Prof. Harding[/caption]
Jane E. Harding, DPhil
Liggins Institute
The University of Auckland
Auckland, New Zealand
MedicalResearch.com: What is the background for this study?
Response: Neonatal hypoglycaemia – low blood sugars in newborns – affects up to one in six babies born. It involves a sustained dip in blood sugar levels following birth. Blood glucose is the only fuel for babies’ brains (adults have alternative, back-up sources). So, if left untreated, this condition can cause developmental brain damage and lowered education outcomes later in life.
In developed economies, as many as a third of babies born are at risk. Risk factors include being born smaller or larger than usual, preterm babies and babies whose mothers have any form of diabetes – this last a growing group, with the rising incidence of gestational (pregnancy-related) diabetes.
We wanted to systematically track a cohort of babies to see if hypoglycaemia in babies affects their long-term health and development. So we designed the CHYLD study – Children with Hypoglycaemia and their Later Development. We are following 614 New Zealand babies born at risk of low blood sugar levels (neonatal hypoglycemia) into childhood to see if the condition affects their later growth and development. Our team includes researchers from the Liggins Institute, the University of Auckland, Waikato Hospital, the University of Canterbury and the University of Waterloo.
Half of the babies in the study were diagnosed with, and treated for low blood sugars. Seventy percent received extra, continuous monitoring of their blood sugar levels, which detected in some babies low levels that were not diagnosed by the heel-prick tests.
Dr. Hartnett[/caption]
Mary Elizabeth Hartnett, MD, FACS, FARVO
Professor of Ophthalmology, Vitreoretinal Service and Surgery
Principal Investigator Retinal Angiogenesis Laboratory
Director of Pediatric Retina, Adjunct Professor of Pediatrics
John A. Moran Eye Center
Salt Lake City UT 84132
On behalf of the co-authors: Julia Shulman, Cindy Weng, Jacob Wilkes, Tom Greene, M. Elizabeth Hartnett
MedicalResearch.com: What is the background for this study?
Response: Maternal preeclampsia causes morbidity to mothers and infants worldwide. Retinopathy of prematurity (ROP) is a leading cause of childhood blindness worldwide. This study was done to gain insight into the effects of preeclampsia on ROP in a clinical population.
The literature is mixed with some reports that preeclampsia increases risk of Retinopathy of prematurity, whereas others suggest preeclampsia is protective or has no effect. The presence of circulating anti-angiogenic factors in preeclamptic mothers that can enter the fetal circulation lends biologic plausibility to the notion that maternal preeclampsia might interfere with developing vascular beds in the fetus, such as the retina, and potentially lead to severe ROP. However, a report using an experimental model provided evidence that uteroplacental insufficiency, a characteristic of preeclampsia, led to protective mechanisms in the offspring that reduced oxygen-induced retinopathy and promoted overall growth.
Dr. Brach[/caption]
Jennifer Brach, Ph.D., P.T.
Associate professor, Department of physical therapy
School of Health and Rehabilitation Sciences
University of Pittsburgh
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This study compared two different group exercise programs to improve mobility in community-dwelling older adults. The first program, a seated program focused on strength, endurance and flexibility, was based on usual care. The second program, called On the Move, was conducted primarily in standing position and focused on the timing and coordination of movements important for walking. Both programs met two times per week for 12 weeks. It was found that the On the Move program was more effective at improving mobility than the usual seated program.
Dr. Leonard[/caption]
Maureen Leonard, MD MMSc
Clinical Director, Center for Celiac Research and Treatment
Instructor in Pediatrics
Associate Investigator, Nutrition Obesity Research Center
Harvard Medical School
Pediatric Gastroenterology & Nutrition
MassGeneral Hospital for Children
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In this systematic review, we discuss the clinical approach to celiac disease and nonceliac gluten sensitivity, highlighting how to distinguish between these two conditions and their management. These disorders cannot be distinguished based on symptoms. A single elevated serology test is not diagnostic for celiac disease, and patients with abnormal serologic testing must be referred to a gastroenterologist for further testing and remain on a gluten-containing diet until their diagnostic evaluation is completed. While the treatment for both conditions is a gluten-free diet, the possibility of long-term complications differs.
Steven Habbous[/caption]
Steven Habbous MSc, PhD candidate
Ontario Cancer Institute
Scarborough, Ontario, Canada
MedicalResearch.com: What is the background for this study?
Response: Human papillomavirus (HPV) is a strong risk factor for oropharyngeal cancers (a subset of head and neck cancers). Because HPV-related oropharyngeal cancers generally respond well to treatment and may be prevented through HPV vaccination, it is critical to be able to accurately estimate the incidence and prevalence of this disease. Only recently, however, has testing for HPV become routine at most cancer centres across Canada. As a result, attempts to estimate the growth of HPV-related oropharyngeal cancer over time may be inaccurate.
Dr. Chino[/caption]
Dr. Fumiko Chino, MD
Duke Radiation Oncology
Duke School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The financial burden of cancer treatment is a growing concern. Out-of-pocket expenses are higher for patients with cancer than for those who have other chronic illnesses. Fifty percent of elderly cancer patients spend at least 10% of their income on treatment-related out-of-pocket expenses. Additionally, high financial burden is associated with both increased risk of poor psychological well-being and worse health-related quality of life. A cancer diagnosis has been shown to be an independent risk factor for declaring personal bankruptcy, and cancer patients who declare personal bankruptcy are at greater risk for mortality. These potentially harmful outcomes resulting from financial burden have been recognized as the financial toxicity of cancer therapy, analogous to the more commonly considered physical toxicity.
We conducted an IRB approved study of financial distress and cost expectations among patients with cancer presenting for anti-cancer therapy. In this cross-sectional, survey based study of 300 patients, over one third of patients reported higher than expected financial burden. Cancer patients with highest financial distress are underinsured, paying nearly 1/3 of income in cancer-related costs. In adjusted analysis, experiencing higher than expected financial burden was associated with high/overwhelming financial distress (OR 4.78; 95% CI 2.02-11.32; p<0.01) and with decreased willingness to pay for cancer care (OR 0.48, 95% CI 0.25-0.95, p=0.03). Sambla, a Scandinavian lender, has been working with many patients to prevent any financial distress resulting from unexpected medical bills. As a result of customer feedback, it has modified the terms of all loans it issues to allow for jumbo loan sizes and reduced interest rates, combined with longer repayment times to help its borrowers.
Dr. McElroy[/caption]
Jane McElroy, Ph.D.
Associate professor
Department of Family and Community Medicine
MU School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: More than 31,000 new cases of endometrial cancer are expected to be diagnosed in 2017. Through a five-year observational study, we found that women with increased levels of cadmium had an increased risk of endometrial cancer. Cadmium is a metal commonly found in foods such as kidneys, liver and shellfish as well as tobacco It’s a finding we hope could lead to new treatments or interventions to prevent the fourth most common cancer in women.
Sarah Kattakuzhy, MD
Clinical and Administrative Director, DC PFAP Hepatitis Clinical Research Program
Assistant Professor, Institute of Human Virology
Division of Infectious Diseases
University of Maryland
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The recent introduction of highly effective, well-tolerated direct-acting antiviral (DAA) therapy for hepatitis C virus infection has raised the possibility of rapid treatment expansion and widespread cure. However, the current specialist workforce is insufficient to meet the treatment demands of the 2.7 million Americans living with HCV infection. Several studies of partial task shifting—shared treatment between specialists and primary care providers—have demonstrated success in improving access to HCV care. Yet, information on the success of nonspecialists practicing independent of specialist supervision is limited.
The primary objective of ASCEND was to evaluate the efficacy of Hepatitis C treatment managed independently by 3 community-based provider types—nurse practitioners (NPs), PCPs, and specialists—after a succinct, guideline-driven educational intervention, set within a real-world, urban population.
In this investigation, 516 out of 600 patients achieved SVR, a response rate of 86% (95% CI, 83.0% to 88.7%), with no major safety signals. Rates of SVR were consistent across the 3 provider types—NPs: 89.3% (CI, 83.3% to 93.8%); PCPs: 86.9% (CI, 80.6% to 91.7%); and specialists: 83.8% (CI, 79.0% to 87.8%). Patient loss to follow-up was the major cause of non-SVR.
Dr. Jackson[/caption]
Michael Jackson PhD, MPH
Kaiser Permanente Washington Health Research Institute (KPWHRI) principal investigator for the United States Influenza Vaccine Effectiveness Network
MedicalResearch.com: What is the background for this study?
Dr. Sutradhar[/caption]
Rinku Sutradhar, Ph.D.
Senior Scientist, Institute for Clinical Evaluative Sciences
Associate Professor, Dalla Lana School of Public Health
University of Toronto, Canada
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Ash[/caption]
Arlene S. Ash, PhD
Department of Quantitative Health Sciences
University of Massachusetts Medical School
Worcester
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: State Medicaid programs (and other health care purchasers) often contract with several managed care organizations, each of which agrees to address all health care needs for some of their beneficiaries. Suppose a Medicaid program has $5000 to spend, on average, for each of its 1 million beneficiaries. How much should they pay health plan “A” for the particular 100,000 beneficiaries it enrolls? If some group, such as those who are homeless, is much more expensive to care for than the payment, plans that try to provide good care for many such people will go broke. We describe the model now used by MassHealth to ensure that plans get more money for enrolling patients with greater medical and social needs. In this medical-social model, about 10% of total dollars is allocated by factors other than the medical-morbidity risk score.
Dr. Hernandez[/caption]
Inmaculada Hernandez, PharmD, PhD
Assistant Professor of Pharmacy and Therapeutics
University of Pittsburgh School of Pharmacy
Pittsburgh, PA 1526
MedicalResearch.com: What is the background for this study?
Response: A few months ago, the results of the FOURIER trial were published. This trial was the first one to evaluate the efficacy of PCSK9 inhibitors in the prevention of cardiovascular events, since the approval of these agents was based on trials that evaluated their efficacy in reducing levels of LDL-C. The results of the FOURIER trial did not meet the expectations generated by prior studies that had simulated how much the risk of cardiovascular events should decrease based on the observed reduction in LDL-C levels. A few hours after the publication of the results of the FOURIER trial, Amgen (evolocumab´s manufacturer) announced that it would be willing to engage in contracts where the cost of evolocumab would be refunded for those patients who suffer a heart attack or a stroke while using the drug.
Dr. Jordan[/caption]
Stanley C. Jordan, M.D
Director, Division of Nephrology
Medical Director, Kidney Transplant Program
Medical Director, Human Leukocyte Antigen and Transplant Immunology Laboratory
Cedars-Sinai, Los Angeles, CA
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The background for this study is as follows: Patients who are highly HLA sensitized have antibodies to transplant targets create an immunologic barrier to transplant. Currently, there are no approved therapies for elimination of these antibodies. Desensitization is available but is not always successful and most desensitized patients are still transplanted with a positive crossmatch. Thus, many patients are not able to receive life-saving kidney transplants unless newer therapies to remove antibodies are found.
The findings of our study published in the New England Journal of Medicine revealed that the use of the enzyme from streptococcal pyogenes called IdeS® (IgG endopeptidase) is very effective in eliminating donor specific antibodies and allowing transplantation to occur. Antibodies were eliminated from one week up to two months after one treatment with Ides® allowing a safe environment for the transplant to occur. Rejections episodes did occur in some of the patients but were generally mild and easily treatable. Only one patient of 25 lost his allograft during the study. Thus, the study shows promising results for a new approach for elimination of pathogenic antibodies that did not exist before.
Dr. Krista Huybrechts[/caption]
Krista F. Huybrechts, MS PhD
Assistant Professor of Medicine
Brigham and Women’s Hospital
Harvard Medical School
Boston, MA 02120
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Neonatal drug withdrawal is common; in the U.S. about 1 infant is born every 25 minutes with signs of drug withdrawal. Neonatal drug withdrawal is a well-recognized complication of intrauterine exposure to illicit or prescription opioids, but other psychotropic medications can also cause signs of withdrawal. Psychotropic medications are frequently co-prescribed with opioids in pregnancy, and the use of both has increased significantly, raising concerns about an increase in the incidence and severity of neonatal drug withdrawal due to potential drug-drug interactions, but these risks are not well understood.
In this study, we found a 30-60% increase in the risk of neonatal drug withdrawal associated with co-exposure to antidepressants, benzodiazepines and gabapentin, compared to opioids alone; no significant increase in risk was observed for atypical antipsychotics and Z-drugs. Exposure to psychotropic polypharmacy along with opioids was associated with a two-fold increased risk of withdrawal.
Dr.Enderling[/caption]
Heiko Enderling, Ph.D.
Associate Member & Director for Education and Outreach
Dept. of Integrated Mathematical Oncology
Dept. of Radiation Oncology
H. Lee Moffitt Cancer Center & Research Institute
Tampa, FL 33612
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Although radiation therapy after breast-conserving surgery for early-stage breast cancer has significantly improved patient prognosis, many patients will face a second cancer diagnosis within 20 years of primary treatment. Experimental and clinical studies have shown that local radiation therapy can activate an immune response that can propagate systemically to attack distant untreated metastases. However, current radiotherapy practice has not specifically focused on enhancing immune responses.
We asked the question if pre-operative irradiation, when applied to the bulk of disease, could have potentially higher immune stimulatory effects. To study this, we analyzed historic outcomes of breast cancer patients treated with either adjuvant (radiation after surgery) or neoadjuvant (radiation before surgery) radiotherapies.
Our analysis showed that the risk of developing a second tumor after neoadjuvant compared with adjuvant RT was significantly lower, especially for estrogen receptor-positive women who underwent breast conserving surgery or mastectomy. Historic data revealed an increase in disease-free survival of 12% over 20 years after treatment of the original tumor.
Dr. Kochunov[/caption]
Peter Kochunov PhD
Professor
Maryland Psychiatric Research Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Schizophrenia is a debilitating disorder that strikes young people at the point of entering adulthood. In the past, we and others demonstrated that patients with schizophrenia are characterized by deficits in the white matter of the brain. White matter is the part of the brain that serves the backbone of cerebral networks transmitting information and interconnecting brain regions.
In this report, we link the impaired white matter of the brain in schizophrenia patients with the disorder-related deficits in the processing speed. We also showed that mental processing speed is a fundamental cognitive construct that partially supports other functions like working memory in patients, where processing speed acting as the intermediate between white matter deficits and reduced working memory. This interesting relationship between processing speed, working memory, and white matter is most obvious in white matter regions most vulnerable to schizophrenia. That was the main finding of the study.
Dr. Jacobs[/caption]
Dr. Lisa K. Jacobs MD
Johns Hopkins School of Medicine
Baltimore, Maryland
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Breast preservation is the preferred treatment for many women diagnosed with breast cancer. The most common question that a patient will ask after the surgery is, “Did you get it all?” In the ideal case, this is accomplished in a single outpatient surgery with very good cosmetic results. In our study, Beyond the Margins-Economic Costs and Complications Associated with Repeated Breast-Conserving Surgeries we evaluated the detrimental effects of an unsuccessful initial surgery due to positive surgical margins. Using private insurance claims data, we found that 16% of patients planning breast preservation required a second breast-conserving surgery and an additional 7% converted to mastectomy. Of those patients that required additional surgery there was a 56% ($16,072) increase in cost and a 48% increase in complications. Those complications include infection, hematoma, seroma, and fat necrosis. This study demonstrates that repeated surgery has not only cosmetic consequences, but also has financial implications and increased risk.
Dr. Adrian Harel[/caption]
Dr. Adrian Harel, PhD
Chief Executive Officer
Medicortex Finland
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Every 15 seconds, someone in the United States suffers a new head injury. Of the 2.5M people treated in hospital emergency rooms each year, 80,000 become permanently disabled because of TBI. Currently, there are no reliable diagnostic tests to assess the presence or severity of an injury on-site, nor are there any pharmaceutical therapies that could stop the secondary injury from spreading. Accurate diagnostics would benefit especially mild cases of TBI (concussions), which, if occurring repeatedly, may cause neurodegenerative conditions such as Chronic Traumatic Encephalopathy (which is typical for athletes in NFL and Ice-hockey).
We have performed extensive preclinical research comparing fluid biopsies from normal and injured lab animals. The results showed some unique biomarkers released as a biodegradation products after head injury. The data served as the basis and confirmation for our patent applications to protect the biomarker concept.
Medicortex has completed a clinical proof-of-concept trial in collaboration with Turku University Hospital (Tyks). Samples from 12 TBI patients and 12 healthy volunteers were collected and analyzed for the presence and for the level of the biomarker in state-of-the-art laboratories. The study demonstrated the diagnostic potential of the new biomarker in humans and it confirmed the prior preclinical findings. This was a significant milestone for Medicortex.
Dr. Willis[/caption]
Jeffrey R. Willis MD, PhD
UC Davis Eye Center
University of California, Davis
Sacramento California
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Diabetic retinopathy is one of the leading causes of blindness in the United States. Yet there is limited national level data on the impact of worsening DR on quality of life and visual function.
Our study aimed to address this knowledge gap by evaluating the functional burden of DR across severity levels, utilizing data from the National Health and Nutrition Examination Survey (NHANES).
We found that one-half of US adults with severe non-proliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR) had difficulty with ≥ 1 visual function task, possibly impacting their daily work/activities. These patients reported a significantly greater vision-related functional burden relative to those with less severe forms of DR.
Dr. Carlijn M. P. le Clercq[/caption]
Dr. Carlijn M. P. le Clercq, MD
Speech and Language Pathology, Pediatrics, Otolaryngology
Erasmus MC , Rotterdam
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: There has been increasing interest for acquired hearing loss among children, and concerns about its prevalence possibly rising over time. One of the questions that come up, is whether there is an association with the growing use of portable music players with headphones, including smartphones and tablets. There have been few longitudinal studies to explore this relation.
In order to examine this relation, among other factors, we have conducted a formal hearing screening among more than 5000 9- to 11-year-old children from a population-based birth cohort in the Netherlands.
Our study showed that nearly one in five children did not have normal hearing. Of the cohort, 7.8% of the children showed signs of permanent hearing loss.
Dr. Kutalik[/caption]
Dr. Zoltán Kutalik, PhD
Group Leader
Swiss Institute of Bioinformatics
Assistant professor at the Institute of Social and Preventive Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Why do some of us live longer than others? While the environment in which we live – including our socio-economic status or the food we eat – plays the biggest part, about 20 to 30% of the variation in human lifespan comes down to our genome. Changes in particular locations in our DNA sequence, such as single-nucleotide polymorphisms (SNPs), could therefore hold some of the keys to our longevity. Until now, the most comprehensive studies had found only two hits in the genome.
Dr. Juraschek[/caption]
Stephen P. Juraschek, MD, PhD
Instructor of Medicine
Beth Israel Deaconess Medical Center
Harvard Medical School
MedicalResearch.com: What is the background for this study?
Response: Many adults experience dizziness and light-headedness when they stand up. This is more common in older adults and is related to risk of falling, fractures, fainting, car crashes, and early death. These symptoms are thought to be caused by a drop in blood pressure after standing also called orthostatic hypotension. However, if measured at the wrong time it is possible to miss this important clinical sign.
For over 2 decades (since 1996), it has been recommended that orthostatic hypotension be identified by measuring blood pressure within 3 minutes of standing. Furthermore, it was also thought that measurements immediately after standing be avoided because they might be inaccurate (based on fluctuation in blood pressure immediately after standing). As a result, a lot of clinical protocols instructing healthcare staff on measuring orthostatic blood pressure encourage measurement at 3 minutes, but this has not been scientifically evaluated.
Dr. Mangione[/caption]
Carol M. Mangione, MD, MSPH, FACP
Barbara A. Levey, MD, and Gerald S. Levey, MD
Endowed chair in medicine
David Geffen School of Medicine
University of California, Los Angeles
Professor of public health at the UCLA Fielding School of Public Health
MedicalResearch.com: What is the background for this study?
Response: Americans can experience several health benefits from consuming healthy foods and engaging in physical activity. The Task Force recommends that primary care professionals work together with their patients when making the decision to offer or refer adults who are not obese and do not have hypertension, high cholesterol, high blood sugar, or diabetes to behavior counseling to promote healthful diet and physical activity. Our focus was on the impact of a healthful diet and physical activity on cardiovascular risk because this condition is the leading cause of premature morbidity and mortality. The Task Force evaluates what the science tells us surrounding the potential benefits and harms of a particular preventive service. In this case, the Task Force found high quality evidence focusing on the impact a healthful diet and physical activity can have on a patient’s risk of cardiovascular disease. Relying on this evidence, the Task Force was able to conclude that there is a positive but small benefit of behavioral counseling to prevent cardiovascular disease.