MedicalResearch.com: Medical Research Exclusive Interviews March 17 2015

MedicalResearch.comExclusive Interviews with Medical Research and

Health Care Researchers from Major and Specialty Medical Research Journals and Meetings

Editor: Marie Benz, MD [email protected]

March 18 2015

For Informational Purposes Only: Not for Specific Medical Advice.

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Nonsurgical Treatments May Equal Surgery For Many Broken ShouldersMedicalResearch.com Interview with: Prof. Amar Rangan

Clinical Professor, Trauma & Orthopaedic SurgerySchool of Medicine & Health, Durham University & Consultant Orthopaedic Surgeon

The James Cook University Hospital Middlesbrough

• Medical Research: What is the background for this study? What are the main findings?

Prof. Rangan: The majority of fractures of the proximal humerus (broken shoulders) occur in people older than 65 years. Although surgical treatment is being increasingly used for the more serious (displaced) fractures, it has been unclear whether surgical intervention (fracture fixation or humeral head replacement) produces consistently better outcomes than non-surgical treatment (arm-sling); both followed by physiotherapy.

• Our multicentre randomized controlled trial (ProFHER), funded by the UK National Institute for Health Research’s Health Technology Assessment Programme, recruited 250 patients aged 16 years or older (mean age, 66 years) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 after sustaining the most common types of acute displaced fracture of the proximal humerus.

• Data for 231 patients (92.4% of 250) included in the primary analysis showed that there was no significant difference between the two treatment groups over two years or at 6, 12 and 24 months follow-up in self-reported pain and function scores. Nor were there significant differences on measures of health-related quality of life, complications related to surgery or shoulder fracture, later surgery or treatment for these complications, and death.

Read the rest of the interviews on MedicalResearch.comContent NOT an endorsement of efficacy and NOT intended as specific medical advice.

http://medicalresearch.com/author-interviews/nonsurgical-treatments-may-equal-surgery-for-many-broken-shoulders/12585/

http://medicalresearch.com/menopause/should-the-ovaries-be-removed-at-time-of-hysterectomy-for-benign-disease/1236/


Nonsurgical Treatments May Equal Surgery For Many Broken ShouldersMedicalResearch.com Interview with: Prof. Amar Rangan

Clinical Professor, Trauma & Orthopaedic SurgerySchool of Medicine & Health, Durham University & Consultant Orthopaedic Surgeon

The James Cook University Hospital Middlesbrough

• Medical Research: What should clinicians and patients take away from your report?

• Prof. Rangan: A broken shoulder can be a particularly painful injury and the function of the arm and shoulder can be considerably compromised – people don’t necessarily regain the independence they had before the injury. Although some of these fractures clearly need surgery, for the majority the results of ProFHER show that surgery does not result in a better outcome. Crucially, these results do not support the trend of increased surgery.

• Medical Research: What recommendations do you have for future research as a result of this study?

• Prof. Rangan: Greater attention needs to be given to identifying optimal non-surgical treatment strategies.

• Non-surgical treatment including rehabilitation should remain the comparator for future research testing new interventions.

• A prospective fully inclusive database of these fractures with collection of outcomes would help further clarify the effectiveness of interventions.

• Citation:

• Rangan A, Handoll H, Brealey S, et al. Surgical vs Nonsurgical Treatment of Adults With Displaced Fractures of the Proximal Humerus: The PROFHER Randomized Clinical Trial. JAMA. 2015;313(10):1037-1047. doi:10.1001/jama.2015.1629.



http://medicalresearch.com/author-interviews/does_milk_increase_bone_fractures/8580/

http://jama.jamanetwork.com/article.aspx?articleid=2190987



ESCAPE Study Evaluates Stepped Care For Chronic Pain in VeteransMedicalResearch.com Interview with:

Matthew J. Bair, MD, MSResearch Service, Veterans Affairs Health Services Research and Development, Center for Health Information and Communication

Richard L. Roudebush Veterans Affairs Medical Center,Department of Medicine, Indiana University School of Medicine,

• MedicalResearch.com: What is the background for this study?

• Dr. Bair: Despite the prevalence and functional, psychological, and economic impact of chronic pain, there have been few intervention studies to treat chronic pain in Veterans.

• MedicalResearch.com: What are the main findings?

• Dr. Bair: A stepped-care intervention that combined analgesics, self-management strategies, and brief cognitive behavioral therapy resulted in statistically significant reductions in pain-related disability, pain interference, and pain severity in Veterans with chronic musculoskeletal pain.


http://medicalresearch.com/pain-research/escape-study-evaluates-stepped-care-for-chronic-pain-in-veterans/12588/



ESCAPE Study Evaluates Stepped Care For Chronic Pain in VeteransMedicalResearch.com Interview with:

Matthew J. Bair, MD, MSResearch Service, Veterans Affairs Health Services Research and Development, Center for Health Information and Communication

Richard L. Roudebush Veterans Affairs Medical Center,Department of Medicine, Indiana University School of Medicine,

• MedicalResearch.com: What should clinicians and patients take away from your report?

• Dr. Bair: Our study adds to the literature about multi-modal approaches that combine pharmacological and non-pharmacological treatments that may be applied in non-specialty settings. Study findings have implications for the patient-centered medical home (PCMH) environment especially an emphasis on team-based care. The ESCAPE study demonstrates a potential model of sequencing pain treatments involving analgesics, self-management strategies, and cognitive behavioral therapy. Furthermore, ESCAPE involved a telephone-based intervention delivered by nurse care managers that may be applied across multiple geographically dispersed clinical settings.

• MedicalResearch.com: What recommendations do you have for future research as a result of this study?

• Dr. Bair: We need to continue to develop and test interventions that combine pharmacologic and non-pharmacologic treatments that address some of the barriers to effective pain management that can be practicably applied in primary care settings.

• Citation:

• Bair MJ, Ang D, Wu J, et al. Evaluation of Stepped Care for Chronic Pain (ESCAPE) in Veterans of the Iraq and Afghanistan Conflicts: A Randomized Clinical Trial. JAMA Intern Med. Published online March 09, 2015. doi:10.1001/jamainternmed.2015.97.



http://medicalresearch.com/pain-research/telecare_monitoring_of_chronic_pain_may_result_in_improved_pain_control/6414/

http://archinte.jamanetwork.com/article.aspx?articleid=2174941



Epigenetics, Not Just Genes, Control Many Complex TraitsMedicalResearch.com Interview with:

Prof. Moshe Szyf Ph.D.James McGill Professor of Pharmacology and Therapeutics

McGill University


• Dr. Szyf: Humans exhibit a marked variation in traits both physical and behavioral and different susceptibilities for developing disease. What causes this inter-individual variation? The prevailing dogma has been that changes in the sequences of genes or heritable genetic differences are responsible for these differences. We tested here an alternative hypothesis that perhaps some of the reason for this natural variation in traits is not caused by differences in inherited genes but by “epigenetic” changes that alter the way genes work without changing the genes. The main difference between genetic and epigenetic changes is that epigenetic changes could be introduced by experience and exposure to environment. The experiences that can cause epigenetic changes include physical as well as social environments. Although we had known that epigenetic differences occur in humans and animals we didn’t have evidence that these changes are behind the natural variation in traits that is observed in humans and animals. Ants are an exciting biological paradigm that exhibits quantitative variations in size and therefore provided a unique opportunity to test this hypothesis.


http://medicalresearch.com/genetic-research/epigenetics-not-just-genes-control-many-complex-traits/12610/





McGill University


• Dr. Szyf: The experiments highlight the fundamental role of environment driven processes in generating differences in traits. The difference between genetics and epigenetics is that we have no control over the genetic traits that we inherited from our ancestors but we do have control over the social and physical environments that we are building. Thus, it should be potentially possible to prevent deleterious traits. Focusing on prevention and identifying those environments that are driving unwanted traits become paramount in early life care and the rest of life as well.

• The second lesson was that we could shift those traits by epigenetic pharmacological manipulation which again focuses on the immense potential opportunity in epigenetictreatments and approaches in altering deleterious traits that increase the risk for disease.



http://medicalresearch.com/genetic-research/epigenetics-more-than-30-genes-affect-allergies-and-asthma/11978/





McGill University


• Dr. Szyf: Although ants are interesting we still need to translate this to humans by examining how we can use this concept of “inter-individual quantitative variations in epigenetics and traits” to develop tools that will allow us better preventions, diagnostics and intervention strategies to help the most vulnerable and develop new epigenetic based approaches to treat disease.

• Citation:

• Sebastian Alvarado, Rajendhran Rajakumar, Ehab Abouheif, Moshe Szyf. Epigenetic variation in the Egfr gene generates quantitative variation in a complex trait in ants. Nature Communications, 2015; 6: 6513 DOI: 10.1038/ncomms7513



http://medicalresearch.com/genetic-research/epigenetic-control-protein-allows-melanoma-cells-metatasize/10949/

http://dx.doi.org/10.1038/ncomms7513



NSAIDS May Be Helpful In Bladder Cancer PreventionMedicalResearch.com Interview with:

James Scheiman, M.D.Professor of Gastroenterology

University of Michigan Medical School


Dr. Scheiman: Using aspirin or other nsaids to reduce the risk of many cancers has been an active area of investigation. This study demonstrates in an animal model that a commonly used nsaid (naproxen) reduces bladder tumor development, while the concomitant use of an acid blocking drug– which has been shown in many clinical studies to reduce the ulcers and bleeding associated with nsaids in humans – is also effective. Naproxen has been shown to reduce colon polyps and skin cancers in animal models as well, so this broad effect demonstrates a novel strategy to test in clinical trials.


• Dr. Scheiman: The study shows that using two commonly used classes of drugs together (one which, the proton pump inhibitor, can mitigate the adverse GI side effects of the other without affecting the cancer-reducing effect) may have value to reduce the risk of a number of common cancers. This idea needs to be studied in a clinical trial.

• Citation:

• Ronald A. Lubet, James M. Scheiman, Ann Bode, Jonathan White, Lori Minasian, M. Margaret Juliana, Daniel L. Boring, Vernon E. Steele, and Clinton J. Grubbs. Prevention of Chemically Induced Urinary Bladder Cancers by Naproxen: Protocols to Reduce Gastric Toxicity in Humans Do Not Alter Preventive Efficacy. Cancer Prevention Research, March 2015 DOI: 10.1158/1940-6207.CAPR-14-0347


http://medicalresearch.com/cancer-_-oncology/nsaids-may-be-helpful-in-bladder-cancer-prevention/12614/

http://medicalresearch.com/cancer-_-oncology/nsaids-may-prevent-squamous-cell-skin-cancers/9861/

http://dx.doi.org/10.1158/1940-6207.CAPR-14-0347


http://medicalresearch.com/cancer-_-oncology/nsaids-may-be-helpful-in-bladder-cancer-prevention/12614/

Pre-pregnancy BMI And Gestational Weight Gain Linked To Childhood ObesityMedicalResearch.com Interview with:

Elizabeth M. Widen, PhD, RDPostdoctoral Fellow in the Institute of Human Nutrition & Department of Epidemiology

Columbia University Mailman School of Public Health New York, NY 10032


• Dr. Widen: The Columbia Center for Children’s Environmental Health Mothers and Newborns Study was started in 1998 and is based in Northern Manhattan and the South Bronx. Pregnant African American and Dominican mothers were enrolled from 1998 to 2006, and mothers and their children have been followed since this time. Pregnancy weight gain and childhood size and body fat was measured, allowing us to examine the role of nutrition in pregnancy on long-term childhood health. We found that high pregnancy weight gain, above the Institute of Medicine 2009 guidelines, was associated with higher body fat and a 300% increased risk of childhood obesity at age seven. Prepregnancy body mass index (BMI) was also positively associated with childhood body fat and obesity. These findings suggest that prepregnancy BMI and pregnancy weight gain have long-term implications for weight-related health in children.


• Dr. Widen: We encourage pregnant women and women planning pregnancy to talk to their health care provider about the recommended guidelines for pregnancy weight gain and strategies to gain within the guidelines. We encourage clinicians to talk to their patients about the recommended guidelines and how gaining too much weight in pregnancy can have long-term implications for childhood body weight and health.


http://medicalresearch.com/weight-research/pre-pregnancy-bmi-and-gestational-weight-gain-linked-to-childhood-obesity/12594/

http://www.iom.edu/en/Reports/2009/Weight-Gain-During-Pregnancy-Reexamining-the-Guidelines.aspx



Pre-pregnancy BMI And Gestational Weight Gain Linked To Childhood ObesityMedicalResearch.com Interview with:

Elizabeth M. Widen, PhD, RDPostdoctoral Fellow in the Institute of Human Nutrition & Department of Epidemiology

Columbia University Mailman School of Public Health New York, NY 10032


• Dr. Widen:: We found that high pregnancy weight gain was associated with childhood obesity and higher body fat. Given that women with the same amount of total weight gain may have a different pattern of weight gain across pregnancy, future studies should examine the role of the pattern of weight gain in childhood health. Future research is also needed to determine how to support women to gain within the guidelines, which is important for maternal and child health.

• Citation:

• Gestational weight gain and obesity, adiposity and body size in African–American and Dominican children in the Bronx and Northern Manhattan. Elizabeth M. Widen, Robin M. Whyatt, Lori A. Hoepner, Noel T. Mueller, Judyth Ramirez-Carvey, Sharon E. Oberfield, AbeerHassoun, Frederica P. Perera, Dympna Gallagher and Andrew G. Rundle. Maternal & Child Nutrition 2015, published ahead of print March 5, 2015, doi: 10.1111/mcn.12174.



http://onlinelibrary.wiley.com/doi/10.1111/mcn.12174/abstract



Inappropriate Breast, Prostate Imaging Regionally ClusteredMedicalResearch.com Interview with: Danil Makarov, MD Lead Investigator

Assistant Professor, Departments of Urology, Population Health and Health PolicyMember, Laura and Isaac Perlmutter Cancer Center

NYU Langone Medical Center, New York, NY

• Medical Research: What is the background for this study?

Dr. Makarov: The background for this study is that regional variation in patterns of care and healthcare spending is widely known. The drivers of this regional variation, though, are poorly understood. Certain policy groups like the IOM have suggested that policy efforts be focused on individual providers and patients. Programs such as Choosing Wisely, which encourage a dialogue between physicians and patients, are a great example of such efforts. However, some of our prior research suggests that regional variation is not random and that there might be are regional-level factors which drive variation.

• To test out our hypothesis, we wanted to see whether inappropriate imaging for two unrelated cancers was associated at a regional level (it should not be).

• Medical Research: What are the main findings?

Dr. Makarov: We found that, at a regional level, inappropriate breast cancer imaging was associated with inappropriate prostate cancer imaging.


http://medicalresearch.com/medical-imaging/inappropriate-breast-prostate-imaging-regionally-clustered/12591/



Inappropriate Breast, Prostate Imaging Regionally ClusteredMedicalResearch.com Interview with: Danil Makarov, MD Lead Investigator

Assistant Professor, Departments of Urology, Population Health and Health PolicyMember, Laura and Isaac Perlmutter Cancer Center

NYU Langone Medical Center, New York, NY


• Dr. Makarov: This finding suggests that regional factors (such as practice norms and medical culture) might be driving regional variation. If proven correct, this might suggest that policy interventions should be regionally targeted based on the presence of these local factors. Choosing wisely is a great first step at encouraging patient and physician participation in healthcare decisions but may not be able to entirely resolve the problems of inappropriate use and regional variation.


• Dr. Makarov: Future research needs to explore further the associations between appropriateness of care across disease states and needs to determine evidence of these practice norms and medical culture using qualitative methods.Citation:

• Regional-Level Correlations in Inappropriate Imaging Rates for Prostate and Breast CancersPotential Implications for the Choosing Wisely Campaign. JAMA Oncology, March 2015 DOI: 10.1001/jamaoncol.2015.37



http://dx.doi.org/10.1001/jamaoncol.2015.37



Germline Mutations Studied In Patients With Family History Of Early Onset Colon CancerMedicalResearch.com Interview with:

Matthew B. Yurgelun, MDInstructor in Medicine

Harvard Medical School


Dr. Yurgelun: Germline mutations in the TP53 gene are linked to Li-Fraumeni syndrome, which is an inherited syndrome associated with a 73-100% lifetime risk of cancer. Classically, cancers linked to Li-Fraumeni syndrome include early-onset breast cancer, leukemias, soft tissue sarcomas, brain cancer, and adrenocortical cancer, although recent data have shown an increased risk of colorectal cancer as well. Our study’s primary aim was to determine the frequency of germline TP53 mutations in patients with early-onset colorectal cancer.

• We studied 457 patients from the multinational Colon Cancer Family Registry who were diagnosed with colorectal cancer at age 40 or younger, and found that 1.3% carried a germline alteration in the TP53 gene. None of these individuals had personal or family histories of cancer that fulfilled clinical criteria for Li-Fraumeni syndrome.


http://medicalresearch.com/genetic-research/germline-mutations-studied-in-patients-with-family-history-of-early-onset-colon-cancer/12619/

http://medicalresearch.com/cancer-_-oncology/colon-cancer/colorectal-cancer-incidence-rising-in-young-adults/10904/







• Dr. Yurgelun: Comprehensive strategies for germline evaluation – such as multigene panel testing and whole exome sequencing – are becoming more commonly available for patients with cancer. With the increasing use of such strategies for germline assessment, our data suggest that TP53 mutations will be found in patients with early-onset colorectal cancer who otherwise lack classic histories for Li-Fraumeni syndrome, yet the clinical significance of this remains unclear. For patients found to carry TP53 mutations in the setting of early-onset colorectal cancer but no other clinical features of LFS, our data suggest that such probands may not have the 73-100% lifetime risk of classic LFS cancers typically quoted for TP53 mutation carriers, although confirmatory studies are certainly needed.









• Dr. Yurgelun: Further data is needed to determine which patients with early-onset colorectal cancer should be considered for germline TP53 mutation analysis. Our data suggest that further research is needed to clarify the clinical significance and optimal management strategies for patients with germline TP53 mutations who otherwise lack clinical histories suggestive of Li-Fraumeni syndrome.

• Citation:

• Yurgelun MB, Masciari S, Joshi VA, et al. Germline TP53 Mutations in Patients With Early-Onset Colorectal Cancer in the Colon Cancer Family Registry. JAMA Oncol. Published online March 12, 2015. doi:10.1001/jamaoncol.2015.0197.



http://oncology.jamanetwork.com/article.aspx?articleid=2194735



Biomarkers Improve Cardiovascular Risk Prediction After STEMIMedicalResearch.com Interview with:

Matthijs A. Velders, MD PhDUppsala Clinical Research Center

Uppsala, Sweden.


Dr. Velders: Outcomes in patients with ST-elevation myocardial infarction have been substantially improved by early reperfusion with primary percutaneous coronary intervention, but recurrent events after the acute phase of myocardial infarction are common. To continue to improve outcome for these patients, identification of high-risk patients is essential. While conventional risk scores rely on clinical and angiographic data for risk stratification, markers of myocardial dysfunction (N-terminal pro-B-type natriuretic peptide, NT-proBNP), myocardial necrosis (high-sensitivity cardiac troponin-T, cTnT-hs) and oxidative stress (growth differentiation factor-15, GDF-15) have been shown to improve risk prediction over traditional risk factors. However, the incremental value of these biomarkers beyond clinical risk factors and angiographic extent of coronary artery disease in patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention remained unclear.

• In this substudy of the PLATO trial (NCT00391872), biomarkers were measured shortly after admission in 5385 patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention. We found that cTnT-hs, NT-proBNP and GDF-15 as well as the angiographic extent of coronary artery disease improved the prediction of cardiovascular death during follow-up in comparison to clinical information alone. The predictive value of the three biomarkers was similar for cardiovascular death and independent of the extent of coronary artery disease. Furthermore, NT-proBNP and GDF-15 showed prognostic value for spontaneous myocardial infarction during follow-up. Thus, for prognostication of both cardiovascular death and spontaneous myocardial infarction after primary percutaneous coronary intervention in ST-elevation myocardial infarction, NT-proBNP as well as GDF-15 will provide useful information beyond what currently is available from clinical and angiographic data.


http://medicalresearch.com/heart-disease/biomarkers-improve-cardiovascular-risk-prediction-after-stemi/12548/

http://medicalresearch.com/heart-disease/which_bnp_better_predicts_cv_events_in_stable_cad/6830/



Biomarkers Improve Cardiovascular Risk Prediction After STEMIMedicalResearch.com Interview with:

Matthijs A. Velders, MD PhDUppsala Clinical Research Center

Uppsala, Sweden.


• Dr. Velders: Biomarker measurement on admission is an objective tool to aid the physician in the early recognition of high-risk patients with ST-elevation myocardial infarction. This potentially allows early initiation of more intensive treatment and intensified follow-up after discharge in attempt to lower the risk for new cardiac events. However, the current study does not answer the question as to how to use the prognostic information provided by the biomarkers.


• Dr. Velders: Future investigations should explore biomarker-guided management strategies in patients with ST-elevation myocardial infarction.

• Citation:

• Biomarkers for Risk Stratification of Patients with ST-Elevation Myocardial Infarction Treated with Primary Percutaneous Coronary Intervention: Insights from the Platelet Inhibition and Patient Outcomes (PLATO) Trial

• Matthijs A. Velders, MD, PhD, Lars Wallentin, MD, PhD et alon behalf of the PLATO Investigators American Heart Journal Available online 4 March 2015



http://medicalresearch.com/heart-disease/long-term-effects-of-ischemic-post-conditioning-with-pci-for-stemi/12362/

http://www.sciencedirect.com/science/article/pii/S0002870315001258

http://www.sciencedirect.com/science/article/pii/S0002870315001258



Lifestyle Factors May Limit Cognitive DeclineMedicalResearch.com Interview with:

Miia Kivipelto MD, PhD, Professor Deputy Head, Senior GeriatricianAging Research Center and Alzheimer Disease Research Center Karolinska Institutet Clinical Trials Unit, Memory Clinic

Karolinska University Hospital Stockholm, Sweden


Dr. Kivipelto: Epidemiological studies have linked several modifiable risk factors to cognitive impairment and dementia but evidence from randomized controlled trials (RCT) has been lacking showing the efficacy of the interventions. Because cognitive impairment, dementia and Alzheimer’s disease are complex, multi-factorial disorders, multidomain interventions targeting several risk factors and disease mechanisms simultaneously could be needed for optimum preventive effect. The FINGER study is the first large, long-term RCT indicating that multi-domain intervention can improve and maintain cognitive functioning in at risk elderly people from the general population. We observed a significant intervention effects on the primary outcome (overall cognition), main secondary outcomes (executive functioning and processing speed) as well as on complex memory tasks and risk of cognitive decline. The multidomain lifestyle intervention was feasible and safe.


Dr. Kivipelto: Lifestyle choices and vascular risk factors affect cognitive functioning; even small changes in lifestyle can have large positive effects. Try to increase and maintain physical activity and combine with mental and social activities if possible. Balanced, healthy diet. Cognitive training. Control of vascular risk factors as early as possible. .


http://medicalresearch.com/mental-health-research/alzheimers-dementia/lifestyle-factors-may-help-limit-cognitive-decline/12630/

http://medicalresearch.com/mental-health-research/alzheimers-dementia/pathology_starts_10-20_years_before_diagnosis/4771/

http://medicalresearch.com/mental-health-research/alzheimers-dementia/early-dementia/2052/



Lifestyle Factors May Limit Cognitive DeclineMedicalResearch.com Interview with:

Miia Kivipelto MD, PhD, Professor Deputy Head, Senior GeriatricianAging Research Center and Alzheimer Disease Research Center Karolinska Institutet Clinical Trials Unit, Memory Clinic

Karolinska University Hospital Stockholm, Sweden


• Dr. Kivipelto: It is important to conduct the extended follow-up in the FINGER study to clarify effects on the incidence of dementia and its suptypes, other secondary outcomes (i.e. depression, functional outcomes) and health economical evaluations. Further, it will be interesting to study possible mechanisms of the intervention and the contribution of each component to the overall effect. The multidomain intervention can also be studied in different settings (i.e. memory clinic, early Alzheimer’s disease patients) and can be tested in combination with pharmacological treatments.

• Citation:

• A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial

• Tiia Ngandu, Jenni Lehtisalo, Alina Solomon, Esko Levälahti, Satu Ahtiluoto, Riitta Antikainen, and others

• The Lancet Published online: March 11, 2015MedicalResearch.com Interview with: Miia Kivipelto MD, PhD, Professor (2015). Lifestyle Factors May Help Limit Cognitive Decline



http://medicalresearch.com/weight-research/obesity-midlife-increases-risk-dementia-alzheimers-disease/9149/

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)60461-5/abstract





Cochlear Implants May Improve Cognition in Elderly PatientsMedicalResearch.com Interview with:

Isabelle Mosnier, MD, Praticien Hospitalier ORLOtologie, Implants Auditifs et Chirurgie de la Base du Crâne

Centre Référent Implant Cochléaire Adulte d’Ile de France Centre Maladies Rares Surdité Génétique de l’adulteet Neurofibromatose de type 2

• MedicalResearch: What is the background for this study? What are the main findings?

• Dr. Mosnier: Association between hearing impairment and cognitive decline has been established; however, the impact on cognition through cochlear implantation in profoundly deaf elderly patients is not known. The focus was to determine the impact of hearing rehabilitation including cochlear implant on cognitive functions, in addition to the influence of cognitive factors on cochlear implant outcomes over time.

• MedicalResearch: What should clinicians and patients take away from your report?

• Dr. Mosnier: Rehabilitation of hearing communication via cochlear implantation in elderly patients was observed to result in improvements in speech perception, cognitive abilities and positively influenced their social activity and quality of life. Further research is needed to assess the relationship between hearing loss and cognition decrease, as well as the long-term impact of cochlear implantation upon cognitive decline. The study demonstrates the importance of hearing rehabilitation in elderly patients, that could delay dementia as well as its progression. Cochlear implantation is the safe procedure, without limitation of age, which must be proposed as early as patients obtain poor benefit with their hearing aids.

• Citation:

• Mosnier I, Bebear J, Marx M, et al. Improvement of Cognitive Function After Cochlear Implantation in Elderly Patients. JAMA Otolaryngol Head Neck Surg. Published online March 12, 2015. doi:10.1001/jamaoto.2015.129.


http://medicalresearch.com/author-interviews/cochlear-implants-may-improve-cognition-in-elderly-patients/12643/

http://medicalresearch.com/author-interviews/cochlear-implants-work-equally-in-younger-and-older-patients/11094/

http://medicalresearch.com/mental-health-research/depression/depression_and_hearing_loss_in_adults/4071/


http://medicalresearch.com/author-interviews/cochlear-implants-may-improve-cognition-in-elderly-patients/12643/

Abuse Deterrent Opioids Inadvertently Led To Increased Heroin UseMedicalResearch.com Interview with:

Theodore J. Cicero, PhDProfessor, Vice Chairman for Research

Department of Psychiatry, Washington University St Louis, Missouri


• Dr. Cicero: Prescription opiate abuse (eg Vicodin, Percocet, OxyContin) has reached epidemic proportions in this country over the past decade. Although most people swallow the drugs whole, a relatively large number either chew the drugs to produce an immediate delivery of large quantities of drugs or they crush them and/or dissolve them in some solvent which makes them useful for intranasal (eg snorting) or intravenous administration. Non-oral routes, particularly injection, represent the most serious public health risk due to a high incidence of infection, including Hepatitis C and HIV, and the much greater severity of abuse. In an effort to reduce these practices, drug companies are introducing so-called abuse deterrent formulations (ADF) which are resistant to crushing or dissolving in an aqueous solution. In one such important effort, the company responsible for distributing one of the most widely abused prescription opiates, OxyContin, introduced an ADF in 2010. Although the abuse deterrent formulations was highly successful in reducing abuse of OxyContin by either chewing, crushing, or dissolving in water, there was none-the-less a clear limit to how effective it was. For example, some people simply switched to the oral route of administration or never did snort or inject the drug, whereas a small number found ways to defeat the abuse deterrent formulations and persisted in harmful patterns of abuse. Unfortunately, there was also an unintended result. ADF-OxyContin caused many individuals to abandon the use of OxyContin – a good thing – in favor of other opiates (a bad thing). Most serious, however, was that 70% of those who switched drugs moved from OxyContin to heroin abuse. Although by no means the only factor, the abuse deterrent formulations has contributed to the wide-spread reports of heroin abuse in suburban and rural Caucasian male and females, a group here-to-fore not the typical heroin users (i.e. poor minorities, living in large urban centers).


http://medicalresearch.com/author-interviews/abuse-deterrent-opioids-inadvertently-led-to-increased-heroin-use/12645/

http://medicalresearch.com/author-interviews/us-opioid-death-rate-flattens-heroin-deaths-increase/11098/







• Dr. Cicero: Physicians should be aware of the potential for abuse of any opiate medication for pain, and abuse deterrent formulations when available should be prescribed. However, it needs to be recognized that some users will continue to misuse their medication no matter what formulation is used. Patients also need to be aware that ADFs do not prevent abuse and care should be taken in their use. In a broader sense, it needs to be understood that abuse-deterrent formulations can have the intended purpose of curtailing abuse, but the extent of their effectiveness has clear limits, resulting in a significant level of residual abuse. Consequently, although drug abuse policy should focus on limiting supplies of prescription analgesics for abuse, including abuse deterrent formulations technology, efforts to reduce supply alone will not mitigate the opioid abuse problem in this country. Rather, demand reduction must be a part of any comprehensive effort to curb the epidemic of licit and illicit opiate use.



http://medicalresearch.com/pain-research/emergency_room_prescriptions_for_opioid_pain_medications_markedly_increase/4217/






• MedicalResearch: What recommendations do you have for future research as a result of this study?

• Dr. Cicero: Efforts need to be made to better understand the demand for opiates-what needs do they meet in abusers-since supply-side efforts to reduce abuse and drug availability, while important, are not the definitive answer to our current epidemic of prescription drug use. Much more systematic efforts need to be undertaken to determine what drives the demand for these drugs.

• Citation

• Cicero TJ, Ellis MS. Abuse-Deterrent Formulations and the Prescription Opioid Abuse Epidemic in the United States: Lessons Learned From OxyContin. JAMA Psychiatry. Published online March 11, 2015. doi:10.1001/jamapsychiatry.2014.3043.



http://medicalresearch.com/author-interviews/opioids-total-daily-dose-indicators-overdose-risk/9612/

http://archpsyc.jamanetwork.com/article.aspx?articleid=2174541



Medical Students Have Mixed Knowledge and Expectations of ACAMedicalResearch.com Interview with:

Tyler Winkelman, M.D.Internal Medicine and Pediatrics – PGY 4 University of Minnesota

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Winkelman: Future physicians will practice after key provisions of the Affordable Care Act (ACA) have been enacted. Whether medical students support or understand the legislation or are willing to engage in its implementation or modification as part of their professional obligation is unknown. We surveyed medical students at 8 U.S. medical schools to assess their views and knowledge of the ACA (RR=52%). We found that the majority of students support the ACA and indicate a professional obligation to assist with its implementation. There are, however, gaps in knowledge with regards to Medicaid expansion and insurance plans available within the health exchanges. Students anticipating a surgical or procedural specialty, compared to those anticipating a medical specialty, were less likely to support the ACA, less likely to indicate a professional obligation to implement the ACA, and more likely to have negative expectation of the ACA. Moderates, liberals, and those with above average knowledge scores were more likely to support the ACA and indicate a professional obligation to assist with its implementation.


http://medicalresearch.com/author-interviews/medical-students-have-mixed-knowledge-and-expectations-of-aca/12648/

http://medicalresearch.com/author-interviews/aca_may_result_in_more_patients_using_emergency_rooms_for_primary_care/9084/





MedicalResearch: What should clinicians and patients take away from your report?

Dr. Winkelman: Our results suggest that future physicians are willing to engage with health care reform legislation that aims to expand access to care. Whether students are adequately prepared to effectively engage in implementation or modification of health care reform measures is less clear. By embracing health policy and public health curricula, medical schools can ensure future physicians are prepared to engage with health reform measures that provide improved access and higher quality at lower cost.



http://medicalresearch.com/author-interviews/er-reimbursements/2534/






• Dr. Winkelman: Whether students’ reported support for health care legislation leads to increased participation in Medicaid as physicians should be explored. How and why students’ views change through residency and beyond could also be examined.

• Citation:

• Medical Students’ Views and Knowledge of the Affordable Care Act: A Survey of Eight U.S. Medical SchoolsTyler N. A. Winkelman MD, Lisa Soleymani Lehmann MD, PhD, MSc, et alJournal of General Internal MedicineMarch 2015 Date: 10 Mar 2015



http://medicalresearch.com/author-interviews/study-shows-families-save-1000-average-states-expanded-medicaid/11449/

http://link.springer.com/article/10.1007/s11606-015-3267-9






Longer Breastfeeding Not Linked To Higher Childhood IQMedicalResearch.com Interview with:

Sabine Roza MD Ph.D.Department of Child and Adolescent Psychiatry & Psychology

Department of Psychiatry, Erasmus MC, Rotterdam, The Netherlands.

Medical Research: What is the background for this study? What are the main findings?

Dr. Roza: WHO guidelines recommend six months of exclusive breastfeeding followed by partial breastfeeding until two years for overall optimum growth and development of children. However, the role of breastfeeding duration on child cognitive development remains a topic of continual debate. Previous research has shown mixed results on the role of breastfeeding duration and exclusivity on child IQ. Several methodological differences in study design inhibit comparisons of these studies and thus limit their generalizability. Furthermore, the association of breastfeeding with child cognitive development is subject to confounding by various factors especially maternal IQ. Therefore, we aimed to study the association between breastfeeding duration and breastfeeding exclusivity with non-verbal IQ in children. We used data the Generation R Study, which is a prospective cohort study from fetal life until young adulthood. Due to the large variability in ethnic backgrounds in our study participants, we focused on non-verbal IQ. In a large sample of 3761 children aged on average 6 years, we found an initial advantage of 0.32 points in non-verbal IQ for every increasing month of breastfeeding, which strongly attenuated after adjustments were made for child factors, maternal factors, sociodemographic factors, parental lifestyle and maternal IQ. Similar attenuation of effect sizes was observed for breastfeeding duration as a categorical variable and duration of exclusive breastfeeding.


http://medicalresearch.com/pediatrics/longer-breastfeeding-not-linked-to-higher-iq/12650/

http://medicalresearch.com/genetic-research/parental-performance-influences-genetic-neurodevelopmental-disability/11291/



Longer Breastfeeding Not Linked To Higher Childhood IQMedicalResearch.com Interview with:

Sabine Roza MD Ph.D.Department of Child and Adolescent Psychiatry & Psychology

Department of Psychiatry, Erasmus MC, Rotterdam, The Netherlands.


• Dr. Roza: Breastfeeding is important for over-all optimum growth of children conferring various health advantages. However, improved IQ with longer duration of breastfeeding is not among those advantages. Sociodemographic factors, parental lifestyle and most importantly maternal IQ mostly explain the association between breastfeeding and child IQ.


• Dr. Roza: Future research should be aimed to investigate other factors that can further explain the complex association between breastfeeding and child IQ such as paternal IQ. Furthermore, other domains of child cognitive development should be investigated in relation to the effects of confounding.

• Citation:

• Breastfeeding duration and non-verbal IQ in childrenSajjad A1, Tharner A2, Kiefte-de Jong JC3, Jaddoe VV4, Hofman A5, Verhulst FC6, Franco OH3, Tiemeier H7, Roza SJ8.J Epidemiol Community Health. 2015 Feb 19. pii: jech-2014-204486. doi: 10.1136/jech-2014-204486. [Epub ahead of print]



http://medicalresearch.com/weight-research/infant_feeding_racial_and_ethnic_differences_require_culturally_tailored_counseling/4273/

http://medicalresearch.com/pediatrics/increased_breastfeeding_would_reduce_morbidities_and_costs/9527/

http://www.ncbi.nlm.nih.gov/pubmed/25700532




Majority of Women Experience Stressful Life Events In Year Before Giving BirthMedicalResearch.com Interview with:

Elizabeth Burns, MPHRollins School of Public Health

Emory University

• MedicalResearch: What is the background for this study? What are the main findings?• Response: Epidemiologic studies suggest that prenatal stress is associated with preterm birth, low

birth weight and peripartum anxiety and depressive symptoms. The most recent population-based study on the prevalence of stress among pregnant women, which used data from 1990-1995, reported that 64% of women experience stressful life events (SLEs) in the year before their infant’s birth. More recent estimates of prevalence and trends of prenatal stressful life events are useful for clinicians in order to understand the risk profile of their patients.

• The Pregnancy Risk Assessment Monitoring System (PRAMS) collects self-reported information on maternal experiences and behaviors before, during, and after pregnancy among women who delivered a live infant. PRAMS includes 13 questions about maternal SLEs experienced in the year preceding the birth of the child. Based on previous research, SLEs were grouped into four dichotomous constructs:

• 1) emotional stressors (family member was ill and hospitalized or someone very close died);2) financial stressors (moved to a new address, lost job, partner lost job, or unable to pay bills);3) partner-associated stressors (separated/divorced, argued more than usual with partner/husband, or husband/partner said he did not want pregnancy); and4) traumatic stressors (homeless, involved in a physical fight, partner or self-went to jail, or someone very close had a problem with drinking or drugs).

• The prevalence of self-reported stressful life events decreased modestly but significantly during 2000–2010. Despite this, 70.2% of women reported ≥1 SLEs in 2010. Prevalence of stressful life events vary by state and maternal demographic characteristics and are especially prevalent among younger women, women with ≤12 years of education (75.6%), unmarried women (79.6%), and women that were covered by Medicaid for prenatal care or delivery of their child (78.7%).


http://medicalresearch.com/author-interviews/majority-of-women-experience-stressful-life-events-in-year-before-giving-birth/12655/

http://medicalresearch.com/general-medicine/bereavement-pregnancy-early-childhood-psychosis-risk/3449/





Emory University


• Response: Current American College of Obstetricians and Gynecologists antepartum care guidelines recommend that women be screened for psychosocial complications and social support. Clinicians should be aware that although stressful life events are especially prevalent among low-income, younger, unmarried, and less educated women, the majority of women with a college education (59.6%), with private insurance (64.2%), and who are married (64.2%) also experience stressful life events.







Emory University


• Response: It would be beneficial to understand how physicians screen their pregnant patients for psychosocial stress and social support, when and where they refer their patients with high levels of stress or stressful life events, and how effective interventions and referrals are for reducing stress. Additionally, more research is needed to develop and scale up effective programs that reduce stress among pregnant women.

• Citation:

• Stressful Life Events Experienced by Women in the Year Before Their Infants’ Births — United States, 2000–2010

• Weekly

• March 13, 2015 / 64(09);247-251



http://medicalresearch.com/author-interviews/link-between-stress-and-fertility-examined/10841/

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6409a3.htm





‘Exercise Pill’ Irisin Appears To Be A MythMedicalResearch.com Interview with:

Harold P. Erickson Ph.D.James B. Duke Professor, Department of Cell Biology

Duke Univ. Med. Center Durham, NC 27710

• MedicalResearch: What is the background for this study?

• Dr. Erickson: In Jan 2012 a paper reported the discovery of irisin, a hormone reportedly lopped off a precursor in muscle and sent through the bloodstream to fat tissue, where it turned white fat into brown fat. Brown fat burns calories, and is what hibernating animals –and even human babies — use to keep warm. Turning on brown fat had exciting promise for obesity, diabetes, etc. Dozens of labs around the world jumped on the discovery and started trials in animals and humans of how irisin levels in blood were altered by exercise and a variety of metabolic challenges.

• MedicalResearch: What are the main findings? Early reports.

• Dr. Erickson: The follow-up studies from different labs reported a huge range of values for the level of irisin in blood, so they could not all be right. And most of them failed to find any significant effect of exercise. In 2013 two papers criticized the irisin study. A commentary article by Harold Erickson (Adipocyte 2:289-93) reported two substantial flaws in the original study. A research paper by S. Raschke, J. Eckel and colleagues (PloS one 8:e73680) concluded that humans did not make significant amount of irisin. The human gene for irisin has a deleterious mutation in the start codon, and Raschke et al showed that this reduced irisinexpression to only 1% the level with the normal start. These two reports may have slowed new labs entering the field, but many groups already invested continued to publish.


http://medicalresearch.com/weight-research/exercise-pill-irisin-appears-to-be-a-myth/12664/

http://medicalresearch.com/weight-research/white_fat_may_be_converted_into_energy_burning_brown_fat/9767/






• MedicalResearch: What are the main findings? New study.

• Dr. Erickson: The new study published in Scientific Reports (5:8889) investigated the commercial ELISA kits that most previous studies used to determine irisin levels in blood. These kits were all based on polyclonal antibodies, which had never been investigated for cross-reaction to non-specific blood proteins. The new study found that these antibodies failed to detect any band of the correct size for irisin in the blood from several animal species. Moreover, each antibody strongly stained a variety of non-specific blood proteins. The conclusion was that the ELISA kits used in multiple published studies were reporting levels of non-specific proteins, not irisin.


• Dr. Erickson: Irisin was never near clinical application. The distant promise of its use in therapy, or as an “exercise pill” is now fading or gone.









• Dr. Erickson: The field really needs an assay validated to be specific for irisin, and hopefully very sensitive. If this confirmed that humans do not have irisin, as expected from the Raschkestudy, the field could quietly die.

• Citation:

• Irisin – a myth rather than an exercise-inducible myokineElke Albrecht, Frode Norheim,Bernd Thiede, Torgeir Holen,Tomoo Ohashi,Lisa Schering,Sindre Lee,Julia Brenmoehl, Selina Thomas,Christian A. Drevon, Harold P. Erickson& Steffen Maak



http://www.nature.com/srep/2015/150309/srep08889/full/srep08889.html






Hispanic and Uninsured Adults May Experience Barriers To Blood Pressure ControlMedicalResearch.com Interview with:

Stella Yi, Ph.D., MPH, Assistant ProfessorDepartment of Population Health

New York University School of Medicine


• Dr. Yi: Self-blood pressure monitoring has been shown to be an effective tool for improving blood pressure control, however most studies have only included white race participants. We were interested in assessing whether distribution of self-blood pressure monitors (intervention) would improve blood pressure and hypertension control over usual care (control) in a 9-month period in a predominantly Hispanic, uninsured population. Systolic blood pressure improved over time in both the intervention (n=409) and the control (n=419) arms by 14.7 mm Hg and 14.1 mm Hg, respectively, as did hypertension control; 39% of study participants overall achieved control at the end of follow-up. However there were no statistical differences between the outcomes in the intervention and usual care groups.


http://medicalresearch.com/author-interviews/hispanic-and-uninsured-adults-may-experience-barriers-to-blood-pressure-control/12670/

http://medicalresearch.com/stroke/mild-hypertension-control-reduces-strokes/9916/







• Dr. Yi: Results indicate that adults who are Hispanic and/or uninsured may experience additional barriers to achieving blood pressure control (i.e., prescription costs, lack of supports for lifestyle modification). From a big picture perspective, we also demonstrated the feasibility of conducting a randomized clinical trial in the electronic health record; screening, randomization and longitudinal data collection were conducted in the electronic health record. This design is within the new vein of the ‘randomized registry trial’ (Lauer & D’Agostino, 2013) that is an efficient use of resources and available data. We have further developed a toolkit for those interested in conducting similar trials on hypertension control, or on other health outcomes in the clinic setting through the electronic health record.



http://medicalresearch.com/author-interviews/ehr-electronic-health-records-cost-challenges-implementation/3651/






• MedicalResearch What recommendations do you have for future research as a result of this study?

• Dr. Yi: The findings of our study were similar to those found by the Agency for Healthcare Research and Quality (AHRQ) on the effectiveness of self-monitoring which was contemporaneously. Ours and the AHRQ report point to the need for the verification of positive results in racially and ethnically diverse communities, particularly those with limited English proficiency and/or health literacy, or with barriers to lifestyle modification. As the nation’s minority and immigrant elderly populations continue to grow, verification of the evidence-base in our culturally diverse communities are a necessity.

• Citation:

• Self-Blood Pressure Monitoring in an Urban, Ethnically Diverse Population: A Randomized Clinical Trial Utilizing the Electronic Health Record

• Stella S. Yi, Bahman P. Tabaei, Sonia Y. Angell, Anne Rapin, Michael D Buck, William G. Pagano, Frank J. Maselli, Alvaro Simmons, and Shadi Chamany

• Circ Cardiovasc Qual Outcomes. 2015;CIRCOUTCOMES.114.000950published online before print March 3 2015, doi:10.1161/CIRCOUTCOMES.114.000950



http://circoutcomes.ahajournals.org/content/early/2015/03/03/CIRCOUTCOMES.114.000950.abstract





Some Athletes May Need Salt Supplementation During Endurance EventsMedicalResearch.com Interview with: Juan Del Coso Garrigós

Profesor CC. de la Act. Física y del DeporteResponsable del Laboratorio de Fisiología del Ejercicio

UNIVERSIDAD CAMILO JOSÉ CELA• MedicalResearch: What is the background for this study? What are the main findings?• Response: From a scientific point of view, it is well known that salt (either in capsules or included in

a drink) can improve physical performance and several other physiological factors such as plasma volume maintenance, thermoregulation, etc in endurance activities. These effects are more evident when the amount of salt ingested during exercise matches the amount of salt lost by sweating. By using only sports drinks, it is impossible to replace all the salt lost by sweating because they only contain a relatively small amount of salt in their compositions (between ½ and 1/3 of the amount of salt lost by sweating).

• In fact, some of the investigations that determined the effectiveness of ingesting salt in sports have been financed by most popular sport drinks trademarks. However, sports drink companies only include a part of the salt lost by sweating because for them, taste is elemental for their markets! I suppose that, if they include more salt in their commercially available drinks, they would be more effective to prevent dehydration and performance decline, but at the same time, the taste of the drink would diminish the amount of beverage ingested worldwide.

• In this case, in the sport drinks market there is a well- established balance between taste and physiological effectiveness.

• As an example, most “salted” sport drinks contain 20-25 mM of sodium while it is well known that sweat sodium concentration ranges from 20 to 60 mM (salty sweater can reach 100 mM!!). This is not a regulatory limitation, because UE considers sports drinks to carbohydrate-electrolyte solutions that contain sodium between 20 and 50 mM.

• Our main finding is: To ingest salt capsules, in addition to the habitual rehydration routines with sports drinks, improves performance in a triathlon. This ergogenic effect was mediated by better maintenance of body water and electrolytes balances.


http://medicalresearch.com/exercise-fitness/some-athletes-may-need-salt-supplementation-during-endurance-events/12674/

http://medicalresearch.com/weight-research/sports_drinks_linked_to_weight_gain_in_adolescents/6627/





UNIVERSIDAD CAMILO JOSÉ CELA


• Response: The results of our investigation are only applicable to athletes and especially to endurance athletes involved in long-distance/long-lasting competitions. For these athletes, the take home message is “matching (or trying to match) sweat electrolyte losses to salt ingestion” might be an easy and effective strategy to improve performance and to avoid electrolyte imbalances such as hyponatremia.

• In this case, it would be incorrect to recommend “an amount of salt for athletes” because the salt lost during exercise varies from disciplines (marathon vs gymnastics, for example, would have very different demands of sodium), environmental conditions, genetics, etc.

• It is also important to remark that the outcomes of this investigation are not applicable to healthy and/or inactive people. They do not need “extra” salt because they do not loss it (the amount of sweat produced during a regular day without exercise or sport activities is very low and the salt lost by urine can be easily recovered with the diet).







UNIVERSIDAD CAMILO JOSÉ CELA


• Response: In the future, investigations should focus on the design of devices that (easily) measure electrolyte concentrations in thermoregulatory sweat, the determination of factors that influence the sweat electrolyte concentrations, efficacy of sport drinks with higher amounts of salt (in comparison to present compositions), etc.

• Citation:

• Del Coso, C. González-Millán, J. J. Salinero, J. Abián-Vicén, F. Areces, M. Lledó, B. Lara, C. Gallo-Salazar, D. Ruiz-Vicente. Effects of oral salt supplementation on physical performance during a half-ironman: A randomized controlled trial. Scandinavian Journal of Medicine & Science in Sports, 2015; DOI: 10.1111/sms.12427

• MedicalResearch.com Interview with: Juan Del Coso Garrigós (2015). Some Athletes May Need Salt Supplementation During Endurance Events



http://dx.doi.org/10.1111/sms.12427



Bacterial DNA Detected In Blood Of Patients With Active PsoriasisMedicalResearch.com Interview with:

Dr. Ana Ramírez-Boscá, MDDepartment of Dermatology and Clinical Research U


• Response: Infections have been related with the pathogenesis of guttate psoriasis, however antibiotic treatment does not improve prognosis nor does it affect the evolution of the disease. The association between psoriasis and other infectious diseases has been reported as well, although in these cases there is scarce information on the causative microbial likely involved and the role of these bacteria in the pathogenesis of this skin disease.

• MedicalResearch: What are the main findings?

• Response: Bacterial DNA may be detected in bloodstream of a significant proportion of patients with active plaque psoriasis. Increased levels of pro-inflammatory cytokines in patients with presence of bacterial DNA but not in patients without presence of bacterial genomic fragments suggest a role of bacterial DNA translocation in inducing an inflammatory response.


http://medicalresearch.com/infections/bacterial-dna-detected-in-blood-of-patients-with-active-psoriasis/12676/






• Response: Data here reported open the possibility of research on new therapeutic paths.

• It remains of great interest to assess if controlling psoriasis may help blockade episodes of bacterial translocation (BT), or if in turn, avoiding BT may help control active plaque psoriasis. We can hypothesize that new therapies might help to decrease the levels of systemic inflammatory markers acting as an adjuvant therapy to the currently known treatment for psoriasis and opening the possibility to improve the clinical situation of patients.



http://medicalresearch.com/author-interviews/psoriasis_linked_to_increased_risk_of_atherosclerosis/8709/






• Response: New studies are needed to clarify if BT is related with the pathogenesis of not only active plaque psoriasis but also all phenotypes of psoriasis. Future investigations on these issues as well as on the intestinal permeability and the intestinal microbiota in psoriatic patients seems necessary to ascertain the real role that all these facts play in the pathogenesis of psoriasis and help designing new therapeutic options. We are still in the beginings of this new finding that is the phenomenon of bacterial translocation in the psoriasis, but multidisciplinary medical treatment involving infectologists, geneticists, immunologists and dermatologists could be the near future in the treatment of psoriasis.

• Citation:

• Ramírez-Boscá A, Navarro-López V, Martínez-Andrés A, et al. Identification of Bacterial DNA in the Peripheral Blood of Patients With Active Psoriasis. JAMA Dermatol. Published online March 11, 2015. doi:10.1001/jamadermatol.2014.5585.



http://medicalresearch.com/diabetes/psoriasis-linked-to-insulin-resistance-and-increased-risk-of-diabetes/11328/

http://archderm.jamanetwork.com/article.aspx?articleid=2174889



Is Liberal Transfusion Threshold After Cardiac Surgery Preferable?MedicalResearch.com Interview with:

Barnaby C. Reeves, D.Phil.Professor of Health Services Research, Clinical Trials & Evaluation Unit

School of Clinical Sciences, University of Bristol Bristol Royal Infirmary Bristol


Response: Variable decisions are made about when to transfuse patients after cardiac surgery. The circumstances of particular patients influence decisions about whether to give a transfusion.

• Transfusion is a life-saving intervention when a patient is experiencing life-threatening bleeding but most patients have only one or two units of red cells transfused. These transfusions are given at varying levels of anaemia. Some doctors prefer to give a transfusion after cardiac surgery when a patient is only mildly anaemic, believing that the transfusion will promote recovery, while other doctors prefer to wait to transfuse until a patient is substantially anaemic, believing that a transfusion may do more good than harm and is wasteful if it is not needed. Therefore, we carried out a randomized controlled trial comparing restrictive (transfuse when haemoglobin <7.5 g/dL) and liberal transfusion thresholds (transfuse when haemoglobin <9.0 g/dL).*


http://medicalresearch.com/heart-disease/is-liberal-transfusion-threshold-after-cardiac-surgery-preferable/12685/

http://medicalresearch.com/author-interviews/study-evaluates-intraoperative-hypothermia-and-transfusion-requirements/10879/







Response: We obtained written informed consent before surgery but only randomized participants after surgery, in intensive care, if their Hb dropped below 9 g/dL. (Hence, we recruited over 3,500 patients but randomized only 2007.) This design avoids ‘diluting’ any difference between groups by including participants who would not usually be ‘considered’ for transfusion.

• The primary outcome was the occurrence of one or more serious complications: heart attack, stroke, acute kidney injury, bowel infarction, infection; this included/involved 35.1% of the patients in the restrictive-threshold group and 33.0% of the patients in the liberal-threshold group. This slight difference – more in the restrictive group – was not statistically significant.

• We then compared the percentages of patients who died; these were 4.2% in the restrictive group and 2.6% in the liberal group. The difference in this secondary outcome was of borderline statistical significance. Frequencies of other secondary outcomes (infections, ischaemic events, days in critical care and hospital, pulmonary complications) were not different in the two groups.

• We also carried out some pre-specified sensitivity analyses for the primary outcome and all-cause mortality. The two most important ones aimed to avoid dilution of the difference between groups as a result of patients having transfusions or outcome events before randomization. Excluding patients who were transfused before randomization shifted the treatment effect to favour the liberal threshold more strongly, for both the primary outcome and mortality. Excluding patients who experienced an outcome event in the first 24 hours after randomization did not change the treatment effect for either outcome.









• Response: The headline finding of no difference in the primary outcome allows us to reject the hypothesis that a restrictive threshold is better. The finding can be considered “supportive” of either a restrictive or a liberal threshold. Given the cost of red-cells (and the very small risks of a transfusion-related harm), not giving a transfusion should logically be preferred. However, some findings pointed to patients in the liberal threshold group having better outcomes, including fewer deaths, and there were no adverse consequences of the liberal threshold; these findings have prompted us to hypothesize that the liberal threshold may be better for patients.









• Response: Researchers responsible for four other liberal vs restrictive transfusion trials in cardiac surgery patients should re-analyse their data, excluding patients in both groups who did not breach the liberal threshold. These re-analyses should increase the ability of the trials to detect a difference and make available the results of all of the trials in a consistent and optimal way. These estimates could then be pooled in a meta-analysis (accepting that the thresholds studied varied in the trials).

• Researchers could do a larger trial powered for mortality. We think this is relevant because doctors would be likely to act on the difference in mortality that we observed (50% higher risk of death at 90 days) if they were confident that the difference really existed. In fact, a new trial, TRICS-III, has started to recruit in Canada and the USA with a target sample size of 3,592. It has a composite primary outcome of death, heart attack, kidney failure requiring dialysis or stroke. A meta-analysis combining the mortality data from this trial with TITRe2 and other trials (ideally analysed as proposed above) would have sufficient power to detect a difference of the magnitude observed in the TITRe2 trial.

• * The trial was funded by the National Institute for Health Research (NIHR) Health Technology Assessment program (ref: 06/402/94). The views and opinions expressed are those of the authors and do not necessarily reflect those of the NIHR Health Technology Assessment program, the National Health Service or the Department of Health.

• Citation:

• Liberal or Restrictive Transfusion after Cardiac Surgery

• Gavin J. Murphy, F.R.C.S., Katie Pike, M.Sc., Chris A. Rogers, Ph.D., Sarah Wordsworth, Ph.D., Elizabeth A. Stokes, M.Sc., Gianni D. Angelini, F.R.C.S., and Barnaby C. Reeves, D.Phil. for the TITRe2 Investigators

• N Engl J Med 2015; 372:997-1008March 12, 2015DOI: 10.1056/NEJMoa1403612



http://medicalresearch.com/author-interviews/battlefield-tested-transfusion-strategy-improves-outcomes/11261/

http://www.nejm.org/doi/full/10.1056/NEJMoa1403612






Tai Chi Based Cardiac Rehabilitation Improved Functional Capacity After Heart AttackMedicalResearch.com Interview with:

Ricardo Stein, MD, ScDExercise Cardiology Research Group, Cardiology Division

Federal University of Rio Grande do Sul, Hospital de Clinicas de Porto Alegre, Porto Alegre, RS, Brazil

• MedicalResearch: What is the background for this study?

• Dr. Stein: Patients with a recent myocardial infarction (MI) present a reduction in functional capacity expressed as a decrease in peak oxygen consumption (VO2 peak). The impact of a Tai Chi Chuan (TCC) cardiac rehabilitation program for patients recovering from recent MI has yet to be assessed. Our goal was to evaluate functional capacity after a TCC-based cardiac rehabilitation program in patients with recent non complicated MI.


http://medicalresearch.com/heart-disease/tai-chi-based-cardiac-rehabilitation-improved-functional-capacity-after-heart-attack/12689/






• MedicalResearch: What are the main findings?

• Dr. Stein: After the 12-week study period, participants in the Tai Chi Chuan group experienced a significant 14% increase in VO2 peak from baseline (21.6 ± 5.2 to 24.6 ± 5.2 mL.Kg-1.min-1), whereas control participants had a non-significant 5% decline in VO2 peak (20.4 ± 5.1 to 19.4 ± 4.4 mL.Kg-1.min-1). There was a significant difference between the two groups (P<0.0001).

• As a primary outcome, CPET results for the TCC and control groups at baseline and after the 12-week intervention period leading to a significant difference in peak VO2 (5.2 mL.Kg-1.min-1; 95% CI, 2.8 to 7.7, in favor to TCC group). This difference remained significant after adjustment to baseline measurements, age, gender, diabetes, and smoking (4.1 mL.Kg-1.min-

1; 95% CI, 2.6 to 5.6, in favor to TCC group).

• Summarizing:

• – We observed a significant increase in VO2 peak in TCC group participants.

• – Our results provide important information data from a randomized clinical trial of Tai Chi Chuan in patients with a history of recent MI.

• – Tai Chi Chuan can be an attractive alternative to cardiac rehabilitation for patients who don’t have access to conventional cardiac rehabilitation programs.








• MedicalResearch: What should clinicians and patients take away from your report?• Dr. Stein: Tai Chi Chuan practice was associated with an increase in VO2 peak in patients with a

recent MI and may constitute an effective form of cardiac rehabilitation in this patient population.• MedicalResearch: What recommendations do you have for future research as a result of this

study?• Dr. Stein: Only a small number of patients have access to rehabilitation programs. In this setting, Tai

Chi Chuan can be an appealing alternative for cardiac rehabilitation, since it does not require any equipment (which lowers its cost), can be group-based, and sessions can be held outdoors whenever possible. Taking into account that the vast majority of patients who suffer a MI do not attend rehabilitation programs, any safe, efficient, and easy-to-implement alternatives to conventional rehabilitation is welcome. Nevertheless, the intervention might not be fully reproducible, it is necessary a trained Tai Chi Chuan leader and that the population might not be generalizable. Also, whether this intervention can be practiced in an unsupervised setting after MIneeds further investigation. Thus, it is important to mention that this is a small feasibility clinical trial that should be replicated.

•Citation:

• Tai Chi Chuan Improves Functional Capacity After Myocardial Infarction: A Randomized Clinical Trial• Rosane Maria Nery, Maurice Zanini, Juliana Beust de Lima, Raquel Petry Bühler, Anderson Donelli

da Silveira, Ricardo SteinPublication stage: In Press Accepted ManuscriptAmerican Heart JournalPublished online: March 14, 2015



http://medicalresearch.com/heart-disease/cardiac-rehabilitation-enhanced-smartphone-app/6271/

http://medicalresearch.com/heart-disease/should_beta_blockers_be_used_after_myocardial_infarction/8905/

http://www.ahjonline.com/article/S0002-8703(15)00172-6/abstract







TAVR Bests Standard Therapy For Sick, Elderly Patients With Severe ASProf Samir R Kapadia MD

Director, Sones Cardiac Catheterization LaboratoriesCleveland Clinic Cleveland, OH

• For patients with severe symptomatic aortic stenosis (AS) who are not candidates for surgical valve replacement, transcatheter aortic valve replacement (TAVR) offers superior benefit to standard therapy, as measured by all-cause mortality, cardiovascular mortality, repeat hospital admission and functional status. PARTNER 1B 5 year data were published simultaneously with PARTNER 1A 5 year data in 2 separate manuscripts in the Lancet (March 15 2105).

• In this landmark trial, TAVR produced a 22 percent survival benefit and a 28 percent reduced risk of cardiovascular mortality, compared with standard treatment.

• According to Cleveland Clinic interventional cardiologist Samir Kapadia, MD, lead author of PARTNER 1B, these findings have changed the treatment paradigm for severe Aortic Stenosis patients who can’t undergo surgical Aortic Valve Replacement.

• “This trial is the first—and will probably be the only—randomized AS trial that includes a standard treatment group, since these results will make it unethical to treat severe AS patients with medical therapy alone without aortic valve replacement. ” he says.


http://medicalresearch.com/heart-disease/tavr-bests-standard-therapy-for-sick-elderly-patients-with-severe-aortic-stenosis/12695/





• Superior survival benefit with TAVR

• PARTNER 1B is the only rigorous randomized trial of extreme-risk aortic stenosis patients that has prospectively reported the outcomes of TAVR versus standard treatment in patients for whom the estimated probability of death or serious irreversible morbidity after surgical aortic valve replacement was 50 percent or greater.

• The trial enrolled 358 patients between May 11, 2007 and March 16, 2009; 179 patients were assigned to TAVR with the first-generation Sapien valve and 179 to standard therapy which includes medical therapy and balloon aortic valvuloplasty. TAVR was performed under general anesthesia with common femoral artery access. Guidance was provided by transesophagel echocardiography and fluoroscopy. The mean age of participants was 83.

• The primary endpoint was all-cause survival. Secondary endpoints included cardiovascular mortality, stroke, vascular complications, major bleeding and functional status.

• At the end of the 5-year follow-up, the overall mortality rate was 71.8 percent in the TAVR group and 93.6 percent in the standard treatment group. Only six patients who had undergone standard therapy were still alive; of these, five had undergone AV replacement and leaving only one surviving patient without aortic valve replacement. This patient had a balloon valvuloplasty. Mean survival in the TAVR group was 31 months, versus 11.7 months in the standard treatment group.

• “This reinforces that aortic valve replacement must be considered very seriously for these patients,” says Dr. Kapadia.







• Despite the low number of survivors in the standard-treatment group, landmark analysis showed that the differences in survival remained significant between 3 and 5 years. For patients who were alive at 3 years, the risk of all-cause mortality at 5 years was 38.9% for TAVR patients and 66.7% in the standard treatment cohort.

• Superior results in secondary endpoints

• At 5-year follow-up, TAVR bested standard treatment in multiple measures:

• Cardiovascular mortality. The risk of cardiovascular mortality was 57.5 percent in the TAVR group and 85.9 percent in the standard treatment group.

• Repeat hospitalization. Only 47.6 percent of TAVR patients required rehospitalization, compared with 87.3 percent of the standard treatment group.

• Valve durability. No increase in transvalvular gradient, attrition of valve area or worsening of aortic regurgitation was seen. No patient had structural valve deterioration requiring intervention.

• Functional status. Of the 49 TAVR patients surviving at 5 years, 86 percent were NYHA class I or II.

• “This benefit is remarkable for inoperable elderly patients and a first- generation device,” says Dr. Kapadia.







• Equivalent stroke risk

• The stroke risk at 5 years was 16 percent with TAVR and 18.2 percent with standard treatment—essentially equivalent. Since so few patients in the standard treatment group survived, the researchers conducted a competing risk analysis for mortality and stroke. “It confirmed there was no continuous hazard of stroke associated with TAVR after the initial procedure risk,” says Dr. Kapadia.

• Fine-tuning patient selection

• TAVR conferred cardiovascular mortality and all-cause mortality benefits in patients with multiple comorbidities, as indicated by higher STS scores. Early survival was not different in these patients, underscoring the probable effect of the comorbidities on early survival, despite successful TAVR.

• “This shows the importance of making every attempt to differentiate patients who will derive survival benefit from those who are unlikely to survive, despite successful TAVR,” says Dr. Kapadia. “Although clinical outcomes with TAVR are encouraging, better patient selection and reduction in procedural complications will help make TAVR even more beneficial.”







• Citations:

• 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial

• Samir R Kapadia, Martin B Leon, Raj R Makkar, E Murat Tuzcu, Lars G Svensson, Susheel Kodali, John G Webb, Michael J Mack, Pamela S Douglas, Vinod H Thourani, Vasilis C Babaliaros, Howard C Herrmann, Wilson Y Szeto, Augusto D Pichard, Mathew R Williams, Gregory P Fontana, D Craig Miller, William N Anderson, Craig R Smith, for the PARTNER trial investigators, Jodi J Akin, Michael J DavidsonDOI: http://dx.doi.org/10.1016/S0140-6736(15)60290-2

• —————————–

• 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial

• Michael J Mack, Martin B Leon, Craig R Smith, D Craig Miller, Jeffrey W Moses, E Murat Tuzcu, John G Webb, Pamela S Douglas, William N Anderson, Eugene H Blackstone, Susheel K Kodali, Raj R Makkar, Gregory P Fontana, Samir Kapadia, Joseph Bavaria, Rebecca T Hahn, Vinod H Thourani, Vasilis Babaliaros, Augusto Pichard, Howard C Herrmann, David L Brown, Mathew Williams, M

• DOI: http://dx.doi.org/10.1016/S0140-6736(15)60308-7

• Both from The Lancet March 1 2015



http://dx.doi.org/10.1016/S0140-6736(15)60290-2

http://dx.doi.org/10.1016/S0140-6736(15)60308-7



ACA: Small Drop In Emergency Room Visits by Young AdultsMedicalResearch.com Interview with:

Asako Moriya Ph.DSchool of Public and Environmental Affairs Indiana University, Bloomington, IN

Center for Financing, Access and Cost Trends Agency for Healthcare Research and QualityRockville, MD


• Response: Historically, young adults have had the lowest rate of insurance coverage. They have also frequently sought non-urgent care in emergency departments (EDs). However, ED care, while appropriate for injuries and other true emergencies, is very expensive and inefficient for non-urgent care. The Affordable Care Act (ACA)’s dependent coverage provision requires health plans that offer dependent coverage to allow young adults to stay on their parents’ private health plans until age 26. This insurance expansion had a potential to improve efficiency by reducing inappropriate ED use.

• We used data from the Agency for Healthcare Research and Quality and found that the quarterly ED-visit rate decreased by a small, but statistically significant amount (1.6 per 1,000 population) among adults age 19-25 after the implementation of the ACA’s dependent coverage provision. The decrease was concentrated among women, weekday visits, non-urgent conditions, and conditions that could be treated in other settings. We found no effect among visits due to injury, weekend visits, and urgent conditions.

• The findings suggest that the ACA’s dependent coverage provision has increased the efficiency of medical care delivery by reducing non-urgent ED use. Having access to their parents’ health insurance appears to be prompting young adults to use medical care more appropriately.


http://medicalresearch.com/author-interviews/aca-small-drop-in-emergency-room-visits-by-young-adults/12659/




ACA: Small Drop In Emergency Room Visits by Young AdultsMedicalResearch.com Interview with:

Asako Moriya Ph.DSchool of Public and Environmental Affairs Indiana University, Bloomington, IN

Center for Financing, Access and Cost Trends Agency for Healthcare Research and QualityRockville, MD


• Response: This study evaluated the ACA’s dependent coverage provision, which only impacts the coverage options for young adults whose parents have private health insurance. The affected young adults most likely are of different socioeconomic and demographic characteristics (for instance, are younger and of higher socioeconomic status) compared to the population that is affected by the overall ACA insurance expansion. Future research will be needed to assess the impact of coverage expansions on the broader range of adults – in terms of both income and age – who will gain coverage under the ACA over the coming decade.

• Citation:

• Changes in Emergency Department Use Among Young Adults After the Patient Protection and Affordable Care Act’s Dependent Coverage Provision

• Antwi, Yaa Akosa et al.

• Annals of Emergency Medicine ; Published Online: March 10, 2015 DOI: http://dx.doi.org/10.1016/j.annemergmed.2015.01.010




http://www.annemergmed.com/article/S0196-0644(15)00027-X/abstract






CT Coronary Angiography Safely Clarifies Heart Disease DiagnosisMedicalResearch.com Interview with:

Prof. David NewbyBritish Heart Foundation Professor of Cardiology University of Edinburgh

Director of the Wellcome Trust Clinical Research Facility


• Dr. Newby: The diagnosis of angina (chest pain) due to coronary heart disease can be very challenging and we often get it wrong. We have a wide range of tests that can try and identify patients with angina due to coronary heart disease. However, even with these tests, we fail to identify 1 in 3 patients who go on to have heart attacks. So we need better tests.

• The study shows that if you add CTCA to a clinic consultation, you clarify the diagnosis in 1 in 4 patients, alter the investigations in 1 in 6 and change the subsequent treatments in 1 in 4. This did appear not only to increase the use of coronary revascularisation but also reduce the risk of subsequent heart attacks by 38-50%.


• Dr. Newby: CT coronary angiography is a rapid safe and effective way to diagnose coronary heart disease that appears to have major additional benefits in terms of clarifying the diagnosis, focusing appropriate investigations and treatments, and potentially reducing the risk of heart attacks.


http://medicalresearch.com/heart-disease/ct-coronary-angiography-safely-clarifies-heart-disease-diagnosis/12635/

http://medicalresearch.com/pain-research/nsaids-after-heart-attack-increase-risks-of-bleeding-and-further-attacks/12138/



CT Coronary Angiography Safely Clarifies Heart Disease DiagnosisMedicalResearch.com Interview with:

Prof. David NewbyBritish Heart Foundation Professor of Cardiology University of Edinburgh

Director of the Wellcome Trust Clinical Research Facility


• Dr. Newby: We need to see the longer term impact of CTCA on symptoms of angina, hospitalisations for chest pain and the long term outcome (5 years) of these patients. We will also need to assess the health economics and cost effectiveness of this approach.

• Citation:

• CT coronary angiography in patients with suspected angina due to coronary heart disease (SCOT-HEART): an open-label, parallel-group, multicentre trial

• The SCOT-HEART investigators

• DOI: http://dx.doi.org/10.1016/S0140-6736(15)60291-4

• The Lancet March 15 2015



http://medicalresearch.com/heart-disease/most_heart_disease_patients_may_not_have_angina/6910/

http://www.thelancet.com/journals/lancet/latestcontent

http://dx.doi.org/10.1016/S0140-6736(15)60291-4

http://www.thelancet.com/journals/lancet/latestcontent



Destination LVAD Devices Come With Caregivers’ Concerns and TensionsMedicalResearch.com Interview with:

Colleen K. McIlvennan, DNP, ANPAssistant Professor of Medicine University of Colorado, Division of Cardiology

Section of Advanced Heart Failure and Transplantation


• Response: Destination therapy left ventricular assist device (DT LVAD) patients are often older with significant comorbidities that preclude heart transplantation. As such, the decision to get a DT LVAD is arguably more complicated than the decision to receive a temporary LVAD in anticipation of a transplant. Centers offering LVADs often require the identification of a caregiver prior to proceeding with the implant. Caregivers are commonly female spouses of DT LVAD patients, who are also older with co-morbidities. Understanding their perspective in DT LVAD decision making is extremely important as they are at particular risk for experiencing stress and caregiver burden due to the increased demands on caregiving with DT LVAD.


• Response: We performed semi-structured qualitative interviews with 17 caregivers: 10 caregivers of patients living with DT LVAD, 6 caregivers of patients who had died with DT LVAD, and 1 caregiver of a patient who had declined DT LVAD. Throughout the interviews, the overarching theme was that considering a DT LVAD is a complex decision-making process.

• Additionally, three dialectical tensions emerged:1) the stark decision context, with tension between hope and reality;2) the challenging decision process, with tension between wanting loved ones to live and wanting to respect loved ones’ wishes; and3) the downstream decision outcome, with tension between gratitude and burden.


http://medicalresearch.com/heart-disease/destination-lvad-devices-come-with-caregivers-concerns-and-tensions/12433/

http://medicalresearch.com/heart-disease/how_do_patients_decide_to_accept_a_lvad/5245/







• Response: Several interventions should be considered for caregivers of patients considering DT LVAD.

• First, in order to better prepare caregivers for the burdens of DT LVAD, LVAD programs should continue to invite caregivers to participate in the decision-making process. This helps to address caregivers’ concerns and works to further engage them as active participants.

• Second, DT LVAD caregiver-specific tools and resources should be developed to outline responsibilities and the impact on the caregiver’s life.

• Third, providing caregivers with tools such as a decision aid may help to manage expectations and relieve the potential for post-decision caregiver burden. It is important for programs to normalize the ambivalence felt by caregivers by informing them that others have experienced this as a very complex decision.

• Fourth, ongoing caregiver support groups, separate from patient support groups, can assist in empowering caregivers as well as validating feelings and concerns.









• Response: Future work surrounding caregivers of patients considering DT LVAD should explore the decision process prospectively. Additionally, future studies should investigate the potential correlations between caregivers and their propensity toward certain tensions (e.g. which characteristics make caregivers more likely to have decision regret). This would lend itself to identifying caregivers who would benefit from tailored caregiver support or interventions, with some caregivers potentially needing no interventions at all.

• Citation:

• ACC15 Abstract 318: Caregiver Experiences with Decision Making in Destination Therapy Left Ventricular Assist Devices: A Qualitative Study

• Colleen K McIlvennan, Jacqueline Jones, Larry A Allen, JoAnn LindenfeldCarolyn Nowels, Keith M Swetz and Daniel D Matlock



http://circoutcomes.ahajournals.org/content/7/Suppl_1/A318?cited-by=yes&legid=circcvoq;7/Suppl_1/A318

http://circoutcomes.ahajournals.org/content/7/Suppl_1/A318?cited-by=yes&legid=circcvoq;7/Suppl_1/A318



Sodium Content In Commercial Foods Remains High and VariableMedicalResearch.com Interview with: Jaspreet Ahuja, Nutritionist

USDA, Agricultural Research ServiceNutrient Data Laboratory

Beltsville, MD 20705


• Response: Most sodium in the U.S. diet comes from commercially processed and restaurant foods. Sodium reduction in these foods is key to several recent public health efforts. In this paper, we provide an overview of a program led by Nutrient Data Laboratory, USDA, in partnership with CDC and FDA to monitor sodium contents in commercially processed and restaurant foods in United States.

• We track about 125 highly consumed, sodium-contributing foods, termed “Sentinel Foods” annually using information from food manufacturers and periodically by nationwide sampling and laboratory analyses. In addition, we monitor over 1,100 other commercially processed and restaurant food items, termed “Priority-2 Foods,” biennially using information from food manufacturers. These foods serve as indicators for assessing changes in the sodium content of commercially processed and restaurant foods in the U.S. In addition to sodium, we are monitoring related nutrients (potassium, total dietary fiber, total and saturated fat, total sugar) because their levels may change when manufacturers and restaurants reformulate their products to reduce their sodium content.

• We sampled all Sentinel Foods nationwide and reviewed all Priority-2 Foods in 2010–2013 to determine baseline sodium concentrations. The results of sodium reduction efforts, based on re-sampling of the Sentinel Foods or re-review of P2Fs, will become available in 2015 on our website. The updated data are also released in USDA food composition databases, National Nutrient Database for Standard Reference and Food and Nutrient Database for Dietary Studies.


http://medicalresearch.com/medical-research-centers/nih/sodium-content-in-commercial-foods-remains-high-and-variable/12702/

http://medicalresearch.com/medical-research-centers/nih/too_little_and_too_much_salt/4630/



Sodium Content In Commercial Foods Remains High and VariableMedicalResearch.com Interview with: Jaspreet Ahuja, Nutritionist

USDA, Agricultural Research ServiceNutrient Data Laboratory

Beltsville, MD 20705


• Response: The sodium content of commercially processed and restaurant foods in the U.S. is high for many foods and often quite variable. Increased awareness of the high sodium content and variability within a food item is important for consumers, clinicians, and dietitians because of its impact on estimates of sodium intakes.


• Response: The baselines values will be compared to analytical values from re-sampling of Sentinel Foods and re-review of Priority-2 Foods to track sodium reduction efforts in the U.S. We need to investigate the impact of sodium reductions on related nutrients when the results from the re-sampling become available, as the picture is complex as changes in the concentrations of related nutrients that the 2010 Dietary Guidelines for Americans recommended for reduced (total and saturated fat, total sugar) or increased (potassium, total dietary fiber) consumption accompany sodium reduction.

• Citation:

• Sodium monitoring in commercially processed and restaurant foodsAhuja JK1, Pehrsson PR1, Haytowitz DB1, Wasswa-Kintu S1, Nickle M1, Showell B1, Thomas R1, Roseland J1, Williams J1, Khan M1, Nguyen Q1, Hoy K1, Martin C1, Rhodes D1, Moshfegh A1, Gillespie C1, Gunn J1, Merritt R1, Cogswell M1.Am J Clin Nutr. 2015 Mar;101(3):622-31. doi: 10.3945/ajcn.114.084954. Epub 2015 Jan 28.



http://medicalresearch.com/author-interviews/salt-intake-reduced-by-warnings-on-salt-containers/10502/

http://medicalresearch.com/author-interviews/dietary_fiber_potential_mechanism_of_appetite_suppression_discovered/5130/






Research Suggests Neural Stem Cells Have Brief LivesMedicalResearch.com Interview with Filippo Calzolari PhD

Institute of Stem Cell Research, ISF-NHelmholtz Zentrum München

Neuherberg Germany


• Dr. Calzolari: Despite their amazing complexity, life-long production of new neurons occurs in only a few well-circumscribed areas in adult mammalian brains, thanks to the activity of adult Neural Stem Cells (NSCs). How Neural Stem Cells in these regions maintain neuronal production throughout life is however poorly understood, due in part to the difficulty of assessing the behavior of single stem cells, in vivo.

• Our work now partially fills this gap, by providing a description of how single Neural Stem Cells of the mouse subependymal zone (SEZ) generate new neurons destined to the olfactory bulb (OB).

• In the SEZ, only a small proportion of Neural Stem Cells are active at any given time, and single stem cells sustain neurogenesis in a rather “bursty” manner, often generating more than a hundred immature neurons within a few weeks. Given such dynamism, it came as a surprise to note that most NSCs became exhausted after a few weeks of starting their activity, thus failing to show a crucial hallmark of “stemness”, i.e. the ability to extensively self-renew. Interestingly, each Neural Stem Cell mostly produced only one of the various subtypes of neurons that make up the adult-generated olfactory bulb neuronal population. These new data thus indicate that both long-term adult neuron generation and the production of a diverse set of neurons are the cumulative result of a population of individually short-lived and subtype-restricted “stem cells”.


http://medicalresearch.com/stroke/research-suggests-neural-stem-cells-have-brief-lives/12705/

http://medicalresearch.com/stem-cells/stem-cells-can-be-grown-from-blood-of-deceased-patients/10305/





Neuherberg Germany


• Dr. Calzolari: Ours is a rather basic description of a biological process, and it is therefore “risky” to come up with catchy messages for clinicians and patients alike. However, a notion that should stick is that aging may be associated with the progressive loss, rather than drift to quiescence, of neural stem cells. Therefore, trying to preserve stem cell numbers over time may be a useful preventive strategy, should any late regenerative response need to be elicited. It´s clear however that a lot needs to be figured out in order to safely attempt such a strategy.







Neuherberg Germany


• Dr. Calzolari: A crucial step will be to figure out the molecular basis for the rather brief nature of neural stem cells activity. Can neuron production from a single NSC be prolonged safely?

• Maybe even more crucial, it will be to find out how much our observations apply to humans. Are our Neural Stem Cells as short-lived as mouse ones?

• Citation:

• Fast clonal expansion and limited neural stem cell self-renewal in the adult subependymal zoneFilippo Calzolari, Julia Michel,Emily Violette Baumgart, Fabian Theis, Magdalena Götz

• & Jovica Ninkovic Nature Neuroscience (2015)

• doi:10.1038/nn.3963



http://www.nature.com/neuro/journal/vaop/ncurrent/full/nn.3963.html





Air Pollution May Raise Risk Of Carotid Artery StenosisMedicalResearch.com Interview with:

Jonathan D. Newman, MD, MPHInstructor of Medicine The Leon H Charney Division of Cardiology and

The Center for the Prevention of Cardiovascular Disease New York University School of MedicineNY, NY 10016


• Dr. Newman: Outdoor fine air pollution (PM2.5 defined as mass concentration of particles < 2.5µM) is ubiquitous and associated with cardiovascular mortality, ischemic heart disease events and stroke. There are known vascular and hemodynamic effects of air pollution exposure that may explain some, but not all, of this increased risk. However, prior to this study it was unknown whether fine particle air pollution exposure is associated with prevalent clinical atherosclerosis, such as carotid artery stenosis.

• For the first time we examined the association between fine particle air pollution exposure and carotid artery stenosis in over 300,000 people living in New York, New Jersey and Connecticut. Working with colleagues in Environmental Medicine from NYU LangoneMedical Center, we used data from the Environmental Protection Agency’s Air Quality System to estimate the average annual fine particle air pollution by zip code in the tri-state area. Air pollution data was then associated with the results of vascular screening tests from tristateresidents age 40-80 participating in the Life Line Vascular Screening (LLS, Independence, Ohio).

• After adjusting for the effects of known cardiovascular disease risk factors such as smoking, hypertension, hyperlipidemia, diabetes and physical inactivity, we found that each 10µg/m3 increase in air pollution exposure was associated with a nearly two-fold increase in risk of carotid artery stenosis (OR 1.90, 95% CI (1.35-2.66). Similarly, compared to the lower levels of air pollution exposure, participants in the highest fourth of air pollution exposure had a 24% increased risk in carotid artery stenosis (OR 1.24 95% CI 1.11-1.37).


http://medicalresearch.com/heart-disease/air-pollution-may-raise-risk-of-carotid-artery-stenosis/12710/

http://medicalresearch.com/stroke/family-history-closely-linked-carotid-artery-stenosis/6432/







• Dr. Newman: Our study shows that air pollution exposure has important vascular effects, even at lower levels of exposure. It also shows that these effects are independent of known strong risk factors for cardiovascular disease, such as smoking, high blood pressure and high cholesterol. Our findings support public health and governmental initiatives to limit and/or reduce air pollution exposure, and also indicate that it may be prudent for individuals with high risk of cardiovascular disease such as people with prior known heart disease, strokes, diabetes or vascular disease to limit the time spent outdoors when indices of air quality are poor.



http://medicalresearch.com/tobacco-research/tobacco/smokers_homes_have_high_air_pollution_levels/8325/







• Dr. Newman: Future studies need to investigate the specific components of air pollution that are associated with vascular disease risk, and to better characterize populations of individuals that – such as people with diabetes – that may have a higher risk of cardiovascular disease with air pollution exposure. Finally, our study also supports future research into novel strategies to reduce or ameliorate the vascular risks of environmental exposures.

• Citation:

• Presented at ACC15 and

• Particulate Air Pollution and Carotid Artery StenosisJonathan D. Newman, MD, MPH; George D. Thurston, ScD; Kevin Cromar, PhD; Yu Guo, MA; Caron B. Rockman, MD; Edward A. Fisher, MD, PhD; Jeffrey S. Berger, MD, MS

• J Am Coll Cardiol. 2015;65(11):1150-1151. doi:10.1016/j.jacc.2014.12.052



http://content.onlinejacc.org/article.aspx?articleid=2173083

http://content.onlinejacc.org/article.aspx?articleid=2173083



Only 1/3 of High Risk Diabetic Patients Comply With MedicationsMedicalResearch.com Interview with:

Sameer Bansilal, MD, MSAsst. Prof.- Medicine and Cardiology

Clinical Trials & Global Health StudiesIcahn School of Medicine at Mount Sinai


Dr. Bansilal: Our group has previously published data from FREEDOM, COURAGE and BARI showing that adherence to recommended therapies are low in diabetic (DM) patients. We have spent the last decade developing a potential solution to this- the Fuster-Ferrer polypill. This study was done to better inform the association between levels of medication adherence and long term major adverse cardiovascular events (MACE) in high risk diabetic patients.

• We analyzed a U.S. health insurers’ claims data for 19,962 high risk diabetic subjects. Using proportion of days covered (PDC) for 1 year after first refill, we stratified patients as fully adherent (FA≥80%), partially adherent (PA ≥40- ≤79%) or non-adherent (NA <40%) and examined the associations with a primary cardiovascualr outcome measure of death, myocardial infarction, stroke and coronary revascularization. We found that only 34% participants were fully adherent to therapy. When compared to being non-adherent at 2 yrsfollow up,, being fully adherent was associated with a 28% lower rate of MACE; being partially adherent was associated with a 21% lower rate of MACE. Efforts towards improving adherence in diabetic subjects may lead to substantial reductions in MACE.


http://medicalresearch.com/diabetes/only-13-high-risk-diabetic-patients-comply-with-medications/12719/






• Dr. Bansilal: Diabetes is as much a cardiovascular disease as an endocrine one. Our endocrinology colleagues, I’m sure, will appreciate the troubling issue of polypharmacy and poor medication adherence in their patients. I was struck by the fact that only 34% of the high risk diabetic participants were adherent to medications. The fact that >80% adherence is associated with a 28% lower risk for major cardiovascular events compared to non-adherence is truly impactful and a goal, I hope clinicians will consider worth striving for. As a physician community interested in improving the outcomes of our diabetic patients, our study drives home the need to employ disruptive and innovative strategies such as emerging technologies, non-physician care models and polypills to get our patients beyond the 80% adherence line to reduce cardiovascular risk.



http://medicalresearch.com/diabetes/medication_adherence_improves_with_information_motivation_and_skills/4207/






• Dr. Bansilal: We are currently initiating a cardiovascular outcomes trial-SECURE for the Fuster-Ferrer polypill in Europe and hope to replicate the benefit of improved adherence prospectively.

• Citation:

• ACC15 abstract:

• Assessing the Impact of Medication Adherence on Long-Term Outcomes in Patients with Diabetes



http://accscientificsession.acc.org/ACC.aspx

http://accscientificsession.acc.org/ACC.aspx



Racial Disparities in Cardiovascular Disease Not Explained by Genome StudiesMedicalResearch.com Interview with:

Jay S. Kaufman, Ph.DCanada Research Chair in Health Disparities

Department of Epidemiology, Biostatistics, and Occupational Health McGill University Montreal, Quebec Canada

Medical Research: What is the background for this study? What are the main findings?

Response: Published scientific articles speculate frequently about genetic predispositions in different racial groups as explanations for observed disease disparities. They infer this from the higher rates observed in racial minorities, even after adjusting for some social and behavioral measures. Taking the example of the racial disparity between blacks and whites in cardiovascular diseases (stroke, heart attack, heart failure, hypertension, etc), ours is the first published study to review all of the existing results from GWAS (genome-wide association studies) to see if they provide any support for this commonly stated position. To date, they do not. We performed an electronic literature search through the PubMed database to identify review articles and meta-analyses related to genetic risk factors for cardiovascular disease in samples that included populations of European and African ancestries. We focused our search on the 7-year period from January 1, 2007 to January 1, 2014, which corresponded to the rapid proliferation of large pooled GWAS activity. This search strategy yielded 197 review articles or meta-analyses. 68 of these articles contained relevant data, but very few reported significant associations in both racial groups, with just 3 variants meeting study-specific significance criteria. For most outcomes, there were too few estimates for quantitative summarization, but when summarization was possible, racial group did not contribute to heterogeneity. Most associations reported from genome-wide searches were small, difficult to replicate, and in no consistent direction that favored one racial group or another.


http://medicalresearch.com/genetic-research/racial-disparities-in-cardiovascular-disease-not-explained-by-genome-studies/12713/







• Response: The first genome-wide association study (GWAS) was published about a decade ago, and more than 1,700 have now been conducted, cataloging over 4,000 single nucleotide polymorphisms (SNPs) in relation to over 200 diseases. It was reported in 2008 that worldwide spending on genomic research was approximately $3 billion per year, with approximately $1 billion annually from the United States. It was an early promise that this investment would lead us to the answers for important population disease patterns, such as the excess of cardiovascular disease in people of African origin living in the Western Hemisphere. Although the substantial investment in this technology might have produced clinical advances, it has thus far made little or no contribution to our understanding of population-level racial health disparities in cardiovascular disease.



http://medicalresearch.com/cancer-_-oncology/prostate-cancer/100_genetic_risk_variants_for_prostate_cancer_identified/7740/







• Response: We examined only populations of African origin and populations or European origin. A logical extension would be to consider East Asian and Native American populations as well, although the number of existing studies may be even smaller.

• One could also extend this kind of analysis to other important health outcomes, especially cancers and diabetes.

• The obvious implication of this “dead-end” for GWAS studies to date is to change the focus away from seeking explanations in single nucleotide polymorphisms (SNPs) and other simple genetic variations. If one wants to pursue genetic research, it may be necessary to look to some kind of interactions between genes and environments. But the accumulated data on these kinds of interactions is so far even more sparse, and the existing methods even more limited at this point in time.

• The obvious alternative to this genetic paradigm, which so far has been unsuccessful at explaining racial disparities in cardiovascular disease mortality at the population level, would be to look to social and environmental factors, such as environmental contaminants, diet, obesity, and psychosocial stress.

• Funding for this study was provided by the Canada Research Chairs Program.• Citation:• The Contribution of Genomic Research to Explaining Racial Disparities in Cardiovascular Disease: A

Systematic Review.• Kaufman JS, Dolman L, Rushani D, Cooper RS.

Am J Epidemiol. 2015 Mar 1. pii: kwu319. [Epub ahead of print]PMID: 25731887



http://www.ncbi.nlm.nih.gov/pubmed?cmd=Link&dbFrom=PubMed&from_uid=25731887






Dark Chocolate May Improve Exercise Capacity and Metabolic ParametersMedicalResearch.com Interview with:

Pam R. Taub, MD, FACCAssistant Professor of Medicine

UC San Diego Health System Division of Cardiology Encinitas, CA 92024


• Dr. Taub: Epidemiological studies indicate that the consumption of modest amounts of dark chocolate (DC), which contains the natural cacao flavanol (-)-epicatechin (Epi,) is associated with reductions in the incidence of cardiovascular diseases (CVD). The health benefits of dark chocolate have been attributed to Epi. Clinical studies using cocoa and/or DC in normal volunteers or subjects with CVD have reported improvements in peripheral and coronary vascular endothelial function, blood pressure, lipids, insulin resistance, and inflammatory markers. The mechanism underlying these improvements is thought to be due to increased nitric oxide levels and improved endothelial function. We have also shown that capacity of Epi to favorable impact mitochondria under normal and disease states.

• We previously conducted pilot study in five patients with heart failure and type II diabetes, and showed that in skeletal muscle (SkM) biopsies there is a severe reduction in mitochondrial volume and cristae, as well as, in structural/functional proteins. After treatment with Epi rich dark chocolate , there was a significant recovery of SkMmitochondrial cristae, structural/functional proteins (e.g. mitofilin), as well as in regulators of mitochondrial biogenesis. However, no studies have examined the capacity of Epi rich dark chocolate to enhance exercise capacity in normal subjects and assess its impact on mitochondrial and oxidative control systems.


http://medicalresearch.com/exercise-fitness/dark-chocolate-may-improve-exercise-capacity-and-metabolic-parameters/12507/







• Dr. Taub: Seventeen subjects were randomized to placebo (n=8) or DC groups (n=9) and consumed 2 squares of chocolate (20 g, provided by Hershey) for 3 months.

• We showed in the chocolate group subjects had improved levels of HDL cholesterol and enhanced exercise capacity that is linked to the stimulation of SkM metabolic control endpoints which enhance mitochondrial function.


• Dr. Taub: Consumption of small amounts (2 small squares) of dark chocolate can improve parameters of exercise capacity and metabolic parameters such as HDL cholesterol in healthy sedentary individuals.



http://medicalresearch.com/author-interviews/pad-polyphenols-dark-chocolate-may-improve-peripheral-artery-disease/6185/

http://medicalresearch.com/pediatrics/high-chocolate-intake-lower-body-fat/2689/







• Dr. Taub: Based on the results of this research would conduct future studies in individuals with sarcopenia (defined as age-associated loss of skeletal muscle mass and function). I am currently conducting a study to assess effects of Epi on patients with statin related decreases in exercise capacity.

• Citation:

• ACC 15 abstract: March 2015

• Effects of Dark Chocolate on Exercise Capacity in Sedentary Older Adults (A Double Blind Placebo Controlled Trial)

• Pam R. Taub, Minal Patel, Erin Higginbotham, Luis Ramon, Aldo Moreno, Ulloa, Israel Ramirez-Sanchez, Guillermo Ceballos, Francisco Villarreal,

• University of California, San Diego, La Jolla, CA, USA, University of Southern Califorinia, Los Angeles, CA, USA



http://accscientificsession.acc.org/~/media/Files/Scientific Sessions/ACC2015 Program PREV.ashx





New Oral Hepatitis C Virus Treatment Works But Will Cost BillionsMedicalResearch.com Interview with:

Jagpreet Chhatwal Ph.D.Assistant Professor, Department of Health Services Research

Division of Cancer Prevention and Population Sciences The University of Texas MD Anderson CenterHouston, TX


Dr. Chhatwal: More than two million people in the U.S. are infected with Hepatitis C (HCV), a virus found in the liver. In 2012, the Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force both recommended a one-time hepatitis C screening for baby boomers – people born between the years 1946 and 1964. Last year, the Food and Drug Administration approved the medications sofosbuvir and ledipasvir for Hepatitis C treatment. The newly approved oral regimen comes at a staggering price to payers – as much as $1,125 per day. As a result, several payers have questioned if the price is justified.

• The study results show that using new therapies is cost-effective in the majority of patients. However, the budget required to treat all eligible patients would be $136 billion over the next five years. Compared with the old drugs, new therapies would cost an additional $65 billion, whereas the cost offsets would be only $16 billion.


• Dr. Chhatwal: While lower drug prices will help, that’s not sufficient. Both the government and private insurers will need additional resources to effectively manage this epidemic. Until more resources become available, physicians need to prioritize the new drugs to the sickest of patients.


http://medicalresearch.com/hepatitis-liver-disease/new-oral-hepatitis-c-virus-treatment-works-but-will-cost-billions/12661/

http://medicalresearch.com/hepatitis-liver-disease/hepatitis-c-sofosbuvirledipasvir-combination-treatment/2798/



New Oral Hepatitis C Virus Treatment Works But Will Cost BillionsMedicalResearch.com Interview with:

Jagpreet Chhatwal Ph.D.Assistant Professor, Department of Health Services Research

Division of Cancer Prevention and Population Sciences The University of Texas MD Anderson CenterHouston, TX


• Dr. Chhatwal: The case of hepatitis C highlights the role of cost-effectiveness and drug costs at health policy level. Clearly, economics need to play an important part of improving the health care system so that access to new treatments can be improved.

• Citation::

• The Changing Burden of Hepatitis C Virus Infection in the United States: Model-Based PredictionsJagpreet Chhatwal, PhD; Fasiha Kanwal, MD, MSHS; Mark S. Roberts, MD, MPP; and Michael A. Dunn, MDAnn Intern Med. 2015;162(6):397-406. doi:10.7326/M14-1336



http://medicalresearch.com/infections/hiv/oral-medication-for-hepatitis-c-hiv-combined-infection/11963/

http://annals.org/article.aspx?articleid=2197176



Radial Artery Access Lowers Angiography and PCI ComplicationsMedicalResearch.com Interview with:

Marco Valgimigli, MD, PhDErasmus MC, Thoraxcenter,Rotterdam The Netherlands


• Dr. Valgimigli: Interventional cardiologists can choose between two entry sites in order to perform a diagnostic coronary angiography and or a percutaneous coronary intervention, namely an artery which is in the groin called femoral artery or an artery which is located in the wrist which is called radial artery. The latter is more superficial and has small calibre as compared to the former. Femoral artery is the entry site which is most frequently used in the world especially in US where the use of radial artery is relatively limited.

• Our study randomly allocated 8,404 patients to undergo diagnostic coronary angiography and PCI, if clinically indicated, either vie the femoral or the radial artery.

• The main results of our study are that radial access reduced the composite of net adverse clinical events driven by a reduction of mortality and of major bleeding, including transfusions and need for surgical repair or the entry site.


http://medicalresearch.com/heart-disease/radial-artery-access-lowers-angiography-and-pci-complications/12640/




Radial Artery Access Lowers Angiography and PCI ComplicationsMedicalResearch.com Interview with:

Marco Valgimigli, MD, PhDErasmus MC, Thoraxcenter,Rotterdam The Netherlands


• Dr. Valgimigli: The entry site which needs to be preferred is today the radial artery. Femoral artery, as entry site, given the entity and magnitude of the benefit observed in our study, should be considered as bailout option meaning that it should be accessed only of radial intervention is not possible or feasible.


• Dr. Valgimigli: After MATRIX, given the sound mortality benefit observed here, it will be difficult to envision other randomised studies comparing these two entry sites. Radial is superior and it may not be ethical anymore to keep exposing patients to transferral intervention. I think next steps will be how to optimise the procedure performed via trans-radial intervention, including how to minimise the risks of occlusion of the artery after the procedure.

• Citation:

• Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: randomised multicentre trial

• Valgimigli, Marco et al.

• The Lancet Published Online: 16 March 2015DOI: http://dx.doi.org/10.1016/S0140-6736(15)60292-6






http://dx.doi.org/10.1016/S0140-6736(15)60292-6



Pre-Hospital Delay Influences Sex Differences in Acute Coronary CareMedicalResearch.com Interview with:

Raffaele Bugiardini, M.D.Professor of CardiologyUniversity of Bologna


Dr. Bugiardini: Our analysis differs from previous reports of outcomes following STEMIbecause prior studies have not looked at sex differences in outcomes adjusted for time from symptom onset to hospital presentation and subsequent utilization of cardiac revascularization procedures, and rates of revascularization are typically significantly lower in women compared with men

• Our study is the first to look at the relationship between delays and outcomes.


• Dr. Bugiardini: We think this is the real message behind our study it’s that it is time to look beyond the in hospital quality initiatives and, therefore, the use of door-to-balloon/needle time as the only performance measures, especially in women. It is time to recognize the limitations of door-to-balloon/needle time in women. It does not represent “time to reperfusion” We need start looking at other ways that can favorably impact women outcomes.


http://medicalresearch.com/heart-disease/pre-hospital-delay-influences-sex-differences-in-acute-coronary-care/12497/

http://medicalresearch.com/heart-disease/long-term-effects-of-ischemic-post-conditioning-with-pci-for-stemi/12362/

http://medicalresearch.com/heart-disease/myocardial_infarction_what_results_in_delays_for_stent_surgery/5809/



Pre-Hospital Delay Influences Sex Differences in Acute Coronary CareMedicalResearch.com Interview with:

Raffaele Bugiardini, M.D.Professor of CardiologyUniversity of Bologna


• Dr. Bugiardini: Further investigation to identify the factors associated with this delay will provide important insights that will lead to improved care.

• The total pre-hospital delay period consists of two times: time taken by patients to recognize that their symptoms are serious and to contact medical help (call to help time) and time taken from requesting help to hospital admission (home-to-hospital delay). Perhaps that home-to-hospital delay is not associated with the attribution of symptoms to a heart attack, but to a variety of symptoms when patients are women, which is namely misdiagnosis and/or medical error. This is an issue on which we need to focus more.

• Citation:

• The study, “Sex-Related Differences in Acute Coronary Care Among Patients with Myocardial Infarction: The Role of Pre-Hospital Delay,” will be presented on March 14, 2015 at 10 a.m. PT/1 p.m. ET/5 p.m. UTC at the American College of Cardiology’s 64th Annual Scientific Session in San Diego.



http://medicalresearch.com/heart-disease/women-with-heart-failure-less-likely-to-be-referred-for-specialty-care/12005/

http://www.acc.org/about-acc/press-releases/2015/03/05/16/33/women-dont-get-to-hospital-fast-enough-during-heart-attack?w_nav=S



Public Outcomes Reporting Linked To Risk Aversion Of Sicker PatientsMedicalResearch.com Interview with:

Stephen W. Waldo, MDResearch Fellow in Medicine

Massachusetts General Hospital


• Dr. Waldo: Public reporting is intended to improve outcomes for our patients. Proponents of public reporting applaud the increased transparency that it offers, allowing both patients and physicians to objectively evaluate health care outcomes for a given institution or individual provider. Previous research has demonstrated, however, that public reporting of procedural outcomes may create disincentives to provide percutaneous coronary intervention for critically ill patients. The present study sought to evaluate the association between public reporting of outcomes with procedural management and clinical outcomes among patients with acute myocardial infarction. As the data demonstrate, public reporting of outcomes is associated with a lower rate of percutaneous revascularization and increased overall in-hospital mortality among patients with an acute myocardial infarction, particularly among those that do not receive percutaneous intervention. This may reflect risk aversion among physicians in states that participate in public reporting, an unintended consequence of this policy.


• Dr. Waldo: Public reporting of outcomes for percutaneous revascularization should balance the benefits of transparency and accountability against the potential for physician risk aversion.


http://medicalresearch.com/heart-disease/public-outcomes-reporting-linked-to-risk-aversion-of-sicker-patients/12653/



Public Outcomes Reporting Linked To Risk Aversion Of Sicker PatientsMedicalResearch.com Interview with:

Stephen W. Waldo, MDResearch Fellow in Medicine

Massachusetts General Hospital


• Dr. Waldo: Future studies should seek to better understand risk aversion among physicians and investigate alternative public reporting systems that maintain transparency while also ensuring optimal patient outcomes. Perhaps changes to the public reporting system that have already been employed in some jurisdictions – censoring of high risk patients with cardiac arrest or cardiogenic shock – will reduce risk aversion and improve patient outcomes.

• Citation:

• Waldo SW, McCabe JM, O’Brien C, Kennedy KF, Joynt KE, Yeh RW. Association Between Public Reporting of Outcomes With Procedural Management and Mortality for Patients With Acute Myocardial Infarction. J Am Coll Cardiol. 2015;65(11):1119-1126. doi:10.1016/j.jacc.2015.01.008.



http://content.onlinejacc.org/article.aspx?articleID=2199403



Back Pain: Early Imaging Of Older Adults Results in More Costs, Not Better OutcomesMedicalResearch.com Interview with:

Jeffrey (Jerry) G. Jarvik MD MPHProfessor, Radiology, Neurological Surgery and Health Services

Adjunct Professor, Pharmacy and Orthopedics & Sports MedicineDirector, Comparative Effectiveness, Cost and Outcomes Research Center University of Washington Seattle, WA


Dr. Jarvik: When I arrived at the Univ of WA over 20 years ago, my mentor, Rick Deyo, had just finished leading a project that was responsible for developing one of the first set of guidelines for the diagnosis and treatment of acute low back pain. These guidelines, published in a booklet by AHRQ (then called AHCPR), recommended that patients with acute low back pain not undergo imaging for 4-6 weeks unless a red flag was present. One of the exceptions was that patients older than 50 could get imaged immediately, the rationale being that older adults had a higher prevalence of potentially serious conditions such as cancer, infections, etc, that would justify the early imaging. As a practicing neuroradiologist, it was clear that a potential problem with this strategy is that the prevalence of age-related changes, which may or may not be related to back pain, also increases with age. So earlier imaging of older adults would almost certainly reveal findings, and these could easily start a series of unfortunate events leading to potentially poor outcomes and more healthcare resource use. Thus this policy of early imaging of older adults didn’t entirely make sense.

• About 5 years ago, these guidelines hit home when I developed acute low back pain and since I was over 50 (barely) my doctor recommended that I get an imaging study. Being a knowledgeable patient and having a reasonable doctor, we mutually agreed not to get the study. I improved but that wasn’t the end of it. When we had the chance to apply for one of the CHOICE ARRA awards funded by AHRQ, we made answering this question of early imaging in older adults one of our primary goals.


http://medicalresearch.com/pain-research/back-pain-early-imaging-of-older-adults-results-in-more-costs-not-better-outcomes/12627/







• Dr. Jarvik:

• Older adults with back pain who seek care and get imaging within 6 weeks of their doctors visit for back pain do not have better outcomes than similar older adults who do not get early imaging.

• While early imaging is not associated with better pain and function outcomes, it is associated with greater use of healthcare services, such as visits, injections, etc.

• The overall difference in resource utilization translates into a nearly $1,500 per patient additional cost for no measurable benefit. This is the opposite of “high value healthcare”- no benefit at great cost.



http://medicalresearch.com/pain-research/acetaminophen-paracetamol-better-placebo-back-pain/6587/







• Dr. Jarvik: Our study suggests that older adults should not be treated differently than younger adults with respect to low back imaging guidelines. In the absence of “red flags” older adults should not undergo immediate spine imaging, but like younger adults, wait at least 6 weeks before being imaged. Early imaging doesn’t help improve outcomes for older adults experiencing back pain, but does lead to great health resource use.



http://medicalresearch.com/pain-research/insurance-study-evaluates-emergency-room-imaging-for-low-back-pain/11307/







• Dr. Jarvik: While we now know that early imaging does not improve the pain or function of older adults with new primary care visits for back pain, we have some evidence from the same cohort of patients that early physical therapy may be beneficial. Work done by one of our junior faculty in Rehabilitation Medicine, Sean Rundell, PhD, suggests this sort of benefit. A rigorous trial investigating early physical therapy could well be informative.

• However, the next challenge that we face on this topic is not so much a need for future research studies, but rather the challenge of communicating and disseminating these results so that they can become integrated into primary care. The routine use of imaging shortly after a patient presents with low back pain, regardless of their age, will hopefully become a thing of the past.

• Citation:

• Jarvik JG, Gold LS, Comstock BA, et al. Association of Early Imaging for Back Pain With Clinical Outcomes in Older Adults. JAMA. 2015;313(11):1143-1153. doi:10.1001/jama.2015.1871.



http://medicalresearch.com/pain-research/sudden-attacks-of-back-pain-more-likely-in-morning/11513/

http://jama.jamanetwork.com/article.aspx?articleid=2203801



New TB Screening Of Immigrants To US Has Resulted in Better Detection and Treatment OpportunitiesMedicalResearch.com Interview with:

Dr.Yecai LiuDivision of Global Migration and Quarantine

Centers for Disease Control and Prevention, Atlanta, Georgia


Response: Since the early 1900s, immigrants and refugees applying for a visa to come to the United States undergo a medical examination that includes tuberculosis (TB) screening. In 2007, CDC began implementing the new screening guidelines, which require people suspected of having TB to receive a much more sensitive sputum culture test to confirm TB to ensure that those individuals who do have TB receive treatment before they arrive in the United States. These requirements have now been completely rolled out to all countries with U.S.-bound immigrants and refugees.

• From 2007 through 2012, half of the 3.2 million arrivals of immigrants and refugees to the United States were screened for TB by the new screening guidelines. Out of more than 4,000 TB cases diagnosed by the new screening guidelines during this period, nearly 2,200 were smear-negative and culture positive. These cases would likely have been missed under the previous screening requirements. The results of this study showed that the updated overseas screening guidelines led to a roughly one-third decrease in the annual number of TB cases among foreign-born persons within their first year in the United States.


http://medicalresearch.com/infections/new-tb-screening-of-immigrants-to-us-has-resulted-in-better-detection-and-treatment-opportunities/12657/

http://medicalresearch.com/infections/quantiferon-tb-testing-for-latent-tb-eliminates-false-positives-from-bcg-vaccination/12142/







• Response: When the new screening guidelines issued in 2007 are implemented in all countries, physicians overseas identify more than 600 additional TB cases (i.e., smear-negative and culture-positive TB) annually in immigrants and refugees bound for the United States. That makes this effort one of the largest and most successful interventions for U.S. TB control in the past decade. Without these updated screening guidelines, which use newer, more sensitive tests, these cases might have gone undetected.



http://medicalresearch.com/infections/hiv/best-manage-co-infection-tb-hiv/5480/







• Response: We recommend to conduct cost-effectiveness studies on expanding TB screening in nonimmigrant visitors from countries with a high TB incidence, and studies on diagnosing and treating latent TB infection among foreign-born persons in the United States.

•

• Citation

• Effect of a Culture-Based Screening Algorithm on Tuberculosis Incidence in Immigrants and Refugees Bound for the United States

• Yecai Liu, MS; Drew L. Posey, MD, MPH; Martin S. Cetron, MD; and John A. Painter,DVM, MS

• Ann Intern Med. 2015;162(6):420-428. doi:10.7326/M14-2082



http://medicalresearch.com/medication-research/neglected-diseases-research-development-landscape/2480/






Targeted Program Reduced Superbug Infections In Nursing Home ResidentsMedicalResearch.com Interview with: Lona Mody, MBBS, MSc

Associate Division Chief, Clinical and Translational Research Associate Director, Clinical Programs, VA GRECCAssociate Professor, Internal Medicine Research Associate Professor, Institute of Gerontology

University of Michigan Geriatrics Ann Arbor, MI


Response: Over 1.5 million residents live in 15,600 Nursing Homes in the US. The acuity of illness in this population has increased substantially in the last decade, as has the risk of acquiring new infections. Multi-drug resistant organisms, also known as MDROs, are endemic in this setting with prevalence estimates upwards of 35% and surpassing those in the hospitals. Nursing homes historically have had few infection prevention resources, which contributes to these high rates. Patients with indwelling devices such as urinary catheters and feeding tubes present an attractive habitat for these ‘superbugs’ and thus carry the added burden of device-related infections.

• The authors examined the effect of a targeted infection program, or TIP, to reduce the prevalence of Multi-drug resistant organisms and new catheter or feeding tube infections among patients with indwelling devices. The TIP intervention was three-fold:

• Surveillance for infections and Multi-drug resistant organism colonization with regular feedback to facilities;

• Extensive and interactive staff education using adult learning theory about key infection prevention practices and hand hygiene; and

• Use of gowns and gown when providing assistance to patients for high-risk activities such as bathing and grooming.


http://medicalresearch.com/infections/targeted-program-reduced-superbug-infections-in-nursing-home-residents/12749/






• Staff education emphasized precautionary measures against the spread of infection and included mock game shows, songs and dances. Hands were cultured for bacteria before and after hand washing. Outcomes were measured by results of the cultures taken for each patient and monitoring infection rates.

• A team of researchers from the University of Michigan and the Veterans Affairs Ann Arbor Health System has demonstrated that simple measures might be all it takes to push back at the spread of Multi-drug resistant organisms or ‘superbugs’ in nursing homes as well as reduce infections. In their study of patients with indwelling devices, MDROs were reduced by 23 percent among 418 residents in six southeast Michigan nursing homes who participated over the course of the three-year study. The numbers of catheter-associated urinary tract infections and MRSA acquisitions also decreased, 46 percent and 22 percent respectively.

• The trial examined the relationship between acquisition of antimicrobial resistance among nursing home residents with the use of devices by adapting new methodological approaches and study designs to study infection prevention interventions including the use of cluster-randomized study design for infection prevention interventions, adopting adult learning practices to engage frontline healthcare personnel and using multi-anatomic site sampling to demonstrate effectiveness of the program.



http://medicalresearch.com/medication-research/genomic-analysis-of-superbug-provides-clues-to-antibiotic-resistance/193/

http://medicalresearch.com/author-interviews/mrsa_also_common_at_body_sites_other_than_nose/6960/







• Response: This research program engages community-based nursing homes with little experience in conducting prospective research. They have few infection prevention resources, but these do not have to be barriers to implementing best practices and enhancing patient safety. The strategies we demonstrate in this study can successfully be adopted in traditionally resource-poor settings, and applied as narrowly or as broadly as desired.

• With the move towards integrated healthcare systems and reducing hospital length of stay, 40% of Medicare beneficiaries now require post-acute care. As a result, today’s nursing home population is sicker, making it increasingly imperative to adapt and enhance evidence-based infection prevention practices accordingly. With the increasing acuity of care in nursing homes, transfers back to hospitals increase as well. Reduction in MDROs among the high risk short-stay and long-stay nursing home population will decrease transmission of these superbugs between institutions.



http://medicalresearch.com/author-interviews/mrsa-nursing-home-admission-denials/3347/







• Response: This study provides a strong argument to reconsider MDRO management in nursing homes. More research on cost-effectiveness of this intervention and designing innovative interventions to reduce infections and superbugs in other high-risk populations is needed. In the meantime, this article addresses an important safety issue for high risk older adults in institutional settings and demonstrates effectiveness of several infection prevention practices

• Citation:

• Mody L, Krein SL, Saint SK, et al. A Targeted Infection Prevention Intervention in Nursing Home Residents With Indwelling Devices: A Randomized Clinical Trial. JAMA Intern Med. Published online March 16, 2015. doi:10.1001/jamainternmed.2015.132.



http://archinte.jamanetwork.com/article.aspx?articleid=2195118



Health & Medicine

MedicalResearch.com: Medical Research Exclusive Interviews March 17 2015