Knee Replacements Soar Among The Under-60s, Finland

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Main Category: Arthritis / Rheumatology
Also Included In: Rehabilitation / Physical Therapy;  Bones / Orthopedics
Article Date: 17 Jan 2012 – 12:00 PST

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A new study published online on 17 January in the journal Arthritis Rheumatism reports that rates of knee
replacement surgery in Finland’s 30 to 59-year-olds soared between 1980 and 2006, with women being the more common
recipients throughout. Lead author Dr. Jarkko Leskinen, an orthopedic surgeon at Helsinki University Central Hospital, and
colleagues also report that the greatest increase was among those aged between 50 and 59.

Knee replacement surgery is the common term for partial and total knee arthroplasty, an operation where part or all of the
diseased or damaged surfaces of the knee joint are replaced with metal and plastic parts shaped to allow the patient to move the
knee normally.

Arthroplasty is often the only treatment option for people who have severe osteoarthritis (OA) of the knee, as Leskinen explained
the press:

“OA risk is shown to increase with age and for severe knee OA arthroplasty is a commonly used treatment option when patients
are unresponsive to more conservative therapies.”

But although arthroplasty has become increasingly more common, we don’t have much information on rates among different parts
of the population, and its effects in younger patients.

For their study, Leskinen and collegues looked at records of all unicondylar (partial) and total knee replacements performed
between 1980 and 2006 in Finland. These records are kept by the Finnish Arthroplasty Registry.

They looked at how incidence rates of arthroplasty for knee osteoarthritis varied by gender, age, and hospital volume.

Their main findings show that:

  • Rates of total knee replacement among those aged 30 to 59 went up 130-fold in the 27-year period.
  • The incidence went up from 0.5 procedures per 100,000 of Finland’s population to 65 per 100,000.
  • The fastest rise happenend between 2001 and 2006 (from 18 to 65 per 100,000).
  • There was a similar rapid rise in partial knee replacements: from 0.2 to 10 procedures per 100,000 of the
    population.
  • In the last ten years of the study (1997 to 2006), the rate of total knee replacements was 1.6 to 2.4 times higher in women
    than in men.
  • The rates of total and partial knee replacements were highest among 50 to 59-year-olds.

The researchers conclude that their study demonstrates “the rapid increase in incidences of arthroplasty among patients with
primary knee osteoarthritis in Finland, especially in age group of 50 to 59 years of aged.”

“There was no single explanatory factor behind this phenomenon though some of the growth might be due to the increase of
incidences observed in low and intermediate volume hospitals,” they note.

Leskinen said:

“Given that younger patients may be at higher risk of artificial knee joint failure and thus in need of a second replacement
surgery, long-term data are needed before widespread use of total knee arthroplasty is recommended for this patient
population.”

In an accompanying editorial, Dr. Elena Losina, of Brigham and Women’s Hospital and Harvard Medical School in Boston,
Massachusetts, agrees with Leskinen. She writes that total knee replacement is an effective treatment for OA in older patients,
those in their 60s, 70s and 80s.

“However, past performance may not guarantee future success, and with an increasing number of knee replacement recipients
under 60 years old, more intensive study of arthroplasty outcomes in younger patients is warranted,” she urges.

According to the World Health Organization (WHO), osteoarthritis is the fourth leading cause of years lived with disability
worldwide.

Experts estimate that around 10 million people are living with osteoarthritis in the US, where over 600,000 knee replacements
were carried out in 2009, according to a report from the Agency for Healthcare Research and Quality. A previous study
estimated that by 2030 the number of such procedures could grow by over 670% to nearly 3.5 million a year.

Written by Catharine Paddock PhD

Copyright: Medical News Today

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Link Between Ultra Short Telomeres And Osteoarthritis

Main Category: Arthritis / Rheumatology
Also Included In: Bones / Orthopedics
Article Date: 17 Jan 2012 – 0:00 PST

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Telomeres, the very ends of chromosomes, become shorter as we age. When a cell divides it first duplicates its DNA and, because the DNA replication machinery fails to get all the way to the end, with each successive cell division a little bit more is missed. New research published in BioMed Central’s open access journal Arthritis Research Therapy shows that cells from osteoarthritic knees have abnormally shortened telomeres and that the percentage of cells with ultra short telomeres increases the closer to the damaged region within the joint.

While the shortening of telomeres is an unavoidable side effect of getting older, telomeres can also shorten as a result of sudden cell damage, including oxidative damage. Abnormally short telomeres have been found in some types of cancer, possibly because of the rapid cell division the cells are forced to undergo.

There has been some evidence from preliminary work done on cultured cells that the average telomere length is also reduced in osteoarthritis (OA). A team of researchers from Denmark used newly developed technology (Universal single telomere length assay) to look in detail at the telomeres of cells taken from the knees of people who had undergone joint replacement surgery. Their results showed that average telomere length was, as expected, shortened in OA, but that also ‘ultra short’ telomeres, thought to be due to oxidative stress, were even more strongly associated with OA.

Maria Harbo who led this research explained, “We see both a reduced mean telomere length and an increase in the number of cells with ultra short telomeres associated with increased severity of OA, proximity to the most damaged section of the joint, and with senescence. Senescence can be most simply explained as biological aging and senescent cartilage within joints is unable to repair itself properly.”

She continued, “The telomere story shows us that there are, in theory, two processes going on in OA. Age-related shortening of telomeres, which leads to the inability of cells to continue dividing and so to cell senescence, and ultra short telomeres, probably caused by compression stress during use, which lead to senescence and failure of the joint to repair itself. We believe the second situation to be the most important in OA. The damaged cartilage could add to the mechanical stress within the joint and so cause a feedback cycle driving the progression of the disease.”

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32 Million Americans Have Autoantibodies That Target Their Own Tissues

Main Category: Immune System / Vaccines
Also Included In: Arthritis / Rheumatology;  Diabetes;  Lupus
Article Date: 17 Jan 2012 – 0:00 PST

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More than 32 million people in the United States have autoantibodies, which are proteins made by the immune system that target the body’s tissues and define a condition known as autoimmunity, a study shows. The first nationally representative sample looking at the prevalence of the most common type of autoantibody, known as antinuclear antibodies (ANA), found that the frequency of ANA is highest among women, older individuals, and African-Americans. The study was conducted by the National Institute of Environmental Health Sciences (NIEHS), part of the National Institutes of Health. Researchers in Gainesville at the University of Florida also participated.

Earlier studies have shown that ANA can actually develop many years before the clinical appearance of autoimmune diseases, such as type 1 diabetes, lupus, and rheumatoid arthritis. ANA are frequently measured biomarkers for detecting autoimmune diseases, but the presence of autoantibodies does not necessarily mean a person will get an autoimmune disease. Other factors, including drugs, cancer, and infections, are also known to cause autoantibodies in some people.

“Previous estimates of ANA prevalence have varied widely and were conducted in small studies not representative of the general population,” said Frederick Miller, M.D., Ph.D., an author of the study and acting clinical director at NIEHS. “Having this large data set that is representative of the general U.S. population and includes nearly 5,000 individuals provides us with an accurate estimate of ANA and may allow new insights into the etiology of autoimmune diseases.” The findings appear online in the journal Arthritis and Rheumatism.

Miller, who studies the causes of autoimmune diseases, explains that the body’s immune system makes large numbers of proteins called antibodies to help the body fight off infections. In some cases, however, antibodies are produced that are directed against one’s own tissues. These are referred to as autoantibodies.

A multi-disciplinary team of researchers evaluated blood serum samples using a technique called immunofluorescence to detect ANA in 4,754 individuals from the 1994-2004 National Health and Nutrition Examination Survey (NHANES). The overall prevalence of ANA in the population was 13.8 percent, and was found to be modestly higher in African-Americans compared to whites. ANA generally increased with age and were higher in women than in men, with the female to male ratio peaking at 40-49 years of age and then declining in older age groups.

“The peak of autoimmunity in females compared to males during the 40-49 age bracket is suggestive of the effects that the hormones estrogen and progesterone might be playing on the immune system,” said Linda Birnbaum, Ph.D., director of NIEHS and an author on the paper.

The paper also found that the prevalence of ANA was lower in overweight and obese individuals than persons of normal weight. “This finding is interesting and somewhat unexpected,” said Edward Chan, Ph.D., an author on the study and professor of the Department of Oral Biology at the University of Florida.

“It raises the likelihood that fat tissues can secrete proteins that inhibit parts of the immune system and prevent the development of autoantibodies, but we will need to do more research to understand the role that obesity might play in the development of autoimmune diseases,” said Minoru Satoh, M.D., Ph.D., another author on the study and associate professor of rheumatology and clinical immunology at the University of Florida.

The researchers say the paper should serve as a useful baseline for future studies looking at changes in ANA prevalence over time and the factors associated with ANA development. The paper is the first in a series analyzing these data from the NHANES dataset, and exploring possible environmental associations with ANA.

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Satoh M, Chan EKL, Ho LA, Rose KM, Parks CG, Cohn RD, Jusko TA, Walker NJ, Germolec DR, Whitt IZ, Crockett PW, Pauley BA, Chan JYF, Ross SJ, Birnbaum LS, Zeldin DC, Miller, FW. 2012. Arthritis and Rheumatism; doi: 10.1002/art.34380 [online 2012 January 11].

NIH/National Institute of Environmental Health Sciences

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Knee Replacement Surgery Incidence Soars In Those Over Age 50

Main Category: Arthritis / Rheumatology
Also Included In: Women’s Health / Gynecology
Article Date: 17 Jan 2012 – 1:00 PST

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Researchers in Finland found that annual cumulative incidences of partial and total knee arthroplasty, commonly known as knee replacement surgery, rose rapidly over a 27-year period among 30 to 59 year-olds in that country, with the greatest increase occurring in patients aged 50 to 59 years. According to the study published in Arthritis Rheumatism, a peer-reviewed journal of the American College of Rheumatology (ACR), incidences were higher in women throughout the study period.

Osteoarthritis (OA) is a highly disabling joint disease that according to a 2002 report by the World Health Organization (WHO) is the fourth leading cause of years lived with disability worldwide. In the U.S., experts say more than 10 million adults are affected by OA and for those with advanced disease arthroplasty may be the only treatment option to relieve the disabling pain and stiffness, and improve quality of life. In fact, the Agency for Healthcare Research and Quality reports that over 600,000 total knee replacements were performed in the U.S. in 2009 and a previous study estimates that number could grow by 673% to 3.48 million procedures by the year 2030.

“OA risk is shown to increase with age and for severe knee OA arthroplasty is a commonly used treatment option when patients are unresponsive to more conservative therapies,” said Dr. Jarkko Leskinen, an orthopedic surgeon at Helsinki University Central Hospital in Finland and lead author of the current study. “Despite the more frequent use of replacement surgery, very few data are published on knee arthroplasty incidence and its effects in younger populations.” To advance understanding of this issue, researchers obtained data collected by the Finnish Arthroplasty Registry of all unicondylar (partial) and total knee replacements performed between 1980 and 2006. The team analyzed the effects of gender, age group and hospital volume on incidence rates of arthroplasty for knee OA.

Findings indicate a 130-fold increase in incidence of total knee arthroplasty among those between the ages of 30 and 59 years during the study period. The incidence increased from 0.5 to 65 operations per 100,000 individuals, with the most rapid increase occurring from 2001 to 2006 (18 to 65 operations per 100,000). Increase in incidence of partial knee replacements was also observed from 0.2 to 10 operations per 100,000 inhabitants. Researchers also found that in the last ten years of the study the incidence of total knee replacements was 1.6 to 2.4-fold higher in women than in men. Incidences of total and partial knee replacements were also higher in the oldest age group (50 to 59 years of age).

Dr. Leskinen concludes, “Our study confirmed rapid growth in incidences of partial and total knee arthroplasty in those less than 60 years of age. Given that younger patients may be at higher risk of artificial knee joint failure and thus in need of a second replacement surgery, long-term data are needed before widespread use of total knee arthroplasty is recommended for this patient population.”

In a related editorial also published in Arthritis Rheumatism, Dr. Elena Losina with Brigham and Women’s Hospital and Harvard Medical School in Boston, Massachusetts agrees, “Total knee arthroplasty is an effective intervention for OA with excellent outcomes for patients in their 60’s, 70’s and 80’s. However, past performance may not guarantee future success, and with an increasing number of knee replacement recipients under 60 years old, more intensive study of arthroplasty outcomes in younger patients is warranted.”

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Do Herbal Meds Help Osteoarthritis? Probably Not

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Article Date: 16 Jan 2012 – 10:00 PST

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A comprehensive review of herbal medicine products in the latest issue of the Drug and Therapeutics Bulletin (DTB) shows that there is little conclusive evidence to justify the widespread use of herbal medicines to relieve the symptoms of the painful joint condition osteoarthritis.

The products involved contain devil’s claw and recently, the UK drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has approved several of these products under the Traditional Herbal Registrations scheme. According to the DTB, the trial results for devil’s claw “are equivocal.”

It is estimated that approximately 8.5 million individuals in the UK suffer from joint pain and other symptoms that are potentially caused by osteoarthritis, which is also known as degenerative arthritis or degenerative joint disease. Osteoarthritis is caused by ageing or wear and tear to the joints, usually the knees or hips and finger, and involves damage to cartilage and other structures in and around the joints.

Various vegetable extracts and herbs have traditionally been used in Herbal medicine for the treatment of osteoarthritis, such as devil’s claw, cat’s claw, ginger, rosehip, Indian frankincense, willow bark, nettleturmeric and vegetable extracts from avocado or soybean oils (ASUs).

The DTB warns that few studies have been conducted on using herbal medicines for osteoarthritis. Previous studies frequently demonstrate limitations and design flaws like differences in the chemical make-up of the same herb, and therefore compromise the validity of any results. In addition, the DTB says, these studies were conducted in insufficient numbers of patients and were too short, which for long-term conditions, such as osteoarthritis, is of particular importance.

According to the DTB, current clinical trial evidence suggests that the ASUs Rosehip and Indian frankincense potentially work, and appear to bring on few unwanted side effects, however they add that: “More robust data are needed.”

The DTB state that: ‘evidence in favor of their use is at best equivocal or unconvincing’ in terms of the remaining ASUs, and points out that Herbal drugs can also interfere with other medicinal products and prescription drugs.

It also states:

“Herbal medicines can have significant pharmacological actions, and so can cause unwanted effects and have potentially dangerous interactions with other medicines (both herbal and conventional).”

For example, the DTB announces that extensive use of nettle can interfere with diabetes drugs and medicine for treating lower blood pressure by depressing the central nervous system. Whilst Willow bark can trigger digestive symptoms and renal problems, some herbal drugs can potentially worsen the symptoms of other underlying conditions. Cat’s claw and nettle should not be used during pregnancy, and willow bark is not recommended for those suffering from asthma, peptic ulcers, or anyone with clotting disorders.

The DTB concludes that:

“Herbal medicines have traditionally been used for the relief of osteoarthritis symptoms. However, there is a lack of licensed herbal medicinal products on the market for such symptoms, and none specifically licensed for osteoarthritis. Also the efficacy and safety of such products is generally under researched and information on potentially significant herb-drug interactions is limited.”

It advises doctors to routinely ask their patients with osteoarthritis if they are taking any herbal products.

Written by Petra Rattue

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Medicare Plans Recruit Healthy Seniors By Offering Gym Benefits

Main Category: Medicare / Medicaid / SCHIP
Also Included In: Seniors / Aging;  Sports Medicine / Fitness
Article Date: 13 Jan 2012 – 0:00 PST

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Because healthy enrollees cost them less, Medicare Advantage plans would profit from selecting seniors based on their health, but Medicare strictly forbids practices such as denying coverage based on existing conditions. Another way to build a more profitable membership is to design insurance benefits that attract the healthiest patients. In a study published in the New England Journal of Medicine, Brown University researchers report that plans have managed to do just that by offering fitness club memberships as a covered benefit.

“Offering a fitness membership does not mean that you are denying people coverage, but you are changing your benefits to appeal selectively to people who are healthy,” said co-author Amal Trivedi, a Brown public health professor and a physician at the Providence VA Medical Center. “Policymakers intended for Medicare Advantage plans to compete on the basis of improving quality and reducing costs, rather than on their ability to attract healthier patients. What we found in the study is that offering coverage for fitness membership is a very effective strategy to attract a much healthier population.”

That conclusion comes from Trivedi’s and lead author Alicia Cooper’s rigorous statistical comparisons among thousands of patients in 22 Medicare Advantage plans – 11 “case” plans that added fitness club memberships in 2004 or 2005 and 11 similar “control” plans that didn’t. They looked at when each plan member enrolled, when plans started offering the benefit, and what each plan member said about his or her health in the Medicare Health Outcomes Survey from 2006 to 2008.

One analysis compared the self-reported health of seniors who enrolled in case plans before the fitness club benefit was offered to the health of those who enrolled after the benefit was offered. While 29.1 percent of the seniors who enrolled before the benefit was available described themselves to be in excellent or very good health, 35.1 percent of the seniors who enrolled after it became available reported that level of health. In the before group, 56.1 percent reported some limitation to their physical activity but only 45.7 percent in the after group did. Also, a third of the before group reported difficulty walking compared to just a quarter in the after group.

Once the Medicare Advantage plans started covering health club memberships, they enrolled healthier enrollees with fewer physical limitations. In the control plans, which did not offer the benefit, self-reported health levels over the same timeframe changed only slightly. In comparison to the control plans, eight of the 11 case plans (the ones that added fitness club coverage) enrolled seniors with better overall health, 10 of the 11 case plans enrolled seniors with fewer restrictions in physical activity, and nine of the 11 case plans enrolled seniors that had less difficulty walking.


An increasing practice

Trivedi and Cooper studied the benefit structures of 101 Medicare Advantage health plans between 2002 and 2008 to select plans for comparison. What they found is a rapid growth in the number of plans offering fitness club memberships, from 14 in 2002 to 58 in 2008.

“This trend suggests that offering fitness memberships may be an attractive business strategy for Medicare plans,” Trivedi said.

Trivedi acknowledged that if every plan offered the fitness benefits, it would no longer be an effective way of selecting for the healthiest members. However, given the continued incentive to enroll more profitable enrollees, he said, insurers may employ other related tactics to cherry-pick desirable enrollees.

“In general, policymakers have regulated the Medicare Advantage insurance market to prevent the ability of private plans to select the healthiest enrollees,” Trivedi said. “If Medicare plans do engage in favorable selection, then unhealthy enrollees can be concentrated in a small number of plans or in the traditional Medicare program, driving up the costs for those enrollees and the tax-payers that fund the Medicare program.”

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Dilated Eye Exams For Medicare Beneficiaries Cost Effective, USA

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Main Category: Eye Health / Blindness
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Article Date: 11 Jan 2012 – 8:00 PST

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A study published Online First in the Archives of Ophthalmology, one of the JAMA/Archives journals, suggests that it “would be highly cost-effective” to replace visual acuity screenings for new Medicare enrollees with coverage of a dilated eye exam for healthy patients who enter the government insurance program for the elderly.

At the age of 65 years, individuals are able to enroll in Medicare. As part of a Welcome to Medicare health evaluation ,within 12 months of enrollment, they are supposed to receive a visual acuity screening and other preventive health checks. The U.S. Preventive Services Task Force reversed its 1996 recommendation in 2009, in favor of visual acuity screening, because of insufficient evidence to support it. At present, it is undecided whether Medicare will continue to include visual acuity screening in its initial preventive physical examination.

The researchers comment:

“Our results support the conclusions of the U.S. Preventive Services Task Force that currently recommended visual acuity screening in primary care settings cannot be demonstrated to result in meaningfully different outcomes than no screening.”

David B. Rein, Ph.D., of Public Health Research at NORC at the University of Chicago, and his team, gathered data on 50,000 simulated patients who matched demographic characteristics to 65 year olds. They used a Monte Carlo cost-effectiveness simulation model and excluded patients with diabetes, given that the cost-effectiveness of visual screening for these patients has been established and also excluded those with diagnosed eye disease.

The findings indicate that dilated eye evaluations increased quality-adjusted life years (QALYs) by 0.008 and increased costs by $94, when compared with a no-screening policy. The researchers established that visual acuity screening raised QALYs in less than 95% of the simulations with an increase in total costs of $32 per person.

They conclude:

“Our research suggests that the current policy of visual acuity screening is a suboptimal use of resources and that replacing this policy with coverage of a dilated eye evaluation for all healthy patients entering Medicare would be highly cost-effective.”

Writen by Petra Rattue

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ED Eye Care In Florida

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Main Category: Eye Health / Blindness
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Article Date: 11 Jan 2012 – 8:00 PST

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A major part of Florida’s emergency department eye care is reimbursed through Medicaid or paid for directly by the patients. According to a study published in the Archives of Ophthalmology, one of the JAMA/Archives journals, these findings may be beneficial in strategic planning as the debate over how best to implement the nation’s new health care reform law progresses.

The background information of the study reveals that the Patient Protection and Affordable Care Act (PPACA) will raise insurance coverage in large part by expanding the eligibility for Medicaid, which is “an already stressed and under-funded system in many states.”

The researchers state that:

“Planning for such change in ophthalmology requires knowledge of what role Medicaid currently plays in the delivery of eye care.”

Matthew T. Witmer, M.D. and team evaluated data sets from the Florida Agency for Health Care Administration emergency department for outpatient visits and admissions for eye care, from 2005 through 2009. They identified a total of 587,227 emergency department visits with a primary diagnosis in need of eye care. 12,105 of these visits resulted in hospitalization. The researchers categorized all patients by age, i.e. younger or older than 18 years, and reviewed the types of insurance coverage.

They established during the 5-year study period that commercial insurance was the most frequent payer of emergency department outpatient services, with 31.1%, followed by 26.2% who paid themselves, and 22% of patients with Medicaid.

According to the findings, 67.7% of patients under the age of 18 years either paid themselves, or the cost was covered through Medicaid. The researchers also discovered that for outpatient emergency department visits, the percentage of change in Medicaid increased by 5.9% for each calendar year, whilst commercial coverage declined by 4.5%.

The researchers indicate that even though the study cannot be “indiscriminately generalized” to other states, they believe the data does apply to other states.

They conclude:

“Emergency department eye care will assume a larger safety-net function if more patients move into categories of Medicaid or self-pay. Already stressed EDs (emergency departments) and hospital staff need to be prepared to navigate change brought on by health care reform and the delayed economic recovery without compromising quality of care. Data within this study – although sobering – should be used for strategic planning as the debate on how to best implement PPACA moves forward.”

Editorial: Emergency Department Use for Eye Care Services and Future Directions in Care

Paul Lee, M.D., J.D., and Jacqueline Dzau, M.D., M.P.H, of the Duke Eye Center at Duke University Medical Center in Durham, N.C., write in an accompanying editorial that:

“The long-term growth in Medicaid, Medicare, and other public payor sources will only accelerate over the next 10 years, creating additional pressures and constraints on how we deliver eye care.

To the extent that ED (emergency department) payments are linked to an increasing proportion of Medicaid patients, traditionally among the lowest paying of all payors for adult care, the economic incentive for ophthalmologists not employed by hospitals to provide coverage will decrease, further exacerbating challenges in obtaining call coverage of eye conditions.”

They conclude that:

“If ‘necessity is the mother of invention,’ the findings described in the study by Witmer et al may be a harbinger of fundamental changes in the financing of ED provision of eye care and in the resulting care delivery models in Florida as well as the United States.”

Written by Petra Rattue

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

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Annual Bleeding Events And Frequency Of Infusions Reduced By Preventive Hemophilia A Treatment

Main Category: Blood / Hematology
Also Included In: Arthritis / Rheumatology;  Pediatrics / Children’s Health;  Preventive Medicine
Article Date: 11 Jan 2012 – 1:00 PST

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A Rush University Medical Center led international research team has announced that a treatment to prevent bleeding episodes in children with hemophilia A also is effective for adolescents and adults.

The preventive therapy will “optimize care for hemophilia patients of all ages by stopping unexpected bleeding events that can have a detrimental impact on the lives of patients,” said Dr. Leonard Valentino, director of the Rush Hemophilia and Thrombophilia Center and principal investigator on the study. The study results appeared in the January online version of the Journal of Thrombosis and Haemostasis. Valentino is associate professor of Pediatrics at Rush University’s Rush Medical College.

The study, sponsored by Baxter Healthcare Corporation, was conducted as part of a comprehensive clinical study of ADVATE Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM) to compare the effectiveness of two prophylactic treatment regimens, as well as between on-demand and prophylaxis treatments, in preventing bleeding in previously treated patients with severe or moderately severe hemophilia A. It is the first study designed to generate prospective data for stringent comparisons of bleeding rates.

Hemophilia A is a rare, inherited, potentially deadly blood clotting disorder that affects 400,000 people worldwide, most of them males.Approximately one in 5,000 individuals is born with hemophilia annually.

In people with hemophilia A, a protein called clotting factor VIII is either absent or present at low levels. Factor VIII replacement, such as rAHF-PFM, is considered the treatment of choice for managing hemophilia A patients who lack inhibitors (antibodies) of factor VIII.

About 90 percent of people who have hemophilia have type A. Of these, 70 percent have the severe form of the disorder, indicated by a factor VIII level of less than 1 percent of normal.

Patients with severe disease are at particular risk for spontaneous bleeding into joints, muscles and internal organs, as well as trauma-induced bleeding following injury and surgery. Joint bleeding may occur as frequently as 20 to 30 times a year, resulting in clinically significant hemophilia-related arthritis.

“The main goal of replacement therapy is to prevent this pathology,” Valentino said.

Primary prophylaxis is already the standard of care for children with hemophilia A. It is believed that the early initiation of prophylaxis may confer a protective effect against factor VIII inhibitor, the most serious complication associated with replacement therapy.

Adult hemophilia patients are treated either in response to bleeding (on demand) or with regular infusion of clotting factor to prevent bleeding and further joint damage. However, while on-demand treatment can slow the progression of hemophilia-related arthritis, it does not seem to prevent the condition.

In the Rush study, one regimen was based on common practice with every-other-day dosing. The other was customized for each individual based on the drug’s activity in the body (pharmacokinetics, or PK) with every-third-day dosing. PK-tailored prophylaxis offers an alternative to standard prophylaxis for the prevention of bleeding.

Study participants aged 7 to 65 years received six months of on-demand treatment with dosing dependent on the severity and type of bleeding episode. After completing the on-demand treatment period, subjects were randomized to receive 12 months of either standard or PK-tailored prophylaxis treatment. Once the prophylaxis period began, factor VIII levels were assessed every three months.

Of the 66 subjects in the study, 22 (33.3 percent) who received prophylaxis had no bleeding episodes, in contrast to the patients treated on demand. No subject developed factor VIII inhibitors. The patients who achieved these results were adherent to the prescribed number of prophylactic infusions.

Compared with on-demand treatment, both prophylaxis regimens significantly reduced bleeding, including spontaneous and traumatic hemorrhaging, and improved the quality of life for adolescent and adults patients. Results of the study suggest that prophylaxis is the optimal treatment for patients with severe hemophilia. Data from the study also confirm and extend the safety and effectiveness of rAHF-PFM for controlling and preventing bleeding in the management of hemophilia A.

The study findings suggest that the PK-tailored prophylaxis regimen, which used similar amounts of rAHF-PFM and one fewer infusion per week, is a viable treatment alternative to standard prophylaxis. The availability of this option could increase treatment adherence, particularly in children and adolescents, for whom compliance with long-term medical regimens is especially challenging. Additionally, the study confirms and extends the safety and effectiveness of rAHF-PFM for controlling and preventing bleeding in the management of hemophilia A.

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Valentino’s co-researchers on the study were Vasily Mamonov, Hematology Research Center under the Russian Academy of Medical Sciences, Department of Reconstructive Orthopedic Surgery for Hemophilia Patients, Moscow, Russian Federation; Andrzej Hellmann, Department of Hematology and Transplantology, Medical University of Gdańsk, Poland; Doris V. Quon, Orthopaedic Hospital, Hemophilia Treatment Center, Los Angeles; Alicja Chybicka, Wroclaw Medical University, Department of Pediatric Bone Marrow Transplantation, Oncology and Hematology, Wroclaw, Poland; and Phillip Schroth, Lisa Patrone, and Wing-Yen Wong, Baxter Healthcare Corporation, Westlake Village, Calif., for the Prophylaxis Study Group.

The Hemophilia and Thrombophilia Center at Rush is the largest hemophilia and thrombophilia program in Illinois. The Center offers clinical and laboratory services onsite for patients with bleeding and clotting disorders.

Rush University Medical Center

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Kaiser Permanente Study Finds Continuous Health Coverage Essential For Patients Managing Diabetes

Main Category: Health Insurance / Medical Insurance
Also Included In: Diabetes;  Medicare / Medicaid / SCHIP
Article Date: 06 Jan 2012 – 0:00 PST

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When patients with diabetes experience interruptions in health – insurance coverage, they are less likely to receive the screening tests and vaccines they need to protect their health. A new study finds that this is true even when patients receive free or reduced-cost medical care at federally funded safety net clinics.

The study was funded in part by the National Institutes of Health and findings published online in the Journal of the American Board of Family Medicine.

“Our study shows that patients need continuous health insurance coverage in order to ensure adequate preventive care, even when that care is provided at a reduced cost,” said Rachel Gold, PhD, MPH, lead author and investigator with the Kaiser Permanente Center for Health Research in Portland, Ore.

“Most of the services at our safety net clinics are free, but some of the diagnostic tests require a small co-pay that is usually covered by Medicaid,” said Amit Shah, MD, study co-author and Medical Director of the Multnomah County Health Department in Portland. “Patients who lose their Medicaid coverage often delay getting the tests because they can’t afford the co-pay.”

The study included 3,384 diabetes patients receiving medical care from 2005-2007 at 50 federally qualified health centers in Oregon. These health centers provide free or reduced-cost care to low-income patients regardless of their insurance status. More than half the patients in the study (52 percent) had continuous coverage, most often provided by Medicaid, a publicly funded insurance program for low-income people. Twenty-seven percent had no insurance, and 21 percent had interrupted coverage, during the three-year study period. Patients with private insurance were excluded from the study.

Researchers examined patients’ electronic health records to determine whether they received four services recommended at least annually for diabetes patients: a lipid test for high cholesterol, a flu vaccine, a test that measures blood sugar levels, and a urine test that can detect kidney damage.

Forty-eight percent of patients with continuous insurance coverage received at least three lipid-screening tests at one of the study clinics over the three-year study period; 25 percent received three or more flu shots; 72 percent received three or more screenings for blood glucose; and 19 percent received three or more screenings for kidney damage. Patients with no coverage, and patients with interruptions in coverage, received significantly fewer of these services than patients with continuous health insurance coverage.

Notably, the study showed no increase in services received as insurance coverage increased; rather, all patients with discontinuous health insurance were equally vulnerable to missing services, compared to the continuously insured. These findings suggest that public insurance coverage must be continuous to ensure that patients receive consistent and timely care.

The study was funded by the Health Resources and Services Administration, the National Library of Medicine, the National Heart, Lung and Blood Institute at the National Institutes of Health, and the Agency for Healthcare Research and Quality; it was also supported by OCHIN, formerly the Oregon Community Health Information Network, the Oregon Health Science University Department of Family Medicine, and by the Multnomah County Health Department.

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