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.
(more…)
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.
(more…)
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.
(more…)
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.
(more…)
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.
(more…)
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.
(more…)
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:
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.
(more…)
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.
(more…)
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.
(more…)
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.
(more…)
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.
(more…)
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…)
MedicalResearch.com Interview with:
Suzanne Dobbinson PhD
Senior Research Fellow
Centre for Behavioural Research in Cancer
Cancer Council Victoria Melbourne Australia
MedicalResearch: What is the background for this study? What are the main findings?Dr. Dobbinson: Australia has one of the highest skin cancer rates in the world due to the country’s high levels of ultraviolet (UV) radiation and a population with susceptible skin types. Two in three Australians will be diagnosed with skin cancer by the age of 70, with more than 40,000 new cases annually in the state of Victoria alone.
Since the 1980s there have been broad public education programs to raise awareness of skin cancer. Television campaigns have been central to these multi-component prevention programs, including SunSmart, which is the longest-running program in Victoria.
This study examined SunSmart television advertisements broadcast over summers between 1987 to 2011 to determine what effect – if any – these advertisements had on people’s sun protection attitudes and behaviours.
Cross-sectional weekly telephone surveys of Melbourne residents were conducted over summers during the study period. Population exposure to campaign TV advertisements was also measured as cumulated weekly target audience rating points (TARPs) for 4 weeks prior to interview. Using multiple logistic and linear regression models, we examined whether there was a relationship between the TARPs and responses of the surveys.
We found that increasing TARPs were related to an increased preference for no tan, increased sunscreen use and overall reduced mean percentage of skin exposed to the sun. Also of note was that this behavioural impact was consistent across all age groups.
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MedicalResearch.com Interview with:
Emma Guttman-Yassky, MD, PhD
Department of Dermatology
Icahn School of Medicine at Mount Sinai Medical Center
New York, NY 10029
Medical Research: What is the background for this study? What are the main findings?
Dr. Guttman-Yassky: Atopic dermatitis/AD is the most common inflammatory skin disease. Increased knowledge about the molecular phenotype of atopic dermatitis has contributed to development of novel therapeutics, including trials with targeted therapeutics. Genomic skin data from these trials largely rely on microarrays that are based on hybridization of labeled RNA/cDNA to single stranded DNA sequences that translate to expression levels. We have recently shown that the atopic dermatitis transcriptome (defined as differentially expressed genes [DEGs] between lesional and non-lesional skin) is reversible with broad and specific therapeutics. For future mechanistic studies within clinical trials, it is important to determine the agreement between microarrays and RNA-seq and to evaluate whether RNA-seq offers additional benefits. This is the first report of the lesional atopic dermatitis phenotype by RNA-seq, and the first direct comparison between the microarray and RNA-seq platforms in this disease. Both platforms robustly characterize the AD transcriptome. Through RNA-seq, we unraveled novel atopic dermatitis disease pathology, including increased expression of the novel TREM-1 signaling pathway and IL-36 cytokine, which might have a pathogenic role in atopic dermatitis. Importantly, good agreement with real time PCR, which serves as the "gold standard" for detection of gene expression was observed for both technique. Overall good agreement was observed with RT-PCR for both RNA-seq and microarrays, but key atopic dermatitis immune cytokines (such as interleukin 13, and interleukin 22), which are highly elevated in atopic dermatitis lesions were only detected by RT-PCR. Overall, both RNA-seq and microarrays can similarly characterize the lesional AD transcriptome and serve as valuable tools for molecular tissue studies within large clinical trials and a core atopic dermatitis pathology is common to microarray and the RNA-seq transcriptomes. RNAseq might play a complementary role for unravelling novel disease pathology, although analyses tools for RNAseq are still being developed.
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MedicalResearch.com Interview with: Alka Mansukhani Ph.D.
Associate Professor
Department of Microbiology
Member of the Laura and Isaac Perlmutter Cancer Center
NYU Langone Medical Center
Medical Research: What is the background for this study? What are the main findings?
Dr. Mansukhani: Osteosarcoma is a highly aggressive pediatric bone cancer that is almost always advanced at diagnosis. Treatment outcomes have not improved in three decades and 40% of patients eventually succumb to the disease. A few years ago we identified that normal bone stem cells relied on the function of a gene called Sox2 to remain immature an self-renew. We went on to find that osteosarcoma cancer stem cells, that arise from immature bone cells, express high levels of Sox2. Like their normal counterparts, these cancer cells also need Sox2. Sox2 maintains the stemness properties of the cancer cells as well as their ability to form tumors in mice. Depleting Sox2 resulted in cells that had reduced tumor-forming potential and instead, were able to become mature bone cells.
http://www.stbaldricks.org/blog/post/new-discovery-may-hold-the-key-to-destroying-osteosarcoma/
In this new study we have identified the mechanism by which Sox2 maintains the properties of osteosarcoma cancer stem cells. Sox2 inactivates the growth restraining function of the well-known tumor suppressive hippo pathway. Hippo signaling restrains the activity of a potent oncogene, YAP. In the osteosarcoma stem cells, Sox2 directly represses two genes (Nf2 and WWC1) in the hippo pathway and thereby unleashes the growth promoting activity of YAP. Like Sox2, YAP is required to maintain the tumorigenic properties of osteosarcoma cells.
Consistently, we found high YAP and low NF2 and WWC1 expression in human osteosarcoma tissues. Our study makes a direct connection between Sox2 and repression of hippo signaling to enable YAP activity in osteosarcomas. This mechanism also operates in glioblastoma, an aggressive brain tumor.
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MedicalResearch.com Interview with:
Caitriona Ryan, MD
Baylor University Medical Center, Dallas
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Ryan: Psoriasis is a common, chronic, inflammatory disorder of the skin which has a considerable impact on social functioning and personal relationships. Genital involvement can have devastating psychosexual implications for psoriasis patients. In a study examining the stigmatization experience in psoriasis patients, involvement of the genitalia was found to be the most relevant, regardless of the overall psoriasis severity. Although sexual function is an integral component of quality of life, dermatology-specific and psoriasis-specific scales largely neglect the impact of disease on sexual health. Despite major advances in other aspects of psoriasis research, there has been little emphasis in recent times on the identification and treatment of genital psoriasis and few studies have examined predisposing risk factors, phenotypical associations or its impact on quality of life and sexual functioning.
This study was designed to examine the prevalence and nature of genital involvement in patients with psoriasis, to ascertain risk factors for the development of genital psoriasis, to determine the impact of genital disease on quality of life and sexual functioning, and to assess patient satisfaction with current topical treatments for genital psoriasis.(more…)
MedicalResearch.com Interview with: Susan C. Jones, Ph.D.
Professor, The Ohio State University
Department of Entomology
Rothenbuhler Research Lab.
Columbus, OH 43210
Medical Research: What is the background for this study?
Response: Bed bugs are important public health pests that have made a huge comeback in developed countries throughout the world which are leading to people needing to buy a new mattress like the ones on Leesa.com. Human health effects from bed bugs include allergic reactions, secondary bacterial infections, asthma, anaphylactic shock, sleeplessness, agitation, and anxiety. Your health should be your top priority. So if you are suffering from bed bug infestation in the home or any form of pests for that matter, the best way to solve this is through looking into something like Pest Control Des Moines to help get this issues sorted.
Bed bugs require multiple integrated pest management (IPM) strategies such as extremely thorough inspections, sanitation, a wide variety of nonchemical and chemical measures, and follow-up monitoring. If you experience this you need bed bugs treatment so it does not get any worse. Evaluating the effectiveness of various bed bug products is an ongoing effort of my research lab.
Medical Research: What are the main findings?
Response: In this study, we provide data demonstrating decreased feeding and fecundity (egg production) of bed bugs after just 10 minutes of exposure to ActiveGuard fabric as compared to untreated fabric. The ActiveGuard Mattress Liner, which is impregnated with 550 mg permethrin per m2, was effective even against bed bug populations that were resistant to pyrethroids.
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MedicalResearch.com Interview with:
Lyn McDivitt Duncan, MD
Professor of Pathology, Harvard Medical School
Chief, Dermatopathology Unit and
Su Luo, MD Dermatology Resident
Massachusetts General Hospital
Boston, MA 02114Medical Research: What is the background for this study? What are the main findings?
Response: We studied 475 patients with cutaneous melanoma diagnosed at the Massachusetts General Hospital (MGH) who also had a sentinel lymph node biopsy procedure performed. There is a practice gap in the sentinel lymph node biopsy procedure ranging from removal of one “sentinel” lymph node to removing the hottest lymph node and any lymph nodes with radioactive tracer of 10% or more of the hottest lymph node’s counts (with an average of three lymph nodes removed). At the MGH we use this latter method. We examined the sentinel lymph nodes in each case to determine whether the positive cases with microscopic melanoma metastases had metastases only in the most radioactive, or "hottest", node or whether tumor was also present in the less hot nodes. We found that in 19% of positive cases there were metastases present only in the less hot nodes. We also performed survival analysis and showed that the less hot nodal positive cases are of equivalent prognostic significance. We found that removal of only the hottest lymph node would have led to under-staging of 19% of patients with melanoma.
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MedicalResearch.com Interview with:Bonny Rockette-Wagner, Ph.D.
Director of physical activity assessment,
University of Pittsburgh Graduate School of Public Health and
Andrea Kriska, Ph.D.
Professor of epidemiology, University of Pittsburgh
Graduate School of Public Health
Researchers’ Note:
Drs. Kriska and Rockette-Wagner: It should be noted that this study looked at adults at high risk for diabetes. Not everyone in the general population would be at high risk. We would hypothesis that the risk increase from TV watching may be lower in those not at high risk for diabetes, but obviously could not test that in our study population.MedicalResearch: What is the background for this study? Response: In this research effort focused on participants in the Diabetes Prevention Program (DPP) study (published in 2002 and funded by the National Institute of Digestive and Diabetes and Kidney Diseases [NIDDK] section of the US National Institutes of Health [NIH]). That study enrolled 3,234 overweight US adults (1996–1999) of at least 25 years of age with the goal of delaying or preventing type 2 diabetes in high risk individuals with either a metformin drug or lifestyle intervention. The DPP demonstrated that the lifestyle intervention was successful at reducing the incidence of diabetes and achieving its goals of 150 minutes per week of moderate intensity activity (such as brisk walking) and a 7% weight loss (New England Journal of Medicine, 2002). There was no goal to reduce sitting in the Diabetes Prevention Program.
Results from other studies suggest that it is unclear if interventions focusing on increasing physical activity also reduce time spent sitting. This current investigation examined whether the Diabetes Prevention Program lifestyle intervention, which was shown to be effective at increasing physical activity, also decreased self-reported sitting time. The effect of sedentary behavior on diabetes development was also examined.
MedicalResearch: What are the main findings?Response: For the lifestyle participants, a reduction in reported TV watching alone and the combination of TV watching and work sitting was observed. This reduction was significantly greater than any changes seen in the other two randomized groups, who did not receive the intervention. Because these reductions were accomplished without an explicit program goal to reduce sitting we feel optimistic that with better awareness of sitting behaviors and goal setting to reduce sitting it may be possible to have an even greater impact than what was achieved in this cohort.
Additionally, our results showed that for every hour spent watching TV there was a 3.4% increased risk of developing diabetes during the 3 year follow-up period in individuals at high risk for diabetes. This finding means that reductions in sitting can translate into a positive health effect separate from improvements in moderate-vigorous activity.
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MedicalResearch.com Interview with:
Pamela S. Douglas, M.D.
Duke University School of Medicine
Duke University Medical Center
Durham, NC 27715
Medical Research: What is the background for this study?
Dr. Douglas: The primary objective of the PROMISE study was to compare the health outcomes of people who went to the doctor with new symptoms such as shortness of breath and/or chest pain that were suggestive of coronary artery disease and that required additional evaluation. This was an important investigation because no large research trial has ever been conducted to help guide the care of such patients. Instead, the selection of tests for such patients—which constitutes at least 4 million patients in the United States each year—has been largely left up to physician and patient preference rather than proven results.
Medical Research: What are the main findings?
Dr. Douglas: 10,003 patients from 193 different medical facilities across the US and Canada agreed to be part of the PROMISE study and were randomized to a functional stress test or an anatomic test Using CT angiography. The study found that the clinical outcomes of participants with suspected coronary artery disease were excellent overall, and were similar in terms of death and major cardiac conditions regardless of whether patients had a functional stress test or a computed tomographic scan. However, the CT scan may be better at ruling out the need for subsequent tests and procedures in patients who are free of heart disease, and involved a lower radiation exposure relative to a stress nuclear study. We also found, in a separately reported study, that the costs of the two diagnostic strategies were similar.
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MedicalResearch.com Interview with:
Anne Vorlat MD
Department of Cardiology
Antwerp University Hospital
Department of Cardiology, Edegem, Belgium
MedicalResearch: What is the background for this study? What are the main findings?Dr. Vorlat: Early diagnosis of myocardial infarction is critical for optimal treatment and prognosis of the patient. The third universal definition of myocardial infarction states that a rise and/or fall of cardiac biomarkers (preferably troponin) with at least one value above the 99th percentile of the upper reference limit is mandatory with symptoms and or ST segment changes on the ECG. Since the development of more sensitive assays for cardiac troponins, myocardial injury can be detected earlier. This has permitted to shorten the timing of the second sampling of cardiac biomarkers from 6h to 3h after the first sampling. Recent studies have tested biomarker protocols with a very short delay (e.g., 1 hour) or with a single measurement of troponin and copeptin (a marker of endogenous stress, not cardiac specific) to rule in or to rule out myocardial injury in a population with chest pain. Although these newer protocols appear to be promising, early presenters (chest pain for less than 2 hours) are underreported. The present study evaluated the usefulness of early rule-in and rule-out biomarker protocols to estimate ischemia-induced myocardial injury in an early presenter model. The “early presenter” model was tested in 107 stable patients after a short period of myocardial ischemia, induced by stenting of a significant coronary artery stenosis. High-sensitivity troponin T (hsTnT), hsTnI and copeptin were measured at the start, and 90, 180 and 360 minutes after stent implantation. We confirmed our hypothesis that short biomarkers protocols underestimate myonecrosis in early presenters.
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