Author Interviews, Breast Cancer, Lancet, Surgical Research / 14.10.2015

MedicalResearch.com Interview with: Dr. R. A. Badwe, MS Director, Tata Memorial Centre E. Borges Marg, Parel Mumbai -India  Medical Research: What is the background for this study? What are the main findings? Response:   The available retrospective clinical data suggested an overall survival benefit for metastatic breast cancer patients treated with surgery, with or without radiation, for the primary breast tumor. These studies were fraught with biases and at the same time, studies showed  removal of the primary tumor improved survival in patients with metastatic renal cell carcinoma. Additionally data from animal experiments suggested that surgical removal of the primary tumor could potentially increase metastatic spread. Our study was thus planned to address the uncertainty on role of surgery of the primary in women presenting with metastatic breast cancer. The main findings of this study suggest that there is no evidence to suggest that loco-regional treatment of the primary tumor confers an overall survival advantage in patients with de-novo metastatic breast cancer and this procedure should not be routinely done. Additionally, we noted though there was significant local control in the loco regional treatment arm, there was a detriment in distant progression-free survival and no difference in overall survival. (more…)
Author Interviews, Cost of Health Care, Race/Ethnic Diversity / 13.10.2015

MedicalResearch.com Interview with: Jeffrey Rhoades, Ph.D. Agency for Healthcare Research and Quality Medical Research: What is the background for this study? Dr. Rhoades: The Medical Expenditure Panel Survey (MEPS) – Household Component (HC) which began in 1996 and is administered annually collects data from a sample of families and individuals in selected communities across the United States, drawn from a nationally representative subsample of households that participated in the prior year's National Health Interview Survey (conducted by the National Center for Health Statistics). During the household interviews, MEPS collects detailed information for each person in the household on the following: demographic characteristics, health conditions, health status, use of medical services, charges and source of payments, access to care, satisfaction with care, health insurance coverage, income, and employment. The panel design of the survey, which features several rounds of interviewing covering two full calendar years, makes it possible to determine how changes in respondents' health status, income, employment, eligibility for public and private insurance coverage, use of services, and payment for care are related. Medical Research: What are the main findings? Dr. Rhoades: In 2013, Hispanics were more likely to be uninsured for the entire year or sometime during the year than other racial/ethnic groups. In 2013, persons living in the South and West regions were more likely to be uninsured for the entire year or sometime during the year than people living in the Northeast or Midwest. Approximately 50 percent of individuals with the lowest hourly wage (less than $10 per hour) were uninsured sometime during the year in 2013. This fraction decreased with increasing wages. (more…)
Author Interviews, JAMA, Pain Research / 13.10.2015

MedicalResearch.com Interview with: Julie M. Fritz, PT, PhD, FAPTA Professor, Department of Physical Therapy Associate Dean for Research, College of Health University of Utah Salt Lake City, UT  84106 Medical Research: What is the background for this study? What are the main findings? Dr. Fritz: Low back pain affects up to 80% of adults at some point in their lives and back pain is among the most common reasons why someone visits their primary care provider.  Despite how common back pain is, the health care system does a surprisingly poor job of managing patients with the condition. There are many things that can happen at the initial primary care visit for back pain that are unhelpful or may even delay recovery such as ordering an MRI or prescribing opioids. Most practice guidelines recommend that primary care providers avoid ordering an MRI or opioid pain medication, reassure the patient that they will begin to feel better quickly and then wait a few weeks before considering referral to physical therapy.  Others have suggested that earlier use of physical therapy may be more beneficial to patients.  We conducted this study to compare early physical therapy with a wait-and-see approach. (more…)
Author Interviews, Cleveland Clinic, JAMA, Multiple Sclerosis / 13.10.2015

Dr. Jeffrey Cohen MD Director Mellen Center for Multiple Sclerosis Treatment and Research Director of the Experimental Therapeutics Program Cleveland Clinic Main CampusMedicalResearch.com Interview with: Dr. Jeffrey Cohen MD Director Mellen Center for Multiple Sclerosis Treatment and Research Director of the Experimental Therapeutics Program Cleveland Clinic Main Campus MedicalResearch: What is the background for this study? What are the main findings? Dr. Cohen: Medications are a major contributor to the high cost of Multiple Sclerosis (MS) care.  As medications go off patent, there is the opportunity to develop generic versions with lower cost.  This trial was conducted after extensive in vitro and animal studies supported the equivalence of a generic glatiramer acetate to the brand drug Copaxone. The trial showed that generic and brand glatiramer acetate have equivalent efficacy as measured by MRI and clinical endpoints, safety, and tolerability. (more…)
Annals Internal Medicine, Author Interviews, Diabetes, Heart Disease, Nutrition / 13.10.2015

Iris Shai MD PhD Professor of Nutrition and Epidemiology of Chronic Diseases Dep. of Public Health Faculty of Health SciencesMedicalResearch.com Interview with: Iris Shai MD PhD Professor of Nutrition and Epidemiology of Chronic Diseases Dep. of Public Health Faculty of Health Sciences Medical Research: What is the background for this study? What are the main findings? Dr. Shai: Despite enormous contribution of observational studies, clinical recommendations for moderate alcohol consumption remain controversial, particularly for people with diabetes, due to lack of long-term, randomized controlled trials, which are needed for evidence-based medicine. People with diabetes are more susceptible to developing cardiovascular diseases than the general population and have lower levels of HDL-c. Also, it is uncertain if red wine confers any advantage over white wine or whether the ethanol is the primary mediator of alcoholic beverages related beneficial associations.  The two-year CArdiovaSCulAr Diabetes and Ethanol (CASCADE) RCT was performed among 224 controlled diabetes patients (aged 45 to 75), who generally abstained from alcohol. Red wine was found to be superior in improving overall metabolic profiles, mainly by modestly improving the lipid profile. As for glycemic control and blood pressure, the effect of both, red or white wine, was dependent on ADH enzyme polymorphism, suggesting personalized approach. Overall, wine of either type did not effect change in liver function tests, adiposity, or adverse events/symptoms. However, sleep quality was significantly improved in both wine groups, compared with the water control group. All comparisons were adjusted for changes in clinical, medical and drug therapy parameters occurring among patients during the years of the study. The trial completed with adherence rate of 87 percent after 2 years. (more…)
Author Interviews, Cleveland Clinic, Heart Disease, JACC, Kidney Disease, Transplantation / 13.10.2015

W.H. Wilson Tang, MD, FACC Assistant Professor in Medicine, Cleveland Clinic Lerner College of Medicine Staff, Section of Heart Failure & Cardiac Transplant Medicine Assistant Program Director, General Clinical Research Center (GCRC) The Cleveland Clinic Cleveland, OHMedicalResearch.com Interview with: W.H. Wilson Tang, MD, FACC  Assistant Professor in Medicine, Cleveland Clinic Lerner College of Medicine Staff, Section of Heart Failure & Cardiac Transplant Medicine Assistant Program Director, General Clinical Research Center The Cleveland Clinic  Cleveland, OH Medical Research: What is the background for this study? What are the main findings? Dr. Tang: Cardiac function is a key determinant of outcomes after surgery, especially transplantation. End-stage renal disease (ESRD) poses a unique scenario, as the metabolic and uremic derangements that result from this condition lead to adverse cardiac remodeling, and kidney transplantation offers a potential for reverse remodeling. We studied patients who underwent kidney transplantation and found that echocardiogram following transplantation demonstrated consistent and significant improvement in cardiac structure and function. Post-transplant improvement in anemia was a vital factor that independently predicted such positive changes, whereas post-transplant changes in blood pressure, renal function at 12 months, and dialysis duration duration did not. Moreover, patients that demonstrated reverse remodeling had outcomes comparable to those with normal baseline cardiac function. (more…)
Author Interviews, Pulmonary Disease / 12.10.2015

MedicalResearch.com Interview with: Eric Stephen White MD Associate Professor of Medicine and Director of Translational Interstitial Lung Disease Research, Pulmonary and Critical Care Medicine University of Michigan Health System Medical Research: What is the background for this study? What are the main findings? Dr. White: The data presented at the European Respiratory Society (ERS) International Congress 2015 provide additional insights into OFEV® (nintedanib), including safety and efficacy over approximately two years. The results show no relevant changes in the safety and tolerability of OFEV. The results also suggest that treatment has a long-term effect (approximately two years) on slowing disease progression across both pivotal and open-label trials (as measured by annual rate of forced vital capacity [FVC] decline). This ongoing study, INPULSIS™-ON, which is an open-label extension trial, is important because Idiopathic Pulmonary Fibrosis (IPF) is a progressive disease that may require ongoing treatment. (more…)
Author Interviews, Cost of Health Care, Surgical Research / 12.10.2015

Kathleen Carey, Ph.D. Professor Department of Health Law, Policy and Management Boston University School of Public Health Boston MA 02118MedicalResearch.com Interview with: Kathleen Carey, Ph.D. Professor Department of Health Law, Policy and Management Boston University School of Public Health Boston MA  02118 Medical Research: What is the background for this study? Dr. Carey: Ambulatory surgery centers (ASCs) are a growing alternative to hospital outpatient departments (HOPDs) for patients undergoing surgeries that do not require an overnight stay. The number of ASCs increased 49% between 2002 and 2012 and now exceeds the number of acute care hospitals. Most Ambulatory surgery centers are specialized in the areas of gastroenterology, ophthalmology or orthopedic surgery. Because of specialization and limitations on the services they provide, it generally is assumed that ASCs can perform the same procedures at a lower cost than HOPDs. In fact, Medicare reimburses ASCs at a rate of roughly 60% of what they reimburse HOPDs. Yet since Medicare doesn’t require ASCs to submit cost reports, this policy is based on little information about the relative costs of ASCs and HOPDs. The cost advantage may offer an explanation for rapid ASC growth. But financial margins are explained by both costs and revenues, and high returns on investment might also be explained by high prices. Here there is even less information, as prices negotiated between commercial health insurers and providers are ordinarily considered highly confidential. In this study, I took advantage of MarketScan Commercial Claims and Encounters, a large national database distributed by Truven Health Analytics that contains information on actual prices paid to ASCs and HOPDs to explore the revenue side of ASC expansion. Medical Research: What are the main findings? Dr. Carey: For this study, I examined six common surgical procedures that are high volume, provided in both ASCs and in HOPDs, and represent the three main ASC specialties: colonoscopy, upper GI endoscopy, cataract surgery, post cataract surgery (capsulotomy), and two knee arthroscopy procedures. Over the period 2007-2012, the ratio of what insurers paid ASCs compared to HOPDs differed considerably across specialty: For colonoscopy and endoscopy, ASCs received 22% less than HOPDS. But for cataract surgery, the payments were relatively comparable, and for knee arthroscopy payments to ASCs exceeded payments to HOPDs by 28% to 30%. Private insurers paid ASCs considerably more than Medicare did – anywhere from 25% more to over twice as much for post cataract surgery. The other interesting finding was that HOPD prices grew much faster than ASC prices between 2007 and 2012. While some  Ambulatory surgery centers prices grew more than others, ASC prices on the whole rose roughly in line with medical care prices generally. HOPD prices for these services, however, rose from 32% to 76% during the same time period. (more…)
Author Interviews, Brigham & Women's - Harvard, Frailty, Geriatrics, Infections / 12.10.2015

Farrin A. Manian, MD, MPH, FACP, FIDSA, FSHEA Inpatient Clinician Educator, Department of Medicine, Massachusetts General Hospital Visiting Associate Professor, Harvard Medical School, Boston, MA 02114MedicalResearch.com Interview with: Farrin A. Manian, MD, MPH, FACP, FIDSA, FSHEA Inpatient Clinician Educator, Department of Medicine, Massachusetts General Hospital Visiting Associate Professor, Harvard Medical School Boston, MA 02114 Medical Research: What is the background for this study? What are the main findings? Dr. Manian:  Falls are a leading cause of injury and death, afflicting about one-third of adults over 65 years of age annually.  Although there are many potential causes for falls, infections have received very little attention, with previous published reports primarily revolving around institutionalized elderly with dementia and urinary tract infection. We found that the spectrum of patients at risk for falls precipitated by infections goes far beyond the institutionalized elderly with dementia and urinary tract infection.  In fact, the majority of our patients fell at home and did not have a diagnosis of dementia.  In addition, besides urinary tract infections which accounted for 44.1% of cases, bloodstream (40.0%) and lower respiratory tract infections (23.0%) were also frequently represented.  Although the mean age of our patients was 76 years, 18% were younger than 65 years.  We also found that the signs and symptoms of these infections at the time of the presentation for the fall were often non-specific (e.g. weakness or mental status changes) or absent, with only 44% of patients meeting the criteria for systemic inflammatory response syndrome and only 20% having fever or abnormal temperature possibly related in part to advanced age.  These factors may make it difficult for the patient, family members and healthcare providers to readily consider infections contributing to the fall.  In fact a coexisting systemic infection was not initially suspected by providing clinicians in 40% of our patients and 31% of those who were later diagnosed with a bloodstream infection. (more…)
Author Interviews, Lung Cancer, Melanoma / 12.10.2015

MedicalResearch.com Interview with: Prof. Martin O. Bergo Sahlgrenska Cancer Center Department of Molecular and Clinical Medicine Institute of Medicine University of Gothenburg Gothenburg, Sweden Medical Research: What is the background for this study? What are the main findings? Prof. Bergo: Dietary antioxidants and antioxidant supplements can protect cells and people from harmful effects of free radicals. The free radicals have the potential, over time, to cause cancer. But why is this research field so enormously fraught with controversy, and why have clinical trials with antioxidants not established this potential anti-cancer effects? We believe it is because the question of “whether antioxidants protect against cancer” should be divided into two separate questions: 1. Do antioxidants protect a healthy cell or a tumor-free person from cancer in the future.?and 2. What is the impact of antioxidant supplementation on an already established tumor? Focusing specifically on the second question, we showed previously that the antioxidants N-acetylcysteine and vitamin E markedly increase lung cancer progression in mice and cause human lung cancer cells to proliferate faster. The mechanism for this effect was directly linked to the ability of the antioxidants to scavenge free-radicals, which is why it is likely that other antioxidants, synthetic or natural, could have a similar effect. In the current study, we argued that it would be important to test this in malignant melanoma for three reasons. First, melanoma cancer cells are known to be sensitive to changes in free radicals. Second, melanoma is the cancer that increases most in incidence and lethality in the western world. And third, primary melanomas may be exposed to antioxidants from both the diet and from skin lotions and sun creams. We found that supplementing the diet of mice with acetylcysteine has no impact on the primary tumors on the skin but doubles the rate of metastasis – i.e. the ability of the tumor cells to spread in the body. We found similar results with human malignant melanoma cells in culture: antioxidants (acetylcysteine and vitamin E) increased their ability to migrate and invade surrounding tissue. Thus, all in all, we have found that antioxidants can worsen cancer in two different ways, one in the lung, and another in the skin.     (more…)
Author Interviews, Cancer Research, End of Life Care, Radiation Therapy / 12.10.2015

MedicalResearch.com Interview with: Dr. Kavita Vyas Dharmarajan M.D., M.Sc Assistant Professor Radiation Oncology Assistant Professor Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai Medical Research: What is the background for this study? Dr. Vyas Dharmarajan: Forty to fifty percent of all patients having radiation therapy as part of cancer treatment are having the treatment for palliative reasons – meaning, not to cure the cancer but rather to alleviate or prevent symptoms caused by it. The most common reason for referral to a radiation oncologist in the setting of advanced cancer is for alleviation of pain or prevention of an impending fracture due to bone metastases. Radiation therapy is very effective at relieving pain; in fact, published response rates are about 60-80%. The standard treatment has been two weeks of radiation treatment, and this is a common treatment scheme followed by many radiation oncologists. This may be too long or burdensome for some patients given their overall state of illness, or other personal or logistical factors. Several large randomized trials have shown that shorter radiation courses, even as short as 1 fraction of treatment, can be just as effective as 10 fractions (or, two weeks) of treatment. However, literature suggests that these condensed approaches are underutilized by radiation oncologists. A major disadvantage of traditional 2-week courses of radiation is that patients who are very debilitated may be kept in the hospital to undergo this treatment. Some patients stop early because it is too burdensome. Moreover, some may not survive long enough after the treatment to appreciate its benefits. At Mount Sinai, we proposed an intervention that combined the technical expertise within radiation oncology with the whole-patient support services of palliative medicine into a service model led by a single radiation oncologist specializing in the care of advanced cancer patients and collaboration with experts in palliative care. The service model was meant to care for patients suffering from advanced cancer with the goal of improving the quality of care that these patients receive. About two years into the establishment of this new model, we assessed patient outcomes of pain improvement, length of hospitalization, utilization of palliative care services after radiation, treatment completion rates, and duration of treatments. To accomplish this study, we reviewed the charts of 336 consecutively treated patients who underwent radiation therapy at the Mount Sinai Hospital over the last 5 years. We compared the outcomes of the patients treated before the model was established in 2013 to those treated after the model was established. Medical Research: What are the main findings? Dr. Vyas Dharmarajan: We found large differences in quality of care for advanced cancer patients being treated for symptomatic bone metastases after establishment of our palliative radiation oncology consult service. The rate of short-course treatments (meaning 5 or fewer radiation fractions) rose from 26% to 61%, while the corresponding rate of traditional length treatments (meaning, treatments over 5 fractions) declined from 74% to 39%. Hospital length of stay declined by 6 days, from 18 to 12 days (median). We also found that more patients were finishing their treatments -- the proportion of treatments left unfinished halved, from 15% to 8%. More patients were accessing palliative care services within 30 days of finishing radiation, (34% vs. 49%). We did not see a significant change in the proportion of patients experiencing pain relief from the treatment. In fact, we saw a slight improvement (74% to 80%), but this was not a statistically significant increase. Medical Research: What should clinicians and patients take away from this report? Dr. Vyas Dharmarajan: Our study validates the importance of cohesive collaboration in cancer care. The palliative radiation oncology service model thrives at the Mount Sinai Hospital because of the unique and strong partnership between palliative care and radiation oncology departments. Yet, there are elements of palliative care practice that can transcend other disciplines including radiation oncology. These include eliciting and attending to goals, preferences, expectations, and concerns of patients and families being evaluated for treatment. Shorter treatment courses for advanced cancer patients are effective, and the implications of using such treatments goes beyond that of just finishing the treatment early. Patients treated within our service model were more likely to finish their treatment and spend 6 more days at home with their families. Clinicians should know that using such an approach did not compromise the efficacy of the treatment. Medical Research: What should patients know about your study? Dr. Vyas Dharmarajan: Patients should know that their voices, their preferences, and their goals matter when making decisions about palliative radiation treatment. My goal as a palliative radiation oncologist is to engage patients and their families to set realistic expectations and incorporate their goals and preferences into their treatment plans. By involving key players in this process, such as palliative care specialists, we can ensure that patients receive the best quality of care that treats the whole person, not just a tumor. Medical Research: What recommendations do you have for future research as a result of this study? Dr. Vyas Dharmarajan: Our study showed that making small changes to everyday practice in the real world can lead to large impacts on patient outcomes in a population of cancer patients who are often the sickest. Our next projects revolve around 1) how best to equip radiation oncologists with the skills needed to appropriately provide treatment and primary palliative care to advanced cancer patients, and 2) to empower patients and families to engage with their physicians in discussions about their treatment including their overall goals and preferences. Both of these concepts ultimately have direct impacts on treatment recommendations and treatment outcomes for advanced cancer patients and their families. Citation: upcoming Palliative Care abstract: A palliative radiation oncology consult service’s impact on care of advanced cancer patients with symptomatic bone metastases.MedicalResearch.com Interview with: Dr. Kavita Vyas Dharmarajan M.D., M.Sc Assistant Professor Radiation Oncology Assistant Professor Geriatrics and Palliative Medicine Icahn School of Medicine at Mount Sinai Medical Research: What is the background for this study?  Dr. Vyas Dharmarajan: Forty to fifty percent of all patients having radiation therapy as part of cancer treatment are having the treatment for palliative reasons – meaning, not to cure the cancer but rather to alleviate or prevent symptoms caused by it. The most common reason for referral to a radiation oncologist in the setting of advanced cancer is for alleviation of pain or prevention of an impending fracture due to bone metastases. Radiation therapy is very effective at relieving pain; in fact, published response rates are about 60-80%. The standard treatment has been two weeks of radiation treatment, and this is a common treatment scheme followed by many radiation oncologists. This may be too long or burdensome for some patients given their overall state of illness, or other personal or logistical factors. Several large randomized trials have shown that shorter radiation courses, even as short as 1 fraction of treatment, can be just as effective as 10 fractions (or, two weeks) of treatment. However, literature suggests that these condensed approaches are underutilized by radiation oncologists. A major disadvantage of traditional 2-week courses of radiation is that patients who are very debilitated may be kept in the hospital to undergo this treatment. Some patients stop early because it is too burdensome. Moreover, some may not survive long enough after the treatment to appreciate its benefits. At Mount Sinai, we proposed an intervention that combined the technical expertise within radiation oncology with the whole-patient support services of palliative medicine into a service model led by a single radiation oncologist specializing in the care of advanced cancer patients and collaboration with experts in palliative care. The service model was meant to care for patients suffering from advanced cancer with the goal of improving the quality of care that these patients receive. About two years into the establishment of this new model, we assessed patient outcomes of pain improvement, length of hospitalization, utilization of palliative care services after radiation, treatment completion rates, and duration of treatments. To accomplish this study, we reviewed the charts of 336 consecutively treated patients who underwent radiation therapy at the Mount Sinai Hospital over the last 5 years. We compared the outcomes of the patients treated before the model was established in 2013 to those treated after the model was established. Medical Research: What are the main findings? Dr. Vyas Dharmarajan: We found large differences in quality of care for advanced cancer patients being treated for symptomatic bone metastases after establishment of our palliative radiation oncology consult service. The rate of short-course treatments (meaning 5 or fewer radiation fractions) rose from 26% to 61%, while the corresponding rate of traditional length treatments (meaning, treatments over 5 fractions) declined from 74% to 39%. Hospital length of stay declined by 6 days, from 18 to 12 days (median). We also found that more patients were finishing their treatments -- the proportion of treatments left unfinished halved, from 15% to 8%. More patients were accessing palliative care services within 30 days of finishing radiation, (34% vs. 49%). We did not see a significant change in the proportion of patients experiencing pain relief from the treatment. In fact, we saw a slight improvement (74% to 80%), but this was not a statistically significant increase. (more…)
Author Interviews, BMJ, Exercise - Fitness, OBGYNE / 12.10.2015

Katrine M. Owe PhD Department of Psychosomatics and Health Behaviour Norwegian Institute of Public Health Norwegian National Advisory Unit on Women's Health Oslo University Hospital, Rikshospitalet OSLO, NorwayMedicalResearch.com Interview with: Katrine M. Owe PhD Department of Psychosomatics and Health Behaviour Norwegian Institute of Public Health Norwegian National Advisory Unit on Women's Health Oslo University Hospital, Rikshospitalet OSLO, Norway  Medical Research: What is the background for this study? What are the main findings? Dr. Owe: Pelvic girdle pain affects 20-45% of all pregnancies and may lead to functional disability, higher levels of depression, reduced quality of life and higher prevalence of sick leave during pregnancy. Many women with pelvic girdle pain often have difficulties performing daily life activities such as walking, standing, sitting and turning over in bed. The aetiology and pathogenesis of pelvic girdle pain are still unknown but some modifiable and non-modifiable risk factors have been identified. Our results showed that women who exercised before they became pregnant with their first child, had the lowest risk of developing pelvic girdle pain in pregnancy. Even those women who reported low frequencies of exercise had a reduced risk of pelvic girdle pain compared with non-exercisers. Exercising up to five times weekly before pregnancy was protective against pelvic girdle pain and no further benefits were reached with higher frequencies of exercise. It seems that women who are running, jogging, playing ballgames/netball, doing high impact aerobics or orienteering before pregnancy, has the lowest risk of pelvic girdle pain. (more…)
AHA Journals, Author Interviews, Dermatology, Heart Disease, NIH / 12.10.2015

Nehal Mehta, M.D., M.S.C.E., F.A.H.A. Lasker Clinical Research Scholar Section of Inflammation and Cardiometabolic Diseases NIHMedicalResearch.com Interview with: Nehal Mehta, M.D., M.S.C.E., F.A.H.A. Lasker Clinical Research Scholar Section of Inflammation and Cardiometabolic Diseases NIH Medical Research: What is the background for this study? What are the main findings? Dr. Mehta: Psoriasis increases cardiovascular disease (CVD), and this study shows for the first time that the amount of psoriasis on the skin is mirrored in the blood vessels by increasing blood vessel inflammation. Medical Research: What should clinicians and patients take away from your report? Dr. Mehta: Even one plaque may be too many if we are seeing a relationship between skin disease severity and vascular inflammation. (more…)
Author Interviews, Cost of Health Care, Dermatology, JAMA / 12.10.2015

Pinar Karaca-Mandic, PhD on behalf of the authors Associate Professor Division of Health Policy and Management University of MinnesotaMedicalResearch.com Interview with: Pinar Karaca-Mandic, PhD on behalf of the authors Associate Professor Division of Health Policy and Management University of Minnesota  Medical Research: What is the background for this study? What are the main findings? Dr. Pinar Karaca-Mandic: Lymphedema is a common disease affecting several million people in the U.S, in particular cancer patients. The disease is associated with edema, recurrent cellulitis, loss of physical function, stress, and of course diminished quality of life. It is also associated with high health care costs. While there is no cure for lymphedema currently, it can be managed well with proper care. Pneumatic compression devices offer a valuable lymphedema self-management option. However, there is limited information on the effectiveness of these devices using data from real world settings.   In this paper, we used administrative and claims-based data from a major national insurer to examine the effectiveness of an advanced pneumatic compression device. We examined health economics costs as well as clinical health utilization outcomes associated with the use of the device. We found that the receipt of the device is associated with large declines in cellulitis rates. For example, among the cancer patients, cellulitis infection rates by 79% (from 21% to 4.5%). We saw similar reductions for patients without cancer (75%). We also observed large reductions in the use of manual therapy and in lymphedema related outpatient hospital visits. Finally, lymphedema related outpatient costs decreased substantially – for example for the cancer patients, they halved reducing from about $1,500 to $700 among cancer patients, and they declined by 65% from about $1,700 to $600 for patients without cancer. Among cancer patients, total lymphedema-related costs per patient, excluding medical equipment, declined by 37% and declined by 36% in patients without cancer. (more…)
Author Interviews, Dermatology, JAMA, Melanoma / 12.10.2015

Eleni Linos, MD DrPH, MPH Assistant Professor UCSF School of MedicineMedicalResearch.com Interview with: Eleni Linos, MD DrPH, MPH Assistant Professor UCSF School of Medicine Medical Research: What is the background for this study? What are the main findings? Dr. Linos: Google offers a remarkable service for non-profit organizations-in our case we used AdWords, Google’s keyword-specific advertising service, to disseminate skin cancer prevention messages to people searching for tanning. Our question was simple: can we send a skin cancer prevention message to someone who is searching for information about tanning beds online? From this preliminary data we found that it is possible to use online advertising to reach a large, targeted audience with specific health messages. Or Online advertising for prevention is a brand new concept. It builds on the knowledge of online advertisers and marketers-and uses this knowledge for good. We hope other social media and technology companies will join this effort to provide precise, tailored health messages to those who need them the most. Marketing is a powerful tool when it comes to getting the message out to a larger audience. As we are thinking of using Google Ads for our services, we were recommended to compare Adwords software and tools, as it would make the decision of finding the right software a lot easier. As technology becomes apparent within businesses, it makes sense for us and other companies to use this to their advantage. (more…)
Author Interviews, Biomarkers, Cleveland Clinic, Heart Disease, JACC, Kidney Disease / 12.10.2015

Dr. Wilson Tang MD Professor of Medicine Cleveland Clinic Lerner College of Medicine Case Western Reserve University Director of the Center for Clinical Genomics Cleveland ClinicMedicalResearch.com Interview with: Dr. Wilson Tang MD Professor of Medicine Cleveland Clinic Lerner College of Medicine Case Western Reserve University Director of the Center for Clinical Genomics Cleveland Clinic  Medical Research: What is the background for this study? What are the main findings? Dr. Tang: Renal impairment has long been associated with worse outcomes in acute heart failure. Administration of diuretic therapy often obscures accurate assessment of renal function by urine output.  Despite extensive literature suggesting the poor outcomes in those with a rise in creatinine following treatment, recent data has suggested that in the presence of effective diuresis, this phenomenon likely represents hemoconcentration and azotemia rather than acute kidney injury.  We observed that using a novel and sensitive biomarker that identified acute kidney injury, specific to tubular injury, we can identify those at higher risk of adverse outcomes in patents admitted for acute heart failure.   However, after adjusting for standard risk factors, the prognostic value was clearly attenuated. (more…)
Author Interviews, CDC, Health Care Systems, Infections, Outcomes & Safety / 12.10.2015

MedicalResearch.com Interview with: James Baggs, PhD Division of Healthcare Quality Promotion Centers for Disease Control and Prevention Atlanta, GA Medical Research: What is the background for this study? Dr. Baggs: The National Action Plan for Combating Antibiotic Resistance Bacteria calls for annual reporting of antibiotic use in inpatient settings as well as the identification of variations at the provider or patient level that can assist in developing interventions. Antibiotic use varies among hospitals, but some portion of that variability is related to the type of patients admitted to the hospital and other hospital characteristics. We evaluated factors in a large cohort of US hospitals that may account for inter-facility variability in antibiotic use, so that we can more appropriately monitor antibiotic use in hospitals. Medical Research: What are the main findings? Dr. Baggs: We utilized data from the Truven Health MarketScan Hospital Drug Database (HDD), which contains detailed administrative records, including inpatient drug utilization data based on billing records, for all patients discharged from a convenience sample of over 500 US hospitals. We retrospectively estimated days of therapy (DOT)/1,000 patient days (PDs) by year from 2006-2012, and created a multivariable model that adjusts for hospital-specific location of antibiotic use (ICU vs. other), average patient age, average patient co-morbidity score, number of hospital beds, teaching status, urban or rural location, proportion of discharges with a surgical diagnosis related code, case mix index, and proportion of patient days with an infectious disease primary ICD-9-CM discharge code. We observed that DOT varied significantly between hospitals; the 10th to 90th percentile values for hospital days of therapy ranged from 546 to 998/1,000 PDs. The variables included in our model accounted for 47-53% of the inter-facility variability, depending on year. However, nearly all of this variability was explained by two predictors: proportion of PDs with an infectious disease diagnosis code and hospital location (ICU vs. other).  (more…)
Author Interviews, Genetic Research, Lancet, Macular Degeneration, Ophthalmology / 12.10.2015

Professor P. Elizabeth Rakoczy Centre for Ophthalmology and Visual Sciences The University of Western Australia Head of Department - Molecular Ophthalmology Lions Eye Institute AustraliaMedicalResearch.com Interview with: Professor  P. Elizabeth Rakoczy Centre for Ophthalmology and Visual Sciences The University of Western Australia Head of Department - Molecular Ophthalmology Lions Eye Institute Australia Medical Research: What is the background for this study? Prof. Rakoczy: Wet age related macular (wet-AMD) is the major cause of blindness in the developed world. It is treated with frequent anti-VEGF injections into the eye. Our preclinical studies demonstrated that following the subretinal injection of a recombinant adeno-associated vector (rAAV) carrying a natural inhibitor of neovascularization (sFlt-1), leaky new, abnormal vessels can be controlled and retinal anatomy improved. The rAAV.sFlt-1 based Ocular Biofactory™ platform has potentially significant advantages over existing technologies as it is designed to provide sustained production of a naturally occurring antiangiogenic agent, sFlt-1, in situ in the eye. In this trial we investigated the safety of rAAV.sFlt-1 in patients diagnosed with wet-AMD. (more…)
Author Interviews, Infections, Respiratory, Vaccine Studies, Vanderbilt / 11.10.2015

Annabelle de St. Maurice MD, MPH Pediatric Infectious Disease Fellow Vanderbilt Children's HospitaMedicalResearch.com Interview with: Annabelle de St. Maurice MD, MPH Pediatric Infectious Disease Fellow Vanderbilt Children's Hospital  Medical Research: What is the background for this study? What are the main findings? Dr. de St. Maurice: Susceptibility to certain infectious diseases appears to vary by gender. For example, males may be at increased risk of certain infections in childhood, including lower respiratory tract infections such as RSV, however females may have more severe infections, such as influenza, during pregnancy. Some early studies have suggested that males may be at increased risk of pneumococcal infections but this has not been confirmed. Furthermore, whether those potential gender differences remain after introduction of pneumococcal conjugate vaccines is unknown. Invasive pneumococcal disease, which includes meningitis, bacteremic pneumonia and bacteremia/septicemia, is a significant cause of morbidity and mortality in the United States in children and adults. The 7-valent pneumococcal conjugate vaccine (PCV7) and the 13-valent pneumococcal conjugate vaccine (PCV13) led to declines in invasive pneumococcal disease rates as well as eliminated racial disparities in regards to invasive pneumococcal disease rates. Our study sought to identify potential gender differences in the incidence of invasive pneumococcal disease, and to determine the impact of vaccines on gender differences in the susceptibility to these diseases. We conducted a large study that used data from a population-based surveillance system of invasive pneumococcal diseases in Tennessee. This is part of a large CDC funded network of surveillance sites for these diseases. For our study, we identified patients with laboratory-confirmed invasive pneumococcal disease, and calculated the incidence of invasive pneumococcal diseases from 1998-2013 by gender. We also stratified the calculations by age groups and race, both well-known factors that affect the occurrence of invasive pneumococcal disease. Our study found that males had generally higher rates of invasive pneumococcal disease than females across age groups, regardless of race. Although introduction of the pneumococcal conjugate vaccines led to a significant decrease in invasive pneumococcal disease rates, males continued to have higher rates than females in several age groups. (more…)
Author Interviews, Chemotherapy, Lung Cancer, NEJM, UT Southwestern / 11.10.2015

David E. Gerber, MD Associate Professor Division of Hematology-Oncology Associate Director for Clinical Research Co-Leader, Experimental Therapeutics Program Co-Director, Lung Disease Oriented Team Harold C. Simmons Cancer Center University of Texas Southwestern Medical Center Dallas, TXMedicalResearch.com Interview with: David E. Gerber, MD Associate Professor Division of Hematology-Oncology Associate Director for Clinical Research Co-Leader, Experimental Therapeutics Program Co-Director, Lung Disease Oriented Team Harold C. Simmons Cancer Center University of Texas Southwestern Medical Center Dallas, TX Medical Research: What is the background for this study? What are the main findings? Dr. Gerber: In this trial, we compared an immunotherapy and a chemotherapy drug in patients with non-squamous non-small cell lung cancer (NSCLC) whose disease continued to progress after first-line chemotherapy. We found that nivolumab immunotherapy improved overall survival compared to docetaxel chemotherapy and was generally well tolerated. These results are significant because options for patients whose lung cancer progresses after initial treatment are limited. Nivolumab is an immunotherapy drug that works by inhibiting the cellular pathway known as PD-1 protein on cells that block the body’s immune system from attacking cancerous cells.  The idea behind nivolumab and other immunotherapy drugs is to kick-start the body’s natural immune response to a cancer. Cancer develops and grows in part because it has put the brakes on the immune response. These drugs take the foot off the brake, allowing the immune system to accelerate and attack the cancer. The phase 3 clinical trial followed more than 500 patients who had non-squamous non-small cell lung cancer (NSCLC): 287 received nivolumab and 268 received the chemotherapy drug docetaxel. The one-year survival rate was 51 percent in the nivolumab arm versus 39 percent in the docetaxel arm. The most common reported side effects with nivolumab were fatigue, nausea, decreased appetite, and weakness, and they were less severe than with docetaxel treatment. In a minority of cases, patients treated with nivolumab also developed autoimmune toxicities affecting various organs. In addition to studying safety and efficacy, the trial examined the protein biomarker PD-L1, which is believed to play a role in suppressing the immune system. The study results suggested that patients with a higher level of PD-L1 in their cancers may experience the greatest benefit from nivolumab, which targets the related molecule PD1. Using a biomarker helps oncologists predict which patients will do best on which treatment, and plan their treatment accordingly. Other promising predictive biomarkers for cancer immunotherapies include the degree of immune cell infiltration within a tumor and the number of mutations a tumor has. Specifically, the more mutations a cancer has, the more foreign it appears to the body, thus marking it for immune attack. With lung cancer, we see the greatest number of tumor mutations – and perhaps the greatest benefit from immunotherapy – among individuals with the heaviest smoking history. (more…)
Author Interviews, OBGYNE, Toxin Research / 11.10.2015

Joan A. Casey, PhD, MA Health and Society Scholar Robert Wood Johnson Foundation UC San Francisco/UC Berkeley MedicalResearch.com Interview with: Joan A. Casey, PhD, MA Health and Society Scholar Robert Wood Johnson Foundation UC San Francisco/UC Berkeley  Medical Research: What is the background for this study? What are the main findings? Dr. Casey: ​Eighteen percent of global gas production now comes from unconventional sources. Pennsylvania, in particular, has seen huge increases in unconventional natural gas development (i.e., "fracking") over the past decade. In 2006, there were fewer than 100 unconventional wells, by 2013, there were over 7,000. Developing a single unconventional well takes hundreds to thousands of diesel truck trips to bring in materials, millions of gallons of water mixed with chemicals and sand, and hydraulic fracturing and production, which can release air pollutants and create noise and other community disturbances. We evaluated whether exposure to unconventional natural gas development activity in Pennsylvania was associated with adverse birth outcomes in those living nearby. Mothers who lived near active natural gas wells operated by the fracking industry in Pennsylvania were at an increased risk for preterm birth and for having a high-risk pregnancy. (more…)
Accidents & Violence, Author Interviews, Emergency Care / 10.10.2015

Tracy Mehan, MA Manager of translational research Center for Injury Research at Policy The Research Institute at Nationwide Children’s Hospital Columbus, OH MedicalResearch.com Interview with: Tracy Mehan, MA Manager of translational research Center for Injury Research at Policy The Research Institute at Nationwide Children’s Hospital Columbus, OH   Medical Research: What is the background for this study? What are the main findings? Response: We noticed an increasing number of ziplines popping up all over the United States and wanted to see if there were any potential safety concerns.  In 2001 there were only 10 commercial ziplines. By 2012, there were more than 200. If you include the number of ziplines now seen in backyards and in places like outdoor education programs and camps, the number skyrockets to over 13,000. We found that from 1997 through 2012, there were just under 17,000 non-fatal zipline-related injuries treated in US emergency departments. Almost 70 percent of these injuries occurred in the last four years of the study indicating that this is a growing problem. In 2012 alone, there were more than 3,600 zipline-related injuries, nearly 10 a day. The majority of the injuries were the result of a fall (77 percent) or a collision (13 percent) into a tree, a support structure, or another person. Close to half of the injuries were broken bones (46 percent) and one of every ten (11.7 percent) patients were admitted to the hospital. (more…)
Author Interviews, Cancer Research, Genetic Research / 10.10.2015

Huma Q. Rana, MD Clinical Director, Cancer Genetics and Prevention Dana-Farber Cancer Institute in BostonMedicalResearch.com Interview with: Huma Q. Rana, MD Clinical Director, Cancer Genetics and Prevention Dana-Farber Cancer Institute in Boston Medical Research: What is the background for this study? What are the main findings? Dr. Rana: -        Li-Fraumeni syndrome (LFS) is thought to be a rare, inherited condition that  causes high lifetime risks for multiple cancers.  It is caused by mutations in the TP53 gene.  Traditionally, only people with striking personal or family histories of cancer underwent genetic testing for TP53 mutations, as there are well-established testing criteria.   This gene was usually tested for in isolation, meaning not combined with testing of other genes.  Due to technological advances, namely multi-gene panels (MGP), many more people are having their TP53gene analyzed.    This included a patient of mine who somewhat surprisingly  tested positive for a TP53 mutation.    This led us to investigate whether people who test positive for TP53 mutations on MGPs are different from ones who test positive on traditional or single-gene (SG) testing. We compared individuals tested for TP53 single gene versus multigene panel testing to determine if there were differences in the percent of mutation carriers meeting current testing criteria for LFS.   Our data showed that 73% of individuals sent in for single gene testing of TP53 met Classic or Chompret (2009) criteria for LFS, whereas only 30% of those sent in for multi-gene panel testing met criteria (p=0.0000001).  When we looked at the most up-to-date testing criteria, which includes Classic, Chompret, or a personal diagnosis of early-onset breast cancer (age at ≤35), 85% of individuals in the single gene group who were positive met criteria, while only 53% of the mutation carriers identified on a multi-gene panel did.   These data suggest that multi-gene panel testing enables us to identify TP53 mutation carriers who may not have otherwise been identified if testing were limited to those who meet established LFS criteria. (more…)
Author Interviews, Brigham & Women's - Harvard, Cost of Health Care, Pancreatic, Surgical Research / 09.10.2015

MedicalResearch.com Interview with: Andrew P. Loehrer, MD David Torchiana Fellow in Health Policy and Management Massachusetts General Physicians Organization Research Fellow Codman Center for Clinical Effectiveness in Surgery Department of Surgery Massachusetts General Hospital Andrew P. Loehrer, MD David Torchiana Fellow in Health Policy and Management Massachusetts General Physicians Organization Research Fellow Codman Center for Clinical Effectiveness in Surgery Department of Surgery Massachusetts General Hospital Medical Research: What is the background for this study? What are the main findings? Dr. Loehrer: The incidence of pancreatic cancer is increasing and is on pace to become the second leading cause of cancer mortality by the year 2020. While surgery remains the only chance for long-term survival, significant and persistent disparities in evaluation for and receipt of surgery remain for underinsured patients across the United States. The Affordable Care Act aims to increase access to care through expansion of health insurance coverage and was modeled on previous reform in the Commonwealth of Massachusetts. We evaluated the impact of the 2006 Massachusetts health reform on rates of surgery for pancreatic cancer. We found the insurance expansion to be independently associated with a 67% increased rate of resection for pancreatic cancer. While disparities in resection rates by insurance status decreased after the health reform, significant gaps remain between privately-insured patients and government-subsidized/self-pay patients. (more…)
Asthma, Author Interviews, Menopause / 09.10.2015

Kai Triebner, MSc Department of Clinical Science University of Bergen Bergen, Norway MedicalResearch.com Interview with: Kai Triebner, MSc Department of Clinical Science University of Bergen Bergen, Norway

Medical Research: What is the background for this study? Response: During the last decades female life expectancy has risen far beyond 50 years worldwide. This means that the quality of life after menopause is highly relevant today. Menopause implies profound hormonal and metabolic changes leading to higher risk of diabetes and cardiovascular diseases. Although researchers are increasingly aware that hormonal status and inflammation may also deteriorate respiratory health, our knowledge is very scarce. So far, no prospective study had investigated whether menopause increases the risk of asthma in the general population. Medical Research:? What are the main findings? Response: We studied the association between menopausal status and newly diagnosed  asthma, after the age of 44. We found that the odds of getting asthma were more than twice as high for women going through the menopausal transition or after menopause, compared to non-menopausal women. The risk was particularly high for overweight and obese women. These results were not due to general aging and were independent of smoking and geographical location. (more…)
Author Interviews, Fertility, Genetic Research / 09.10.2015

Rajiv McCoy, PhD Dept. of Genome Sciences Univ. of WashingtonMedicalResearch.com Interview with: Rajiv McCoy, PhD Dept. of Genome Sciences Univ. of Washington Medical Research: What is the background for this study? What are the main findings? Dr. McCoy:  Aneuploidy—the inheritance of extra or missing chromosomes compared to the typical 46-chromosome set—is extremely common in human embryos. The vast majority of aneuploidies result in preclinical pregnancy loss, often before the pregnancy is even recognized by the mother. This is thought to be the primary reason why only ~30% of all conceptions result in successful live birth. Many aneuploidies arise during egg formation, with the frequency increasing with maternal age. In addition to meiotic errors, a large proportion of aneuploidies affecting cleavage-stage embryos are mitotic in origin, arising during the initial post-fertilization cell divisions. These initial divisions are controlled by machinery contributed by the mother in the egg (before the embryo's genome has been activated). While these mitotic errors are frequent in cleavage-stage embryos, we found that they are rare in embryos at day-5 of development (the blastocyst stage), suggesting that embryos and/or cells with extensive mitotic errors do not survive to day 5. We discovered that some women have a greater propensity to produce embryos with mitotic errors than others, and our idea was that maybe differences in the mitotic machinery could help explain this. Using data from in vitro fertilized embryos screened by our collaborators at Natera, we found that women who have a particular version of a gene called PLK4 tend to produce more aneuploid embryos, regardless of age. This genetic variant is actually very common—more than half of people carry at least one copy—and is present in nearly all populations. PLK4 has a well-known role in ensuring the proper distribution of chromosomes. We also found that patients referred for embryo screening due to previous IVF failure had higher rates of mitotic error, which underscores the clinical importance of this form of whole-chromosome abnormality. (more…)
Author Interviews, JAMA, Ophthalmology / 08.10.2015

Prof-Jeremy-A-GuggenheimMedicalResearch.com Interview with: Professor Jeremy A. Guggenheim School of Optometry & Vision Sciences Cardiff University Cardiff, UK Medical Research: What is the background for this study? Dr. Guggenheim: An increased risk of myopia (nearsightedness) in first-born vs. non-first-born individuals was noticed in a 2013 study, which focused on 4 cohorts of children and young adults. We wanted to know whether the link between birth order and myopia was present in an earlier generation – before the invention of mobile phones and other gadgets. Also, first-born children tend to get slightly higher exam grades than do non-first-born children, an effect that has been attributed to slightly greater investment of time and energy by parents in the education of their first-born child. A high level of education is a well-known risk factor for myopia, therefore we were interested to find out whether the association between birth order and myopia was attributable to the slightly greater educational exposure of first-born individuals  (more…)
Author Interviews, JAMA, PTSD / 08.10.2015

Kathryn Magruder, Ph.D., M.P.H. Johnson Veterans Affairs Medical Center Charleston, S.C.MedicalResearch.com Interview with: Kathryn Magruder, Ph.D., M.P.H. Johnson Veterans Affairs Medical Center Charleston, S.C. Medical Research: What is the background for this study? What are the main findings? Dr. Magruder: There has been lots of attention and concern over PTSD in your younger veterans — both male and female -- and in male Vietnam veterans.  Too often the women who served during the Vietnam Era have been largely overlooked.  We felt like we owed it to them to understand better their responses to their wartime experiences — even if 40 years later.  It’s never too late to do the right thing! Our main finding is that the women who served in Vietnam had high prevalence of PTSD (20% lifetime, 16% current) and this was not attributable to cases that had developed prior to entering the military.  This was higher than the women who served near Vietnam or in the United States.  When we looked at their reported experiences during the Vietnam Era, the women who were in Vietnam reported higher levels of exposure to all of the items on our scale.  It was these experiences — especially sexual harassment, performance pressures, and experiences with triage and death — that explained their higher levels of PTSD. (more…)
Author Interviews, JAMA, Mental Health Research, Surgical Research / 08.10.2015

Dr. Junaid A. Bhatti MBBS PhD Sunnybrook Health Sciences Centre Toronto, ONMedicalResearch.com Interview with: Dr. Junaid A. Bhatti MBBS PhD Sunnybrook Health Sciences Centre Toronto, ON Medical Research: What is the background for this study? What are the main findings? Dr. Bhatti:  Bariatric surgery remains an important option for morbidly obese patients where other obesity management options fail. It is a safe procedure with mortality risk not higher than any other major procedure of this type. Some studies report that some patients may experience psychological stress following surgery. Studies on the long-term outcomes noted that there was a higher suicide risk in bariatric patients as compared to the general population. It was not clear whether these risks increased following surgery. In this study, we used the data of bariatric patients from Ontario who underwent surgery between 2006 and 2011. We assessed their emergency room visits three years before and three years following surgery. We looked into whether these patients had significantly more visits related to suicide attempts before compared to post surgery period. Overall, about 111 patients (1%) of the cohort had suicide attempts during follow-up. What we saw is that suicide risk increased by 50% following surgery than before surgery period. The risks were higher, but not significantly higher than others, if they were 35 years or older or from low-income or rural settings. The emergency services utilization of suicide attempts following surgery was more intense for the visits before surgery. (more…)