Author Interviews, Heart Disease, Kidney Disease, Surgical Research / 25.09.2016

MedicalResearch.com Interview with: Pablo Codner, MD; Amos Levi, MD (firsts authors) and Prof. Ran Kornowski, MD, FACC, FESC (senior author) Rabin Medical Center Derech Ze`ev Israel. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Transcatheter aortic valve replacement (TAVR) is a well-established treatment for patients with severe aortic stenosis (AS) who are deemed inoperable by the “heart team”, for those at high risk for surgery and also for patients at intermediate surgical risk. Currently this therapeutic alternative is being compared with surgical aortic valve replacement in patients at low risk for surgery. Patients with chronic kidney disease were excluded from most randomized trials. We evaluated outcomes within a large multicenter cohort of patients undergoing TAVR distinguished by renal function, from 11 high volume centers in 8 different countries across Europe and Asia. In our experience patients with renal dysfunction were associated with poor clinical outcomes. All-cause and cardiovascular mortality rates during the follow-up period increased with declining renal function. A glomerular filtration rate ≤30 mL/min was identified on multivariate analysis as an independent predictor for all-cause and cardiovascular mortality. We also found higher rates of severe bleeding and vascular complications among patient with advanced or end stage renal failure.
Author Interviews, CDC, Cost of Health Care, Frailty / 23.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28318" align="alignleft" width="144"]Gwen Bergen, PhD Division of Unintentional Injury National Center for Injury Prevention and Control CDC Dr. Gwen Bergen[/caption] Gwen Bergen, PhD Division of Unintentional Injury National Center for Injury Prevention and Control CDC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Older adult falls are the leading cause of injury death and disability for adults aged 65 years and older (older adults). In this study, we analyzed data from the Centers for Disease Control and Prevention’s (CDC) Behavioral Risk Factor Surveillance System (BRFSS) survey. Our study found that, in 2014, older Americans reported 29 million falls. Almost a quarter of these or 7 million falls required medical treatment or restricted activity for at least one day. Women reported a higher percentage of falls (30%) compared with men (27%). Whites and American Indian/Alaskan Natives (AI/AN) were more likely to fall compared with Blacks and Asian/Pacific Islanders; and AI/AN were more likely to report a fall injury compared with all other racial/ethnic groups. The percentage of older adults who reported a fall varied by state, ranging from 21% in Hawaii to 34% in Arkansas.
Author Interviews, Heart Disease, Technology / 23.09.2016

MedicalResearch.com Interview with: biotricityWaqaas Al-Siddiq, Founder and CEO of Biotricity MedicalResearch.com: Would you tell us a little about yourself? How did you get interested in combining healthcare with technology? [caption id="attachment_28381" align="alignleft" width="200"]Waqaas Al-Siddiq Waqaas Al-Siddiq[/caption] Response: I am the president and CEO of biotricity which is a healthcare technology company dedicated to providing diagnostic and post-diagnostic solutions for both the physician and consumer for long-term chronic care management. I got interested in combining healthcare and technology while I was doing research for monitoring remote environments in critical scenarios. I thought that it would be very interesting to apply that to healthcare because it’s a problem that no one has figured out how to solve yet. And it’s a problem that is driving healthcare costs out of control.
Author Interviews, Breast Cancer, Brigham & Women's - Harvard, Nature, Technology / 23.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28309" align="alignleft" width="157"]Natalie Artzi PhD principal research scientist MIT's Institute for Medical Engineering and Science (IMES) and Assistant professor of medicine Brigham and Women's Hospital And co-authors: Avital Gilam, João Conde, Daphna Weissglas-Volkov, Nuria Oliva Eitan Friedman, Noam Shomron Dr. Natalie Artzi[/caption] Natalie Artzi PhD principal research scientist MIT's Institute for Medical Engineering and Science and Assistant professor of medicine Brigham and Women's Hospital With co-authors: Avital Gilam, João Conde, Daphna Weissglas-Volkov, Nuria Oliva, Eitan Friedman, Noam Shomron MedicalResearch.com: What is the background for this study? What are the main findings? Response: Metastases are the primary cause for mortality in breast cancer, the most common cancer in women regardless of ethnicity. Recent studies show that germline sequence variants, such as single-nucleotide polymorphisms (SNPs) in miRNA-binding sites, can disrupt the downregulation by miRNAs, with a profound effect on gene expression levels and consequentially on the phenotype, including increased risk for cancer. In the current study, we aimed to determine the potential effect of SNPs within miRNA-binding sites on metastatic breast cancer progression and their potential use as suppression targets to prevent metastasis. Our collaborators at Tel-Aviv Universityin a research led by Dr. Noam Shomron found that the SNP, rs1071738, located in a target site for miR-96 and miR-182 on the 3’-UTR of the PALLD gene, encodes the Palladin actin-associated protein, which is a documented player in breast cancer motility. In vitro experiments revealed a functional downregulation of Palladin levels by miR-96 and miR-182, which subsequently reduces migration and invasion abilities of breast cancer cells. My lab then showed in an in vivo experiment that the use of nanoparticles embedded in a hydrogel scaffold as a miRNA delivery vehicle enables an efficient and specific delivery of miR-96/miR-182 directly to breast tumours, which results in marked reduction of breast cancer metastasis. We then proceeded to study the effect of combination therapy in which we will use a chemotherapy drug to shrink the primary tumor and the miRNAs to prevent metastasis. The intercalation of a chemotherapy drug, cisplatin, to the miR-conjugated nanoparticles further improved the effect, leading to significant reduction in both primary tumour growth and metastasis. Our study highlights the therapeutic potential of miRNAs, and specifically miR-96 and miR-182, and support the importance of Palladin regulation in breast cancer metastasis.
Aging, Author Interviews, Genetic Research / 23.09.2016

Dr-Bastiaan-Heijmans.jpg MedicalResearch.com Interview with: Dr. Bastiaan Heijmans Leiden University Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Epigenetic change is a hallmark of ageing but its link to ageing mechanisms in humans remains poorly understood. While DNA methylation at many CpG sites closely tracks chronological age, DNA methylation changes relevant to biological age are expected to gradually dissociate from chronological age, mirroring the increased heterogeneity in health status at older ages. In a large-scale analysis of the methylome of over 3000 individuals, we discovered and validated 6000 sites in the genome that became more variable in their DNA methylation level with age. These sites frequently co-localized with repressed regions that are characterized by polycomb repression. While sites accumulating variability with age were commonly associated with the expression of (neuro)developmental genes in cis, they were linked to transcriptional activity of genes in trans that have a key role in well-established ageing pathways such as intracellular metabolism, apoptosis, and DNA damage response.
Author Interviews, Epilepsy, JAMA, Mayo Clinic, Neurological Disorders / 23.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28300" align="alignleft" width="180"]Brian Nils Lundstrom, MD, PhD Department of Neurology Mayo Clinic Rochester, Minnesota Dr. Brian Lundstrom[/caption] Brian Nils Lundstrom, MD, PhD Department of Neurology Mayo Clinic Rochester, Minnesota MedicalResearch.com: What is the background for this study? What are the main findings? Response: About as many people have drug-resistant focal epilepsy as have multiple sclerosis, and treatment options are limited. This study describes an alternative treatment option that has proven very helpful for the majority of participants. Electrical stimulation is delivered continuously via implanted electrodes to the region of brain where seizures start. The electrical stimulation decreases the seizure-related discharges from the brain, and for about 40% of patients their disabling seizures were completely stopped.
Author Interviews, Cost of Health Care, CT Scanning, Health Care Systems / 23.09.2016

MedicalResearch.com Interview with: Hui Zhang, Ph.D., MBA Virginia Polytechnic Institute and State University Blacksburg MedicalResearch.com: What is the background for this study? What are the main findings? Response: To promote healthcare coordination and contain the rising costs in the US healthcare system, a variety of payment innovations has been developed and field-tested in both public and private sector. Among them, the Medicare Shared Savings Program (MSSP) for Accountable Care Organizations (ACOs), administered by the Centers for Medicare and Medicaid Services (CMS) has received considerable attention. Our study took a mathematical modeling approach and comprehensively captured and analyzed the effect of this new payment systems on healthcare stakeholder decisions and system-wide outcomes. Our results provided decision-making insights for payers on how to improve MSSP, for ACOs on how to distribute MSSP incentives among their members, and for hospitals on whether to invest in new CT imaging systems.
Author Interviews, JAMA, Pharmacology, Rheumatology / 23.09.2016

MedicalResearch.com Interview with: Jacques-Eric Gottenberg, MD, PhD Department of Rheumatology National Reference Center for Systemic Autoimmune Diseases Strasbourg University Hospital, Université de Strasbourg Strasbourg, FranceJacques-Eric Gottenberg, MD, PhD Department of Rheumatology National Reference Center for Systemic Autoimmune Diseases Strasbourg University Hospital, Université de Strasbourg Strasbourg, France MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is no recommendation for the choice of the second biologic in patients with rheumatoid arthritis and insufficient response to a first anti-TNF, which is a common situation in our daily practice (approximately one third of patients treated with anti-TNF). We therefore conducted the first randomized trial to date to investigate the best strategy in such a setting.
Author Interviews, Memory, Scripps / 23.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28286" align="alignleft" width="144"]Ron L. Davis, PhD Professor and Chair Department of Neuroscience Florida campus of The Scripps Research Institute Dr. Ron Davis[/caption] Ron L. Davis, PhD Professor and Chair Department of Neuroscience Florida campus of The Scripps Research Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: While calcium’s importance for our bones and teeth is well known, its role in neurons—in particular, its effects on processes such as learning and memory—has been less well defined. Our new study, published in the journal Cell Reports, offers new insights how calcium in mitochondria—the powerhouse of all cells—can impact the development of the brain and adult cognition. Specifically, we show in fruit flies, a widely used model system, that blocking a channel that brings calcium to the mitochondria called “mitochondrial calcium uniporter” causes memory impairment but does not alter learning capacity. That surprised us – we thought they wouldn’t be able to learn at all. This is important because defects in the same calcium channel function have been shown to be associated with intellectual disability in humans.
Author Interviews, Cancer Research, Technology / 23.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28279" align="alignleft" width="200"]Grace G. Bushnell PhD candidate Department of Biomedical Engineering University of Michigan Ann Arbor, Michigan Grace Bushnell[/caption] Grace G. Bushnell PhD candidate Department of Biomedical Engineering University of Michigan Ann Arbor, Michigan MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study builds off of previous work from the Shea and Jeruss laboratories at the University of Michigan, which reported that implanted scaffolds can capture early metastatic cells in vivo prior to the colonization of other organs and serve as a platform for early detection of metastatic disease. Furthermore, the presence of a scaffold reduced the tumor burden in other metastatic locations. In this work, the major finding was that early detection using a scaffold combined with a therapeutic intervention led to a survival advantage relative to mice that did not receive a scaffold. The scaffolds had been designed to persist in vivo for longer periods of time than in the original study. Additionally, the scaffold was implanted prior to the inoculation of metastatic cancer cells in the mouse. The role of the immune system in the process was further refined, as the immune cell composition at the scaffold changed significantly after disease initiation. These studies demonstrate that early intervention in a metastatic setting can lead to enhanced survival. This principle of early intervention is well established for the primary tumor, and these studies suggest that this principle may be extended to metastatic disease.
Author Interviews, Breast Cancer, Cancer, Genetic Research, UT Southwestern / 23.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28272" align="alignleft" width="96"]Roshni Rao, M.D Breast Surgery University of Texas Southwestern Dr. Roshni Rao[/caption] Roshni Rao, M.D Breast Surgery University of Texas Southwestern MedicalResearch.com: What is the background for this study? What are the main findings? Response: Triple negative breast cancer (TNBC) is characterized by not having estrogen, progesterone, or Her2Neu receptors. Although a less common type, it is aggressive, and leads to a disproportionate number of deaths from breast cancer. TNBC is more common in young, African American women, but can be found in other ethnic groups as well. This study performed mitochondrial DNA (mtDNA) analysis, to evaluate for patient genetic ancestry, in 92 patients with TNBC. In regards to self-identified ethnicity, there were 31 African-Americans, 31 Whites, and 30 Hispanics. Utilizing mtDNA, 13% of patients had discordance between self identified ethnicity and mtDNA analysis. Discordance was highest in the Hispanic group. The Hispanic patients were also much younger at initial age of diagnosis, and less likely to have a family history of breast cancer. Ancestry from Nigeria, Cameroon, or Sierre Leone were most common in the African-Americans with triple negative breast cancer.
ASCO, Author Interviews, Cancer Research, Journal Clinical Oncology / 22.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28253" align="alignleft" width="200"]Darren R. Feldman, MD Medical Oncologist Memorial Sloan Kettering Cancer Center Dr. Darren Feldman[/caption] Darren R. Feldman, MD Medical Oncologist Memorial Sloan Kettering Cancer Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is limited knowledge as to why a minority of patients with advanced germ cell tumors are resistant to chemotherapy while the majority achieve complete responses. Patients with cisplatin-resistant disease require intensive salvage treatment and are at high risk of dying from their disease. We sought to determine whether certain genomic alterations within tumors might be associated with cisplatin-resistance in GCT. We also wanted to identify the spectrum of genomic alterations in this population which might represent novel targets for existing or new drug development in this disease.
Author Interviews, ENT, Surgical Research / 22.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28269" align="alignleft" width="133"]Senior Faculty,Otolaryngology The Mount Sinai Hospital New York Eye and Ear Infirmary of Mount Sinai Dr. Mark Courey[/caption] Dr. Mark Courey, MD Senior Faculty,Otolaryngology The Mount Sinai Hospital New York Eye and Ear Infirmary of Mount Sinai MedicalResearch.com: Would you tell us a little about yourself? How did you become interested in voice disorders? Response: I became interested in voice disorders because during my residency in the late 1980’s there was little known about how to help patients with disorders of voice. The main instrument we use to evaluate vocal folds (the stroboscope) was just becoming clinically available. Only a handful of physicians had one available. We could not see vocal fold function and could only see the lesions on the vocal folds. We did not know how the lesions affected function. So many surgeons only treated patients with laryngeal cancer and told the others to be happy that they did not have cancer.
Author Interviews, ENT, Surgical Research / 22.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28267" align="alignleft" width="160"]Eric E Smouha, MD Professor, Otolaryngology The Mount Sinai Hospital New York Eye and Ear Infirmary of Mount Sinai Dr. Eric E Smouha[/caption] Eric E Smouha, MD Professor, Otolaryngology The Mount Sinai Hospital New York Eye and Ear Infirmary of Mount Sinai MedicalResearch.com: Would you tell us a little about yourself? How did you become interested in ENT and specifically middle ear problems? Response: I am a neurotologist, i.e. , ENT physician specialized in disorders of the ear and skull base. Neurotologists treat problems of the middle ear and inner ear. Middle ear problems are interesting because they are prevalent, and surgery frequently results in restoration of function.
Author Interviews, Kidney Disease, PLoS, Primary Care / 22.09.2016

MedicalResearch.com Interview with: Dr. Adam Shardlow Derby Teaching Hospitals NHS Foundation Trust UK MedicalResearch.com: What is the background for this study? What are the main findings? Response: Chronic Kidney Disease (CKD) is common in the general population, and many people are managed in primary care rather than by specialist nephrologists. This study was designed to investigate 5 year outcomes in people with mild to moderate CKD (CKD stage 3). The main findings were that the majority of participants were stable, and progression to end stage renal disease was a rarity. Interestingly, and contrary to common thinking about CKD, we found that a significant minority no longer had evidence of CKD stage 3 at 5 years, which we have termed ‘CKD remission’.
Author Interviews, ENT, Surgical Research, Technology / 22.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28265" align="alignleft" width="160"]Alfred Marc Calo Iloreta Dr. Alfred Marc Calo Iloreta[/caption] Alfred Marc Calo Iloreta, MD Assistant Professor Skull Base Surgery and Rhinology Department of Otolaryngology - Head and Neck Surgery Icahn School of Medicine at Mount Sinai New York, New York MedicalResearch.com: Would you tell us a little about yourself? How did you become interested in ENT and your subspecialty in particular? Response: I am a ENT/Head and Neck Surgeon practicing in Manhattan at the Mount Sinai Hospital. I trained here in New York City for residency and also completed a fellowship in Rhinology and Skull Base Surgery. I chose this field and sub-specialty because of the intricate and complex anatomy of the head and neck. In addition rhinology and skull base surgery utilizes multiple advanced technologies from high definition optics, to neuronavigation to allow us to work with this complex anatomy.
Author Interviews, Case Western, Genetic Research / 22.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28236" align="alignleft" width="200"]Carlos E. Crespo-Hernández PhD Associate Professor and Co-director of the Center for Chemical Dynamics Department of Chemistry Case Western Reserve University Cleveland, Ohio Dr. Carlos E. Crespo-Hernández[/caption] Carlos E. Crespo-Hernández PhD Associate Professor and Co-director of the Center for Chemical Dynamics Department of Chemistry Case Western Reserve University Cleveland, Ohio MedicalResearch.com: What is the background for this study? What are the main findings? Response: Two new letters of DNA have recently been successfully incorporated and replicated by a modified strain of E. coli, thus generating the world’s first semi-synthetic organism with an expanded genetic alphabet. With the expansion of the genetic alphabet, the question arises as to whether the incorporation of unnatural DNA base pairs into cells can adversely affect the integrity of the genetic code and the viability of the cells upon exposure to sunlight or even conventional laboratory lighting. Natural DNA is susceptible to damage by ultraviolet light, but this damage is largely repaired by enzymatic repair mechanisms in living cells. Our recent study has found that the two new, unnatural DNA bases—d5SICS and dNaM—are able to efficiently absorb near-visible light, which is abundant in sunlight and standard fluorescent lighting. Not only that, but upon absorbing near-visible light these unnatural bases produce up to 100 times more reactive species than the most reactive natural DNA base. A line of skin cancer cells incorporating one of these unnatural DNA bases was used to investigate these effects on living cells. Following exposure to a low dose of near-visible light, we observed an increase in the generation of reactive oxygen species within cells containing the unnatural DNA base and a significant decrease in cell survival.
Author Interviews, Baylor College of Medicine Houston, Biomarkers, Weight Research / 22.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28232" align="alignleft" width="144"]Makoto Fukuda Ph.D. Assistant Professor Children's Nutrition Research Center Department of Pediatrics Baylor College of Medicine Houston, Texas 77030 Dr. Makoto Fukuda[/caption] Makoto Fukuda Ph.D. Assistant Professor Children's Nutrition Research Center Department of Pediatrics Baylor College of Medicine Houston, Texas 77030 MedicalResearch.com: What is the background for this study? What are the main findings? Response: A hallmark characteristic of obesity is diminished actions of metabolic hormones that are critically required to maintain whole body energy balance and glucose homeostasis. Leptin is a crucial and powerful hormone that keeps body weight normal. It was hoped that leptin might be a “magic bullet” that could cure obesity. Shortly after the discovery, however, obese individuals were found to have little or no response to exogenously administered leptin, a state of “leptin resistance”. These observations created a central question to be addressed in the field, which would help our understanding of the core of pathophysiology of obesity. While we and other groups previously demonstrated that Epac, a signaling molecule known as a GTP/GDP exchange factor directly activated by cAMP, is involved in cellular leptin resistance, the role of brain Epac signaling in the whole body metabolism has not yet established. We approached this question by using brain-specific knockout mice of Rap1, a direct activator of Epac. As expected from previous results, mice with brain-specific deficiency of Rap1 failed to develop leptin resistance even when they were challenged with a hypercaloric diet. What impressed us most in this study was that Rap1 in the brain plays a key role in the whole body metabolic control, beyond its role in controlling leptin sensitivity. Loss of brain Rap1 protects mice from diet-induced obesity and disordered glucose balance, whereas these knockout mice maintained a similar body weight to that of control mice on a normal regular diet. Further, pharmacological inhibition of this pathway reversed leptin resistance and reduced the body weight of dietary obese mice. At the cellular level, we found an unexpected link between Rap1 and endoplasmic reticulum (ER) stress that has emerged as a causative contributor to the development of leptin resistance.
Author Interviews, Diabetes, Diabetologia, NIH, OBGYNE / 21.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28228" align="alignleft" width="158"]Cuilin Zhang MD, PhD Senior Investigator NICHD, National Institutes of Health Dr. Cuilin Zhang[/caption] Cuilin Zhang MD, PhD Senior Investigator NICHD, National Institutes of Health  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Pregnant women are at high risk of developing depressive symptoms; at least 10% US women suffering from depression during pregnancy. Gestational diabetes is a common pregnancy complication, affecting 4-7% of pregnancies in the U.S..  Gestational diabetes has  adverse health implications on both women and their children.   Depression and glucose intolerance commonly co-occur among non-pregnant individuals; however, the temporal relationship between gestational diabetes and depression during pregnancy and the postpartum period is less understood.
Author Interviews, Hematology, PAD / 21.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28262" align="alignleft" width="175"]Michael P. Murphy, MD Dr. Michael Murphy[/caption] MedicalResearch.com: What is the background for this study? What are the main findings? Response: Critical limb ischemia (CLI) is the most severe form of peripheral arterial disease whereby a severe obstruction of the arteries markedly reduces blood flow to the extremities (hands, feet and legs) causing severe pain, skin ulcers, sores, or gangrene.  Up to 30% of patients with CLI do not qualify for conventional interventions, such as a bypass or angioplasty, putting them at risk for amputation. The MOBILE trial (MarrOwStim™ PAD Kit for the Treatment of Critical LimB IschemIa in Subjects with Severe Peripheral ArteriaL DiseasE) was designed to assess the safety and efficacy of using autologous concentrated bone marrow aspirate (cBMA), cells derived from the patient's own bone marrow, to restore blood flow and prevent amputations in patients with CLI. MOBILE is a Phase 3, double-blind, randomized, placebo-controlled trial that evaluated 152 patients with CLI at 24 centers in the U.S. Patients were randomized to receive cBMA or placebo via injection at 40 sites on the symptomatic leg.  The cBMA was obtained from each patient using the MarrowStim PAD kit.  The placebo group underwent a sham bone marrow aspiration and received needle punctures in the index leg. The primary efficacy endpoint was amputation-free survival, defined as freedom from all causes of death and/or major amputation, at 52 weeks after treatment. Other endpoints included changes in blood flow in the leg, wound healing, measures of pain and quality of life, and distance walked in 6 minutes. The trial completed in June 2016, and a preliminary analysis found that cBMA demonstrated a meaningful improvement in amputation-free survival and a comparable safety profile to placebo.
Author Interviews, JAMA, Opiods / 21.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28220" align="alignleft" width="130"]Bradley D. Stein, MD, MPH, PhD RAND Corporation University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania Dr. Bradley Stein[/caption] Bradley D. Stein, MD, MPH, PhD RAND Corporation University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania MedicalResearch.com: What is the background for this study? What are the main findings? Response: The United States is in the midst of a serious opioid abuse epidemic and we know that medically assisted treatment is one of the best ways to help people with addiction to opioids. The drug buprenorphine has advantages over methadone, the historic medical treatment, because it can be prescribed by physicians in the community who receive a waiver allowing them to prescribe it after undergoing eight hours of training.. Methadone is dispensed at special clinics that many people with opioid addition may be unable to get to with the frequency required by effective treatment. To better understand patterns of the use of buprenorphine, we examined treatment patterns in the states with the most buprenorphine-waivered physicians (California, Florida, Massachusetts, Michigan, New York, Pennsylvania and Texas). Our data came from a prescription records that account for over 80 percent of the retail pharmacies in the nation. We examined use patterns among 3,200 physicians who treated 250,000 patients. We had two surprising findings:  First, the median length of treatment with buprenorphine was 53 days, which is much shorter than the duration that most individuals are likely to need for optimal results. Second, despite concerns that federal limits on the number of patients and waivered physician can treat being a significant barrier for many individuals obtaining treatment, we found that most physicians were treating far fewer patients than would be allowed by the patient limits. In fact, 22 percent of the physicians treated an average of 3 patients per month and just 9 percent treated 75 or more patients per month.
Author Interviews, Columbia, NEJM, Orthopedics, Osteoporosis / 21.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28216" align="alignleft" width="118"]MedicalResearch.com Interview with: Felicia Cosman, M.D. Dr. Felicia Cosman[/caption] Felicia Cosman, M.D. Medical Director of the Clinical Research Center Helen Hayes Hospital Professor of Medicine Columbia University College of Physician and Surgeons New York Editor-in-Chief, Osteoporosis International MedicalResearch.com: What is the background for this study? What are the main findings? Response: Amgen and UCB presented detailed data from the Phase 3 FRAME study in an oral session at ASBMR 2016, and the data were also published in the New England Journal of Medicine. Additionally, the FRAME abstract has been awarded the 2016 ASBMR Most Outstanding Clinical Abstract Award. The FRAME data show significant reductions in both new vertebral and clinical fractures in postmenopausal women with osteoporosis. Patients receiving a monthly subcutaneous 210 mg dose of romosozumab experienced a statistically significant 73 percent reduction in the relative risk of a vertebral (spine) fracture through 12 months, the co-primary endpoint, compared to those receiving placebo (fracture incidence 0.5 percent vs. 1.8 percent, respectively [p<0.001]). By six months, new vertebral fractures occurred in 14 romosozumab and 26 placebo patients; between six to 12 months, fractures occurred in two versus 33 additional patients in each group, respectively. Patients receiving romosozumab experienced a statistically significant 36 percent reduction in the relative risk of a clinical fracture, a secondary endpoint, through 12 months compared to those receiving placebo (fracture incidence 1.6 percent vs. 2.5 percent, respectively [p=0.008]). In patients who received romosozumab in year one, fracture risk reduction continued through month 24 after both groups transitioned to denosumab treatment through the second year of the study: there was a statistically significant 75 percent reduction in the risk of vertebral fracture at month 24 (the other co-primary endpoint) in patients who received romosozumab followed by denosumab vs. placebo followed by denosumab (fracture incidence 0.6 percent vs. 2.5 percent, respectively [p<0.001]). Clinical fractures encompass all symptomatic fractures (both non-vertebral and painful vertebral fractures; all clinical fractures assessed in the FRAME study were symptomatic fragility fractures. A 33 percent reduction in relative risk of clinical fracture was observed through 24 months after patients transitioned from romosozumab to denosumab compared to patients transitioning from placebo to denosumab (nominal p=0.002, adjusted p=0.096).
Author Interviews, Global Health, Infections, NEJM / 21.09.2016

MedicalResearch.com Interview with: Dr. Heinke Kunst, M.D. Queen Mary University Hospital, London, United Kingdom MedicalResearch.com: What is the background for this study? What are the main findings? Response: Multidrug resistant tuberculosis (MDR-TB) has been on the increase worldwide over the past decade. Many patients who have been identified with MDR-TB live in the European region. Despite treatment with expensive second-line drug regimens, curing MDR TB remains a challenge and cure rates were thought to be very low. As part of the EU Commission funded TB-PANNET project 380 patients with MDR-TB were observed at 23 TB centers in countries of high, intermediate and low TB burden in Europe over a period of 5 years. Observation started from the time of diagnosis and lasted until one year after the end of the treatment. The TBNET proposed new definitions for “cure” and “failure” of MDR-TB treatment based on the sputum culture status at 6 month after the initiation of therapy and whether patients were free from disease recurrence one year after the end of therapy. The researchers found that the WHO criterion for “cure” could not be applied in the majority of patients, simply because most patients who were being treated successfully were not able to produce sputum after 8 months of therapy. The TB-PANNET study showed much higher cure rates using a new definition of cure and failure of treatment for MDR TB in the European region. (61% cure rates compared to only 31% when using WHO criteria.) The study also demonstrates that the results for “cure” from MDR-TB correlate very well with the level of drug resistance and the time to culture conversion that means the time when TB bacilli are no longer detectable in sputum. The new definitions are also independent of the total duration of treatment and can be applied to the standard 20 months MDR-TB regimen as well as to the 9-12 months shorter course MDR-TB treatment that was recently proposed by the WHO.
Author Interviews, Baylor College of Medicine Houston, Brain Injury, Depression, JAMA / 21.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28208" align="alignleft" width="200"]Ricardo E. Jorge MD Professor of Psychiatry and Behavioral Sciences Director Houston Translational Research Center for TBI and Stress Disorders Senior Scientist Beth K. and Stuart C. Yudofsky Division of Neuropsychiatry Michael E DeBakey VA Medical Center Baylor College of Medicine Dr. Ricardo Jorge[/caption] Ricardo E. Jorge MD Professor of Psychiatry and Behavioral Sciences Director Houston Translational Research Center for TBI and Stress Disorders Senior Scientist Beth K. and Stuart C. Yudofsky Division of Neuropsychiatry Michael E DeBakey VA Medical Center Baylor College of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Depressive disorders affect between one-third and one-half of patients with traumatic brain injury (TBI). Once established, these disorders are difficult to treat and frequently follow a chronic and refractory course. Depression has a deleterious effect on TBI outcomes, particularly affecting the community reintegration of TBI patients. In this randomized clinical trial that included 94 adult patients with TBI, the hazards for developing depression for participants receiving placebo were about 4 times the hazards of participants receiving sertraline treatment.
Author Interviews, Cost of Health Care, Depression, JAMA, Pediatrics / 21.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28010" align="alignleft" width="173"]Laura P. Richardson, MD, MPH Interim Chief | Division of Adolescent Medicine Director | UW Leadership Education in Adolescent Health (LEAH) Program Professor | UW Department of Pediatrics Seattle Children's | University of Washington Dr. Laura Richardson[/caption] Laura P. Richardson, MD, MPH Interim Chief | Division of Adolescent Medicine Director | UW Leadership Education in Adolescent Health (LEAH) Program Professor | UW Department of Pediatrics Seattle Children's | University of Washington MedicalResearch.com: What is the background for this study? Response: Adolescent depression is one of the most common mental health conditions during adolescence. Up to one in five adolescents experience an episode of major depression by age 18. Depressed youth are at greater risk of suicide, dropping out of school and poor long-term health. Treatments, including medications and psychotherapy, have been proven to be effective but most depressed teens don’t receive any treatment. Two years ago, we showed that the Reaching Out to Adolescents in Distress (ROAD) collaborative care model (a.k.a. Reach Out 4 Teens) designed to increase support and the delivery of evidence-based treatments in primary care was effective in treating depression in teens, significantly improving outcomes. We ran a randomized clinical trial at nine of Group Health’s primary care clinics and reported effectiveness results in JAMA. The current paper represents the next step in this work, examining the cost-effectiveness of collaborative care for adolescent depression in our intervention sample of 101 adolescents with depression, ages 13-17 years.
Author Interviews, Outcomes & Safety, PLoS / 21.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28026" align="alignleft" width="107"]Dr Su Golder PhD Research Fellow Department of Health Sciences University of York Dr. Su Golder[/caption] Dr Su Golder PhD Research Fellow Department of Health Sciences University of York MedicalResearch.com: What is the background for this study? What are the main findings? Response: Serious concerns have emerged regarding publication bias or selective omission of outcomes data, whereby negative results are less likely to be published than positive results. There remains considerable uncertainty about the extent of unpublished data on adverse events beyond that reported in the published literature. We aimed to estimate the potential impact of additional data sources and the extent of unpublished information when conducting syntheses of adverse events. We found that less published papers contain adverse events information. The median percentage of published documents with adverse events information was 46% compared to 95% in the corresponding unpublished documents. There was a similar pattern with unmatched studies, for which 43% of published studies contained adverse events information compared to 83% of unpublished studies. We also found even when adverse events are reported in the published and unpublished versions of the same study that the numbers of adverse events do not always match The percentage of adverse events that would have been missed had each analysis relied only on the published versions varied between 43% and 100%, with a median of 64%. Lastly we found that inclusion of unpublished data increased the precision of the pooled estimates (narrower 95% confidence intervals) in three-quarters of pooled analyses, but did not markedly change the direction or statistical significance of the risk in most cases.
Author Interviews, Diabetes, JAMA, Mayo Clinic, Outcomes & Safety / 21.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28018" align="alignleft" width="166"]Victor M. Montori, MD Mayo Clinic Dr. Victor Montori[/caption] Victor M. Montori, MD MSc Knowledge and Evaluation Research Unit in Endocrinology Mayo Clinic, Rochester, Minnesota MedicalResearch.com: What is the background for this study? Response: Hypoglycemia can acutely disrupt patients’ lives through symptoms ranging from bothersome to life-threatening; worsen quality of life; and hinder medication adherence and glycemic control. Hypoglycemia is now known to increase risk of mortality, cognitive impairment, and cardiovascular events. In order to improve the quality of diabetes care, healthcare organizations use publicly reported performance measures for quality measurement and improvement, and pay-for-performance initiatives. The degree to which existing performance measures are aligned with guidelines, particularly in regard to hypoglycemia avoidance, is uncertain.
Allergies, Author Interviews, JAMA, Pediatrics / 21.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28127" align="alignleft" width="200"]Dr Robert Boyle Senior lecturer in paediatric allergy honorary consultant, Paediatric allergist Imperial College Healthcare NHS Trust Dr. Robert Boyle[/caption] Dr Robert Boyle Senior lecturer in paediatric allergy honorary consultant, Paediatric allergist Imperial College Healthcare NHS Trust MedicalResearch.com: What is the background for this study? What are the main findings?   Editors' note: Please discuss food introduction with your child's pediatrician before embarking on any new foods. Response: Food allergy is a common problem which may be getting more common. We have known for over 100 years that feeding egg to animals such as guinea pigs can prevent egg allergy. However randomised trials of allergenic food introduction for preventing food allergy in human infants have not been done until the past 5 years, and have so far yielded mixed results. One trial for peanut allergy was positive, with less peanut allergy in infants who were fed the food from early in life compared with infants who avoided it for 5 years. Other trials have yielded null findings, but may have been too small to yield a conclusive result. We used a technique called meta-analysis to combine the results of all previous trials of timing of allergenic food introduction and risk of food allergy. We also evaluated other allergic and autoimmune diseases. Our analysis yielded conclusive results for both egg and peanut – that early introduction of these foods into an infant’s diet might reduce their risk of egg and peanut allergy by around 40-70%. We were surprised to see null findings in our meta-analysis of timing of gluten or wheat introduction and risk of coeliac disease (gluten intolerance) which is a different type of allergy to egg and peanut allergy. This suggests that early introduction of allergenic foods does not reduce risk of all types of food allergy.
Author Interviews, JAMA, Nutrition, Social Issues / 21.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28068" align="alignleft" width="133"]Lisa Harnack, DrPH, RD | Professor and Director Nutrition Coordinating Center Division of Epidemiology and Community Health School of Public Health, University of Minnesota Minneapolis, MN 55454-1087 Dr. Lisa Harnack[/caption] Lisa Harnack, DrPH, RD | Professor and Director Nutrition Coordinating Center Division of Epidemiology and Community Health School of Public Health, University of Minnesota Minneapolis, MN 55454-1087 MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is interest in considering ways to reshape SNAP so that it better meets meet its objective to help families buy the food they need for good health. Prohibiting the purchase of foods such as soft drinks with SNAP benefits is one of the proposed program changes. Offering an incentive for the purchase of fruits and vegetables is another program change that is being discussed. Little is known about the effects of prohibitions and restrictions on food purchasing and consumption. Consequently, we carried out an experimental trial to evaluate effects. In our study we found that a food benefit program that includes both prohibitions on the purchase of less nutritious foods and incentives for purchasing nutritious foods may lead to a number of favorable changes in diet. To elaborate, we found those enrolled in a food benefit program that prohibited the purchase of sugar sweetened beverages, sweet bakes goods, and candies with food program benefits and provided a 30% financial incentive for fruit and vegetable purchases had a number of favorable dietary changes that were significantly different from changes among those enrolled in a food benefit program that had neither prohibitions or incentives. These favorable changes included reduced consumption of calories, sugar sweetened beverages, sweet baked goods, and candies; and increased consumption of fruit. The overall nutritional quality of the diet also improved. Fewer nutritional improvements were observed among those enrolled in food benefit programs that included prohibitions or incentives only.