Ankylosing Spondylitis (Bechterew's Disease) is a painful chronic inflammatory rheumatic disease, associated with stiffening of the vertrebral column. Between 100,000 and 150,000 cases have already been diagnosed in Germany, but milder forms of the disease may remain undiagnosed.
The research team, led by Dr. Roland R. Wick, with Dr. Elke A. Nekolla, Prof. Dr. Albrecht M. Kellerer and the late Prof. Dr. Wolfgang G?¶ssner have conducted a long-term follow-up study of 1,471 ankylosing spondylitis patients, whose disease symptoms were treated with repeated intravenous injections of 224Radium. A control cohort of 1,324 ankylosing spondylitis patients treated without the use of radioactive compounds and/or X-rays were also studied.
In the current publication an elevated rate of leukaemias was seen, a malignant disease of the haematopoietic system: In all, 19 observed cases of leukaemia were documented compared with 6.8 cases that would be expected in an age- and gender-matched cohort of a normal population. In particular, the incidence of acute myeloid leukaemia was significantly increased with 7.0 cases compared with 1.8 cases expected in a "normal" population.
Furthermore, four additional cases of preleukaemic diseases of the bone marrow were present in the exposed group and no cases in the control group. The frequency of leukaemia was not increased significantly in the control group compared with the expected value for a normal population.
"It is rather unlikely that impurities present in the radium preparations used before 1950 are responsible for the elevated appearance of myeloproliferative diseases in the exposed group observed here," commented Dr. Roland R. Wick. "In addition, the increased incidence of leukaemia is in line with experimental observations involving the treatment of animals with similar alpha emitting radioisotopes."
The results of these studies by the Helmholtz Zentrum M??nchen have contributed decisively to 224Radium preparations being declared obsolete and have resulted in the revocation of the licensing of SpondylAT ® by the Federal Institute for Drugs and Medical Devices (BfArM) and the decision by the licence holders to discontinue development of the treatment. In earlier legal proceedings the Cologne Administrative Court, in its decision of October 26th, 2006, came to the conclusion that the "increase of myeloid leukaemia [??¦] could be explained causally with the deposition of radium as a calcium-like element into the bone", because, due to its short half-life of only 3.66 days, the radiation released from 224Radium has its effect mainly at the bone surface in the proximity of the blood-forming bone marrow cells.
Although previous studies have shown that radium treatment has an analgesic effect the risks of 224Radium treatment exceed its benefit, particularly, since there are many other therapeutic options available. Accordingly, the Committee for Quality Assurance of the German Society for Rheumatology no longer include this therapy in its recommendations.
Source: Dr. Roland R. Wick
Helmholtz Zentrum M??nchen - German Research Center for Environmental Health
воскресенье, 30 октября 2011 г.
четверг, 27 октября 2011 г.
Rheumatoid Arthritis Patients At Higher Risk For Unrecognized Heart Disease And Cardiac Sudden Death
People with rheumatoid arthritis not only have a higher risk of coronary heart disease than those in the general
population, but they have more silent, unrecognized heart attacks and sudden cardiac deaths, according to a Mayo Clinic study
published in the February issue of Arthritis & Rheumatism (rheumatology/publications/ar). They are also much less likely to complain of chest pain.
The increased heart disease risk may be present even before the diagnosis of rheumatoid arthritis, according to the
researchers. During the two years before diagnosis of rheumatoid arthritis, patients with this disease were three times more
likely to have been hospitalized for an acute heart attack and five times more likely to have an unrecognized heart attack.
They were also less likely to have had a history of chest pain, compared to those without rheumatoid arthritis. After their
diagnosis, the rheumatoid arthritis patients were twice as likely to experience unrecognized heart attacks and sudden cardiac
deaths.
Hilal Maradit Kremers, M.D., lead study investigator and research associate in the Mayo Clinic Department of Health Sciences
Research, says the study suggests three major messages for rheumatoid arthritis patients:
-- The risk of heart attack is already there at the time a rheumatoid arthritis diagnosis is first made.
-- Heart disease can remain silent in those with rheumatoid arthritis. Regular cardiac checkups are important, as is lowering
traditional cardiac risk factors, such as taking care of blood pressure and cholesterol and quitting smoking.
-- Heart disease in rheumatoid arthritis patients can manifest for the first time as a cardiac sudden death.
The researchers were surprised to find that the increased cardiac events in rheumatoid arthritis patients could not be
explained by an increase in traditional heart disease risk factors such as elevated cholesterol, blood pressure and body mass
index, diabetes, and alcohol abuse, indicates Dr. Maradit Kremers.
"What we are finding is that though traditional cardiovascular risk factors are important, they are less important for those
with rheumatoid arthritis," says Dr. Maradit Kremers. "Something else is going on. It could be that rheumatoid arthritis and
heart disease have a common origin. What we do know is that the cause cannot be explained by just one factor. It is
multifactorial."
To date, there also is no definitive information for rheumatoid arthritis patients about steps they can take to avoid heart
disease, according to the Mayo Clinic researchers. Meanwhile, they indicate that it is critical that rheumatoid arthritis
patients recognize their risks for heart disease and that they seek medical care for any cardiac symptoms or complaints.
Dr. Maradit Kremers explains that the silent heart attacks found in the study usually were detected when the rheumatoid
arthritis patient saw a physician for some other reason and an electrocardiogram was ordered, revealing a past heart attack.
"It's possible that people suffering from rheumatoid arthritis have so much pain in their joints and are receiving so many
painkillers that they either don't feel the chest pain in the same way as those without rheumatoid arthritis or don't
appreciate its importance," she says.
Previous research has shown rheumatoid arthritis patients have a higher risk of early death than others and that these deaths
are mostly due to cardiovascular disease. The Mayo Clinic research team conducted this study to discover exactly why.
"We suspect that the systemic inflammation that characterizes rheumatoid arthritis also promotes cardiovascular disease and
cardiovascular death," says Sherine Gabriel, M.D., the study's senior author and Mayo Clinic rheumatologist, epidemiologist
and chair of the Department of Health Sciences Research. "And the goal of our research is to disentangle the complex
relationships between these two diseases."
For this study, Mayo Clinic researchers studied a group of 603 Rochester residents diagnosed with rheumatoid arthritis
between Jan. 1, 1955 and Jan. 1, 1995 and compared them with 603 Rochester residents of the same ages and gender without
rheumatoid arthritis. Both the patients and the comparison subjects were followed up for a median of 26 years before
rheumatoid arthritis diagnosis and 15 years after diagnosis. The researchers collected detailed information about all study
subjects' cardiac events and their traditional cardiovascular risk factors: diabetes, blood pressure, cholesterol, body mass
index and smoking.
The paper detailing these findings is entitled "Increased Unrecognized Coronary Heart Disease and Sudden Deaths in Rheumatoid
Arthritis: A Population-Based Cohort Study."
Note for reporters: As the subjects in which the present analysis was conducted 1) have no direct patient relationship with
the investigators and 2) participated in this study under strict confidentiality agreements, the participants are not
available for news media interviews. The lead investigator, Dr. Gabriel, is available to speak to news media.
To obtain the latest news releases from Mayo Clinic, go to mayoclinic/news. MayoClinic (mayoclinic) is
available as a resource for your health stories.
Lisa Lucier
newsbureaumayo
Mayo Clinic
population, but they have more silent, unrecognized heart attacks and sudden cardiac deaths, according to a Mayo Clinic study
published in the February issue of Arthritis & Rheumatism (rheumatology/publications/ar). They are also much less likely to complain of chest pain.
The increased heart disease risk may be present even before the diagnosis of rheumatoid arthritis, according to the
researchers. During the two years before diagnosis of rheumatoid arthritis, patients with this disease were three times more
likely to have been hospitalized for an acute heart attack and five times more likely to have an unrecognized heart attack.
They were also less likely to have had a history of chest pain, compared to those without rheumatoid arthritis. After their
diagnosis, the rheumatoid arthritis patients were twice as likely to experience unrecognized heart attacks and sudden cardiac
deaths.
Hilal Maradit Kremers, M.D., lead study investigator and research associate in the Mayo Clinic Department of Health Sciences
Research, says the study suggests three major messages for rheumatoid arthritis patients:
-- The risk of heart attack is already there at the time a rheumatoid arthritis diagnosis is first made.
-- Heart disease can remain silent in those with rheumatoid arthritis. Regular cardiac checkups are important, as is lowering
traditional cardiac risk factors, such as taking care of blood pressure and cholesterol and quitting smoking.
-- Heart disease in rheumatoid arthritis patients can manifest for the first time as a cardiac sudden death.
The researchers were surprised to find that the increased cardiac events in rheumatoid arthritis patients could not be
explained by an increase in traditional heart disease risk factors such as elevated cholesterol, blood pressure and body mass
index, diabetes, and alcohol abuse, indicates Dr. Maradit Kremers.
"What we are finding is that though traditional cardiovascular risk factors are important, they are less important for those
with rheumatoid arthritis," says Dr. Maradit Kremers. "Something else is going on. It could be that rheumatoid arthritis and
heart disease have a common origin. What we do know is that the cause cannot be explained by just one factor. It is
multifactorial."
To date, there also is no definitive information for rheumatoid arthritis patients about steps they can take to avoid heart
disease, according to the Mayo Clinic researchers. Meanwhile, they indicate that it is critical that rheumatoid arthritis
patients recognize their risks for heart disease and that they seek medical care for any cardiac symptoms or complaints.
Dr. Maradit Kremers explains that the silent heart attacks found in the study usually were detected when the rheumatoid
arthritis patient saw a physician for some other reason and an electrocardiogram was ordered, revealing a past heart attack.
"It's possible that people suffering from rheumatoid arthritis have so much pain in their joints and are receiving so many
painkillers that they either don't feel the chest pain in the same way as those without rheumatoid arthritis or don't
appreciate its importance," she says.
Previous research has shown rheumatoid arthritis patients have a higher risk of early death than others and that these deaths
are mostly due to cardiovascular disease. The Mayo Clinic research team conducted this study to discover exactly why.
"We suspect that the systemic inflammation that characterizes rheumatoid arthritis also promotes cardiovascular disease and
cardiovascular death," says Sherine Gabriel, M.D., the study's senior author and Mayo Clinic rheumatologist, epidemiologist
and chair of the Department of Health Sciences Research. "And the goal of our research is to disentangle the complex
relationships between these two diseases."
For this study, Mayo Clinic researchers studied a group of 603 Rochester residents diagnosed with rheumatoid arthritis
between Jan. 1, 1955 and Jan. 1, 1995 and compared them with 603 Rochester residents of the same ages and gender without
rheumatoid arthritis. Both the patients and the comparison subjects were followed up for a median of 26 years before
rheumatoid arthritis diagnosis and 15 years after diagnosis. The researchers collected detailed information about all study
subjects' cardiac events and their traditional cardiovascular risk factors: diabetes, blood pressure, cholesterol, body mass
index and smoking.
The paper detailing these findings is entitled "Increased Unrecognized Coronary Heart Disease and Sudden Deaths in Rheumatoid
Arthritis: A Population-Based Cohort Study."
Note for reporters: As the subjects in which the present analysis was conducted 1) have no direct patient relationship with
the investigators and 2) participated in this study under strict confidentiality agreements, the participants are not
available for news media interviews. The lead investigator, Dr. Gabriel, is available to speak to news media.
To obtain the latest news releases from Mayo Clinic, go to mayoclinic/news. MayoClinic (mayoclinic) is
available as a resource for your health stories.
Lisa Lucier
newsbureaumayo
Mayo Clinic
понедельник, 24 октября 2011 г.
Understanding What People With Arthritis Believe About Exercise
Study of Perceived Exercise Barriers, Enablers, and Benefits Suggests Ways to Increase the Rates of Regular Exercise Among Arthritis Patients.
Arthritis is the leading cause of disability in the United States. In total, the treatment and toll of this progressive disease costs our country about $86 billion per year, a figure expected to rise as Baby Boomers age. Among the many approaches to disease management, exercise has been shown to reduce pain, delay disability, and improve physical function, muscle strength, and quality of life. Yet, despite such compelling, well-documented benefits, rates of participation in regular exercise are lower among individuals with arthritis than those without it.
Understanding what motivates and enables some people with arthritis to exercise, and what prevents others, is the focus of a study featured in the August 2006 issue of Arthritis Care & Research (interscience.wiley/journal/arthritiscare). Conducted at the University of South Carolina, and supported by a grant from the Centers for Disease Control and Prevention and the Association of Schools of Public Health, its findings have direct implications for how to market exercise to arthritis patients, how to tailor exercise programs to their challenges, and how to encourage and sustain their participation.
To identify the perceived barriers to and benefits of exercise among people with arthritis, 68 people with arthritis were divided into 12 focus groups. To help participants feel more comfortable and willing to talk openly, the groups were segmented by exercise status, socioeconomic status, and race. Each focus group came together and discussed their perceptions of exercise, as well as their experiences. Each discussion was transcribed and coded by two people. Following the sessions, NVivo software was used to extract themes for exercisers with arthritis, defined by participation in moderate activities on at least 3 days per week for 30 minutes per day or vigorous activities on at least 3 days per week for 20 minutes per day or strength training on at least 3 days per week for 20 minutes per day, and for non-exercisers with arthritis. Among them:
-- Pain. Although all focus groups stressed pain as a barrier, exercisers were more likely to make adaptations and work through the pain to attain the benefits of exercise, while non-exercisers were more likely to give up exercise altogether.
-- Attitudes and beliefs. Non-exercisers were much more likely than exercisers to express the belief that they were physically unable to exercise.
-- Lack of support. Non-exercisers were more likely to cite their physician's failure to refer them to helpful exercise programs and to voice their desire for exercise partners with similar limitations.
-- Lack of programs. For both exercisers and non-exercisers, the lack of exercise programs or facilities for individuals with arthritis emerged as a barrier.
-- Symptom management. Exercisers tended to be more positive about how exercise could reduce pain, improve mobility, and more, because they had experienced these benefits. Non-exercisers often used such phrases as "this is what I hear" or "this is what I understand" to describe desired outcomes.
"Our findings provide useful information for understanding the experiences with and beliefs about exercise among persons with arthritis," notes study author, Sara Wilcox, Ph.D., "and informing recruitment and intervention strategies." To increase the rates of regular exercise among arthritis patients, Dr. Wilcox and her colleagues offer concrete recommendations for health care professionals and communities, including:
-- Make a practice of prescribing exercise, with referrals and instruction.
-- Work to expand the availability of arthritis-specific exercise programs.
-- Emphasize ways in which individuals with arthritis can modify exercise to accommodate their physical limitations and effectively manage the pain.
-- Move beyond knowledge-based approaches to change the mindsets and behavior of non-exercisers.
Article:
"Perceived Exercise Barriers, Enablers, and Benefits Among Exercising and Nonexercising Adults With Arthritis: Results From a Qualitative Study,"
Sara Wilcox, Cheryl Der Ananian, Jill Abbott, JoEllen Vrazel, Cornelia Ramsey, Patricia A. Sharpe, and Teresa Brady
Arthritis Care & Research, August 2006
(DOI: 10.1002/art.22098).
© 2005 American College of Rheumatology
rheumatology
Arthritis is the leading cause of disability in the United States. In total, the treatment and toll of this progressive disease costs our country about $86 billion per year, a figure expected to rise as Baby Boomers age. Among the many approaches to disease management, exercise has been shown to reduce pain, delay disability, and improve physical function, muscle strength, and quality of life. Yet, despite such compelling, well-documented benefits, rates of participation in regular exercise are lower among individuals with arthritis than those without it.
Understanding what motivates and enables some people with arthritis to exercise, and what prevents others, is the focus of a study featured in the August 2006 issue of Arthritis Care & Research (interscience.wiley/journal/arthritiscare). Conducted at the University of South Carolina, and supported by a grant from the Centers for Disease Control and Prevention and the Association of Schools of Public Health, its findings have direct implications for how to market exercise to arthritis patients, how to tailor exercise programs to their challenges, and how to encourage and sustain their participation.
To identify the perceived barriers to and benefits of exercise among people with arthritis, 68 people with arthritis were divided into 12 focus groups. To help participants feel more comfortable and willing to talk openly, the groups were segmented by exercise status, socioeconomic status, and race. Each focus group came together and discussed their perceptions of exercise, as well as their experiences. Each discussion was transcribed and coded by two people. Following the sessions, NVivo software was used to extract themes for exercisers with arthritis, defined by participation in moderate activities on at least 3 days per week for 30 minutes per day or vigorous activities on at least 3 days per week for 20 minutes per day or strength training on at least 3 days per week for 20 minutes per day, and for non-exercisers with arthritis. Among them:
-- Pain. Although all focus groups stressed pain as a barrier, exercisers were more likely to make adaptations and work through the pain to attain the benefits of exercise, while non-exercisers were more likely to give up exercise altogether.
-- Attitudes and beliefs. Non-exercisers were much more likely than exercisers to express the belief that they were physically unable to exercise.
-- Lack of support. Non-exercisers were more likely to cite their physician's failure to refer them to helpful exercise programs and to voice their desire for exercise partners with similar limitations.
-- Lack of programs. For both exercisers and non-exercisers, the lack of exercise programs or facilities for individuals with arthritis emerged as a barrier.
-- Symptom management. Exercisers tended to be more positive about how exercise could reduce pain, improve mobility, and more, because they had experienced these benefits. Non-exercisers often used such phrases as "this is what I hear" or "this is what I understand" to describe desired outcomes.
"Our findings provide useful information for understanding the experiences with and beliefs about exercise among persons with arthritis," notes study author, Sara Wilcox, Ph.D., "and informing recruitment and intervention strategies." To increase the rates of regular exercise among arthritis patients, Dr. Wilcox and her colleagues offer concrete recommendations for health care professionals and communities, including:
-- Make a practice of prescribing exercise, with referrals and instruction.
-- Work to expand the availability of arthritis-specific exercise programs.
-- Emphasize ways in which individuals with arthritis can modify exercise to accommodate their physical limitations and effectively manage the pain.
-- Move beyond knowledge-based approaches to change the mindsets and behavior of non-exercisers.
Article:
"Perceived Exercise Barriers, Enablers, and Benefits Among Exercising and Nonexercising Adults With Arthritis: Results From a Qualitative Study,"
Sara Wilcox, Cheryl Der Ananian, Jill Abbott, JoEllen Vrazel, Cornelia Ramsey, Patricia A. Sharpe, and Teresa Brady
Arthritis Care & Research, August 2006
(DOI: 10.1002/art.22098).
© 2005 American College of Rheumatology
rheumatology
пятница, 21 октября 2011 г.
The Critical Role Of The Meniscus In Osteoarthritis Of The Knee
Cartilage loss is a major component of osteoarthritis (OA), a joint disease that affects over 20 million Americans. In knee OA, cartilage loss is influenced by knee injury, as well as obesity and age. Every healthy knee is supported and protected by a pair of meniscus. This C-shaped tissue has many functions in the knee, including load bearing, shock absorption, and stability enhancement. The onset of knee OA after meniscectomy, the surgical removal of all or part of a torn meniscus, is fairly common and traditionally considered a result of the joint injury that leads to the operation in the first place.
While meniscectomy appears to be a significant risk factor for OA, researchers know little about the effect of meniscal damage and abnormalities on cartilage loss in knees with a predisposition for the disease. The March 2006 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis) shares the results of a study that sheds new light on the importance of an intact and functioning meniscus for patients with symptomatic knee OA.
The study, led by David Hunter of Boston University School of Medicine, focused on 257 subjects enrolled in the Boston Osteoarthritis of the Knee Study. The majority, 58 percent, were men and the mean age was 66.6 years. All subjects met the American College of Rheumatology criteria for symptomatic knee OA, confirmed by X-rays and self-reports of frequent knee pain and stiffness. At the study's onset and follow-up examinations at 15 and 30 months, participants underwent magnetic resonance imaging (MRI) of the more symptomatic knee. Using the MR images, researchers measured the position of the meniscus, as well as evaluated and scored the severity of meniscal damage. Among the MRI-assessed knees, 29% had a previous injury, 27% had a previous surgery, and 5% had a previous meniscectomy.
The researchers, as expected, found a high correlation between meniscal malposition and meniscal damage. The impact of meniscal abnormality on cartilage lost was most pronounced in the medial tibiofemoral joint--the inner joint connecting the knee to the lower leg. Each measure of meniscal misalignment was associated with an increased risk of cartilage loss. There was also a strong association of meniscal tears with cartilage loss. Reductions in the coverage and height of the meniscus, provoked by partial dislocation of the meniscus, also increased the risk of cartilage loss.
This study does not distinguish the type of meniscal tear that may propel cartilage loss or implicate meniscus damage as a cause of OA. However, it does call attention to the potential of a strong, whole meniscus to protect the knee from rapid devastation in the early stages of OA, and perhaps even mitigate the need for need replacement surgery. "At present, efforts are being made to preserve a damaged meniscus rather than remove it, and an industry of meniscal replacement is developing," Dr. Hunter notes. "Our study points to the need for critical, prospective evaluation of these new therapeutic options."
Article: "The Association of Meniscal Pathologic Changes With Cartilage Loss in Symptomatic Knee Osteoarthritis," D.J. Hunter, Y.Q. Zhang, J.B. Niu, X. Tu, S. Amin, M. Clancy, A. Guermazi, M. Grigorian, D. Gale, and D. T. Felson, Arthritis & Rheumatism, March 2006, 54:3, pp. 795-801.
Contact: Amy Molnar
amolnarwiley
John Wiley & Sons, Inc.
While meniscectomy appears to be a significant risk factor for OA, researchers know little about the effect of meniscal damage and abnormalities on cartilage loss in knees with a predisposition for the disease. The March 2006 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis) shares the results of a study that sheds new light on the importance of an intact and functioning meniscus for patients with symptomatic knee OA.
The study, led by David Hunter of Boston University School of Medicine, focused on 257 subjects enrolled in the Boston Osteoarthritis of the Knee Study. The majority, 58 percent, were men and the mean age was 66.6 years. All subjects met the American College of Rheumatology criteria for symptomatic knee OA, confirmed by X-rays and self-reports of frequent knee pain and stiffness. At the study's onset and follow-up examinations at 15 and 30 months, participants underwent magnetic resonance imaging (MRI) of the more symptomatic knee. Using the MR images, researchers measured the position of the meniscus, as well as evaluated and scored the severity of meniscal damage. Among the MRI-assessed knees, 29% had a previous injury, 27% had a previous surgery, and 5% had a previous meniscectomy.
The researchers, as expected, found a high correlation between meniscal malposition and meniscal damage. The impact of meniscal abnormality on cartilage lost was most pronounced in the medial tibiofemoral joint--the inner joint connecting the knee to the lower leg. Each measure of meniscal misalignment was associated with an increased risk of cartilage loss. There was also a strong association of meniscal tears with cartilage loss. Reductions in the coverage and height of the meniscus, provoked by partial dislocation of the meniscus, also increased the risk of cartilage loss.
This study does not distinguish the type of meniscal tear that may propel cartilage loss or implicate meniscus damage as a cause of OA. However, it does call attention to the potential of a strong, whole meniscus to protect the knee from rapid devastation in the early stages of OA, and perhaps even mitigate the need for need replacement surgery. "At present, efforts are being made to preserve a damaged meniscus rather than remove it, and an industry of meniscal replacement is developing," Dr. Hunter notes. "Our study points to the need for critical, prospective evaluation of these new therapeutic options."
Article: "The Association of Meniscal Pathologic Changes With Cartilage Loss in Symptomatic Knee Osteoarthritis," D.J. Hunter, Y.Q. Zhang, J.B. Niu, X. Tu, S. Amin, M. Clancy, A. Guermazi, M. Grigorian, D. Gale, and D. T. Felson, Arthritis & Rheumatism, March 2006, 54:3, pp. 795-801.
Contact: Amy Molnar
amolnarwiley
John Wiley & Sons, Inc.
вторник, 18 октября 2011 г.
Millions Of People With Musculoskeletal Conditions At Risk Of Being Let Down By NHS
One-in-five (21%) primary care trusts (PCTs) do not offer 'clinical assessment
and treatment services' (CATS) for people with musculoskeletal conditions, denying them services
deemed a 'keystone' of the government's 2006 musculoskeletal services strategy1. A report based on
Freedom of Information requests and published by the Arthritis and Musculoskeletal Alliance
(ARMA) also reveals that just under half (45%) of PCTs do not define life-long conditions such as
arthritis as 'long-term', meaning people with musculoskeletal conditions are being ignored in large areas
of the country1.
"The millions of people with musculoskeletal conditions in the UK have long been forced to endure low
standards of care from the NHS," said report lead Professor David Marsh, Consultant Orthopaedic
Surgeon, Royal National Orthopaedics Hospital. "The government has long recognised that the situation
must improve and its 2006 strategy should have been the starting point of the process, but people in
many areas are still receiving patchy and poor care."
The report - supported by an initial grant from the British Society of Rheumatology as well as Roche
Products Ltd and DePuy UK - also confirms the huge variation in spending on people with
musculoskeletal conditions, ranging from under ??100 per head in Lewisham PCT to almost ??1,400 per
head in Western Cheshire PCT1. To address these variations the report calls for the appointment of a
'tsar', to oversee improvements for people at a national level, and lead on revamping the Department of
Health's own musculoskeletal reform strategy.
"Long-standing musculoskeletal conditions are a major cause of long-term disability, ill-health and
ultimately the inability to work," said Ros Meek, Director of ARMA. "It is truly appalling to find so many
serious failings in the identification and management of these conditions across the country. We want to
see real leadership from the Department of Health in rectifying this, starting with a new plan for better
care. The people living with these conditions deserve not to be ignored."
'Musculoskeletal conditions' is a term which encompasses around 200 different problems affecting the
muscles, joints and skeleton2. Over 9.6 million adults, and around 12,000 children, have a musculoskeletal
condition in England today2. These conditions impose a huge burden on the country with NHS costs in
2006-7 totalling over ??3.5 billion3 and 11.2 million working days lost per annum on average over the
last three years4.
The development and distribution of this press release was sponsored by Roche Products Ltd.
Arthritis and Musculoskeletal Alliance (ARMA)
ARMA, a registered charity, is the umbrella organisation for the UK musculoskeletal community,
bringing together 36 patient / user and professional organisations campaigning for better services for
people living with musculoskeletal conditions. The member organisations of ARMA are:
- Arthritis Care
- Arthritis Research Campaign (ARC)
- BackCare
- Birmingham Arthritis Resource Centre
- British Chiropractic Association
- British Health Professionals in Rheumatology
- British Institute of Musculoskeletal Medicine (BIMM)
- British Orthopaedic Association
- British Osteopathic Association
- British Sjogren's Syndrome Association (BSSA)
- British Society for Paediatric and Adolescent
Rheumatology (BSPAR)
- British Society for Rheumatology (BSR)
- British Society of Rehabilitation Medicine
- Chartered Society of Physiotherapy
- Children's Chronic Arthritis Association
- COT Specialist Section - Rheumatology
- Early Rheumatoid Arthritis Network (ERAN)
- Fibromyalgia Association
- Lupus UK
- MACP
- Marfan Association (UK)
- McTimoney
- National Ankylosing Spondylitis Society (NASS)
- National Association for the Relief of Paget's Disease
- National Osteoporosis Society
- National Rheumatoid Arthritis Society (NRAS)
- Podiatry Rheumatic Care Association
- Primary Care Rheumatology Society
- Psoriasis Association
- Psoriasis & Psoriatic Arthritis Alliance (PAPAA)
- Raynaud's and Scleroderma Association
- Rheumatoid Arthritis Surgical Society
- Royal College of Nursing Rheumatology Forum
- RSI Action
- Scleroderma Society
- Society for Back Pain Research (SBPR)
The musculoskeletal services strategy
The musculoskeletal services strategy was launch in 2006 by current Secretary of State for Health Andy
Burnham MP.
The report
The report published - Joint working? An audit of the Department of Health's musculoskeletal services
Strategy- was kindly supported by an initial grant from the British Society of Rheumatology as well as
DePuy UK and Roche Products Ltd, who also sponsored the development and distribution of this press
release.
References
1. Arthritis and Musculoskeletal Alliance. Joint working? An audit of the Department of Health's musculoskeletal
services strategy July 2009
2. Department of Health. A joint responsibility: doing it differently - the musculoskeletal services framework. July
2006
3. Department of Health. Departmental Report 2008. May 2008
4. Hansard. 26 January 2009, Col. 84W
Source
NHS
and treatment services' (CATS) for people with musculoskeletal conditions, denying them services
deemed a 'keystone' of the government's 2006 musculoskeletal services strategy1. A report based on
Freedom of Information requests and published by the Arthritis and Musculoskeletal Alliance
(ARMA) also reveals that just under half (45%) of PCTs do not define life-long conditions such as
arthritis as 'long-term', meaning people with musculoskeletal conditions are being ignored in large areas
of the country1.
"The millions of people with musculoskeletal conditions in the UK have long been forced to endure low
standards of care from the NHS," said report lead Professor David Marsh, Consultant Orthopaedic
Surgeon, Royal National Orthopaedics Hospital. "The government has long recognised that the situation
must improve and its 2006 strategy should have been the starting point of the process, but people in
many areas are still receiving patchy and poor care."
The report - supported by an initial grant from the British Society of Rheumatology as well as Roche
Products Ltd and DePuy UK - also confirms the huge variation in spending on people with
musculoskeletal conditions, ranging from under ??100 per head in Lewisham PCT to almost ??1,400 per
head in Western Cheshire PCT1. To address these variations the report calls for the appointment of a
'tsar', to oversee improvements for people at a national level, and lead on revamping the Department of
Health's own musculoskeletal reform strategy.
"Long-standing musculoskeletal conditions are a major cause of long-term disability, ill-health and
ultimately the inability to work," said Ros Meek, Director of ARMA. "It is truly appalling to find so many
serious failings in the identification and management of these conditions across the country. We want to
see real leadership from the Department of Health in rectifying this, starting with a new plan for better
care. The people living with these conditions deserve not to be ignored."
'Musculoskeletal conditions' is a term which encompasses around 200 different problems affecting the
muscles, joints and skeleton2. Over 9.6 million adults, and around 12,000 children, have a musculoskeletal
condition in England today2. These conditions impose a huge burden on the country with NHS costs in
2006-7 totalling over ??3.5 billion3 and 11.2 million working days lost per annum on average over the
last three years4.
The development and distribution of this press release was sponsored by Roche Products Ltd.
Arthritis and Musculoskeletal Alliance (ARMA)
ARMA, a registered charity, is the umbrella organisation for the UK musculoskeletal community,
bringing together 36 patient / user and professional organisations campaigning for better services for
people living with musculoskeletal conditions. The member organisations of ARMA are:
- Arthritis Care
- Arthritis Research Campaign (ARC)
- BackCare
- Birmingham Arthritis Resource Centre
- British Chiropractic Association
- British Health Professionals in Rheumatology
- British Institute of Musculoskeletal Medicine (BIMM)
- British Orthopaedic Association
- British Osteopathic Association
- British Sjogren's Syndrome Association (BSSA)
- British Society for Paediatric and Adolescent
Rheumatology (BSPAR)
- British Society for Rheumatology (BSR)
- British Society of Rehabilitation Medicine
- Chartered Society of Physiotherapy
- Children's Chronic Arthritis Association
- COT Specialist Section - Rheumatology
- Early Rheumatoid Arthritis Network (ERAN)
- Fibromyalgia Association
- Lupus UK
- MACP
- Marfan Association (UK)
- McTimoney
- National Ankylosing Spondylitis Society (NASS)
- National Association for the Relief of Paget's Disease
- National Osteoporosis Society
- National Rheumatoid Arthritis Society (NRAS)
- Podiatry Rheumatic Care Association
- Primary Care Rheumatology Society
- Psoriasis Association
- Psoriasis & Psoriatic Arthritis Alliance (PAPAA)
- Raynaud's and Scleroderma Association
- Rheumatoid Arthritis Surgical Society
- Royal College of Nursing Rheumatology Forum
- RSI Action
- Scleroderma Society
- Society for Back Pain Research (SBPR)
The musculoskeletal services strategy
The musculoskeletal services strategy was launch in 2006 by current Secretary of State for Health Andy
Burnham MP.
The report
The report published - Joint working? An audit of the Department of Health's musculoskeletal services
Strategy- was kindly supported by an initial grant from the British Society of Rheumatology as well as
DePuy UK and Roche Products Ltd, who also sponsored the development and distribution of this press
release.
References
1. Arthritis and Musculoskeletal Alliance. Joint working? An audit of the Department of Health's musculoskeletal
services strategy July 2009
2. Department of Health. A joint responsibility: doing it differently - the musculoskeletal services framework. July
2006
3. Department of Health. Departmental Report 2008. May 2008
4. Hansard. 26 January 2009, Col. 84W
Source
NHS
суббота, 15 октября 2011 г.
Forest Laboratories, Inc. And Cypress Bioscience, Inc. Announce Positive Results Of Phase III Study Of Milnacipran For The Management Of Fibromyalgia
Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB) announced positive top-line results from a 1,025 patient, multicenter, double-blind, placebo-controlled phase III study of milnacipran for the management of fibromyalgia. These results, which confirm the findings from the two previous phase III trials, showed that milnacipran demonstrated a highly statistically significant difference to placebo in responder analyses based on a concurrent and clinically meaningful improvement in pain, patient global impression of change, and physical functioning. Comprehensive analyses of the study data will be completed in the coming weeks, and it is anticipated that further results will be presented during 2009.
Study Background
In this study, designated MLN-MD-03, patients with an established history of fibromyalgia were enrolled at 75 centers in North America and randomized to receive a daily dose of 100 mg of milnacipran (n=516) or placebo (n=509). The design of the double-blind study included a 4 to 6-week dose escalation phase, a 12-week stable-dose treatment phase, and a 2-week discontinuation phase. The primary efficacy endpoints were the proportion of subjects meeting criteria as composite responders based on one of two definitions. In the first co-primary analysis, a patient had to demonstrate simultaneous improvements on both their daily pain ratings (visual analog scale) and on an overall measure of how their fibromyalgia condition had been since the start of the study (Patient Global Impression of Change or PGIC). In the second co-primary analysis, a patient had to demonstrate simultaneous improvements on three measures -- pain, PGIC, and physical functioning (as measured by the SF-36 Physical Component Summary).
Preliminary Results
A greater proportion of patients treated with milnacipran (100 mg/day) experienced at least a 30% reduction in pain from baseline and also rated themselves as "very much improved" or "much improved" based on the patient global assessment (PGIC) (p < 0.001). In addition, a greater proportion of patients treated with milnacipran met the criteria for a treatment response as measured by concurrent improvements in pain, patient global assessment (PGIC) and physical function (improvement of at least 6 points in SF-36 PCS), as compared to subjects on placebo (p < 0.001). Primary analysis results were conducted using the Baseline Observation Carried Forward (BOCF) imputation method.
Milnacipran was generally well tolerated. Similar to the safety data from the two previous U.S. phase III trials of milnacipran in fibromyalgia, the most common treatment emergent adverse events observed through the stable-dose treatment period of the placebo-controlled trial included nausea (37% vs. 21% placebo), constipation (15% vs. 4% placebo), hot flush (11% vs. 4% placebo), dizziness (11% vs. 5% placebo), hyperhidrosis (8% vs. 1% placebo), palpitations (7% vs. 3% placebo), tachycardia (5% vs. 1% placebo), and hypertension (5% vs. 1%).
Overall premature discontinuation rates (all causes including adverse event related) through the stable-dose treatment period of the trial were 31% for patients receiving 100 mg per day of milnacipran, and 30% for patients receiving placebo. Similar to the safety data from the two previous U.S. phase III trials of milnacipran in fibromyalgia, the most common adverse events that led to early withdrawal among the milnacipran treated patients were nausea (3.5%) and headache and palpitations, each of which occurred at a rate of less than 2%.
About Milnacipran
Milnacipran is a dual-reuptake inhibitor that preferentially blocks the reuptake of norepinephrine with higher potency than serotonin, two neurotransmitters thought to play a central role in the symptoms of fibromyalgia. Milnacipran is being developed for fibromyalgia in the United States jointly by Forest Laboratories, Inc. and its licensor, Cypress Bioscience, Inc. Milnacipran was originally developed, and is sold outside of the U.S. by Pierre Fabre Medicament. The FDA accepted for review the New Drug Application (NDA) for milnacipran for the management of fibromyalgia in February 2008. The application includes efficacy data from two pivotal phase III trials involving 2,084 patients (1,460 milnacipran, 624 placebo-treated subjects), which showed that milnacipran demonstrated improvement compared to placebo in treating the symptoms of fibromyalgia based on responder analyses. As previously disclosed, the FDA has yet to provide an action based on the NDA application. The Prescription Drug User Fee Act (PDUFA) date was October 18, 2008.
About Fibromyalgia
Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and decreased physical functioning. According to the American College of Rheumatology fibromyalgia is estimated to affect over 6 million Americans. It is most often diagnosed in the primary care setting and is the second most commonly diagnosed condition in rheumatology clinics in the United States after osteoarthritis. Despite the high prevalence and severity of this condition, there are limited treatment options specifically approved for fibromyalgia in the United States.
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit FRX.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
About Cypress Bioscience
Cypress Bioscience, Inc. is developing therapeutics and personalized medicine services, to facilitate improved and individualized patient care. Cypress' goal is to address the evolving needs of specialist physicians and their patients by identifying unmet medical needs in the areas of pain, rheumatology, and physical medicine and rehabilitation, including challenging disorders such as fibromyalgia and rheumatoid arthritis. We intend to use this approach to improve patient care and create a unique partnership with physicians.
For more information about Cypress, please visit the Company's website at cypressbio.
This press release, as well as Cypress' SEC filings and website at cypressbio, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the potential of milnacipran to treat fibromyalgia. Actual results could vary materially from those described as a result of a number of factors, including those set forth in Cypress' Annual Report on Form 10-K, the most recent Quarterly Report on Form 10-Q and any subsequent SEC filings and including, but not limited to, that more detailed analysis of the trial results may not be favorable or may lead to different conclusions and that milnacipran may not be approved by the FDA for the management of fibromyalgia and even if approved may not achieve market acceptance.
Cypress Bioscience, Inc.
cypressbio
Study Background
In this study, designated MLN-MD-03, patients with an established history of fibromyalgia were enrolled at 75 centers in North America and randomized to receive a daily dose of 100 mg of milnacipran (n=516) or placebo (n=509). The design of the double-blind study included a 4 to 6-week dose escalation phase, a 12-week stable-dose treatment phase, and a 2-week discontinuation phase. The primary efficacy endpoints were the proportion of subjects meeting criteria as composite responders based on one of two definitions. In the first co-primary analysis, a patient had to demonstrate simultaneous improvements on both their daily pain ratings (visual analog scale) and on an overall measure of how their fibromyalgia condition had been since the start of the study (Patient Global Impression of Change or PGIC). In the second co-primary analysis, a patient had to demonstrate simultaneous improvements on three measures -- pain, PGIC, and physical functioning (as measured by the SF-36 Physical Component Summary).
Preliminary Results
A greater proportion of patients treated with milnacipran (100 mg/day) experienced at least a 30% reduction in pain from baseline and also rated themselves as "very much improved" or "much improved" based on the patient global assessment (PGIC) (p < 0.001). In addition, a greater proportion of patients treated with milnacipran met the criteria for a treatment response as measured by concurrent improvements in pain, patient global assessment (PGIC) and physical function (improvement of at least 6 points in SF-36 PCS), as compared to subjects on placebo (p < 0.001). Primary analysis results were conducted using the Baseline Observation Carried Forward (BOCF) imputation method.
Milnacipran was generally well tolerated. Similar to the safety data from the two previous U.S. phase III trials of milnacipran in fibromyalgia, the most common treatment emergent adverse events observed through the stable-dose treatment period of the placebo-controlled trial included nausea (37% vs. 21% placebo), constipation (15% vs. 4% placebo), hot flush (11% vs. 4% placebo), dizziness (11% vs. 5% placebo), hyperhidrosis (8% vs. 1% placebo), palpitations (7% vs. 3% placebo), tachycardia (5% vs. 1% placebo), and hypertension (5% vs. 1%).
Overall premature discontinuation rates (all causes including adverse event related) through the stable-dose treatment period of the trial were 31% for patients receiving 100 mg per day of milnacipran, and 30% for patients receiving placebo. Similar to the safety data from the two previous U.S. phase III trials of milnacipran in fibromyalgia, the most common adverse events that led to early withdrawal among the milnacipran treated patients were nausea (3.5%) and headache and palpitations, each of which occurred at a rate of less than 2%.
About Milnacipran
Milnacipran is a dual-reuptake inhibitor that preferentially blocks the reuptake of norepinephrine with higher potency than serotonin, two neurotransmitters thought to play a central role in the symptoms of fibromyalgia. Milnacipran is being developed for fibromyalgia in the United States jointly by Forest Laboratories, Inc. and its licensor, Cypress Bioscience, Inc. Milnacipran was originally developed, and is sold outside of the U.S. by Pierre Fabre Medicament. The FDA accepted for review the New Drug Application (NDA) for milnacipran for the management of fibromyalgia in February 2008. The application includes efficacy data from two pivotal phase III trials involving 2,084 patients (1,460 milnacipran, 624 placebo-treated subjects), which showed that milnacipran demonstrated improvement compared to placebo in treating the symptoms of fibromyalgia based on responder analyses. As previously disclosed, the FDA has yet to provide an action based on the NDA application. The Prescription Drug User Fee Act (PDUFA) date was October 18, 2008.
About Fibromyalgia
Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and decreased physical functioning. According to the American College of Rheumatology fibromyalgia is estimated to affect over 6 million Americans. It is most often diagnosed in the primary care setting and is the second most commonly diagnosed condition in rheumatology clinics in the United States after osteoarthritis. Despite the high prevalence and severity of this condition, there are limited treatment options specifically approved for fibromyalgia in the United States.
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit FRX.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC filings.
About Cypress Bioscience
Cypress Bioscience, Inc. is developing therapeutics and personalized medicine services, to facilitate improved and individualized patient care. Cypress' goal is to address the evolving needs of specialist physicians and their patients by identifying unmet medical needs in the areas of pain, rheumatology, and physical medicine and rehabilitation, including challenging disorders such as fibromyalgia and rheumatoid arthritis. We intend to use this approach to improve patient care and create a unique partnership with physicians.
For more information about Cypress, please visit the Company's website at cypressbio.
This press release, as well as Cypress' SEC filings and website at cypressbio, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the potential of milnacipran to treat fibromyalgia. Actual results could vary materially from those described as a result of a number of factors, including those set forth in Cypress' Annual Report on Form 10-K, the most recent Quarterly Report on Form 10-Q and any subsequent SEC filings and including, but not limited to, that more detailed analysis of the trial results may not be favorable or may lead to different conclusions and that milnacipran may not be approved by the FDA for the management of fibromyalgia and even if approved may not achieve market acceptance.
Cypress Bioscience, Inc.
cypressbio
среда, 12 октября 2011 г.
Tipsheet: Focus On Gait Training, Pain Relief, Pressure Ulcers And Hearing Aid Training
Location of plantar ulcerations in diabetic patients referred to a Department of Veterans Affairs podiatry clinic, pg. 421
We described the location of foot ulcers through a chart review of diabetic patients in a Department of Veterans Affairs podiatry clinic and looked for connections between ulcer location and specific medical features. We hypothesized that individuals with diabetes rarely have heel ulcers but that heel ulcers are directly related to peripheral neuropathy and diminished vascular function. We found that patients with reduced vascular function were five times more likely to have heel ulcers than patients with adequate vascular function. The importance of understanding the risk factors for heel ulcers stems from a lack of available treatments. Further research should study the effectiveness of interventions for patients with reduced vascular status.
Effects of footwear on medial compartment knee osteoarthritis, pg. 427
This pilot study investigated whether lateral-wedge insoles inserted into shock-absorbing walking shoes relieved pain and stiffness and improved walking in people with painful knee osteoarthritis. People with knee pain in the medial knee compartment were asked to wear lateral-wedge insoles in lightweight cushioned walking shoes for 4 weeks. They answered questions about the amount of pain, stiffness, and problems with activity they had before wearing the insoles and after wearing them for 4 weeks. The results of this study showed that the lateral-wedge insoles decreased pain and stiffness and improved functional status in people with knee osteoarthritis. Pain was especially decreased for stair-climbing activities.
Isometric performance following total hip arthroplasty and rehabilitation, pg. 435
We examined differences in strength between total hip arthroplasty (THA) patients and community-dwelling older adults to provide comparative data for therapists who treat THA patients. Studies based on self-report data indicate that THA surgery successfully alleviates pain and improves function relative to presurgical levels. However, studies based on objective performancebased measures indicate that despite postoperative improvements, THA patients continue to exhibit deficits in strength, postural stability, and gait. Average hip strength during flexion (pushing upward) was significantly less for hip patients (in both their replaced and nonreplaced hip) compared with community-dwelling older adults. These deficits indicate that rehabilitation is not restoring THA patients to a level similar to their peers. Clinicians and therapists can use these results to improve current rehabilitation protocols.
Influence of a 6-week arm exercise program on walking ability and health status after hip arthroplasty: A 1-year follow-up pilot study, pg. 445
This follow-up study of elderly patients after total hip arthroplasty (THA) examined the effect of our arm exercise program on health status and walking ability. Though THA had a major effect on our patients' physical fitness and functional status, the added effects of the training were significant on those outcomes at both 2 months and 1 year after surgery. In a 6-minute walk test, the training group (TG) walked significantly longer distance than the normal rehabilitation group with a faster speed, longer stride length, and higher step cadence. Therefore, besides an improvement in fitness, the TG also might have improved gait efficiency. These preliminary results suggest the importance of endurance-type upper-body aerobic training after THA.
Are patient ratings of chronic pain services related to treatment outcome? pg. 451
We examined the relationships between ratings of services and outcomes of patients who received pain treatment at a teaching hospital. A group of 122 patients who completed a multidisciplinary pain-management program rated their satisfaction with and the effectiveness of services as well as changes in their pain condition and quality of life. The results indicated improvement on ratings of pain severity, pain interference, and depression. The patients' service ratings were significantly related to their outcomes; however, we found no significant change in disability. The results support the importance of assessing not only patients' satisfaction with treatment but also their perceived changes in disability, pain, and quality of life after pain-management services.
Using cranial electrotherapy stimulation to treat pain associated with spinal cord injury, pg. 461
Cranial electrotherapy stimulation (CES) sends microcurrents to the brain via electrodes clipped to the ears. CES can effectively treat spinal, head, dental, and muscle pain and control conditions associated with pain (anxiety, depression, insomnia, and stress). We studied how daily 1-hour active CES or sham CES treatment for 21 days affected pain in 38 males with spinal cord injury (SCI). The active CES group reported significantly greater decreases in daily pain intensity than the sham CES group. Our results suggest that CES can effectively treat chronic pain in people with SCI. We also found that people with SCI can and will use the CES device at home for a 3-week period.
Race/ethnicity: Who is counting what? pg. 475
We examined the racial/ethnic classifications of 1,084 veterans with stroke in Florida who received inpatient and outpatient services within the Department of Veterans Affairs (VA) healthcare system. We compared the reliability of racial/ethnic classifications from the VA inpatient data with the VA outpatient data and the VA data with Medicare data. Misclassification of race/ethnicity in research data may produce spurious conclusions if overlooked or ignored. Our results showed that the rate of unknown racial/ethnic classification in VA outpatient and inpatient data was high. We also found that black and white classifications in the VA data had stronger agreement with Medicare data and Medicare data may underrepresent Hispanic patients. Minimizing the unknowns by substituting known values from other data when available would greatly enhance the overall and individual classification reliability.
Treadmill training with harness support: Selection of parameters for individuals with poststroke hemiparesis, pg. 485
Locomotor training with a treadmill and harness support is a promising, task-oriented approach to restoring gait function in individuals with poststroke hemiparesis. Considerable latitude exists in the application of locomotor training, and training protocols vary widely between experimenters and clinical settings. Recent studies indicate that the prescription of certain parameters, including body-weight support and treadmill speed, can affect treatment outcome in hemiparetic individuals. We reviewed the literature for studies that quantified the immediate effects of adjusting body-weight support, treadmill speed, support stiffness, and handrail hold during treadmill walking in hemiparetic and nondisabled subjects. We then summarized results from personal investigations of these parameters. Based on the currently available evidence, we discuss the scientific rationale for selecting certain training parameters for individuals with poststroke hemiparesis and outline future directions for research.
Caregiver distress in parkinsonism, pg. 499
We examined the frequency and degree of caregiver burden in persons with parkinsonism (PWP). Supporting the functioning of caregivers is vital for the successful medical management of individuals with chronic illness and disability. Associations between perceived caregiver burden and physical, cognitive, and functional impairments were assessed with well-established tools for PWP. Caregiver burden was significantly negatively associated with activities of daily living and motoric difficulties, self-reported sleep, and caregiver coping ability. Results did not demonstrate an association among mentation, behavior, and mood or between patients' self-reported pain and caregiver burden. An improved understanding of the severity and correlates of caregiver burden in PWPs may allow clinicians to better prioritize treatment strategies for PWP and be more aware of the caregivers' needs.
A noncontact sensor for measurement of distal residual-limb position during walking, pg. 509
We developed a noncontact means of measuring position of the residual-limb surface relative to the distal prosthetic socket during walking in a transtibial amputee so the amount of slip, or pistoning, between a limb and socket with different suspension systems for different activities could be evaluated. Results showed an average of 41.7 mm of displacement during swing phase relative to stance phase. A rest period caused the limb to displace in the socket approximately 4.8 mm during subsequent walking trials, possibly reflecting limb enlargement and thus a more proximal position in the socket after the rest period. This sensor could be used to identify systems that decrease limb-socket movement since excessive pistoning might detrimentally affect socket fit.
Acclimatization in wide dynamic range multichannel compression and linear amplification hearing aids, pg. 517
We studied acclimatization in hearing-impaired patients with no previous hearing aid (HA) experience who were fit bilaterally with either wide dynamic range multichannel compression (WDRMCC) or linear amplification (LA) HAs. Throughout 32 weeks of normal HA use, we monitored changes in nonsense syllable perception in speechspectrum noise. Syllable recognition for WDRMCC users improved by 4.6% over the first 8 weeks, but the 2.2% improvement for LA users was complete in 2 to 4 weeks. Consonant confusion analyses indicated that WDRMCC experience facilitated consonant identification, while LA users primarily changed their response biases. These results provide evidence for acclimatization in new users of WDRMCC HAs but not in new users of LA HAs. Acclimatization depended on the type of amplification and on the previous amplification experience.
Perceptual training improves syllable identification in new and experienced hearing aid users, pg. 537
We investigated the effects of perceptual training on speech processing in new and experienced hearing aid (HA) users with sensorineural hearing loss. New HA users were randomly assigned to immediate training (IT) or delayed training (DT) groups. IT subjects underwent 8 weeks of syllable identification training and in-laboratory testing, whereas DT subjects underwent identical in-laboratory testing without training. Training produced large improvements in syllable identification in the IT group, whereas untrained DT group showed minimal improvement. DT group then underwent training and showed performance improvements comparable with IT subjects. We also tested experienced HA users using identical training and testing procedures as those used for new HA users. The experienced users also showed significant performance improvements. Perceptual training appears to be a promising tool for improving speech perception in all HA users.
Interface pressure and cutaneous hemoglobin and oxygenation changes under ischial tuberosities during sacral nerve root stimulation in spinal cord injury, pg. 553
We studied how neuromuscular stimulation through a magnetic coil and a sacral anterior root stimulator (SARS) implant (used for bladder emptying) affects pressure and skin blood circulation under the ischial tuberosities (ITs) of participants with spinal cord injury (SCI). The ITs are the most common site for pressure ulcers among wheelchair users with SCI. With optimal stimulation through a magnetic coil, average IT peak pressure and gradient at peak pressure decreased significantly in five seated participants with SCI. Similar results were achieved in six seated participants with SCI during sacral nerve stimulation through their SARS implants. Results indicated that stimulation caused enough gluteal muscle contraction to significantly change the participants' pressures while they sat. In addition, long-term stimulation through a SARS implant may build up the gluteal muscles and help prevent or reduce pressure ulcers in people with SCI.
Antinociceptive effect of linear polarized 0.6 to 1.6 ?¬m irradiation of lumbar sympathetic ganglia in chronic constriction injury rats, pg. 565
Linear polarized near-infrared light has been used to treat various painful disorders. We examinedthe effects of irradiation applied to an area near the lumbar sympathetic ganglia on the ligated side in a chronic constriction injury model in rats, which is believed to be an animal model of complex regional pain syndrome (CRPS). We believe the results of this study are relevant to the effect of irradiation for patients with upper-limb CRPS: that irradiation near the lumbar sympathetic ganglia of the rat is effective for thermal, but not mechanical, pain.
Skin and bone integrated prosthetic pylon: A pilot animal study, pg. 573
Direct skeletal attachment of limb prostheses is an alternative to traditional techniques based on a socket-residuum attachment. We investigated cell adhesion and penetration into the pores of a porous titanium pylon in rats. We hypothesized that the risk of skin infection during direct attachment of limb prostheses might be reduced with this type of pylon. Electronic scanning and morphological analysis showed that the porous titanium pylon integrated with the surrounding skin. Therefore, developing a natural barrier against the infection associated with direct skeletal attachment of limb prostheses may be possible. We preliminarily conclude that the experimental porous pylon provided an inviting environment for the surrounding tissues.
Contact: Stacieanne C. Yuhasz, PhD
VA Research Communications Service
We described the location of foot ulcers through a chart review of diabetic patients in a Department of Veterans Affairs podiatry clinic and looked for connections between ulcer location and specific medical features. We hypothesized that individuals with diabetes rarely have heel ulcers but that heel ulcers are directly related to peripheral neuropathy and diminished vascular function. We found that patients with reduced vascular function were five times more likely to have heel ulcers than patients with adequate vascular function. The importance of understanding the risk factors for heel ulcers stems from a lack of available treatments. Further research should study the effectiveness of interventions for patients with reduced vascular status.
Effects of footwear on medial compartment knee osteoarthritis, pg. 427
This pilot study investigated whether lateral-wedge insoles inserted into shock-absorbing walking shoes relieved pain and stiffness and improved walking in people with painful knee osteoarthritis. People with knee pain in the medial knee compartment were asked to wear lateral-wedge insoles in lightweight cushioned walking shoes for 4 weeks. They answered questions about the amount of pain, stiffness, and problems with activity they had before wearing the insoles and after wearing them for 4 weeks. The results of this study showed that the lateral-wedge insoles decreased pain and stiffness and improved functional status in people with knee osteoarthritis. Pain was especially decreased for stair-climbing activities.
Isometric performance following total hip arthroplasty and rehabilitation, pg. 435
We examined differences in strength between total hip arthroplasty (THA) patients and community-dwelling older adults to provide comparative data for therapists who treat THA patients. Studies based on self-report data indicate that THA surgery successfully alleviates pain and improves function relative to presurgical levels. However, studies based on objective performancebased measures indicate that despite postoperative improvements, THA patients continue to exhibit deficits in strength, postural stability, and gait. Average hip strength during flexion (pushing upward) was significantly less for hip patients (in both their replaced and nonreplaced hip) compared with community-dwelling older adults. These deficits indicate that rehabilitation is not restoring THA patients to a level similar to their peers. Clinicians and therapists can use these results to improve current rehabilitation protocols.
Influence of a 6-week arm exercise program on walking ability and health status after hip arthroplasty: A 1-year follow-up pilot study, pg. 445
This follow-up study of elderly patients after total hip arthroplasty (THA) examined the effect of our arm exercise program on health status and walking ability. Though THA had a major effect on our patients' physical fitness and functional status, the added effects of the training were significant on those outcomes at both 2 months and 1 year after surgery. In a 6-minute walk test, the training group (TG) walked significantly longer distance than the normal rehabilitation group with a faster speed, longer stride length, and higher step cadence. Therefore, besides an improvement in fitness, the TG also might have improved gait efficiency. These preliminary results suggest the importance of endurance-type upper-body aerobic training after THA.
Are patient ratings of chronic pain services related to treatment outcome? pg. 451
We examined the relationships between ratings of services and outcomes of patients who received pain treatment at a teaching hospital. A group of 122 patients who completed a multidisciplinary pain-management program rated their satisfaction with and the effectiveness of services as well as changes in their pain condition and quality of life. The results indicated improvement on ratings of pain severity, pain interference, and depression. The patients' service ratings were significantly related to their outcomes; however, we found no significant change in disability. The results support the importance of assessing not only patients' satisfaction with treatment but also their perceived changes in disability, pain, and quality of life after pain-management services.
Using cranial electrotherapy stimulation to treat pain associated with spinal cord injury, pg. 461
Cranial electrotherapy stimulation (CES) sends microcurrents to the brain via electrodes clipped to the ears. CES can effectively treat spinal, head, dental, and muscle pain and control conditions associated with pain (anxiety, depression, insomnia, and stress). We studied how daily 1-hour active CES or sham CES treatment for 21 days affected pain in 38 males with spinal cord injury (SCI). The active CES group reported significantly greater decreases in daily pain intensity than the sham CES group. Our results suggest that CES can effectively treat chronic pain in people with SCI. We also found that people with SCI can and will use the CES device at home for a 3-week period.
Race/ethnicity: Who is counting what? pg. 475
We examined the racial/ethnic classifications of 1,084 veterans with stroke in Florida who received inpatient and outpatient services within the Department of Veterans Affairs (VA) healthcare system. We compared the reliability of racial/ethnic classifications from the VA inpatient data with the VA outpatient data and the VA data with Medicare data. Misclassification of race/ethnicity in research data may produce spurious conclusions if overlooked or ignored. Our results showed that the rate of unknown racial/ethnic classification in VA outpatient and inpatient data was high. We also found that black and white classifications in the VA data had stronger agreement with Medicare data and Medicare data may underrepresent Hispanic patients. Minimizing the unknowns by substituting known values from other data when available would greatly enhance the overall and individual classification reliability.
Treadmill training with harness support: Selection of parameters for individuals with poststroke hemiparesis, pg. 485
Locomotor training with a treadmill and harness support is a promising, task-oriented approach to restoring gait function in individuals with poststroke hemiparesis. Considerable latitude exists in the application of locomotor training, and training protocols vary widely between experimenters and clinical settings. Recent studies indicate that the prescription of certain parameters, including body-weight support and treadmill speed, can affect treatment outcome in hemiparetic individuals. We reviewed the literature for studies that quantified the immediate effects of adjusting body-weight support, treadmill speed, support stiffness, and handrail hold during treadmill walking in hemiparetic and nondisabled subjects. We then summarized results from personal investigations of these parameters. Based on the currently available evidence, we discuss the scientific rationale for selecting certain training parameters for individuals with poststroke hemiparesis and outline future directions for research.
Caregiver distress in parkinsonism, pg. 499
We examined the frequency and degree of caregiver burden in persons with parkinsonism (PWP). Supporting the functioning of caregivers is vital for the successful medical management of individuals with chronic illness and disability. Associations between perceived caregiver burden and physical, cognitive, and functional impairments were assessed with well-established tools for PWP. Caregiver burden was significantly negatively associated with activities of daily living and motoric difficulties, self-reported sleep, and caregiver coping ability. Results did not demonstrate an association among mentation, behavior, and mood or between patients' self-reported pain and caregiver burden. An improved understanding of the severity and correlates of caregiver burden in PWPs may allow clinicians to better prioritize treatment strategies for PWP and be more aware of the caregivers' needs.
A noncontact sensor for measurement of distal residual-limb position during walking, pg. 509
We developed a noncontact means of measuring position of the residual-limb surface relative to the distal prosthetic socket during walking in a transtibial amputee so the amount of slip, or pistoning, between a limb and socket with different suspension systems for different activities could be evaluated. Results showed an average of 41.7 mm of displacement during swing phase relative to stance phase. A rest period caused the limb to displace in the socket approximately 4.8 mm during subsequent walking trials, possibly reflecting limb enlargement and thus a more proximal position in the socket after the rest period. This sensor could be used to identify systems that decrease limb-socket movement since excessive pistoning might detrimentally affect socket fit.
Acclimatization in wide dynamic range multichannel compression and linear amplification hearing aids, pg. 517
We studied acclimatization in hearing-impaired patients with no previous hearing aid (HA) experience who were fit bilaterally with either wide dynamic range multichannel compression (WDRMCC) or linear amplification (LA) HAs. Throughout 32 weeks of normal HA use, we monitored changes in nonsense syllable perception in speechspectrum noise. Syllable recognition for WDRMCC users improved by 4.6% over the first 8 weeks, but the 2.2% improvement for LA users was complete in 2 to 4 weeks. Consonant confusion analyses indicated that WDRMCC experience facilitated consonant identification, while LA users primarily changed their response biases. These results provide evidence for acclimatization in new users of WDRMCC HAs but not in new users of LA HAs. Acclimatization depended on the type of amplification and on the previous amplification experience.
Perceptual training improves syllable identification in new and experienced hearing aid users, pg. 537
We investigated the effects of perceptual training on speech processing in new and experienced hearing aid (HA) users with sensorineural hearing loss. New HA users were randomly assigned to immediate training (IT) or delayed training (DT) groups. IT subjects underwent 8 weeks of syllable identification training and in-laboratory testing, whereas DT subjects underwent identical in-laboratory testing without training. Training produced large improvements in syllable identification in the IT group, whereas untrained DT group showed minimal improvement. DT group then underwent training and showed performance improvements comparable with IT subjects. We also tested experienced HA users using identical training and testing procedures as those used for new HA users. The experienced users also showed significant performance improvements. Perceptual training appears to be a promising tool for improving speech perception in all HA users.
Interface pressure and cutaneous hemoglobin and oxygenation changes under ischial tuberosities during sacral nerve root stimulation in spinal cord injury, pg. 553
We studied how neuromuscular stimulation through a magnetic coil and a sacral anterior root stimulator (SARS) implant (used for bladder emptying) affects pressure and skin blood circulation under the ischial tuberosities (ITs) of participants with spinal cord injury (SCI). The ITs are the most common site for pressure ulcers among wheelchair users with SCI. With optimal stimulation through a magnetic coil, average IT peak pressure and gradient at peak pressure decreased significantly in five seated participants with SCI. Similar results were achieved in six seated participants with SCI during sacral nerve stimulation through their SARS implants. Results indicated that stimulation caused enough gluteal muscle contraction to significantly change the participants' pressures while they sat. In addition, long-term stimulation through a SARS implant may build up the gluteal muscles and help prevent or reduce pressure ulcers in people with SCI.
Antinociceptive effect of linear polarized 0.6 to 1.6 ?¬m irradiation of lumbar sympathetic ganglia in chronic constriction injury rats, pg. 565
Linear polarized near-infrared light has been used to treat various painful disorders. We examinedthe effects of irradiation applied to an area near the lumbar sympathetic ganglia on the ligated side in a chronic constriction injury model in rats, which is believed to be an animal model of complex regional pain syndrome (CRPS). We believe the results of this study are relevant to the effect of irradiation for patients with upper-limb CRPS: that irradiation near the lumbar sympathetic ganglia of the rat is effective for thermal, but not mechanical, pain.
Skin and bone integrated prosthetic pylon: A pilot animal study, pg. 573
Direct skeletal attachment of limb prostheses is an alternative to traditional techniques based on a socket-residuum attachment. We investigated cell adhesion and penetration into the pores of a porous titanium pylon in rats. We hypothesized that the risk of skin infection during direct attachment of limb prostheses might be reduced with this type of pylon. Electronic scanning and morphological analysis showed that the porous titanium pylon integrated with the surrounding skin. Therefore, developing a natural barrier against the infection associated with direct skeletal attachment of limb prostheses may be possible. We preliminarily conclude that the experimental porous pylon provided an inviting environment for the surrounding tissues.
Contact: Stacieanne C. Yuhasz, PhD
VA Research Communications Service
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