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, Diabetes, Vitamin D / 09.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49667" align="alignleft" width="142"]Anastassios G. Pittas, M.D MS Professor Co-Director, Diabetes and Lipid Center; Tufts University School of Medicine Dr. Pittas[/caption] Anastassios G. Pittas, M.D MS Professor Co-Director, Diabetes and Lipid Center; Tufts Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Observational studies have consistently reported an association between low blood vitamin D level and development of type 2 diabetes. However, whether vitamin D supplementation lowers risk of developing diabetes is not known. We designed and conducted the Vitamin D and diabetes (D2d) study to answer this question.  We randomized 2,423 people with prediabetes to 4,000 IU/day of vitamin D3 or placebo and followed them for new-onset diabetes with blood tests every 6 months for an average of 2.5 years. About 80% of participants had sufficient vitamin D level at baseline (25-hydroxyvitamin D level >= 20 ng/mL). The trial was designed to show a reduction of 25% or more in diabetes risk with vitamin D. The study was unable to show a reduction of 25% or more. At the end of the study, there was a 12% reduction in risk of developing diabetes with vitamin D, which missed statistical significance (hazard ration 0.88; 95% confidence interval 0.75 to 1.04). In a small subgroup of participants with vitamin D deficiency at baseline (25-hydroxyvitamin D level < 12 ng/mL) there was 62% reduction in risk of diabetes with vitamin D (hazard ration 0.38; 95% confidence interval 0.18 to 0.80).
Author Interviews, Diabetes, Diabetologia, Stroke / 09.06.2019

MedicalResearch.com Interview with: Rongrong Yang, PhD candidate Tianjin Medical University  MedicalResearch.com: What is the background for this study? Response: Worldwide, cerebrovascular disease (CBD) and type 2 diabetes mellitus (T2DM) are common disorders that have become among the top ten leading causes of death, killing approximately 8 million people in 2016. Both T2DM and CBD are complex genetic and lifestyle-related disorders. Genetic and familial environmental factors (e.g. foetal environment, maternal smoking and childhood socioeconomic status) have been shown to be involved in the development of both conditions. Accumulating evidence from previous studies suggests that T2DM is independently associated with an increased risk of CBD, especially ischemic CBD.
Allergies, Author Interviews, Cancer Research, Immunotherapy / 07.06.2019

MedicalResearch.com Interview with: Prof. Olivier Lambotte, MD, PHD Professor of Internal Medicine Paris XI University Medical School Research Director Control of Chronic Viral Infections DepartmentProf. Olivier Lambotte, MD, PHD Professor of Internal Medicine Paris XI University Medical School Research Director Control of Chronic Viral Infections Department MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Immune checkpoint inhibitors (ICIs) anti-programmed death-1 (PD-1) or anti-programmed death ligand-1 (PD-L1) have proven efficacy in the treatment of many cancers but patients may experience immune-related adverse events (irAEs). Immune checkpoint inhibitors is usually stopped when grade 2 or higher irAE occur. Data are very limited  on the safety of resuming treatment after such an event. We  studied all adult patients referred to the ImmunoTOX toxicity review board at the Gustave Roussy cancer center (Villejuif, France) in 2015-2017 with  irAE grade 2 or higher for whom the  rechallenge was questioned. Among 93 patients with a broad spectrum of cancers, 40 patients (43%) were rechallenged with the same anti-PD-1 or anti-PD-L1. The rechallenged and non-rechallenged groups did not differ in terms of age, time to initial irAE, irAE severity, or steroid use. With a median follow-up period of 14 months, the same irAE or a different irAE occurred in 22 patients (55%). The second irAEs were not more severe than the first. Earlier initial toxicity was associated with more frequent irAE recurrence.
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, Kidney Disease / 06.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49649" align="alignleft" width="150"]Rita R. Alloway, PharmD, FCCP Research Professor of Medicine Director, Transplant Clinical Research University of Cincinnati College of Medicine, Department of Internal Medicine Division of Nephrology  Kidney C.A.R.E. Program  (Clinical Advancement, Research & Education) Cincinnati OH 45267 Dr. Alloway[/caption] Rita R. Alloway, PharmD, FCCP Research Professor of Medicine Director, Transplant Clinical Research University of Cincinnati College of Medicine, Department of Internal Medicine Division of Nephrology Kidney C.A.R.E. Program (Clinical Advancement, Research & Education) Cincinnati OH 45267  MedicalResearch.com: What is the background for this study? Response: Transplant recipients are required to take lifelong immunosuppression to sustain the function of their transplant.  Unfortunately these immunosuppressants have significant side effects.  The most significant of these side effects are worsening kidney function, hypertension, hypercholesterolemia, post transplant diabetes, tremors and headaches.  Researchers focused on improving post transplant outcomes are looking for immunosuppressant regimens with similar efficacy while minimizing harmful side effects. Tacrolimus and steroids are the immunosuppressants associated with the worst side effect profiles.  This study eliminated both of these immunosuppressants and replace tacrolimus with belatacept.  Belatacept is a once monthly intravenous infusion with a more favorable side effect profile compared to tacrolimus.  In addition, since it is a monthly infusion, adherence can improved compared to an oral medication taken twice daily.
ASCO, Author Interviews, Cancer Research, Cost of Health Care, Race/Ethnic Diversity / 06.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49644" align="alignleft" width="161"]Blythe J.S. Adamson, PhD, MPH Senior Quantitative Scientist Flatiron Health Dr. Adamson[/caption] Blythe J.S. Adamson, PhD, MPH Senior Quantitative Scientist Flatiron Health MedicalResearch.com: What is the background for this study? Response: Racial disparities in access and outcomes have been documented across the full trajectory of cancer-related care. This includes access to prevention and screening, to early diagnosis, treatment, survival and other health outcomes. While these disparities have been well documented, finding mechanisms to reduce disparities is more challenging. One potential mechanism to reduce treatment disparities is to improve access to insurance coverage. The Affordable Care Act (ACA), passed in March 2010, included as its overall goals the improvement in healthcare quality and access, and enhancing equity in treatment and outcomes. The ACA allowed states to expand Medicaid to poor and near-poor adults, and this was implemented by many states starting in 2014. In addition, the ACA established private insurance marketplaces with income-based premium subsidies and limits on out-of-pocket spending for qualifying low-income enrollees. Prior research has demonstrated that ACA Medicaid expansions are associated with increased coverage and improved overall access for cancer survivors; and for newly diagnosed patients, the ACA was associated with increased coverage and shifts to earlier stage diagnosis for some cancers. To our knowledge, no research has yet demonstrated that the ACA coverage expansions affected the process of cancer care, specific cancer treatments received or specific treatment outcomes, let alone whether disparities were reduced.  In this study we looked at the time from advanced/metastatic diagnosis to start of systemic treatment for black vs. white patients and based on whether they were diagnosed at a time and in a state that had vs. had not implemented Medicaid expansion. Our study hypothesis was that Medicaid expansion reduced disparity in timely treatment of black patients compared to white patients with advanced cancer. We defined timely treatment as start of systemic therapy within 30 days of advanced/metastatic diagnosis. This is a retrospective observational study, not a randomized controlled trial. In other words, we selected a cohort of patients diagnosed with advanced or metastatic cancers over time and observed whether they received timely treatment. The Flatiron Health EHR-derived database was the principal data source for this research. Flatiron contributing practices include 280 cancer community based clinics and academic hospital outpatient settings (~800 sites of care) representing more than 2.2 million patients with cancer in the United States. Practices are located in 40 states. To produce the database, Flatiron extracted data from structured fields, including demographics, and recorded medication orders and administrations. Flatiron also abstracted unstructured data, using technology assisted review by highly trained clinicians. Abstracted data include diagnosis date, stage, and prescribed oral anticancer medications. The database used for research purposes was de-identified. We also used data from the Kaiser Family Foundation which has tracked Medicaid implementation policies for over twenty years, and the US Bureau of Labor Statistics from which we pulled state-year unemployment rates.
Author Interviews, Dermatology, FDA / 06.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49640" align="alignleft" width="148"]Stephanie L. Kuschel, B.A Indiana University School of Medicine Indianapolis, IN, 46202 Dr. Kuschel[/caption] Stephanie L. Kuschel, MD Indiana University School of Medicine Indianapolis, IN, 46202 Robert Dellavalle, MD, PhD, MSPH Professor of Dermatology and Public Health University of Colorado School of Medicine Colorado School of Public Health Chief, Dermatology Service US Department of Veterans Affairs Eastern Colorado Health Care System Denver, CO 80220  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Physicians can serve as external experts and voting members of FDA advisory committee panels, which help determine if a drug is acceptable for the US market. Considering that financial conflicts of interest (FCOI) have been shown to influence voting member habits, the FDA has regulations in place to minimize these FCOI. However, the FDA can grant waivers for some financially conflicted individuals if they meet certain requirements (like offering key insights that may out-weigh the risk of a possible FCOI). Additionally the FDA does not make stipulations regarding post-advisory role financial relationships. In fact, many former FDA committee advisors later engage in financial relationships with pharmaceutical companies. Some worry these post-hoc financial relationships could pose an ethical dilemma whereby future FDA advisory members are incentivized to alter their voting habits in expectation of future rewards. Others argue the situation may be more complex than expected. For example, the author of one study, found that while there was evidence for a pro-industry voting bias among committee members with exclusive financial relationships to the sponsoring manufacturer (of the drug under review), this was not the case for members with nonexclusive financial ties to both the sponsor and its competitors 1. Furthermore, the author found that advisors with many corporate ties were (on average) actually more likely than their peers without any financial ties to vote against the sponsor. The author argued that these advisors were more likely to be experienced researchers, and their voting habits may reflect their experience evaluating medical research. While this author and others have offered valuable insights into financial relationships of advisors during their advisory role, unfortunately little information is available regarding post-advisory role financial relationships and whether these relationship have any influence on the integrity of the voting process. The purpose of our study was to review Open Payment data on industry payments to former physician FDA dermatologic drug committee members. 
Accidents & Violence, Author Interviews, ENT, Pediatrics / 06.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49636" align="alignleft" width="200"]Dr. Garth Essig, MD Otolaryngologist The Ohio State University Wexner Medical Center.  Dr. Essig[/caption] Dr. Garth Essig, MD Otolaryngologist The Ohio State University Wexner Medical Center.  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Dog bites are a significant yet modifiable public health concern, but the true magnitude is difficult to estimate with such wide ranges in reporting, severity of injury and varieties of breeds that bite.  We reviewed bites from reports in the literature and from two regionally distinct medical centers. We concluded that bite frequency and severity could be attributed to certain breeds in this sample, if the breed is known. Our study also acknowledged the significant risk of biting with the mixed breed population, which creates a dilemma with identification.
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.
Author Interviews, Opiods, Pain Research, Sleep Disorders / 05.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49610" align="alignleft" width="133"]Dr-Nicole Tang Dr. Tang[/caption] Nicole Tang, D.Phil, C.Psychol (Reader) Department of Psychology Warwick Sleep and Pain Lab University of Warwick MedicalResearch.com: What is the background for this study? What are the main findings? Response: Current guidelines recommend non-opioid therapy as the preferred treatment of chronic non-malignant (CNP) pain, with opioids reserved to situations “when benefits for pain and function are expected to outweigh risks” [1,10]. Whilst the effectiveness of opioid therapy is usually measured in terms of pain outcomes, less is known about its effect on day-to-day functions. A particular function of concern to patients with chronic non-malignant pain is the ability to get a good night's sleep. The current systematic review has identified a set of papers with relevant outcomes regarding the effect of opioid therapy on sleep quality and sleep architecture in CNP patients. It extends our understanding from the drug's respiratory depression effect in healthy individuals to the potential risks and utility of opioid therapy for chronic non-malignant pain patients with sleep disturbances. Whilst the narrative synthesis and the exploratory meta-analysis of a subset of data both suggest that the use of opioid therapy is associated with an overall report of sleep quality improvement, such an improvement is not consistently replicated across studies or substantiated by improvements in sleep parameters linked to deeper and better-sleep quality. Moreover, the improvement may be accompanied by undesirable side effects and increased daytime sleepiness that contradict with the very idea of improved sleep quality. We are also painfully aware of the methodological limitations of the studies reviewed; their exposure to different sources of biases has heightened the risk of result inflation. To many patients with chronic non-malignant pain, improved sleep is a top priority when evaluating the performance of a new drug and non-drug intervention. If we were to advance our current understanding of the opioid-sleep relationship, future trials need to be designed with this interdisciplinary question in mind such that validated measures of sleep can be incorporated as an outcome measure alongside pain.
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. 
Author Interviews, Bayer, Biomarkers, Colon Cancer / 05.06.2019

MedicalResearch.com Interview with: Joseph Germino, M.D., PhD Vice President US Medical Affairs Oncology Bayer Healthcare Pharmaceuticals Whippany, N.J. 07981 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumor angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF), metastasis (VEGFR3, PDGFR, FGFR) and tumor immunity (CSF1R). This prospective pharmacokinetic (PK) ancillary study is part of a prospective phase II study evaluating treatment response with regorafenib in patients with chemorefractory metastatic colorectal cancer (mCRC) called TEXAN, which aimed to investigate correlations between overall survival (OS) and regorafenib, or its enterohepatic cycle-dependent active metabolites M-2 and M-5 concentrations. As measured by LC-MS/MS, the main findings showed that regorafenib, M-2 and M-5 were respectively 1.99 (1.03-2.73), 1.44 (0.89-2.49) and 1.61 (0.79-2.37) mg/L during the first cycle at day 15 (C1D15) and 1.90 (1.10-2.76), 1.29 (0.77-2.24) and 1.17 (0.45-2.42) mg/L at during the second cycle at day 15 (C2D15). 
ASCO, Author Interviews, Bayer, Leukemia, Pediatrics / 05.06.2019

MedicalResearch.com Interview with: Joseph Germino, M.D., PhD Vice President US Medical Affairs Oncology Bayer Healthcare Pharmaceuticals Whippany, N.J. 07981 MedicalResearch.com: What is the background for this study? Response: Sorafenib (Nexavar®) is an oral anticancer therapy approved in more than 100 countries worldwide. It is approved for the treatment of patients with advanced hepatocellular carcinoma (HCC); advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy; progressive, locally advanced or metastatic differentiated thyroid carcinoma (papillary/follicular/Hürthle cell), that is refractory to radioactive iodine (RAI). The AAML 1031 is a recently completed Phase III clinical trial evaluating the use of bortezomib and sorafenib in patients 30 years or younger with newly diagnosed acute myeloid leukemia (AML). At the 2019 ASCO Annual meeting, results of a report from the AAML1031 trial, which assessed whether intensification of Induction II chemotherapy (ADE or AraC/ Mitoxantrone) and liberalized stem cell transplant (SCT) donor source criteria improved clinical outcomes in patients with residual AML. 
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. 
AstraZeneca, Kidney Disease / 04.06.2019

MedicalResearch.com Interview with: AstraZenecaJill Davis, MS Director, Health Economics and Outcomes Research AstraZeneca  MedicalResearch.com: What is the background for this study? Who is most at risk for hyperkalemia post discharge? Response: In the United States, an estimated 30 million people suffer from chronic kidney disease (CKD), about 3.7 million of which have hyperkalemia (elevated potassium level). Hyperkalemia (HK) can be chronic, so it’s important that those who have been diagnosed with hyperkalemia previously or have CKD have their potassium levels monitored by their healthcare provider. Additionally, although HK is estimated to be prevalent in more than 66,000 emergency department (ED) visits annually, there is limited knowledge about the management of patients with HK in the ED setting and post-discharge. We decided to focus our study to better understand and compare the ED management and post-discharge outcomes among patients with varying levels of hyperkalemia To conduct this study, we analyzed the electronic medical record data from the Research Action for Health Network (2012-2018) of 6,222 adult patients with a randomly selected HK-related ED visit. We concluded that improved management of HK patients in the ED and post-discharge period is needed to reduce the recurrence of hyperkalemia.
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.
ASCO, Author Interviews, Education, Gender Differences, Surgical Research / 04.06.2019

MedicalResearch.com – Responses [caption id="attachment_49547" align="alignleft" width="200"]Marina Stasenko, MD Memorial Sloan Kettering Cancer Center Dr. Stasenko
Photo: MSKCC[/caption] Marina Stasenko, MD Memorial Sloan Kettering Cancer Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Sexual harassment is a form of discrimination that includes gender harassment, unwanted sexual attention, and sexual coercion. A recent report in Fortune magazine noted that over half of US women have experienced sexual harassment at some point in their lives. Until recently, much of the conversation about sexual harassment in the workplace has been relegated to private discussions behind closed doors. However, the MeToo movement has shined a spotlight on the pervasive nature of sexual harassment in various fields, like media and business world. Although there are more female physicians in practice today than ever before, with women accounting for over 50% of young physicians, sexual harassment and gender disparities continue to plague the field of medicine. Despite the large female representation, gynecologic oncology is not immune from gender disparities. The Society of Gynecologic Oncology is a professional organization of over 2000 physicians, scientists, allied health professionals, nurses, and patient advocates dedicated to the care of patients with gynecologic cancer. As of 2015, 46% of members of the SGO were women, and that number is steadily growing. SGO leadership is also increasingly female – with 2 of the last 3 presidents being women. Despite the large female representation, gynecologic oncology is not immune from gender disparities. The 2015 SGO practice survey noted that while 22% of male Gynecologic Oncologists held the rank of professor, only 11% of their female counterparts held the title. They also noted that the mean annual salary for male physicians was nearly 150,000$ greater than salary for female physicians. Given the fact that there is little objective data on sexual harassment in gynecologic oncology, the objective of our study was to evaluate perceptions of sexual harassment and gender disparities among physician members of the Society of Gynecologic Oncology.
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, Environmental Risks, Nutrition, Race/Ethnic Diversity / 04.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49576" align="alignleft" width="200"]Joe F. Bozeman III, MS, CEM, Ph.D. Candidate Chair, Gordon Research Seminar (Industrial Ecology) University of Illinois at Chicago (UIC) Institute for Environmental Science and Policy Joe F. Bozeman III[/caption] Joe F. Bozeman III, MS, CEM, Ph.D. Candidate Chair, Gordon Research Seminar (Industrial Ecology) University of Illinois at Chicago (UIC) Institute for Environmental Science and Policy MedicalResearch.com: What is the background for this study?   Response: This study is actually a part of my dissertation which explores how climate change, human health, and other socioecological factors can be used to manage food-energy-water impacts. After establishing environmental impact and climate change adaptation implications of food consumption across major U.S. demographic groups in a previous study, my colleagues and I decided it would be interesting to investigate how food spending and household income correlate with food-consumption environmental impacts. Our efforts led to the development of a novel quantitative metric (i.e., food-consumption impact per dollar spent [FCI$]) which encompasses land, water, and greenhouse gas emission impacts of basic foods; the amount spent on food; and socioeconomic status. All major food groups are included in this study.
ASCO, Author Interviews, Bayer, Cancer Research, Pediatrics / 03.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49569" align="alignleft" width="173"]Douglas S. Hawkins, M.D. Hematology/Oncology Division Chief and Professor Pediatrics at Seattle Children's Hospital University of Washington School of Medicine Dr. Hawkins[/caption] Douglas S. Hawkins, M.D. Hematology/Oncology Division Chief and Professor Pediatrics at Seattle Children's Hospital University of Washington School of Medicine MedicalResearch.com: What is the background for this study? Response: TRK fusion cancer is caused by a rare genomic alteration called a neurotrophic receptor tyrosine kinase (NTRK) gene fusion. Larotrectinib is a central nervous system (CNS) active, oral and highly selective TRK inhibitor used for the treatment of adult and pediatric patients with solid tumors that have a rare genomic alteration called an NTRK gene fusion. Larotrectinib was approved at the end of 2018 in the U.S. under the brand name VITRAKVI®, with European and worldwide regulatory submissions underway. At ASCO 2019, we will be presenting results from a new analysis specifically looking at the efficacy and safety of larotrectinib in pediatric patients (n=34) included in the expanded dataset from both adults and children across 24 tumor types, which was presented first at the European Society for Medical Oncology (ESMO) 2019 Annual Meeting. 
Author Interviews, Cancer Research, Prostate Cancer / 03.06.2019

[caption id="attachment_49560" align="alignleft" width="181"] Dr. Julie Graff[/caption] MedicalResearch.com Interview with: Julie N. Graff, MD Associate Professor of Medicine Knight Cancer Institute Chief of Hematology/Oncology VA Portland Health Care System MedicalResearch.com: What is the background for this study? Response: Androgen deprivation therapy is often deployed in patients with a rising PSA after local therapy (such as radical prostatectomy or radiation therapy). With time, the prostate cancer can develop resistance to ADT, at which point it is called castration resistant prostate cancer (CRPC). There were 6 treatments for metastatic CRPC that have shown improved survival. However, in non-metastatic disease, there was nothing that showed improved survival. The SPARTAN study was designed to determine if a next generation androgen receptor antagonist could delay the time to metastatic disease. Overall survival was a secondary endpoint. 
ASCO, Author Interviews, Cancer Research, J&J-Janssen, Leukemia / 03.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49526" align="alignleft" width="144"]Paul M. Barr, M.D. Associate Professor of Medicine and Director of the Clinical Trials Office Director of the Clinical Trials Office Wilmot Cancer Institute Dr. Barr[/caption] Paul M. Barr, M.D. Associate Professor of Medicine and Director of the Clinical Trials Office Director of the Clinical Trials Office Wilmot Cancer Institute  MedicalResearch.com: What is the background for this study?   Response: When the study was designed, chronic lymphocytic leukemia (CLL)  treatment options were largely limited to chemotherapy and monoclonal antibodies. Ibrutinib had shown promise in early studies. The intent was to compare ibrutinib to a standard of care treatment option at that time, of atumumab, in patients with relapsed or refractory disease. The goal of the current analysis is to evaluate the durability of ibrutinib and report the long-term safety results.
Accidents & Violence, Author Interviews, Pediatrics, Pediatrics, Toxin Research / 03.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49551" align="alignleft" width="144"]Dr-Gary A. Smith Dr. Gary Smith[/caption] Dr. Gary Smith, MD MPH Director, Center for Injury Research and Policy Nationwide Children’s Hospital Columbus, OH MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our 2016 study (https://pediatrics.aappublications.org/content/137/5/e20154529) investigated calls to US poison control centers related to laundry and dishwasher detergent exposures among children younger than 6 years old from 2013 through 2014 and found that poison control centers received more than 30 calls a day about children who had been exposed to a laundry detergent packet, which is about one call every 45 minutes. The current study investigated trends in calls to poison control centers across the country for exposure to liquid laundry detergent packets in order to evaluate the impact of the voluntary safety standard for this product with a focus on young children. The study found only a modest decrease (18%) in calls for children younger than 6 years of age following adoption of a 2015 product safety standard as well as an increase in calls for older children and adults. Exposures to the eyes also continued to climb. The observed decrease in exposures among young children is considerably less than the 40% to 55% decrease in toxic ingestions seen after passage of the Poison Prevention Packaging Act. This demonstrates that the current liquid laundry detergent safety standard is inadequate and needs to be strengthened.
Author Interviews, Emergency Care, Mental Health Research, Psychological Science / 03.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49541" align="alignleft" width="143"]Stephen L. Ristvedt, Ph.D. Associate Professor of Anesthesiology Washington University St. Louis, MO  63110-1093 Dr. Ristvedt[/caption] Stephen L. Ristvedt, Ph.D. Associate Professor of Anesthesiology Washington University St. Louis, MO  63110-1093  MedicalResearch.com: What is the background for this study? Response: Having a usual source of healthcare – either with a regular doctor or a medical clinic – is the best way to manage one’s health in a proactive way.  Doctors and clinics can provide ongoing guidance with regard to the use of preventive medical screenings as well as the management of chronic illness.  Unfortunately, a significant proportion of US adults do not have a usual source of healthcare.  Also, many people often rely for their healthcare needs on a hospital emergency department, where there is neither sufficient continuity of care nor counseling for prevention. We wanted to investigate what factors might contribute to suboptimal utilization of healthcare resources.  We were particularly interested in looking at individual psychological factors that might play a role in the choices that people make when seeking healthcare.  One specific psychological characteristic proved to be important in our study.  That characteristic is called “threat sensitivity,” and it is measured with a simple questionnaire.  People who are relatively high in threat sensitivity are prone to experience high levels of anxiety in potentially threatening situations 
Author Interviews, Cannabis / 03.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49531" align="alignleft" width="150"]Julie Bobitt, PhD Director Interdisciplinary Health Sciences College of Applied Health Sciences University of Illinois at Urbana Champaign Champaign, IL  61820 Dr. Bobitt[/caption] Julie Bobitt, PhD Director Interdisciplinary Health Sciences College of Applied Health Sciences University of Illinois at Urbana Champaign Champaign, IL  61820 MedicalResearch.com: What is the background for this study? Response:  Older adults are using cannabis at an increasing rate but little is known about their attitudes about, and experiences – including outcomes- with, recreational and medical cannabis use. We believed a qualitative study, where we conducted focus group interviews, would provide a novel perspective to our understanding and help to identify the most salient themes concerning the use of medical and recreational cannabis by adults aged 60 and older living in Colorado.
Author Interviews, Breast Cancer, Cancer Research, Genetic Research, Novartis / 03.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49521" align="alignleft" width="170"]Fabrice André, MD, PhD Research director and head of INSERM Unit U981 Professor in the Department of Medical Oncology Institut Gustave Roussy in Villejuif, France Global SOLAR-1 Principal Investigator. Dr. Fabrice André[/caption] Fabrice André, MD, PhD Research director and head of INSERM Unit U981 Professor in the Department of Medical Oncology Institut Gustave Roussy in Villejuif, France Global SOLAR-1 Principal Investigator. MedicalResearch.com: What is the background for this study? How does Piqray®  differ from other treatments for this type of advanced breast cancer? 
  • The US Food and Drug Administration (FDA) approved Piqray® (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test after disease progression following an endocrine-based regimen.
  • Piqray is the first and only combination treatment with fulvestrant specifically for postmenopausal women, and men, with HR+/HER2- advanced or metastatic breast cancer with a PIK3CA mutation following progression on or after an endocrine-based regimen, bringing a biomarker-driven therapy option to this population for the first time.
  • Advanced breast cancer is incurable, and patients with all types need more treatment options. With this approval, physicians can now use an FDA-approved test to determine if their patients’ HR+/HER2- advanced breast cancer has a PIK3CA mutation and may be eligible for treatment with Piqray plus fulvestrant combination therapy. 
Author Interviews, ENT / 03.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49517" align="alignleft" width="138"]Edward McCoul, MD, MPH, FACS Associate Professor Director, Rhinology and Sinus Surgery Department of Otorhinolaryngology Ochsner Clinic New Orleans, Louisiana Dr. McCoul[/caption] Edward McCoul, MD, MPH, FACS Associate Professor Director, Rhinology and Sinus Surgery Department of Otorhinolaryngology Ochsner Clinic New Orleans, Louisiana  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Although the potential for doctors and patients to misunderstand each other has been noted in other areas of medicine, the meaning of the word "congestion" had not previously been the subject of study.  This paper calls attention to the relevance of potential communication gap in otolaryngology.  This is particularly important since congestion is a major diagnostic criteria of sinusitis, which ranks nationwide in the top 5 reasons for clinical encounters year after year.  If a communication gap is evident around this particular term, which is integral to establishing a diagnosis of sinusitis, then the likelihood increases that patients who present with "sinusitis" will be incorrectly diagnosed. The process of congestion refers to the microscopic accumulation of blood and/or fluid within cells or the spaces between cells in a particular tissue or body part.  When this occurs in the nose, the result is swelling inside the nose, which narrows the space for air to flow.  A patient would perceive this as blockage or obstruction of airflow.  This can be treated with anti-inflammatory medication that reduces swelling.  Medications that clear up mucus generally are not great at reducing swelling.  Many over-the-counter products are available that combine both types of medications, but using those products runs the risk of overmedication, which can have adverse consequences.