Blog – Medical Research News and Interviews
10 Dec Reduction of Surgical Resident Duty Hours Resulted In No Change In Outcomes
MedicalResearch.com Interview with:
Ravi Rajaram MD
Division of Research and Optimal Patient Care, American College of Surgeons Surgical Outcomes and Quality Improvement Center (SOQIC), Department of Surgery and Center for Healthcare Studies in the Institute for Public Health and Medicine
Feinberg School of Medicine, Northwestern University, Chicago, Illinois
Medical Research: What is the background for this study? What are the main findings?
Dr. Rajaram: The Accreditation Council for Graduate Medication Education (ACGME) first implemented restrictions to resident duty hours in 2003. In surgical populations, these reforms have not been associated with a change in patient outcomes.
However, in 2011, the ACGME further restricted resident duty hours to include: a maximum of 16 hours of continuous duty for first-year residents (interns), direct supervision of interns at all times, a maximum of 4 hours for transitions in care activities for residents in-house for 24 hours, and that these residents be given 14 hours off prior to returning to work. The association between the 2011 ACGME resident duty hour reform with surgical patient outcomes and resident education has not previously been reported.
The 2011 resident duty hour reform was not associated with a change in death or serious morbidity in the two years after the reform was implemented. Additionally, the 2011 duty hour reform was not associated with a change in any of the secondary outcomes examined, including any morbidity, failure to rescue, surgical site infection, and sepsis.
Furthermore, common measures of surgical resident education, such as in-training examination scores and board certification pass rates, were unchanged after the implementation of the 2011 duty hour reform when compared to scores prior to the reform.
10 Dec Few Physicians Are Bilingual Despite Growing Need
MedicalResearch.com Interview with:
Lisa Diamond, MD, MPH, FACP | Assistant Attending
Memorial Sloan-Kettering Cancer Center
Immigrant Health and Cancer Disparities Service
Department of Psychiatry & Behavioral Sciences | Department of Medicine Evelyn Lauder Breast Center New York, NY 10065
Medical Research: What is the background for this study? What are the main findings?
Dr. Diamond: More than 25 million U.S. residents have limited English proficiency, an 80 percent increase from 1990 to 2010. Limited English proficiency (LEP) may impede participation in the English language-dominant health care system. Little is known about the non-English-language skills of physicians in training. In our analysis of the non-English-language skills of applicants to residency programs in the U.S., we found that although applicants are linguistically diverse, most of their languages do not match the languages spoken by the U.S. population with Limited English proficiency.
10 Dec Preeclampsia Raises Risk of Autism Spectrum Disorder
MedicalResearch.com Interview with:
Cheryl K. Walker, MD
Associate Professor
Department of Obstetrics & Gynecology
Faculty, The MIND Institute
School of Medicine, University of California, Davis
Medical Research: What is the background for this study? What are the main findings?
Dr. Walker: Autism spectrum disorder (ASD) is a neurobehavioral condition identified in 1 in 68 U.S. children and is part of a broader group of developmental disabilities that affects 1 in 6 children. Growing evidence suggests that Autism spectrum disorder and developmental delay originate during fetal life. Preeclampsia is a complicated and frequently dangerous pregnancy condition that appears to arise from a shallow placental connection and may increase the risk of abnormal neurodevelopment through several pathways.
Medical Research: What are the main findings?
Dr. Walker: Children with Autism spectrum disorder were more than twice as likely to have been exposed to preeclampsia compared with children with typical development. Risk for ASD was increased further in children born to mothers with more severe presentations of preeclampsia. Mothers of children with developmental delay were more than 5 times more likely to have had severe forms preeclampsia – often with evidence of reduced placental function – compared with mothers of children with typical development.
09 Dec Ultrasonography For All Dense Breasts Not Cost Effective
MedicalResearch.com Interview with:
Brian L. Sprague, PhD
Office of Health Promotion Research,
University of Vermont, Burlington, VT
MedicalResearch: What is the background for this study?
Dr. Sprague: Mammographic breast density refers to the appearance of breast tissue on a mammogram. High breast density means that there is a greater amount of glandular tissue and connective tissue, which appears white on a mammogram. It is more difficult to detect breast cancer on a mammogram when there is greater breast density. It has also been shown that women with dense breasts are at a higher risk of developing breast cancer. Because of these two factors, women with dense breasts have a greater chance of developing breast cancer after a normal screening mammogram than women whose breasts are not dense. Many states have now passed laws that require mammography facilities to inform women with dense breasts so that they are aware of this. Similar legislation is now under consideration at the national level. More than 40% of women undergoing mammography screening have dense breasts.
Researchers are trying to determine whether supplemental breast cancer screening with other tools would improve outcomes for women with dense breasts. One possible approach is to use ultrasound imaging to screen for breast cancer in women with dense breasts after they have had a normal mammogram. We wanted to estimate the benefits, harms, and cost-effectiveness of this approach compared to mammography screening only. No randomized trials or observational studies have assessed long term outcomes after ultrasound screening for women with dense breasts, but we have short term data on how often cancer is diagnosed by ultrasound screening and how often false positive exams occur. We used computer simulation modeling to estimate long term outcomes by combining the currently available data on mammography and ultrasound screening with the best available data on breast cancer risk and survival.
09 Dec Chromosomal Location of Exceptional Memory Identified
MedicalResearch.com Interview with:
Sandra Barral Rodriguez, Ph.D
Assistant Professor
G. H. Sergievsky Center & Taub Institute
Columbia University Medical Center
New York, NY 10032
Medical Research: What is the background for this study? What are the main findings?
Dr. Barral: We already know that there is a substantial genetic contribution to the variability observed in different cognitive tasks including memory performance. Previous work reported heritability estimates for episodic memory ranging between 30% and 60%. However, we can’t fully explain why some individuals demonstrate a better memory performance in late life, while others do not.
We have previously defined a cognitive endophenotype based on exceptional episodic memory performance (EEM) and demonstrated that there is a familial aggregation of EEM in families selected on their basis of their exceptional survival, the Long Life Family Study. We performed genome-wide linkage analysis of long-lived families selected on the basis of their exceptional episodic memory and the follow-up SNP association analysis with episodic memory in four independent cohorts of more than 4,000 non-demented elderly cohorts.
Our results provide strong evidence for potential candidate genes related to exceptional episodic memory on 6q24.
09 Dec Distance To Hospital Prevents Timely PCI and Lytic Therapy For Many Patients
MedicalResearch.com Interview with:
Dr. Amit Navin Vora MD, MPH
Third Year Cardiovascular Fellow
John Hopkins University
Medical Research: What is the background for this study? What are the main findings?
Response: Current guidelines recommend timely reperfusion in patients presenting with ST-elevation myocardial infarction, with primary PCI being the preferred method if delivered in an expedient fashion. Otherwise, guidelines recommend that eligible patients should be treated with fibrinolysis prior to transfer to a PCI capable hospital. In our study, we used Google Maps to estimate drive times between the initial presenting hospital and the PCI-capable hospital looked at the association between estimated drive time and reperfusion strategy (primary PCI or fibrinolysis) selection.
We found that less than half of eligible patients with an estimated drive time of more than 30 minutes received primary PCI in time, and only half of patients with more than an hour’s drive received lytics before transfer. This suggests that neither primary PCI nor pre-transfer fibrinolytic therapy is being used optimally. Among eligible patients with a drive time of 30-120 minutes, we found no significant mortality difference but higher bleeding risk among patients receiving lytics prior to transfer; this increased bleeding risk was focused in patients that required rescue PCI.
09 Dec Perspective on ER Residents Work Hour Regulations
MedicalResearch.com Interview with:
Catherine A. Marco, MD, FACEP Professor
Department of Emergency Medicine
Wright State University
Kettering, OH 45429
Medical Research: What is the background for this study? What are the main findings?
Dr. Marco: In 2003, the Accreditation Council for Graduate Medical Education (ACGME) implemented standards on duty hours and supervision. A maximum of 80 hours of duty per week were stipulated. The aim of these standards was to promote resident learning and patient safety. However, evidence has not clearly demonstrated whether the 2003 requirements improved trainee well-being or patient safety. On July 1, 2011, the ACGME implemented additional regulations on duty hours and supervision, including a 16 hour maximum shift length for PGY1 residents. The duty hours standards were implemented to ensure patient safety and provide an excellent teaching environment. Emergency Medicine has additional duty hours requirements for emergency department rotations, including a maximum of 12 continuous scheduled hours, and a maximum 60 scheduled hours per week seeing patients in the emergency department, and no more than 72 duty hours per week.
We found that among a large cohort of 4134 Emergency Medicine residents, the majority of residents stated that they are working the appropriate number of hours to practice independently at graduation. The majority of residents believe that current duty hours regulations improve patient safety. The majority of residents agreed that duty hour regulations are currently appropriate.
09 Dec Ferric Citrate – Auryxia™ – Demonstrates Safety and Cost Savings in Dialysis Patients
MedicalResearch.com Interview with:
Dr. Julia Lewis, MD, Lead Investigator
Nephrologist and Professor of Medicine
Vanderbilt University Medical Center
Medical Research: What is the background for this study? What are the main findings?
Dr. Lewis: The 48-week Open Label Extension (OLE) study for Auryxia™ (ferric citrate) was conducted to determine long term safety following the Phase 3 52-week active-control period. The study also evaluated changes in serum phosphorus, transferrin saturation (TSAT), serum ferritin, hemoglobin, hematocrit and additional parameters, as well as intravenous (IV) iron and erythropoiesis-stimulating agent (ESA) usage.
In the OLE study, Auryxia demonstrated long-term safety in dialysis-dependent chronic kidney disease (CKD) patients. The results were consistent with those seen in the published pivotal Phase 3 trial.
The study demonstrated that the adverse events (AE’s) profile of Auryxia was similar to that seen in the Phase 3 52-week active-control period. AEs occurred in 142 patients treated with Auryxia. They were primarily non-serious gastrointestinal (GI) - related AE’s, including diarrhea, nausea, vomiting and constipation. Serious adverse events occurred in 75 patients, though none were related to Auryxia. In addition, there were no clinically or statistically significant differences in liver enzymes or aluminum levels observed from baseline to the end of the 48 weeks.
Similar to the original trial, we witnessed excellent phosphorus control with the drug, along with an increase and then a plateau in serum ferritin and TSAT levels with Auryxia. The plateauing of serum ferritin and TSAT further supports iron absorption is highly regulated by the gastrointestinal track as seen in the 52-week active control period. This suggests that the body absorbs iron as needed for effective erythropoiesis.
Additionally, iron store increases from ferric citrate resulted in, by the end of the extension study, 85% of subjects not using any IV iron.
We presented this data at the 2014 American Society of Nephrology Meeting. The abstract can be found online at www.asn-online.org.
08 Dec CT Scan May Predict Risk of Second Stroke
MedicalResearch.com Interview with Jeff Perry, MD, MSc, CCFP-EM Associate Professor, Department of Emergency Medicine Senior Scientist, Ottawa Hospital Research Institute Research Chair in Emergency Neurological Research, University of Ottawa Emergency Physician, Epidemiology Program, The Ottawa Hospital, Ottawa, Ontario Medical Research: What is the background for this study? What are the main findings? Dr. Perry: Currently many patients with a TIA or non-disabling stroke have a subsequent stroke which may be very disabling or result in death prior to having all investigations completed and maximal stroke prevention implemented. Prior to this study, the utility of CT findings for predicting subsequent stroke was incompletely understood in this patient population. Dr. Perry: Main findings: Compared to patients without ischemia, the probability of another stroke occurring within 90 days of the initial episode was:- 2.6 times greater if the CT image revealed newly damaged tissue due to poor circulation (acute ischemia);
- 5.35 times greater if tissue was previously damaged (chronic ischemia) in addition to acute ischemia;
- 4.9 times greater if any type of small vessel damage occurred in the brain, such as narrowing of the small vessels in addition to acute ischemia;
- 8.04 times greater if acute and chronic ischemia occurred in addition to microangiopathy.
07 Dec Diabetes and Cardiovascular Disease Share Several Key Driver Genes
MedicalResearch.com Interview with:
Simin Liu, MD, ScD, Professor of Epidemiology
School of Public Health, Professor of Medicine
The Warren Alpert School of Medicine
Director, Molecular Epidemiology and Nutrition
Brown University
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Liu: Cardiovascular Disease (CVD) and type 2 diabetes (T2D) are highly heritable and share many risk factors and show ethnic-specific prevalence. Nevertheless, a comprehensive molecular-level understanding of these observations is lacking. We conducted a comprehensive assessment of whole genome assessment using network-based analysis in >15,000 women and identified eight molecular pathways share in both diseases as well as several “key driver” genes that appear to form the gene networks in which these pathways connect and interact.
07 Dec Few Diabetics Participate in Diabetes Self-management Education and Training
MedicalResearch.com Interview with Dr. Rui Li, PhD Division of Diabetes Translation National Center for Chronic Disease Prevention and Health Promotion CDC Medical Research: What is the background for this study? What are the main findings? Dr. Li: Diabetes is a serious disease associated with severe complications and premature death. Diabetes Self-management Education and Training (DSMT) helps patients improve blood sugar control, which could reduce the risk for diabetes complications, hospitalizations, and health care costs. However, data showed that fewer than 7% of persons with private health insurance received DSMT within 1 year after diagnosis with diabetes. Furthermore, across different population subgroups, DSMT participation rates were less than 15%.06 Dec Reversing Blindness With A Wireless Nanotube System
MedicalResearch.com Interview with: Lilach Bareket School of Electrical Engineering, ‡Tel Aviv University Center for Nanoscience and Nanotechnology, and ⊥School of Chemistry, Tel Aviv University, Tel Aviv 69978, Israel Medical Research: What is the background for this study? Response: Neuro-prosthetic devices aim to restore impaired function through artificial stimulation of the nervous system. Visual prosthetic devices, operating by light activation of neurons, are presently developed as an approach to treat blindness. In particular, in the case of patients suffering from age-related macular degeneration in which the photoreceptors in the retina degenerate.06 Dec Staggering Number of Hospital Monitors Leads to Alarm Fatigue
MedicalResearch.com Interview with:
Barbara J. Drew, RN, PhD, FAAN, FAHA
David Mortara Distinguished Professor in Physiological Nursing Research, Clinical Professor of Medicine, Cardiology
University of California, San Francisco (UCSF)
Department of Physiological Nursing San Francisco
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Drew: Hospital cardiac monitors are plagued with alarms that create a cacophony of sounds and visual alerts causing “alarm fatigue” which creates an unsafe patient environment because a life-threatening arrhythmia may be missed in this milieu of sensory overload. Our study is the largest prospective study to date on the alarm fatigue problem. We found a staggering total number of alarms (>2,500,000 in one month) in 461 consecutive patients treated in our 77 adult intensive care unit beds. Although many of these alarms were configured to be visual text messages, we still found a high audible alarm burden of 187 audible alarms per bed per day. A noisy alarm environment interrupts patients’ sleep and invokes fear in patients and their families. We analyzed nearly 13,000 arrhythmia alarms and found that 88% of them were false alarms.
05 Dec Concussions Raise Risk of PTSD, Depression and Anger in Returning Military Personnel
MedicalResearch.com Interview with: James L . Spira, PhD, MPH, ABPP Professor, Department of Psychiatry, John A Burns School of Medicine, University of Hawaii Director, National Center for PTSD, Department of Veterans Affairs, Pacific Islands Division Medical Research: What is the background for this study? Dr. Spira: Approximately 1.5 million Americans survive a traumatic brain injury (TBI) from traffic accidents, assaults, sports, and work injuries, with the vast majority of these being primarily mild (mTBI), otherwise known as concussion.1 Concussion, however, is uniquely problematic in the military given the new strategies of war encountered by service members when fighting an insurgency using improvised explosive devices. The rate of concussion experienced by United States (U.S.) service members engaging in combat during the wars in Afghanistan and Iraq has been estimated at between 15% and 22%.2–4There has been controversy in the area of neurotrauma as to whether persistent postconcussive symptoms (PPCSx) are due to neurological causes or solely due to the psychological sequelae of having been exposed to a traumatic event. The recent wars in Iraq and Afghanistan have afforded an opportunity to examine these factors, although teasing them apart has proven difficult. The most influential study of persistent effects of concussion in service members is that of Hoge and colleagues,5 in which they failed to find an independent effect of prior concussion on PPCSx, once depression and posttraumatic stress (PTSD) was taken into account. They went so far as to recommend that assessment for concussion following deployment is unnecessary. Others, however, have reported persistent cognitive, emotional, and physical symptoms following concussion.05 Dec Sleep Apnea Predicts Atrial Fibrillation after CABG
MedicalResearch.comInterview with: Amro Qaddoura BHSc Research Student of Adrian Baranchuk, MD Department of Medicine, Queen's University, Kingston, Ontario, Canada MedicalResearch: What is the background for this study? What are the main findings? Response: This publication was a letter to the editor in response to comments on our recent systematic review and meta-analysis that showed...
05 Dec Genes Influence Body Weight in Smokers and Never-Smokers
MedicalResearch.com Interview with:
Marcus Munafò PhD
Professor of Biological Psychology
MRC Integrative Epidemiology Unit
UK Centre for Tobacco and Alcohol Studies
School of Experimental Psychology
University of Bristol United Kingdom
Medical Research: What is the background for this study? What are the main findings?
Dr. Munafo: We were conducting an analysis of data on smoking behaviour and body mass index (BMI), in order to better understand the potential causal effects of smoking on different measures of adiposity. Mendelian randomisation uses genetic variants associated with the exposure of interest (in this case smoking) as proxies for the exposure, in order to reduce the risk of spurious associations arising from confounding or reverse causality. As expected, we found that, among current smokers, a genetic variant associated with heavier smoking was associated with lower BMI, providing good evidence that smoking reduces BMI. However, we also unexpectedly found that the same variant was associated with higher BMI in never smokers. This suggests that this variant might be influencing BMI via pathways other than smoking.
05 Dec Gene Network Linked To Lifetime Alcohol Consumption
MedicalResearch.com Interview with: R. Dayne Mayfield PhD and Sean Farris Post Doc Fellow Harris Lab Waggoner Center for Alcohol and Addiction Research University of Texas at Austin MedicalResearch: What is the background for this study? Response: Alcoholism is psychiatric disorder adversely affecting the health of millions of individuals worldwide. Despite considerable research efforts, alcoholism cannot be attributed to any individual gene. We sought out to identify coordinately regulated gene networks, rather than a single candidate gene, that may be collectively driving the consumption of alcohol.05 Dec Increased Breastfeeding Would Reduce Morbidities and Costs
MedicalResearch.com Interview with Rosemary Dodds Senior Policy Adviser NCT (formerly National Childbirth Trust), London, UK Medical Research: What is the background for this study? What are the main findings? Response: The study, which was commissioned by UNICEF UK, was designed to take an in-depth look at how raising breastfeeding rates might save money for the health service through reducing illness. It found that low breastfeeding rates in the UK are costing the health service millions of pounds. We calculated that from reducing rates of illnesses, where the evidence is strongest, moderate increases in breastfeeding could see potential annual savings to the health service of around £40m per year. It should be noted however, that this figure is likely to be only the tip of the iceberg when the full range of conditions affected by breastfeeding are taken into account. Economic models around five illnesses (breast cancer in the mother, and gastroenteritis, respiratory infections, middle ear infections and necrotising enterocolitis (NEC) in the baby), show that moderate increases in breastfeeding would translate into the following cost savings for the NHS:- If half those mothers who currently do not breastfeed were to do so for up to 18 months over their life, there would be:
- If 45% of babies were exclusively breastfed for four months, and if 75% of babies in neonatal units were breastfeeding at discharge, each year there would be:
05 Dec Investigating Role of Cold Viruses in Acute Asthma Attacks
MedicalResearch.com Interview with: Katarzyna Niespodziana, PhD and Rudolf Valenta, MD Division of Immunopathology, Department of Pathophysiology and Allergy Research,Medical University of Vienna, Austria MedicalResearch: What is the background for this study? What are the main findings? Response: Infections with the common cold virus (Rhinovirus, RV) are in fact a major trigger factor for acute exacerbations of asthma and COPD (chronic obstructive pulmonary disease). An attack can also lead to the worsening of the underlying disease. In previous studies we have found that although the human body produces antibodies against rhinoviruses, these are not directed against the surface structures on the virus which the virus uses to infect host cells and therefore do not protect against infection. In the framework of the EU project "Predicta”, we have collaborated with investigators from London and published in EBioMedicine a novel study which shows for the first time that increases of antibodies against a portion of the rhinovirus coat protein VP1 might be strain-specific surrogate markers for the severity of rhinovirus-induced respiratory symptoms. In this work, asthma patients and healthy subjects were infected with the rhinovirus under controlled conditions. Results of the subsequent antibody tests with recombinant virus antigens showed that the asthmatics that experienced the most severe respiratory symptoms upon infections produced significantly higher antibodies to a part of the structure protein VP1, than any of the subjects with mild or no symptoms.05 Dec Mediterranean Diet May Delay Telomere Shortening, Increase Longevity
MedicalResearch.com Interview with:
Immaculata De Vivo PhD
Associate Professor Harvard Medical School
Director, Dana Farber/Harvard Cancer Center High Throughput Genotyping Core
Facility. Channing Division of Network Medicine
Boston, MA 02115
MedicalResearch: What is the background for this study? What are the main findings?
Dr. De Vivo: Our study found that greater adherence to the Mediterranean diet is associated with longer telomeres. Following a diet closer to the Mediterranean diet, can prevent accelerated telomere shortening. Our unique contribution to the literature is that we provide a potential molecular mechanism, preventing telomere shortening. Telomeres are bits of DNA that protect your chromosomes.
MedicalResearch: Is telomere shortening reversible?
Dr. De Vivo: Telomere shortening is a biological process, the shorten with age.
However, lifestyle choices can help to prevent accelerated shortening.
Fruits, vegetables, olive oil and nuts – key components of the Mediterranean diet have well known antioxidant and anti-inflammatory effects that could balance out the “bad effects” of smoking and obesity.
04 Dec Antacid Medications May Improve Head/Neck Cancer Survival
MedicalResearch.com Interview with:
Silvana Papagerakis M.S., M.D., Ph.D.
Research Assistant Professor, Department of Otolaryngology-Head and Neck Surgery
Director, Oral, Head and Neck Cancer Invasion and Metastasis Laboratory, Ann Arbor MI
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Papagerakis: We had suspicions that these medications somehow had a favorable impact on patient outcomes. This led us to review our large cohort of patients and screen them for common medications, focusing on antacids. In fact, our study did show that people taking antacids are doing better. What this study makes clear is that these medications may be more beneficial to the patients than just controlling side effects of chemotherapy or radiation treatment for head and neck cancer.
04 Dec Traumatic Brain Injury: Link Between Cognitive Reserve and Long-Term Memory Impairment
MedicalResearch.com Interview with
Joshua Sandry, Ph.D.
Neuropsychology & Neuroscience Research
Kessler Foundation, West Orange, NJ
Assistant Professor, Department of Physical Medicine and Rehabilitation
Rutgers New Jersey Medical School
Medical Research: What is the background for this study? What are the main findings?
Dr. Sandry: We were interested in better understanding the relationship between cognitive reserve and long-term memory impairment in moderate to severe Traumatic Brain Injury, from a cognitive perspective. The theory of cognitive reserve suggests that individuals who engage in intellectually enriching activities may be less susceptible to the negative cognitive consequences of long-term memory impairment that often accompanies neurological disorders. There’s significant evidence in support of cognitive reserve; however, it’s somewhat unclear what particular cognitive processes are involved in this relationship and how those cognitive processes may differ across high and low reserve individuals. We derived our predictions on the basis of well-established cognitive theory and found that working memory capacity partially mediates the cognitive reserve – long-term memory relationship in Traumatic Brain Injury. Or to put it another way, working memory may be one underlying cognitive process involved in this relationship. Importantly, this finding corroborates some recent related work we have conducted in multiple sclerosis.
04 Dec Meniscal Knee Surgery May Accelerate Arthritis and Cartilage Loss
MedicalResearch.com Interview with:
Frank W. Roemer, MD
Associate Professor of Radiology
Co-Director, Quantitative Imaging Center (QIC), Department of Radiology Boston University School of Medicine
and Associate Professor of Radiology, University of Erlangen-Nuremberg, Germany
Medical Research: What is the background for this study? What are the main findings?
Dr. Roemer: Meniscal surgery is one of the most common orthopedic procedures performed in order to alleviate pain and improve joint function. However, increasing evidence is emerging that suggests that meniscal resection is detrimental for knee joint preservation including accelerated rates of OA and joint deterioration defined as cartilage loss. Our study focuses on disease onset and shows that structural damage due to surgery might also be observed in these early stages of disease. In light of this the indications for performing meniscal surgery might need to be defined more stringently as is the case today in order to preserve joint structure in the long term.
04 Dec Monoclonal Idarucizumab Antibody May Reverse Dabigatran Anticoagulation
Posted at 04:22h
in Heart Disease
MedicalResearch.com Interview with:
Dr. Joanne van Ryn, PhD
Department of CardioMetabolic Disease Research
Boehringer Ingelheim GmbH & Co., Germany
MedicalResearch: What is the background for this study? What are the main findings?
Response: Idarucizumab is a humanized antibody fragment, or Fab, being investigated as a specific antidote to reverse the anticoagulant effect of dabigatran. Currently, there are no specific antidotes available for any of the newer oral anticoagulants, or NOACs, to complement the existing range of bleed management options during critical care situations. Idarucizumab is being developed to provide physicians with an additional therapeutic option they could consider should a patient require emergency intervention or if a patient experiences uncontrolled bleeding.
Pre-clinical studies indicated idarucizumab binds specifically to and inhibits dabigatran. Phase I data with idarucizumab in healthy volunteers demonstrated the potential of idarucizumab to achieve immediate, complete and sustained reversal of dabigatran-induced anticoagulation. In that placebo-controlled study, idarucizumab did not cause any clinically relevant side effects.
This phase I sub-study in 35 healthy volunteers showed that idarucizumab restores dabigatran-induced inhibition of fibrin formation at a small wound site. Fibrin, the main component of a blood clot, was assessed by measuring levels of fibrinopeptide A (FPA), a substance that is released when fibrin is formed. Fibrin formation was assessed after a small scratch, similar to a paper cut, was made. Measurements were conducted at baseline, after administration of dabigatran, and after subsequent administration of idarucizumab or placebo. The results showed that dabigatran almost completely inhibited the production of FPA at the wound site, and that idarucizumab restored FPA production:
- At baseline, before the volunteers took dabigatran, the average level of FPA was 3981 ng/mL.
- On day three, 2.5 hours after the volunteers took dabigatran, the average level of FPA was 208 ng/mL, an approximate 95 percent decrease compared to baseline.
- On day four, 2.5 hours after the volunteers took dabigatran and 30 minutes after they were infused with 1 g, 2 g or 4 g of idarucizumab, FPA levels were 24 percent, 45 percent and 95 percent, respectively, of the average baseline level.
04 Dec Dabigatran vs Warfarin in Non-Valvular Atrial Fibrillation
Posted at 03:08h
in Heart Disease
MedicalResearch.com Interview with:
Dr. John Seeger, PharmD, DrPH
Department of Medicine, Brigham and Women’s Hospital
Dr. Seeger: What is the background for this study? What are the main findings?
Response: This study is part of an ongoing research program initiated in 2013 to assess prescribing patterns and real-world safety and effectiveness of oral anticoagulants, including dabigatran, for the reduction of stroke risk. The study program is expected to run through the end of 2016. Boehringer Ingelheim and Brigham and Women’s Hospital are aiming to gather data from more than 100,000 U.S. NVAF patients.
Using a sequential matched cohort design, the safety and effectiveness of dabigatran compared to warfarin among patients with non-valvular atrial fibrillation (NVAF) receiving these medications in routine care settings can be assessed periodically. The interim findings at this stage come from 38,378 non-valvular atrial fibrillation patients in two health insurance databases, MarketScan (31,058 patients) and UnitedHealth (7,320 patients). The primary analysis follows patients from start of therapy until a switch or discontinuation of the anticoagulant, an outcome event, or disenrollment. The average follow-up was five months for patients in the dabigatran group and four months for those taking warfarin. The primary outcomes measured in the analysis are stroke and major hemorrhage.
Interim findings from the combined databases showed a 25 percent reduction in the rate of major hemorrhage (hazard ratio [HR] 0.75, 95 percent confidence interval [CI] 0.65-0.87, 354 vs. 395 events) and a 23 percent reduction in strokes (HR 0.77, CI 0.54-1.09, 62 vs 69 events) for dabigatran compared to warfarin among these patients with NVAF. The database-specific results indicate a reduction in the rate of major hemorrhage with dabigatran (MarketScan: HR 0.78, CI 0.67- 0.91; UnitedHealth: HR 0.56, CI 0.36-0.86). In the larger MarketScan database, dabigatran reduced the stroke rate by 36 percent (HR 0.64, CI 0.44-0.95), while in the smaller UnitedHealth database, stroke rates were not different between the two anticoagulants, as there were only 26 strokes in total which led to wide confidence intervals (HR=1.62, CI 0.72-3.66).
04 Dec Risk-Based Mammography Recommendations May Miss Some Breast Cancers
MedicalResearch.com Interview with:
Elissa R. Price, MD
Assistant Professor of Clinical Radiology
Director of Clinical Operations, Breast Imaging
Breast Imaging Fellowship Program Director
Department of Radiology and Biomedical Imaging
University of California, San Francisco San Francisco, CA 94115
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Price: Screening mammography recommendations for the 40 - 49 age group is very controversial. 2009 USPTF guidelines emphasized taking patient context into account when making decisions for these young women. Recent publications have suggested risk-based screening strategies. Family history and breast density are important are easily accessible risk factors.
Had we been using this risk-based approach to screening mammography at our institution, we would have missed more than 3Ž4 of the screen detected breast cancers in the 40-49 age group, thereby foregoing most of the survival benefit from screening mammography.
03 Dec Lung Cancer: More Efficient CT Screening Model Proposed
MedicalResearch.com Interview with:
Dr. Martin C. Tammemägi
Professor (Epidemiology), Brock University
Department of Health Sciences
St. Catharines, Ontario, Canada L2S 3A1
Medical Research: What is the background for this study? What are the main findings?
Dr. Tammemägi: Lung cancer is the leading cause of cancer death in North America and the world. Lung cancer survival following diagnosis is generally poor, in the range of 10% to 15%, and has improved little over the last four decades. The biggest recent breakthrough for reducing lung cancer mortality came with the findings of the National Lung Screening Trial (NLST), a large, well-conducted randomized screening trial, which demonstrated that low dose computed tomography (LDCT) screening versus chest X-ray (CXR) screening can reduce lung cancer mortality by 20%. Currently, most guidelines for selecting screenees for lung screening use the NLST enrolment criteria of 30 or more pack-years smoked, former smokers must have quit smoking within 15 years and ages between 55 and 74, or use a variant of the NLST criteria. The US Preventive Services Task Force (USPSTF) essentially recommends using the NLST criteria but extended the inclusion age to 80 years.
The current study applied the PLCOm2012 lung cancer risk prediction model1 to NLST data and identified that the risk above which lung cancer mortality is consistently lower in the LDCT arm compared to the CXR arm, is ≥1.51% 6-year risk (65th percentile). The USPSTF and the PLCOm2012 risk ≥0.0151 criteria were then applied to the Prostate Lung Colorectal and Ovarian Cancer Screening Trial (PLCO) intervention arm smokers (the PLCOm2012 was developed in PLCO controls) to determine who would be selected for lung cancer screening. Compared to USPSTF criteria, the PLCOm2012 risk ≥0.0151 threshold selected 8.8% fewer individuals, but identified 12.4% more lung cancers (sensitivity 80.1% vs. 71.2%), and had fewer false positives (specificity 66.2% vs. 62.7%). 26% of smokers who were USPSTF criteria positive had risks below the PLCOm2012 risk ≥0.0151 threshold. Of PLCO former smokers who quit more than 15 years ago, 8.5% had PLCOm2012 risk ≥0.0151, suggesting that they might benefit from screening (2.9% of them developed lung cancer in 6 year). None of 65,711 never-smokers in the PLCO had PLCOm2012 risk ≥0.0151, indicating that never-smokers should not be screened. Individuals age ≥65–80 years had significantly higher risks and more lung cancers than those 55-64 years.
03 Dec Maternal Obesity Linked To Increase Infant Mortality
MedicalResearch.com Interview with:
Stefan Johansson, MD PhD
consultant neonatologist
Stockholm, Sweden
Medical Research: What is the background for this study?
Dr. Johansson: Maternal obesity (BMI ≥ 30) has previously been linked to increased infant mortality. However, research has not produced consistent results. For example, there are disagreements whether infants to overweight mothers (BMI 25-29) are at increased risk, and research on BMI-related specific causes of death is scarce.