Author Interviews, JAMA, Prostate, Prostate Cancer, Urology / 25.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49921" align="alignleft" width="160"]Kari Tikkinen, MD, PhD, Adjunct Professor Departments of Urology and Public Health University of Helsinki and Helsinki University Hospital Helsinki, Finland Dr. Tikkinen[/caption] Kari Tikkinen, MD, PhD, Adjunct Professor Departments of Urology and Public Health University of Helsinki and Helsinki University Hospital Helsinki, Finland MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Men’s choice of whether to undergo screening is value and preference sensitive: fully informed men will make different choices depending on their experience and perspective. For such decisions, shared decision-making represents an ideal approach to decision making. In shared decision-making both the patient and health care provider contribute to the medical decision-making process. The health care provider explains alternatives to patients, informs them of the best evidence regarding the anticipated consequences of a decision for or against the intervention, and helps them choose the option that best aligns with their preferences. All major guidelines of prostate cancer screening acknowledge the importance of informing men about risks and benefits of PSA screening. Shared decision-making is challenging because it requires time, knowledge, and specific skills. Prostate cancer screening decisions aids may, by summarizing the current best evidence and by supporting conversations that address what matters most to men, address these challenges. The impact of decision aids on the decision-making process is, however, uncertain. We therefore undertook a systematic review and meta-analysis of the randomized trials that have addressed the impact of decision aids in the context of prostate cancer screening. 
Amgen, Author Interviews, Cost of Health Care, JAMA, Lipids, UCLA / 24.06.2019

MedicalResearch.com Interview with: [caption id="attachment_25325" align="alignleft" width="160"]Gregg C. Fonarow, MD, FACC, FAHA Eliot Corday Professor of Cardiovascular Medicine and Science Director, Ahmanson-UCLA Cardiomyopathy Center Co-Chief of Clinical Cardiology, UCLA Division of Cardiology Co-Director, UCLA Preventative Cardiology Program David Geffen School of Medicine at UCLA Los Angeles, CA, 90095-1679 Dr. Gregg Fonarow[/caption] Gregg C. Fonarow, MD, FACC, FAHA Eliot Corday Professor of Cardiovascular Medicine and Science Director, Ahmanson-UCLA Cardiomyopathy Center Co-Chief of Clinical Cardiology, UCLA Division of Cardiology Co-Director, UCLA Preventative Cardiology Program David Geffen School of Medicine at UCLA Los Angeles, CA  MedicalResearch.com: What is the background for this study? Response: Last year, Amgen made the PCSK-9 inhibitor evolocumab available at a reduced list price of $5,850 per year This 60% reduction was aimed at improving patient access by lowering patient copays, especially for Medicare beneficiaries. Additionally, the treatment landscape for PCSK9 inhibitors was further defined in 2018 when the American College of Cardiology/American Heart Association Multisociety Clinical Guideline on the Management of Blood Cholesterol recommended PCSK9 inhibitors for, among other patient populations, patients with very high-risk (VHR) ASCVD whose low-density lipoprotein cholesterol levels remain at 70 mg/dL or more  despite a heart-healthy lifestyle and treatment with standard background therapy.
Author Interviews, CDC, JAMA, Nutrition, Pediatrics, Weight Research / 24.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49924" align="alignleft" width="150"]Liping Pan, MD, MPH Epidemiologist Division of Nutrition, Physical Activity, and Obesity National Center for Chronic Disease Prevention and Health Promotion Centers for Disease Control and Prevention Dr. Pan[/caption] Liping Pan, MD, MPH Epidemiologist Division of Nutrition, Physical Activity, and Obesity National Center for Chronic Disease Prevention and Health Promotion Centers for Disease Control and Prevention MedicalResearch.com: What is the background for this study? Response: Children with severe obesity face significant health and social challenges. Children with obesity are at higher risk for having other chronic health conditions and diseases, such as asthma, sleep apnea, bone and joint problems, and type 2 diabetes. They also have more risk factors for heart disease such as high blood pressure, impaired glucose tolerance, and high cholesterol than their healthyweight peers. Children with obesity can be bullied and teased more than their healthyweight peers. They are also more likely to suffer from social isolation, depression, and lower self-esteem. Children with obesity are also more likely to have obesity as adults. This can lead to lifelong physical and mental health problems. Adult obesity is associated with a higher risk of type 2 diabetes, heart disease, and many types of cancers.  Childhood obesity is more common among children from lower-income families, as many lack access to healthy, affordable foods and beverages and opportunities for low-cost physical activity.
Author Interviews, Geriatrics, JAMA, Ophthalmology, University of Michigan / 21.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49831" align="alignleft" width="144"]Joshua R. Ehrlich, MD, MPH Assistant Professor, Ophthalmology and Visual Sciences Kellogg Eye Center Department of Ophthalmology and Visual Sciences University of Michigan Dr. Ehrlich[/caption] Joshua R. Ehrlich, MD, MPH Assistant Professor, Ophthalmology and Visual Sciences Kellogg Eye Center Department of Ophthalmology and Visual Sciences University of Michigan  MedicalResearch.com: What is the background for this study?   Response: This study came out of data collected as part of the National Poll on Healthy Aging (NPHA). The NPHA is funded by AARP and the Institute for Healthcare Policy and Innovation at the University of Michigan to inform the public, healthcare providers, and policymakers on a variety issues related to health. The vision survey, conducted in March 2018, was just one of many NPHA surveys. Due to aging of the population, the number of older U.S. adults with blindness and vision impairment is expected to double over the next 30 years. Thus, this study was designed to provide crucial data  on contemporary data on patterns of eye care utilization in older adults.
Author Interviews, Cancer Research, Cost of Health Care, JAMA, Pain Research / 21.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49868" align="alignleft" width="200"]Changchuan (Charles) Jiang MD, MPH MSSLW Internal Medicine Residency Program, Class of 2020 Ichan School of Medicine at Mount Sinai Dr. Jiang[/caption] Changchuan (Charles) Jiang MD, MPH MSSLW Internal Medicine Residency Program Class of 2020 Ichan School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Response: Chronic pain is one of the common side effects of cancer treatments and it has been linked to low life quality, lower adherence to treatment, higher medical cost. As the population of cancer survivors grows rapidly, chronic pain will be a major public health issue in this population. We know from previous studies that chronic pain is common in certain cancers such as breast cancer. However, little was known about the epidemiology of chronic pain in the cancer survivors until our study.
Author Interviews, CT Scanning, JAMA, Surgical Research, Technology / 21.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49894" align="alignleft" width="200"]Christian Krautz, MD Department of Surgery, Universitätsklinikum Erlangen Friedrich-Alexander-Universität Erlangen Nürnberg Erlangen, Germany Dr. Krautz[/caption] Christian Krautz, MD Department of Surgery, Universitätsklinikum Erlangen Friedrich-Alexander-Universität Erlangen Nürnberg Erlangen, Germany  MedicalResearch.com: What is the background for this study? What are the main findings? Response: In this preclinical study that included 720 case evaluations, visualization with Cinematic Rendering allowed a more correct and faster comprehension of the surgical anatomy compared to conventional CT imaging independent from the level of surgical experience. Therefore,Cinematic Rendering is a tool that may assist HPB surgeons with preoperative preparation and intraoperative guidance through an improved interpretation of computed tomography imaging data.
Author Interviews, JAMA, Outcomes & Safety, Surgical Research / 19.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49834" align="alignleft" width="155"]William Cooper, M.D., M.P.H. Cornelius Vanderbilt Professor Pediatrics and Health Policy Associate Dean for Faculty Affairs Director, Center for Patient and Professional Advocacy Vanderbilt University Medical Center Dr. Cooper[/caption] William Cooper, M.D., M.P.H. Cornelius Vanderbilt Professor Pediatrics and Health Policy Associate Dean for Faculty Affairs Director, Center for Patient and Professional Advocacy Vanderbilt University Medical Center MedicalResearch.com: What is the background for this study?   Response: For surgical teams, high reliability and optimal performance are dependent on effective communication, mutual respect, and continuous situational awareness. Surgeons who model unprofessional behaviors may contribute to undermining a culture of safety, threaten teamwork, and thereby increase risk for medical errors and surgical complications.
Author Interviews, Dermatology, Infections, JAMA / 19.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49801" align="alignleft" width="200"]Example of cellulitis erysipelas from DermnetNZ.org Example of cellulitis erysipelas from DermnetNZ.org[/caption] Richard Brindle DM FRCP Honorary Reader, University of Bristol, UK  MedicalResearch.com: What is the background for this study? Response: This review is an update of the 2010 Cochrane Review of Interventions for cellulitis and erysipelas (DOI: 10.1002/14651858.CD004299) but focusing on antibiotics.  It provides a valuable resource for clinicians in summarizing current best evidence and highlighting gaps in the research. This review will inform the production of evidence-based guidelines covering antibiotic choice, route of administration, duration of treatment and the role of combinations of antibiotics.
Author Interviews, Geriatrics, Hip Fractures, JAMA, Orthopedics, Osteoporosis / 17.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49813" align="alignleft" width="132"]Kristine E. Ensrud MD MPH Professor of Medicine and Epidemiology and Community Health University of Minnesota Core Investigator, Center for Care Delivery and Outcomes Research Minneapolis VA Health Care System Dr. Ensrud[/caption] Kristine E. Ensrud MD MPH Professor of Medicine and Epidemiology and Community Health University of Minnesota Core Investigator, Center for Care Delivery and Outcomes Research Minneapolis VA Health Care System  MedicalResearch.com: What is the background for this study? Response: Women aged 80 years and older, a rapidly growing segment of the population, account for the majority of hip fractures in the United States. Hip fractures account for 72% of fracture-related health care expenditures and lead to significant morbidity and mortality. However, many late-life women at high risk of hip fracture are undiagnosed. Clinicians have difficulty identifying late-life women most likely to benefit from osteoporosis screening and interventions to prevent hip fracture in part due to concerns about comorbidity burden and prognosis in this patient population.
Author Interviews, Cost of Health Care, Heart Disease, JAMA, Medical Imaging / 17.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49804" align="alignleft" width="142"]Quinn R Pack, MD Assistant Professor of Medicine at University of Massachusetts Medical School - Baystate Adjunct Assistant Professor of Medicine Tufts University School of Medicine Dr. Pack[/caption] Quinn R Pack, MD Assistant Professor of Medicine University of Massachusetts Medical School - Baystate Adjunct Assistant Professor of Medicine Tufts University School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Because echocardiograms are non-invasive, very low risk, and nearly universally available, it is easy to over-use this technique.  In myocardial infarction, echo is also recommended in guidelines. However, in our lab, we frequently find echocardiograms that are ordered purely out of routine, without any thought as to the likelihood of finding an abnormality.   Prior studies also suggested that as many as 70% of echocardiograms provide no additional diagnostic value. When spread across the approximate 600,000 patients in the United States each year, this low diagnostic yield represents an opportunity to reduce costs by reducing echocardiograms. 
Author Interviews, Heart Disease, JAMA, Surgical Research / 16.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49721" align="alignleft" width="198"]Fausto Biancari, Professor of Surgery, University of Turku, Finland Professor of Cardiothoracic Surgery, University of Oulu, Finland Heart Center, T-Hospital, Hämeentie Turku, Finland Prof. Biancari[/caption] Fausto Biancari, MD, PhD Professor University of Turku and University Oulu, Finland MedicalResearch.com: What is the background for this study? Response: Current data is scarce regarding the short- and midterm benefit of transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR) in low-risk patients with severe aortic valve stenosis. MedicalResearch.com: What are the main findings? Response: In this observational study on 2841 low-risk patients with aortic valve stenosis from the Finnish nationwide FinnValve registry, propensity score matching analysis showed similar 30-day and three-year survival after TAVR and SAVR.
Author Interviews, Dermatology, JAMA, Smoking, Surgical Research / 14.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49759" align="alignleft" width="144"]Ian A. Maher, MD Department of Dermatology St Louis University, St Louis, Missouri Dr. Maher[/caption] Ian A. Maher, MD Department of Dermatology St Louis University, St Louis, Missouri  MedicalResearch.com: What is the background for this study? What are the main findings? Response: One of our wonderful trainees at Saint Louis University was interested in the role of smoking in flap failures.  Dogma has been that smoking was a major risk factor for flap failures.  Looking at our database as well as published data, flap failures are a rare event, so rare as to be difficult to definitively associate with anything.  We decided to look more broadly at complications both acute (infections failures) and chronic (mainly cosmetic scarring associated) in flaps and grafts.
Author Interviews, JAMA, Johns Hopkins, Kidney Disease, Surgical Research / 13.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49763" align="alignleft" width="80"]Caitlin W. Hicks, M.D., M.S. Assistant Professor of Surgery Recipient of the Department of Surgery Rothman Early Career Development Award for Surgical Research Johns Hopkins Medicine Dr. Hicks[/caption] Caitlin W. Hicks, M.D., M.S. Assistant Professor of Surgery Recipient of the Department of Surgery Rothman Early Career Development Award for Surgical Research Johns Hopkins Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Arteriovenous fistula are associated with better long-term patency, lower rates of infection, and lower long-term costs compared to arteriovenous graft. As a result, the Fistula First Catheter Last Guidelines recommend placement of an arteriovenous fistula over an AVG whenever possible. We looked at individual physician utilization of AVF vs AVG for first-time AV access in Medicare beneficiaries. We found that the median physician utilization rate for AVG was only 18%, but that 21% of physicians use AVG in more than 34% of cases, which is above currently recommended  practice guidelines. 
Author Interviews, JAMA, PTSD / 13.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49746" align="alignleft" width="178"]Dr. Heike Gerger | Senior Postdoc University of Basel | Faculty of Psychology | Clinical Psychology and Psychotherapy Basel | Switzerland Dr. Gerger[/caption] Dr. Heike Gerger | Senior Postdoc University of Basel | Faculty of Psychology | Clinical Psychology and Psychotherapy Basel | Switzerland MedicalResearch.com: What is the background for this study? Response: Posttraumatic stress disorder (PTSD) is one of the most prevalent mental disorders, with a high risk of chronicity, comorbidity, and functional impairment. PTSD is complicated to treat, and the debate on the most efficacious treatment approach is ongoing. Treatment guidelines for the treatment of PTSD typically recommend different types of trauma-focused psychotherapeutic treatments as first-line PTSD treatment. However, concerning pharmacological therapies recommendations are inconsistent.
Author Interviews, Environmental Risks, JAMA, Weight Research / 12.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49741" align="alignleft" width="100"]Lead author: Yong-Moon (“Mark”) Park, MD, PhD Postdoctoral fellow Epidemiology Branch National Institute of Environmental Health Sciences Dr. Park[/caption] Lead author: Yong-Moon (“Mark”) Park, MD, PhD Postdoctoral fellow Epidemiology Branch National Institute of Environmental Health Sciences [caption id="attachment_49742" align="alignleft" width="150"]Senior author: Dale P. Sandler, PhD Chief, Epidemiology Branch, National Institute of Environmental Health Sciences National Institutes of Health Dr. Sandler[/caption]   Senior author: Dale P. Sandler, PhD Chief, Epidemiology Branch, National Institute of Environmental Health Sciences National Institutes of Health MedicalResearch.com: What is the background for this study?   Response: A few studies had suggested that exposure to artificial light while sleeping was associated with obesity. However, the previous studies were cross-sectional, so we really do not know which came first - exposure to artificial light while sleeping or obesity. Another problem was that previous studies did not fully account for other characteristics that could affect this association, such as sleep duration and quality, calorie intake and dietary patterns, and physical activity. We studied nearly 44,000 women ages 35-74 from across the US who are enrolled in the Sister Study cohort. Women had body weight characteristics measured at baseline and provided self-reported information on weight at baseline and follow-up – on average 5.7 years later.
Author Interviews, Hepatitis - Liver Disease, JAMA, Kaiser Permanente, Pharmacology / 10.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49631" align="alignleft" width="200"]Elizabeth A. McGlynn, PhD Vice President for Kaiser Permanente Research Executive Director Kaiser Permanente Center for Effectiveness and Safety  Dr. McGlynn[/caption] Elizabeth A. McGlynn, PhD Vice President for Kaiser Permanente Research Executive Director Kaiser Permanente Center for Effectiveness and Safety  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: A report from the Institute for Safe Medication Practices based on FDA data and observations from a Kaiser Permanente physician leader raised questions about whether direct acting antiviral medications for the treatment of Hepatitis C posed any significant safety risks for patients. Since the decision to take medications requires making tradeoffs between benefits (which had been clearly established in clinical trials) and risks (which are often harder to ascertain until drugs are in widespread use in the real world) we decided this was an important question to pursue.  We found no evidence of increased risks of significant side effects associated with taking these drugs.  In this cohort study of 33,808 patients in three large health systems we found lower adjusted odds of experiencing the following adverse events:  death, multiple organ failure, hepatic decompensation, acute-on-chronic liver event, and arrhythmia. 
Author Interviews, Cost of Health Care, Heart Disease, JAMA, University of Pennsylvania / 07.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49581" align="alignleft" width="180"]Sameed Khatana, MD, MPH Fellow, Cardiovascular Medicine, Perleman School of Medicine Associate Fellow, Leonard Davis Institute of Health Economics University of Pennsylvania Dr. Khatana[/caption] Sameed Khatana, MD, MPH Fellow, Cardiovascular Medicine, Perleman School of Medicine Associate Fellow, Leonard Davis Institute of Health Economics University of Pennsylvania  MedicalResearch.com: What is the background for this study?   Response: The Affordable Care Act (ACA) led to the largest increase in Medicaid coverage since the beginning of the program. However, a number of states decided not to expand eligibility. Studies of prior smaller expansions in Medicaid, such as in individual states, have suggested evidence of improved outcomes associated with Medicaid expansion. Additionally, studies of Medicaid expansion under the ACA of certain health measures such as access to preventive care and medication adherence have suggested some improvements as well. However, there have been no large, population-level studies to examine whether Medicaid expansion under the ACA led to changes in mortality rates. Given, a high burden of cardiovascular risk factors in the uninsured, we examined whether states that had expanded Medicaid had a change in cardiovascular mortality rates after expansion, compared to states that have not expanded Medicaid.
Author Interviews, Cost of Health Care, JAMA, Mental Health Research / 06.06.2019

MedicalResearch.com Interview with: [caption id="attachment_48428" align="alignleft" width="200"]Hefei Wen, PhDAssistant Professor, Department of Health Management & PolicyUniversity of Kentucky College of Public Health Dr. Wen[/caption] Hefei Wen, PhD Assistant Professor, Department of Health Management & Policy University of Kentucky College of Public Health  MedicalResearch.com: What is the background for this study? Response: Medicaid is the principal payer of behavioral health services in the U.S. and expected to play an increasing role in financing behavioral health services following Medicaid expansions under the ACA.
Accidents & Violence, Author Interviews, Cost of Health Care, JAMA, Surgical Research, University of Michigan / 05.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49606" align="alignleft" width="156"]Dr. Mark R. Hemmila MD Associate Professor of Surgery Division of Acute Care Surgery University of Michigan Dr. Hemmila[/caption] Dr. Mark R. Hemmila MD Associate Professor of Surgery Division of Acute Care Surgery University of Michigan  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Traumatic injury has a tendency to be thought of as a disease that preferentially impacts younger people.  We wanted to explore the prevalence and impact of traumatic injury within the population of patients for whom Medicare is the third party payer. 
Accidents & Violence, Author Interviews, Exercise - Fitness, Geriatrics, JAMA / 05.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49471" align="alignleft" width="150"]Teresa Liu-Ambrose, PT, PhDCanada Research Chair (Tier II), Physical Activity, Mobility, and Cognitive NeuroscienceDirector, Aging, Mobility, and Cognitive Neuroscience LaboratoryUniversity of British Columbia Dr. Liu-Ambrose[/caption] Teresa Liu-Ambrose, PT, PhD Canada Research Chair (Tier II), Physical Activity, Mobility, and Cognitive Neuroscience Director, Aging, Mobility, and Cognitive Neuroscience Laboratory University of British Columbia MedicalResearch.com: What is the background for this study? Response:  Falls in older adults are the third-leading cause of chronic disability and the leading cause of hospitalization for adults over age 65. Older adults who experience multiple falls are at increased risk for disability, loss of independence, and even death. How to best prevent falls in this high risk group is not well established. 
Author Interviews, JAMA, Pediatrics, Sexual Health / 04.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49588" align="alignleft" width="135"]Monika K. Goyal, M.D., MSCE Assistant chief of Children’s Division Emergency Medicine and Trauma Services Dr. Goyal[/caption] Monika K. Goyal, M.D., MSCE Assistant chief of Children’s Division Emergency Medicine and Trauma Services  MedicalResearch.com: What is the background for this study? Response: Adolescents are disproportionately affected by sexually transmitted infections (STIs) and often present to the emergency department for care. I have devoted almost 15 years of my career trying to improve the sexual health of teens through advocacy and the development of novel interventions in the emergency department to increase access to sexual health services for youths.
Author Interviews, Emergency Care, JAMA, Medical Imaging, Pediatrics / 04.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49477" align="alignleft" width="200"]Eyal Cohen, MD, M.Sc, FRCP(C)Professor, PediatricsUniversity of TorontoCo-Founder, Complex Care ProgramThe Hospital for Sick Children Dr. Cohen[/caption] Eyal Cohen, MD, M.Sc, FRCP(C) Professor, Pediatrics University of Toronto Co-Founder, Complex Care Program The Hospital for Sick Children   MedicalResearch.com: What is the background for this study? Response: Minimizing care that provides little benefit to patients has become an important focus to decrease health care costs and improve the quality of care delivery.  Diagnostic imaging in children is a common focus for campaigns designed to reduce overuse both in Canada and the US. There are some suggestions that there may be more overuse of care in the United States than Canada, but there has been little study in children. We compared the use of low-value diagnostic imaging rates from four pediatric emergency departments in Ontario to 26 in the United States from 2006 to 2016.  We defined low-value imaging as situations where children are discharged from an emergency department with a diagnosis for which routine use of diagnostic imaging may not be necessary, like asthma or constipation. 
Author Interviews, Heart Disease, JAMA, Surgical Research / 04.06.2019

MedicalResearch.com Interview with: Rajat Kalra, MBCh Cardiovascular Division University of Minnesota, Minneapolis MedicalResearch.com: What is the background for this study? Response: New-onset atrial fibrillation after aortic valve procedures is thought to occur frequently after aortic valve procedures, such as transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (AVR). However, the incidence estimates and implications of this new-onset atrial fibrillation in the contemporary era are unclear. We sought to examine the incidence of atrial fibrillation after aortic valve procedures, compare the incidence between TAVI and AVR, and evaluate the associated morbidity and mortality implications using a ‘big data’ approach. This big data approach employed the National Inpatient Sample and was validated in the New York State Inpatient Database. Both are publicly available datasets that are developed as part of the Healthcare Cost and Utilization Project, a federal-state-industry partnership that is sponsored by the Agency for Healthcare Research and Quality. 
Author Interviews, Brigham & Women's - Harvard, Exercise - Fitness, JAMA / 02.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49426" align="alignleft" width="133"]I-Min Lee, MD, ScDProfessor of Medicine, Harvard Medical SchoolProfessor of EpidemiologyHarvard T.H. Chan School of Public Health Prof. I-Min Lee[/caption] I-Min Lee, MD, ScD Professor of Medicine, Harvard Medical School Professor of Epidemiology Harvard T.H. Chan School of Public Health  MedicalResearch.com: What is the background for this study? Response: While we have many studies showing that physical activity is beneficial for health, there are few data on steps and health, particularly long-term health outcomes.  An expert committee – the 2018 Physical Activity Guidelines Advisory Committee, which reviewed the scientific evidence to support the recently released Physical Activity Guidelines for Americans, 2nd edition – noted this (i.e., the relation between steps and health outcomes) to be a critical gap in knowledge, since many individuals are using wearables and monitoring their step counts. We often hear the number 10,000 steps cited as a daily goal, but the basis for this number is unclear. It likely originated as a marketing tool: in 1965, the Yamasa Clock and Instrument Company, Japan sold a pedometer called “Manpo-kei” – “ten thousand steps meter” in Japanese. For many older people, 10,000 steps/day can be a very daunting goal; thus, we wanted to investigate whether this was necessary for lower mortality rates in older women.  Additionally, steps taken can be fast or slow, and there are no published studies on step intensity and long-term health outcomes.  Note that walking pace and step intensity are not the same concept: walking pace gauges intensity when walking purposefully (e.g., for exercise or transportation), while step intensity assesses an overall best natural effort in our daily life.
Author Interviews, Dermatology, JAMA / 01.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49481" align="alignleft" width="150"]Dr-Jung Min Bae Dr. Jung Min Bae[/caption] Jung Min Bae, MD, PhD Associate Professor, Department of Dermatology St. Vincent's Hospital College of Medicine, The Catholic University of Korea  MedicalResearch.com: What is the background for this study? Response: Vitiligo is a common chronic skin disease affecting 1% of the population, and it causes low self-esteem and social stigma. To date, there are no approved drugs for the treatment of vitiligo, even though growing evidence indicates favorable therapeutic responses of topical calcineurin inhibitors (TCIs) including tacrolimus and pimecrolimus. In this study, we conducted a systematic review and meta-analysis of all relevant prospective studies (n = 46) and identified remarkable therapeutic responses of TCI monotherapy and TCI plus phototherapy for vitiligo.
Author Interviews, Clots - Coagulation, Duke, Genetic Research, Heart Disease, JAMA / 30.05.2019

MedicalResearch.com Interview with: [caption id="attachment_49440" align="alignleft" width="133"]Thomas J. Povsic, MD, PhDInterventional CardiologistDuke Clinical Research InstituteDuke University School of MedicineDurham, North Carolina  Dr. Povsic[/caption] Thomas J. Povsic, MD, PhD Interventional Cardiologist Duke Clinical Research Institute Duke University School of Medicine Durham, North Carolina  MedicalResearch.com: What is the background for this study?  Response: The background for this study is that it is unknown how mandatory reporting of CYP2C19 metabolizer status affects how doctors treat patients or to what degree provision of this information would affect choice of a P2Y12 inhibitor within a clinical trial. As part of the GEMINI-ACS trial, all patients underwent CYP2C19 metabolizer testing.  This trial enrolled patients with a recent acute coronary syndrome and randomized them to aspirin or a low dose of rivaroxaban.  All patients were also to be treated with ticagrelor or clopidogrel, which was at the discretion of the investigator.  Investigators were given information regarding the CYP2C19 metabolizer status about a week after randomization.  Importantly prior to randomization, all investigators were asked how they expected to use this information, and then we followed what they actually did.
Author Interviews, Brigham & Women's - Harvard, Cancer Research, FDA, JAMA, Pharmacology / 29.05.2019

MedicalResearch.com Interview with: [caption id="attachment_49366" align="alignleft" width="200"]Bishal Gyawali  MD PhD Med Onc. Asst. Professor  Dr. Gyawali[/caption] Bishal Gyawali  MD PhD
  • Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
  • Department of Oncology, Department of Public Health Sciences, and Division of Cancer Care and Epidemiology, Queen’s University, Kingston, Ontario, Canada
MedicalResearch.com: What is the background for this study? What are the main findings? Response: Accelerated approval pathway from the FDA allows cancer drugs to come to market sooner by showing improvement in surrogate measures such as change in tumor size. Surrogate measures do not reflect clinical benefit in terms of living longer or feeling better. So, when a drug receives accelerated approval, the drug is required to undergo a confirmatory trial to confirm that true clinical benefit from the drug actually exists. Last year, a paper from the FDA argued that accelerated approval pathway is working effectively because 55% of such drugs confirmed clinical benefit. However, we saw that most of those drugs were actually improving only a surrogate measure even in confirmatory trials. So the confirmatory trials were not confirming clinical benefit but actually confirming benefit in a surrogate endpoint. We investigate that issue in our study using updated results from the confirmatory trials that were ongoing at the time of FDA review. Our main finding is that only one-fifth of cancer drugs that received accelerated approval actually improved overall survival later in confirmatory trials. For, 20% of other drugs, the confirmatory trials tested the same surrogate endpoint as did the preapproval trial. For another 21%, the confirmatory trial showed benefit in a surrogate endpoint different from the one used in preapproval trial. Furthermore, when drugs fail to confirm clinical benefits in confirmatory trials, they still continue to remain on market. 
Author Interviews, Exercise - Fitness, JAMA, Mental Health Research, Pediatrics, UCLA / 29.05.2019

MedicalResearch.com Interview with: Molly C. Easterlin, MD Fellow, UCLA National Clinician Scholars Program Clinical Instructor, Pediatrics, Cedars-Sinai Medical Center  MedicalResearch.com: What is the background for this study? Response: Adverse childhood experiences or ACEs (including physical or emotional neglect or abuse, sexual abuse, domestic abuse, exposure to household substance misuse or mental illness, parental separation or divorce, and parental incarceration) are common with about half of children experiencing 1 and one-quarter of children experiencing 2 or more. Children exposed to adverse childhood experiences have worse mental health throughout life, including higher rates of depression and anxiety. However, little is known about what factors improve long-term mental health in those exposed to ACEs. Additionally, as far as we are aware, no studies have looked at team sports participation as a potential factor that may be associated with improved mental health among those with adverse childhood experiences.