Author Interviews, Cost of Health Care, Diabetes / 10.07.2017

MedicalResearch.com Interview with: Maria L. Alva, DPhil Economist RTI International -  Research Triangle Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: We have strong evidence from trials of structured lifestyle intervention programs (e.g. the Diabetes Prevention Program (DPP)) showing that half of new diabetes cases could be avoided if persons with prediabetes changed their lifestyle habits to lose a modest amount of body weight. Moreover, the DPP has been successfully translated into cost-effective community-based prevention interventions, but nationally, these evidence-based interventions (EBIs) are not being used sufficiently. To scale up the implementation of diabetes prevention EBIs, we need to address the challenges of getting organizations to adopt EBIs, and community members to enroll. Because cost is a primary barrier we wanted to understand what was the perceived value and demand for diabetes prevention programs in NC. And in particular, the role that community health workers and technology could play in program delivery, from the perspectives of both potential recipients (adults at high risk or diagnosed with prediabetes) and decision-makers in healthcare/public health delivery. (more…)
Author Interviews, BMJ, Gastrointestinal Disease / 09.07.2017

MedicalResearch.com Interview with: Ziyad Al-Aly MD FASN Assistant Professor of Medicine Co-director for Clinical Epidemiology Center Department of Medicine, Washington University School of Medicine Saint Louis, Missouri Associate Chief of Staff for Research and Education Veterans Affairs Saint Louis Health Care System MedicalResearch.com: What is the background for this study? What are the main findings? Response: Proton Pump Inhibitors (PPI) are commonly used, and they are associated with adverse events including kidney disease, dementia, fractures, cardiovascular disease, and pneumonia. We asked the question of whether this translates to increased risk of death. We conducted this large cohort study to specifically examine the association between PPI use and risk of death. The results consistently showed an association between use of PPI and increased mortality risk. Moreover, there was a graded relationship between duration of PPI use and risk of death in that longer duration of use was associated with incrementally higher risk of death. (more…)
Author Interviews, Cancer Research, CDC / 07.07.2017

MedicalResearch.com Interview with: Lisa C. Richardson, MD, MPH, Oncologist Director,Division of Cancer Prevention and Control CDC MedicalResearch.com: What is the background for this study? Response: This MMWR report is the first complete description of cancer incidence and mortality comparing rural and urban America.  From previous reports we know that rural residents are more likely to be older, have more comorbid conditions and participate in high risk behaviors that can lead to cancer. CDC researchers were interested in how these factors were related to new cancers and cancer deaths in rural counties compared to metropolitan counties. Researchers found that rates of new cases for lung cancer, colorectal cancer, and cervical cancer were higher in rural America. In contrast, rural areas were found to have lower rates of new cancers of the female breast, and prostate. Rural counties had higher death rates from lung, colorectal, prostate, and cervical cancers. (more…)
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Dermatology, JAMA / 07.07.2017

MedicalResearch.com Interview with: Dr. Chrysalyne D. Schmults, MD, MSCE Associate Professor of Dermatology, Harvard Medical School Director, Mohs and Dermatologic Surgery Center and Mr. Pritesh S. Karia, MPH Department of Epidemiology Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland Department of Dermatology Brigham and Women's Faulkner Hospital Harvard Medical School, Boston, Massachusetts Jamaica Plain, MA 02130-3446  MedicalResearch.com: What is the background for this study? Response: Perineural nerve invasion (PNI) is a well-recognized risk factor for poor prognosis in patients with cutaneous squamous cell carcinoma (CSCC). Most cases of CSCC with PNI are identified on histologic examination at the time of surgery and the patient has no clinical symptoms or radiologic evidence of PNI. These cases are classified as incidental PNI (IPNI). However, some patients with PNI present with clinical symptoms and/or radiologic evidence of PNI. These cases are classified as clinical PNI (CPNI). A few studies have shown differences in disease-related outcomes between CSCC patients with IPNI and CPNI but consensus regarding adjuvant treatment and detailed guidelines on follow-up schedules have not yet materialized. (more…)
Author Interviews, Diabetes, Ophthalmology / 07.07.2017

MedicalResearch.com Interview with: Dr. David Kita, PhD Founder and Head of R&D Verseon CorporationDr. David Kita, PhD Founder and Head of R&D Verseon Corporation

MedicalResearch.com: What is the background for this study?

Dr. Kita: The preclinical data presented at the 2017 BIO International Conference provided details about Verseon’s plasma kallikrein inhibitors for the treatment of diabetic macular edema (DME). DME affects millions of people worldwide and is a major cause of vision loss in patients with diabetes mellitus. Upregulation of the kallikrein-kinin system in response to diabetes can result in retinal vascular permeability, which can damage the retina and eventually lead to the central vision loss associated with DME. The current treatment options for DME include intravitreal injections of anti-VEGF agents or corticosteroids into the eye and surgical laser treatments. Long-term use of intravitreal injections is associated with side effects such as inflammation, infections, and cataracts. For anti-VEGF drugs in particular, there is also a growing concern about geographic atrophy. In addition, about 50% of patients reported at most moderate vision improvements following anti-VEGF therapy in clinical trials. This highlights the need for a new treatment that can serve as a monotherapy or as an adjuvant to current therapies. At Verseon, we are working on inhibitors of the serine protease plasma kallikrein (KLKB1) that can be administered either topically or orally. Verseon’s unique computer-driven drug discovery platform allows us to design potent, selective drug candidates that are unlikely to be found using traditional approaches. We have generated a number of chemically distinct series of KLKB1 inhibitors and optimized multiple lead candidates, which show good activity, permeability, and solubility. (more…)
Author Interviews, Genetic Research, Ophthalmology, University Texas / 07.07.2017

MedicalResearch.com Interview with: Stephen P. Daiger, PhD Professor, Human Genetics Center Thomas Stull Matney, Ph.D. Professor in Environmental and Genetic Sciences Mary Farish Johnston Distinguished Chair in Ophthalmology The University of Texas Health Science Center at Houston   MedicalResearch.com: What is the background for this study? What are the main findings? Response: Thanks for your questions about our research.  My research group and I have a long-term interest in finding genes and mutations causing inherited retinal diseases.  Our main focus is on retinitis pigmentosa (RP) and, more specifically, the autosomal dominant form of RP. Inherited retinal diseases are progressive, degenerative diseases of the retina.  Onset can be very early in life, even at birth, or much later in life.  As the degeneration develops an affected person may first experienced limited loss of vision, progressing to severe loss of vision, ending, in many cases, in legal or complete blindness.  About 300,000 Americans are affected by inherited retinal disease and 50% of these have RP.  RP, like most hereditary conditions, can be inherited in an autosomal dominant, autosomal recessive or X-linked fashion. One of the surprising, and in some sense, disturbing findings in studying  retinitis pigmentosa is that mutations in many different genes can cause this disease.  We now know that mutations in more than 80 genes can cause RP and thousands of different mutations have been found in these genes.  With next-generations sequencing it is possible to find the cause of RP in from 50% to 80% of cases, depending on the underlying mode of inheritance.For example, in our research we can find the disease-causing mutation in about 75% of families with autosomal dominant RP.  Needless to say, a primary aim of our research is to find the cause in the remaining 25%. In looking for the cause of retinitis pigmentosa in the remaining 25%, that is, those in whom mutations were not detected by earlier methods, we found a potential dominant-acting mutation in the arrestin-1 gene (gene symbol “SAG”) using whole-genome sequencing.  Molecular modeling suggests this mutation is damaging.  This was unexpected because previously-reported mutations in this gene were associated with Oguchi disease, a recessive retinal disease with symptoms distinct from RP.  On further testing our cohort of patients with autosomal dominant RP, we found this mutation in nearly 4% of families.  Even more surprisingly, when we looked closely at the affected families, and worked with our collaborators to test other patients, we discovered that all of the families with the dominant-acting SAG mutation -- 12 total -- were of Hispanic origin.  By interviewing informative family members we learned that these families have their roots in the Southwestern United States.  Historically, the mutation may have arisen hundreds of years ago, consistent with genetic variation tracking with the mutation. (more…)
Author Interviews, Social Issues, Technology / 07.07.2017

MedicalResearch.com Interview with: Leon Sütfeld The Institute of Cognitive Science University of Osnabrück  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Self-driving cars, and especially future fully autonomous cars, pose a number of ethical challenges. One of these challenges is making the "right" decision when it comes to a so-called dilemma situation, in which a collision is unavoidable (or highly probable), but a decision can be made as to which of multiple different collisions to choose. Our study assesses the behavior of human participants in such dilemma situations and evaluates algorithmic models that are trained on this data to make predictions. Our main findings are that in a controlled virtual reality environment, the decisions of humans are fairly consistent and can be well described by simple value-of-life models. (more…)
Author Interviews, Cancer Research, Dermatology, JAMA, University of Pennsylvania / 06.07.2017

MedicalResearch.com Interview with: Mackenzie R. Wehner, MD, MPhil Department of Dermatology University of Pennsylvania Philadelphia, PA MedicalResearch.com: What is the background for this study? Response: For some diseases, we have national registries, in which information about every person with that disease is entered for research purposes. For other diseases, unfortunately, we do not have such registries. There are growing opportunities to use information like internet searches to better understand behaviors and diseases, however. Our study was a proof-of-concept: we aimed to find out whether internet searches for diseases correlated with known incidence (how many people are diagnosed with the disease) and mortality (how many people die of the disease) rates. E.g. does the number of people who searched 'lung cancer' online correlate with the number of people who we know were diagnosed with or who died of lung cancer during that same time period? This is important to know if researchers in the future want to use internet search data for diseases where we lack registry information. (more…)
Author Interviews, Prostate Cancer, Race/Ethnic Diversity / 06.07.2017

MedicalResearch.com Interview with: Dr. Norman Lee PhD Professor of Pharmacology and Physiology School of Medicine and Health Sciences George Washington University MedicalResearch.com: What is the background for this study? What are the main findings? Response: There are health disparities when it comes to prostate cancer. The African American population, in general, has a higher prostate cancer incidence and mortality rate compared to other racial groups such as European Americans. A major reason for this disparity is due to socioeconomic factors such as access to health care. There are also biological influences for the disparities, such as specific gene mutations and genetic polymorphisms that are found at a higher incidence in the African American population. My lab has been studying other potential contributing biological factors in prostate cancer disparities; namely, RNA splicing. RNA splicing is a cellular program that increases the diversity of expressed proteins by regulating which exons are included in an mRNA transcript, leading to mRNA variants encoding slightly different proteins (or isoforms) in different cells, organs, and individuals. One can think of RNA splicing as a form of genetic diversity. What we have found is that the repertoire of mRNA variants can differ in prostate cancer between African and European Americans. We also find that the mRNA variants in African American prostate cancer encode signal transduction proteins that are more oncogenic and resistant to targeted therapies, compared to the variants found in European American prostate cancer. (more…)
Author Interviews, Depression, JAMA / 06.07.2017

MedicalResearch.com Interview with: Robb B. Rutledge, PhD Max Planck University College London Centre for Computational Psychiatry and Ageing Research University College London London, England MedicalResearch.com: What is the background for this study? What are the main findings? Response: Depression is associated with deficits in how the brain responds to rewards, something the neurotransmitter dopamine is strongly implicated in. Dopamine represents what is called a reward prediction error, the difference between experienced and predicted reward. This error signal is used for learning. For example, if the outcome of a decision is better than expected, you can update your expectations using this error signal and you should expect more next time. Previous research has shown that depression reduces these signals in the brain when people are learning about the world around them. We designed a task where participants did not have to learn anything during the experiment and we found that in this situation reward prediction error signals were not affected by depression. The signals we measured in the ventral striatum, a brain area with a lot of input from the dopamine neurons, looked the same in depressed and non-depressed individuals. We also found that the emotional impacts of reward prediction errors were similar in depressed and non-depressed individuals when we eliminated the need for learning during the task in both the lab and using a smartphone experiment with 1833 participants. (more…)
Author Interviews, JAMA, Pediatrics / 06.07.2017

MedicalResearch.com Interview with: Seetha Shankaran, M.D. Professor, Neonatology Wayne State University School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: The study was performed because infants with moderate or severe hypoxic-ischemic encephalopathy (abnormal neurological exam within 6 hours of birth due to lack of blood and oxygen supply to the brain at birth) have rates of death or survival with disability that were still high in spite of current intensive care including hypothermia. Whole-body hypothermia, cooling the infant for 72 hours at a depth of 33.5°C that was performed by the Neonatal Research Network funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development was the first trial of this therapy in the USA. We found that hypothermia therapy did decrease the rate of death or survival with disability from 62 to 44%. Since 44% is still high we wanted to see if longer cooling or deeper cooling or both would reduce this rate. This was a randomized controlled clinical trial to examine whether longer cooling or deeper cooling or both reduced the rate of death or survival with disability among full term neonates with hypoxic-ischemic encephalopathy. The study lasted from October of 2010 to January 2016. 364 infants were enrolled. Neonates were randomly assigned to 4 groups of cooling therapy and the major findings were that neither longer cooling nor deeper cooling nor both were more superior to cooling for 72 hours at 33.5°C. Our results were surprising because at the time we planned this study there were reports from animal model studies that longer/deeper cooling were more protective to the brain. (more…)
Author Interviews, Electronic Records, JAMA, UCSF / 05.07.2017

MedicalResearch.com Interview with: Neda Ratanawongsa, MD, MPH Associate Chief Health Informatics Officer for Ambulatory Services, San Francisco Health Network Associate Professor, Division of General Internal Medicine UCSF Center for Vulnerable Populations Physician, Richard H. Fine People's Clinic (RHPC) Zuckerberg San Francisco General Hospital San Francisco, CA 94110 MedicalResearch.com: What is the background for this study? What are the main findings? Response: U.S. federal incentives allowed many safety net healthcare systems to afford fully functional electronic health record systems (EHRs). Although EHRs can help clinicians provide care to vulnerable populations, clinicians may struggle with managing the EHR workload, particularly in resource-limited settings. In addition, clinicians’ use of EHRs during clinic visits may affect how they communicate with patients. There are two forms of EHR use during clinic visits.  Clinicians can multitask, for example, by ordering laboratory tests while chatting with a patient about baseball.  However, like distracted driving, using EHRs while talking with increases risks – in this case, the risk of errors in patient-provider communication or in the EHR task. Alternatively, clinicians can use EHRs in complete silence, which may be appropriate for high-risk tasks like prescribing insulin. However, silence during visits has been associated with lower patient satisfaction and less patient-centered communication. So we studied how primary and specialty care clinicians used EHRs during visits with English- and Spanish-speaking patients in a safety net system with an EHR certified for Centers for Medicare & Medicaid Services meaningful use incentive programs. We found that multitasking EHR use was more common than silent EHR use (median of 30.5% vs. 4.6% of visit time). Focused patient-clinician talk comprised one-third of visit time. We also examined the transitions into and out of silent EHR use. Sometimes clinicians explicitly stated a need to focus on the EHR, but at times, clinicians drifted into silence without warning. Patients played a role in breaking silent EHR use, either by introducing small talk or by bringing up their health concerns. (more…)
Author Interviews, Diabetes, JAMA, Pharmacology / 05.07.2017

MedicalResearch.com Interview with: Wendy Lane MD Director of Clinical Research Mountain Diabetes and Endocrine Center Asheville, NC MedicalResearch.com: What is the background for this study? What are the main findings? Response: The SWITCH1 trial was the first double blinded insulin trial to compare the rate of severe, nocturnal severe and symptomatic blood glucose-confirmed hypoglycemia between two basal insulins, insulin glargine U100 and insulin degludec U100, in patients with type 1 diabetes. The trial design (double blinded crossover treat-to-target) eliminated any bias in the results, which showed clear-cut reductions in all categories of hypoglycemia with insulin degludec compared to insulin glargine. Severe hypoglycemia has dangerous and greatly feared consequences including cognitive impairment, seizures, coma and death, and it is the main barrier to effective use of insulin in the treatment of type 1 diabetes. Insulin degludec, which was shown to reduce the risk of hypoglycemia compared to insulin glargine in the SWITCH1 trial, should be viewed by clinicians as an advancement in insulin therapy which will increase its safety and improve the quality of life of our patients with type 1 diabetes. (more…)
Author Interviews, Education, NYU, Sexual Health / 05.07.2017

MedicalResearch.com Interview with: Richard E. Greene, MD, FACP Medical Director, Bellevue Adult Primary Care Center Assistant Professor, NYU School of Medicine Associate Program Director, Primary Care Residency Program Director, Gender and Health Education, Office of Diversity Affairs, NYU School of Medicine, OUTList Medical Director, CHIBPS, The Center for Health, Identity, Behavior and Prevention Studies VP of Membership and Development, GLMA-Health Professionals Advancing LGBT Equality  MedicalResearch.com: What is the background for this study? Response: Transgender individuals face complex health disparities and have historically been mistreated and even denied care in medical settings. As a provider in New York City, I saw how this affected my trans patients, resulting in mistrust of the health care system, resulting in negative health outcomes. This sparked my interest in improving medical education to serve the needs of trans patients. It’s important to teach medical students and residents that they are not just treating a set of symptoms, they are working with a individuals with complex lived experiences who deserve compassionate care. I found with traditional didactic methods, like lectures, learners smiled and nodded in agreement, but when faced with a patient who was transgender, they would stammer and feel uncomfortable with aspects of the cases that were specific to transgender patients, from pronouns to hormones. Residents should be prepared to treat transgender patients not only with dignity, but also in medically appropriate ways. Without exposure to the transgender community, it’s difficult for providers to decipher their trans patients’ health care needs and contextualize them within a care plan. In order to provide a low stakes environment for residents to practice these skills, we developed an OSCE focused on a transgender woman with health care needs specific to her transition. The goal of the case was to discuss the patient’s medical concerns while also taking into consideration her goals around her hormone therapy and surgical interests. (more…)
Author Interviews, CDC, Exercise - Fitness, JAMA / 04.07.2017

MedicalResearch.com Interview with: Emily Neusel Ussery, MPH PhD Epidemiologist, Physical Activity and Health Branch CDC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Walking is an easy way for most people to start and maintain a physically active lifestyle. Step It Up! The Surgeon General’s Call to Action to Promote Walking and Walkable Communities identifies walking as an important public health strategy to increase physical activity levels in the U.S. A previous report found that the percentage of adults who reported walking for transportation or leisure increased by 6 percentage points between 2005 and 2010, but it is unknown if this increase has continued. This report examined trends in the proportion of U.S. adults who reported walking for transportation or leisure for at least one 10-minute period in the past week, using nationally representative data from the 2005, 2010, and 2015 National Health Interview Surveys. We also examined differences in walking trends by sociodemographic characteristics. If you take walking seriously, make sure you invest in some custom boots to make sure you don't damage your feet. For those who need to transport larger items while walking isn't an option, utilizing a Large Item Courier service can help ensure safe and efficient delivery. (more…)
Author Interviews / 04.07.2017

MedicalResearch.com Interview with: Chintan V. Dave, PharmD Department of Pharmacotherapy and Translational Research College of Pharmacy, University of Florida Gainesville, FL MedicalResearch.com: What is the background for this study? Response: Use of generic drugs as a percentage of total dispensed prescriptions has increased in recent years, from 57% in 2004 to 86% in 2013. The U.S. health care system has recently witnessed a relatively new phenomenon where prices for some older generic drugs have increased hundreds — even thousands — of percentage points in a short time span. Many factors have been linked to these price increases, including shortages in the manufacturing supply chain (leading to reduced production) and a reduction in the number of manufacturers of a drug (resulting in insufficient competition). Understanding how prices relate to market changes may help identify drugs at risk for price changes so that interventions may occur before patient care is affected. (more…)
Author Interviews, JAMA, Pain Research / 04.07.2017

MedicalResearch.com Interview with: Esther Maas, PhD Postdoctoral Research Fellow Partnership for Work, Health and Safety School of Population and Public Health University of British Columbia Vancouver, BC  MedicalResearch.com: What is the background for this study? Esther Maas, PhD Chronic low back pain causes more disability than any other condition, and has major social and economic consequences. Radiofrequency denervation is a commonly used treatment in pain clinics for a subgroup of patients with chronic low back pain resulting from anatomical structures such as facet joints, sacroiliac joint and intervertebral disc. Radiofrequency denervation uses an electric current that damages the innervating nerve of the painful structure. Despite its frequent application, until now, there was only very low quality and conflicting evidence for its effectiveness. The aim of this study was to establish whether radiofrequency denervation in addition to a standardized exercise program is more effective than the standardized exercise program alone in the selected subgroup of patients with chronic low back pain. (more…)
Abuse and Neglect, Hearing Loss, JAMA, Johns Hopkins / 04.07.2017

MedicalResearch.com Interview with: Nicholas S. Reed, AuD Instructor | Department of Otolaryngology-Head/Neck Surgery PhD Candidate  | Graduate Training Program in Clinical Investigation Center on Aging and Health Johns Hopkins University School of Medicine Johns Hopkins University Bloomberg School of Public Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: Hearing Aids are medical devices regulated by the FDA which must be purchased through a licensed individual while personal sound amplification products (PSAPs) are essentially unregulated devices some of which can manipulate and increase sound similar to a hearing aid but cannot market themselves are devices for hearing loss. PSAPs can be purchased online or in the back of a store and are generally less expensive than hearing aids. We aimed to explore a select group of PSAPs to see if they helped someone with mild to moderate hearing loss improve speech understanding (i.e. ability to repeat back sentences) in the presence of mild background noise (think a lunch crowd at a restaurant) as well as a hearing aid. We selected four PSAP devices that were technologically strong (i.e. meet many standards a hearing aid might be asked to meet) and one PSAP that was technologically fairly poor (i.e. lots of sound distortion) after an in-house electroacoustic analysis of devices. Our hearing aid was selected because it was a popular choice at a university audiology clinic. Forty-two people completed the speech testing unaided (i.e. with no device) and then with each of the five PSAPs and one hearing aid (order of devices was randomized). We looked at improvement with the devices from unaided. We found that some PSAPs help people understand speech about as well as a hearing aid in this controlled environment while one PSAP actually hindered participants’ ability to understand speech due to sound distortion – imagine how difficult it can be when listening on a poor cell phone signal. (more…)
Author Interviews, Diabetes / 04.07.2017

MedicalResearch.com Interview with: Stefan Amisten, PhD The Oxford Centre for Diabetes, Endocrinology & Metabolism University of Oxford, Oxford Diabetes Research Group, Division of Diabetes & Nutritional Sciences King’s College London, Faculty of Life Sciences & Medicine, London UK MedicalResearch.com: What is the background for this study? Response: Type 2 diabetes is a global epidemic that is causing an increasing medical and financial burden on both individuals and society in general. Type 2 diabetes is characterized by insulin resistance, poor insulin response to blood glucose which leads to chronically elevated blood glucose and damage to the cardiovascular system and other organs, which may ultimately lead to blindness, kidney failure, blindness, toe amputations, cardiovascular disease and premature death. Although a number of drugs are available for the treatment of Type 2 diabetes, no drug is currently able to cure diabetes, as they are only able to slow down the disease progression. There is therefore a need to develop novel therapies to treat Type 2 diabetes. G-protein coupled receptors (GPCRs) constitute a family of almost 400 cell surface receptors that is the target of a large number of modern medicines. Interestingly, only a small subset of all GPCRs are currently targeted by modern medicines, which means that a large number of GPCRs still have untapped therapeutic potential, largely because they have not been studied in-depth, or because their ligands (i.e. binding partners) have not been identified. This study is a result of a thorough cataloguing of all G-protein coupled receptors (GPCRs) in human pancreatic islets (Amisten et al. Pharmacol Ther. 2013 Sep;139(3):359-91.), where the receptor GPRC5C was identified as one of the most abundant orphan GPCRs in human islets. (more…)
Author Interviews, BMJ, Dermatology / 03.07.2017

MedicalResearch.com Interview with: Joann G. Elmore M.D., M.P.H. Professor of Medicine, Adjunct Professor of Epidemiology, University of Washington School of Medicine Harborview Medical Center Seattle, WA 98104-2499 MedicalResearch.com: What is the background for this study? JE: Previous studies on diagnostic accuracy in interpreting melanocytic lesions exist but have small sample size, inclusion of experts only, or small numbers of specimens. We sought to examine accuracy and reproducibility in melanocytic skin lesions by improving upon the methodological limitations of previous studies. Specifically, we recruited a large national sample of practicing community and academic pathologists with a wide range of experience, and we utilized a large sample of biopsy cases that were carefully selected. Given that diagnostic errors can lead to patient deaths and invasive melanoma kills more than 9,000 Americans each year, we wanted to study the issue of diagnostic accuracy in interpreting melanocytic skin lesions in a very robust fashion. (more…)
Author Interviews, Heart Disease, JAMA, Surgical Research / 29.06.2017

MedicalResearch.com Interview with: Suzanne J. Baron, MD, MSc Saint Luke’s Mid America Heart Institute School of Medicine University of Missouri, Kansas City MedicalResearch.com: What is the background for this study? What are the main findings? Response: Transcatheter Aortic Valve Replacement (TAVR) has emerged as a viable treatment option for patients with severe aortic stenosis in patients at high and intermediate surgical risk.  Prior studies have demonstrated that both TAVR and surgical AVR (SAVR) results in substantial quality of life benefit in patients at high surgical risk. Whether these results applied to an intermediate risk population was unknown and so we performed a prospective study alongside the PARTNER 2A trial to compare both short- and long-term health status outcomes in intermediate-risk patients with AS treated with either TAVR or SAVR.   The analysis included 1833 patients (950 TAVR, 833 SAVR), who were evaluated at 1 month, 1 year and 2 years post procedure.  By 1 month, quality of life had improved in both the TAVR and SAVR groups, although the gain was significantly greater in patients treated with TAVR via the transfemoral approach as opposed to patients treated with SAVR or with TAVR via the transthoracic approach (i.e. direct aortic access or transapical access).   At 1 and 2 years, both TAVR (via either approach) and SAVR were associated with similarly large, clinically meaningful improvements from baseline in both disease-specific and generic health status scales at 2 years. (more…)
Author Interviews, Neurological Disorders, Technology / 29.06.2017

MedicalResearch.com Interview with: Howard Jay Chizeck ScD Professor, Electrical Engineering Adjunct Professor, Bioengineering Co-Director UW Biorobotics Laboratory Graduate Program in Neuroscience UW CoMotion Presidential Innovation Fellow Research Thrust Testbed Co-Leader MedicalResearch.com: What is the background for this study? What are the main findings? Response: Essential Tremor is treated using Deep Brain Stimulation (DBS) in some patients. Current clinical practice involves Deep Brain Stimulation with an "always on" stimulation. This causes extra battery drain, because stimulation is applied when not needed. Also excessive stimulation is not necessarily a good thing, Our work is aimed at adjusting the stimulation, so that it comes on and turns off only when needed to suppress tremor symptoms. (more…)
Author Interviews, Brigham & Women's - Harvard, Environmental Risks, NEJM, Race/Ethnic Diversity / 29.06.2017

MedicalResearch.com Interview with: Qian Di, M.S, Doctoral Student Department of Environmental Health and Francesca Dominici, Ph.D. Principal Investigator of this study Professor of Biostatistics co-Director of the Harvard Data Science Initiative Harvard T.H. Chan School of Public Health Boston, MA MedicalResearch.com: What is the background for this study? What are the main findings? Response: The Clean Air Act requires Environmental Protection Agency to set National Ambient Air Quality Standard (NAAQS). Currently the annual NAAQS for PM2.5 is 12 microgram per cubic meter; and there is no annual or seasonal ozone standard. However, is current air quality standard stringent enough to protect human health? This is our main motivation. We conducted the largest attainable cohort study, including over 60 million Medicare participants, to investigate the association between long-term exposure to ozone/PM2.5 and all-cause mortality. We found significant harmful effect of PM2.5 even below current NAAQS. Each 10 microgram per cubic meter increase in PM2.5 is associated with 13.6% (95% CI: 13.1%~14.1%) increase in all-cause mortality. For ozone, 10 ppb increase in ozone exposure is associated with 1.1% (95% CI: 1.0%~1.2%) increase in mortality. Also, there is no appreciable level below which mortality risk tapered off. In other words, there is no “safe” level for PM2.5 and ozone. In other words, if we would reduce the annual average of PM2.5 by just 1 microgram per cubic meter nationwide, we should save 12,000 lives among elder Americans every year; 5 microgram --- 63,817 lives every year. Similarly, if we would reduce the annual summer average of ozone by just 1 ppb nationwide, we would save 1,900 lives every year; 5 ppb --- 9537 lives. Besides, we found black people, males and people of low SES are more vulnerable to air pollution. (more…)
Author Interviews, Gender Differences / 29.06.2017

MedicalResearch.com Interview with: Sanger Insitute - Wellcome Trust. Photo by Phil MynottDr Natasha Karp PhD Senior Staff Scientist – Biostatistician Wellcome Trust Sanger Institute MedicalResearch.com: What is the background for this study? Response: There is evidence that the prevalence of disease, the symptoms experienced,  the progression,  and the side effects can be  dependent on sex.  However, women are underrepresented within biomedical research and this can be seen in the reporting, design of the experiments and subsequent statistical analysis. Examples
  • A review of international animal research between 2011 and 2012 found that 22 per cent of studies did not state the sex of the animals, and of those that did, 80 per cent of studies used solely males and only 3 per cent included both males and females (https://www.ncbi.nlm.nih.gov/pubmed/25175501)
  • In a study across 10 fields of biology,  80% of the rodents were male  (Beery and Zucker 2011 Neurosci Biobehav Rev).  This rate has not changed in 20 years  (Mazure and Jones 2015 BMC Women’s health)
  • Women encounter adverse drug reactions more often than men (odds ratio 1.596 confidence interval: 1.3-1.94)( Zopf et al 2008  Eur J Clinic Pharmacol)
  • Example – cardiovascular disease is the number one killer of US women,  and women differ to men in symptoms, outcomes and risk factors, yet only one third of cardiovascular trials subjects are female and only 31% of trials report results by sex (http://www.brighamandwomens.org/Departments_and_Services/womenshealth/ConnorsCenter/Policy/ConnorsReportFINAL.pdf)
  • Example – It took 21 years to lower the  dosing guidelines for women for the insomnia drug Zolpidem due to differences in the clearance rate of the drug exposing women to greater health risks (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4918870/)
As a result of these observations, multiple bodies have called for sex to be considered as a biological variable in preclinical research.  The largest funders of biomedical research (National Institute of Health) made inclusion of sex a requirement of funding with a few well defined exceptions.  There was some push back on this,  particularly that scientists should be trusted and would know when sex was a variable and it was a waste of resources. I felt there was a knowledge gap on the role of sex.  We have had published studies of individual examples where sex had a role but no large scale study. (more…)
Aging, Author Interviews, McGill, Nature / 29.06.2017

MedicalResearch.com Interview with: Pr. Siegfried Hekimi PhD McGill University MedicalResearch.com: What is the background for this study? What are the main findings? Response: We analyzed data about the longest living individuals over the period of time during which the record can be trusted. We found that there was no detectable plateauing of the maximum possible lifespan. This is consistent with not clearly observed plateau in the currently increasing average lifespan as well. (more…)
Author Interviews, Cancer Research, Melatonin, Occupational Health / 28.06.2017

MedicalResearch.com Interview with: Parveen Bhatti, PhD Associate Member Fred Hutchinson Cancer Research Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Evidence in humans for an association between shift work and cancer has been mixed. This may be due to difficulties in accurately assessing long-term exposures to shift work in studies of cancer risk. We took a different approach that circumvented these difficulties. Rather than look at cancer risk directly, we measured, among actively employed shift workers, a marker of DNA damage that has been linked to cancer. When repaired by cellular machinery, this particular marker is excreted in urine where it can be measured. We found that, compared to sleeping at night during their night off, shift workers had lower urinary levels of the DNA damage marker during their night work. This effect appears to be driven by reductions in circulating melatonin levels among shift workers during night work relative to night sleep. Given that melatonin has been shown to enhance repair of DNA damage, our results suggest that, during night work, shift workers have reduced ability to repair DNA damage resulting in lower levels being excreted in their urine. Because of this, shift workers likely have higher levels of DNA damage remaining in their cells, which can lead to mutations and cause cancer. (more…)
Aging, Author Interviews, Geriatrics, Sexual Health / 28.06.2017

MedicalResearch.com Interview with: Dr Hayley Wright BSc(Hons) MSc PhD C.Psychol Research Associate Faculty of Health and Life Sciences, Coventry University Centre for Research in Psychology, Behaviour and Achievement, Coventry University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Last year, we published a study that showed a significant association between sexual activity and cognitive function (Wright & Jenks, 2016). This study showed that sex is linked to cognition, even after we account for other factors such as age, education, and physical and mental wellbeing. One important question that emerged from this study was centred around the role of frequency with which we engage in sexual activity. In the current study (Wright, Jenks & Demeyere, 2017), we found that engaging in sexual activity on a weekly basis is associated with better scores on specific cognitive tasks. (more…)
Author Interviews, CDC, Occupational Health / 28.06.2017

MedicalResearch.com Interview with: Taylor M. Shockey MPH CDC/National Institute for Occupational Safety and Health CDC MedicalResearch.com: What is the background for this study? Response: Our study examined health-related quality of life (HRQOL) among 22 major occupation groups using the Behavioral Risk Factor Surveillance System (BRFSS) data. The BRFSS is an annual telephone survey that collects data from U.S. residents on their health-related risk behaviors, chronic health conditions, and use of preventive services. HRQOL is an individual’s self-perception of their physical and mental health over time and it provides a valuable measure of well-being. HRQOL is used by a variety of different fields, outside of public health, including psychology, social work, economics, and urban planning. HRQOL is a measure capable of linking these different fields and is used to determine disease burden, to monitor progress in achieving the Healthy People goals, to guide policy and legislation, to develop interventions, and to allocate resources where they are most needed. The Healthy People goals are 10-year targets for improving the health of Americans through health promotion activities and disease prevention efforts. In relation to occupation, prior research that has evaluated HRQOL has typically focused on employment status, but not on specific job type. It’s been established, however, that job characteristics such as high demand, low control, role stress, bullying, work hours, etc., are associated with greater risk for common mental health problems as well as physical outcomes like headaches, fatigue, and gastrointestinal problems. Our study wanted to determine if differences in HRQOL would exist among occupation groups. (more…)
Author Interviews, JAMA, Urology / 28.06.2017

MedicalResearch.com Interview with: Baoyan Liu, MD Guang’an Men Hospital China Academy of Chinese Medical Sciences Beijing, China MedicalResearch.com: What is the background for this study? What are the main findings? Response: The prevalence of stress urinary incontinence(SUI) is as high as 49% and varies according to the population studied and the definition of stress urinary incontinence. SUI causes psychological burden, affects relationships, lowers physical productivity, and decreases quality of life in women. Yet, few effective therapies are available for treating stress urinary incontinence. In this randomized clinical trial that included 504 women, the mean decrease in urine leakage, measured by the 1-hour pad test from baseline to week 6, was 9.9 g with electroacupuncture vs 2.6 g with sham electroacupuncture, a significant difference. (more…)
Author Interviews, Emory, Flu - Influenza, Lancet, Technology, Vaccine Studies / 28.06.2017

MedicalResearch.com Interview with: Dr Nadine G Rouphael MD Associate Professor of Medicine, Emory University Director of the VTEU and HIPC networks at the Hope Clinic of the Emory Vaccine Center Decatur GA 30030, USA MedicalResearch.com: What is the background for this new technology and study? What are the main findings? Response: Different groups including a group of researchers at Georgia Tech have been working on the microneedle technology for more than 20 years. The dissolvable microneedle patches are already used in several cosmetic products and drugs. However, vaccination with microneedle patches has been studied mostly in animals. Our phase 1 trial published this week in The Lancet showed that vaccination with the microneedle patches was safe, with no related serious adverse events reported. Local skin reactions to the patches were mostly mild itching and faint redness that lasted two to three days. No new chronic medical illnesses or influenza-like illnesses were reported with either the patch or the injection groups. Antibody responses generated by the vaccine, as measured through analysis of blood samples, were similar in the groups vaccinated using patches and those receiving intramuscular injection, and these immune responses were still present after six months. When asked after immunization, more than 70 percent of patch recipients reported they would prefer patch vaccination over injection or intranasal vaccination for future vaccinations. (more…)