Author Interviews, Columbia, Genetic Research, OBGYNE / 03.11.2016

MedicalResearch.com Interview with: Sarah Horvath, MD Paula M. Castaño, MD, MPH Anne R. Davis, MD, MPH Columbia University Medical Center MedicalResearch.com: What is the background for this study? What are the main findings? Response: Approximately 3% of pregnant women in the United States will receive a prenatal diagnosis of fetal aneuploidy (such as trisomy 21) or fetal structural abnormality (such as cardiac or CNS malformations). Many of these women will undergo abortion. Advances in screening over the past few decades have allowed earlier diagnosis of aneuploidy, but most structural abnormalities cannot be diagnosed until the anatomy ultrasound at 18-20 weeks gestational age because of fixed patterns of fetal development. Our analysis examines gestational age at time of abortion for these two types of fetal diagnosis from 2004-2014. Our main finding was that median gestational age at time of abortion for fetal aneuploidy decreased from 19 weeks to 14 weeks. However, over the same 11 year period, median gestational age at time of abortion for fetal structural abnormalities remained unchanged and at or above 20 weeks gestation. (more…)
Author Interviews, Kaiser Permanente, Mayo Clinic, Prostate Cancer / 03.11.2016

MedicalResearch.com Interview with: Lauren P. Wallner, PhD, MPH Assistant Professor, Departments of Medicine and Epidemiology, University of Michigan Adjunct Investigator Kaiser Permanente Southern California North Campus Research Complex Ann Arbor, MI MedicalResearch.com: What is the background for this study? What are the main findings? Response: 5 alpha-reductase inhibitors (5ARIs) are often used for the management of lower urinary tract symptoms in men. Two prior clinical trials found 5ARIs also reduced the risk of prostate cancer, but there was an increase in more aggressive (Gleason 7-10) cancers among the men who were diagnosed. Thus, concerns over whether 5ARIs may increase the risk of prostate cancer death have limited their use in the prevention of prostate cancer, which remains controversial. To address the safety of 5ARIs for the primary prevention of prostate cancer, we conducted a large population-based study of over 200,000 men in community practice settings of over a 19 year observation period to assess whether 5ARI use (as compared to alpha-blocker use) was associated with prostate cancer mortality. Our results suggest that 5ARI use was not associated with an increased risk of prostate cancer mortality when compared to alpha-blocker use. (more…)
Author Interviews, Pharmacology, Weight Research / 03.11.2016

MedicalResearch.com Interview with: Dr Todd Hobbs MD Chief medical officer (CMO) Novo Nordisk in North America MedicalResearch.com: What is the background for this study? Response: There is little data that describes weight loss and other outcomes separately in early weight loss responders and early weight loss non-responders. Early weight loss, whether through lifestyle or pharmacotherapy, can be a good predictor of long-term weight loss. Consequently, all recently-approved weight loss medication labels include ‘stopping rules’ for discontinuing medication if a threshold weight loss is not achieved by a specified milestone. Bottom line, it’s important patients don’t continue on a therapy that isn’t working for them. This makes this form of research important from a clinical standpoint but also in the larger obesity treatment paradigm - including payers and how pharmaceutical treatments are labeled. (more…)
Author Interviews, End of Life Care, HIV, Pediatrics, Pediatrics / 03.11.2016

MedicalResearch.com Interview with: Maureen E. Lyon PhD Division of Adolescent and Young Adult Medicine, Center for Translational Science/Children’s Research Institute, Children’s National The George Washington University School of Medicine and Health Sciences Washington, District of Columbia MedicalResearch.com: What is the background for this study? Response: Despite policy recommendations to include adolescents with chronic and life-limiting conditions in decision-making about their own end-of-life care, barriers continue in clinical practice, including fear of distressing vulnerable adolescents and providers’ beliefs that these conversations are potentially harmful. (more…)
Allergies, Author Interviews, Pediatrics / 03.11.2016

MedicalResearch.com Interview with: Dr. Daniela Posa, MD Department of Paediatric Pneumology & Immunology Charité–Universitätsmedizin Berlin Berlin, Germany MedicalResearch.com: What is the background for this study? Response: Allergy to house dust mites contributes to chronic rhinitis and asthma in hundreds million children and adults worldwide, causing tremendous health and economic burden in high- and middle-income countries. The disease is caused by antibodies called immunoglobulin E (IgE), it starts in childhood and can be controlled with drugs and allergen avoidance. However, there is no cure, hence primary and secondary prevention of mite allergy is a global research priority. We wanted to discover how allergy to mites starts and evolves and why some children develop more severe sensitization and symptoms than others. (more…)
Author Interviews, End of Life Care, JAMA, Race/Ethnic Diversity, UCSF / 02.11.2016

MedicalResearch.com Interview with: Krista Lyn Harrison, PhD Division of Geriatrics School of Medicine University of California San Francisco VA Medical Center San Francisco, CA 94121 MedicalResearch.com: What is the background for this study? Response: Advance care planning (ACP) is the process of discussing plans and preferences for end-of-life care. It may include completion of advanced directives or a living will and designation of a surrogate decision-maker in a durable power of attorney for health care. There is a growing awareness of the benefits of such discussions for both elders and their families. In absence of these discussions, loved ones are left to guess what the affected individual wanted or may even get mired in unexpected legal issues. But until recently, it was unknown if all races/ethnicities, education levels, and incomes have benefited from efforts to improve engagement in advance care planning, and if these discussions are greater among those in worse health and with a poorer prognosis. (more…)
Author Interviews, HIV, Immunotherapy / 02.11.2016

MedicalResearch.com Interview with: Jacob Lalezari, MD Quest Clinical Research San Francisco, CA  MedicalResearch.com: What is the background for this study? What are the main findings?
  • Tremendous strides have been made since HIV-1 was first discovered 35 years ago. However, while many HIV patients can control the infection with currently-approved therapies, there is an urgent need for new treatments that can address viruses that are resistant to multiple antiretroviral treatment classes. With people starting treatments earlier and staying on them longer, some patients also face long-term safety and tolerability issues associated with current therapies.
  • Thousands of people are infected with HIV-1 with resistance to three classes of antiretroviral therapy (ART), and are in dire need of treatment. There are limited or no treatment options available for these patients.
  • As multi-drug resistant (MDR) HIV can be transmitted, it is imperative that it be controlled in order to prevent it from becoming a larger problem. It is important to not only focus on the patient being treated but also consider those they could infect.
  • Ibalizumab is the first biologic long-acting investigational ART to show efficacy in patients in just seven days. The Phase III TMB-301 results showed that patients with MDR HIV-1 and with limited treatment options experienced a significant decrease in viral load after receiving a loading dose of ibalizumab (2,000 mg intravenously) in addition to their failing ART therapies.
    •  A total of 40 patients were enrolled in the study.
    • Seven days after the loading dose, 83% of patients achieved a ≥ 0.5 log10 decrease from baseline compared with 3% during the seven-day control period.
    • These results were statistically significant (p<0.0001). Moreover, during that same period, 60% achieved a decrease of ≥1.0 log10.
    • The average viral load decrease for the total population was 1.1 log10
    • There were no treatment-related serious adverse events or discontinuations reported during the initial seven-day treatment period. 
(more…)
Author Interviews, JAMA, OBGYNE, Pediatrics, Vaccine Studies / 02.11.2016

MedicalResearch.com Interview with: Malini B. DeSilva, MD, MPH Clinician Investigator HealthPartners Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: This is a retrospective study of more than 324,000 live births at seven Vaccine Safety Datalink sites between 2007 and 2013 which showed that the Tdap vaccine in pregnant mothers was not associated with increased risk for microcephaly or other major birth defects in their offspring. (more…)
Author Interviews, CHEST, Clots - Coagulation, Surgical Research / 02.11.2016

MedicalResearch.com Interview with: William T. Kuo, MD, FSIR, FCCP, FSVM Director, Stanford IVC Filter Clinic Director, IR Fellowship Program Founding Director, IR-DR Residency Program Associate Professor, Interventional Radiology Stanford University Medical Center Stanford, CA MedicalResearch.com: What is the background for this study? What are the main findings? Response: In the USA, over 250,000 IVC filters are now implanted each year, and rising filter use has led to an increase in filter-related morbidity and recognition of the potential complications from indwelling IVC filters. Consequently, the FDA has issued two safety communications alerting all physicians caring for patients with IVC filters to consider removing the filter as soon as protection from pulmonary embolism is no longer needed: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm221676.htm http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm396377.htm?so urce=govdelivery&utm_medium=email&utm_source=govdelivery Despite heightened awareness, up to 40-60% of IVC filters cannot be easily removed using standard methods alone, after the filter becomes firmly embedded. Additionally, many patients have undergone prior placement of a permanent-type filter not even designed for retrieval, leaving them with few options for safe device removal. Although all of these patients can develop filter-related morbidity especially after chronic implantation, there is currently no routine option for removing embedded IVC filters refractory to standard retrieval methods. Our 5-year first-in-human study of a novel procedure—laser-assisted filter removal— demonstrates the safety and efficacy of this technique to treat such patients. In a cohort refractory to standard retrieval methods and high force, endovascular laser-assisted retrieval was overall safe and successful in removing a variety of filter types including permanent filters, regardless of dwell time and without the need for open surgery. (more…)
Author Interviews, Pediatrics, Race/Ethnic Diversity / 01.11.2016

MedicalResearch.com Interview with: Jennifer Howse, Ph.D. President of the March of Dimes Foundation MedicalResearch.com: What is the background for this study? What are the main findings? Response: The March of Dimes Premature Birth Report Card was created in 2007 to raise awareness of the unfair burden of preterm birth in certain communities and geographic areas in the United States. We also want to monitor progress, or lack of it, towards our goal to lower the national preterm birth rate to 8.1 percent by 2020 and to 5.5 percent by 2030. This year’s Report Card finds that, for the first time in eight years, the nation’s preterm birth rate did not decline – it worsened from 9.57 percent of all live births in 2014 to 9.63 percent in 2015, earning the nation a “C” grade. Seven states -- Arkansas, Connecticut, Idaho, Nebraska, New Mexico, Utah, and Wisconsin – received worse grades this year than last year on the Report Card. The March of Dimes strives for a world where every baby has a fair chance for a full-term pregnancy and a healthy birth, yet this is not the reality for many mothers and babies. The 2016 Report Card shows that babies in this country have different chances of surviving and thriving simply based on the circumstances of their birth. (more…)
ADHD, Author Interviews, Genetic Research, Pediatrics / 01.11.2016

MedicalResearch.com Interview with: Dr. Josephine Elia, M.D. Neuroscience Center Department of Child and Adolescent Psychiatry Nemours/Alfred I. DuPont Hospital for Children MedicalResearch.com: What is the background for this study? What are the main findings? Response: Glutamate neurotransmission may play an important role in ADHD and other neuropsychiatric disorders. The purpose of this study is to determine the frequency of genetic mutations involving specific genes (GRM network genes) which influence glutamatergic neurotransmission. A total of 23 study sites across the USA enrolled 1,013 children, aged 6-17 years who had been previously diagnosed with ADHD. Saliva samples were submitted to The Center for Applied Genomics (CAG) at CHOP for analysis of mutations of interest. Information on medical history, including other neuropsychiatric diagnoses and family history as well as areas of academic and social concern were also collected. Overall, the mutation frequency was 22%, with a higher prevalence of 25% observed in patients aged 6-12. When compared to mutation negative ADHD patients, the patients with the mutations of interest were more likely to have concerns about anger control and disruptive behaviors. (more…)
Accidents & Violence, Author Interviews, JAMA, Karolinski Institute, Mental Health Research / 01.11.2016

MedicalResearch.com Interview with: Zheng Chang PhD Dept. of Medical Epidemiology and Biostatistics Karolinska Institutet and Seena Fazel MD Department of Psychiatry Warneford Hospital University of Oxford, Oxford, England MedicalResearch.com: What is the background for this study? What are the main findings? Response: There were more than 10 million prisoners worldwide in 2015, with approximately 2.2 million in the United States alone. Despite reported decreases in violence in many countries, reoffending rates remain high. From 2005 through 2010, more than one-third of released prisoners in the United States and the United Kingdom were reconvicted of a new crime within 2 years. Most programs to reduce reoffending focus on psychosocial interventions, but their effect sizes are weak to moderate. As psychiatric and substance use disorders, which increase reoffending rates, are overrepresented among jail and prison populations. This study investigated the main psychotropic medication classes prescribed to prisoners using longitudinal Swedish population registers and examined the association between prescription of psychotropic medication and risk of violent reoffending. We found that three classes of psychotropic medications were associated with substantial reductions in violent reoffending: antipsychotics, a 42% reduction; psychostimulants, 38%; and drugs used in addictive disorders, a 52% reduction. The magnitudes of these associations were as strong as and possibly stronger than those for widely disseminated psychological programs in prison. (more…)
Author Interviews, JAMA, Pediatrics, Sleep Disorders, Technology / 01.11.2016

MedicalResearch.com Interview with: Dr Ben Carter PhD Senior Lecturer in Medical Statistics Statistics Editor for the Cochrane Skin Group (Honorary Associate Professor, Nottingham University) Institute of Primary Care and Public Health Cardiff University MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study leads from the growing use of mobile and media device use in children. We report the impact of devices leads to poorer sleep outcomes. MedicalResearch.com: What should readers take away from your report? Response: Using or even merely access to your mobile and media device should be restricted 90 minutes prior to bedtime. (more…)
Addiction, Author Interviews, CHEST, Toxin Research / 01.11.2016

MedicalResearch.com Interview with: Guy Soo Hoo, MD West Los Angeles VA Medical Center Los Angeles, CA MedicalResearch.com: What is the background for this study? What are the main findings? Response: Wound botulism occurs as a result of infection by material contaminated with C. botulinum. While typically associated with trauma and crush injury, it is also an infection associated with injection drug users especially with “skin popping”. Black tar heroin is an especially common vehicle for the development of wound botulism. Black tar heroin is the predominant form of heroin used in the western United States and there has been an epidemic of wound botulism cases associated with black tar heroin users especially in California. In fact, the vast majority of wound botulism cases in California occurs in injection drug users, specifically those who inject the drug subcutaneously or intramuscularly. The typical presentation in wound botulism in an acute neurologic illness with cranial nerve palsies, flaccid descending paralysis. Respiratory failure requiring mechanical ventilation may occur and may require an extended period of ventilator support for recovery. A high index of suspicion as well as general supportive care is needed for optimal treatment and recovery. Optimal treatment includes wound debridement, early administration of botulinum antitoxin and penicillin therapy. This case is unique in that the initial presentation was bilateral vocal cord paralysis and cranial nerve function was initially intact. The patient subsequently developed a flaccid paralysis that included cranial nerve palsies, functional quadriplegia and respiratory failure. He recovered to be discharged to a rehabilitation facility about six weeks after his initial presentation. (more…)
Author Interviews, Rheumatology / 01.11.2016

MedicalResearch.com Interview with: Marie Hudson, MD MPH FRCPC Jewish General Hospital and Lady David Research Institute Montreal, QC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Statins are widely used to treat hypercholesterolemia. In addition to their effect on cholesterol levels, statins also attenuate inflammation and have immunomodulatory properties. Whether this translates into meaningful differences in health outcomes, though, remains uncertain. We therefore undertook this study to determine whether people exposed to high doses of statins were at a lower risk of developing rheumatoid arthritis compared to those at lower doses. We studied a large population-based cohort of over half a million people exposed to statins for the first time and followed them on average for 3 years. We found that those exposed to the highest intensity statin quintile had a 33% lower risk of developing rheumatoid arthritis compared to those in the lowest intensity quintile (adjusted HR 0.77; 95% CI: 0.63-0.95). We conducted several additional secondary analyses that all pointed in the same direction and suggested that statins reduce the risk of rheumatoid arthritis. (more…)
Author Interviews, Exercise - Fitness, Heart Disease, Lifestyle & Health / 31.10.2016

MedicalResearch.com Interview with: Ulrik Wisløff, PhD Professor, Head of K.G. Jebsen Center for Exercise in Medicine Department of Circulation and Medical Imaging Norwegian University of Science and Technology Norway MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prolonged time spent sedentary on a daily basis is detrimental for general health and is associated with increased risk of developing and dying from lifestyle related diseases such as cardiovascular disease – even in those following todays advice for physical activity given by health authorities worldwide. Number of hours spent inactive tend to increase with increased age. A person’s fitness level is regarded the best predictor of future health. We tested, in older adults (aged 70-77 years old) whether meeting physical activity recommendations and/or having high age-specific fitness level attenuated the adverse effect of prolonged sedentary time on cardiovascular risk factor clustering. Main finding was that high age-specific fitness level fully attenuated the adverse effect of prolonged sedentary time on clustering of cardiovascular risk factors, independent of meeting the physical activity recommendation in older adults. (more…)
Author Interviews, Beth Israel Deaconess, Electronic Records, HIV / 31.10.2016

MedicalResearch.com Interview with: Douglas Krakower, MD Infectious Disease Division Beth Israel Deaconess Medical Center Boston, MA, MedicalResearch.com: What is the background for this study? What are the main findings? Response: There are 45,000 new HIV infections in the US annually, so effective HIV prevention strategies are needed. HIV pre-exposure prophylaxis (PrEP), whereby a person who is HIV-uninfected uses an HIV treatment medication on a daily basis to protect themselves from becoming infected with HIV, is over 90% effective when taken with high adherence. The Centers for Disease Control and Prevention estimates that there are 1.2 million Americans who are likely to benefit from using PrEP. However, only 80,000 persons have been prescribed PrEP. One of the barriers to implementing PrEP is that clinicians face challenges with identifying persons who are most likely to benefit from PrEP, given infrequent sexual health history assessments during routine clinical care. We thus sought to develop an automated algorithm that uses structured data from electronic health records (EHRs) to identify patients who are most likely to benefit from using PrEP. Our methods included extracting potentially relevant EHR data for patients with incident HIV and without HIV from nearly a decade of EHR data from a large ambulatory practice in Massachusetts. We then used machine learning algorithms to predict HIV infection in those with incident HIV and those without HIV. We found that some algorithms could offer clinically useful predictive power to identify persons who were more likely to become infected with HIV as compared to controls. When we applied these algorithms to the general population and identified a subset of about 1% of the population with risk scores above an inflection point in the total distribution of risk scores; these persons may be appropriate for HIV testing and/or discussions about PrEP. (more…)
Author Interviews, Gastrointestinal Disease, Kidney Stones / 31.10.2016

MedicalResearch.com Interview with: Dr. Hatim A. Hassan MD PhD Section of Nephrology, Department of Medicine The University of Chicago Chicago, IL 60637 MedicalResearch.com: What is the background for this study? Response: Nephrolithiasis is the second most prevalent kidney disease in USA after hypertension, with a rising prevalence and complications including advanced chronic kidney disease (CKD) and end stage renal disease (ESRD). It remains a major source of patient discomfort and disability, lost working days, and health-care expenditure, with an annual economic cost approaching $10 billion. Hyperoxaluria is a major risk factor for kidney stones (KS), and 70-80% of KS are composed of calcium oxalate. Urinary oxalate is an important determinant of supersaturation, and the risk for stone formation is affected by small increases in urine oxalate. Oxalate is a metabolic end product that cannot be further metabolized and is highly toxic. The mammalian intestine plays a crucial role in oxalate homeostasis, by regulating the amount of absorbed dietary oxalate and providing an avenue for enteric oxalate excretion. Anion exchanger SLC26A6 (A6)-mediated intestinal oxalate secretion plays a critical role in preventing hyperoxaluria and calcium oxalate kidney stones (COKS). Inflammatory bowel disease patients have a significantly increased risk of kidney stones due to the associated enteric hyperoxaluria. Obesity is a risk factor for KS and obese stone formers often have mild to moderate hyperoxaluria. Hyperoxaluria is also emerging as a major complication (developing in > 50% of patients) of bariatric surgery for obesity. With the rising prevalence of obesity and increased utilization of bariatric surgery, it is expected that the incidence of hyperoxaluria and related COKS (including the associated cost burden) will continue to increase at a significant rate. Primary hyperoxaluria (PH) is an inherited disease in which there is endogenous oxalate overproduction, which leads to recurrent KS and/or progressive nephrocalcinosis, ESRD, as well as significant hyperoxalemia, systemic oxalosis and premature death. Systemic deposition of calcium oxalate (oxalosis) leads to bone disease, cardiac arrhythmias, cardiomyopathy, skin ulcers, erythropoietin refractory anemia, and digital gangrene. The only treatment known to fully correct the underlying metabolic defect is liver transplantation or combined kidney-liver transplantation once ESRD develops. In addition, significant hyperoxalemia is also seen in ESRD. Cardiovascular diseases are the leading cause of morbidity and mortality in ESRD patients, and a recent report raised the possibility that the ESRD-associated hyperoxalemia might contribute to this increased risk. Lowering serum oxalate might improve cardiovascular outcomes in ESRD patients if these findings are confirmed. Unfortunately, there is currently no specific therapy that effectively lowers urine and/or plasma oxalate level(s), and the risk of recurrent COKS, nephrocalcinosis, oxalate nephropathy, ESRD, & systemic oxalosis remains substantial in the absence of treatment. (more…)
Author Interviews, Orthopedics, Pain Research, Smoking, Surgical Research / 31.10.2016

MedicalResearch.com Interview with: Dr. David Kusin MD University of Nebraska Medical Center Omaha MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is a wealth of research showing that cigarette smoking impairs healing through various mechanisms, including microvascular injury. Some evidence also suggests that tobacco use results in direct neurological injury to the peripheral and central nervous systems. Many studies have also shown that smoking reduces fusion rates and time to fusion in orthopedic surgery, including cervical surgery. Prior to our work, only a few high quality studies had been conducted to investigate prognostic factors in patients undergoing surgery for cervical myelopathy, and these identified smoking as a risk factor for a poorer outcome. The purpose of our study was to investigate this relationship further. We conducted a retrospective cohort study of 87 nonsmokers and 47 smokers and correlated postoperative change in Nurick score (a measure of severity of cervical myelopathy from 0-5 with 5 being the worst) with smoking status. After controlling for age, sex, diabetes, duration of preoperative symptoms, severity of preoperative symptoms, signal change on MRI, surgical approach, number of spinal levels operated on, and alcohol use, we found that smokers had a significantly decreased improvement in Nurick score. Nonsmokers improved by 1.5 points whereas smokers only improved by 0.6 points. We also found that this was a dose response relationship, such that those with a history of greater tobacco use by pack years or packs per day had a greater decrease in improvement postoperatively. Interestingly, we found no correlation between tobacco use and preoperative severity of symptoms. (more…)
Author Interviews, Cost of Health Care / 31.10.2016

MedicalResearch.com Interview with: Timothy M. Capstack, MD, FACP, SFHM Regional Medical Director, Physicians Inpatient Care Specialists, LLC (MDICS) Hanover MD MedicalResearch.com: What is the background for this study? What are the main findings? Response: Hospitalists—medical providers who provide medical care to hospital inpatients—have become a pervasive part of American medical care. Hospitalists with internal medicine training earn, on average, a little over twice as much as do physician assistants (PAs). The researchers studied the hospitalist staffing model of Physicians Inpatient Care Specialists (MDICS) hospitalists at a 384-bed community hospital in Annapolis, Maryland. MDICS used specifically trained and supported PAs working collaboratively with their physicians to see a large proportion of their patients rather than relying mainly or exclusively on physicians, as many groups do. MDICS believed that their model would provide equal quality of care while saving on salary costs. The MDICS expanded-PA model was compared with a conventional group of hospitalists who used mostly physicians to care for their inpatients. 16,964 inpatient hospitalizations were identified for study; 6,612 expanded-PA and 10,352 conventional patients were seen by the groups over the 18 months that were included. (more…)
Addiction, Author Interviews, Opiods, Pediatrics / 30.10.2016

MedicalResearch.com Interview with: Julie R Gaither, PhD, MPH, RN Postdoctoral Fellow in Biostatistics Yale School of Medicine MedicalResearch.com: What is the background for this study? Response: In light of the prescription opioid epidemic that has affected the adult US population in recent years, our objective with this study was to examine how hospitalization rates for prescription opioid poisonings have changed over time in the pediatric population. In addition, because prescription opioids are thought to be a precursor to illicit opioid use, we examined in older adolescents hospitalization rates for heroin overdose. In all children, we determined whether the poisoning was of an accidental nature or could be attributed to suicidal intent. To address these questions, we used the Kids’ Inpatient Database, a nationally representatives sample of pediatric hospital records released every three years, starting in 1997. (more…)
Author Interviews, Heart Disease, Surgical Research / 30.10.2016

MedicalResearch.com Interview with: Prof. Lars Wallentin MD Department of Medical Sciences, Cardiology Uppsala Clinical Research Center Uppsala University, Uppsala, Sweden MedicalResearch.com: What is the background for this study? Response: The FRISC2 study was performed 1996 – 1998 and reported 1999 for the first time a significant reduction in death and myocardial infarction by early invasive compared to non-invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). These pivotal results have been the basis for the current international treatment guidelines recommending an early invasive treatment strategy in patients with NSTE-ACS and elevated troponin and/or other indicators of a raised risk. Still there are remaining controversies concerning the long-term effects, the appropriate selection of patients for this approach and the opportunities for a more personalised approach to early invasive procedures. (more…)
Author Interviews, Breast Cancer, Vaccine Studies / 30.10.2016

MedicalResearch.com Interview with: Josef Singer MD, PhD Comparative Medicine Messerli Research Institute of the University of Veterinary Medicine Medical University Vienna University Vienna, Austria & Department for Comparative Immunology and Oncology Institute of Pathophysiology and Allergy Research Medical University Department of Internal Medicine II University Hospital Krems Karl Landsteiner University of Health Sciences Krems, Austria  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Immunotherapy of cancer has gained increasing interest in treatment of oncologic patients. Especially passive immunotherapy with monoclonal antibodies against tumor-associated antigens has been very successful due to good response rates with relatively moderate side effects compared to conventional chemotherapy. Trastuzumab, an antibody against the human epidermal growth-factor receptor-2 (HER-2), is widely applied for the treatment of metastatic breast cancer. Trastuzumab leads to longer progression-free and overall survival in patients with HER-2 positive disease. However, monoclonal antibody therapies have to be repetitively applied, which represents a risk for infusion-related side effects and, due to the high costs, a massive burden for social security systems. Our aim was to replace the passive immunotherapy by a vaccine actively inducing patients´ own antibodies with the same specificity as trastuzumab. A novel mimotope library platform enabled the development of a HER2-specific cancer vaccine: Mimotopes are small peptides that are able to mimic antibody epitopes on tumor-associated antigens, in our case the trastuzumab antigen on HER-2. We use Adeno-associated-viruses (AAV) as carriers for our HER2 vaccine as they are highly immunogenic and safe. We could demonstrate that this HER-2 mimotope AAV-vaccine induced antibodies against human HER- 2 similar to the clinically used trastuzumab. In a mouse tumor model the HER-2 mimotope AAV vaccine was able to delay the growth of tumors significantly. (more…)
Author Interviews, Colon Cancer, JAMA / 30.10.2016

MedicalResearch.com Interview with: Fausto Petrelli, MD Oncology Unit, Oncology Department Treviglio ,Italy MedicalResearch.com: What is the background for this study? What are the main findings? Response: This meta-analysis evaluated if side (excluding rectum site) represents an independent prognostic factor for survival in patients with stages 1-4 colon cancer. This variable is in fact associated with an adverse outcome with a reduced risk of death by 20% if patients are affected by a left colon cancer compared to those with right colon cancers. Implications are enormous: for prognosis first but also for follow-up, stratification into clinical trials and treatment (for both medical and surgical therapies). The power of the study is relevant: it enclosed 66 studies with more than 1 million of patients retrospectively or prospectively analyzed for survival according to common variables known to be prognostic in colorectal cancer (age, sex, stage, race, adjuvant CT..etc) in multivariate analysis. Side is significantly associated with survival independent of other covariates analyzed. The question of the side is old and partially known, but no study systematically explored the published literature to confirm this suggestion. Recent large randomized trials in metastatic disease showed different results according to the site of disease with right colon cancers usually less responsive to anti-EGFR treatment due to a different molecular behavior and conversely left colon cancers which attained the greater benefit from cetuximab and panitumumab due to less BRAF mutations in their tissue. Also, a less extensive and radical lymphadenectomy in right-sided cancers, without a complete mesocolon excision during surgery, could hamper their cure rate, as our colorectal surgeon's team lead by Prof. Giovanni Sgroi and Luca Turati MD, suggested in the discussion. It is also well known the leads term bias with a later diagnosis of right cancers due to clinical and anatomic reasons. (more…)
Author Interviews, Heart Disease, JACC, Medical Imaging / 29.10.2016

MedicalResearch.com Interview with: Kristina H. Haugaa, MD, PhD, FESC Ida Skrinde Leren MD, PhD Department of Cardiology and Center for Cardiological Innovation, Oslo University Hospital, Rikshospitalet Oslo, Norway MedicalResearch.com: What is the background for this study? Response: Arrhythmogenic right ventricular cardiomyopathy (ARVC) is an inheritable cardiomyopathy, predisposing to life-threatening arrhythmias. Ventricular arrhythmias are frequent in ARVC patients and importantly, arrhythmias may occur also before evident structural changes are seen, making risk stratification challenging. Additional tools are needed to detect early disease and to optimize medication and timing of implantation of a cardioverter defibrillator (ICD). We aimed to explore early markers of ARVC disease and their association with previous ventricular arrhythmias. (more…)
Author Interviews, Endocrinology, Hormone Therapy, JCEM / 29.10.2016

MedicalResearch.com Interview with: Mario Philip Reyes Festin, MD World Health Organization Geneva, Switzerland.  MedicalResearch.com: What is the background for this study? Response: Researchers are trying to identify a hormonal male contraceptive that is effective, reversible, safe, acceptable, affordable, and available. Most of the research has been done either by groups of university researchers. However, in the 1990s, WHO undertook two multi-center, multinational studies. The studies were unable to provide evidence to support the development of a commercially viable, and user-acceptable product. (more…)
Author Interviews, Heart Disease, JACC, Surgical Research / 28.10.2016

MedicalResearch.com Interview with: Anna Franzone, MD and Prof.Thomas Pilgrim, MD Department of Cardiology Bern University Hospital INSELSPITAL Bern, Switzerland MedicalResearch.com: What is the background for this study? What are the main findings? Response: Surgical aortic valve replacement is the therapeutic standard for patients with pure native aortic regurgitation (AR). However, transcatheter aortic valve implantation (TAVI) is emerging as a novel treatment option for patients deemed inoperable or at high-risk for surgery because of advanced age and multiple comorbidities. We performed a systematic review and meta-analysis including 237 patients with pure native AR undergoing TAVI across 13 studies. The primary study endpoint, all-cause mortality at 30-day, ranged from 0% up to 30% with a summary estimate rate of 7% . The occurrence of complications such as the need for a second valve implantation was relatively low as well as the rates of other endpoints (cerebrovascular events, major bleeding and vascular complications). (more…)
Author Interviews, Biomarkers, Cancer, Cancer Research, University of Pennsylvania / 28.10.2016

MedicalResearch.com Interview with: Eric Ojerholm, MD Resident, Radiation Oncology Hospital of the University of Pennsylvania MedicalResearch.com: What is the background for this study? Response: Multiple studies reported that a blood test —the neutrophil-to-lymphocyte ratio (NLR)—might be a helpful biomarker for bladder cancer patients. If this were true, NLR would be very appealing because it is inexpensive and readily available. However, previous studies had several methodological limitations. MedicalResearch.com: What did you do in this study Response: We therefore put NLR to the test by performing a rigorous “category B” biomarker study—this is a study that uses prospectively collected biomarker data from a clinical trial. We used data from SWOG 8710, which was a phase III randomized trial that assessed surgery with or without chemotherapy for patients with muscle-invasive bladder cancer. We tested two questions. First, could NLR tell us how long a bladder cancer patient would live after curative treatment? Second, could NLR predict which patients would benefit from chemotherapy before surgery? (more…)