MedicalResearch.com Interview with: [caption id="attachment_24949" align="alignleft" width="133"] Dr. Meike Vernooij[/caption] Meike Vernooij, MD PhD Associate professor Radiology and Epidemiology Neuroradiologist and head & neck radiologist Rotterdam,...
Dr. Andrea Cipriani[/caption]
Andrea Cipriani, MD PhD
Associate Professor
Department of Psychiatry
University of Oxford
Warneford Hospital
Oxford UK
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Cipriani: Major depressive disorder is common in young people, with a prevalence of about 3% in school-age children (aged 6–12 years) and 6% in adolescents (aged 13–18 years). Compared with adults, children and adolescents with major depressive disorder are still underdiagnosed and undertreated, possibly because they tend to present with rather undifferentiated depressive symptoms—eg, irritability, aggressive behaviours, and school refusal. Consequences of depressive episodes in these patients include serious impairments in social functioning, and suicidal ideation and attempts. Our analysis represents the most comprehensive synthesis of data for currently available pharmacological treatments for children and adolescents with acute major depressive disorder (5620 participants, recruited in 34 trials).
Among all antidepressants, we found that only fluoxetine was significantly better than placebo. According to our results, fluoxetine should be considered the best evidence-based option among antidepressants when a pharmacological treatment is indicated for children and adolescents with moderate to severe depression. Other antidepressants do not seem to be suitable as routine treatment options.
Dr. Laura Kann[/caption]
Laura Kann, PhD
Chief, School-Based Surveillance Branch Division of Adolescent and School Health
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)
Centers for Disease Control and Prevention (CDC)
MedicalResearch.com: What is YRBSS?
Dr. Kann: The Youth Risk Behavior Surveillance System (YRBSS) is the only surveillance system designed to measure the major health risk behaviors among our nation's high school students and to track those behaviors over time at the national, state, and local levels. Reports from this surveillance system have been released every two years since 1991. More information is available at: www.cdc.gov/yrbs.
Adam Glassman[/caption]
MedicalResearch.com Interview with:
Adam Glassman, M.S.
Director, DRCRnet Coordinating Center
Jaeb Center for Health Research
Tampa, FL 33647
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Diabetic macular edema (DME) is the most common cause of vision loss in patients with diabetes, impairing the vision of approximately 750,000 people in the United States. The most common treatment involves the injection into the eye of one of 3 drugs that inhibit vascular endothelial growth factor (VEGF). The Diabetic Retinopathy Clinical Research Network, funded by the National Institutes of Health, conducted a randomized clinical trial on the comparative effectiveness of the 3 anti-VEGF drugs EYLEA®, Avastin®, or Lucentis® for eyes with decreased vision from diabetic macular edema. There are substantial cost differences between the three drugs. In the United States, EYLEA® costs approximately $1850, repackaged (compounded) Avastin® $60, and Lucentis® $1170 per injection. In eyes with relatively good starting vision, there were no differences in vision outcomes; all three groups, on average, had improved vision. In eyes with starting vision of 20/50 or worse, EYLEA® had better vision outcomes at 1 year than either Avastin® or Lucentis®, and better vision outcomes at 2 years than Avastin®. However, given that, on average, eyes will receive 9 to 10 injections within the first year of treatment and 5 injections in the second year, neither EYLEA® nor Lucentis® would be considered cost effective by standard benchmarks compared with Avastin® unless their prices decrease substantially.
Dr. Alexander Egeberg[/caption]
Alexander Egeberg, MD PhD
Gentofte Hospital
Department of Dermatology and Allergy
Denmark
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Egeberg: While psoriasis has been associated with an increased risk of cardiovascular disease (CVD), studies have generally neglected to adjust for family history of CVD which is a well-established cardiovascular risk factor.
In a population-based study of young patients with psoriasis, we found an increased risk of CVD only in patients with a positive family history of CVD but not in those patients that did not have a positive family history.
Dr. Mathew Jankowich[/caption]
Matthew D. Jankowich, MD
Assistant Professor of Medicine
Alpert Medical School of Brown University
Staff physician at the Providence VA Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Jankowich: For some time, endothelin-1 has been known to cause vasoconstriction in the pulmonary circulation, and elevated endothelin-1 levels have been noted in patients with pulmonary arterial hypertension and decompensated congestive heart failure, as well as other advanced disease states. However, endothelin-1 has not been well studied in members of the general population. In our study, we examined plasma endothelin-1 levels in participants in the Jackson Heart Study and the relationship of plasma endothelin-1 levels to pulmonary hypertension, mortality and heart failure. We found increased odds of having pulmonary hypertension, defined as an echocardiography estimation of the pulmonary artery systolic pressure>40mmHg, in those participants with higher plasma endothelin-1 levels. Having higher endothelin-1 levels was also associated with an increased risk of both mortality and heart failure. Those participant with both high endothelin-1 levels (a level in the top 25%) and pulmonary hypertension were at the highest risk of mortality.
David Beversdorf, M.D.
Associate professor in the departments of radiology, neurology and psychological sciences
University of Missouri and
Missouri University Thompson Center for Autism and Neurodevelopmental Disorders
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Beversdorf: Our previous work had demonstrated in retrospective surveys a higher incidence of prenatal psychosocial stress exposure during the late 2nd and early 3rd trimester in pregnancies where the offspring had developed autism spectrum disorder (ASD). This had been confirmed in other studies, including a study examining the timing of exposure to tropical storms during pregnancy. However, not everyone exposed to stress during pregnancy has a child with ASD, so we began to look at genetic risk for augmented stress reactivity. This initial exploration involved examination of the interaction between stress exposure during ASD-associated pregnancies and the maternal presence of variations in one gene well known to affect stress reactivity. Variations in this gene were also targeted as they have been associated with ASD in some studies. We found in two independent groups of patients (one in Missouri, one in Ontario, Canada) that maternal presence of at least one copy of the stress-susceptible variant of this gene is associated with the link between maternal stress exposure during this time window of pregnancy and subsequent development of ASD in the offspring.
Nate Miersma[/caption]
MedicalResearch.com: What is the background of the Stryker Surgicount Safety-Sponge System?
Mr. Miersma: Retained surgical sponges are the number one reported surgical never event, occurring roughly a dozen times per day in the United States. SurgiCount helps hospitals eliminate retained sponges by supplementing and verifying the manual count of sponges using a unique bar code for each sponge.
• The traditional manual sponge-counting method expects nurses and surgical technicians to track sponges with extreme precision using only a whiteboard and dry-erase marker. Though the majority of nurses and surgical technicians are experienced and thorough, the fast-paced, high-pressure environment of an operating room creates the risk for false-correct counts caused by distraction, exhaustion or personnel changes. At a rate of 11 times per day, the ‘white board while multi-tasking’ method clearly isn’t sufficient.
• When using SurgiCount, a nurse or surgical technician scans the barcodes to enter them into the computer’s backup count. During the closing count at the end of the procedure, a nurse or surgical technician scans each bar code again, while the computer tracks which sponges have been counted out and which remain. If the counts do not match, the SurgiCount scanner identifies which sponge or sponges are still unaccounted for, and directs staff to resolve the count by locating the outstanding sponge or sponges. Numerous clinical studies indicate that the primary cause of retained surgical sponges is false-correct counts. SurgiCount ensures that these false-correct counts no longer occur during the busy closing process.
• The scanner never gets tired or distracted, and can’t accidentally count the same sponge out twice, or count out a sponge which was accidentally introduced to the case possibly from another room, or from a sponge which was hidden and left over from a previous case.
Dr. Arjun Balar[/caption]
Dr. Arjun Balar MD
Assistant Professor, Department of Medicine
Co-Leader Genitourinary Cancers Program
NYU Langone Medical Center
Laura and Isaac Perlmutter Cancer Center
MedicalResearch.com: What is the background for this study?
Dr. Balar: Standard treatment for advanced urothelial cancer includes cisplatin chemotherapy. But more than half of patients are not expected to tolerate
it well and alternative treatment is inferior to cisplatin. The average survival for these patients is in the range of 9-10 months with carboplatin-based treatment, which is the most commonly used alternative
to cisplatin. Atezolizumab is a PD-L1 blocking antibody that reactivates
the body¹s immune system to fight bladder cancer and has been recently
FDA approved in the management of advanced urothelial cancer in the
second-line setting after failure of platinum-based chemotherapy.
Dr. Addolorata Pisconti[/caption]
Dr Addolorata Pisconti Ph.D.
Department of Biochemistry
Institute of Integrative Biology
University of Liverpool
Liverpool United Kingdom
MedicalResearch.com: What is the background for this study?
Dr. Pisconti: Duchenne muscular dystrophy (DMD) is a genetic disorder caused by lack of the cytoskeletal protein dystrophin which, under normal conditions, protects the muscle fibres during the stress of contraction. In the absence of dystrophin, muscle fibres are more fragile and are easily damaged leading to progressive loss of muscle mass and strength, loss of ambulation, difficulties breathing, cardiomyopathy and eventually premature death. There is no cure for DMD.
In Duchenne muscular dystrophy the resident muscle stem cells are impaired and therefore regeneration of damaged muscle fibres is also impaired. Some of the mechanisms leading to impaired muscle stem cell function have been hypothesised, however this remains to date an elusive topic. Chronic inflammation and fibrosis are a hallmark of dystrophic muscle but how they affect muscle stem cells and their regenerative potential remains largely unknown.
MedicalResearch.com Interview with: [caption id="attachment_25047" align="alignleft" width="131"] Dr. Philipp Bohm[/caption] Dr. Philipp Bohm MD Institute of Sports and Preventive Medicine Saarland University, Saarbrücken, Germany MedicalResearch.com:...
Dr. Cynthia Ogden[/caption]
Cynthia L Ogden PhD, MRP
Public Health, Nutrition and Dietetics
CDC Atlanta
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Ogden: Monitoring trends in obesity prevalence is important because of the health risks associated with obesity and because obesity often tracks from childhood to adulthood. The most recent data before this point showed no increases overall in youth, men or women over the previous decade.
We used the most recent nationally representative data with measured weights and heights from the National Health and Nutrition Examination Survey to look at trends in obesity prevalence.
Dr. Lena S. Sun[/caption]
Lena S. Sun, MD
E. M. Papper Professor of Pediatric Anesthesiology
Professor of Anesthesiology and Pediatrics
Executive Vice Chairman, Department of Anesthesiology
Chief, Division of Pediatric Anesthesiology
Columbia University Medical Center
New York, New York 10032
MedicalResearch.com: What is the background for this study?
Dr. Sun: The background for the study is as follow: There is robust evidence in both rodent and non-human primate studies that exposure of the developing brain leads to impairment in cognitive function and behavior later in life. The evidence from human studies derives mostly from retrospective studies and the results have been mixed. Some have demonstrated anesthesia in early childhood was associated with impaired neurocognitive function, while others have found no such association. Our study is the first to specifically designed to address the question of effects of general anesthesia exposure on cognitive function, comparing exposure with no exposure.
Dr. Robert Ferris[/caption]
Robert L. Ferris, M.D., Ph.D.
Robert L. Ferris, M.D., Ph.D.
UPMC Endowed Professor and Vice-Chair
Associate Director for Translational Research
Co-Leader, Cancer Immunology Program
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Ferris: Investigators at the University of Pittsburgh Cancer Institute<http://upci.upmc.edu/> (UPCI) co-led CheckMate-141<https://clinicaltrials.gov/ct2/show/NCT02105636> a large, randomized international phase III clinical trial that enrolled 361 patients with recurrent or metastatic head and neck squamous cell carcinoma who had not responded to platinum-based chemotherapy, a rapidly progressing form of the disease with an especially poor prognosis. Patients were randomized to receive either nivolumab or a single type of standard chemotherapy until tumor progression was observed.
Nivolumab, which belongs to a class of drugs known as immunotherapeutics, enables the body’s immune system to destroy cancer cells. It currently is approved to treat certain types of cancers, including melanoma and lung cancer. The nivolumab group achieved better outcomes than the standard chemotherapy group by all accounts. After 12 months, 36 percent of the nivolumab group was alive, compared to just 17 percent of the standard chemotherapy group.
Nivolumab treatment also doubled the number of patients whose tumors shrunk, and the number whose disease had not progressed after six months of treatment. Importantly, these benefits were achieved with just one-third the rate of serious adverse events reported in the standard chemotherapy group. In addition, on average, patients receiving nivolumab reported that their quality of life remained stable or improved throughout the study, while those in the chemotherapy group reported a decline. The new trial was considered so successful that it was stopped early to allow patients in the comparison group to receive the new drug.
Dr. Laura Ferris[/caption]
MedicalResearch.com Interview with:
Laura Ferris, M.D., Ph.D.
Associate professor, Department of Dermatology
University of Pittsburgh School of Medicine and
Member of the Melanoma Program
University of Pittsburgh Cancer Institute
MedicalResearch.com: What is the background for this study?
Dr. Ferris: Rates of melanoma, the most dangerous form of skin cancer, are on the rise, and skin cancer screenings are one of the most important steps for early detection and treatment. Typically, patients receive skin checks by setting up an appointment with a dermatologist. UPMC instituted a new screening initiative, which was modeled after a promising German program, the goal being to improve the detection of melanomas by making it easier for patients to get screened during routine office visits with their primary care physicians (PCPs). PCPs completed training on how to recognize melanomas and were asked to offer annual screening during office visits to all patients aged 35 and older. In 2014, during the first year of the program, 15 percent of the 333,788 eligible UPMC patients were screened in this fashion.
Marissa Hall[/caption]
Marissa G. Hall, MSPH
Doctoral Candidate, Department of Health Behavior
Gillings School of Global Public Health
University of North Carolina at Chapel Hill
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The US Food and Drug Administration (FDA) requires pictorial warnings on cigarette packs, but implementation was stalled by a 2012 lawsuit by the tobacco industry. The US Court of Appeals for the DC Circuit ruled against pictorial warnings, saying that FDA had “not provided a shred of evidence” that the pictorial warnings reduce smoking. To address this critique, our randomized trial examined the impact on smoking behavior of adding pictorial warnings to the front and back of cigarette packs. We found that smokers with pictorial warnings on their packs were more likely to attempt to quit and to successfully quit than those whose packs had text-only warnings.
MedicalResearch.com Interview with: [caption id="attachment_25021" align="alignleft" width="200"] Dr. Daniel Belsky[/caption] Daniel Belsky, PhD Assistant Professor of Medicine Duke University School of Medicine Durham, NC 27708 MedicalResearch.com:...
Dr. William Sandborn[/caption]
William J. Sandborn, MD
Professor of Medicine and Adjunct Professor of Surgery
Chief, Division of Gastroenterology
Director, UCSD IBD Center
University of California San Diego and UC San Diego Health System
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Sandborn: The Phase 3 IM-UNITI study investigated the efficacy and safety of Stelara (ustekinumab) in the treatment of moderate to severe Crohn’s disease as an every 8 or 12 week maintenance therapy.
The study showed a significant proportion of adults with moderate to severe Crohn’s disease who received Stelara maintenance treatment achieved clinical remission.
Susanne Cutshall[/caption]
SUSANNE M. CUTSHALL, APRN, CNS, D.N.P.
Division of General Internal Medicine
Mayo Clinic, Rochester, MN
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Several years ago a group of practitioners from the Mayo Clinic, including Sue Cutshall and Larry Bergstrom took my functional medicine training program that I teach through The Kalish Institute. They were interested in researching the effectiveness of the functional medicine techniques I’ve developed over the last twenty years, so we embarked on this study together. The study showed women on the program experienced increased energy, were better able to handle stress and had less physical pain. Additional information gathered from follow-up testing, but not reported in the formal study, showed a significant improvement in digestive health as well.
Dr. Yan Alicia Hong[/caption]
MedicalResearch.com Interview with:
Yan Alicia Hong, Ph.D.
Associate Professor
Dept of Health Promotion & Community Health Sciences
School of Public Health
Texas A&M Health Science Center
College Station, TX, 77843
MedicalResearch.com: What is the background for this study and discussion? What are the main findings?
Dr. Hong: Medical tourism has grown rapidly in the past decade, as Internet has greatly facilitated information sharing. A 2013 online survey from US reported that 27% of patients had engaged in some form of medical tourism. The global market of medical tourism is estimated at $439 billion. Traditionally, medical tourists travel from high-income countries to middle- and low-income countries to seek comparable or identical care at a lower price. But in recent years, more and more patients from middle- and low-income countries travel to the high-income countries for better diagnostic capabilities, state-of-the-art medical technologies, and advanced treatment options that may not be available in their home countries. I wrote up this article in response to the opening of a Chinese-American Physicians E-Hospital, a new online service to facilitate Chinese patients seeking medical care in U.S..
Dr. Rozalina McCoy[/caption]
Rozalina McCoy, M.D
Assistant Professor of Medicine
Division of Primary Care Internal Medicine
Department of Medicine
Mayo Clinic Rochester
MedicalResearch.com: What is the background for this study?
Dr. McCoy: Hypoglycemia is a serious potential complication of diabetes treatment; it worsens quality of life and has been associated with cardiovascular events, dementia, and even death. Most professional societies recommend targeting HbA1C levels less than 6.5% or 7%, with individualized treatment targets based on patient age, other medical conditions, and risk of hypoglycemia with therapy. Treating patients to very low HbA1c levels is not likely to improve their health, especially not in the short-term, but can cause serious harms such as hypoglycemia. The goal of our study was to assess how frequently patients with type 2 diabetes are treated intensively, focusing specifically on patients who are elderly or have serious chronic conditions such as dementia, kidney disease including dialysis need, heart disease, stroke, lung disease, and cancer. Moreover, while prior studies have suggested that intensive treatment may be common, there was no strong evidence that intensive treatment does in fact increase risk of hypoglycemia. Our study was designed specifically to assess this risk.
We examined medical claims, pharmacy fill data, and laboratory results of 31,542 adults with stable and controlled type 2 diabetes who were included in the OptumLabs™ Data Warehouse between 2001 and 2013. None of the patients were treated with insulin or had prior episodes of severe hypoglycemia, both known risk factors for future hypoglycemic events. None of the patients had obvious indications for very tight glycemic control, such as pregnancy.
“Intensive treatment” was defined as being treated with more glucose-lowering medications than clinical guidelines consider to be necessary given their HbA1C level. Patients whose HbA1C was less than 5.6 percent (diabetes is defined by HbA1C 6.5 percent or higher) were considered intensively treated if they were taking any medications. Patients with HbA1C in the “pre-diabetes” range, 5.7-6.4 percent, were considered to be intensively treated if using two or more medications at the time of the test, or if started on additional medications after the test, because current guidelines consider patients with HbA1C less than 6.5 percent to already be optimally controlled. For patients with HbA1C of 6.5-6.9 percent the sole criteria for intensive treatment was treatment intensification with two or more drugs or insulin.
The patients were separated by whether they were considered clinically complex (based on the definition by the American Geriatrics Society)—75 years of age or older; or having end-stage kidney disease, dementia; or with three or more serious chronic conditions. This distinction has been made to help identify patients for whom adding glucose-lowering medications is more likely to lead to treatment-related adverse events, including hypoglycemia, while not providing substantial long-term benefit.
Dr. Ramon Estruch[/caption]
Dr Ramon Estruch, MD PhD
Senior Consultant in the Internal Medicine Department of the Hospital Clinic
Barcelona
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Estruch: Although weight stability requires a balance between calories consumed and calories expended, it seems that calories from vegetable fats have different effects that calories from animals on adiposity. Thus, an increase of dietary fat intake (mainly extra virgin olive oil or nuts) achieved naturally in the setting of Mediterranean diet does not promote weight gain or increase in adiposity parameters such as waist circumference.
Dr. Catherine Diefenbach[/caption]
Dr. Catherine S. M. Diefenbach MD
Assistant Professor of Medicine
NYU Cancer Center
New York, NY 10016
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Diefenbach: It is well known that age is important prognostic factor in non-Hodgkin’s lymphoma (NHL). Multiple studies have illustrated that elderly lymphoma patients have inferior survival outcomes as compared to their younger counterpart. While the tumor biology is often different in these two groups, and may play a role in this discordancy, elderly patients are often frail or have multiple medical comorbidities. These include geriatric syndromes, such as: cognitive impairment, falls, polypharmacy, and potentially inappropriate medication (PIM) use. All of these may contribute to poor outcomes for elderly patients. In addition, elderly patients are often under-treated for their aggressive lymphoma out of concern for toxicity or side effects, even though the data clearly demonstrates that elderly patients can still benefit from curative intent chemotherapy.
Dr. Giovanni Esposito[/caption]
Giovanni Esposito MD, PhD
Associate Professor of Cardiology
Department of Advanced Biomedical Sciences
Federico II University, Naples
Napoli - Italy and
Giuseppe Gargiulo, MD
PhD Student
Federico II University of Naples, Italy