MedicalResearch.com Interview with:
Julie M. Donohue, Ph.D.
Associate professor and Vice Chair for Research
Graduate School of Public Health Department of Health Policy and Management
University of Pittsburgh
Medical Research: What is the background for this study? What are the main findings?
Dr. Donohue: We looked at data on medication use from January through September 2014 on 1 million Affordable Care Act-established marketplace insurance plan enrollees. Our analysis found that among people who enrolled in individual marketplaces, those who enrolled earlier were older and used more medication than later enrollees. Marketplace enrollees, as a whole, had lower average drug spending per person and were less likely to use most medication classes than patients enrolled in employer-sponsored health insurance. However, marketplace enrollees were much more likely to use medicines for hepatitis C and for HIV, which is particularly important given the general concerns about the rising costs of these medications for consumers.
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MedicalResearch.com Interview with:
Tom E. Robinson
School of Population Health
University of Auckland, New Zealand
Medical Research: What is the background for this study? What are the main findings?Response: Diabetic foot disease affects up to 50% of people with diabetes and lower limb amputation is a serious complication that has a great impact both on patient quality of life and healthcare costs. Foot complications are however potentially preventable with good diabetes and foot care and early intervention. There is international evidence of unexplained ethnic variations in the incidence of lower limb amputation. This study found that ethnicity was strongly associated with risk of lower limb amputation. For example, New Zealand Maori people with diabetes have 63% higher rates of lower limb amputations and this increased risk is not altered by controlling for a range of demographic and clinical risk factors. Asian New Zealander's have much lower risks of amputation but this may, at least in part, be explained by the 'healthy migrant effect'. (more…)
MedicalResearch.com Interview with:
Paula Chatterjee, MD, MPHDepartment of Medicine, Brigham and Women’s Hospital
Harvard Medical School
Boston, Massachusetts
Medical Research: What is the background for this study? What are the main findings?
Dr. Chatterjee: Thousands of patients die every year due to organ shortages. Finding ways to address this public health issue is critical. States have designed a variety of strategies to promote organ donation and transplantation, however we don’t know if any of these strategies have been successful. The goal of our study was to try to figure out which strategies have been most successful in terms of increasing organ donation and transplantation.
We found that states have implemented a wide and creative set of strategies, but unfortunately, it seems that these strategies have had almost no effect on increasing organ donation and transplantation. In states that adopted these strategies compared to those that did not, the rates of donation and transplantation increased at nearly the same rate over the past two decades. The only strategy that seemed to have a small effect was when states created revenue pools dedicated toward organ donation activities.
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MedicalResearch.com Interview with:
Daniel F. Hayes, M.D.
Stuart B. Padnos Professor of Breast Cancer Research
University of Michigan Comprehensive Cancer Center
Ann Arbor MI
Medical Research: What is the background for this study? What are the main findings?
Dr. Hayes: We have developed a circulating tumor cell endocrine therapy index that we hypothesize will identify patients with estrogen receptor positive metastatic breast cancer but who will not benefit from endocrine (anti-estrogen) therapy. We can now semi-quantifiably measure er as well as bcl2, her2, and ki67 in a highly accurate and reproducible fashion. We are now conducting a multi-institutional prospective trial in North America (the Circulating Tumor Cell-Endocrine Therapy COMETI study) to determine if our hypothesis is correct.
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MedicalResearch.com Interview with:
Andrew Bastawrous, MRCOphth
International Centre for Eye Health, Clinical Research Department
London School of Hygiene and Tropical Medicine (LSHTM), London, England
Medical Research: What is the background for this study? What are the main findings?
Dr. Bastawrous: As part of my PhD with the International Centre for Eye Health at the London School of Hygiene & Tropical Medicine, I led the follow-up of a major cohort study of eye disease [http://www.biomedcentral.com/1471-2415/14/60] following up 5,000 people in 100 different locations across the Great Rift Valley in Kenya. It was really challenging, two-thirds of the locations had no road access or electricity and we were carrying over £100,000 worth of fragile eye equipment and a team of 15 people in two vans to be able to carry out high quality measures of eye disease and answer some important questions for planning eye services.
What we found was that in the most difficult to reach locations we would find lots of people waiting to see us who had been unnecessarily blind from preventable/treatable diseases. Despite the locations having no roads, electricity and often no water, nearly all the locations had good phone signal.
Together with a brilliant team of developers, engineers and ophthalmologists we developed a suite of smartphone based tests to see if we could replace some of the standard equipment being used, in the hope that we could make it more portable and easier for non-specialists to perform so that ultimately the most high-risk individuals could be reached and treated.
This paper describes one of those tests, the visual acuity test - Peek Acuity.
Our field workers tested patients in their own homes using a standard card based Snellen chart (the type of vision test most non-ophthalmic healthcare workers are familiar with and has been the most commonly used acuity test for several decades now) and Peek Acuity. The same tests were repeated by the same healthcare worker in the clinic the following day as well as a reference standard vision test (LogMAR ETDRS) performed by an eye trained clinical officer.
This allowed us to perform "test re-test", a measure of a tests repeatability. i.e. if you have the same test at two separate time points we would expect the the measures to be very close. We found that for both Peek Acuity and Snellen they were highly repeatable. An advantage of Snellen is the speed of the test, Peek Acuity came out slightly quicker overall. We also found when compared to the reference standard test, Peek Acuity was highly comparable and within a clinically acceptable limit of difference.
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MedicalResearch.com Interview with:
Dagfinn Aune, PhD student
Norwegian University of Science and Technology and
Imperial College London
Medical Research: What is the background for this study? What are the main findings?
Response: There are more than 360 million people worldwide that are affected by diabetes, and this number is projected to increase to more than 550 million by 2030, with serious consequences for the health and economy of both developed and developing countries. While previous research has found an association between increased dietary fibre intake and a reduced risk of developing type 2 diabetes, most of these data come from the United States, and amounts and sources of fiber intake differ substantially between countries. In this article the we evaluated the associations between total fiber as well as fiber from cereal, fruit, and vegetable sources, and new-onset type 2 diabetes in a large European cohort across eight countries, in the EPIC-InterAct Study (and included 12403 type 2 diabetes cases and 16835 sub-cohort members). We also conducted a meta-analysis where we combined the data from this study with those from 18 other independent studies from across the globe.
We found that participants with the highest total fiber intake (more than 26 g/day) had an 18% lower risk of developing diabetes compared to those with the lowest total fiber intake (less than 19g/day), after adjusting for the effect of other lifestyle and dietary factors. When the results were adjusted for body mass index (BMI) as a marker of obesity, higher total fiber intake was found to be no longer associated with a lower risk of developing diabetes, suggesting that the beneficial association with fiber intake may be mediated at least in part by BMI. In other words, dietary fiber may help people maintain a healthy weight, which in turn reduces the chances of developing type 2 diabetes.
In a meta-analysis of the EPIC-InterAct study and 18 other independent studies (>41000 type 2 diabetes cases) we found that the risk was reduced by 9% for each 10 g/day increase in total fiber intake and 25% for each 10 g/day increase in cereal fiber intake. There was no statistically significant association between fruit or vegetable fiber intake and diabetes.
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MedicalResearch.com Interview with:
Mark L. Friedell, MD, FACS
Chairman Department of Surgery
University of Missouri Kansas City
School of Medicine
Kansas City, MO 64108
Medical Research: What is the background for this study? What are the main findings?
Response: The controversial practice of administering pre-surgery beta-blockers to patients having noncardiac surgery was associated with an increased risk of death in patients with no cardiac risk factors but it was beneficial for patients with three to four risk factors, according to a report published online by JAMA Surgery.
Pre-surgery β-blockade is a widely accepted practice in patients having cardiac surgery. But its use in patients at low risk of heart-related events having noncardiac surgery is controversial because of the increased risk of stroke and hypotension (low blood pressure).
Because of the persistent controversy, researcher Mark L. Friedell, M.D., of the University of Missouri-Kansas City School of Medicine, and coauthors analyzed data from the Veterans Health Administration to examine the effect of perioperative β-blockade on patients having noncardiac surgery by measuring 30-day surgical mortality.
The analysis included 326,489 patients: 314,114 (96.2 percent) had noncardiac surgery and 12,375 (3.8 percent) had cardiac surgery. Overall, 141,185 patients (43.2 percent) received a β-blocker. Of the patients having cardiac surgery, 8,571 (69.3 percent) received a β-blocker and 132,614 (42.2 percent) of the patients having noncardiac surgery got one.
The unadjusted 30-day mortality rates among patients having noncardiac surgery for those not receiving β-blockers were 0.5 percent for patients with no cardiac risk factors, 1.4 percent for patients with one to two risk factors and 6.7 percent for patients with three to four risk factors. For those patients having noncardiac surgery who did receive β-blockers, the unadjusted 30-day mortality rates for patients with no cardiac risk factors, one to two risk factors and three to four risk factors were 1 percent, 1.7 percent and 3.5 percent, respectively, according to the results.
The results suggest that among patients with no cardiac risk factors having noncardiac surgery, those patients receiving β-blockers were 1.2 times more likely to die than those not receiving β-blockers. The risk of death decreased for those patients with one to two risk factors but the reduction was not significant. However, for patients having noncardiac surgery with three to four cardiac risk factors, those receiving β-blockers were significantly less likely to die than those not receiving β-blockers, the authors found. The authors did not observe similar results in patients having cardiac surgery.
“β-blockade is beneficial perioperatively for patients with three to four cardiac risk factors undergoing NCS [noncardiac surgery] but not in patients with one to two cardiac risk factors. Most important, the use of β-blockers in patients with no cardiac risk factors appears to be associated with a higher risk of death, which has, to our knowledge, not been previously reported,” the study concludes.
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MedicalResearch.com Interview with:
Prof. Ze'ev Ronai Ph.D
Scientific Director
Sanford-Burnham's La Jolla
Medical Research: What is the background for this study? What are the main findings?
Prof. Ronai: There is an urgent need to find new approaches to treat melanoma in patients that are resistant to current therapeutic regimes—and this represents a significant percent of melanoma patients. We used samples from patients with drug resistant tumors to study the molecular basis of resistance and screened for genes involved in the process.
We have identified a new player in melanoma resistance to therapy—a molecular target, which provides the basis for clinical trials with drugs currently available to these targets. We found that JAK1 kinase is one target that is upregulated in the resistant tumors. Inhibiting JAK1 kinase can effectively overcome such resistance. (more…)
MedicalResearch.com Interview with:
Winfried Meissner, M.D.
Dep. of Anesthesiology and Intensive Care
Jena University Hospital
University Hospital Jena, Germany
Medical Research: What is the background for this study?
Dr. Meissner: Post-operative pain is managed inadequately worldwide. There are probably many reasons for this, one of which may be lack of evidence about outcomes of treatment in the clinical routine.
PAIN OUT was established as a multi-national research network and quality improvement project offering healthcare providers validated tools to collect data about pain-related patient reported outcomes and management after surgery. Patients fill in a questionnaire asking for pain intensity, pain interference and side effects of pain management. The questionnaire has now been translated into 20 languages. Data are collected electronically and clinicians are provided with feedback about management of their own patients, compared to similar patients in other hospitals. Furthermore, the findings are used for outcomes and comparative effectiveness research. PAIN OUT is unique in that outcomes of postoperative pain management can be examined internationally.
PAIN OUT was created in 2009 with funds from the European Commission, within the FP7 framework and has now been implemented in hospitals in Europe, USA, Africa and SE Asia. The findings allow us to gain insights as to how pain in managed in different settings and countries.
For this particular study, we compared management of pain in the US to other countries. We assessed a large group of patients who underwent different types of orthopedic surgery and compared their patient reported outcomes and management regimens. We included 1011 patients from 4 hospitals in the USA and 28,510 patients from 45 hospitals in 14 countries (“INTERNATIONAL”).
Medical Research: What are the main findings?
Dr. Meissner: Postoperative pain intensity of US patients was higher than in INTERNATIONAL patients; they felt more often negatively affected by pain-associated anxiety and helplessness, and more US patients stated they wished to have received more pain treatment. However, other patient-reported outcomes like time in severe pain or the level of pain relief did not differ.
We found that treatment regiments of American patients differed compared to INTERNATIONAL patients. More US patients received opioids, and their opioid doses were higher compared to INTERNATIONAL patients. In contrast, INTERNATIONAL countries use more nonopioid medications intraoperatively and postoperatively. Thus, under-supply with opioids cannot explain our findings.
Mean BMI of US patients was 30.3 while for INTERNATIONAL it was 27.4. However, insufficient evidence exists that this finding might account for differences in pain intensity.
Routine pain assessment was performed in almost all US patients, in contrast to about 75% in the INTERNATIONAL group. Obviously, routine pain assessment, as practiced in the United States, fails to result in lower postoperative pain. Perhaps it has the opposite effect by directing patients’ attention to the pain.
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MedicalResearch.com Interview with:
Howard L. Kaufman, MD, FACS
Rutgers Cancer Institute of New Jersey
New Brunswick, NJ
Medical Research: What is the background for this study? What are the main findings?
Response: The study clearly demonstrated that advanced melanoma patients achieved a significant improvement in both response rate and durable response rate with Talimogene laherparepvec, or T-VEC. T-VEC is the first oncolytic virus to show a clinical benefit in a randomized phase 3 clinical trial for the treatment of cancer. Patients who received T-VEC also had an improved progress-free and overall survival with nearly 11% obtaining a complete response. T-VEC is an oncolytic virus that mediates anti-tumor activity by directly killing injected tumor cells and by initiating a systemic immune response. Treatment was also associated with few side effects, which were mostly low grade fever, fatigue, chills, nausea and pain at the injection site.
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MedicalResearch.com Interview with:
Prof. Michael Breakspear MB BS, Ba(Hons), Bsc(Med), PhD
QIMR Berghofer Medical Research Institute
Royal Brisbane Hospital
Medical Research: What is the background for this study? What are the main findings?
Prof. Breakspear: The first 72 hours following complicated full-term or premature delivery of a newborn represents a critical window in which survival and long term brain development hangs in the balance. During this window of time, there does not currently exist a reliable, non-invasive, real-time measure of neuropathology that provides neurologists and neonatologists prognostic indicators of clinical outcome. We developed a tool that draws on techniques in physics used to characterize naturally occurring phenomena, such as earthquakes and avalanches, to analyze brain activity recordings of preterm infants. Our tool allows early identification of preterm infants at significant risk of developing poor long-term neurodevelopmental outcomes, such as cerebral palsy and learning difficulties at two years of age.
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MedicalResearch.com Interview with:
Meng Yang, PhD MPH
Research Fellow
Harvard T. H. Chan School of Public Health
Medical Research: What is the background for this study? What are the main findings?
Dr. Yang: There are nearly 3 million American men living with prostate cancer. However, there is very little information for patients and clinicians about how to manage patients’ lifestyles, like diet, after prostate cancer diagnosis to decrease the risk of death due to this disease and improve their survivorship.
The most important finding is that men initially diagnosed with prostate cancer without metastases whose diet was more “Westernized”, i.e. higher processed meats, refined grains, potatoes and high-fat dairy, had a significantly higher prostate cancer-related death and all cause mortality. Men whose diet was more “prudent”, i.e. higher intake of vegetables, fruits, fish, whole grains and healthy oils had a lower risk of death.
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MedicalResearch.com Interview with:
Yuyuan Li, PhD
Liaoning Provincial Key Laboratory of Brain Diseases
Institute for Brain Disorders, Dalian Medical University
College of Basic Medical Sciences, Dalian Medical University
Dalian ChinaMedical Research: What is the background for this study? What are the main findings?
Dr. Li: Traumatic brain injury (TBI) will become the leading cause of death and lifelong disability in the general population by the year 2020. Early determination of prognosis based on epidemiological data is the key to inform care of these patients. Neurobiochemical markers, like Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) have shown a prognostic value for outcome prediction. Recently, several studies have investigated the correlation between serum UCH-L1 concentrations and TBI, however the results thus far have been inconsistent. In the present study, we conducted a systematic review and meta-analysis to evaluate the prognostic value of serum UCH-L1 concentrations after traumatic brain injury. Five studies (including 673 TBI and 1004 controls) were included in the meta-analysis and the overall results reveal that the serum UCH-L1 level was significantly higher in patients with traumatic brain injury compared to those of the control group. Importantly, there was no statistical evidence of a publication bias among the contributing studies from the result of Egger’s test either.
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MedicalResearch.com Interview with:
Christopher X WongMBBS MSc PhD
Clinical Research Fellow | Clinical Trial Service Unit, Oxford
Clinical Senior Lecturer | Centre for Heart Rhythm Disorders, Adelaide
Clinical Trial Service Unit, University of Oxford
Roosevelt Drive, Oxford
Medical Research: What is the background for this study? What are the main findings?Dr. Wong: Atrial fibrillation is an increasingly common heart rhythm disorder. This study demonstrates that even small increments in obesity are associated with a significantly increased risk of atrial fibrillation. Our data suggest that for every 1 unit reduction in body mass index there may be a 3-5% reduction in atrial fibrillation; for every 5 unit reduction, there may be 10-29% reductions. It should also be noted that this is likely to be a significant underestimate of the effect of weight reduction on atrial fibrillation rates as weight control has favourable effects on other risk factors for atrial fibrillation, such as hypertension and diabetes. Given the more than 45 million people with atrial fibrillation worldwide, even small but widespread reductions in obesity would thus help contain this ‘epidemic’ of atrial fibrillation.
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MedicalResearch.com Interview with:
R. Kenneth Marcus, FRSC & FAAAS
Professor of Chemistry
Clemson University
Medical Research: What is the background for this study? What are the main findings?
Prof. Marcus: We had previously shown that chromatographic columns formed from aligned capillary-channeled polymer (C-CP) fibers were highly effective in analytical scale and preparative separations of proteins from diverse media. The C-CP fibers are extracted from commodity fibers such as polyester, nylon, and polypropylene. The key aspects in using the C-CP fibers are very high bed porosity and rapid protein-surface mass transfer, this allows for very rapid separations. Packing of the fibers in narrow-bore polymer tubing (0.8 mm id x 1 cm long) allows them to be fixed to the end of a micropipette tip. Urine samples of 10 microliter-to-milliliter volumes can be spun through on a microcentrifuge, washed with DI-water, and then eluted with a solvent. Thus the proteins are isolated and pre-concentrated on the fiber surface. The elution solvent can be chosen based on the analytical method employed (e.g., MALDI- or ESI-MS). (more…)
MedicalResearch.com Interview with:
Dr. Renjie Chen PhD and Dr. Haidong Kan, PhDSchool of Public Health, Key Lab of Public Health Safety of the Ministry of Education, Fudan University, Shanghai, ChinaMedicalResearch: What is the background for this study? What are the main findings?
Response: Although several previous studies in developed countries with cleaner air have reported health benefits due to air filtration, no such interventional studies were conducted in a developing country with much severer air pollution problems. Our main findings suggested that even a short-term intervention (2 days) could significantly reduce indoor air pollution and improve cardiopulmonary health among healthy young adults. (more…)
MedicalResearch.com Interview with:
Yann Klimentidis Ph.D.
Assistant Professor
Mel and Enid Zuckerman College of Public Health
University of ArizonaMedical Research: What is the background for this study? What are the main findings?
Dr. Klimentidis: Previous studies have hinted at the possibility that genes which are associated with higher triglyceride levels may also be associated with lower type-2 diabetes. We set out to test this hypothesis in multiple prospective cohort studies, in European-Americans and in African-Americans. We found that on a collective basis, the alleles which are associated with higher triglycerides are also associated with reduced type-2 diabetes risk. We also identified some individual genetic variants which are driving this trend.
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MedicalResearch.com Interview with:
Anees B. Chagpar, MD, MSc, MPH, MA, MBA, FRCS(C), FACS, Associate Professor, Department of Surgery
Director, The Breast Center -- Smilow Cancer Hospital at Yale-New Haven, Assistant Director -- Global Oncology, Yale Comprehensive Cancer Center
Program Director, Yale Interdisciplinary Breast Fellowship
Yale University School of Medicine Breast Centerm
New Haven, CT,
Medical Research: What is the background for this study? What are the main findings?
Response: Every year in the US, nearly 300,000 women are diagnosed with breast cancer -- the majority of these will have early stage breast cancer, and will opt for breast conserving surgery to remove their disease. The goal of this operation is to remove the cancer with a rim of normal tissue all the way around it (i.e., a margin), but sadly, 20-40% of women will have cancer cells at the edge of the tissue that is removed, often mandating a return trip to the operating room to remove more tissue to ensure that no further disease is left behind. No one likes to go back to the operating room -- so we asked the question, "How can we do better?". Surgeons have debated various means of obtaining clear margins. Some have advocated taking routine cavity shave margins -- a little bit more tissue all the way around the cavity after the tumor is removed at the first operation. Others have argued that this may not be necessary; that one could use intraoperative imaging of the specimen and gross evaluation to define where more tissue may need to be removed (if at all) -- i.e., selective margins. We conducted a randomized controlled trial to answer this question. We told surgeons to do their best operation, using intraoperative imaging and gross evaluation, and removing selective margins as they saw fit. After they were happy with the procedure they had performed and were ready to close, we opened a randomization envelope intraoperatively, and surgeons were either instructed to close as they normally would ("NO SHAVE"), or take a bit more tissue all the way around the cavity ("SHAVE").
Patients in both groups were evenly matched in terms of baseline characteristics. The key finding was that patients who were randomized to the "SHAVE" group half as likely to have positive final margins and require a re-operation than patients in the "NO SHAVE" group. On their postoperative visit, we asked patients, before they knew which group they had been randomized to, what they thought of their cosmetic results. While the volume of tissue excised in the "SHAVE" group was higher than in the "NO SHAVE" group, the distribution of patient-perceived cosmetic outcomes were identical in both groups. Complication rate was also no different between the two groups. We will be following patients for five years for long-term cosmetic and recurrence outcomes. (more…)
MedicalResearch.com Interview with:
Tanguy Seiwert, MD
Assistant Professor, Dept. of Medicine
Associate Director, Head and Neck Cancer Program
Section of Hematology/Oncology
Fellow, Institute for Genomics and Systems Biology
Speciality Chief Editor
Frontiers in Head and Neck Cancer
University of Chicago Chicago, IL 60637
Medical Research: What is the background for this study?
Dr. Seiwert: Recurrent/metastatic Head and Neck Squamous Cell Cancer (HNSCC) remains poorly treatable with a median OS of 10-13 months
There is evidence of a prominent immune escape observed in squamous cell carcinoma of the head and neck (SCCHN) suggesting that anti-PD1 agents (similar to e.g. melanoma) may be active.
Medical Research: What are the main findings?
Dr. Seiwert:
One in four patients with Head/Neck cancer treated with pembrolizumab showed marked tumor shrinkage (so called – partial/complete responses), and 57% of patients experienced any decrease in the size of their tumors.
Pembrolizumab is broadly active in both HPV(-) and HPV(+) types of squamous cell carcinoma of the head and neck.
Pemborliuzmab treatment is active in heavily pretreated squamous cell carcinoma of the head and neck patients.
Responses seem to be durable è 86% of responding patients remain in response.
Treatment overall was well tolerated with less than 10% of patients experiencing severe side effects (≥Grade 3).
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MedicalResearch.com Interview with:
David Katz, MDDivisions of Cardiology, and Neonatology,
University of Colorado School of Medicine
Aurora, Colorado
Medical Research: What is the background for this study? What are the main findings?
Dr. Katz: Sudden infant death syndrome (SIDS) is the leading cause of infant mortality in the US between 1 month and 1 year of life. This is the first large study to demonstrate an association between high altitude and SIDS. In particular there is a doubling of risk above 8,000 feet of elevation relative to below 6,000 feet.
Medical Research: What should clinicians and patients take away from your report?Dr. Katz: There is an association between high altitude residence and Sudden infant death syndrome (SIDS). The reason for this association is still unknown, but hypoxia may be the common link. While the population living above 8000 feet is small in the US, it is large worldwide. Better understanding this association is of great medical importance.
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MedicalResearch.com Interview with:
Dr. Samson Y. Gebreab, Ph.D., M.Sc.
Lead Study Author and Research Scientist
National Human Genome Research Institute
Bethesda, Maryland
Medical Research: What is the background for this study?
Dr. Gebreab: It is well known that African Americans hold a commanding lead in cardiovascular disease (CVD) mortality and morbidity compared to whites and other ethnic groups. Furthermore, the risk for developing CVD begins early in life and extends over a lifecourse. Previous studies have indicated the influence of both childhood and adult socioeconomic status (SES) on CVD risk. However, the impact of lifecourse socioeconomic status (both childhood and adulthood) on CVD risk in African American population is not fully understood. The purpose of our study was to investigate the associations of different measures of lifecourse socioeconomic status with cardiovascular disease risk in African Americans and whether the associations were modified by sex and/ or age after controlling for known cardiovascular disease risk factors. We analyzed 10-year follow-up data of African American adults who were participating in Jackson Heart Study, Jackson, MS.
Medical Research: What are the main findings?Dr. Gebreab: Our findings highlights that among those of lower socioeconomic status, women and younger (<=50 years old) African Americans are at increased risk of CVD, including heart disease and stroke compared to their counterparts of higher socioeconomic status groups.
African American women in the lowest socioeconomic status, had more than twice the risk of developing cardiovascular disease than those in the highest socioeconomic status group.
African Americans of 50 years and younger in the lowest socioeconomic status group had more than three times higher risk of experiencing a cardiovascular disease event than those in the highest socioeconomic status group.(more…)
MedicalResearch.com Interview with:
Prof. Dr. Robert Sanders MD
Assistant Professor, Anesthesiology & Critical Care Trials & Interdisciplinary Outcomes Network (ACTION)
Department of Anesthesiology
University of Wisconsin, Madison, WI
Medical Research: What is the background for this study? What are the main findings?
Dr. Sanders: While it is known that chronic raised blood pressure exerts important effects on long term health outcomes, it is unclear how pre-operative blood pressure levels effect risk from surgery. In this study we show that after adjustment for other diseases, high blood pressure does not increase perioperative risk. Rather low blood pressure is associated with an increase in risk of death following surgery and anesthesia.
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MedicalResearch.com Interview with:
Bruno M. Heleno MD
The Research Unit for General Practice and Section of General Practice
Department of Public Health
University of Copenhagen
Medical Research: What is the background for this study? What are the main findings?Dr. Heleno: False positive mammography causes psychological distress. Several observational studies have shown this, and their results have been summarized in systematic reviews. However, it was unclear whether women requiring invasive tests (needle or surgical biopsy) were more distressed than women only requiring non-invasive procedures (clinical examination or imaging). Contrary to previous research, we found that these two groups of women were equally distressed during the 36 months of follow-up in our cohort. The best estimate for the difference for 12 related measures of distress was always close to zero.
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MedicalResearch.com Interview with:
Ruben A. Mesa, MD, FACP
Consultant Hematologist Chair, Division of Hematology & Medical Oncology
Deputy Director, Mayo Clinic Cancer Center
Professor of Medicine Mayo Clinic Cancer CenterNCI Designated Comprehensive Cancer Center
Scottsdale, AZ
Medical Research: What is the background for this study? What are the main findings?
Dr. Mesa: Myelofibrosis is a rare and chronic blood cancer associated with significantly reduced quality of life and shortened survival. In patients with this disease, spleen enlargement (splenomegaly) is a very common and debilitating symptom – and as the disease progresses, the body slows production of important blood cells.
The results presented at ASCO were from the PERSIST-1 study, which is a Phase 3 registration-directed trial designed to compare pacritinib — an investigational oral multikinase inhibitor with specificity for JAK2 and FLT3 – to best available therapy (exclusive of a JAK inhibitor) in patients with myelofibrosis — regardless of their platelet counts. Data from this study showed that compared to best available therapy, pacritinib resulted in a significantly higher proportion of patients with spleen volume reduction and control of disease-related symptoms, regardless of platelet levels at the time of enrollment.
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MedicalResearch.com Interview with:
Brodie Nolan, MD BSc
PGY3 Emergency Medicine Resident
University of Toronto, Faculty of Medicine
Medical Research: What is the background for this study? What are the main issues?
Dr. Nolan: Police are commonly encountered in the emergency department (ED). They support EMS, transport patients, are a source of collateral information for health care professionals, and help provide a safe environment for hospital staff. However, there is a potential for conflict due to the nature of police investigation and the emergency physician’s duty to protect patients’ confidentiality and personal health information. Any disclosure of patient information to police without consent could potentially violate the patient’s right to privacy of personal health information.
Unfortunately, it is not uncommonly the case that patients in the emergency department for whom the police have an interest are unable or unwilling to provide consent. Education for emergency medicine residents on police-physician exchanges is variable however it is important to understand the legislation surrounding these practices to ensure patients’ rights are protected and avoid any potential for litigation.
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MedicalResearch.com Interviews with:
Dr. Sunil M. Kurian Ph.D.
Lead- Biomarker Discovery at the Laboratory of Functional Genomics and Cell Therapy
The Scripps Research Institute and Transplant Genomics Inc. and
Dr. John J. Friedewald, MD
Associate Professor of Medicine and Surgery
Northwestern University’s Feinberg School of Medicine and a transplant nephrologist at Northwestern Memorial Hospital and the Kovler Organ Transplant Center
Editor’s note: These interviews are based on two abstracts presented at the American Transplant Congress 2015.MedicalResearch: What is the background for these studies?
Response: Previous studies by the scientific founders of Transplant Genomics Inc. helped lay the groundwork for the company’s development of genomic biomarker tests for kidney transplant graft status and demonstrated feasibility as noninvasive monitoring tools that could enable differential diagnosis of graft status in kidney transplant recipients.1-3
These included a study involving five transplant centers published in the American Journal of Transplantation.4 In that study, peripheral blood gene expression profiling was used to classify kidney graft recipients into three key categories of graft status based on gene expression signatures – clinical acute rejection, acute dysfunction no rejection, and stable graft performance - with very high predictive accuracy.
STUDY A: Validation of Blood and Biopsy Gene Expression-Based Molecular Diagnostics for Subclinical Acute Rejection: Comparing DNA Microarrays vs. Next-Generation RNA SequencingMedicalResearch: What are the main findings?
Response: The current study presented recently at the 2015 American Transplant Congress5 validated that gene expression signatures as indicators of kidney graft status can be detected as robustly with RNA sequencing as with microarrays, with implications for reduced cost of analysis, faster turnaround times and improved throughput for sample processing.
In this study, we substantiated RNA sequencing as an alternative data generation platform for analyzing gene expression profiles in peripheral blood and tissue from kidney transplant recipients. The data validated that gene expression signatures for subclinical acute rejection (a histological acute cellular rejection in the presence of a normal or stable serum creatinine that is associated with decreased graft survival), clinical acute rejection and stable graft performance can be detected as robustly with RNA sequencing as with microarrays.
MedicalResearch: What should clinicians and patients take away from your report?Response: The key point of this study is that gene expression profiles generated and validated using microarray technology have been successfully translated to a technology platform based on RNA sequencing. Sequencing has the potential to offer advantages such as reduced cost of analysis, faster reporting back to the clinician and improved throughput for sample processing. In addition, it could facilitate development of kits enabling standardized assay performance on local lab-based sequencing systems and expansion of test use worldwide.
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MedicalResearch.com Interview with:
Nathan Clark, PharmD
Clinical pharmacy supervisor, anticoagulation and anemia management services and
Thomas Delate, PhD
Clinical research scientist
Kaiser Permanente ColoradoMedicalResearch: What is the background for this study? What are the main findings?
Response: Patients with a history of blood clots are commonly prescribed warfarin, an anticoagulant, to decrease the body’s ability to form additional clots. Clinicians typically stop the use of warfarin in patients to reduce the risk of serious bleeding when invasive procedures, such as colonoscopy or orthopedic surgery are scheduled. However, when warfarin interruptions occur, patients are exposed to an increased risk of blood clots three to five days before and five or more days after invasive procedures. Bridge therapy with another, faster acting anticoagulant is often initiated in an attempt to reduce the patients’ risk for developing blood clots during that gap.
Bridging has been a part of standard therapy for venous thromboembolism (VTE) patients undergoing invasive procedures for many years. But only limited data outlining the rates of bleeding and VTE recurrence were available to help clinicians analyze the risks and benefits of bridge therapy.
We examined the electronic medical records of 1,178 patients with VTE who underwent 1,812 invasive diagnostic or surgical procedures between January 2006 and March 2012 that required the interruption of warfarin therapy. Study patients were categorized into three groups based on their annual risk of VTE recurrence without anticoagulant therapy. Within those groups, a total of 555 patients – 28.7 percent of low-risk, 33.6 percent of moderate-risk and 63.2 percent of high-risk patients – received bridging anticoagulant therapy. The 1,257 patients who did not receive bridge therapy interrupted their warfarin use and received no other anticoagulants during the perioperative period. The use of bridge therapy resulted in a 17-fold higher risk of bleeding without a significant difference in the rate of blood clot formation compared to patients who didn’t receive bridge therapy. In addition, there were no significant differences in the rates of blood clot occurrence or death between the bridged and non-bridged patient groups. (more…)
MedicalResearch.com Interview with:
Dr. Marie C. Leger, MD, PhD
Assistant Professor
Ronald O. Perelman Department of Dermatology
NYU Langone Medical Center
Medical Research: What inspired this study? How did it come about?
Dr. Leger: As a dermatologist at NYU, I have taken care of several patients with tattoo reactions--some of them mild (like longstanding itching for example) and some of them more severe (like long term reactions to a particular color that can severely disfigure the tattoo) and wondered how common it was for people to have adverse tattoo reactions or complications. There were lots of case reports in the literature but only a few larger studies examining how common these kinds of complaints were--and these were all European studies. We decided to do a quick survey to give us a better idea of how common it is for people to have problems with their tattoos.
Medical Research: What do you think is the most important takeaway from this study for the consumer?Dr. Leger: Tattoos have risks associated with them--which is part of their appeal I'm sure--but I do think it's important for people to know that long term tattoo reactions (including for example, itching, scaling, swelling) may be more common than we realize. A recent Danish study shows that these kinds of reactions can be quite distressing for people and significantly impact their quality of life.
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MedicalResearch.com Interview with:
Aaron P. Thrift, Ph.D.
Assistant Professor, Department of Medicine
Dan L. Duncan Cancer Center
Baylor College of Medicine
Houston, TX 77030-3498
Medical Research: What is the background for this study? What are the main findings?
Dr. Thrift: Greater attained adult height is associated with increased risk of all cancers combined; however, the association may differ by cancer site and between women and men. For colorectal cancer, epidemiological studies suggest that the association with height may be stronger for women than for men. We used data from over 10,000 patients with colorectal cancer and over 10,000 population-based controls and conducted multiple analyses, including using Mendelian randomization (which incorporates genomic data with traditional approaches) to overcome potential issues of confounding and bias in observational studies, to further examine the association between height and risk of colorectal cancer. Overall, we found that taller height was associated with increased risk of colorectal cancer (8% increased risk per 10cm increase in height). When we examined women and men separately, our results strongly suggest that height is causally associated with colorectal cancer risk for women, whereas there was weaker evidence for a causal association between height and colorectal cancer risk for men.
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MedicalResearch.com Interview with:
Akrit Sodhi, M.D., Ph.D.
Assistant Professor of Ophthalmology
Retina Division
Wilmer Eye Institute
Johns Hopkins Medical Institutions
Medical Research: What is the background for this study? What are the main findings?Dr. Sodhi: Diabetic eye disease is the most common cause of severe vision loss in the working age population in the developed world, and proliferative diabetic retinopathy (PDR) is its most vision-threatening sequela. In proliferative diabetic retinopathy, retinal ischemia leads to the upregulation of angiogenic factors that promote neovascularization. Therapies targeting vascular endothelial growth factor (VEGF) delay the development of neovascularization, in some, but not all diabetic patients, implicating additional factor(s) in proliferative diabetic retinopathy pathogenesis. In our study, we demonstrate that the angiogenic potential of aqueous fluid from PDR patients is independent of VEGF concentration, providing an opportunity to evaluate the contribution of other angiogenic factor(s) to PDR development. We identified angiopoietin-like 4 (ANGPTL4) as a potent angiogenic factor whose expression is upregulated in hypoxic retinal Müller cells in vitro and the ischemic retina in vivo. Expression of ANGPTL4 was increased in the aqueous and vitreous of PDR patients, independent of VEGF levels, correlated with the presence of diabetic eye disease, and localized to areas of retinal neovascularization. Inhibition of ANGPTL4 expression reduced the angiogenic potential of hypoxic Müller cells; this effect was additive with inhibition of VEGF expression. An ANGPTL4 neutralizing antibody inhibited the angiogenic effect of aqueous fluid from proliferative diabetic retinopathy patients, including samples from patients with low VEGF levels or receiving anti-VEGF therapy. Collectively, our results suggest that targeting both ANGPTL4 and VEGF may be necessary for effective treatment or prevention of proliferative diabetic retinopathy and provide the foundation for studies evaluating aqueous ANGPTL4 as a biomarker to help guide individualized therapy for diabetic eye disease.
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MedicalResearch.com Interview with:
Julie M. Donohue, Ph.D.
Associate professor and Vice Chair for Research
Graduate School of Public Health Department of Health Policy and Management
University of Pittsburgh
Medical Research: What is the background for this study? What are the main findings?
Dr. Donohue: We looked at data on medication use from January through September 2014 on 1 million Affordable Care Act-established marketplace insurance plan enrollees. Our analysis found that among people who enrolled in individual marketplaces, those who enrolled earlier were older and used more medication than later enrollees. Marketplace enrollees, as a whole, had lower average drug spending per person and were less likely to use most medication classes than patients enrolled in employer-sponsored health insurance. However, marketplace enrollees were much more likely to use medicines for hepatitis C and for HIV, which is particularly important given the general concerns about the rising costs of these medications for consumers.
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