MedicalResearch.com Interview with: James Louis Januzzi, Jr, MD, FACC, FESC Director, Cardiac Intensive Care Unit Director, Dennis and Marilyn Barry Fellowship in Cardiology Research Massachusetts General Hospital Boston, MA, 02114. Medical Research: What is the background for this study? What are the main findings? Dr. Januzzi: Evaluation for suspected or proven acute coronary syndrome is...
MedicalResearch.com Interview with:
Oleh Taratula, Ph. D.
Assistant Professor of Pharmaceutics
Department of Pharmaceutical Sciences
College of Pharmacy Oregon State University
Corvallis, OR 97331-3507
Medical Research: What is the background for this study? What are the main findings?
Dr. Taratula: Our research group is focused on the development of novel nanotechnology-based approaches to treat different cancers, including ovarian cancer. For many cancers, surgery is a first choice of treatment. For example, only optimal surgical resection of most abdominal metastases can significantly reduce ovarian cancer recurrence and, therefore, improve patient survival. However, it is challenging to remove most of the cancer tumors and residual cancer cells eventually may lead to cancer relapse. Therefore, our aim is to develop a nanomedicine platform, which could help surgeons achieve maximal tumor resection, using the intraoperative guidance with real-time near infrared (NIR) fluorescence signal. Moreover, we expect that the same nanoplatform could further enhance surgical outcomes by combinatorial phototherapy to be performed intraoperatively after tumor resection to eradicate unresected cancer cells.
Our data published in Nanoscale is the first step towards our main goal. At this point, by utilizing naphthalocyanine, we have developed a single-agent-based nanomedicine platform capable of both NIR fluorescence imaging and combinatorial phototherapy. Naphthalocyanine is a commercially available compound, but its potential clinical application is limited by low water solubility and aggregation. Especially, aggregation diminishes the imaging ability and phototherapeutic efficacy of this compound. To address these shortcomings, we discovered that the loading of naphthalocyanine into the dendrimers significantly enhances water solubility, prevents aggregation and preserves imaging and therapeutic abilities. Our data demonstrated that naphthalocyanine-based nanoplatform can generate a NIR fluorescence signal in the cancer tumors, required for elimination of autofluorescence from healthy tissue and body fluids. Furthermore, our results also indicated that the developed nanoplatform is an efficient therapeutic agent which, upon exposure to NIR light, destroys chemotherapy-resistant ovarian cancer tumors by producing both heat and toxic reactive oxygen species.
Finally, many organic fluorophores, including naphthalocyanine, can undergo photobleaching under exposure to light, which could be misinterpreted as a lack of fluorescence signal during the surgery. We demonstrated that the dendrimer encapsulated naphthalocyanine exhibits extremely high photostability and could overcome the above mentioned issue.
MedicalResearch.com Interview with:
Kasia Joanna Lipska MD, MHS
Assistant Professor of Medicine (Endocrinology)
Yale School of Medicine
New Haven, CT 06520-8020
Medical Research: What is the background for this study? What are the main findings?
Dr. Lipska: Diabetes is common and affects about 1 in 4 older adults (65 years or more). For younger adults with diabetes, most guidelines suggest lowering blood sugar levels to a hemoglobin A1c below 7%. However, in older patients, especially those with complex medical problems, the benefits of this strategy are unclear. What’s more, this strategy can cause harm. Aiming for a hemoglobin A1c below seven increases the risk for hypoglycemia. And older adults are especially susceptible to this risk. As a result, many guidelines suggest that treatment should be more cautious for these vulnerable elders and that aiming for “tight” blood sugar control may not be worth the risk.
Medical Research: What are the main findings?
Dr. Lipska: We looked at diabetes treatment of older adults using nationally representative data from 2001 to 2010. We found that 62% of older adults with diabetes had a hemoglobin A1c below 7%. But what’s really striking is that this proportion was similar for patients who were relatively healthy, for those with intermediate health, and for those with poor health. What’s more, the use of insulin or sulfonylureas (drugs that increase the risk for hypoglycemia) was common and similar across these groups.
MedicalResearch.com Interview with:
Caroline Attardo Genco, PhD
Professor Department of Medicine, Section of Infectious Diseases Department of Microbiology
Boston University School of Medicine
Boston MA
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Genco: Atherosclerosis is a common cardiovascular disease associated with heart attack and stroke. Although it has been shown that a diet high in fat as well as exposure to certain bacteria can cause atherosclerosis (the buildup of fats, cholesterol, and other substances on artery walls which can restrict blood flow), we have for the first time identified distinct gene pathways that are altered by these different stimuli. One of these bacteria, Porphyromonas gingivalis, is found in the mouth of humans with periodontal disease. Another is the bacteria Chlamydia pneumoniae, which causes pneumonia. We found that even though these three different stimuli all cause atherosclerosis, the gene pathways are distinct depending upon stimulus. This is the first study that has performed side-by-side comparison of genome-wide gene expression changes to address this issue.
In this study, we used four experimental groups to compare genome-wide expression changes in vascular tissue. The first group was subjected to Porphyromonas gingivalis, while the second group received Chlamydia pneumoniae. The third group was placed on a high-fat Western style diet, while the fourth group was the control group. In collaboration with the Clinical and Translational Science Institute (CTSI) at Boston University, we performed genome-wide microarray profiling and analysis of vascular tissue from all groups to reveal gene pathways altered in vascular tissue by each treatment group.
These findings may explain how specific infections or high-fat diet may cause atherosclerotic plaques to undergo changes that affect their size and stability and may ultimately lead to a heart attack.
MedicalResearch.com Interview with:
Professor Eleni Petridou
Preventive Medicine & Epidemiology, Department of Hygiene
Epidemiology and Medical Statistics,
Athens University Medical School Athens Greece
Medical Research: What is the background for this study? What are the main findings?
Prof. Petridou: Impressive gains in survival from childhood leukemia have been achieved during the last decades mainly on account of advancements in treatment of the disease. Yet, these big improvements do not seem to be equally shared by all sick children. Disparities in the survival of children suffering leukemia who live in high versus low-income countries, as well as among different racial groups pointed to socio-economic status (SES) of the family as a factor that might adversely affect the outcome. SES, however, is a multifaceted variable comprising economic, social and professional components, which cannot be easily assessed. Therefore, an array of area of residence- and individual family- based proxy indices have been used in order to investigate the association between SES and overall or event-free survival from childhood leukemia. We have intensively searched for published articles around the globe and also analyzed primary data kindly provided by the US National Cancer Institute Surveillance, Epidemiology and End Results Program (SEER) for the period 1973-2010 as well as the Nationwide Registry for Childhood Hematological Malignancies (NARECHEM) in Greece for the period 1996-2011. This study is the first meta-analysis summing up the findings of 29 individual studies and quantifying the adverse effect in the survival due to SES differentials among 60 000 afflicted children. According to the findings, lower socio-economic status children suffering, at least, the more common Acute Lymphoblastic Leukemia (ALL) type have nearly two fold higher death rates compared to those of high socio-economic status. Of note, the SEER data show that the survival gap was wider in the USA with increased risk of death from ALL in the lower SES children (by 20-82%) and widening during the last 40 years time period.
MedicalResearch.com Interview with:
Dr Geeske Peeters
Postdoctoral Research Fellow
School of Public Health
The University of Queensland Australia
Medical Research: What is the background for this study? What are the main findings?
Dr. Peeters:
The hypothesis we set out to investigate was that statin use is associated with reduced joint pain/stiffness and consequently improved physical functioning and quality of life. This hypothesis was based on findings from previous studies suggesting that statin use may prevent the development of radiographic osteoarthritis. However, in contrast with this hypothesis, results from this large study did not demonstrate an association between statin use and reduced onset of joint pain or stiffness. Moreover, statin use did seem to be associated with an increased risk of functional limitations and poorer self-reported health, especially in the middle-aged women.
MedicalResearch.com Interview with:
Hazel B. Nichols, PhD
Assistant Professor, Department of Epidemiology
University of North Carolina
Gillings School of Global Public Health
MedicalResearch:What is the background for this study?
Dr. Nichols: Tamoxifen, a drug that is often used to treat breast cancer, has also been approved to prevent breast cancer in women who may be at high risk for developing the disease. Taking tamoxifen for 5 years can lower breast cancer risk by up to 48%. The United States Federal Drug Administration (FDA) approved tamoxifen for breast cancer prevention more than 15 years ago (in 1998) for women ages 35 and older who are at high risk of breast cancer and who are at low risk for serious side effects.
National estimates show that <1% of women who are eligible to use tamoxifen actually use it for breast cancer prevention. While tamoxifen lowers breast cancer risk it does cause hot flashes and may lead to serious side effects such as cataract, stroke, and uterine cancer. Women who start taking may also stop taking it before the recommended 5-years due to side effects.
We used a tool developed by scientists at the National Cancer Institute (NCI) to calculate whether the benefits of tamoxifen outweighed the risks for women in the Sister Study, a study of more than 50,000 U.S. and Puerto Rican women with a family history of breast cancer. The tool uses information on a woman’s age, race, breast cancer risk, menopausal status, and whether she had a hysterectomy (surgical removal of the uterus) to estimate whether there is no, moderate or strong evidence that the benefits of tamoxifen will outweigh the risks.
MedicalResearch.com Interview with:
John N. Mafi, M.D.
Fellow, Harvard Combined Program in General Medicine
Beth Israel Deaconess Medical Center
Brookline, MA 02446
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Mafi: Headache costs our healthcare system over 30 billion dollars annually. Clinical guidelines recommend conservative treatments for uncomplicated headache, such as counseling on dietary trigger avoidance. The Choosing Wisely Campaign of the American Board of Internal Medicine has in turn identified advanced imaging (e.g. CT or MRI) and opioid or barbiturate medications as low value treatments in the management of headache. In this context we used a nationally representative database to evaluate trends in physician practice patterns on headache management. We found a doubling in use of advanced imaging, referrals to other physicians and no change in opioid/barbiturate medications, although these continued to be used at high rates (18%). We also found a decline in life-style modification counseling, meant to prevent headaches from starting.
MedicalResearch.com Interview with:
Dr. Chao Cheng PhD
Department of Genetics
Geisel School of Medicine at Dartmouth
Hanover 03755, NH
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Chao Cheng: Cancer survival prognosis—“How long do I have, Dr.?” is a topic of great importance to cancer patients and their families. While clinical and pathological variables, such as cancer type, stage, grade, and patient demographics, have long been used to predict survival outcomes, only recently have molecular signatures become incorporated into survival prediction. A molecular approach holds great promise for improving prediction accuracy and additionally elucidating mechanisms of disease, however it is fraught with difficulty due to assay “noise” and “big data” statistical issues, such as the multiple comparisons problem
In this study, we began by analyzing transcription factor binding profiles across available cell lines. By restricting our analysis to transcription factors, DNA expression regulators known to be involved in tumor genesis, we reasoned that we could avoid many of the “big data” issues and achieve results that would make mechanistic and biological sense. We first employed a statistical method we described previously to calculate which genes were the major downstream targets of our transcription factors. With these targets identified, we then analyzed gene expression data using a bioinformatics method to infer the relative activity of each transcription factor based upon the overall expression levels of their gene targets. From here, we incorporated cancer survival data and examined how each transcription factor’s regulatory activity did, or did not, correlate with survival.
The most prognostic transcription factor was E2F4, a member of the E2F family and a known regulator of the cell cycle. We therefore restricted our analysis to E2F4 and examined how its activity level impacted survival in breast cancer patients.
We found that tumors with high E2F4 regulatory activity as compared to low E2F4 regulatory activity had much worse survival outcomes. These results were stable even after controlling for tumor stage, grade, patient age, and treatment, and were based on data from over 1900 patients across eight independent datasets. These results demonstrate that E2F4 is an independent and enhancing predictor of survival above the currently examined variables.
MedicalResearch.com Interview with:
Dr. Robert S. DiPaola
Director, Rutgers Cancer Institute of New Jersey
New Brunswick, NJ 08901
Medical Research: What is the background for this study? What are the main findings?
Dr. DiPaola: Despite significant recent improvements in the treatment of advanced castration-resistant prostate cancer, there remains a need for a standard therapy for those patients who have an early relapse with PSA progression after local therapy. Immune therapy with poxvirus vaccines are optimal, because they can induce potent immune responses by mimicking natural infection, have great flexibility regarding antigen composition and are easily administered.
ECOG-ACRIN Cancer Research Group investigators conducted a Phase II clinical trial examining adult patients from member institutions with advanced prostate cancer (as evidenced by two rising prostate-specific antigen or PSA values and no visible metastasis) who had prior surgery or radiation. We explored two different experimental treatment options.
In step one, patients were treated with PROSTVAC-V/TRICOM and PROSTVAC-F/TRICOM. PROSTVAC-V is derived from a vaccinia virus that was used for many years to vaccinate against smallpox. This virus is modified to produce a PSA protein that helps focus the body’s immune response to the PSA in the prostate tumor. In addition, it is modified to produce three other proteins that help increase an immune cell’s ability to destroy its target (TRICOM). PROSTVAC-F is made from the fowlpox virus, which is found in birds and not known to cause any human disease. It contains the same genetic material as PROSTAC-V, but is given multiple times to further boost the body’s immune system.
Patients in the study were given one cycle of PROSTVAC-V/TRICOM followed by PROSTVAC-F/TRICOM for subsequent cycles in combination with a drug known as GM-CSF. GM-CSF is a protein normally made by the body to increase the amount of certain white blood cells and make them more active. When in drug form, it is used to boost the body’s immune system to fight off disease. After six months from first treatment, 25 of 40 eligible patients (63 percent) were found to have no disease progression and experienced minimal toxicity. The rate of rise of PSA also decreased. The second part of the study included the addition of hormone therapy (androgen ablation) to the PROSTVAC-VF/TRICOM combination. In the 27 patients eligible for this step, 20 patients (74 percent) experienced a significant response at seven months.
MedicalResearch.com Interview with:
David L. Katz, MD MPH FACPM FACP
President of the American College of Lifestyle Medicine
Yale University Prevention Research Center
Derby, CT; Griffin Hospital, Derby, CT
Medical Research: What is the background for this study? What are the main findings?
Dr. Katz: We have long advised patients at risk for heart disease to avoid eggs- but have thought relatively little about what they might wind up eating instead. While coronary care units banish eggs, they routinely serve white bread, bagels, pancakes, etc. In general, the exclusion of eggs from the diet may result in more sugary, starchy foods- and if so, might do net harm. We have previously studied egg intake in healthy and dyslipidemic adults, and seen no adverse effects on blood flow or biomarkers in the short term (6 wks). This study examined this issue in adults with coronary artery disease- and again, no adverse effects were seen.
MedicalResearch.com Interview with:
Julio C. Martinez-Trujillo, MD, PhD
Canada Research Chair in Neuroscience
Associate Professor, Department of Physiology McGill University
Montreal, Quebec, Canada
Medical Research: What is the background for this study? What are the main findings?
Dr. Martinez-Trujillo: Humans and other primates have an extraordinary ability to voluntarily and efficiently focus attention on important information while ignoring distraction. For decades it has been hypothesized that this ability relies on the evolutionary expansion of the lateral prefrontal cortex, a part of the brain located in the lateral convexity of the frontal lobe, that reaches its highest level of complexity in primates. Several studies have demonstrated that the activity of single neurons in the lateral prefrontal cortex of behaving primates is strongly modulated by allocating attention to different objects or locations. However, one fundamental outstanding question in this field of research is whether assemblies of simultaneously active lateral prefrontal cortex neurons (neuronal assembly) can generate sufficient information to implement the cognitive operation of attention. This is not trivial since when multiple neurons are simultaneously active the amount of information they generate depends on processes such as correlated noise and trial-to-trial response variability, which can substantially impair the information carried by a neuronal population.
In order to investigate this issue we recorded the activity of hundreds of lateral prefrontal neurons in non-human primates while they allocated attention to one of several objects across the visual field. We input the recorded signals into a machine-learning algorithm running on a personal computer that mimicked the computations performed by a brain network of interconnected neurons. We tested the hypothesis that the computer will reliably signal where the subjects allocated attention on a computer display. Indeed, the machine could predict with 100 milliseconds resolution where the subjects directed attention on the display. This prediction was made well in advance the subjects executed any action towards the attended object. Thus, assemblies of prefrontal neurons can reliably signal the allocation of attention across the visual field within realistic timeframes.
MedicalResearch.com Interview with:
Zvonko Rumboldt, MD, PhD Professor emeritus
Split University School of Medicine;
Split, Croatia
Medical Research: What is the background for this study? What are the main findings?
Dr. Rumboldt: Arterial hypertension is the major common denominator of a number of cardiovascular diseases and untoward outcomes including stroke, myocardial infarction, terminal renal insufficiency, heart failure and death. Excessive salt intake is the leading causative factor of blood pressure elevation across the world. It has been shown beyond any reasonable doubt that reduction in salt consumption decreases the prevalence of arterial hypertension and eases its management. Therefore many endeavors and campaigns aimed at moderation in salt ingestion have been launched with fair but less than expected results. The main source of ingested salt in developed countries is processed food, while in transitional and developing countries it is addition during food preparation (cooking), serving and salting at the table.
This study, executed in Mostar, Bosnia and Herzegovina, and Split, Croatia, was designed to evaluate the effects of emphasized warning, consisting in self-adhesive stickers with clear, short message, put on household salt containers. Analyzed were 150 treated hypertensives, randomized in two groups, both receiving oral information and written leaflet concerning salt-hypertension relationship; the intervention group received in addition warning labels to be put on salt containers. In both groups measured were 24-hour urinary sodium excretion (natriuria), blood pressure, and several other parameters at inception of the trial, and one and two months later. In the intervention group observed was a marked decrease in sodium excretion (e.g. from 211 mmol/l at the beginning to 176 mmol/l at two months), much less (from some 207 to 200 mmol/l) in the control group. At the same time, the mean blood pressure (already fairly well controlled) was reduced by additional 4 mm Hg in the intervention group (from 104 to 100 mm Hg), which was not the case in the control group (from 104 to 103 mm Hg).
MedicalResearch.com Interview with:
Zugui Zhang PhD
Value Institute, Christiana Care Health System
Newark, Delaware
MedicalResearch: What is the background for this study?
Dr. Zhang: The strategies of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) for revascularization have been compared in randomized clinical trials. Questions still remain concerning the comparative effectiveness of PCI and CABG. The best way to control for treatment-selection bias is to conduct a randomized trial, but such trials often have limited power to evaluate subgroups. More importantly, the results may not be generalizable, since patients are often highly selected. Nonrandomized, observational data from clinical databases can complement data from clinical trials, because observational data, if they are from a larger and more representative population, may better reflect real-world practice.
ASCERT (American College of Cardiology Foundation and the Society of Thoracic Surgeons Collaboration on the Comparative Effectiveness of Revascularization Strategies) was a large observational study designed to compare the long-term effectiveness of CABG and PCI to treat coronary artery disease (CAD) over 4 to 5 years. This study examined the cost-effectiveness of CABG versus PCI for stable ischemic heart disease.
MedicalResearch: What are the main findings?
Dr. Zhang: This study examined the cost-effectiveness of CABG versus PCI for stable ischemic heart disease. Adjusted costs were higher for CABG for the index hospitalization, study period, and lifetime by $10,670, $8,145, and $11,575, respectively. Patients undergoing CABG gained an adjusted average of 0.2525 and 0.3801 life-years relative to PCI over the observation period and lifetime, respectively. The life-time incremental cost-effectiveness ratio of CABG compared to PCI was $30,454/QALY gained.
This study shows that over a period of 4 years or longer, CABG is associated with better outcomes but at higher cost than PCI among older patients with 2- or 3-vessel CAD. Under the assumption that our analysis has fully accounted for both measured and unmeasured confounding, in patients with stable ischemic heart disease, CABG will often be considered cost-effective at thresholds of $30,000 or $50,000/QALY.
MedicalResearch.com Interview with:
Andrea Kaye Chomistek ScD
Assistant Professor Epidemiology and Biostatistics
Indiana University Bloomington
Medical Research: What is the background for this study? What are the main findings?
Dr. Chomistek: Although mortality rates from coronary heart disease in the U.S. have been in steady decline for the last four decades, women aged 35-44 have not experienced the same reduction. This disparity may be explained by unhealthy lifestyle choices. Thus, the purpose of our study was to determine what proportion of heart disease cases and cardiovascular risk factors (diabetes, hypertension, and high cholesterol) could be attributed to unhealthy habits.
We defined healthy habits as not smoking, a normal body mass index, physical activity of at least 2.5 hours per week, watching seven or fewer hours of television a week, consumption of a maximum of one alcoholic drink per day on average, and a diet in the top 40 percent of a measure of diet quality based on the Alternative Healthy Eating Index.
We found that women who adhered to all six healthy lifestyle practices had a 92 percent lower risk of heart attack and a 66 percent lower risk of developing a risk factor for heart disease. This lower risk would mean three quarters of heart attacks and nearly half of all risk factors in younger women may have been prevented if all of the women had adhered to all six healthy lifestyle factors.
MedicalResearch.com Interview with:
Prof. H. Szajewska
The Medical University of Warsaw
Department of Paediatrics
Warsaw, Poland
Medical Research: What is the background for this study?
Dr. Szajewska: Proton pump inhibitors (PPIs) are increasingly being used in the management of irritability and excessive crying in young infants. For example, a 7-fold increase in PPI prescriptions for infants was demonstrated in one US-based study. While differences among countries may occur, over-prescription of PPIs for infants remains a problem. The use of PPIs is mainly based on the assumption that these symptoms are attributable to gastroesophageal reflux or gastroesophageal reflux disease. Indeed, in infants, common symptoms of both conditions include regurgitation or vomiting associated with irritability or crying. However, there is still uncertainty with regard to the role of proton pump inhibitors for the management of excessive crying and irritability.
Dr. Szajewska: What are the main findings?
We aimed to examine whether proton pump inhibitors are effective in the management of excessive crying and irritability in infants. Only 5 randomized controlled trials fulfilled the inclusion criteria, so the evidence remains limited. There was variability in how crying/irritability outcomes were reported, but all trials used reliable methods. Some trials showed a decrease in crying/irritability from baseline to the end of the intervention; a similar effect was observed in the control group. However, no significant differences between the treatment groups were observed.
MedicalResearch.com Interview with:
Sakthivel Sadayappan, PhD, MBA
Associate Professor Department of Cell and Molecular Physiology
Loyola University Chicago Health Sciences Division
Maywood, IL 60153-5500, USA.
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Sadayappan: Hypertrophic cardiomyopathy (HCM) is the most common form of genetic heart defect, affecting 1 in 500 people in the general population. HCM results in excessive thickening of heart muscle without an obvious cause, such as hypertension or exercise stress. Often, HCM results in sudden cardiac arrest as a result of cardiac arrhythmia. Electrocardiogram, echocardiogram and cardiac magnetic resonance imaging are commonly used to diagnose HCM. However, genetic defects in more than 10 genes could also cause HCM, and standard screening for these genes is readily available. Notwithstanding our ability to diagnose the disease, a major challenge arises from its heterogeneity. That is, individuals with the same genetic defect often present with different symptoms, ranging from no symptoms at all to severe heart enlargement. Therefore, treatment options vary from person to person, and, at present, no permanent cure is available for HCM. Beta-blockers, calcium antagonists and anti-arrhythmic drugs are currently being used to manage the disease. However, scientists must discover the reasons that explain why some people experience more severe symptoms than others.
In today’s modern world, people are afflicted with stresses including, for example, diabetes, hypertension, hyperlipidemia (high cholesterol), and alcoholism. Therefore, we have hypothesized that additional cardiac stresses can aggravate the onset of Hypertrophic cardiomyopathy. To prove our hypothesis, we used a mouse model having a genetic defect known to affect cardiac muscle contractility. We subjected these mice to severe cardiac stress over a period of 12 weeks. Compared with normal mice, we found that the mutant mice showed significant cardiac abnormalities, including those associated with HCM. Thus, this demonstrated, for the first time, that additional cardiac stress applied in the presence of known genetic defects exacerbates the onset of HCM.
MedicalResearch.com Interview with:
Ahmad Haidar PhD
Institut de Recherches Cliniques de Montreal
Montreal, QC, Canada
Medical Research: What is the background for this study? What are the main findings?
Response: We published a study in 2013 (Canadian Medical Association Journal 185.4 (2013): 297-305) where we did the first randomized trial comparing dual-hormone artificial pancreas against conventional pump therapy. We showed spectacular reduction in hypoglycemia (8-fold) with the artificial pancreas, but the first question people asked: Out of the improvement you showed, how much is due to simply closing the loop between the glucose sensor and the insulin pump, and how much is due to adding glucagon? In other words: if you just close the loop with insulin alone and use an advanced dosing algorithm, you may get a very high reduction of hypoglycemia that glucagon may not be needed (glucagon is associated with increased cost and device complexity). We were not able to answer this question with our study design.
Since then, there have been other studies by other groups either comparing single-hormone artificial pancreas vs conventional pump therapy, or comparing dual-hormone artificial pancreas vs conventional pump therapy, and most of these studies showed improvement of both artificial pancreas systems compared to conventional pump therapy. However, there has been no study comparing the three interventions to allow us to quantify the relative benefits of simply closing the loop between glucose sensor and insulin pump versus adding glucagon to the system. Quantifying the relative benefits of glucagon is important given the increased cost and device complexity of the dual-hormone artificial pancreas.
So our study compared the three interventions, and is the first study to do so.
MedicalResearch.com Interview with:
Eva Schernhammer, MD, DrPH
Associate Professor of Medicine
Brigham and Women's Hospital and Harvard Medical School
Associate Professor of Epidemiology
Harvard School of Public Health
Channing Division of Network Medicine
Medical Research: What is the background for this study? What are the main findings?
Prof. Schernhammer: The study is an observational cohort study of over 70,000 registered nurses from within the US who reported the total number of years they had worked rotating night work and were followed for several decades. We examined overall mortality in these women, and observed significantly higher overall mortality, as well as higher mortality from cardiovascular disease in women with several years of rotating night shift work, compared to nurses who had never worked night shifts. There was also some suggestion for modest and non-significant increases in mortality from a few cancers. The study is unique due to its size, the fact that all participants were nurses (eliminating potential biases arising from differing occupational exposures), the long follow-up, and the possibility to take into account most known risk factors for chronic diseases that we currently know of (all of this information has been collected regularly and repeatedly).
MedicalResearch.com Interview with:
Dr. Kongkiat Chaikriangkrai MD
Department of Medicine, Houston Methodist Hospital
Houston, TX 77030
Medical Research: What is the background for this study?
Dr. Chaikriangkrai: Coronary computed tomography angiography (CCTA) and coronary artery calcium score are well known to be useful tools for patients suspected for coronary artery disease. Although both imaging studies are similar in many ways (e.g. CT-based studies, anatomical evaluation of coronary artery disease, etc.), they are completely independent tests that measure different aspects of coronary artery. Furthermore, each test also requires its own separate scan.
In earlier times, calcium score testing was routinely performed prior to CCTA since high calcium score can affect diagnostic accuracy of CCTA. Therefore, CCTA may not be the best option for patients who are known to have high calcium score and other tests along the line can be further considered. However; there have been debates over the need for calcium score scan in this setting alone without enough evidence of additive prognostic benefit of measuring calcium score on top of CCTA due to concerns of extra radiation exposure from performing CT scanning twice.
From this very clinical question, our study was designed to examine whether there was any additional benefit of measuring calcium score over CCTA alone (i.e. Does a patient with high calcium score have worse prognosis than a patient with lower calcium score given that both have similar CCTA results?)
Medical Research: What are the main findings?
Dr. Chaikriangkrai: Our study found that both CCTA and calcium score testing carried its own prognostic value which was independent from each other. Furthermore, measuring calcium score also gave extra ability to predict bad clinical outcomes on top of the information obtained from CCTA alone in patients suspected for coronary artery disease (i.e. A patient with high calcium score did have worse prognosis than a patient with lower calcium score given that both have similar CCTA results).
MedicalResearch.com Interview with:
Mary Puckett, PhD
CDC
Division of Cancer Prevention and Control.
Medical Research: What is the background for this study? What are the main findings?
Dr. Puckett: Smoking causes 480,000 deaths per year in the United States. Quitline services are offered by all 50 states. In addition to telephone quitlines, 96% of states also offer some form of web-based cessation service. Seven months after enrollment in the study, participants from four state quitlines were asked if they had smoked in the past 30 days as a measure of their smoking cessation success. Participants who used quitlines and web-based services in combination had higher rates of smoking cessation than participants who used only one of these services.