Author Interviews, JAMA, Nutrition, Pediatrics / 10.07.2017

MedicalResearch.com Interview with: Dr. Anne-Louise M. Heath and Professor Rachael Taylor Co-Principal Investigators for the BLISS study. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Conventional approaches to complementary feeding generally advise parents to spoon-feed their infant pureed foods, gradually progressing to greater variety and texture so that by the time the infant is one year of age, they are eating more or less what the family does. Baby-led weaning (BLW) is an alternative approach where the infants feeds themselves right from the start of complementary feeding. Because children of this age cannot use utensils, this means hand-held foods are necessary. Advocates of BLW suggest that children have a lower risk of obesity because they remain in control of their own food intake, but research examining this issue directly is scarce. Health professionals have also expressed concern that BLW might put the infant at increased risk of iron deficiency (parents might avoid red meat for fear of the infant choking, and iron-fortified cereals are not easy for the infant to feed themselves), growth faltering (if only low energy foods are offered) and choking (from the infant feeding themselves ‘whole’ foods). Our study therefore examined a version of BLW that had been modified to address these issues (called BLISS - a Baby-Led Introduction to SolidS). Two hundred families took part in our 2-year intervention, with half following traditional feeding practices and half receiving guidance and support to follow our BLISS approach. We found that BLISS children were not less likely to be overweight than those following traditional feeding practices, nor was growth faltering an issue. BLISS child ate about the same amount of food as control children, and their ability to eat to appetite was not different either. However, it seems that children following a baby-led approach to complementary feeding are less fussy about food, and have a healthier attitude to food, which might make a difference to their health long term.
Author Interviews, BMJ, Gastrointestinal Disease / 09.07.2017

MedicalResearch.com Interview with: [caption id="attachment_35797" align="alignleft" width="145"]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 Dr. Ziyad Al-Aly[/caption] 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.
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.
Author Interviews, Cancer Research, Dermatology, JAMA, University of Pennsylvania / 06.07.2017

MedicalResearch.com Interview with: [caption id="attachment_35759" align="alignleft" width="200"]Mackenzie R. Wehner, MD, MPhil Department of Dermatology University of Pennsylvania Philadelphia, PA Dr. Weher[/caption] 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.
Author Interviews, Depression, JAMA / 06.07.2017

MedicalResearch.com Interview with: [caption id="attachment_35752" align="alignleft" width="144"]Robb B. Rutledge, PhD Max Planck University College London Centre for Computational Psychiatry and Ageing Research University College London London, England Dr. Rutledge[/caption] 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.
Author Interviews, JAMA, Pediatrics / 06.07.2017

MedicalResearch.com Interview with: [caption id="attachment_35668" align="alignleft" width="150"]Seetha Shankaran, M.D. Professor, Neonatology Wayne State University School of Medicine Dr. Shankaran[/caption] 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.
Author Interviews, Electronic Records, JAMA, UCSF / 05.07.2017

MedicalResearch.com Interview with: [caption id="attachment_35660" align="alignleft" width="132"]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  Dr. Ratanawongsa[/caption] 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.
Author Interviews, Diabetes, JAMA, Pharmacology / 05.07.2017

MedicalResearch.com Interview with: [caption id="attachment_35738" align="alignleft" width="150"]Wendy Lane MD Director of Clinical Research Mountain Diabetes and Endocrine Center Asheville, NC  Dr. Lane[/caption] 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.
Author Interviews, CDC, Exercise - Fitness, JAMA / 04.07.2017

MedicalResearch.com Interview with: [caption id="attachment_35687" align="alignleft" width="200"]Emily Neusel Ussery, MPH PhD Epidemiologist, Physical Activity and Health Branch CDC Dr. Ussery[/caption] 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.
Author Interviews, JAMA, Pain Research / 04.07.2017

MedicalResearch.com Interview with: [caption id="attachment_35689" align="alignleft" width="133"]Esther Maas, PhD Postdoctoral Research Fellow Partnership for Work, Health and Safety School of Population and Public Health University of British Columbia Vancouver, BC  Dr. Maas[/caption] 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.
Abuse and Neglect, Hearing Loss, JAMA, Johns Hopkins / 04.07.2017

MedicalResearch.com Interview with: [caption id="attachment_35679" align="alignleft" width="200"]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 Dr. Nicholas Reed[/caption] 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.
Author Interviews, BMJ, Dermatology / 03.07.2017

MedicalResearch.com Interview with: [caption id="attachment_35671" align="alignleft" width="142"]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 Dr. Elmore[/caption] 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.
Author Interviews, Heart Disease, JAMA, Surgical Research / 29.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35663" align="alignleft" width="171"]Suzanne J. Baron, MD, MSc Saint Luke’s Mid America Heart Institute School of Medicine University of Missouri, Kansas City Dr. Baron[/caption] 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.
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.
Aging, Author Interviews, McGill, Nature / 29.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35643" align="alignleft" width="165"]Pr. Siegfried Hekimi PhD McGill University Prof. Hekimi[/caption] 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.
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 [caption id="attachment_35600" align="alignleft" width="200"]Patient with Electroacupuncture Patient with Electroacupuncture[/caption] 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.
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.
Author Interviews, Heart Disease, JACC, Women's Heart Health / 27.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35621" align="alignleft" width="200"]C. Noel Bairey Merz, MD, FACC  Director, Barbra Streisand Women's Heart Center Director, Linda Joy Pollin Women's Heart Health Program Director, Erika Glazer Family Foundation Women's Heart Disease Initiative Director, Preventive Cardiac Center  Professor of Medicine  Cedars-Sinai Medical Center Dr. Merz[/caption] C. Noel Bairey Merz, MD, FACC  Director, Barbra Streisand Women's Heart Center Director, Linda Joy Pollin Women's Heart Health Program Director, Erika Glazer Family Foundation Women's Heart Disease Initiative Director, Preventive Cardiac Center Professor of Medicine Cedars-Sinai Medical Center MedicalResearch.com: What is the background for this study? Response: Cardiovascular disease (CVD) is the number 1 killer of women in the U.S.A., yet few younger women personalize awareness. CVD campaigns focus little attention on physicians and their role assessing risk. MedicalResearch.com: What are the main findings? Response: Overall, 45% of women were unaware that CVD is the #1 killer of women, only 11% knew a woman who has died from it.  Overall, 45% of women reported it is common to cancel or postpone a physician appointment until losing weight. Cardiovascular disease was a top concern for only 39% of PCPs, after weight and breast health. A minority of physicians (22% of PCPs and 42% of cardiologists) felt well prepared to assess women’s CVD risk, and infrequently use guidelines.
Author Interviews, Emergency Care, Heart Disease, JAMA, Stanford / 27.06.2017

MedicalResearch.com Interview with: Alexander Sandhu, MD MS Cardiology Fellow Stanford University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Millions of patients present to the emergency department with chest pain but most do not have lab or EKG findings that indicate the patient is having a heart attack. In patients without signs of a heart attack, stress testing is frequently used to determine the need for further workup and treatment. However, there is limited evidence regarding the benefit of stress testing in these patients. We evaluated how cardiac testing - stress testing and coronary angiography - in these low-risk patients was associated with clinical outcomes. We used a statistical approach that took advantage of the fact that testing is more available on weekdays than weekends. We found that testing was associated with more angiography and revascularization (coronary stenting or coronary artery bypass surgery) but was not associated with a reduction in future heart attacks.
Author Interviews, Dermatology, HPV, PLoS / 22.06.2017

MedicalResearch.com Interview with: Prof. Dr. med. Sigrun Smola Institute of Virology, Saarland University Homburg/Saar, Germany MedicalResearch.com: What is the background for this study? Response: Non-melanoma skin cancer (NMSC), the most common cancer in humans, is caused by UV-irradiation. The potential co-factor role of cutaneous genus beta-human papillomaviruses (beta-HPV) in skin carcinogenesis, particularly in immunosuppressed patients, has become a major field of interest. However, the underlying mechanisms were unclear. The skin has natural mechanisms providing protection against UV-induced damage. One important factor suppressing UV-induced skin carcinogenesis is the transcription factor C/EBPα belonging to the CCAAT/enhancer binding protein family. C/EBPα can induce cellular differentiation and is regarded as a tumor suppressor in various tissues. When C/EBPα expression is blocked in these tissues, tumorigenesis is enhanced. Another important factor is the microRNA-203. It has been shown to control “stemness” in normal skin by suppressing a factor called p63. In many tumors miR-203 expression is shut off releasing this “brake”. In our study we demonstrate that cutaneous beta-HPV interferes with both protective factors providing an explanation how cutaneous beta-HPV enhances the susceptibility to UV-induced carcinogenesis. Moreover, we provide evidence that these viruses regulate miR-203 via C/EBPα. We have investigated this mechanism in Epidermodysplasia verruciformis (EV) patients that serve as a human model disease for studying the biology of genus beta-HPVs. They are highly susceptible to persistent genus beta-HPV infection, such as HPV8, and have an increased risk to develop non-melanoma skin cancer at sun-exposed sites.
Author Interviews, JAMA, Pediatrics, Weight Research / 22.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35533" align="alignleft" width="140"]David C. Grossman, M.D., M.P.H. US Preventive Services Task Force Chair Senior Investigator, Kaiser Permanente Washington Health Research Institute Senior Associate Medical Director, Market Strategy & Public Policy Kaiser Permanente Washington Physician, Washington Permanente Medical Group, Pediatrics Dr. Grossman[/caption] David C. Grossman, M.D., M.P.H. US Preventive Services Task Force Chair Senior Investigator, Kaiser Permanente Washington Health Research Institute Senior Associate Medical Director, Market Strategy & Public Policy Kaiser Permanente Washington Physician, Washington Permanente Medical Group, Pediatrics MedicalResearch.com: What is the background for this recommendation? Response: Recognizing that obesity is a nation-wide health problem, affecting approximately 17% of 2-to 19-year-old children and adolescents in the U.S., the Task Force finalized its recommendation on screening for obesity in children and adolescents and the benefits and harms of weight management interventions. The Task Force found sufficient evidence to recommend screening for obesity in children and adolescents age 6 years and older and then offering or referring those who are found to be obese comprehensive, intensive behavioral interventions to manage their weight and improve overall health. MedicalResearch.com: What are the potential benefits and harms of early screening and intervention for obesity in children? Response: The Task Force found that intensive behavioral interventions for children and adolescents who have obesity can result in benefits of improvement in weight status for up to 12 months’ post-intervention. Additionally, the evidence indicated very little harm from screening and comprehensive, intensive behavioral interventions. This is due to likely minimal harms of using BMI (body mass index), the absence of reported harms of behavioral interventions, and the noninvasive nature of the programs.
Author Interviews, Flu - Influenza, NEJM, Vaccine Studies / 22.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35441" align="alignleft" width="200"]Lisa M. Dunkle, M.D. Chief Medical Officer Protein Sciences Corporation 1000 Research Parkway Meriden, CT  Dr. Dunkle[/caption] Lisa M. Dunkle, M.D. Chief Medical Officer Protein Sciences Corporation 1000 Research Parkway Meriden, CT MedicalResearch.com: What is the background for this study? What are the main findings? Response: The first and only recombinant protein influenza vaccine (RIV, Flublok) was approved in 2013 as a trivalent formulation for use in adults 18 years of age and older. This approval was based on demonstration of clinical efficacy (full approval) in adults 18-49 years of age and accelerated approval was granted for adults 50 years of age and older. Two clinical trials were conducted in 2014-2015 with RIV4 (Flublok Quadrivalent), of which the trial reported in the current NEJM is one. These studies supported full approval of Flublok in adults 50 years of age and older and approval of Flublok Quadrivalent in all adults 18 years of age and older. The second trial of immunogenicity of Flublok Quadrivalent in adults 18-49 years of age will be the subject of another publication in the near future. The main findings of the current trial are well summarized in the Conclusion of the Abstract: “RIV4 provided better protection than standard-dose IIV4 against confirmed influenza-like illness in older adults.” Additionally, the recombinant vaccine (RIV4, Flublok Quadrivalent) demonstrated significantly less injection site pain and tenderness following vaccination. Based on the characteristics of the study participants, one can conclude that RIV4 is safe and effective in most individuals with underlying chronic diseases
Author Interviews, NEJM, Stroke / 22.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35404" align="alignleft" width="133"]Craig Anderson | MD PhD FRACP Executive Director  Professor of Neurology and Epidemiology, Faculty of Medicine, UNSW Sydney Neurologist, Neurology Department, Royal Prince Alfred Hospital The George Institute for Global Health at Peking University Health Science Center Haidian District | Beijing, 100088 P.R. China Prof. Anderson[/caption] Craig Anderson | MD PhD FRACP Executive Director Professor of Neurology and Epidemiology, Faculty of Medicine, UNSW Sydney Neurologist, Neurology Department, Royal Prince Alfred Hospital The George Institute for Global Health at Peking University Health Science Center Haidian District | Beijing, 100088 P.R. China MedicalResearch.com: What is the background for this study? What are the main findings? Response: Preliminary small studies indicate that lying flat increases blood flow and oxygenation to the brain.  Thus, patients with acute ischemic stroke may benefit from lying flat in bed.  Conversely, sitting up in bed, with the head elevated to at least 30 degrees, may reduce swelling in the brain for patients who have large ischemic or hemorrhagic forms of stroke.  The optimal head position to produce the best outcome from acute stroke, and avoid potential risks, such as aspiration pneumonia, is unknown.  We undertook a large scale multicentre randomized controlled trial where 114 hospitals were randomised to sequentially apply lying flat or sitting up head positioning as a policy of care to a consecutive series of patients, that overall totalled over 11000 patients, presenting with acute stroke.  The study showed there was no difference in the chance of good physical recovery for patients between the two head positions but also that there were no excessive harms for either. In other words, head positioning alone didn’t produce any benefits or harms in patients with acute stroke
Author Interviews, Genetic Research, Nature, Scripps / 21.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35494" align="alignleft" width="146"]Michael Farzan PhD Co-chair and Professor Department of Immunology and Microbiology Florida Campus The Scripps Research Institute Jupiter, Florida Dr. Farzan[/caption] Michael Farzan PhD Co-chair and Professor Department of Immunology and Microbiology Florida Campus The Scripps Research Institute Jupiter, Florida MedicalResearch.com: What is the background for this study? What are the main findings? Response: CRISPR is system for immune protection of bacteria.  It has now been widely adopted for use in editing mammalian cells.  The most commonly used CRISPR effector protein is Cas9.  Cas9 binds a guide RNA to recognize a DNA target, for example an incoming virus infecting a bacterium, or a gene in a human chromosome.  In bacteria, Cas9 requires a second protein to clear the guide RNA from a longer "CRISPR array", basically a string of guide RNAs. We have been studying a CRISPR effector protein related to Cas9 called Cpf1.  In bacteria it was know that, unlike Cas9, Cpf1 could cleave a CRISPR array by itself, without assistance from a second protein.  We knew that if it could do the same thing in human cells, it would help to simplify a number of gene-editing applications.  We were able to show that Cas9 could indeed excise multiple guide RNAs from a single message RNA in human cells.  We further showed that this approach was more efficient than the previous ways that guide RNAs were generated for gene editing, even more so when multiple guide RNAs were needed.
Author Interviews, Brigham & Women's - Harvard, Education, PLoS, Sleep Disorders / 21.06.2017

MedicalResearch.com Interview with: Dr. Dorothee Fischer Department of Environmental Health Harvard T.H. Chan School of Public Health, Boston, Massachusetts Center for Injury Epidemiology, Liberty Mutual Research Institute for Safety Hopkinton, Massachusetts, MedicalResearch.com: What is the background for this study? What are the main findings? Response: Chronotypes are a result of how the circadian clock embeds itself into the 24h light-dark cycle, producing earlier and later individuals ("larks and owls") with regards to rhythms in physiology, cognition and behavior, including sleep. It can be beneficial for health and safety to sync forced wake times (work, school) with individual chronotypes, thereby reducing the misalignment between sleep, circadian rhythms and external demands. To better inform potential interventions such as tailored work schedules, more information is needed about the prevalence of different chronotypes and how chronotype differs by age and sex. To the best of our knowledge, this is the first large-scale and nationally representative study of chronotypes in the US.
Author Interviews, Lancet, Rheumatology, UT Southwestern / 20.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35455" align="alignleft" width="150"]Roy Fleischmann, MD MACR Medical Director Metroplex Clinical Research Center Clinical Professor of Medicine University of Texas Southwestern Medical Center Dallas, TX 75231 Dr. Fleischmann[/caption] Roy Fleischmann, MD MACR Medical Director Metroplex Clinical Research Center Clinical Professor of Medicine University of Texas Southwestern Medical Center Dallas, TX 75231 MedicalResearch.com: What is the background for this study? What are the main findings? Response: In the phase 3 studies of tofacitinib, it was noted that the clinical responses to tofacitinib monotherapy were higher than the responses to tofaciotinib plus MTX and that tofacitinib plus methotrexate had numerically higher clinical responses compared to adalimumab plus methotrexate. This study was a non-inferiority design which compared tofacitinib monotherapy to tofacitinib + MTX and to adalimumab +MTX and tofacitinib monotherapy to tofacitinib +MTX in MTX incomplete responders. It was found that tofacitinib + MTX is non-inferior to adalimumab + MTX (and vice versa) and neither was superior to the other. The results of tofacitinib to either combination was non-conclusive showing neither non-inferiority or inferiority, but suggesting that either combination will be effective in more patients in a group of patients.
Author Interviews, Biomarkers, Colon Cancer, JAMA / 19.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35515" align="alignleft" width="160"]Anastasia Katsoula, MD MSc Aristotle University of Thessaloniki Greece  Dr. Katsoula[/caption] Anastasia Katsoula, MD MSc Aristotle University of Thessaloniki Greece  MedicalResearch.com: What is the background for this study? Response: Early detection of colorectal cancer (CRC) has proven to be effective in reduction of cancer-related mortality. Fecal immunochemical testing (FIT) has been recently advocated for population-based screening for CRC in average-risk individuals due to its high accuracy and potential for adherence, based on results from previous systematic reviews and meta-analyses in average-risk populations. However, the potential role of FIT for screening of subjects at increased risk for CRC has not yet been elucidated, hence colonoscopy is currently the only recommended screening option for subjects at increased risk of CRC. We performed a systematic review and meta-analysis to explore the diagnostic accuracy of FIT for CRC or advanced neoplasia (AN) in patientswith personal or familial history of CRC, using colonoscopy as the reference standard.
Addiction, Author Interviews, JAMA, Opiods, Pediatrics / 19.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35432" align="alignleft" width="154"]Scott Hadland, MD, MPH, MS Youth Addiction Specialist Assistant Professor of Pediatrics Boston University School of Medicine Dr. Hadland[/caption] Scott Hadland, MD, MPH, MS Youth Addiction Specialist Assistant Professor of Pediatrics Boston University School of Medicine Director, Urban Health and Advocacy Track, Boston Children’s Hospital and Boston Medical Center Associate Program Director, Boston Combined Residency Program in Pediatrics, Boston Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Almost no data have been available on this topic to date.  A recent study showed that teens in subspecialty treatment for opioid addiction were significantly less likely than adults to receive a medication.  Our study was the first to comprehensively look across the health care system, including looking at adolescents and young adults diagnosed with opioid use disorder in outpatient clinics, emergency departments, and inpatient hospitals. We had three important findings.  First, looking at a large sample of 9.7 million adolescents and young adults between the age of 13 and 25 years, we found that the number of youth diagnosed with opioid use disorder increased six-fold from 2001 to 2014.  This is perhaps not surprising given the national opioid crisis we know to be occurring. Second, we found that only a minority of youth (1 in 4) received buprenorphine or naltrexone, the two medications available for opioid addiction that can be prescribed in usual medical settings.  These two medications are evidence-based and their use is recommended by the American Academy of Pediatrics.  Utilizing them is critical to ensure that we offer effective treatment early in the life course of addiction, which can help prevent the long-term harms of addiction. Third, we found significant differences in who received medications.  Whereas approximately 1 in 3 young adults in our study received a medication, only 1 in 10 of the 16- and 17-year-olds we studied received one, and among adolescents under 15 years of age, 1 in 67 received a medication.  Females were less likely than males to receive medications, as were black youth and Hispanic youth relative to white youth.
AHA Journals, Author Interviews, Race/Ethnic Diversity, Stroke / 18.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35369" align="alignleft" width="133"]George Howard, Dr.PH PI of the REasons for Geographic And Racial Differences in Stroke (REGARDS) Study Department of Biostatistics University of Alabama at Birmingham Birmingham, AL Dr. Howard[/caption] George Howard, Dr.PH PI of the REasons for Geographic And Racial Differences in Stroke (REGARDS) Study Department of Biostatistics University of Alabama at Birmingham Birmingham, AL MedicalResearch.com: What is the background for this study? What are the main findings? Response: Rural areas have been known to have a higher death rate than urban, and higher death from stroke in rural areas is a major contributor to this disparity. The goal of the research was to assess if the higher deaths from stroke was because rural people are more likely to have a stroke, or more likely to die from a stroke once it occurs.   This distinction is critically important, since intervention to reduce stroke deaths in rural area would focus on stroke prevention if the former, but would focus on improving stroke care (after the stroke) if the latter. We found that the higher mortality from stroke appears to be almost completely due to more people having stroke.   As such, we need to focus on efforts to reduce the risk of rural areas.   While there are well-documented differences in stroke care between urban and rural areas, resolving these differences will not be likely reduce the rural excess death from stroke. It would seem that the higher risk of having a stroke could be due to the observation that those in rural areas are more likely to have major stroke risk factors, including hypertension, diabetes and cigarette smoking; however, the higher prevalence of these risk factors don’t seem to explain the higher risk.   So what causes the higher risk remains a mystery.