Dr. Deykin[/caption]
Aaron Deykin MD
Vice President, Late Stage Clinical Development
Biogen
MedicalResearch.com: What data support the U.S. Food and Drug Administration’s (FDA) approval of VUMERITY™ (diroximel fumarate)?
Response: The FDA approval of VUMERITY was based on a New Drug Application (NDA) submitted under the 505(b)(2) filing pathway. It included data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA® (dimethyl fumarate) to establish bioequivalence, and relied, in part, on the FDA’s findings of safety and efficacy for TECFIDERA.
The NDA submission also included interim exposure and safety findings from EVOLVE-MS-1, an ongoing, Phase 3, single-arm, open-label, two-year safety study evaluating VUMERITY in patients with relapsing-remitting multiple sclerosis (MS). Interim results from EVOLVE-MS-1 at the time of NDA submission included a low overall rate of VUMERITY treatment discontinuation due to adverse events (6.3 percent), and a rate of less than one percent of patients who discontinued VUMERITY treatment due to gastrointestinal (GI) adverse events. Additional exploratory efficacy endpoints in the ongoing EVOLVE-MS-1 study showed changes in clinical and radiological measures compared to baseline.
Matthew Budoff MD
Dr. Deshmukh[/caption]
Ashish Deshmukh, PhD, MPH
Assistant Professor
UTHealth School of Public Health
Houston
MedicalResearch.com: What is the background for this study?
Response: Anal cancer is one of the six human papillomavirus associated cancers. Rates of anal cancer are increasing in the US, but no prior study quantified the contemporary trends (i.e., increase in rates over time) in anal cancer incidence. It was unknown whether the rise is real or driven by increased screening in some high-risk populations. Incidence trends according to age and stage at diagnosis was also never comprehensively studied. Furthermore, it was unknown whether the rise in incidence has led to a rise in mortality. Our objective was to answer these questions.
Dr. Vella[/caption]
Michael A. Vella, M.D., M.B.A.
Assistant Professor of Surgery
Division of Acute Care Surgery and Trauma
University of Rochester School of Medicine and Dentistry
MedicalResearch.com: What is the background for this study?
Response: There is a lot of (appropriate) focus on the mortality statistics related to gun violence, but sometimes we forget about the large number of survivors of gunshot wounds. We wanted to specifically look at the long term physical and mental health outcomes in this patient population.
Prof. Anderson[/caption]
Jeffrey L. Anderson, MD FAHA FACC MACP
Distinguished Research Physician
Professor of Medicine with Tenure
University of Utah School of Medicine
MedicalResearch.com: What is the background for this study?
Response: Omega-3 supplements are widely used for cardiovascular prevention. However, a study published in the Journal of the National Cancer Institute (105:1132, 2013) reported as an incidental finding in a plasma bank study that the risk of prostate cancer increased with increasing levels of docosahexaenoic acid (DHA) and trended to increase with eicosapentaenoic acid (EPA).
Dr. Gyamfi-Bannerman[/caption]
Cynthia Gyamfi-Bannerman, MD, MSc
Vice Chair for Faculty Development
Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN
Director, Maternal-Fetal Medicine Fellowship Program
Co-Director, CUMC Preterm Birth Prevention Center
MedicalResearch.com: What is the background for this study?
Response: Delayed cord clamping (DCC) at delivery has been associated with neonatal benefit. Specially, it decreases the likelihood of anemia. It became widely recommended as a practice for all deliveries even though the literature showing benefit to the neonates was largely only for low risk women with vaginal deliveries. In theory, DCC could result in increased blood loss during a cesarean due to the blood loss encountered when cutting into a gravid uterus.
Dr. Birtwhistle[/caption]
Dr. Richard Birtwhistle, Professor
Departments of Family Medicine and Community Health and Epidemiology
Director of the Centre for Studies, Primary Care, Department of Family Medicine
Queen’s University
MedicalResearch.com: What is the background for this study?
Response: Testing for thyroid dysfunction is a commonly done by primary care practitioners. While the Thyroid stimulating hormone (TSH) test is an easy blood test to perform results outside the normal range are often found and will revert to normal over time without treatment in patients without symptoms.
We wanted to see if there was any clinical benefit to patients by screening for thyroid dysfunction.
Dr. Pierre Amarenco[/caption]
Pierre Amarenco, MD
Professor and Chairman
Paris University, Paris, France
INSERM
Department of Neurology and Stroke Centre
Bichat Hospital
Paris, France
MedicalResearch.com: What is the background for this study?
Response: The rationale of the Treat Stroke to target trial was that after we published the SPARCL trial in 2006 (atorvastatin 80 mg/day vs placebo in patients with stroke) which showed a 16% relative risk reduction of recurrent stroke, we performed several pre specified and post hoc analyses, showing that in SPARCL patients randomized with "atherosclerotic disease" the risk reduction for the primary endpoint was much higher (33%), and in in patients achieving a LDL cholesterol of less than 70 mg/dL as compared to those achieving a LDL cholesterol 100 mg/dL or higher, the risk reduction was 28%.
Therefore to confirm this findings, we designed the TST trial, which was an investigator initiated trial funded by the french ministry of health, and enrolled patients with an ischemic stroke due to atherosclerotic stenosis and randomized them to either a target LDL cholesterol of less than 70 mg/dL or a target LDL cholesterol of 90 to 110 mg/dL. To achieve these goals, the investigators could use any statin available on the market, and titrate the dosage of the statin to get to the assigned target. They could also use ezetimibe on top of statin therapy if a high dosage of statin was not sufficient to get to the target level assigned by randomization.
Dr. Markus Boos[/caption]
MedicalResearch.com Interview with:
Markus Boos, MD, PhD
Member of the Society for Pediatric Dermatology.
Attending pediatric dermatologist
Seattle Children's Hospital
Assistant Professor in the Department of Pediatrics
University of Washington School of Medicine
MedicalResearch.com: What is the background for this study?
Response: Our understanding of the cutaneous health of sexual and gender minority (SGM) individuals (lesbian, gay, bisexual, transgender, queer, asexual, intersex, nonbinary, etc.) remains nascent. This dearth of understanding of the unique needs of SGM children is even more pronounced.
This 2-part review article provides practical advice on how to best engage with young SGM patients and serve the distinct needs of this minority population, with a specific emphasis on dermatologic conditions.
Dr. Gardner[/caption]
Jennifer M. Gardner, MD
Clinical Assistant Professor of Dermatology
University of Washington School of Medicine
MedicalResearch.com: What is the background for this study?
Response: This study looked at age-specific differences of melanoma incidence in the United States. It was an observational study looking at population-based registry data extracted from the combined National Program of Cancer Registries-Surveillance Epidemiology and End Results United States Cancer Statistics (NPCR-SEER) database.
The overall take home message from this study is that though melanoma incidence has continued to climb in the past decade for both men and women, most of the increase is seen in adults greater than age 40 years of age. In contrast, melanoma incidence decreased in adolescents (ages 10-19 years of age) and young adults (ages 20-29) after peaking around 2004-2005.
Melanoma is more common in males in older individuals (older than 50 years of age) but in younger individuals (<50 years of age), melanoma is more common in females. According to a recently published JAMA-Otolaryngology paper by Bray and colleagues, there may be a subset of younger individuals where males are at a higher risk than females in regard to head and neck melanoma, and after that study was published we noted this to be true in our numbers, as well (we didn’t publish this in our study), further identifying a possibly “at risk” demographic within the younger age groups in addition to young women.
Dr. Melnick[/caption]
Edward R. Melnick, MD, MHS
Assistant Professor of Emergency Medicine
Program Director, Yale-VA Clinical Informatics Fellowship Program
Principal Investigator, EMBED Trial Network
Yale School of Medicine
New Haven, CT 06519
MedicalResearch.com: What is the background for this study?
Response: We know that physicians are frustrated with their EHRs and that EHRs are a driver of burnout. This is the first study to measure these issues nationally.
We included a standardized metric of technology from other industries (System Usability Scale, SUS; range 0-100) on the AMA’s 2017 physician burnout survey. This metric has been used in >1300 other studies so we can compare where the EHR’s usability is to other everyday technologies. We are also able to measure the relationship between physicians’ perception of their EHR’s usability and the likelihood they are burned out.
Mammograms showing a normal breast (left) and a breast with cancer (right, white arrows). Wikipedia Image[/caption]
Dr. Elham Kharazmi, MD, PhD
Co-Leader, Risk Adapted Prevention (RAD) Group
Division of Preventive Oncology
National Center for Tumor Diseases (NCT)
German Cancer Research Center (DKFZ)
Germany
MedicalResearch.com: What is the background for this study?
Response: Breast cancer is the most common cancer in women worldwide and the second leading cause of cancer death in American women, exceeded only by lung cancer. Available evidence suggests that implementation of a screening program can decrease breast cancer mortality.
Reductions in breast cancer mortality in Europe over the past two decades have been associated at least in part with the implementation of screening programs. Screening enables the detection of tumors at an early stage, when more treatment options are feasible and most effective. However, screening is associated with substantial risks, such as over-diagnosis, false-positive results, and physical and psychological harms, particularly when large numbers of women with low risk are frequently screened.
Dr. Bland[/caption]
Christopher M. Bland, Pharm.D., FCCP, FIDSA, BCPS
Clinical Associate Professor
Clinical and Administrative Pharmacy
University of Georgia College of Pharmacy
Clinical Pharmacy Specialist
St. Joseph’s/Candler Health System
Savannah, GA
MedicalResearch.com: What is the background for this study?
Response: Nearly 10% of the United States population self-report a penicillin allergy. However 90% of these allergies are found to be false upon reconciliation which includes patient interview, graded challenge, direct challenge, or penicillin skin testing. This is crucial as patients labeled with a penicillin allergy often receive more expensive antibiotics that additionally cause more adverse effects. While reconciling penicillin allergies is an important antimicrobial stewardship goal, resources are often limited in various healthcare settings to accomplish several of these endeavors.
Our study evaluated the use of pharmacy students to serve as patient interviewers to aid in reconciling penicillin allergies.
Dr. Stark[/caption]
Dr. Mitchell Stark, B.App.Sc (Hons), PhD
NHMRC Research Fellow
The University of Queensland Diamantina Institute
Woolloongabba, QLD
MedicalResearch.com: What is the background for this study?
Response: Uveal nevi (moles) mimic the appearance of uveal melanoma and their transformation potential cannot be definitively determined without a biopsy. Moles or naevi in the eye are common but can be difficult to monitor because changes to their shape or colouring can’t always be seen as easily as on the skin. As naevi are difficult to biopsy, they are usually “monitored” at regular intervals. If there is a melanoma in the eye, then outcomes are poor for people if their cancer spreads to the liver.
This study aimed to identify a “biomarker” that could be measured in patients’ blood that could be used as an early indicator of melanoma formation (from a mole) or progression to other body sites.
Sandra Crouse Quinn, PhD
Professor and Chair, Department of Family Science
Senior Associate Director, Maryland Center for Health Equity
School of Public Health
University of Maryland
College Park, MD
MedicalResearch.com: What is the background for this study?
Response: Millions of Americans use Facebook (FB) for a variety of purposes, including seeking health information. However, it is difficult for FB users to discern what is credible and scientifically sound information on the platform. Facebook ads also focus on health issues including vaccination, which is labelled by FB as an issue of national importance. We were the first team to conduct a research study examining the FB Ad Archive and analyzed ads that contained vaccine content.
Dr. Nowell[/caption]
Benjamin Nowell, Ph.D.
Director of Patient-Centered Research
CreakyJoints, Principal Investigator of ArthritisPower
MedicalResearch.com: What is the background for this study?
Response: Patient-reported outcomes (PROs) are important indicators of treatment effectiveness, but little is known about which PRO measures that patients find the most important to track for their disease management and to evaluate treatment effectiveness and health outcomes. In this study, we used the ArthritisPower Research Registry to evaluate which PROs patients with rheumatological conditions voluntarily selected to understand their experience of disease.
Dr. Nagarajan[/caption]
Sairaman Nagarajan, MD
Clinical Fellow at State University
New York (SUNY) Downstate Medical Center College of Medicine
MedicalResearch.com: What is the background for this study?
Response: The impetus for this study came from our previous research linking asthma, hay-fever and overall cancer diagnoses using the CDC’s National Health Interview Survey database.
The division of Allergy and Immunology at SUNY Downstate has also conducted two pilot studies on the relationship between parental cancer and childhood asthma in Brooklyn’s population; one from Lutheran Medical Center focusing on Hispanics and Asian patients, and the other on African-American and Afro-Caribbean patients.
Dr. Ruzycki[/caption]
Shannon Ruzycki, MD, MPH, FRCPC, (she/hers)
General Internist & Clinical Lecturer
Department of Medicine
Department of Community Health Sciences
Cumming School of Medicine
University of Calgary
MedicalResearch.com: What is the background for this study?
Response: After hearing about the National Academies of Science, Engineering, and Medicine 2018 report to congress on sexual harassment of women in academia, our Department Head asked myself and Dr. Aleem Bharwani to study experiences of gender inequity or equity in our Department.
We conducted an in-depth, 18-month mixed methods study of women and men in our Department, including semi-structured interviews and survey.
Dr. Cerdá[/caption]
Magdalena Cerdá DrPH
Associate Professor and Director
Center for Opioid Epidemiology and Policy
Department of Population Health
NYU Langone School of Medicine
MedicalResearch.com: What is the background for this study?
Response: Legalization of recreational marijuana use is increasingly enacted across US states and across the world. In the US, 11 states and D.C. have legalized recreational use of marijuana, while 33 states and D.C. have legalized medical use of marijuana. In light of these changes, we need to know the impact that recreational marijuana legalization has on marijuana use.
To our knowledge, our is the first study to look at the impact that recreational marijuana legalization has had on both use and cannabis use disorder among different age groups.
Dr. McCormick[/caption]
Natalie McCormick, Ph.D.
Post-Doctoral Research Fellow
Clinical Epidemiology Program
Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital
Department of Medicine, Harvard Medical School
Arthritis Research Canada
MedicalResearch.com: What is the background for this study?
Response: Biologic disease-modifying anti-rheumatic drugs (bDMARDs) have improved the health and productivity of many people living with moderate-to-severe inflammatory rheumatic diseases. They are also among the highest-spend drugs in the USA, with substantial out-of-pocket costs that pose barriers to treatment initiation and adherence. To understand the drivers of ongoing bDMARD spending growth, and effective ways of containing costs, we analysed drug spending data for all bDMARD claims in Medicare Part D, Part B fee-for-service, and Medicaid over 2012 to 2016, isolating the impact of changes in drug prices from changes in utilisation.
Dr. Bannuru[/caption]
Raveendhara R. Bannuru MD, PhD, FAGE
Director, Center for Treatment Comparison and Integrative Analysis (CTCIA)
Deputy Director, Center for Complementary and Integrative Medicine (CCIM)
Asst Professor of Medicine, Tufts University School of Medicine
Asst Professor of Clinical & Translational Science, Sackler School of Graduate Biomedical Sciences
Division of Rheumatology, Tufts Medical Center
Boston, MA
MedicalResearch.com: What is the background for this study?
Response: Given the current controversy regarding the use of opioids in chronic pain, we wanted to delve deeper into the efficacy and safety profiles of oral opioid drugs in osteoarthritis patients. Temporal assessments like ours can reveal peak periods of efficacy, and can provide clinicians with a blueprint for optimal durations of treatment regimens. With respect to subgroup analyses based on strength of opioid binding affinity, we sought to explore currently held paradigms that strong opioids may be useful for the treatment of severe pain, and to specifically assess their relevance in OA populations. Knowledge of the relative efficacy and safety profiles of strong versus weak opioids can give clinicians the information they need to weigh benefits and harms of specific subgroups of opioids.
Kelly Gavigan[/caption]
Kelly Gavigan, MPH
Manager, Research and Data Science
CreakyJoints
MedicalResearch.com: What is the background for this study?
Response: Over the past fifteen years, there have been significant improvements in quality of life among people living with rheumatic and musculoskeletal disease with the introduction of biologics and targeted therapies. However, despite a variety of treatments to try, patients often seek non-pharmacological alternative and complementary treatments, such as marijuana for medical use (MMU), to help manage their condition and symptoms. MMU is becoming increasingly available in the United States as different states legalize it under specific circumstances.
Legal or not, according to a survey conducted by CreakyJoints using the ArthritisPower Research Registry (n=1,059 participants), people with arthritis are trying marijuana for medical use.
Dr. Kroon[/caption]
Féline PB Kroon MD
Department of Rheumatology
Leiden University Medical Centre LUMC ·
MedicalResearch.com: What is the background for this study?
Response: Hand osteoarthritis (OA) is a prevalent joint condition that causes pain, functional disability, and decreased quality of life, for which patients frequently consult health-care providers. Symptoms usually fluctuate over time, with episodes of joint swelling and erythema. Evidence from previous studies has shown that inflammation plays an important role in the disease, being an important predictor for pain and radiographic damage progression.
Therefore, we hypothesized that inflammation could be a treatment target in OA, and we investigated this using prednisolone, a potent anti-inflammatory drug. The aim of the HOPE study was to investigate the clinical efficacy and safety of a six-week course of prednisolone 10 mg daily in patients with painful hand OA who had evidence of synovial inflammation.
Dr. Francis-Sedlak[/caption]
Megan Francis-Sedlak, PhD
Director of Medical Affairs
Horizon Therapeutics
Lake Forest, Illinois
MedicalResearch.com: What is the background for this study?
Response: The prevalence of gout is more than ten-fold greater among patients who have undergone a kidney transplant than the general population as post-transplant medications to prevent organ rejection can contribute to increased uric acid levels. Overall studies have shown this can lead to higher rates of uncontrolled gout among this vulnerable population with organ transplants.
While we have seen higher mortality rates for patients who have received a kidney transplant with uncontrolled gout compared to kidney transplant patients without uncontrolled gout, we wanted to evaluate the impact of gout on transplant-related complications to better inform patient care and treatment approaches.
Dr. McGregor[/caption]
Tracy McGregor, MD MSCI
Alnylam Pharmaceuticals
Cambridge, Massachusetts
MedicalResearch.com: What is the background for this study?
Emily S. Ruiz, MD, MPH
Director, High-Risk Skin Cancer Clinic, Dana Farber/Brigham and Women’s Cancer Center
Assistant Professor, Harvard Medical School, Dermatology
Brigham And Women's Faulkner Hospital
MedicalResearch.com: What is the background for this study?
Response: Innovation in oncology has led to increased development and market entry of anticancer drugs. For example, from 2009 to 2013, the US FDA approved 51 oral and systemic anticancer drugs for 63 indications. Prices for anticancer drugs have risen faster than inflation over time, especially for older drugs, and prices in the US have largely been set by market forces rather than novelty or efficacy.
Understanding the evolving cancer economic landscape requires consideration of annual and cumulative rates of change for key metrics, such as total spending, drug cost per beneficiary, out-of-pocket cost, and utilization. This study sought to weigh the proportional impacts of rising drug costs and utilization on increased Medicare Part D spending for a cohort of oral anticancer drug utilized from 2013-2017.
Dr. Nobles[/caption]
Alicia Nobles, PhD, MS
Research Fellow
Department of Medicine
UC San Diego
MedicalResearch.com: What is the background for this study?
Response: Sexually transmitted diseases (STDs) are at record-high rates according to the Centers for Disease Control. Between STDs being highly stigmatized infections and people lacking access to health care, people may elect to turn to social media to connect with others. This is precisely why social media sites are so popular - because they do allow for people to talk with others rapidly.
Reddit, a social media site that rivals Twitter with 330 million active users and is the 6th most visited website in the United States, is organized into online communities, many of which discuss health topics. We monitored all r/STD (www.reddit.com/r/STD/) posts, where users can find “anything and everything STD related,” from its inception in November 2010 through February 2019.