MedicalResearch.com Interview with:
Amneet Sandhu, MD
Department of Internal Medicine
Division of Cardiovascular Medicine
University of Colorado
Aurora, CO 80045.Medical Research: What is the background for this study? What are the main findings?
Dr. Sandhu: Control of hypertension has improved nationally to guideline recommended levels. To date, the focus of hypertensive care has been around identification and appropriate treatment to blood pressure goals. Less emphasis has been placed on maintenance of control or tracking patients with high rates of relapse after achieving control.
This study sought to assess the rate of recidivism in a cohort of hypertensive patients with controlled blood pressure and identify patient and process of care factors associated with recidivism. We found approximately 25% of hypertensive patients with baseline controlled blood pressure relapse over a median time period of 7.3 months. Patients with diabetes, high normal baseline blood pressure and poor medication adherence were more likely to suffer from recidivism.
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MedicalResearch.com Interview with:
Kira S. Birditt, Ph.D.
Research Associate Professor
Life Course Development Program
The Institute for Social Research
University of Michigan Ann Arbor, MI
Medical Research: What is the background for this study? What are the main findings?
Dr. Birditt: We know that negative marital quality (e.g., conflict, irritation) has important implications for physical health but the mechanisms that account for these links are still unclear. This study explored links between negative marital quality (e.g., criticism, demands), stress (long term chronic stresses) and blood pressure among older married couples in a large longitudinal nationally representative sample of couples in the U.S.. We found that husbands had higher blood pressure when wives reported greater stress and that this link was even greater when husbands felt more negative about the relationship. In addition, negative marital quality experienced by only one member of the couple was not associated with blood pressure but when both members of the couple reported higher negative marital quality they had higher blood pressure. (more…)
MedicalResearch.com Interview with:Jeanne M. Meck, PhDFACMG
Director, Prenatal Diagnosis & Cytogenomic
GeneDx
Gaithersburg, MD 20877
Medical Research: What is the background for this study?
Dr. Meck: Non-invasive prenatal screening (NIPS) for fetal aneuploidy is a new test which requires only a blood sample from the pregnant mother to provide a risk estimate of whether or not her fetus has a chromosomal aneuploidy such as trisomy 21 (Down syndrome), trisomies 13 or 18, or a sex chromosome abnormality. This testing relies on the fact that circulating maternal blood contains cell free fetal DNA. Published studies have reported very high specificities and sensitivities. However, the more important question is what is the positive predictive value (PPV= #true positive results/#true positive + false positive results) since it answers the question of interest to physicians and patients: “Given an Non-invasive prenatal screening result that shows a high risk for a given fetal aneuploidy, what is the chance that the fetus is affected?” We attempted to answer this question by looking at the results of fetal chromosome analyses on chorionic villus samples (CVS) or amniotic fluid that were referred to our cytogenetics laboratories after Non-invasive prenatal screening in order to see if NIPS correctly predicted the fetal karyotype.
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MedicalResearch.com Interview with:
Stacie B. Dusetzina PhD
Assistant professor in the Eshelman School of Pharmacy and the Gillings School of Global Public Health
University of North Carolina at Chapel Hill
Member of the Lineberger Comprehensive Cancer Center
Medical Research: What is the background for this study? What are the main findings?
Dr.Dusetzina: Charges for health services — the amounts providers request before payments are negotiated — have not been widely known for services delivered in physicians’ offices. Charges can be considered the maximum amount that would be paid by a person without insurance who does not or is unable to negotiate for a lower price. In this study we used recently released data from the Medicare Provider Utilization and Payment Public Use File and other sources to measure what physicians charged for chemotherapy drugs delivered intravenously in 2012 and the amounts reimbursed by Medicare and private health plans for the same services.
We found that uninsured cancer patients may be asked to pay from 2 to 43 times what Medicare pays for chemotherapy drugs. Medicare and insurers don’t pay the sticker price of health care. They pay a discounted rate. However, uninsured patients don’t have the bargaining power, or they may not try to negotiate for a better price. On average, Medicare paid approximately 40 percent of the charged amounts for chemotherapy drugs. Private insurers paid nearly 57 percent of the charged amounts on average. We also looked at what cancer patients were asked to pay for an office visit. Uninsured patients may be asked to pay from $129 to $391, depending on the complexity of the visit. Medicare paid between $65 and $188 and private insurance paid between $78 and $246 for the same visits.(more…)
MedicalResearch.com Interview with:
Dr. Riccardo Capocaccia
Evaluative Epidemiology Unit
Department of Preventive and Predictive Medicine
Fondazione Istituto Nazionale Tumori
Milan, Italy
Medical Research: What is the background for this study? What are the main findings?Dr. Capocaccia: Life expectancy of cancer patients is usually provided at diagnosis, as a measure of cancer burden. However, no systematic data are available on life expectancy at different times after diagnosis, as a measure of the residual impact of the disease in survivors.
At diagnosis, young patients face a higher loss in life expectancy, with respect to cancer-free people of the same age, than older ones. Thereafter, life expectancy gradually approaches, but hardly reaches, that of all patients of the general population.
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MedicalResearch.com Interview with:
Luis Squiquera, MD
Tamir Biotechnology
MedicalResearch: What is the background for this study? What are the main findings?Dr. Squiquera: Ranpirnase is a small peptide that has a characteristic enzymatic activity against double stranded RNA (dsRNA). As a drug it has been extensively tested intravenously in high concentration for oncology in over 1000 patients with different types of malignancy, especially mesothelioma, with minimal side effects and mainly a transient increase of serum creatinine level observed.
In the last year we started a comprehensive antiviral program and obtained encouraging results in several RNA and DNA virus families. Several research groups have already studied the anti HIV activity. HPV was one of many viruses that showed a high selectivity index in our antiviral screening (the relationship between efficacy and cytotoxicity). We were encouraged by the low concentrations (nanomolar range) needed to stop virus reproduction in cell cultures. We performed in vitro analysis of two of the main HPV types that cause human disease (HPV 11 and 16). HPV 11 was highly sensitive to ranpirnase; and since this is one of the main virus type responsible for inducing genital warts, we decided to focus our efforts in bringing the drug to a new route of administration.
We set out to obtain and did obtain a formulation that was extremely stable, even at high temperatures. Before using it in patients, we performed testing for irritation using standardized Draize animal models. Even though we ran these tests in high concentrations (1 mg/ml) the final product was not irritant and was deemed safe to use in a clinical setting.
With these safety data on hand – plus extensive experience in IV dosing and non-irritation in animal models – we decided to make the formulation available as a compassionate use for patients with genital warts.
As we reported in our presentation in San Francisco, all cases that completed an 8-week treatment showed clearance of the lesions. Some of the cases were cleared in as soon as two weeks and the average time for clearance was 33 days. One of the patients had to be discontinued due to an eczematous skin reaction. We will be studying the characteristic of this effect in our trials. (more…)
MedicalResearch.com Interview with:
Cary P. Gross MD
Professor of General Medicine, of Epidemiology (Chronic Diseases) and of Faculty of Arts and Sciences
Yale...
MedicalResearch.com Interview with: Dr. Lim Lee Wei
School of Biological Sciences, Nanyang Technological University, Singapore;
Department of Biological Sciences, Sunway University, MalaysiaMedical Research: What is the background for this study? What are the main findings?
Response: To date, pharmacological treatments for dementia have limited effects (most of the drugs failed in the second or third clinical trials) and there are no known treatments that cure or delay the progression of this memory impairment. Therefore, a novel non-pharmacological approach such as deep brain stimulation (DBS) is currently considered as an alternative treatment to reduce the symptomatic and progression of this memory deterioration.
Deep brain stimulation for dementia-related disease is currently evaluated as a potential therapy. In line with this development, evidence from recent studies suggests that deep brain stimulation might enhance memory functions when particular brain areas are stimulated. Of particular interest in our study, electrical stimulation of the Prefrontal Cortex induced striking antidepressant activity in both patients and animals studies (see our recent study, Lim et al., 2015 Translational Psychiatry; http://www.nature.com/tp/journal/v5/n3/full/tp201524a.html). However, no studies have shown the putative role of Prefrontal Cortex deep brain stimulation in learning and memory performance. In our finding, we have shown that deep brain stimulation of this region (Prefrontal Cortex) improved the short-term and long-term memory by a very important mechanism, which led to the formation of new brain cells in another region of the brain called the hippocampus, which is also involved in memory. Therefore, our findings suggest that deep brain stimulation of the Prefrontal Cortex has the potential to be developed into a therapy to treat dementia and other conditions that lead to memory loss in humans.
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MedicalResearch.com Interview with:
Bryan B. Shapiro
Harold Simmons Center for Kidney Disease Research and Epidemiology and
Division of Nephrology and Hypertension
Los Angeles Biomedical Research Institute
Harbor–UCLA Medical Center Torrance, California
Medical Research: What is the background for this study? What are the main findings?
Response: The inverse relationship between body mass index (BMI) and mortality rates is well-documented in maintenance hemodialysis (MHD) patients. Virtually everyone has assumed that this relationship reflects the effect of body weight, and especially fat mass, on mortality in these patients. However, height is also a component of the BMI equation (BMI = body weight (kg)/height (m²)) and may be independently associated with mortality in MHD patients. The results of this study, which examined 117, 644 MHD patients and was controlled for many demographic and laboratory variables, indicate that height, adjusted for body weight, is directly associated with mortality in a manner that is opposite to the weight-mortality relationship. Moreover, we found that the contribution of height to the inverse BMI-mortality relationship in dialysis is essentially as great as the contribution of weight. (more…)
MedicalResearch.com Interview with:
Emily Finlayson, MD, MS
Department of Surgery, Division of General Surgery
Department of Medicine, Division of Geriatrics
Philip R Lee Institute for Health Policy
University of California, San Francisco
Director, UCSF Center for Surgery in Older Adults
Medical Research: What is the background for this study? What are the main findings?
Dr. Finlayson: In general, the goal of lower extremity revascularization is to preserve the leg so that patients can maintain the ability to ambulate and maintain functional independence. We evaluated the results of this operation in older nursing home residents in the United States. We found that over the 3 year study period, over 10,000 nursing home residents underwent this procedure. Most of them were functionally dependent before surgery, 3/4 were unable to walk, and over half had dementia.
After 1 year, half of the residents had died. Among residents who could not walk before surgery, 89% were dead or non ambulatory 1 year after surgery.
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MedicalResearch.com Interview with:
Thomas Karakolis
Department of Kinesiology
University of Waterloo
Waterloo, Ontario, Canada
Medical Research: What is the background for this study? What are the main findings?Response: Major League Baseball (MLB) pitchers have an injury rate approaching 1 in 4, depending on the study you look at. As an occupational injury rate, this number is extremely high. In fact, I think you would be hard pressed to find another industry where the injury rate is that high.
One way that coaches and managers in MLB are trying to lower the
injury rate is to restrict the total 'workload' on pitchers per
season. Particularly in young pitchers, many MLB organizations
restrict the number of innings a pitcher can pitch based upon the
number of innings they pitched the previous year. Essentially, they
are using innings pitched as a surrogate for workload.
If this is an effective strategy, you would expect a correlation
between the increase in number of innings pitched between successive
seasons and future injury. Our study found that no such correlation
exists. Innings pitched does not appear to be a sensitive enough
measure to asses the true workload a pitcher experiences throughout
the season.
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MedicalResearch.com Interview with:
Dr. Joseph Bosco MD III
Orthopedic Surgery
The New York University Langone Medical Center
Medical Research: What is the background for...
MedicalResearch.com Interview with:
Kimberly Gudzune, MD, MPH
Assistant Professor; The Johns Hopkins University School of Medicine
Core Faculty; Welch Center for Prevention, Epidemiology, and Clinical Research
The Johns Hopkins Digestive Weight Loss Center
Medical Research: What is the background for this study? What are the main findings?
Dr.Gudzune: Changes in healthcare policy may encourage healthcare providers to screen their patients for obesity, so it is critical to then have a weight management plan if obesity is identified. Recent guidelines recommend that clinicians consider referring patients to high intensity weight loss programs. Commercial weight loss programs may be one of the options available, so providers need to know which programs help people lose weight and keep it off.
We found that only 11 out of 32 programs that we looked at had rigorous studies reporting on weight loss, which means that we do not know whether most programs work. Several well-known commercial programs have been scientifically tested and two programs, Weight Watchers and Jenny Craig, achieved significant weight loss that was sustained 12 months later.
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MedicalResearch.com Interview with: Dr. Reshma Jagsi MD, DPhil
Associate Professor and Deputy Chair for Faculty and Financial Operations in the Department of Radiation Oncology at the University of Michigan Health System
Research Investigator at the Center for Bioethics and Social Sciences in Medicine
University of Michigan
Medical Research: What is the background for this study? What are the main findings?
Dr. Jagsi: We surveyed women diagnosed with breast cancer and found that many women were concerned about the genetic risk of developing other cancers themselves or of a loved one developing cancer. Overall, 35 percent of the women we studied expressed a strong desire for genetic testing, but 43 percent of those did not have a relevant discussion with a health care professional. In addition, minority patients with a strong desire for testing were less likely to discuss it with a professional, even though studies show that minority patients are not at lower risk for these mutations.
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MedicalResearch.com Interview with:
Anthony Delitto, PT, Ph.D, FAPTA
Professor and Chair
Department of Physical Therapy
Associate Dean for Research, SHRS
School of Health and Rehabilitation Sciences
University of Pittsburgh
Medical Research: What is the background for this study? What are the main findings?
Dr. Delitto: I work with a team, many of whom were authors on the paper, and we see a lot of patients with lumbar spinal stenosis. Some of them did very well with Physical Therapy and avoided surgery. Some people didn’t do well and we ended up having surgery. We really wanted to do a study that compared, in a randomized format, doing surgery vs. a non-surgical approach to lumbar spinal stenosis. The idea we had was to really put the two approaches head to head – a randomized trial of surgery vs. physical therapy for people with lumbar spinal stenosis. We decided only to recruit patients after they had consented to surgery in order to avoid the pitfalls of previous studies where people crossed over after being assigned to a group, for example, being assigned to surgery and then deciding against having surgery.
Medical Research: What should clinicians and patients take away from your report?Dr. Delitto: Probably the biggest point to put across to physicians, patients and practitioners, one of the things we realized was: patients don’t exhaust all of their non-surgical options before they consent to surgery. And physical therapy is one of the non-surgical options. The obvious finding is, when you compare the two groups, they seem to do the same. The results were equivalent at two years. Now, embedded in that, there are patients who did well in surgery, and patients who failed in surgery. There are patients who did well in Physical Therapy, and there are patients who failed with PT. But when we looked across the board at all of those groups, their success and failure rates were about the same. So it tells us that for the most part there were equivalent outcomes at two years.
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MedicalResearch.com Interview with:
Holly Gooding, MD, MS
Harvard T.H. Chan School of Public Health
Instructor in Pediatrics at Harvard Medical School
Division of Adolescent/Young Adult Medicine, Boston Children’s Hospital Division of General Internal Medicine
Brigham and Women’s Hospital Boston, MA
Medical Research: What is the background for this study? What are the main findings?
Dr. Gooding: As an adolescent medicine physician, I primarily care for patients between the ages of 12 and 30, although I first trained in internal medicine. One of the things I noticed when I started working with this age group is that pediatric and adult guidelines differ for many conditions. Cholesterol treatment is one condition that comes up frequently, because the NHLBI and the AAP recommend screening youth ages 17 to 21 for cholesterol problems.
The study team and I set out to discover the proportion of American youth ages 17 to 21 who would meet criteria for pharmacologic treatment of abnormal cholesterol levels if clinicians applied the pediatric versus the adult guidelines. We found that 2.6% of young people ages 17 to 21 would qualify for pharmacologic treatment of abnormal LDL cholesterol levels under the pediatric guidelines, but less than 1% would qualify under the adult guidelines. This translates to almost 500,000 youth qualifying for treatment under the pediatric guidelines, but only about 78,000 under the adult guidelines. Those who met pediatric criteria had lower LDL levels but higher proportions of high blood pressure, smoking, and obesity.
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MedicalResearch.com Interview with:
Dr. Mark Roschewski, MD and Dr Wyndham H Wilson MD-PhD
Lymphoma Therapeutics Section
Lymphoid Malignancies Branch, Center for Cancer Research
National Cancer Institute, National Institutes of Health
Bethesda, MD 20892
Medical Research: What is the background for this study? What are the main findings?
Response: Monitoring patients with diffuse large B-cell lymphoma (DLBCL) has relied on computed tomography (CT) scans which are imprecise, expensive and include radiation. We investigated the ability of a blood-based assay to monitor patients with DLBCL during and after their initial therapy. The assay we studied amplifies and quantifies small amounts of circulating tumor DNA from the patient’s blood. We showed that this assay effectively predicts which patients will relapse and identifies recurrence 3.5 months before CT scans.
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MedicalResearch.com Interview with:
Prof. Chetna Malhotra M.B.B.S., M.D. M.P.H.
Lien Centre for Palliative Care
Duke-NUS Graduate Medical School Singapore, Singapore
Medical Research: What is the background for this study? What are the main findings?Dr. Malhotra: Patients with advanced cancer often have to make difficult decisions, such as how much to spend on moderately life- extending treatments. This and other end-of-life decisions are also influenced by their informal caregivers. In this study, we aim to understand the relative value that advanced cancer patients and their caregivers place on various aspects of end-of-life care. We conducted a cross-sectional survey of 211 patients with stage IV cancer and their primary informal caregivers. Participants were asked to choose their most-preferred end-of-life scenarios out of a series of options that varied along key dimensions, including years of life remaining, degree of pain experienced, place of death, level of burden on caregivers, quality of healthcare experience, cost, and source of payment (cash, Medisave, or family members’ cash or Medisave). Using the results, we quantified patients and caregivers willingness to pay to improve their end of life experience. We found that the patients’ willingness to pay to extend their life by one year was valued at S$18,570, which is lower than their willingness to pay to avoid severe pain (S$22,199), or to die at home (S$31,256). Caregivers had a three-fold greater willingness to pay than patients to extend life by one year and for most of the other features considered. These results suggest that health insurers and physicians may be putting too much emphasis on life extending treatments for these patients. Further, there is a need to elicit patient preferences during treatment decision making as opposed to just relying on caregiver input.(more…)
MedicalResearch.com Interview with:
Dr. Karla Unger-SaldañaUnit of Epidemiology
Instituto Nacional de Cancerología
Mexico City, Mexico.
Medical Research: What is the background for this study?
Dr. Unger-Saldaña: Even though Breast Cancer is most common in the developed world, most cancer deaths actually occur in developing regions. This is mainly because patients are diagnosed in advanced stages, with poor chances of survival. Most studies have shown that long times between symptom discovery and treatment start (total delay) are associated with advanced clinical stage. Like total delay, patient delay -a prolonged time between symptom discovery and the first medical consultation- has also shown to be associated with advanced clinical stage. But the impact of health system delay -the time between the first clinical consultation and the start of cancer treatment- is less clear. Studies have shown contradictory findings. For example, studies in developed countries have found the reverse association: advanced stages associated with short times between first medical consultation and treatment start. This has been attributed to the ability of doctors to quickly identify patients with advanced cancer and somehow accelerate their care.
Medical Research: What are the main findings?
Dr. Unger-Saldaña: In this study, done among 886 patients, we found that the majority started cancer treatment in advanced stages, with only 15% being diagnosed in stages 0 and I. Also, we found long delays for breast cancer diagnosis and treatment in most cases. The median time between symptom discovery and cancer treatment start was 7 months. The longest subinterval was that between the first medical consultation and diagnosis confirmation, which had a median of 4 months. The most relevant result was that not only was patient delay associated with advanced stage, but also health system delay. For every additional month of health system delay, the probability of starting treatment in advanced stage was increased by 1%.
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MedicalResearch.com Interview with:
Hannah Arem, MHS, PhD
Division of Cancer Epidemiology and Genetics
National Cancer Institute, Bethesda, Maryland
Medical Research: What is the background for this study?
Dr. Arem: The 2008 Physical Activity Guidelines for Americans recommend a minimum of 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity activity per week for “substantial” health benefit, and suggest “additional” benefit with more than double the exercise minimum. However, the guidelines note that there is a lack of evidence for an upper limit of health benefit. We set out to define the dose-response relationship between leisure-time physical activity and mortality and to determine the upper limit of benefit associated with higher levels of aerobic exercise.
Medical Research: What are the main findings?
Dr. Arem: We found that study participants who met the recommended minimum level of leisure-time physical activity derived most of the mortality benefit, with a 31% lower risk of death compared to inactive individuals. Study participants who engaged in three to five times the recommended minimum level of leisure-time physical activity had a marginally increased mortality benefit, with a 39% lower risk of death compared to inactive individuals. Three to five times the recommended minimum is equivalent to a weekly minimum of walking 7 hours or running 2 hours 15 minutes.
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MedicalResearch.com Interview with:
Klaus Gebel
GradDipExRehab, MExSc, MAppSc, PhD
Senior Research Fellow
Centre for Chronic Disease Prevention
College of Public Health, Medical & Veterinary Sciences
James Cook University
Cairns Australia
Medical Research: What is the background for this study?
Response: The physical activity guidelines in most countries recommend for adults to accumulate at least 150 minutes of moderate physical activity (e.g. brisk walking) or 75 minutes of vigorous activity (e.g. jogging or cycling) or an equivalent combination of moderate and vigorous activities where 2 minutes of moderate-intensity activity counts the same as 1 minute of vigorous-intensity activity. However, there have only been a few studies that examined the health benefits of different proportions of moderate and vigorous activity in the composition of total activity. The objective of this study was to examine whether the proportion of total moderate-to-vigorous activity that is achieved through vigorous activity is associated with all-cause mortality, independently of the total amount of moderate-to-vigorous activity. Data were used from the 45 and Up study from the state of New South Wales in Australia, the largest cohort study ever conducted in the Southern hemisphere.
Medical Research: What are the main findings?
Response: During 1,444,927 person-years of follow-up, 7,435 deaths were registered. Compared with those who reported no moderate-to-vigorous activity (crude death rate=8.34%), the adjusted hazard ratios for all-cause mortality were 0.66 (95% CI 0.61-0.71; crude death rate=4.81%), 0.53 (0.48-0.57; 3.17%), and 0.46 (0.43-0.49; 2.64%) for reporting 10-149, 150-299, and for ≥300 minutes of activity per week respectively. Among those participants who reported any moderate-to-vigorous physical activity, the proportion of vigorous activity showed a dose-response relationship with all-cause mortality: compared with those reporting no vigorous activity (crude death rate=3.84%) the fully-adjusted hazard ratio was 0.91 (95% CI=0.84-0.98; crude death rate=2.35%) in those who reported some vigorous activity (but <30% of total activity); and 0.87 (0.81-0.93; 2.08%) among those who reported ≥30% of activity as vigorous. These associations were consistent in men and women, across categories of body mass index and volume of moderate-to-vigorous physical activity, and in those with and without existing cardiovascular disease or diabetes mellitus.
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MedicalResearch.com Interview with:
Professor of Pediatrics Hans Bisgaard, MD, DMSc
Copenhagen Prospective Studies on Asthma in Childhood
Herlev and Gentofte Hospital,
University of Copenhagen, Denmark
Medical Research: What is the background for this study?Dr. Bisgaard: Extended breast-feeding is recommended for
newborn children at risk of allergy-associated diseases, but the
evidence of a protective effect on sensitization and these diseases
remains elusive.
Medical Research: What are the main findings?Dr. Bisgaard: Exclusive breastfeeding does not affect
sensitization in early childhood or associated diseases at 7 years
of age in at-risk children.
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MedicalResearch.com Interview with:
Marya Viorst Gwadz, Ph.D
Senior Research Scientist Director,
Transdisciplinary Methods Core
Center for Drug Use and HIV Research (CDUHR)
New York University College of Nursing
New York, NY 10010Medical Research: What is the background for this study?
Dr. Gwadz: HIV is a major success story in that the tolerability, convenience, and efficacy of antiretroviral medications have improved dramatically over the last decade. A number of years ago in the course of another research study with vulnerable individuals infected with HIV in New York City, and we noticed that a substantial proportion of study participants were medically eligible for HIV medications, and had access to medications, but had declined or stopped taking them. We then turned our attention to understanding why this is the case, that is, to identify the individual, social, and structural barriers that persons living with HIV/AIDS (PLHA) experience to antiretroviral therapy. We focused in particular on African American/Black and Latino/Hispanic PLHA, because the overall emphasis of our research group at the NYU College of Nursing is the development and evaluation of culturally targeted intervention approaches to address health disparities. Around 2011, studies of the “HIV cascade of care” began to emerge, which highlighted the problem of poor engagement in HIV care and antiretroviral therapy nationally. The ultimate goal of HIV treatment is viral suppression, but at present, the Centers for Disease Control and Prevention (CDC) estimates that we have achieved that goal with only 30% of PLHA.
Medical Research: What kind of intervention approach that emerged from these background findings?Dr. Gwadz: We found that barriers to HIV medication are complex and multi-faceted for PLHA from African American/Black and Latino/Hispanic backgrounds. In particular, PLHA experience serious emotional barriers to the uptake of HIV medications, such as fear of side effects, stigma, and disclosure of HIV status. Further, high rates of substance use and mental health distress, and barriers to accessing services for these concerns, impede medication uptake. Moreover, PLHA who are wary of HIV medication tend to avoid HIV primary care, often because they do not want to feel pressured to take medications, or explain to their providers why they are not taking them. So poor engagement in HIV care, which is very common among PLHA, and low uptake of HIV medication are actually related problems.
With funding from the National Institute of Mental Health (grant #R34MH093352), and in collaboration with Mount Sinai Beth Israel and Mount Sinai St. Luke’s-Roosevelt Hospital Center, we developed a multi-component culturally targeted intervention grounded in the Motivational Interviewing approach that included three individual sessions, 12-24 weeks of patient navigation (as needed), up to five support groups with other PLHA who had declined medication, which were co-led by a “successful” peer who was engaged in HIV care and were taking HIV medication with good adherence. One novel aspect of the intervention was its focus on emotional barriers to HIV medication, and the program’s “no pressure, no judgment” stance, congruent with the Motivational Interviewing approach, was key to engaging participants into the study to talk about these difficult issues.
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MedicalResearch.com Interview with:
Trever G. Bivona MD PhD
Assistant Professor, Hematology and Oncology
UCSFMedical Research: What is the background for this study? What are the main findings?
Dr. Bivona: Resistance to targeted cancer therapy remains a problem in the treatment of cancer patients. These targeted drugs are often effective at shrinking the tumor, but do so incompletely. This incomplete response results in residual disease that is drug resistant and eventually grows to cause relapse that is lethal in patients. We investigated the mechanisms underlying this residual disease state in lung cancers treated with the EGFR targeted therapy Tarceva. We discovered that the tumor cells survival initial EGFR targeted therapy treatment by activating a signaling pathway called NF-kappa B. This NF-kappa B pathway then promotes tumor cell survival, residual disease, and eventual relapse in the lung cancer models we studied.
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Alison Ng PhD, BSc(Hons), MCOptom
Post-Doctoral Fellow
Centre for Contact Lens Research
School of Optometry & Vision Science
University of Waterloo
Waterloo, Ontario Canada
Medical Research: What is the background for this study? What are the main findings?
Dr. Ng: Eye care practitioners often see patients coming into our clinics with eyeliner “floating” in the tears or adhered to the surface of contact lenses during our routine examinations. When products such as eyeliner enters and contaminates the tear film, some patients complain of temporary discomfort, and if they wear contact lenses, they may report blurred vision if the lenses become spoiled. Specifically in this pilot study, we wanted to look at how differently eyeliner migrated into the tear film when applied in two different ways: inside the lash line and outside of the lash line.
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MedicalResearch.com Interview with:
Gustavo C Machado, PhD student
The George Institute for Global Health, Sydney Medical School
University of Sydney Sydney Australia
(Editor’s note: Paracetamol isalso known as acetaminophen)
MedicalResearch: What is the background for this study? What are the main findings?
Response: Back pain and osteoarthritis are the two major musculoskeletal conditions affecting people worldwide, and paracetamol is the most used over the counter medicine to treat these conditions. Recent debates on the efficacy and safety of paracetamol prompted us to conduct a systematic review of literature on the efficacy of this medication. In our study we included all available clinical trials that compared paracetamol to placebo, and our conclusions are based on data from more than 5,300 patients with low back pain and hip or knee osteoarthritis. We found that paracetamol is ineffective for low back pain and provides small and not clinically important benefits to patients with osteoarthritis.
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MedicalResearch.com Interview with:
Ricardo Battaglino, Ph.D.
Department of Mineralized Tissue Biology
The Forsyth Institute, Cambridge, Massachusetts
Department of Oral Medicine, Infection, and Immunity
Harvard School of Dental Medicine,
Boston, Massachusetts
Medical Research: What is the background for this study? What are the main findings?
Dr. Battaglino: Mutations in sorting nexin 10 (Snx10) have recently been found to account for roughly 4% of all human malignant osteopetrosis, some of them fatal. To study the disease pathogenesis, we investigated the expression of Snx10 and created mouse models in which Snx10 was knocked down globally or knocked out in osteoclasts. We found that Snx10, a molecule expressed in osteoclasts, was also expressed in the stomach. Studies in tissue specific or global knock-down mice showed that Snx10 deficiency resulted in a phenotype that was a consequence of deficiencies in both osteoclasts and gastric zymogenic cells. Our studies add to a growing list of genes, including atp6i (Tcirg1), whose expression is required both in bone and stomach to maintain normal gastric acidification and calcium absorption.
Medical Research: What should clinicians and patients take away from your report?Dr. Battaglino: Our work provides additional insight into the mechanisms governing the regulation of bone accrual by the gastrointestinal tract. Because osteopetrorickets has not been described clinically in Snx10-related osteopetrosis, these findings highlight the importance of considering impaired acidification in both stomach and bone in osteopetrotic patients with mutations in SNX10 and other genes with similar patterns of expression and activities. Reliance solely on hematopoietic stem cell transplantation can leave hypocalcemia uncorrected with sometimes fatal consequences. Because defects in gastric differentiation and/or gastric acidification may cause or contribute to hypocalcemia, bone insufficiency, and early death, our results suggest that dietary calcium supplementation could be a life-saving intervention in these patients.
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MedicalResearch.com Interview with:
Amalia Z. Berna
CSIRO Food and Nutrition Flagship
Acton ACT 2601
MedicalResearch: What is the background for this study? What are the main findings?Response: Globally an estimated 3.2 billion people in 97 countries are at risk of malaria and, in 2013, an estimated 198 million cases and 584,000 deaths were attributed to this infection. Accurate diagnosis of malaria is important to provide adequate treatment, conserve valuable drugs, and help prevent the emergence of resistant strains of the parasite. It is becoming important to be able to diagnose low level and asymptomatic cases, to support the drive towards local and/or global eradication.
Detection of volatile chemicals in expired breath has been used to diagnose or monitor a small number of diseases, including Helicobacterpylori infection, diabetes and lung inflammation but, if breath analysis is to be more broadly useful, we need to identify reliable biomarkers for a wider range of diseases and to develop more robust methods for breath analysis.
In collaboration with Professor James McCarthy of the QIMR Berghofer Institute and Associate Professor Kevin Saliba of the ANU, we found:
Four specific thioether biomarkers in the breath of volunteers with experimentally induced blood stage Plasmodium falciparum
That the levels of the volatiles strongly correlate with the levels of malaria parasitaemia.
That the thioethers are not produced by in vitro cultures of falciparum.
That although we do not know the metabolic origin of the thioethers, our results suggest that interplay between host and parasite metabolic pathways is involved in their production.
We think it is important to emphasise that no volunteer was infected with malaria primarily for the purpose of this study. Our research was entirely piggy-backed on pre-existing trials of malaria therapeutics.
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MedicalResearch.com Interview with: Nan Hee Kim M.D., Ph.D., Professor
Korea University Ansan Hospital,
Gojan1-dong, Danwon-gu, Gyunggi-do, Korea
MedicalResearch: What is the background for this study? Dr. Nan Hee Kim: Many individuals in modern society experience a discrepancy between social and biological time. Especially during the work or school week, we are often forced to be awake against our preferred time. In addition, the increase of light, TV, computer and internet make people stay up late at night. However, night owls (evening persons) have been reported to have more health and behavioral problems than morning persons. Evening persons experience eating disorders, negative mood and insufficient sleep compared to morning persons. They initiate sleep later in the night but need to wake up earlier than their biologic morning due to social demands. There is abundant evidence that short sleep duration and insomnia are significant risk factors for obesity and diabetes. Therefore, we feel the necessity to reveal whether evening persons are associated with metabolic abnormalities in the general population.
MedicalResearch: What are the main findings?Dr. Nan Hee Kim: In middle-aged adults, people who stayed up late had a 1.7-fold increased risk for type 2 diabetes and metabolic syndrome, and a 3.2-fold increase in risk for sarcopenia as compared with morning persons, independent of sleep duration and lifestyle. Evening persons were associated with reduced muscle mass in men and increased fat mass including visceral fat in women.
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MedicalResearch.com Interview with:
Dr Richard Forshee PhDAssociate Director for Research in the Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, MD
On behalf of the study authorsMedical Research: What is the background for this study? What are the main findings?
Dr. Forshee: Influenza continues to be a major public health concern causing illness, hospitalization, and death. The elderly are at highest risk for seasonal influenza complications, including hospitalization and death. As people grow older their ability to raise a strong protective immune response can weaken. The availability of a vaccine that uses a higher dose to induce a stronger immune response could reduce the serious impact of influenza in this age group. The purpose of this study was to determine whether a high-dose inactivated influenza vaccine was more effective for prevention of probable influenza infections and influenza-related hospital admissions, compared to standard-dose inactivated influenza recipients.
In December 2009, the U.S. Food and Drug Administration (FDA) licensed Fluzone High Dose, an injectable inactivated trivalent seasonal influenza vaccine for people ages 65 years and older. This high-dose vaccine contains four times more hemagglutinin—the active ingredient in influenza vaccines that cause the human body to produce antibodies against the influenza viruses—than the standard-dose vaccine. The FDA approved the high-dose vaccine using the accelerated approval regulatory pathway, which allows the agency to approve products for serious or life-threatening diseases based on reasonable evidence of a product’s effectiveness. This pathway reduces the time it takes for needed medical products to become available to the public. Studies conducted prior to licensure showed an enhanced immune response to the high-dose vaccine compared with the standard-dose vaccine in individuals 65 years of age and older indicating that the high-dose vaccine was reasonably likely to be more effective in preventing influenza disease.
As part of the accelerated approval process, the manufacturer, Sanofi Pasteur, was required to conduct a randomized clinical study post-licensure to confirm that the high-dose vaccine decreased seasonal influenza disease after vaccination relative to standard dose vaccine. This confirmatory study demonstrated that the high–dose vaccine prevented 24% more cases of laboratory-confirmed influenza illness compared to standard-dose vaccines in people 65 years of age and older. However, the study was not large enough to determine efficacy of the vaccine against severe disease.
A team of scientists from FDA, the Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, and Acumen LLC ( an independent research organization) studied the relative effectiveness of the high-dose influenza vaccine in the U.S. population ages 65 years and older. The observational study, which covered the 2012-2013 influenza season, found a significant reduction both in influenza-associated illness and in influenza-related hospitalizations among individuals who received the high-dose vaccine, compared to those receiving the standard dose.
Additional background about this study: “Comparative effectiveness of high-dose versus standard-dose influenza vaccines in US residents aged 65 years and older from 2012 to 2013 using Medicare data: a retrospective cohort analysis” is available at:
http://dx.doi.org/10.1016/S1473-3099(14)71087-4
A commentary on the study titled “Novel observational study designs with new influenza vaccines” is available at:
http://dx.doi.org/10.1016/S1473-3099(15)70020-4(more…)
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