Author Interviews, Breast Cancer, Cancer Research, Chemotherapy, JAMA / 24.12.2015

MedicalResearch.com Interview with: Filippo Montemurro, M.D. Director, Investigative Clinical Oncology (INCO) Fondazione del Piemonte per l'Oncologia Candiolo Cancer Institute (IRCCS) Torino, Italy Medical Research: What is the background for this study? Dr. Montemurro: The evaluation of treatment-related side effects is a critical step in cancer patient management. It is important in the clinical practice, where the decision to modify doses, omit administrations or establish supportive care measures is based on treatment tolerance and side effects severity and duration. It is also important in the context of clinical trials. In the latter setting, the mere information of the antitumor activity of a new drug or regimen under investigation is worth little if it not accompanied by an accurate reporting of the side effect profile. For this reason, over the years reference protocols to standardize the process of toxicity reporting in clinical trials have been established. The most recent and widespread is the Common Terminology Criteria for Adverse Events (CTCAE), that is issued and constantly updated by the National Cancer Institute. The CTCAE allows the description of the incidence and on the grade of severity on a scale ranging from 0 (no toxicity) to 5 (death due to that toxicity). Normally, the medical or nursing staff data collects information to fill in the CTCAE reports either by interviewing patients or extracting data from the clinical notes taken by physicians. The "indirectness" of this process has consequences that are becoming acknowledged for their potential implications. The incidence and severity of toxicities results often underestimated by doctors when their reports are compared with corresponding reports provided directly by patients without intermediaries (so called Patient reported outcomes-PRO). If this phenomenon is described in the context of clinical trials, it might occur to a greater extent also in the clinical practice, where the process of toxicity reporting is not mandated by a protocol and no reference standard is recommended. Based on these premises, we designed a study to pursue two aims;
  • the first was to assess whether a 10-item questionnaire derived by the CTCAE could be used by breast cancer patients receiving adjuvant chemotherapy after surgery in the daily clinical practice;
  • the second was to compare doctors and patients reports of toxicities at corresponding time-points.
Medical Research: What are the main findings? Dr. Montemurro: We administered the 10-item questionnaire after the first and third cycle of adjuvant chemotherapy to 601 women who had undergone surgery for breast cancer. To develop this questionnaire, CTCAE definitions of severity for each item (nausea, vomiting, constipation, anorexia, dysgeusia, diarrhea, fatigue, pain, paresthesia, and dyspnea) were translated into Italian and rephrased into statements. Patients were asked to choose the statement that best represented the worst experience with that side effect after the reference cycle of chemotherapy. At the same time-points, research nurses extracted information from the medical charts and reported them in paired doctor questionnaires. A total of 99% and 97% of the patient returned filled in questionnaires. Pairwise comparisons showed that doctors systematically underestimated both incidence and severity for all the side effects. Interestingly, comparison of the two patient questionnaires revealed temporal changes that were possibly related to the effect of prophylactic measures taken after the first cycle (i.e. reduction in vomiting, diarrhea and pain) or to cumulative toxicties (i.e. worsening dysgeusia and dyspnea). No such changes except for worsening dyspnea were observed comparing the two doctors questionnaires. Finally, we found a direct relationship between number of patients and magnitude of discrepancy in side effects reporting was observed, suggesting that the workload could be a factor influencing this phenomenon. (more…)
Author Interviews, Obstructive Sleep Apnea, Vitamin D / 24.12.2015

MedicalResearch.com Interview with: Ken M. Kunisaki , MD Associate Professor of Medicine Pulmonary, Allergy, Critical Care and Sleep Medicine University of Minnesota  Medical Research: What is the background for this study? What are the main findings? Dr. Kunisaki : Obstructive sleep apnea (OSA) is a very common condition that is the result of recurrent complete or partial closure of the upper airway during sleep.  OSA leads to poor sleep quality and excessive daytime sleepiness. A previous study suggested that OSA is more common in the winter, but there were no vitamin D measurements in that study, which seemed potentially relevant since many people have lower vitamin D levels in the winter, due to less sunlight exposure in the winter.  Several studies have also shown that people with low vitamin D levels have worse muscle function.  Since muscles are partially responsible for keeping the upper airway open during sleep, we wondered whether people with low vitamin D levels might have weaker upper airway muscles and therefore be more prone to having OSA. In our study, we found that indeed, persons with OSA had lower vitamin D levels than those without OSA, but this was explained by obesity.  In other words, the low vitamin D levels seen in OSA patients is likely just a marker of obesity and not likely related to the presence or absence of OSA. (more…)
Author Interviews, CT Scanning, Heart Disease / 24.12.2015

MedicalResearch.com Interview with: Dr. Joan Pinto-Sietsma MD PhD Department of Clinical Epidemiology, Biostatistics and Bioinformatics Academic Medical Center Amsterdam, The Netherlands.  Medical Research: What is the background for this study? What are the main findings? Response: A positive family history for premature coronary artery disease is an important risk factor for coronary artery disease. Therefore, it is frequently proposed to be included in current risk assessment tools and clinical practice guidelines. On the other hand, a positive family history for coronary artery disease only identifies families at risk, whereas it fails to identify which specific individual within a family is at particular risk. Therefore, its applicability in clinical practice is limited. The detection of subclinical atherosclerosis as assessed by assessing coronary artery calcification, with CT scanning, has emerged as prognostic evaluation of coronary artery disease. Prospective follow-up studies have shown that coronary artery calcification predicts cardiovascular events, independent of risk factors. Therefore, assessing coronary artery calcifications in families with premature coronary artery disease might help in determining which individuals within such families are at particular risk and therefore help decide regarding treatment. We analysed the association between a positive family history for premature coronary artery disease and coronary artery calcifications in 704 asymptomatic individuals. Furthermore, we assessed the predictive value of coronary artery calcifications in individuals with a positive family history for premature coronary artery disease in a sub analysis in 834 individuals of the St. Francis Heart Study, in which subjects were followed for about 3.5 years. We observed, that individuals of high risk families (a positive family history of premature coronary artery disease) had a 2 time higher risk to have a calcium score > the 80th percentile as compared to individuals with a negative family history of premature coronary artery disease. Besides, individuals from high risk families with a high calcium score (> the 80th percentile) had a 2 time higher risk to get a cardiovascular event in 3,5 years, whereas individuals of high risk families without coronary calcifications did not have an increased risk at all. (more…)
Author Interviews, Cancer Research, Lymphoma, NEJM / 24.12.2015

MedicalResearch.com Interview with: Dr. Michael van Leeuwen PhD Department of Epidemiology Netherlands Cancer Institute Amsterdam, the Netherlands Medical Research: What is the background for this study? What are the main findings? Response: Over the last decades cure rates for Hodgkin’s lymphoma patients have increased dramatically. Cure and long-term survival may, however, come at a price, in the form of an increased risk of second cancers and other late effects. Since the late 1980’s treatment of Hodgkin’s lymphoma has been changed towards smaller radiation target volumes and more effective, generally less toxic chemotherapy. In a study which included 3905 Hodgkin’s lymphoma patients treated between 1965 and 2000 in the Netherlands, the impact of these treatment changes on second malignancy risk was evaluated. Hodgkin’s lymphoma patients were between the ages of 15 and 50 years and had survived at least 5 years after treatment. During follow-up, 1055 second cancers were diagnosed in 908 survivors, corresponding to a risk of 4.6 times as high as the occurrence of cancer in the general population. Up to at least 40 years after treatment for Hodgkin’s lymphoma, survivors remained at increased risk for second cancers. The cumulative incidence of a second cancer was 33.2% at 30 years, compared with 9.6% in the general population, and 48.5% at 40 years, compared with 19.0% in the general population. Breast cancer was the most common second cancer reported followed by lung and gastrointestinal cancers. Thirty-year cumulative incidence was 16.6% for breast cancer, 7.1% for lower respiratory tract cancers, 7.0% for gastrointestinal cancers, and 3.7% for non-Hodgkin’s lymphomas. The risk of solid cancer after treatment for Hodgkin’s lymphoma was not lower among more recently treated patients (patients treated between 1989 and 2000) than among those who were treated in earlier time periods, despite changes in treatment. Nonetheless, patients treated with smaller radiation fields (e.g., a supradiaphragmatic field radiotherapy not including the axilla) were at a 63% lower relative risk of breast cancer as a second malignancy than if they received complete mantle-field radiotherapy. The lack of change in the cumulative incidence of solid cancers could be due to an incomplete adoption of the more modern radiotherapy concepts but may also be explained on the basis of a change in the chemotherapy regimens used in the 1990s. Because in the 1970’s many women exposed to high doses of alkylating agents were experiencing premature menopause, doses of alkylating agents were lowered over time to preserve fertility. However, early menopause introduced with the alkylating regimens was likely responsible for decreasing the breast cancer incidence. With the lower doses of the alkylating agents, this protection was taken away. The cumulative incidence of non-Hodgkin’s lymphoma and of leukemia (and the myelodysplastic syndrome) was, however, much lower among patients who were treated in the period from 1989 through 2000 than among those who were treated in the period from 1965 through 1976. For leukemia, the decrease in cumulative incidence is likely due to the much lower doses of alkylating agents used in Hodgkin’s lymphoma treatment in the 1990’s compared to earlier decades. It is important to realize that current common practice in radiation oncology, including involved-node or involved-site radiotherapy, three-dimensional conformal radiation treatment planning, and radiation doses of less than 36 Gy, was not applied in our study population. It is hoped that these changes may reduce the risk of solid cancer among patients treated after 2000. (more…)
Author Interviews, Immunotherapy, NEJM, Rheumatology / 24.12.2015

MedicalResearch.com Interview with: Prof. dr. D.L.P. Baeten MD Clinical Immunology and Rheumatology Academic Medical Center University of Amsterdam Amsterdam, The Netherlands Medical Research: What is the background for this study? What are the main findings? Prof. Baeten: Ankylosing spondylitis is a debilitating rheumatic condition which affects young adults and with NSAIDS and TNF inhibitors as only therapeutic option. Over the last years, we generated evidence that IL-17 is an important inflammatory mediator in this condition. In the two studies reported here in the NEJM, we demonstrate that IL-17 inhibition with secukinumab has a very profound and long-lasting effect on signs and symptoms as well as inflammation in ankylosing spondylitis patients, even in those patients that failed a TNF blocker before. (more…)
Author Interviews, Blood Pressure - Hypertension, Heart Disease, Lancet / 24.12.2015

MedicalResearch.com Interview with: Kazem Rahimi | FRCP DM MSc FESC Associate Professor of Cardiovascular Medicine, University of Oxford Deputy Director, The George Institute for Global Health James Martin Fellow in Healthcare Innovation, Oxford Martin School Honorary Consultant Cardiologist, Oxford University Hospitals NHS Trust Medical Research: What is the background for this study? What are the main findings? Prof. Rahimi: Although the benefits of blood pressure lowering treatment for prevention of cardiovascular disease are well established, the extent to which these effects differ by baseline blood pressure, presence of co-morbidities (such as stroke or diabetes), or drug class is less clear. Medical Research: What should clinicians and patients take away from your report? Prof. Rahimi: Our study has several implications for clinical practice. Our findings suggest that blood pressure lowering to levels below those recommended in current guidelines (ie, systolic blood pressure of less than 140 mm Hg) will reduce the risk of cardiovascular disease. By showing no evidence for a threshold below which blood pressure lowering ceases to work, the findings call for blood pressure lowering based on an individual’s potential net benefit from treatment rather than treatment of the risk factor to a specific target. Furthermore, the differences we identified between classes of drugs support more targeted drug use for individuals at high risk of specific outcomes (eg, calcium channel blocker therapy for individuals at high risk of stroke or and diuretics are more eff ective for prevention of heart failure). Overall, our findings clearly show that treating blood pressure to a lower level than currently recommended could greatly reduce the incidence of cardiovascular disease and potentially save millions of lives if the treatment was widely implemented. The results provide strong support for reducing systolic blood pressure to less than 130 mmHg, and blood pressure-lowering drugs should be offered to all patients at high risk of having a heart attack or stroke, whatever their reason for being at risk.  (more…)
Author Interviews, Frailty, Mayo Clinic, Pulmonary Disease, Transplantation / 23.12.2015

MedicalResearch.com Interview with: Cassie Kennedy, M.D. Pulmonology and Critical Care Medicine Mayo Clinic  Medical Research: What is the background for this study? Dr. Kennedy: Lung transplant is a surgical procedure that can offer extended life expectancy and improved quality of life to selected patients with end-stage lung disease. However there are about 1700 patients awaiting lung transplant at any given time in the United States because transplant recipients far exceed potential donors.  In addition, even with carefully chosen candidates, lung transplant recipients live on average about 5.5 years.  It is therefore very important for transplant physicians to choose patients who will receive the most benefit from their lung transplant. Frailty (defined as an increased vulnerability to adverse health outcomes) has typically been a subjective consideration by transplant physicians when choosing lung transplant candidates.  The emergence of more objective and reproducible frailty measures from the geriatric literature present an opportunity to study the prevalence of frailty in lung transplant (despite that subjective screening) and to determine whether the presence of frailty has any impact on patient outcomes. Medical Research: What are the main findings? Dr. Kennedy: Frailty is quite common --46 percent of our patient cohort was frail by the Frailty Deficit Index. We also saw a significant association between frailty and worsened survival following lung transplantation: one-year survival rate for frail patients was 71.7 percent, compared to 92.9 percent for patients who were not frail. At three years this difference in survival persisted--the survival rate for frail patients was 41.3 percent, compared to 66.1 percent for patients who were not frail. (more…)
Author Interviews, Cancer Research, Prostate Cancer, Surgical Research, Transplantation / 23.12.2015

MedicalResearch.com Interview with: Gerardo Vitiello, MD Emory University School of Medicine Emory Transplant Center NYU Langone Medical Center Department of Surgery  Medical Research: What is the background for this study? What are the main findings? Dr. Vitiello:   Screening for prostate cancer with prostate specific antigen (PSA) levels is highly controversial, as it is a non-specific marker for prostate cancer. A PSA level may be elevated in a variety of disease processes (not only prostate cancer), and even in the general population, the benefit of early intervention for prostate cancer is unclear. In contrast, end stage renal disease (ESRD), where patients no longer have renal function and require dialysis, is a major health problem with a huge impact on a patient’s quality of life. The only cure for ESRD is kidney transplantation, which has been shown to have an enormous health and quality of life benefit for transplant recipients. Transplant centers have rigorously screened candidates for potential malignancy prior to transplantation to ensure that there are no contraindications to receiving a transplant. For the first time, we demonstrate that screening for prostate cancer in kidney transplant candidates is not beneficial, and may actually be harmful, since it delays time to transplant and reduces a patient’s chance of receiving a transplant without an apparent benefit on patient survival. (more…)
AHA Journals, Author Interviews, Education, Heart Disease, Stroke / 23.12.2015

MedicalResearch.com Interview with: Carole Decker, RN, PhD, CPHQ, FAHA Director, Cardiovascular Outcomes Research Saint Luke's Mid America Heart Institute Kansas City, MO 64111 Medical Research: What is the background for this study? What are the main findings? Dr. Decker: Stroke is the leading cause of disability and the fifth leading cause of death. The utilization of thrombolytic therapy is the national standard of care for acute ischemic stroke (AIS) treatment resulting in improved outcomes at 90 days and yet only 7% of patients with AIS receive a thrombolytic. The American College of Emergency Physicians emphasizes the importance of using a shared medical decision-making model with AIS patients and their caregivers to discuss benefits and risks of treatment. The recommended door-to-needle (emergency door to thrombolytic administration) is 60 minutes to achieve the optimal patient outcomes which can be problematic in that conversation on benefits and risks occurs in a hurried emergency setting. Multiple risk models to identify individualized benefits and risks of thrombolytic therapy have been developed but few are used prospectively and are not used at the point of care. Our team created ePRISM (Personalized Risk Information Services Manager), a Web-based tool, to generate personalized documents with patient-specific outcomes based on validated risks models. To support knowledge transfer and creation of a shared decision-making tool, our multidisciplinary team conducted qualitative interviews to define the information needs and preferred presentation format for stroke survivors, caregivers, and clinicians considering thrombolytic treatment. (more…)
Author Interviews, HPV, Infections, Pediatrics, Sexual Health / 23.12.2015

MedicalResearch.com Interview with: Seo Yoon Lee, RN Department of Health Policy and Management Graduate School of Public Health Eun-Cheol Park MD, PhD Institute of Health Services Research Department of Preventive Medicine Yonsei University, Seoul, South Korea  Medical Research: What is the background for this study? What are the main findings? Response: Sexually Transmitted Infections (STIs) are a major public health issue which causes acute illness, infertility, long-term disability or other serious medical and psychological consequences, around the world. Adolescence is a key developmental period with rapid cognitive growth. In recent decades, substantial change in the sexual behaviors and attitudes of adolescents has occurred and this would lead them greater risk of STIs than other. Our study looked at the relationship between adolescents’ first sexual intercourse age and their STI experience, as well as to identify vulnerable time table of their sexual activity by considering the time gap between their secondary sex characteristic occurrence age and first sexual intercourse age. The findings from our study show that earlier initiation of sexual intercourse increases the odds of experiencing STIs. Also as the age gap gets shorter, the odds of experiencing STIs increase. Approximately 7.4% of boys and 7.5% of girls reported had STI. For both boys and girls, the chance of experiencing STIs increased as the age of first sexual intercourse decreased [boys: before elementary school (age 7 or under) OR=10.81, first grade (age 7or 8) OR=4.44, second grade (age 8 or 9) OR=8.90, fourth grade (age 10 or 11) OR=7.20, ninth grade (age 15 or 16) OR=2.31; girls: before elementary school OR=18.09, first grade OR=7.26, second grade OR=7.12, fourth grade OR=8.93, ninth grade OR=2.74]. The association between the absolute age gap (AAG: defined as absolute value of “Age gap” = [Age at first sexual intercourse] - [age of secondary sexual manifest]) and STI experience was examined additionally which the result showed, students who had sexual intercourse after their secondary sexual manifestation, as the AAG increases, the odds of STI experience were decreased (boys OR=0.93, girls OR=0.87). (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, JAMA, Nutrition / 23.12.2015

MedicalResearch.com Interview with: Philipp Schuetz, MD, MPH University Department of Medicine Clinic for Endocrinology/Metabolism/Clinical Nutrition, Kantonsspital Aarau, Aarau, Switzerland Medical Faculty of the University of Basel Basel, Switzerland Medical Research: What is the background for this study? What are the main findings? Dr. Schuetz: Malnutrition is common in hospitalised patients and associated with detrimental metabolic consequences. The current clinical approach is to provide at risk patients nutritional support as a strategy to tackle malnutrition and its associated adverse outcomes. Yet, whether this strategy is effective and improves clinical outcomes in the medical inpatient population is unclear. In addition, recent trials from critical care have shown adverse outcomes when nutritional therapy was used too aggressively. Herein, our metaanalysis is the first to systematically investigate effects of nutritional support in medical inpatients. Our analysis shows that nutritional support is highly effective in increasing energy and protein intake and helps to stabilize weight loss. Also, risk for unplanned readmission after discharge from the hospital was reduced and length of stay was shorter in the patient population with established malnutrition. Yet, for other important clinical outcomes such as mortality and functional outcomes effects of nutritional support remained uncertain. Also, the quality of evidence was found to be moderate to low. (more…)
Author Interviews, Breast Cancer, Genetic Research, Journal Clinical Oncology / 23.12.2015

MedicalResearch.com Interview with: Dr. Marjanka Schmidt PhD Group Leader, Molecular Pathology Netherlands Cancer Institute Medical Research: What is the background for this study? What are the main findings? Dr. Schmidt: BRCA1/2 mutation carriers who developed a primary breast cancer are thought to be at high risk to develop a contralateral breast cancer (breast cancer in the opposite breast). Our study is one of the first to provide unbiased risk estimates for young breast cancer patients with a pathogenic BRCA1/2 mutation. We also showed that age of onset of the first breast cancer is a predictor for the development of contralateral breast cancer in BRCA1/2 mutation carriers, but not in non-carriers. (more…)
Author Interviews, Diabetes, Diabetes Care, OBGYNE / 23.12.2015

MedicalResearch.com Interview with: Dr. Janet Rowan Obstetric Physician National Women's Health, Auckland Medical Research: What is the background for this study? Dr. Rowan: Clinicians are interested in screening during early pregnancy to identify women with previously unrecognised diabetes, as these women have increased risks of adverse pregnancy outcomes. HbA1c is a simple and reproducible measure of glucose elevations, but its usefulness as an early pregnancy screening test is not clear. The aim of this study was to examine whether pregnant women with an HbA1c of 41-49mmol/mol (5.9-6.6%) are a high risk subgroup and whether treating these women from early pregnancy improves outcomes compared with identifying them during routine screening for gestational diabetes (GDM) from 24 weeks’ gestation. This observational study compared women referred to the diabetes clinic <24 weeks’ who had an early pregnancy HbA1c of 41-49mmol/mol (5.9-6.6%) with women who, at the time of diagnosis of GDM ≥24 weeks’ (typically by 75gOGTT), had an HbA1c of 41-49mmol/mol (5.9-6.6%). Both groups were compared with women diagnosed with GDM who had a lower HbA1c at diagnosis. (more…)
Author Interviews, Diabetes, JAMA, Ophthalmology, Telemedicine / 23.12.2015

MedicalResearch.com Interview with: Christina Y. Weng, MD, MBA Assistant Professor-Vitreoretinal Diseases & Surgery Baylor College of Medicine-Cullen Eye Institute  Medical Research: What is the background for this study? What are the main findings? Dr. Weng: Telemedicine has been around for a long time, but only recently have technological advances solidified its utility as a reliable, effective, and cost-efficient method of healthcare provision.  The application of telemedicine in the field of ophthalmology has been propelled by the development of high-quality non-mydriatic cameras, HIPAA-compliant servers for the storage and transfer of patient data, and the growing demand for ophthalmological care despite the relatively stagnant supply of eye care specialists.  The global epidemic of diabetes mellitus has contributed significantly to this growing demand, as the majority of patients with diabetes will develop diabetic retinopathy in their lifetime. Today, there are over 29 million Americans with diabetes, and diabetic retinopathy is the leading cause of blindness in working age adults in the United States.  The American Academy of Ophthalmology’s and American Diabetes Association’s formal screening guidelines recommend that all diabetic patients receive an annual dilated funduscopic examination.  Unfortunately, the compliance rate with this recommendation is quite dismal at an estimated 50-65%.  It is even lower amongst minority populations which comprise the demographic majority of those served by the Harris Health System in Harris County, Texas, the third most populous county in the United States. In 2013, the Harris Health System initiated a teleretinal screening program housed by eight of the district’s primary care clinics.  In this system, patients with diabetes are identified by their primary care provider (PCP) during their appointments, immediately directed to receive funduscopic photographs by trained on-site personnel operating non-mydriatic cameras, and provided a follow-up recommendation (e.g., referral for in-clinic examination versus repeat imaging in 1 year) depending on the interpretation of their images.  The images included in our study were interpreted via two different ways—once by the IRISTM (Intelligent Retinal Imaging Systems) proprietary auto-reader and then again by a trained ophthalmic specialist from the IRISTM reading center.  The primary aim of this study was to evaluate the utility of the auto-reader by comparing its results to those of the reading center. Data for 15,015 screened diabetic patients (30,030 eyes) were included.  The sensitivity of the auto-reader in detecting severe non-proliferative diabetic retinopathy or worse, deemed sight threatening diabetic eye disease (STDED), compared to the reading center interpretation of the same images was 66.4% (95% confidence interval [CI] 62.8% - 69.9%) with a false negative rate of 2%.  In a population where 15.8% of diabetics have STDED, the negative predictive value of the auto-reader was 97.8% (CI 96.8% - 98.6%). (more…)
Author Interviews, Cancer Research, Colon Cancer, Cost of Health Care, JAMA, Social Issues, University of Michigan / 23.12.2015

MedicalResearch.com Interview with: Christine Veenstra MD Clinical Lecturer, Internal Medicine Medical Oncology University of Michigan Ann Arbor, MI  48109-5343 MedicalResearch: What is the background for this study? What are the main findings? Dr. Veenstra: Patients with cancer face many costs and incur financial burden as they go through diagnosis and treatment. For working patients, cancer diagnosis and treatment may come with the additional burden of time away from work, lost income, and even long-term job loss. Although 40% of US workers do not have access to paid sick leave, we hypothesized that availability of paid sick leave could reduce the need to take unpaid time away from work during cancer treatment and might therefore be associated with job retention and reduced personal financial burden. In a survey of over 1300 patients with Stage III colorectal cancer, we found that only 55% of those who were employed at the time of their cancer diagnosis retained their jobs. Working patients with paid sick leave were nearly twice as likely to retain their jobs compared with working patients who did not have paid sick leave. This held true even when controlling for income, education and health insurance. Furthermore, working patients without paid sick reported significantly higher personal financial burden than those who had paid sick leave available. (more…)
Author Interviews, Cancer Research, JAMA, Lung Cancer, Surgical Research / 23.12.2015

MedicalResearch.com Interview with: Dr Najib Rahman D Phil MSc MRCP Consultant and Senior Lecturer Lead for Pleural Diseases Oxford Centre for Respiratory Medicine Clinical Director, Oxford Respiratory Trials Unit Tutor in Clinical Medicine University College, Oxford Medical Research: What is the background for this study? Dr. Rahman : Up to TIME1, the evidence base behind optimal pleurodesis for malignant pleural effusion in terms of tube size and analgesia was poor. Optimal pleurodesis in this context is one which is successful (i.e. the patient needs no further pleural interventions for that malignant effusion), but occurs with the minimum discomfort. This is particularly important as the treatment intent in malignant effusion pleurodesis is palliative. This is the first adequately powered randomized trial to address two important issues in pleurodesis for malignant pleural effusion - that of whether NSAIDs reduce pleurodesis efficacy, and if smaller chest tubes (12F) are "as good as" larger chest tubes (24F) for pleurodesis success and in terms of pain. Medical Research: What are the main findings? Dr. Rahman : The main and somewhat surprising findings are that:
  1. NSAIDs given short term but at high dose do not impair pleurodesis - they are no better than morphine for pain control (in fact, they needed modestly more rescue medication), but can be freely used during malignant effusion pleurodesis with no fear of reducing pleurodesis success.
  1. Smaller tubes were marginally less painful than larger tubes - but this difference was not clinically very relevant
  1. Smaller tubes cannot now be said to be "as good as" larger tubes for malignant effusion pleurodesis. Our data shows that they failed in non-inferiority to larger tubes for pleurodesis success at 3 months. 
  1. Smaller tubes resulted in higher fall our rates, a higher incidence of not being able to administer talc and were associated with more complications during insertion .
(more…)
Author Interviews, Pediatrics, Weight Research / 23.12.2015

MedicalResearch.com Interview with: S. Bryn Austin, ScD, Professor Dept. of Social and Behavioral Sciences Harvard T.H. Chan School of Public Health Director, Strategic Training Initiative for the Prevention of Eating Disorders and Katherine L. Record JD, MPH Massachusetts Health Policy Commission Boston  Medical Research: What is the background for this editorial? What are the main concerns regarding thinness in 'Paris' models? Response: The fashion industry has long been criticized for promoting unrealistic and patently unhealthy standards of thinness for girls and women. Furthermore, decades of psychological research have documented the pervasive and pernicious harm caused to body image and sense of self especially for adolescent girls during a most vulnerable time of development. What is often left out of the discussion, though, is the immediate and sometimes deadly harm caused to the girls and young women working as professional models as a result of what amounts to coerced starvation as a condition of employment. Most models begin working in the industry in their early or mid teens -- in other words, as children. We must ask ourselves, what other industry or employer in the United States would ever be allowed by our government to foster practices of coerced starvation of American child labor? (more…)
Author Interviews, Genetic Research, Immunotherapy / 22.12.2015

MedicalResearch.com Interview with: Benjamin Greenbaum, PhD Assistant Professor and Professor Nina Bhardwaj MD PhD Hematology and Medical Oncology Tisch Cancer Institute Icahn School of Medicine at Mount Sinai New York, NY 10029 Medical Research: What is the background for this study? Response: It has recently become clear that, due to epigenetic alterations, tumors transcribe non-coding RNAs that are typically silenced. Often such RNA emanates from the “dark matter” genome. Many of these regions consist of repetitive elements and endogenous retroelements that are rarely transcribed in normal tissue. At the same time, due to immunotherapy, understanding the role of the immune system and immune activation in tumors has become critically important. The activation of specific elements of the innate immune system in a tumor may have either beneficial or detrimental effects for patients. Moreover, recent work has suggested that endogenous element activation can lead to improved immunotherapy outcomes. Therefore, it is critically important to understand the nature of innate immune activation in tumors and what triggers are responsible for these responses. We have been developing methods to detect abnormal patterns in viral RNA that may indicate activation of the innate immune system. We have found that patterns of motif usage avoided in the evolution of viruses, such as influenza, indicate RNA features that provoke an innate immune response. The innate immune system is capable of sensing motifs in viruses. We tested directly whether these avoided patterns are immunostimulatory. (more…)
Author Interviews, Dermatology, Pharmacology / 22.12.2015

MedicalResearch.com Interview with: Dr. Diana Lac, PhD Senior Scientist at BioPharmX Corporation. Dr. Lac received her PhD in Pharmacology and Toxicology from the University of California, Davis and currently focuses on the development of topical treatments for acne. MedicalResearch: What is the background for this study? What are the main findings? Dr. Lac: Acne affects almost 90% of people in western societies during their teenage years and may persist into adulthood. Currently, the oral tetracycline class of drugs dominates the acne treatment market. However, these treatments have been associated with a variety of adverse effects, such as headaches, dizziness, fatigue, nausea, photosensitivity, and severe itchiness. While a variety of acne treatments do exist, topical antibiotics particularly have had limited success due to formulation challenges. A topical minocycline formulation will provide a superior alternative for local treatment of acne, thereby limiting the amount of systemic exposure to the antibiotic and addressing the overall global antibiotic resistance problem. We believe that by directly delivering the drug to the skin we can decrease the amount of antibiotic exposure and also limit the off-target effects. We have developed a novel, stable minocycline gel formulation allowing for efficient delivery of minocycline directly to the pilosebaceous unit in the skin where Propionibacterium acnes typically reside. In this poster presentation we have demonstrated this effectively in live rats. A dose ranging study was conducted where drug delivery and safety of our novel formulation was assessed. A number of dose formulations were tested (up to 4% minocycline formulations) and were found to be non-irritating and safe for topical use. (more…)
Author Interviews, Exercise - Fitness, PNAS / 22.12.2015

MedicalResearch.com Interview with: Ekaterina Subbotina, Ph.D. Postdoctoral Research Scholar University of Iowa Carver College of Medicine Iowa City, IA 52242  Medical Research: What is the background for this study? Dr. Subbotina: Exercises represent the most natural and effective way to maintain physical and metabolic well-being. Lack of physical activity can contribute to many preventable diseases such as cardiovascular disease, stroke, cancer, diabetes and obesity. It is known that moderate exercise is beneficial for health but the mechanism of this effect is only partially understood. It becomes more and more evident that skeletal muscles function as an organ that produces and secretes biologically active molecules called myokines. Studies of the biological role and mechanism of action of myokines are important for understanding of muscle function under sedentary and exercise conditions. (more…)
Author Interviews, CDC, Pediatrics, Race/Ethnic Diversity / 22.12.2015

MedicalResearch.com Interview with: Kim Van Naarden Braun, Ph.D. Epidemiologist Developmental Disabilities Branch National Center on Birth Defects and Developmental Disabilities Centers for Disease Control and Prevention Atlanta, GA  30341 Medical Research: What is the background for this study? What are the main findings? Dr. Van Naarden Braun: Over the past five decades, remarkable improvements have been made in obstetric and neonatal care resulting in significant declines in infant mortality both in the US and abroad, particularly for infants born premature and very low birthweight. Successes in neonatal survival have been met by concerns that the occurrence of developmental disabilities, most notably cerebral palsy, would increase. By monitoring changes over time in the prevalence of cerebral palsy, we can try to understand the impact of these advances further. Our recently published study reported that the birth prevalence of cerebral palsy has not decreased from the mid-1980’s to early 2000’s. The study also looked at whether the birth prevalence over time differed for children with cerebral palsy who were in certain racial and ethnic groups, had certain birth characteristics, or had other developmental disabilities and found that:
  • The birth prevalence of children with cerebral palsy with moderate to severe intellectual disability decreased about 2.6% each year from 1985 to 2002.
  • Birth prevalence of cerebral palsy among black children was higher than among white and Hispanic children, and this higher prevalence continued over the 17-year period.
  • Overall, there was no change over time in cerebral palsy birth prevalence among children born at certain birthweights or gestational age, but there were some differences when looking at these factors in different racial/ethnic groups.
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Author Interviews, CDC, Opiods / 22.12.2015

MedicalResearch.com Interview with: R. Matthew Gladden, PhD Behavioral Scientist Division of Unintentional Injury Prevention CDC Medical Research: What is the background for this study? What are the main findings? Dr. Gladden: The rate for drug overdose deaths has increased approximately 140% since 2000, driven largely by opioid overdose deaths. Nearly every aspect of the opioid overdose death epidemic worsened in 2014. Drug overdose deaths increased significantly from 2013 to 2014. Increases in opioid overdose deaths were the main factor in the increase in drug overdose deaths. The death rate from the most commonly prescribed opioid pain relievers (natural and semisynthetic opioids) increased 9%, the death rate from heroin increased 26%, and the death rate from synthetic opioids (a category that includes illicitly-made fentanyl and synthetic opioid pain relievers other than methadone) increased 80%. (more…)
Author Interviews, JAMA, MRI, Stroke / 22.12.2015

MedicalResearch.com Interview with: Sepideh Amin-Hanjani, MD FAANS FACS FAHA Professor & Program Director Co-Director, Neurovascular Surgery Department of Neurosurgery University of Illinois at Chicago Past Chair, AANS/CNS Cerebrovascular Section  Medical Research: What is the background for this study? What are the main findings? Dr. Amin-Hanjani: Posterior circulation strokes account for up to 30% of all ischemic strokes, and atherosclerotic occlusive disease of the vertebrobasilar (VB) is responsible for approximately one third of these cases. Symptomatic atherosclerotic VB occlusive disease is associated with a high risk of recurrent stroke despite medical therapy, in the range of 10-15% within 2 years. There have been advances in treatment options, particularly endovascular angioplasty and stenting, aimed at reverting the blockage; however these procedures themselves carry risks, and are likely to benefit only selected patients who are at highest risk without intervention. Our study, VERiTAS, aimed to determine if measurement of blood flow in the posterior circulation vessels could identify the high risk patients. Flow measurements were performed using the technique of quantitative magnetic resonance angiography (QMRA) relying on standard MR sequences and  the commercial software NOVA. These flow measurements were used to designate patients presenting with symptomatic vertebrobasilar disease as flow compromised or not, and patients were then followed for a median of 23 months in a blinded fashion to determine the risk of subsequent strokes. We found that among 72 such patients, only one quarter (18 patients) demonstrated flow compromise on QMRA, but that this group had a significantly higher risk of subsequent stroke at one year, 22% vs only 4% in the other group. The hazard ratio for subsequent stroke was markedly elevated at 11.5 even after adjusting for age and other stroke risk factors. (more…)
Author Interviews, Emory, Race/Ethnic Diversity, Social Issues / 22.12.2015

MedicalResearch.com Interview with: Abigail Sewell PhD Assistant Professor of Sociology Emory University Medical Research: What is the background for this study? Dr. Sewell: Ethnoracial minorities report poorer quality of care than do whites. However, one key dimension of health care quality - trust in one's personal physician - indicates mixed associations with race. This study examines five dimensions of the patient-physician relationship independently of each other to identify the aspects of health care where minorities feel most alienated from their doctors. Medical Research: What are the main findings? Dr. Sewell: The results of the study show that Blacks and Latinos are less likely to believe that their doctors really care about them as a person than are Whites. (more…)
Author Interviews, Cancer Research, Leukemia / 21.12.2015

MedicalResearch.com Interview with: Renaud Capdeville, MD Global Program Head Oncology Global Development Novartis Medical Research: What is the background for this study? What are the main findings? Dr. Capdeville: RATIFY (Randomized AML Trial in FLT3 in patients <60 Years Old; CALGB 10603) was a Phase III, international, randomized, placebo-controlled, double-blind group trial of newly-diagnosed (Acute myeloid leukemia, acute myelogenous leukemia) AML patients aged 18 to less than 60 who have a FLT3 mutation. In the study, patients who received the investigational compound PKC412 (midostaurin) plus standard induction and consolidation chemotherapy experienced a 23% improvement in overall survival (OS) (hazard ratio [HR] = 0.77, P =0.0074) compared with those treated with standard induction and consolidation chemotherapy alone. The median OS for patients in the PKC412 (midostaurin) treatment group was 74.7 months (95% confidence interval [CI]: 31.7, not attained), versus 25.6 months (95% CI: 18.6, 42.9) for patients in the placebo group. The data, collected and analyzed in partnership with the Alliance for Clinical Trials in Oncology, are from the largest clinical trial in FLT3-mutated AML to date, with 3,279 patients screened and 717 study participants from around the world. (more…)
Author Interviews, Breast Cancer, Cancer Research, Dental Research, Smoking / 21.12.2015

MedicalResearch.com Interview with: Jo Freudenheim, PhD UB Distinguished Professor and Interim Chair Department of Epidemiology and Environmental Health School of Public Health and Health Professions University at Buffalo Buffalo, NY Medical Research: What is the background for this study? What are the main findings? Dr. Freudenheim: There have been a number of studies that have shown an association between periodontal disease and chronic diseases, particularly stroke and heart attacks. There is also some newer evidence that periodontal disease is associated with cancer, particularly cancers of the gastrointestinal tract. Ours is the first large prospective study of periodontal disease and breast cancer. This was part of a study of more than 70,000 postmenopausal women from throughout the United States, the Women’s Health Initiative. Women provided information about their health and other related factors and then those women were followed to see who developed certain diseases. We found that women who had been told that they had periodontal disease were more likely to develop breast cancer. In particular, women who were former smokers (quit within the last 20 years) and who had periodontal disease were at increased breast cancer risk. There was a similar increase in risk for current smokers with periodontal disease but it was not statistically significant. (There was a relatively small number of current smokers in the WHI study.) (more…)
Author Interviews, Endocrinology, Kidney Disease, Transplantation, Vitamin K / 21.12.2015

MedicalResearch.com Interview with: Josep M Cruzado, MD Head, Nephrology Department Hospital Universitari de Bellvitge  Medical Research: What is the background for this study? What are the main findings? Dr. Cruzado: Tertiary hyperparathyroidism is frequent after renal transplantation. Inappropriately high parathyroid hormone levels are associated with hypercalcemia, hyperphosphatemia, both allograft and vascular calcification and bone mineral density loss. Cinacalcet is highly effective to control hypercalcemia in this setting although there were no studies comparing cinacalcet with subtotal parathyroidectomy. Main findings are that subtotal parathyroidectomy is superior to cinacalcet in normalizing hypercalcemia amb iPTH, increased bone mineral density at femoral neck and is more cost effective (the cost of subtotal parathyroidectomy is equal to 14 months of cinacalcet and this drug should be maintained overtime). (more…)
Author Interviews, Dermatology, Technology / 21.12.2015

MedicalResearch.com Interview with: Christie Riemer MD Candidate-Class of 2016 Michigan State University College of Human Medicine Medical Research: What is the background for this study? What are the main findings? Response: Online physician rating sites allow patients to recommend, grade, and publicly comment on physician performance. Despite increases in physician rating website popularity, little information exists regarding the online footprint of dermatologists. Many physicians also remain wary of these websites for fear of malicious reviews. Our study aimed to investigate the patterns of dermatologist online ratings. We found the average ratings for dermatologists were high, >3.5 stars, on the top 5 websites (ZocDoc, Healthgrades, Yelp, RateMDs, and Vitals.com), we also searched for more specific geographic criteria such as including a location in our search for example a dermatologist in columbia sc, by doing this we found that the online ratings were not only national and but state wide too allowing us to look for local and national patterns of ratings. Most importantly, these ratings were consistently high across the 3 sites with the most dermatologist profiles. There were no differences in rating based on gender or subspecialty training. Four of the sites offer the option to write comments. ZocDoc had significantly fewer negative comments, and also had the most comments per dermatologist, there are also dermatologists in different areas of the United States, for example, there is a dermatologist in nyc that those who live in that area can look into. (more…)
Author Interviews, Biomarkers, Emergency Care, Heart Disease / 21.12.2015

MedicalResearch.com Interview with: Florence Leclercq, MD, PhD Department of Cardiology Arnaud de Villeneuve Hospital University hospital of Montpellier Montpellier,France Medical Research: What is the background for this study? What are the main findings? Response: Patients with history of coronary artery disease (CAD) are considered as a population with high risk of further coronary events. However, frequent pre-existing ECG changes observed in these patients result in difficulty interpreting new ECG aspects in case of chest discomfort. Furthermore, anxiety frequently induced non-cardiac causes of chest pain in these patients, leading to unjustified admission to cardiology units.  Moreover, levels of troponin are usually higher in patients with previous CAD compared to patients without history of angina, resulting in difficulty interpreting baseline values in this population.  Conversely, copeptin may be influenced by the severity of myocardial ischemia and resulting endogenous stress, and could be a useful additional marker to exclude severe coronary stenosis in high-risk patients with recent chest pain. This propective monocentric study evaluates the incremental value of copeptin associated with high-sensitivity cardiac T troponin (hs-cTnT) to exclude severe coronary stenosis in 96 patients with coronary artery disease  (CAD) and acute chest pain.   Mean age of patients was 60 +/- 13.8 years and the mean time between chest pain onset and blood samples of copeptin was 4.2 +/-2.7 hours. According to clinical decision, coronary angiography was performed in 71 patients (73.9 %) and severe stenosis diagnosed in 14 of them (14.6%). No ischemia was detected on SPECT imaging (n=25). Among the 69 patients with a negative kinetic of hs-cTnT and a negative baseline copeptin, 5 (7.4%) had a severe stenosis (NPV 0.93; 95% CI: 0.87-0.99), 4 of them related to in-stent restenosis (NPV for exclusion of native coronary stenosis: 0.98; 95% CI: 0.93-1). We can conclude that in patients with preexisting CAD, and once Acute Myocardial Infarction (AMI) is excluded, copeptin increases the NPV of  hs-cTnT  to rule out severe coronary stenosis or significant myocardial ischemia. Coronary stenosis not detected with this strategy concerned exclusively in-stent restenosis or stenosis related to infarcted -related  coronary artery without myocardial viability. (more…)