that provide information on available treatment options and information about those options that is important to patients and clinicians, which can facilitate greater patient engagement through shared decision making.  To develop these tools, it is important to identify the information important to patients and clinicians when making treatment decisions. By conducting a national survey of individuals with depression and clinicians who treat depression across the US, we found that patients and clinicians felt that the effectiveness of treatment, potential side-effects and time to recovery were important to discuss. However, where patients wanted to know about about cost and insurance coverage of treatment, clinicians did not focus on these priorities. Yet when asked to take the patient’s perspective, clinicians had the same priorities as patients, including cost and insurance coverage. In addition, only 18% of patient respondents reported experiencing a high level of shared decision making on the CollaboRATE survey (www.collaboratescore.org).  (more…)
Author Interviews, Mineral Metabolism, Supplements / 12.01.2016

MedicalResearch.com Interview with: Prof. Peter Lay PhD Professor of Inorganic Chemistry School of Chemistry | Faculty of Science Director, Vibrational Spectroscopy Core Facility Research Portfolio The University of Sydney Medical Research: What is the background for this study? What are the main findings? Response: My group has been studying the molecular mechanisms of chromium(VI)-induced cancers and the biochemistry of vanadium over the last three decades. Vanadium drugs have been in clinical trials for their anti-diabetic effects that occur via species with very similar chemistry to chromium(VI).  The more we understood the biochemistry of each, the more we questioned whether the efficacies of anti-diabetic chromium(III) supplements were associated with the generation of carcinogenic chromium(VI) and chromium(V). To test this, we conducted experiments to either provide evidence for our hypothesis or disprove it.  This work commenced some 15 years ago with studies on the changes in the nature of chromium(III) supplements exposed to simulated gastrointestinal juices, as well as in human and animal blood serum over times that mimicked the residence time of the supplements in the human body. We discovered that all supplements were changed to a range of different Cr(III) species in both the GI tract and the blood.1,2  Common species were observed, but the rates at which they formed were dependent on the nature of the chromium(III) supplement.  Both the supplements themselves and the chromium(III) species that formed in blood serum were partially oxidised to Cr(VI) at concentrations of the oxidant, hydrogen peroxide (a type of bleach), found in the blood of people with type II diabetes.1,2 One of the clinical features of patients with type II diabetes is increased levels of oxidants, such as hydrogen peroxide, in their blood and cells. These oxidants are associated with many of the side-effects of type II diabetes that are associated with reduced life expectancy. These transformed chromium(III) species bound to blood proteins were more easily oxidised to chromium(VI) than the administered Cr(III) supplements.  The faster a particular chromium(III) supplement reacted with blood proteins to form these easily oxidised chromium(III)-protein species, the more active was the Cr(III) supplement in its anti-diabetic activity in animal and human studies reported by other groups.1-5  According to many health and regulatory bodies, chromium(III) has minimal or no efficacy in glucose metabolism and no other beneficial effects, such as weight loss or muscle building, in well conducted human and animal trials with non-diabetic subjects. This is consistent with our proposed mechanism of action. It is only under oxidising physiological conditions associated with type II diabetes that chromium(III) can be partially transformed to sufficient concentrations of carcinogenic chromium(VI) to enable significant biological activity.  In a large clinical trial where diabetic patients were treated with high doses of chromium(III) picolinate (one of the least efficacious supplements in animal studies), there was no efficacy in patients with controlled type II diabetes. Only those patients with uncontrolled type II diabetes exhibited improved glucose metabolism.  These patients, who have the highest concentrations of oxidants with the ability to transform chromium(III) to chromium(VI) in blood, are therefore at the greatest risk of developing Cr-induced cancers. Even where efficacy was observed, glucose metabolism was only reduced to the levels in patients with controlled type II diabetes; i.e., no patients exhibited a return to normal glucose metabolism.4,5 Coupled with all of this information our separate studies showed that chromium(VI) and chromium(V), but not chromium(III), are strong inhibitors of protein tyrosine phosphatase (PTP) enzymes.  The relevance of this is that drugs that inhibit PTPs activate circulating insulin in people with type II diabetes.  That is, it causes insulin to bind more strongly to cells involved in glucose metabolism (such as fat cells) to bring about the cascade of biochemical reactions that import glucose into cells and metabolise it.1-5 Thus we were able to link all of the animal, human and in vitro studies to show that physiological conditions under which chromium(III) had the highest probability of being transformed to chromium(VI) were also those in which chromium(III) supplements were most active.1-5 Moreover, we were able to provide a mechanism of activity that required chromium(VI) and chromium(V) to be generated for insulin enhancing activity.1-5  What remained was to establish whether we could observe Cr(VI) and Cr(V) in cells treated with chromium(III) supplements. This has now been established in our most recent study6 that have just been published. Contrary to the press releases of the dietary supplement industry, the published paper was carefully planned to mimic those conditions found in vivo.  The chromium(III) supplement chosen was that which had a chemical structure most closely resembling those generated in blood plasma. Thus we were able to complete the circle in linking our extensive studies on the biochemistry of chromium(III) species generated from chromium(III) supplements in the blood and show that such species were absorbed by the relevant cells and partially oxidised to chromium(VI) and chromium(V). (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, Heart Disease, Sleep Disorders / 11.01.2016

MedicalResearch.com Interview with: Sunil Sharma MD, FAASM Associate Professor of Medicine Director, Pulmonary Sleep Medicine Associate Director, Jefferson Sleep Disorders Center Thomas Jefferson University and Hospitals Philadelphia, PA 19107 Medical Research: What is the background for this study? Dr. Sharma: Congestive heart failure (CHF) is the most common cause of hospital admission and readmissions in United States. More health care dollars are spent on CHF than any other diagnosis. A large chunk of this cost is due to hospital admission.  An estimated 50% of the CHF patients are readmitted within 6 months of discharge. The recent Protection Affordable Care Act (ACA) imposes penalties on hospitals for readmissions within first 30-days. It is therefore imperative to find ways to impact the natural history of the disease. Sleep disordered breathing is a common disorder associated with CHF. It is estimated that up to 70% of the patient with CHF may have SDB. Studies have shown that untreated SDB can worsen CHF and treatment of Sleep disordered breathing has been shown to improve heart function (ejection fraction).  (more…)
AHA Journals, Author Interviews, Frailty, Geriatrics, Heart Disease, Johns Hopkins / 10.01.2016

MedicalResearch.com Interview with: Ariel R. Green, M.D., M.P.H Assistant Professor of Medicine Johns Hopkins University School of Medicine Medical Research: What is the background for this study? What are the main findings? Response: Implantable cardioverter-defibrillators (ICDs) are widely used to prevent sudden cardiac death in patients with systolic heart failure. Older adults with heart failure often have multiple coexisting conditions and are frail, increasing their risk of death from non-cardiac causes. Our understanding of outcomes in older patients with ICDs is limited. Medical Research: What should clinicians and patients take away from your report? Response: Our major finding was that more than 10% of patients currently receiving ICDs for primary prevention of sudden cardiac death (meaning that they have never had a potentially lethal arrhythmia but are at risk for one, usually due to systolic heart failure) are frail or have dementia.​ Patients with these geriatric conditions had substantially  higher mortality within the first year after ICD implantation than those without these conditions. Frailty and dementia were more strongly associated with mortality than were traditional comorbidities such as diabetes. (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, Genetic Research, UT Southwestern / 09.01.2016

MedicalResearch.com Interview with: Rhonda Bassel-Duby, Ph.D. and Dr. Chengzu Long, PhD Department of Molecular Biology UT Southwestern Medical Center Dallas, TX 75390-9148 Medical Research: What is the background for this study? What are the main findings? Response: Duchenne muscular dystrophy (DMD), which was first described by Duchenne de Boulogne (1806-1875) in 1860s, is one of the most severe and common type of muscular dystrophy. DMD is caused by mutations in the gene for dystrophin (DMD) on the X chromosome and affects approximately 1 in 3500 to 5000 boys. Without dystrophin, a large cytoskeletal protein, muscles degenerate, causing myopathy. Symptoms can be visible between 1 to 6 years old. Most Duchenne muscular dystrophy patients are confined to a wheelchair by age 12. Death of DMD patients usually occurs by age 25, typically from breathing complications and cardiomyopathy. Hence, therapy for  Duchenne muscular dystrophy necessitates sustained rescue of skeletal, respiratory and cardiac muscle structure and function. Although several gene therapies have been tested, there is no curative treatment so far. Duchenne muscular dystrophy arises from a monogenic mutations in dystrophin gene. This makes DMD an ideal disease model for CRISPR-mediated gene editing therapeutics, a major breakthrough in gene engineering in the past three years. This system can remove the defect within the gene. In 2014, in a first proof of concept study, Olson’s team used CRISPR-mediated gene editing to correct the dystrophin gene mutation in the germline of DMD mouse model. In this new paper, we advanced the same technology to postnatal muscle tissues by delivery gene editing components via a harmless adeno-associated virus. Skeletal and cardiac muscle showed progressive rescue of dystrophin protein. (more…)