Dr. Eric Ojerholm[/caption]
Eric Ojerholm, MD
Resident, Radiation Oncology
Hospital of the University of Pennsylvania
MedicalResearch.com: What is the background for this study?
Response: Multiple studies reported that a blood test —the neutrophil-to-lymphocyte ratio (NLR)—might be a helpful biomarker for bladder cancer patients. If this were true, NLR would be very appealing because it is inexpensive and readily available. However, previous studies had several methodological limitations.
MedicalResearch.com: What did you do in this study
Response: We therefore put NLR to the test by performing a rigorous “category B” biomarker study—this is a study that uses prospectively collected biomarker data from a clinical trial. We used data from SWOG 8710, which was a phase III randomized trial that assessed surgery with or without chemotherapy for patients with muscle-invasive bladder cancer. We tested two questions.
First, could NLR tell us how long a bladder cancer patient would live after curative treatment?
Second, could NLR predict which patients would benefit from chemotherapy before surgery?
MedicalResearch.com Interview with: [caption id="attachment_29058" align="alignleft" width="192"] Dr. Hiroyuki Hikichi[/caption] Hiroyuki Hikichi, Ph.D. Research Fellow Harvard T.H. Chan School of Public Health Boston, MA 02215 MedicalResearch.com: What is the background for this study? Response: Recovery after major disaster poses potential risks of dementia for the elderly population, such as resettlement in unfamiliar surroundings or psychological trauma....
Dr. Miguel Regueiro[/caption]
MedicalResearch.com Interview with:
Miguel Regueiro, M.D., AGAF, FACG, FACP
Professor of Medicine and Professor, Clinical and Translational Science
University of Pittsburgh School of Medicine
Senior Medical Lead of Specialty Medical Homes
University of Pittsburgh Medical Center
IBD Clinical Medical Director
Division of Gastroenterology, Hepatology, and Nutrition
Pittsburgh PA, 15213
MedicalResearch.com: What is the background for this study?
Response: The background for the study is that we created an Inflammatory Bowel Disease (IBD) patient centered medical home in conjunction with our UPMC Health Plan. The IBD medical home has been designated UPMC IBD Total Care and provides whole person care for patients with ulcerative colitis and Crohn’s disease. Unlike primary care medical homes, the gastroenterologist is the principle care provider in this specialty medical home model. We created this medical home to improve the IBD patient experience, provide high quality care, and decrease utilization and cost.
Prof. Tim Slade[/caption]
Tim Slade, PhD
Associate Professor
National Drug and Alcohol Research Centre
University of New South Wales
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Historically, men have been more likely to drink alcohol than women and to drink in quantities that damage their health. However, evidence points to a significant shift in the drinking landscape with rates of alcohol use converging among men and women born in more recent times. In a bid to quantify this trend over time, we pooled data from 68 published research studies in 36 countries around the world. We looked at how the ratio of men’s to women’s alcohol use differed for people born in different time periods and found that the gap between the sexes consistently narrowed over the past 100 years or so. For example, among cohorts born in the early 1900s men were just over two times more likely than women to drink alcohol. Among cohorts born in the late 1900s this ratio had decreased to almost one meaning that men’s and women’s drinking rates have reached parity.
Dr. Elizabeth Walker[/caption]
Elizabeth Walker, PhD, MPH, MAT
Research Assistant Professor
Assistant Director of Evidence-based Learning
Department of Behavioral Sciences and Health Education
Rollins School of Public Health
Emory University
MedicalResearch.com: What is the background for this study?
Response: Previous research has shown that many adults in the United States have one or more chronic health condition; however, not much was known about multimorbidities – having multiple chronic conditions – among people with mental disorders. We used nationally representative data from the National Survey on Drug Use and Health to determine the patterns of co-occurrence of mental illness, substance abuse and/or dependence, and chronic medical conditions. We also examined the association between the cumulative burden of these conditions, as well as living in poverty, and self-rated health.
Dr. Manisha Juthani-Mehta[/caption]
Manisha Juthani-Mehta, MD, FACP, FIDSA, FSHEA
Associate Professor, Section of Infectious Diseases
Infectious Diseases Fellowship Program Director
Yale University School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: One of the first studies that showed that cranberry juice was effective in older women living in nursing homes and assisted living facilities was published in 1994. Since that time, there have been multiple conflicting studies as to the effect of cranberry juice or capsules. We started our study in 2012. Shortly thereafter, a Cochrane review suggested that the vast body of evidence did not suggest that cranberry products work for UTI prevention, but questions still existed as to whether the appropriate dose of cranberry was being tested. Since cranberry juice is hard for older women to drink (taste, sugar load, volume), capsules at a high dose of the active ingredient (72mg type A proanthocyanidin [PAC}) was worthwhile to test.
This study was a clinical trial of two cranberry capsules with a total of 72mg of proanthocyanidin (pac) vs two placebo capsules to prevent bacteria in the urine of older women who live in nursing homes.
Unfortunately, it didn't work. It also didn't reduce the number of hospitalizations, deaths, antibiotics used, or antibiotic resistant bugs in the urine.
Jay Margolis, PharmD
Sr. Research Scientist
Truven Health
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Vitamin K antagonists (VKAs), most commonly warfarin, had been the only orally available anticoagulants available for the last 60 or so years. While highly effective, use of these agents was often problematic due to their narrow therapeutic index, need for routine coagulation monitoring, and interactions with food and other drugs. Recently introduced new oral anticoagulants (NOACs), particularly rivaroxaban, had been shown in clinical trials to provide comparable efficacy to the VKAs without the need for routine coagulation monitoring. There have been few studies outside of clinical trials showing benefits that translate to real-world populations.
In our study using real-world data from a large sample of geographically and demographically diverse US hospitals, patients hospitalized for incident venous thromboembolisms (VTE) initiating oral anticoagulant treatment with rivaroxaban had significantly shorter hospital stays and lower hospitalization costs compared with warfarin-treated patients.
Dr.Adewole S. Adamson[/caption]
Adewole S. Adamson, MD, MPP
Department of Dermatology
The University of North Carolina at Chapel Hill
Chapel Hill, NC
MedicalResearch.com: What is the background for this study?
Response: As the United States has moved to increasing levels of electronic medical record keeping, electronic prescribing has become an important part of improving the quality of care and patient experience. E-prescribing increases co-ordination between pharmacist and physician and decreases prescription errors. However, it is less certain whether e-prescribing affects patient primary adherence to medications, meaning whether or not a patient will fill and pick up their medication at the pharmacy. Although it may seem intuitive that primary adherence would increase by removing the patient from the prescription-to-pharmacy routing process, there have been few studies directly comparing primary adherence of patients given traditional paper prescriptions versus e-prescriptions.
Prof. Marc Dewey[/caption]
Professor Marc Dewey
Heisenberg professor of radiology
Vice Chairman of the Department of Radiology at Charité (Campus Mitte)
Berlin Germany
MedicalResearch.com: What is the background for this study?
Response: Over 3.5 million cardiac catheterisations are performed in Europe each year. This study, jointly conducted by radiologists and cardiologists at Charité – Universitätsmedizin Berlin and published in today’s issue of The BMJ, compares computed tomography (CT) with cardiac catheterisation in patients with atypical chest pain and suspected coronary artery disease (CAD).
MedicalResearch.com: What are the main findings?
Response: CT reduced the need for cardiac catheterisation from 100% to 14% in the group of patients who received CT first instead of catheterisation. If catheterisation was needed in the CT group, the proportion of catheterisations showing obstructive CAD was 5 times higher than in the catheterisation group. Over a period of 3.3 years, the patients in the CT group neither had more cardiac catheterisations nor an increase in cardiovascular events. Moreover, CT shortened the length of stay by 23 hours and 79% of patients said they would prefer CT for future examinations of the heart. Overall, the results of the BMJ study show that CT is a gentle test for reliably ruling out CAD in patients with atypical chest pain who are currently being referred for cardiac catheterisation in routine clinical practice.
Dr. Peter M. Glazer[/caption]
Peter M. Glazer, MD, PhD
Robert E. Hunter Professor of Therapeutic Radiology and Professor of Genetics; Chair, Department of Therapeutic Radiology
Yale University
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: It is generally recognized that gene editing in blood stem cells could provide a strategy for treatment of inherited disorders such as sickle cell disease and thalassaemia. Recent excitement has focused on CRISPR/Cas9 technology because of it is so easy to use. However, the CRISPR approach introduces an active DNA cutting enzyme into cells, which can lead to off-target cuts in the genome. As an alternative, we have pursued triplex-forming peptide nucleic acids (PNAs) designed to bind site-specifically to genomic DNA via strand invasion and formation of PNA/DNA/PNA triplexes. PNAs consist of a charge-neutral peptide-like backbone and nucleobases enabling hybridization with DNA with high affinity. PNA/DNA/PNA triplexes recruit the cell’s own DNA repair machinery to initiate site-specific editing of the genome when single-stranded ‘donor DNAs’ are co-delivered as templates containing the desired sequence modification.
We found that triplex-forming PNAs substituted at the gamma position yielded high levels of gene editing in blood stem cells in a mouse model of human β-thalassaemia. Injection of thalassemic mice with nanoparticles containing gamma PNAs and donor DNAs ameliorated the disease phenotype, with sustained elevation of blood hemoglobin levels into the normal range and up to 7% β-globin gene correction in stem cells, with extremely low off-target effects. We conclude that the combination of nanoparticle delivery and next generation PNAs may offer a minimally invasive treatment for genetic disorders of the blood that can be achieved safely and simply by intravenous administration.
Dr. Brett Wolfson-Stofko[/caption]
Brett Wolfson-Stofko, PhD Post-Doctoral Fellow
Behavioral Science Training Program
Center for Drug Use and HIV/HCV Research
Rory Meyers College of Nursing
New York University New York, NY 10003
Research Associate Institute for Special Populations
National Development & Research Institutes, Inc.
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Drug overdose mortality rates per year continue to rise in the US. Previous research suggests that public bathrooms are among the most popular public injection locations for people who inject drugs (PWID) in New York City. Though syringe exchange programs provide sterile injection equipment they are not authorized to offer a safe and sanitary space for injection which leads many, particularly those that are unstably housed, to inject in public spaces. This study interviewed 86 business managers throughout NYC and 58% (n = 50) of these managers had encountered drug use in their business bathroom within the past 6 months. Over one-third found improperly disposed syringes and 14% encountered unresponsive individuals. Only 10% of managers reported some form of overdose recognition and naloxone training while 64% of managers thought overdose recognition and naloxone training would be useful for them and their staff.
Dr. Pauline Camacho[/caption]
Pauline Camacho, MD, FACE
Professor, Endocrinology
Director, Loyola University Osteoporosis and Metabolic Bone Disease Center, Fellowship Program Director, Endocrinology, Medical Director, Osteoporosis Center
MedicalResearch.com: What is the background for this report? What is the prevalence and significance of osteoporosis in US women?
Response: Osteoporosis is widely prevalent and is increasing in prevalence not only in the US but also around the world. 10.2 million Americans have osteoporosis and that an additional 43.4 million have low bone mass. More than 2 million osteoporosis-related fractures occur annually in the US, more than 70% of these occur in women ( from National Osteoporosis Foundation (NOF) estimates).
Dr. Rachel H. Farr[/caption]
Rachel H. Farr, Ph.D.
Assistant Professor
Department of Psychology
University of Kentucky
MedicalResearch.com: What is the background for this study?
Response: Controversy continues to surround parenting by lesbian and gay (LG) adults and outcomes for their children. As sexual minority parents increasingly adopt children, longitudinal research about child development, parenting, and family relationships is crucial for informing such debates. This longitudinal study compared outcomes for children, parents, couples, and the overall family system among nearly 100 (N = 96) adoptive families with lesbian, gay, and heterosexual parents at two time points: when children were preschool-age, and approximately 5 years later, when children were in middle childhood. Child outcomes were assessed via parent- and teacher-reported behavior problems, while parent outcomes were assessed via self-reports of parenting stress levels. Couple and family outcomes were evaluated by parent reports of couple adjustment and overall family functioning.
Prof. Paul Aveyard[/caption]
Paul Aveyard PhD MRCP FRCGP FFPH
Professor of Behavioural Medicine
Nuffield Department of Primary Care Health Sciences
University of Oxford
Radcliffe Primary Care Building
Radcliffe Observatory Quarter
Oxford
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: We know that opportunistic brief interventions by physicians can be effective, but there is no evidence that they are so for obesity. Physicians worry that broaching this topic will be offensive, time-consuming, and ineffective. We needed a randomised trial to assess whether physicians’ fears were justified, or in fact brief interventions could be as effective for patients who are overweight as they are for smoking or problem drinking and that’s what we did.
Dr. Kelechi Okoroha[/caption]
Kelechi Okoroha, M.D.
Orthopaedic Surgery House Officer
Henry Ford Health System
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Historically, patient perceptions of surgeon reimbursement have been exaggerated compared with actual reimbursement. Currently there has been an increased focus or reducing health care cost, increasing access to health care and a shift to tie Medicare and insurance reimbursement to quality outcomes. Among these changes was the reduction in reimbursement payments for orthopedic surgeons. When we polled over 200 of our clinic patients, we found that most patients don’t think an orthopedic surgeon is overpaid but they greatly exaggerate how much a surgeon is reimbursed by Medicare for performing knee surgery. When told of the reimbursement payments, patients found them too be low and said they would be willing to pay more out-of-pocket costs. Patients also believe a surgeon should be compensated more for having fellowship training.
• Nearly 90 percent of patients say physicians are not overpaid and their salaries should not be cut.
• 61 percent of patients say a surgeon’s salary should not be tied to outcomes.
• 79 percent of patients say reimbursement to drug and device companies should be reduced.
Prof. Tony Charman[/caption]
Prof. Tony Charman
Chair in Clinical Child Psychology
King's College London, Institute of Psychiatry, Psychology & Neuroscience (IoPPN)
Department of Psychology
PO77, Henry Wellcome Building
De Crespigny Park
Denmark Hill London
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The study is a follow-up of a treatment trial on which we have previous reported. In the original Preschool Autism Communication Trial (PACT), 152 children aged 2-4 with autism were randomised to receive the 12 month early intervention or treatment as usual. The type of early intervention used in this study focuses specifically on working with parents. Through watching videos of themselves interacting with their child and receiving feedback from therapists, parents are able to enhance their awareness and response to their child’s unusual patterns of communication; they become better able to understand their child and communicate back appropriately in a focused way. Parents take part in 12 therapy sessions over 6 months, followed by monthly support sessions for the next 6 months. In addition, parents agree to do 20-30 minutes per day of planned communication and play activities with the child.
The study published today is the follow-up analysis of the same children approximately 6 years after the end of treatment. The main findings are that children who had received the PACT intervention aged 2-4 had less severe overall symptoms six years later, compared to children who only received ’treatment as usual’ (TAU) with improved social communication and reduced repetitive behaviours, although no changes were seen in other areas such as language or anxiety. These findings on an international recognised and blind rated observational measure of autism symptoms were accompanied by improvements in children’s communication with their parents for the intervention group, but no differences in the language scores of children. Additionally, parents in the intervention group reported improvements in peer relationships, social communication and repetitive behaviours. However, there was no significant difference between the two groups on measures of child anxiety, challenging behaviours (eg, conduct/oppositional disorder) or depression.
Dr. Geoffrey Mueller[/caption]
Geoffrey Mueller, Ph.D.
Staff Scientist
Genome Integrity and Structural Biology Laboratory
National Institute of Environmental Health Sciences
National Institutes of Health
Research Triangle Park, NC 27709
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: While allergic disease is a wide spread problem, it is actually a select few proteins, called allergens, that initiate allergy symptoms. This study was focused on looking for fundamental biochemical differences between allergens and non-allergens derived from the house dust mite.
We found that the mite allergens, as a group, are distinctly different from the non-allergens in that they are more highly produced, and more stable. Previous anecdotal evidence suggested that these properties would lead to more allergens surviving the journey from the source (either mites or pollens) to a person. In addition, the greater stability of allergens may influence the decision making of the immune system to target these proteins as dangerous instead of harmless.
Dr. Ann Kurth[/caption]
Ann Kurth, Ph.D., C.N.M., R.N.
USPSTF Task Force member
Dean of the Yale School of Nursing
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Breastfeeding is beneficial for both mothers and their babies, with the evidence showing that babies who are breastfed are less likely to get infections such as ear infections, or to develop chronic conditions such as asthma, obesity, and diabetes. For mothers, breastfeeding is associated with a lower risk for breast and ovarian cancer and type 2 diabetes. While breastfeeding rates have been rising in recent decades—with 80 percent of women starting to breastfeed and just over half still doing so at six months—they are still lower than the Healthy People 2020 targets and the Task Force wanted to review the latest evidence around how clinicians can best support breastfeeding.”
After balancing the potential benefits and harms, the Task Force found sufficient evidence to continue to recommend interventions during pregnancy and after birth to support breastfeeding. This recommendation includes the same types of interventions the Task Force recommended in 2008, such as education about the benefits of breastfeeding, guidance and encouragement, and practical help for how to breastfeed.
Dr. Susan L. McElroy[/caption]
Dr. Susan L. McElroy, M.D.
Professor of Psychiatry and Behavioral Neuroscience
Chief Research Officer
Lindner Center of HOPE
University of Cincinnati College of Medicine.
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: SPD489-346, designed as a multi-center, double-blind, placebo-controlled, dose-optimized, randomized-withdrawal study, is the first-ever longer-term pharmacologic study (38 weeks) to evaluate the maintenance of efficacy between Vyvanse and placebo in adults with moderate to severe binge eating disorder (B.E.D.).
Study SPD489-346 evaluated the longer-term maintenance of efficacy (38 weeks) between Vyvanse and placebo based on the primary endpoint of time to relapse during the randomized-withdrawal phase in adults aged 18 to 55 (N=267) with moderate to severe B.E.D. based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition – Text Revision (DSM-IV-TR®) criteria. In the study, relapse was defined as having two or more binge days per week for two consecutive weeks prior to any visit and an increase in Clinical Global Impressions-Severity (CGI-S) score of two or more points relative to the randomized-withdrawal baseline visit
Results from SPD489-346 indicated that Vyvanse (n=136) demonstrated significant maintenance of efficacy compared to placebo (n=131) based upon the primary endpoint of time to relapse. At the conclusion of the study, maintenance of efficacy for patients who had an initial response during the open-label phase, and then continued on Vyvanse during the randomized-withdrawal phase, was demonstrated with Vyvanse being superior over placebo as measured by time to relapse.
Safety and tolerability evaluations of Vyvanse included treatment-emergent adverse events (TEAEs) and vital signs. The safety profile for Vyvanse in this study was generally consistent with the known profile reported in previous studies in adult patients with moderate to severe B.E.D.
Vyvanse is indicated for the treatment of moderate to severe B.E.D. in adults. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.
Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Vyvanse may harm others and is illegal.
Dr. Jeri Nieves[/caption]
Dr. Jeri Nieves PhD
Director of bone density testing
New York's Helen Hayes Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Amyotrophic lateral sclerosis (ALS) is a devastating severe neurodegenerative disorder that causes progressive muscle atrophy, paralyses, and eventual respiratory failure.
Our objective was to evaluate the associations between nutrition and severity of ALS around the time of diagnosis. This was a cross-sectional analysis of data from a multicenter cohort of 302 patients with ALS. We assessed nutrient intake using a modified Block Food Frequency Questionnaire. The outcomes were respiratory function (measured using percentage forced vital capacity; FVC%) and functional performance measured by ALS Functional Rating Scale–Revised (ALSFRS-R), both considered important indicators of the severity of ALS. Results of the regression analysis were that higher intakes of antioxidants and carotenes from vegetable intake were associated with higher ALSFRS-R scores or better %FVC.
We used a novel analysis to evaluate the diet as a whole and found that higher intakes of antioxidants, fiber from grains, vegetables, fruit, eggs, fish, and poultry were all associated with higher function in patients with ALS. However, milk and lunch meats were associated with lower measures of function. These consistent results from two different statistical analyses indicate that diet may help minimize the severity of ALS. Perhaps these findings point to the role of oxidative stress in ALS severity.
In summary, increased consumption of antioxidant nutrients, foods high in carotenoids and fiber, vegetables and fruits, poultry and fish are associated with better function around the time of ALS diagnosis.