Author Interviews, CDC, Zika / 08.06.2016
CDC Recommends Urine Testing of Patients Suspected of Acute Zika Infection
MedicalResearch.com Interview with:
Andrea M. Bingham, PhD
Vector-Borne Disease Surveillance Coordinator
Florida Department of Health
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Bingham: Since its introduction to Brazil in 2015, Zika virus has spread throughout the Caribbean and South and Central America. We are constantly learning new things about Zika virus, including its potential for sexual transmission and its ability to cause certain birth defects such as microcephaly. Because many states, including Florida, have mosquito vectors that can potentially be infected with Zika virus, being able to identify infected people is important to ensure proper response and control measures are put in place to prevent local introductions. Improving testing capacity helps ensure that we have the ability to rapidly detect local Zika virus introductions if they occur.
On the basis of previous small Zika fever case studies that reported positive testing of patient urine and/or saliva samples, the Florida Department of Health made the decision to collect multiple specimen types from persons with suspected acute travel-related Zika fever in order to determine the most sensitive and efficient testing algorithm. Testing performed at our state public health laboratories in Tampa and Jacksonville suggested that urine was the most useful specimen for identifying acute Zika fever infections. Zika virus real time reverse-transcriptase polymerase chain reaction (RT-PCR) testing conducted on urine and serum samples collected the same day from 66 travel-associated Zika fever patients, detected Zika virus in nearly twice as many urine samples (61) as serum samples (31). Viral RNA was also detectable in urine longer than in serum. Although a high percentage of saliva samples also tested positive, no additional cases were identified through saliva testing alone. Based on these results and those of the small case studies, CDC updated their guidance to include urine as a recommended specimen type for testing of patients with suspected acute Zika fever.
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.
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
Dr. Maria Schwaederle[/caption]
Maria Schwaederle PharmD
Clinical Research Scientist
Center for Personalized Cancer Therapy
UCSD Moores Cancer Center
La Jolla, CA 92093
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Schwaederle: We performed this analysis with experts in the field, including but not limited to Drs Schilsky, Lee, Mendelsohn and Kurzrock, all known for their experience in the area of precision/personalized medicine.
Historically, phase I trials (which are often first in human or highly experimental in other ways) were believed to be examining only toxicity. Our meta-analysis of 13,203 patients shows that in the era of precision medicine, this historical belief needs to be discarded. Second, it is the use of precision medicine that makes this belief outdated.
Indeed, Phase I trials that utilized a biomarker-driven approach that is the essence of precision medicine had a median response rate of about 31%, which is higher than many FDA approved drugs, and this is in spite of the fact that phase I patients are a highly refractory group having failed multiple lines of conventional therapy.
Importantly, however, it was not the use of targeted agents alone that was important. It was the biomarker-based approach where patients are matched to drugs. Without matching, response rates were dismal—about 5%.
Dr. Vincent Chung[/caption]
Dr Vincent Chung
Assistant Professor, Jockey Club School of Public Health and Primary Care
Associate Director (Education), Hong Kong Institute of Integrative Medicine
Registered Chinese Medicine Practitioner
The Chinese University of Hong Kong
MedicalResearch.com: What is the background for this study?
Response: Primary carpal tunnel syndrome (CTS) is one of the most common forms of peripheral entrapment neuropathy. It is a major cause of disability on the upper extremity incurring considerable limitation on daily activities among patients. Currently, there is no consensus on appropriate treatment for patients with chronic (≥6 months) mild to moderate symptoms [Archives of physical medicine and rehabilitation. 2014;95(12):2253-63].
Electroacupuncture is a common technique for managing pain and neuropathy in Chinese medicine. Current CTS treatment guidelines from the UK National Institute for Health and Care Excellence (NICE), American Academy of Orthopaedic Surgeons (AAOS) and the American College of Occupational and Environmental Medicine (ACOEM) made no specific recommendations for or against electroacupuncture.
Dr. Sara Brownell[/caption]
Sara E. Brownell PhD
School of Life Sciences
Arizona State University
Tempe, AZ
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Brownell: Our group has been broadly interested in gender biases in introductory biology
since we published a study that showed that women underperform on course
exams and under participate in whole class discussions compared to men
(http://www.lifescied.org/content/13/3/478.full). We were curious why women
might be under performing on these course exams so in this new study, we
examined characteristics of the exams to see if that had an impact. What we
found was that women and men perform equally on questions that test basic
memorization. However, when questions tested more higher-level critical
thinking skills, women were not scoring as high as men. This happened even
when we took into account the academic ability of the students - women and men
who had the same ability coming into the class. We also found that students
from lower socioeconomic statuses also underperformed on these higher-level
critical thinking questions compared to students from higher socioeconomic
statuses, again even when we took into account academic ability.
Dr. Andrew Anglemyer[/caption]
Andrew Anglemyer, PhD MPH
Operations Research Department
U.S. Naval Postgraduate School
Monterey, CA 93943
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Anglemyer: Suicide prevention programs in the military are ubiquitous. We aimed to identify the trends in suicide for each service specifically and explore any nonclinical factors that may be associated with the chosen methods of suicide. The trends in suicide are similar to what others have found.
The differences in those rates between services are striking, though. Not only are most suicides in the active duty military among the Army personnel, but the suicide rate among Army personnel is the highest and has been every year since 2006. Additionally, among Army personnel and Marines who committed suicide, those with an infantry or special operations job classification were significantly more likely to use a firearm to commit suicide than those without those job classifications.
Dr. Jeffrey Schussler[/caption]
Jeffrey M. Schussler, MD, FACC, FSCAI, FSCCT, FACP
Baylor Scott & White Health Care System
Cardiology: Baylor University Medical Center, Dallas, Tx
Medical Director: CVICU Hamilton Heart and Vascular Hospital
Professor of Medicine: Texas A&M School of Medicine
MedicalResearch.com: What is the background for this study?
Dr. Schussler: For the past few years, there has been an increased interest in performing coronary catheterization through the wrist. This is a technique that has been done (with great success and low complication rate) in other countries for years, with adoption rates >90% in some places. The US has been slower to adopt performing catheterization from the wrist, but the rate of using this approach has grown tremendously in the last 5 years. While less than 5% of all interventions were done using radial access previously, it now appraches 30% nationally. This increased rate of adoption been spurred on by studies which have shown lower incidences of complications, as well as some mortality benefit, and in particular in those patients who are highest risk for complications.
Pegged Software[/caption]
Myra Norton
President and COO of 
Myra Norton[/caption]
Ms. Norton: Big data and predictive analytics alone will not solve the problem of pay inequality. What these tools can do is illuminate talent in a way that removes the biases that undermine equality across gender, ethnicity, socio-economic status and other dimensions. For example, predictive analytics allows organizations to identify candidates with the highest likelihood of improving patient experience, being retained, remaining an engaged employee, lowering thirty day readmissions, and positively impacting other organizational outcomes.
Dr. Dawn Hershman[/caption]
Dawn L. Hershman, MD MS
Professor of Medicine and Epidemiology
Leader, Breast Cancer Program
Herbert Irving Comprehensive Cancer Center
Columbia University
NY NY
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Hershman: Chemotherapy induced peripheral neuropathy is a common side effect of anti cancer therapy and there are currently no ways to prevent it. We used a large clinical trials database, SWOG, and linked it to Medicare claims for patients over the age of 65. We found that age and type of taxane were associated with the development of CIPN. We also found a significant increase when a taxane was given along with a platinum agent. We found a doubling of risk among patients with a prior history of diabetes. No other chronic condition was associated with an increased risk of CIPN. We found a suggestion of a decreased risk among patients with a prior history of auto-immune disease.
Dr. Katie Greenzang[/caption]
Katie Greenzang, MD
Dana-Farber/Boston Children’s Cancer and Blood Disorders Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Greenzang: Advances made over the last several decades mean that more than 80 percent of children diagnosed with cancer will become long-term survivors. However, many of these survivors experience physical and cognitive late effects of the treatment that cured them. We surveyed 352 parents of children recently diagnosed with cancer to assess how well they understood their children’s risk of future limitations in physical abilities, intelligence, and quality of life. We found that an overwhelming majority of parents (92 percent) are very interested in learning about possible late effects, and most (86 percent) seek detailed information. Yet, parent and physician predictions of a child’s risk of experiencing late effects of treatment often don’t match. Among children identified by their oncologists as being at high risk for such challenges, only 38 percent of parents recognized this risk in physical abilities, 21 percent in intelligence, and 5 percent in quality of life.
Dr. Gregory Idos[/caption]
Gregory Idos MD
Division of Gastroenterology and Hepatology
Keck School of Medicine
University of Southern California
Los Angeles, CA 90033
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Idos: Identifying individuals at increased risk for hereditary cancer prompts enhanced cancer surveillance as early detection mitigates disease specific morbidity and mortality. This justifies germ line genetic testing for specific cancer risk alleles. In recent years, the field of cancer genetics has moved from a gene by gene sequencing approach to now having the ability to examine multiple genes concurrently. Multiplex gene panel (MGP) testing allows simultaneous analysis of multiple high- and moderate- penetrance genes. As a result, more pathogenic mutations and variants of uncertain significance (VUS) are discovered. MGP tests are increasingly being used by cancer genetic clinics, but questions remain about the clinical utility and complexities of these tests.
We are conducting a multi center prospective trial to measure the added yield of detecting pathogenic mutations using the MGP approach. In our interim analysis of the first 1000 participants, we found that multiplex gene panel testing increased the yield of detection of pathogenic mutations by 26%. In some cases, we found patient’s who had a mutation in the BRCA gene, but their family history did not indicate a history of breast or ovarian cancer.
Dr. Sarmad Sadeghi[/caption]
Sarmad Sadeghi MD, MS, PhD
Assistant Professor of Medicine
Norris Comprehensive Cancer Center
University of Southern California
MedicalResearch.com: What is the background for this study?
Dr. Sadeghi: Several years ago analyses of outcomes for radical prostatectomy highlighted the significant impact of surgical experience on the oncological outcome for the patients. In this case experience was measured by the number of radical prostatectomies performed by the surgeon, and oncological outcome was measured by treatment failure rates (rising PSA). Despite this data, the move for redirecting patients to “high volume centers” where more experienced surgeons perform the operation has been sluggish. There was insufficient data on what is involved in referring patients to high volume centers and whether or not such action is cost effective.
In a previous study we demonstrated that for every referral to a high volume center, there would be an average of $1,800 over a follow-up period of 20 years in societal cost savings. The main source of these savings is fewer treatment failures.
The next question was who is a good candidate for referral and whether these savings can offset the referral costs.
Dr. Philip McCarthy[/caption]
Philip McCarthy, BA, MD
Professor of Oncology
Director, Blood and Marrow Transplant Program
Roswell Park Cancer Institute
Associate Professor of Medicine
Jacobs School of Medicine and Biomedical Sciences
State University of New York at Buffalo
Buffalo, NY 14263
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. McCarthy: There have been three Phase III studies that examined the role of maintenance lenalidomide after autologous stem cell transplant (ASCT) for newly diagnosed multiple myeloma patients. IFM 2005-02 (France), CALGB 100104 (Alliance, USA), GIMEMA-RVMM-PI-209 (Italy). All three studies had progression free survival (PFS) as their primary endpoint and all demonstrated a superior PFS when compared to placebo or no therapy after ASCT. However only the CALGB 100104 study demonstrated a statistically superior overall survival (OS). Thus, a meta-analysis was necessary to assess the effect of post-ASCT lenalidomide maintenance on overall survival. This study utilized a pooled analysis of updated primary-source patient data from all three studies after the primary efficacy analyses had been conducted. The meta-analysis demonstrated that there is a statistically superior OS (P value=0.001, HR=0.74 (0.62-0.89)), Median OS for no maintenance or placebo was 86 months and the median OS for lenalidomide had not been reached. The median OS for lenalidomide treatment arm was extrapolated to be 116 months based on median of the control arm and HR (median, 86 months; HR = 0.74). Thus, there is a 26% reduction in the risk of death which is an estimated 2.5 year increase in median OS. There is an increased incidence of second primary malignancies with lenalidomide maintenance when compared to placebo but this risk is less than the risk of dying when not receiving lenalidomide.