BMI And Waist Circumference Can Predict The Risk Of Fatal And Non-Fatal Disease

Body mass index (BMI) and waist circumference are well known risk factors for cardiovascular diseases (CVD), but a new study reported in the European Journal of Cardiovascular Prevention and Rehabilitation (a journal of the European Society of Cardiology) now concludes that these risk factors, when accurately measured by trained staff, can actually predict the risk of fatal and non-fatal disease.(1) The findings, which emerged from a large prospective study of more than 20,000 Dutch men and women aged 20-65 years begun in 1993, show that the associations of BMI and waist circumference with heart disease are equally strong, and explain one half of all fatal and one quarter of non-fatal CVD in those who are overweight and obese.

Studies which have so far established the association between BMI and waist circumference as risk factors for heart disease have, say the investigators, been based on self-reported data, and these measures frequently underestimate the true prevalence of obesity. For a true estimation of the association, accurate “anthropometric” measurements are necessary. And this is what the present study did. The Monitoring Project on Risk Factors for Chronic Diseases (MORGEN) of the National Institute for Public Health and the Environment in the Netherlands professionally measured between 1993 and 1997 both BMI and waist circumference (as well as other variables) in a cohort of 20,500 men and women. And then all subjects in the study were linked to hospital discharge and national cause-of-death records – with only 556 lost to follow-up.

BMI measurements were defined according to WHO recommendations in three categories: normal as 18.5-24.9 kg/m2; overweight as 25-29.9 kg/m2; and obese as 30 kg/m2 or more. Similarly, waist circumference measurements in men were defined as normal (< 94 cm), overweight (94-101.9 cm) and abdominally obese (>102 cm); in women these measures were < 80 cm, 80-87.9 cm, and >88 cm respectively.

When age-adjusted BMI and waist circumference measurements were correlated with hospital records and cause-of-death statistics, results showed that in those categorised as overweight and obese around one half (53%) of all fatal CVD and one quarter (25-30%) of all non-fatal CVD were ascribed to the fact that the individual was overweight or obese.

The study also found that the overall risk of a first non-fatal CVD was ten times higher than that of fatal CVD.

Commenting on the public health implications of the study, principal investigator Ineke van Dis from the Netherlands Heart Foundation said: “Throughout Western Europe – as in the Netherlands – there has been a decline in cardiovascular mortality in recent years, which is reflected in a prevalence shift from mortality to morbidity. What this study shows is the substantial effect which overweight and obesity have on cardiovascular disease, whether fatal or non-fatal. In the near future the impact of obesity on the burden of heart disease will be even greater.

For consumer groups and our national heart foundations, these findings underline the need for policies and activities to prevent overweight in the general population. And I think that general practitioners and cardiologists can do even more to tackle these problems, especially in obese patients under 65 years, as highlighted in this study.”

Extrapolating their study results to the general population, the investigators calculated (based on a population prevalence of overweight and obesity of 46%) that one third of all fatal CVD cases (and one in seven non-fatal cases) can be ascribed to overweight and obesity.

Notes:

1) Van Dis I, Kromhout D, Geleijnse M, et al. Body mass index and waist circumference predict both 10-year non-fatal and fatal cardiovascular disease risk in 20,000 Dutch men and women aged 20-65. Eur J Cardiovasc Prev Rehabil 2009; doi: 10.1097/HJR.0b013e328331dfc0.

The study was a joint initiative of the National Institute for Public Health and the Environment in the Netherlands and Wageningen University and was supported by The Netherlands Heart Foundation.

Cardiovascular disease, and particularly coronary heart disease, is the leading cause of death in Europe, accounting for 38% of all deaths in men and 45% in women.

Source:
ESC Press Office
European Society of Cardiology Continue reading

ANNA Publishes New Edition Of Scope And Standards For Advanced Practice In Nephrology Nursing

To help advanced practice nurses (nurse practitioners and clinical nurse specialists) improve patient care delivery and optimize outcomes for renal patients, ANNA has released the 2008 edition of the Scope and Standards of Advanced Practice in Nephrology Nursing. This valuable resource also serves as a reference for nurses, physicians, and the nephrology community at large regarding the role of advanced practice nurses in nephrology. The Scope and Standards is $15, with an ANNA member-discounted price of $10. The new edition is available for purchase in ANNA’s Online Store.

About ANNA

The mission of the American Nephrology Nurses’ Association (ANNA) is to advance nephrology nursing practice and positively influence outcomes for patients with kidney disease through advocacy, scholarship, and excellence.

Since it was established as a nonprofit organization in 1969, ANNA has been serving members who span the nephrology nursing spectrum. ANNA has a membership of over 11,000 registered nurses and other health care professionals at all levels of practice. Members work in such areas as conservative management, peritoneal dialysis, hemodialysis, continuous renal replacement therapies, transplantation, industry, and government/regulatory agencies.

ANNA is committed to advancing the nephrology nursing specialty and nurturing every ANNA member. We achieve these goals by providing the highest quality educational products, programs, and services. Our members are leaders who advocate for patients, mentor each other, and lobby legislators, all to inspire excellence.

American Nephrology Nurses’ Association Continue reading

Alnylam And Collaborators Publish New Pre-Clinical Research On Therapeutic Silencing Of Parkinson’s Disease Gene

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, and collaborators at The Parkinson’s Institute and the Mayo Clinic have published new research findings in the journal Public Library of Science (PLoS). The new data show effective silencing of the alpha-synuclein gene with an RNAi therapeutic administered directly to the substantia nigra in the CNS of non-human primates. Alpha-synuclein is widely believed to play a central role in the development of Parkinson’s disease, where the accumulation of excess alpha-synuclein protein in the substantia nigra has been associated with the cause and/or progression of the disease.

“These new findings add to a growing body of data on the applications of RNAi therapeutics for the treatment of neurodegenerative disorders, such as Parkinson’s disease. Indeed, direct delivery of RNAi therapeutics in the CNS represents an important component of our overall product development strategy,” said David Bumcrot, Ph.D., Director, Research at Alnylam. “We remain committed to advancing this promising therapeutic modality to patients.”

Parkinson’s disease is a chronic, degenerative neurological disorder that affects dopaminergic neurons in the brain involved in the control of movement. Symptoms include tremor, slowed movement, and rigid muscles. Recent research indicates that at least one million people in the United States, and more than five million worldwide, suffer from Parkinson’s disease. There exists a significant need for disease modifying therapies for the treatment of Parkinson’s disease as no such treatments are currently available.

“A wide range of genetic, epidemiologic, and laboratory data support the hypothesis that reducing levels of alpha-synuclein in the brain may slow or even halt the progression of Parkinson’s disease and its associated symptoms,” said Donato A. Di Monte, M.D., Professor & Senior Research Group Leader at the German Center for Neurodegenerative Diseases (DZNE) in Bonn, and previously with The Parkinson’s Institute. “Accordingly, we are encouraged by these important results, which for the first time demonstrate RNAi-mediated silencing of alpha-synuclein in the substantia nigra of non-human primates. To date, no drugs have been identified that are capable of lowering alpha-synuclein levels, and these data certainly support further development of an RNAi-based approach for the treatment of Parkinson’s disease.”

The published data (McCormack et al., PloS ONE, 5: e12122, 2010) demonstrated that direct delivery of chemically modified siRNAs specific for alpha-synuclein resulted in significant silencing of the target gene in the substantia nigra in the non-human primate brain. A significant 40-50% suppression of both alpha-synuclein mRNA and protein levels was observed in treated animals, as compared to controls. In these preliminary studies, the siRNA was found to be well tolerated after direct CNS administration; no complications or adverse events were observed, including the absence of detectable microglial activation or change in the number of nigral dopaminergic neurons. These results suggest that RNAi therapeutics may be useful in reducing the pathogenic burden of alpha-synuclein in patients with Parkinson’s disease.

The study was conducted in collaboration with scientists at Mayo Clinic and The Parkinson’s Institute, and funded by a “LEAPS” (Linked Efforts to Accelerate Parkinson’s Solutions) award from The Michael J. Fox Foundation for Parkinson’s Research. Alnylam has an agreement with the Mayo Clinic whereby Mayo has granted Alnylam an exclusive license to certain patents and know-how related to alpha-synuclein.

About RNA Interference (RNAi)

RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon. Small interfering RNAs (siRNAs), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, target the cause of diseases by potently silencing specific mRNAs, thereby preventing disease-causing proteins from being made. RNAi therapeutics have the potential to treat disease and help patients in a fundamentally new way.

Source:

Alnylam Pharmaceuticals Continue reading

Amnesics Remember Grammar, But Not Meaning Of New Sentences

Syntactic persistence is the tendency for speakers to produce sentences using similar grammatical patterns and rules of language as those they have used before. Although the way this occurs is not well understood, previous research has indicated that this effect may involve a specific aspect of memory function. Memory is made up of two components: declarative and procedural. Declarative memory is used in remembering events and facts. Procedural memory helps us to remember how to perform tasks, such as playing the piano or riding a bike. A recent study suggests that the common phrase, “it’s so easy, it’s like riding a bike” should perhaps be replaced with “it’s so easy, it’s like forming a sentence.”

In this experiment, Victor S. Ferreira from the University of California San Diego along with Kathryn Bock, Michael P. Wilson and Neal J. Cohen from the University of Illinois at Urbana-Champaign, examined which type of memory function contributes to syntactic persistence by comparing amnesics with a group of control volunteers. The amnesics in this study experience anterograde amnesia and exhibit problems forming new memories – they cannot remember facts & events that occurred following their head injury. However, their procedural memory is still intact. For example, these patients will not remember that they received a new bike, but they will improve at riding the bike.

In this study, controls and amnesics heard a sentence containing a specific grammatical structure (a prime sentence) and were asked to repeat it aloud. Subjects were then shown a picture and had to describe it. This was followed by a memory test where subjects heard another sentence (a probe sentence) and were asked if it was identical to the prime sentence shown initially. Probe sentences sometimes were identical to the prime sentence, had the same meaning as the prime sentence but a different grammatical structure, had the same grammatical structure but different meaning as the prime sentence or differed from the prime sentence in both grammatical structure and meaning.

The results, reported in the September issue of Psychological Science, a journal of the Association for Psychological Science, indicate that both controls and amnesics exhibited syntactic persistence and to the same degree. That is, the sentences that they used to describe the pictures had similar grammatical structure to the prime sentence that they had seen at the start of the experiment.

However, the amnesics were worse than controls at recognizing the sentence they had seen before. During the memory test, control subjects rejected novel sentences more often when they differed from the prime sentence in meaning. When control subjects were presented with sentences which had a similar grammatical structure (although different meaning) as the prime sentence, they were more likely to say that they recognized them. The fact that amnesics did poorly throughout this entire section indicates that they had forgotten the meaning of the prime sentence. However, their descriptions of the pictures indicate that they still retained the grammatical structure of the prime sentence.

These results support the idea that there are two components of language function- one for content and another for structure. The results presented here indicate that the content aspect of language (meaning/semantics) is associated with declarative memory and that the structural aspect of language (grammar and syntax) is associated with procedural memory.

The researchers propose that syntactic knowledge is a specialized skill, akin to riding a bike. The authors conclude, “The core knowledge underlying the human syntactic ability-one of the most creative capacities known in nature, and one that is commonly thought to depend on advanced and flexible intelligent functioning- is shaped by a specialized system of basic memory mechanisms that are themselves found in even the simplest of organisms.”

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Psychological Science is ranked among the top 10 general psychology journals for impact by the Institute for Scientific Information. Article: “Memory for Syntax Despite Amnesia.”

Source: Barbara Isanski

Association for Psychological Science Continue reading

CMS Proposal Would Limit Industry Practice That Raises Costs For Some Medicare Drug Plan Beneficiaries

A CMS proposal under consideration would limit a practice used by pharmacy benefit managers known as “lock-in pricing” that can increase costs for beneficiaries enrolled in the Medicare drug benefit and bring them into the so-called “doughnut hole” coverage gap more quickly, the Wall Street Journal reports. The doughnut hole begins when total annual drug spending by beneficiaries and their health insurers reaches $2,510. When in the doughnut hole, a beneficiary is responsible for 100% of prescription drug costs until total spending reaches $5,726 for the year.

Under lock-in pricing, PBMs charge a higher rate to insurers with whom they have contracted to administer their drug benefit than what they pay pharmacies to dispense the drugs to beneficiaries, according to the Journal. The PBMs then keep the difference.

Beneficiaries can reach the doughnut hole faster under lock-in pricing because the insurer is charged more than a drug’s actual cost, increasing total annual spending more quickly. According to the Journal, the proposal would mitigate that effect by requiring insurers to break down PBM payments into two rates: the cost of the drug and an “administrative” cost. The administrative cost would be the difference between a PBM’s drug price and the insurer’s payment. The proposal would not ban lock-in pricing.

CMS estimates that about 19% of drug benefit plans are using lock-in pricing. The agency says the practice affects about 14% of the 25.8 million beneficiaries enrolled in the drug benefit program. According to the Journal, the price difference from using lock-in pricing is much higher for generic drugs than brand-name drugs.

The Journal reports that CMS officials have been attempting to counter the effect of lock-in pricing almost since the inception of the Medicare drug benefit. Abby Block, director of the Center for Drug and Health Plan Choice at CMS, said that the agency thought lock-in pricing was prohibited when the drug benefit was created. “We thought we had a clear policy,” Block said, adding, “We learned that there are different ways of interpreting a policy statement.” CMS plans to make a final rule later this summer that would go into effect in 2010.

PBMs, Insurers Defend Practice
According to the Journal, some PBMs defend lock-in pricing, saying that it is common in the private insurance market and that they use the extra money to encourage beneficiaries to use less expensive drugs. Some insurers say they will be forced to increase premiums if they are not permitted to add the extra charge to plans’ total annual drug spending, the Journal reports. Steve Littlejohn, a spokesperson for the PBM Express Scripts, said the company’s overall per-prescription profit margin from using lock-in pricing is a “single digit” percentage. He also said that the company’s pricing on generics “is generally far better than (uninsured) cash-paying customers obtain on their own” (Rubenstein, Wall Street Journal, 7/22).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading

Commonly Used Drug Offers Promise For Premature Babies

Scientists have found evidence that the cox-2 inhibitor celecoxib, a common pain reliever used to treat arthritis, may offer a new way to reduce the risk of the most common cause of brain damage in babies born prematurely.

The work involves shoring up blood vessels in a part of the brain that in premature infants is extremely fragile and vulnerable to dangerous bleeding, which affects an estimated 12,000 children a year, leaving many permanently affected by cerebral palsy, mental retardation, and seizures.

“Stabilizing the blood vessels right before the baby is born is a tremendous opportunity to save the baby from potentially lifelong complications,” said Maiken Nedergaard, M.D., Ph.D., a neuroscientist at the University of Rochester Medical Center who is presenting the results at a neuroscience meeting, Brain ’07, in Osaka, Japan May 20-23.

The laboratory research was done primarily in a laboratory at New York Medical College led by neonatologist Praveen Ballabh, M.D. Ballabh’s team worked with Rochester neuroscientists including Nedergaard, Steven Goldman, M.D., Ph.D., and Nanhong Lou, Ph.D. A research article describing the work appeared in the April issue of Nature Medicine, which included a cover photograph taken by the Rochester team showing the brain cells involved in the brain damage seen in some premature infants.

The research is based on extensive brain studies of infants who died prematurely as well as on findings with newborn rabbits, whose brains resemble those of premature babies in some very important ways. The medication would need to be tested rigorously in pregnant women before being considered as a treatment for their babies. But the investigators point out that celecoxib is already used widely in people, including pregnant women, making a clinical trial in people feasible.

The researchers focused on a part of the brain known in developing infants as the germinal matrix, a temporary structure that is the birthplace of all brain cells in an infant. The structure runs like a jagged coastline just below spaces in the brain called ventricles, and in premature infants it’s extremely active, churning out new brain cells that migrate and settle into other parts of the brain.

“This is a very, very important part of the brain, from which neurons and glia cells migrate out to form all the layers of the brain,” said Ballabh, an associate professor in the Department of Pediatrics, Cell Biology, and Anatomy at New York Medical College, and a neonatologist at Westchester Medical Center.

The germinal matrix is designed to be active until around week 36 of gestation. Then, with most of the infrastructure of the brain in place, the germinal matrix disintegrates and shrinks into a much smaller brain region known as the ventricular zone in adults.

The problem is that the germinal matrix is as fragile as it is crucial during its brief existence. While it’s turning out new brain cells, it demands more oxygen and more blood flow, a demand that the body meets by building a network of temporary – and very fragile, awkward, and leaky – blood vessels.

In a normally developing fetus, the blood vessels do their job and then disappear by the time the baby is born. But when a baby is born prematurely, the structure is suddenly thrust into a role for which it is not designed, handling high rates of blood flow and pressure. It’s as if a building being outfitted with strong support structures is hit by an earthquake while the scaffolding is still up and construction is underway – the whole structure is at risk of collapse.

In the case of prematurely born infants, the baby’s brain literally does not have the time to tie up its loose ends before blood vessels never intended to exist by the time an infant breathes on its own are suddenly required to carry blood. In the case of a bleed, the blood vessels break, cutting off the supply of oxygen to some brain tissue and directly damaging parts of the brain.

Babies most at risk are those born between 24 and 32 weeks gestation that weigh less than 1500 grams, or about 3 lbs., 5 ounces. About 20 percent of such infants have a bleed, known as a germinal matrix hemorrhage or an intraventricular hemorrhage. While the problem sometimes is very small and hardly noticeable, other times the bleed causes tremendous brain damage. The risk is greatest in the infant’s first 48 hours of life.

With funding from the National Institute of Neurological Disorders and Stroke and the Philip Morris Organization, the team set out to reduce the risk, focusing much of their effort on a molecule known as VEGF, which is largely responsible for answering the brain’s call for more oxygen by actively building new blood vessels. It’s the same compound that many cancerous tumors use to feed their demand for oxygen and to grow.

The goal was to make the germinal matrix a little hardier in cases of premature birth, by eliminating the active building of new, but very fragile, blood vessels that bleed more easily than established blood vessels. The team used celecoxib to knock down the production of cox-2, which in turn slowed production of VEGF. The team also studied an anti-cancer drug known as ZD6474, which affects another molecule, angiopoietin-2, that the body uses to build blood vessels.

The team found that in human brain tissue, the compounds greatly reduced the production of cells used to build blood vessels, and decreased levels of angiopoietin-2 and VEGF, the two molecules very active in building new blood vessels.

Results were dramatic in female rabbits that were given the drugs for two days before delivering their offspring prematurely. The team showed that celecoxib cut the risk in offspring of having a moderate or severe bleed in half, from 90 percent to 45 percent. The percentage was reduced even more when ZD6474 was used as well, from 45 to 27 percent, but Nedergaard and Ballabh point out that ZD6474 is a very potent medication not likely to be given to pregnant women in the near future.

Overall, the best way to prevent the problem, doctors say, is to do everything possible to allow a pregnant woman to carry a pregnancy for a full 40 weeks. So doctors put a great deal of effort into preventing preterm labor. But when premature labor can’t be prevented, doctors do have a few tools at their disposal to try and prevent bleeds in the germinal matrix.

Steroids, commonly used to help develop the lungs of a premature infant, can help prevent bleeds too. And recent research has shown that indomethacin, which like celecoxib is a non-steroidal anti-inflammatory drug, has been shown to help prevent such bleeds and is used to treat premature infants for other problems, but it has some severe side effects, Ballabh said. And a 2002 report by researchers at Washington University and Northwestern University indicated that celecoxib – the same drug that Nedergaard and Ballabh showed helps prevent the bleeds – might also be effective in preventing preterm labor.

“This work is very exciting, but the work is ongoing, and we must investigate the use of celecoxib more thoroughly before considering it for widespread use to prevent this problem,” said Ballabh. “We can fix many problems in the premature infant, but brain damage is one problem that cannot be fixed – it must be prevented. Right now there is nothing available that has been shown to be really effective at preventing this problem.”

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Rochester authors of the paper include Nedergaard, professor in the Department of Neurosurgery; Goldman, professor in the departments of Neurology and Neurosurgery; and Lou, research assistant professor. At New York Medical College, authors in addition to Ballabh are Hongmin Xu, Furong Hu, Alex Braun, Kira Smith, Aracelie Rivera, Zoltan Ungvari, and Anna Csiszar.

Contact: Tom Rickey

University of Rochester Medical Center Continue reading

CMS Proposes Policy And Payment Rate Changes For Inpatient Stays In Acute Care And Long-Term Care Hospitals In FY 2011

The Centers for Medicare & Medicaid Services (CMS) proposed the fiscal year (FY) 2011 policies and payment rates for inpatient services furnished to people with Medicare by both acute care hospitals and long-term care hospitals. The proposals are intended to ensure that Medicare pays appropriately for high quality, efficient and safe inpatient care.

The proposed rule does not address inpatient hospital related provisions of the recently enacted Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively referred to as the ‘Affordable Care Act’). CMS expects to provide further information on the implementation of health care reform provisions in these laws that affect FY 2010 and FY 2011 IPPS payments in the near future.

In today’s action, CMS is proposing to update acute care hospital rates by 2.4 percent for inflation, a slight increase over the FY 2010 inflation rate, and apply an adjustment of -2.9 percentage points to recoup one-half of the estimated excess spending in FY 2008 and 2009 aggregate payments, due to changes in hospital coding practices that did not reflect increases in patients’ severity of illness. Under legislation passed in 2007, CMS is required to recoup the entire amount of FY 2008 and 2009 excess spending from changes in hospital coding practices by FY 2012. CMS estimates that payments to general acute care hospitals under the proposed rule for operating expenses in FY 2011 will decline by 0.1 percent, or $142 million, compared with FY 2010, and taking into account all factors that would affect spending.

CMS is similarly proposing to update long-term care hospital (LTCH) rates by 2.4 percent for inflation and apply an adjustment of -2.5 percentage points for the estimated increase in spending in FYs 2008 and 2009 due to documentation and coding that did not reflect increases in patients’ severity of illness. Based on these two proposed provisions and other proposed changes, CMS estimates that payments to LTCHs would increase by 0.8 percent or $41 million.

The projected inflation updates for both types of hospitals may be revised in the final rule based on more recent data.

‘The proposals we are announcing today take a significant step towards improving the accuracy of Medicare payments for inpatient hospital stays, while continuing and expanding payment incentives to hospitals to improve the quality and safety of care they furnish to beneficiaries,’ said Jonathan Blum, Deputy Administrator and Director for the Center for Medicare.

The proposed rule would apply to approximately 3,500 acute care hospitals paid under the Inpatient Prospective Payment System (IPPS), and approximately 420 long-term care hospitals paid under the Long-Term Care Hospital Prospective Payment System (LTCH PPS), beginning with discharges occurring on or after October 1, 2010. Proposed payment rates are based on the most recently available data and may be revised in the final rule to reflect more current data.

Under current law, hospitals that successfully report quality measures included in the Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU) program will receive the full update for 2011. Hospitals that do not participate in the quality reporting program will get the update less two percentage points. Based on the required reporting in 2009, 96 percent of participating hospitals are receiving the full update this year.

CMS is proposing to add 45 measures to the RHQDAPU set for reporting in 2011. However, only 10 of the proposed measures ‘ including rates of occurrence for eight of 10 categories of conditions that are subject to the hospital-acquired conditions (HACs) policy – will be considered in determining a hospital’s FY 2012 update. The remaining 35 measures – many of which CMS is proposing to be reported through registries – would be considered in determining the hospital’s FY 2013 update, and hospitals would not be required to report all of the proposed registry-based measures. The proposed use of registries would prevent hospitals from having to report the same data twice. In addition, CMS is proposing to retire one existing measure for reporting – mortality for selected surgical procedures (composite).

The proposed rule was placed on display at the Federal Register today, and can be found under Special Filings here.

CMS will accept comments on this proposed rule until June 18, and will respond to them in a final rule to be issued by August 1, 2010.

For more information, please see here.

Note

More information about the proposed rule, including the documentation and coding adjustment and the RHQDAPU changes and HACs discussion, can be found in Fact Sheets on our Web page.

Source
Centers for Medicare & Medicaid Services Continue reading

Are All Calories Created Equal? A New Study Shows A Serving Of Almonds Can Help You Feel Full, Without Leading To Weight Gain

Scientists have noticed for many years that people who regularly eat almonds tend to weigh less than people who do not – even though they tend to eat more calories over the course of a day.1 Why? A new study published in the British Journal of Nutrition sheds light on the mechanisms behind almonds’ ability to provide valuable nutrition and help lower LDL cholesterol levels without contributing to weight gain.

In the study, women were instructed to eat 344 calories worth of almonds (around 56 grammes) every day for one 10-week period, and then eat their customary diet for another 10 weeks. The women did not gain weight during the period they consumed almonds. In addition, because of the high Vitamin E and magnesium content in almonds, they met the daily dietary recommendations for these two nutrients.

The researchers determined that the study participants felt satisfied, so they naturally compensated for most of the calories in almonds by reducing their intake of other foods in their normal daily diet. They also noted a decrease in total carbohydrate intake, suggesting almonds may have replaced carbohydrate-rich foods.

Additionally, the researchers found that the fibre in almonds appears to block some of the fat they contain from being digested and absorbed. This means that almonds may provide fewer calories than would be expected. This raises broader questions about the availability of energy from foods.

“Solid data has shown that eating one to three daily portions of almonds (28 to 84 grammes) can help lower LDL cholesterol levels,” said study co-author Rick Mattes, Ph.D., R.D. from Purdue University in West Lafayette, USA. “But many health care providers have been hesitant to recommend almonds as a daily snack because they’re a relatively high-calorie food and could contribute to weight gain. This study challenges that assumption.”

Study Details

The research team at Purdue University conducted a study with 20 women, most of whom were overweight. One group was instructed to eat a normal diet for 10 weeks, but make one change – add 344 calories worth of almonds every day, around 56 grammes. The other group was instructed to eat their customary diet and no almonds. The groups then took a break for three weeks, and switched, so the second group ate almonds and the first group ate none. Researchers measured body weight, metabolic rates, and physical activity at various points during the study. Compliance to almond consumption was assessed through diet records, as well as by measuring blood levels of Vitamin E. This measurement was used because eating almonds, a leading source of Vitamin E, has been shown to increase Vitamin E levels in the blood.

The researchers found that when people were eating the 344 calories worth of almonds every day they were, in total, only taking in an extra 77 calories. This is because the participants naturally compensate for the great majority of the calories in almonds, about 74 percent, as they found them to be satiating, or satisfying.

A further portion of these extra daily 77 calories was offset because the fibre structure of almonds blocked the fat in almonds from being fully absorbed. Although not statistically significant, the researchers also noted an increase in energy expenditure through an increase in resting energy expenditure, the number of calories used while participants were at rest. Based on the various measures in the study, the researchers concluded that the calories from almonds were compensated for by natural reduction in the consumption of other foods, by some of the fat from the almonds passing through the body without being digested, and by an increase in resting energy expenditure.

Also notable was that eating almonds led to significant increases in the intake of several important nutrients: monounsaturated and polyunsaturated fat, Vitamin E, magnesium and copper.
v
“This study further demonstrates that almonds are not only nutritious, they can be satisfying – a good choice in place of something less nutrient-rich and less filling” commented Dr Tony Leeds, Senior Lecturer in Nutrition at Kings College London.

Building on Previous Research

This study adds to the evidence that almonds are satiating and may play a valuable role in weight management. Previous studies have shown that the addition of nuts, and almonds specifically, to a daily diet does not cause weight gain and increases satiety.1 In fact, almonds have been included in amounts up to 570 calories a day without contributing to weight gain.1 Recent research has also shown that almonds may help reduce spikes in blood sugar following a carbohydrate-based meal. High blood sugar levels often lead to a feeling of hunger which can prompt people to eat more than they should. 1,2

A 28 gramme, 160-calorie handful of almonds is an excellent source of Vitamin E and magnesium, a good source of protein and fibre, and offers potassium, calcium, phosphorous, iron, and monounsaturated fat.
For additional information about almonds, including easy recipes and snack ideas, visit AlmondsAreIn.

Summary of Published Study:

- Journal: British Journal of Nutrition, September 2007

- Research Organizations: Purdue University, West Lafayette, Ind.

- Study Title: Effect of chronic almond consumption on body weight of healthy humans.

- Authors: James Hollis, PhD; Rick Mattes, PhD, RD

- Objective: To determine if the inclusion of a 344 calorie serving of almonds in the daily diet results in positive energy balance, and body composition change.

- Subjects: 20 women with an average age of 24 and an average BMI of 25

Study description: In this 23 week crossover study, participants were randomized to one of two conditions, almonds or control. The almond group was instructed to consume two ounces of raw, unsalted almonds for 10 weeks in addition to their normal daily diet. The control group followed their usual diet. After 10 weeks and a three week washout period, the groups crossed over (the almond group became the control and vice versa). Body weight, metabolic rates, and physical activity were measured during weeks one and eight. Stool samples and serum vitamin E levels were also measured.

Results: Ten weeks of almond supplementation did not cause a change in body weight despite an overall increase in caloric intake. Seventy-four percent of the calories in almonds were compensated for through reduced food intake from other sources. Inefficiency in the absorption of energy from almonds was also observed. The fibre structure of the almonds appears to block the fat in almonds from being fully available. No changes in physical activity or metabolism were noted. In addition, the consumption of almonds led to a significant increase in the intake of polyunsaturated fat (4.4 g, p Continue reading

A Stem Cell Target For Expanding Waistlines?

Researchers may have found the key to developing a method to rid the body of stem cells responsible for driving fat expansion. According to a report in the June 16 Cell Stem Cell, a Cell Press publication, they’ve landed the first protein marker on the surface of those so-called adipose stromal cells (ASCs), which serve as progenitors of the cells that make up fat tissue.

“Our long-term goal is to identify an approach to inactivate these cells in disease,” said Mikhail Kolonin of University of Texas Health Science Center at Houston. “By administering a peptide with a toxin to ASCs, we could deplete these cells.” In past studies, he has used a similar approach to develop a therapy targeting the blood vessels that feed fat tissue.

The first step to targeting ASCs was to find a marker on their surfaces that uniquely identifies them. The method the research team developed relies on billions of viral particles each displaying a different peptide on its outer coat. The goal was to find one or more that binds specifically to ASCs in live mice and to then use it as “bait” to isolate the target receptor.

That exercise led them to a previously undescribed fragment of decorin, a multifunctional protein regulating cell adhesion, proliferation, and migration. Interestingly, the team shows that this new marker (referred to as delta-decorin) interacts with a hormone known as resistin. Despite resistin’s fame in scientific circles for its connection to obesity and insulin resistance, its receptor had remained elusive.

“The expansion of fat tissue is the foundation of obesity,” Kolonin said. “For that to happen, you need progenitors to proliferate and spread around.” The effects of resistin in ASCs, acting via decorin, appear to be responsible.

The findings may have other benefits as well. Although ASCs may be part of the problem in the case of obesity, they can also be harvested for use in regenerative therapies and hundreds of clinical trials are now underway. “The lack of markers for the cells has been limiting in the clinical context,” Kolonin explained, because it has made it difficult to tell whether administered cells are stable and whether they end up where they should be.

“These cells can be useful, but they are also potentially dangerous,” he said, noting that they’ve been linked to cancer progression. The new findings show it is possible to direct probes to stromal cells in vivo in an organ-specific manner. In the future, the identified cell surface biomarker can be exploited for imaging or therapeutic ASC targeting.

But there is more work to do. “While identification of decorin as a prospective ASC marker makes a step toward stem cell targeting applications, cell surface molecules differentially expressed on progenitor cells in other organs are yet to be identified,” the researchers write. “Other peptides isolated in our study, based on their homing to lung, muscle, and bone marrow stromal cells, set the foundation for subsequent identification of protein interactions marking stromal progenitors of these organs.”

Source:
Elisabeth (Lisa) Lyons

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Abbott Advances Blood Bank Testing Technology With U.S. Launch of Abbott PRISM(R)

Abbott announced today that the first, fully-automated blood screening instrument, Abbott PRISM(R) System and a test for hepatitis B, will be available to blood banks across the United States, marking a major step forward in blood bank testing technology. Before a blood donation can enter the blood supply, it is tested for evidence of exposure to viruses that might cause disease. This screening process involves numerous assays, multiple test instruments and many manual steps. The PRISM instrument consolidates much of this testing into a single system, reducing the risk of accidents, errors and tampering by automating the manual testing procedures and steps currently used to screen blood.

“Abbott has a strong history and commitment to ensuring the safety of the world’s blood supply. Now, the PRISM system’s advanced screening technology will be available to U.S. blood banks for hepatitis core screening, helping to make America’s blood supply as safe as possible,” said Joseph M. Nemmers, senior vice president, Diagnostic Operations, Abbott. “PRISM’s automated technology will minimize the potential for manual errors and allow donated blood to be quickly tested and verified before being released into the blood supply.”

Outside the United States, the PRISM system is used in more than 30 countries. Nearly half of these countries rely on PRISM to screen 100 percent of their blood donations.

“Prior to acquiring the PRISM system, infectious disease testing was a very labor intensive process involving numerous steps and requiring more time to test blood before it could enter the blood supply,” said Graham Sher, M.D., chief executive officer, Canadian Blood Services, a non-profit organization that manages the blood supply at 42 sites in Canadian provinces and territories outside of Quebec. “The PRISM technology has not only allowed us to enhance the safety of the blood supply by eliminating this manual intervention, but also our organization is able to easily process the sudden increase in collections that are occasionally required during emergencies.”

PRISM features a built-in quality control system that monitors critical functions and verifies proper processing of each sample. Blood banks across the U.S. have been eager to bring the PRISM system into their labs due to its ability to handle a high number of tests with very little manual intervention. A mistake made during the screening process may produce a false result that might unnecessarily defer a donor or allow an infected unit of blood to be made available for transfusion.

“Even though donated blood is screened following rigorous protocol to ensure a safe blood supply, there are still a number of manual steps performed in the testing process,” said Louis M. Katz, M.D., executive vice president, medical affairs, Mississippi Valley Regional Blood Center. “The PRISM instrument is a completely closed system so there is very little, if any, chance for operator errors during sample processing.”

A hepatitis B test, PRISM(R) HBcore, is the first test approved by the U.S. Food and Drug Administration (FDA) for use on the PRISM system. Additional hepatitis and retrovirus screening tests, which includes a test for HIV, are currently under FDA review. Abbott also has other PRISM assays in development.

According to the American Association of Blood Banks (AABB), approximately eight million volunteers donate about 15 million units of whole blood each year. Each donated unit of blood is tested for infectious diseases including hepatitis, HIV and other retroviruses.

On any given day, approximately 38,000 units of red blood cells are needed. Donated blood is used to treat accident victims, people undergoing surgery and patients receiving treatment for leukemia, cancer or other diseases such as sickle cell disease and thalassemia.

About Abbott PRISM System

Fast and efficient, the PRISM system can run 160 samples per hour or up to 800 tests, making it possible to test more than 1,200 samples per eight hour shift. Numerous safety features built into the system help track and monitor each sample throughout the testing process providing documentation and quality control for testing facilities. Additionally, PRISM’s testing methodology, Chemiluminescent Immunoassay (ChLIA), allows the system to better detect infectious agents or antibodies which may be present in a sample.

About Abbott

Abbott is a leader in ensuring the safety of the world’s blood supply. In 1985, Abbott developed the world’s first HIV blood screening test. Concentrating efforts in hepatitis and retrovirus detection, Abbott continues to set the standards of excellence in blood screening.

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 60,000 people and markets its products in more than 130 countries.

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