Working group publishes results in Archives of Physical Medicine and Rehabilitation

The November 2010 issue of the Archives of Physical Medicine and Rehabilitation, Official Journal of the American Congress of Rehabilitation Medicine, has published a set of 9 articles on traumatic brain injury (TBI) that will accelerate future research in the field by establishing common language for the degree of injury, how it is measured and classified, treatment and potential outcomes. It provides the first set of recommendations intended to promote greater consistency and collaboration among researchers on TBI and psychological health regardless of funding source.

According to the Archive’s Deputy Editor Dr. Leighton Chan, “This was a monumental undertaking, bringing together the NIH, DOD, VA, CDC, and other international partners. This set of papers will set the stage for all future clinical research on TBI and post-traumatic stress disorder (PTSD), diverse, yet interrelated, fields.”

ARTICLE HIGHLIGHTS:

Commentary: Common Data Elements for Research on Traumatic Brain Injury and Psychological Health: Current Status and Future Development
John Whyte, MD, PhD, Jennifer Vasterling, PhD, Geoffrey T. Manley, MD, PhD

The commentary describes the current status of this multiagency endeavor, the obstacles encountered, and possible directions for future development. The authors point out that links between TBI and psychological health (PH) have long been recognized. However, the recent wars in Iraq and Afghanistan have highlighted how intertwined TBI and stress-related PH conditions may be, their sequelae often sharing common risk factors (eg, intensive combat), symptoms (eg, irritability, concentration problems), associated features (eg, sleep disturbance), and functional impairment (eg, occupational dysfunction).

Advancing Integrated Research in Psychological Health and Traumatic Brain injury: Common Data Elements
Veronica A. Thurmond, PhD, Ramona Hicks, PhD, Theresa Gleason, PhD, A. Cate Miller, PhD, Nicholas Szuflita, BA, Jean Orman, ScD, Karen Schwab, PhD

The use of different measures to assess similar study variables and/or assess outcomes limits important advances in psychological health (PH) and TBI research. Without a set of common data elements (CDE) comparison of findings across studies is challenging. The federal agencies involved in PH and TBI research, the National Institute of Neurological Disorders and Stroke, Department of Veterans Affairs, National Institute on Disability and Rehabilitation Research, Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, and Defense and Veterans Brain Injury Center, therefore cosponsored a scientific initiative to develop CDEs for PH and TBI research. Scientific experts were invited to participate in 1 of 8 working groups to develop recommendations for specific topic driven CDEs.

Position Statement: Definition of Traumatic Brain Injury
David K. Menon, MD, PhD, Karen Schwab, PhD, David W. Wright, MD, Andrew I. Maas, MD, PhD, on behalf of The Demographics and Clinical Assessment Working Group of the International and Interagency Initiative toward Common Data Elements for Research on Traumatic Brain Injury and Psychological Health

A clear, concise definition of traumatic brain injury (TBI) is fundamental for reporting, comparison, and interpretation of studies on TBI. TBI is defined as an alteration in brain function, or other evidence of brain pathology, caused by an external force. This article discusses new criteria for considering or establishing a diagnosis of TBI, with a particular focus on the problems of how a diagnosis of TBI can be made when patients present late after injury and how mild TBI may be differentiated from non-TBI causes with similar symptoms.

Common Data Elements for Traumatic Brain Injury: Recommendations from the Interagency Working Group on Demographics and Clinical Assessment
Andrew I. Maas, MD, Cynthia L. Harrison-Felix, PhD, David Menon, MD, P. David Adelson, MD, Tom Balkin, PhD, Ross Bullock, MD, Doortje C. Engel, MD, PhD, Wayne Gordon, PhD, Jean Langlois Orman, ScD, Henry L. Lew, MD, PhD, Claudia Robertson, MD, Nancy Temkin, PhD, Alex Valadka, MD, Mieke Verfaellie, PhD, Mark Wainwright, MD, David W. Wright, MD, Karen Schwab, PhD

Comparing results across studies in traumatic brain injury (TBI) has been difficult because of the variability in data coding, definitions, and collection procedures. The global aim of the Working Group on Demographics and Clinical Assessment was to develop recommendations on the coding of clinical and demographic variables for TBI studies applicable across the broad spectrum of TBI, and to classify these as core, supplemental, or emerging. Templates were produced to summarize coding formats, motivation of choices, and recommendations for procedures. Work is ongoing to include more international participation and to provide an electronic data entry format with pull-down menus and automated data checks. This proposed standardization will facilitate comparison of research findings across studies and encourage high-quality meta-analysis of individual patient data.

Recommendations for the Use of Common Outcome Measures in Traumatic Brain Injury Research
Elisabeth A. Wilde, PhD, Gale G. Whiteneck, PhD, Jennifer Bogner, PhD, Tamara Bushnik, PhD, David X. Cifu, MD, Sureyya Dikmen, PhD, Louis French, PsyD, Joseph T. Giacino, PhD, Tessa Hart, PhD, James F. Malec, PhD, Scott R. Millis, PhD, Thomas A. Novack, PhD, Mark Sherer, PhD, David S. Tulsky, PhD, Rodney D. Vanderploeg, PhD, Nicole von Steinbuechel, PhD

This article summarizes the selection of outcome measures by the interagency Traumatic Brain Injury (TBI) Outcomes Workgroup to address primary clinical research objectives, including documentation of the natural course of recovery from TBI, prediction of later outcome, measurement of treatment effects, and comparison of outcomes across studies.

Common Data Elements in Radiologic Imaging of Traumatic Brain Injury
Ann-Christine Duhaime, MD, Alisa D. Gean, MD, E. Mark Haacke, PhD, Ramona Hicks, PhD, Max Wintermark, MD, Pratik Mukherjee, MD, PhD, David Brody, MD, Lawrence Latour, PhD, Gerard Riedy, MD, Common Data Elements Neuroimaging Working Group Members, Pediatric Working Group Members

Radiologic brain imaging is the most useful means of visualizing and categorizing the location, nature, and degree of damage to the central nervous system sustained by patients with traumatic brain injury (TBI). In addition to determining acute patient management and prognosis, imaging is crucial for the characterization and classification of injuries for natural history studies and clinical trials.

Common Data Elements for Traumatic Brain Injury: Recommendations from the Biospecimens and Biomarkers Working Group
Geoffrey T. Manley, PhD, Ramon Diaz-Arrastia, MD, PhD, Mary Brophy, MD, MPH, Doortje Engel, MD, PhD, Clay Goodman, MD, Katrina Gwinn, MD, Timothy D. Veenstra, PhD, Geoffrey Ling, MD, PhD, Andrew K. Ottens, PhD, Frank Tortella, PhD, Ronald L. Hayes, PhD

Human biospecimens and biofluids represent an important resource from which molecular data can be generated to detect and classify injury and to identify molecular mechanisms and therapeutic targets. To date, there has been considerable variability in biospecimen and biofluid collection, storage, and processing in traumatic brain injury (TBI) studies. To realize the full potential of this important resource, standardization and adoption of best practice guidelines are required to insure the quality and consistency of these specimens. With the adoption of these standards and best practices, future investigators will be able to obtain data across multiple studies with reduced costs and effort and accelerate the progress of genomic, proteomic, and metabolic research in TBI.

Consensus Recommendations for Common Data Elements for Operational Stress Research and Surveillance: Report of a Federal Interagency Working Group
William P. Nash, MD, Jennifer Vasterling, PhD, Linda Ewing-Cobbs, PhD, Sarah Horn, BBA, Thomas Gaskin, PhD, John Golden, PhD, William T. Riley, PhD, Stephen V. Bowles, PhD, James Favret, PhD, Patricia Lester, MD, Robert Koffman, MD, Laura C. Farnsworth, BS, Dewleen G. Baker, MD

Empirical studies and surveillance projects increasingly assess and address potentially adverse psychological health outcomes from the stress of military operations, but no standards yet exist for common concept definitions, variable categories, and measures. This article reports the consensus recommendations of the federal interagency Operational Stress Working Group for common data elements to be used in future operational stress research and surveillance with the goal of improving comparability across studies. Operational stress encompasses more than just combat; it occurs everywhere service members and their families live and work. Posttraumatic stress is not the only adverse mental or behavioral health outcome of importance. The Operational Stress Working Group contends that a primary goal of operational stress research and surveillance is to promote prevention of adverse mental and behavioral outcomes, especially by recognizing the preclinical and subclinical states of distress and dysfunction that portend a risk for failure of role performance or future mental disorders.

Common Data Elements for Posttraumatic Stress Disorder Research
Danny G. Kaloupek, PhD, Kathleen M. Chard, PhD, Michael C. Freed, PhD, Alan L. Peterson, PhD, David S. Riggs, PhD, Murray B. Stein, MD, MPH, Farris Tuma, ScD, MHS

An expert work group with 7 members was formed under the co-sponsorship of 5 U.S. federal agencies to identify common data elements for research related to posttraumatic stress disorder (PTSD). Eight construct domains relevant to PTSD were identified: (1) traditional demographics, (2) exposure to stressors and trauma, (3) potential stress moderators, (4) trauma assessment, (5) PTSD screening, (6) PTSD symptoms and diagnosis, (7) PTSD related functioning and disability, and (8) mental health history.

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On the Net:

• Elsevier Health Sciences
• Archives of Physical Medicine and Rehabilitation

(Ivanhoe Newswire) — The criminal mind is a damaged one.  A recent study by University of Exeter researchers found a high rate of Traumatic Brain Injuries (TBI) in young offenders when compared to the population as a whole.  They made a connection between TBI and a higher amount of convictions, and also discovered that offenders with three or more TBIs usually had committed more aggravated offenses.

Exeter professor and lead author of the study Huw Williams points out that TBI is a possible “marker” for risk factors such as a sensation seeking personality, poor self-care, deprivation, and a lack of quality opportunities.  Unlike non-violent young men, whose TBIs are often the result of sports or play related activities, the TBIs of young offenders are mainly the result of violence.

The study was drawn from self-reports of 197 young male participants aged 11 to 19, and gathered information about previous head injury, criminal history, mental health problems and drug use.  TBI was defined as an incident involving a severe blow to the head resulting in a loss of consciousness (LOC), and 46% of the surveyed young men reported it.  This percentage far exceeded the estimates for their surrounding societal population, which ranged from 5% to 30% depending on age.

A third of the participants indicated that they had been “knocked out” more than once in their short lives.  An accumulation of three or more TBIs was often connected to more violent offenses.  All offenders with previous TBIs were at a heightened risk for mental health problems and were more likely to abuse marijuana.

These results compare well with a study Exeter researchers conducted earlier this year on adult offenders in prison, 60% of whom reported a concussion at some point in their lives.  The participants in this study were an average of five years younger than the non-injured control group when they were first incarcerated, and also had a higher average of repeat offenses.

“Taking account of brain injury could help reduce repeat offending in those affected,” Williams was quoted as saying.  “Screening for TBI could be included in the health assessments of offenders to identify those who need more detailed assessment for providing appropriate management.”

Especially when accompanied by longer LOC, TBI is known to cause impairments of attention, memory, planning and behavior – the latter including anger and impulse control problems.  When occurring at formative ages, young TBI victims are put at an increased risk.

“Importantly, adolescence could be a critical window of opportunity for diverting young offenders at risk of injury and of further offending into non-offending lifestyles,” Williams was quoted as saying.

The University of Exeter and partners such as the United Kingdom Acquired Brain Injury Forum and The Child Brain Injury Trust have started a special interest group to raise awareness of, and clarify, the dynamics between brain injury and young criminal activity.  They hope to work with the criminal justice system to provide early screenings for adjudicated offenders, and to make rehabilitative programs available for those affected by TBIs.

SOURCE: Neuropsychological Rehabilitation, November 2010

(Ivanhoe Newswire) ““ The U.S. has one of the highest rates for teenage pregnancy in the world. This study shows that females are more likely to have an unprotected first sexual encounter than their male counterparts.

“I’m looking at the interaction between sexual education and how it impacts young adolescent sexual behavior,” Nicole Weller, an Arizona State University graduate student working toward her doctoral degree in sociology was quoted as saying. “This in particular was an interesting finding because males usually report that they are having more sex than females.”

Weller’s research looks for answers to questions such as: Are adolescents more likely to have unprotected sex or protected sex? Are adolescents who know the risk of sexually transmitted diseases more likely to use contraception?

“In general, the younger that you are when you have sex, the more at risk you are of contracting a sexually transmitted disease,” Weller said. Teaching adolescents about sex early is vital because the younger they learn the more likely they’ll take precautions when they do have a sexual encounter.

“The younger one receives sexual education, the less likely you are to engage in risky sex,” Weller said.

Weller analyzed data from the National Survey of Family Growth that has been conducted since 1973. It reports information on topics like sexual health and pregnancy.

The data showed that young people are waiting longer than in the past to have a first sexual encounter, but the age when most people contract a STD is lessening.

“Fifteen to 19-year-olds have the most sexually transmitted diseases,” Weller explained. “Even though they are waiting, they are having risky sex and not taking precautions.”

Weller found that African American males and females are more likely to have unprotected sex than their peers because they typically live a lower class lifestyle and may not have the extra money for protection.

Sexual education is prevalent in America’s school system. Schools teach a wide range from abstinence to sexually transmitted disease awareness and from birth control to pregnancy awareness. “It varies in school districts and from state to state. More than 80 percent of students get some type of sex education in the school,” she said. In addition, young people receive sexual education from parents, peers and medical professionals.

Future research will be done to look at the different types of contraception use since some prevent pregnancy, others prevent STDs, and some prevent both. Measurements will be acquired to determine adolescent’s knowledge of different methods of contraception, and whether or not they know which methods are best to use. Weller wants to determine whether teens are having sex with a serious boyfriend or girlfriend or just a random hook-up.

SOURCE: 138th annual American Public Health Association Social Justice Meeting and Expo held on Monday, Nov. 8 in Denver, CO

Researchers have found that the skin of Caucasian women is more likely to show wrinkles sooner than African American women. Scientists believe this may have more to do with aging than declining estrogen levels through menopause.

These findings are giving lighter skinned women more reason to protect their skin from damaging UVA rays, which can penetrate up to 250 micrometers into the skin.

It’s always been thought that the melanin in dark skin keeps it resistant to the signs of aging, but it is unclear whether there are actual racial differences in the aging of our skin.

In addition, while skin cells have receptors for estrogen, the extent to which estrogen loss after menopause may contribute to skin aging also remains unclear.

To put these theories to test, scientists took 65 Caucasian women and 21 African American women in their 50s who had gone through menopause over the past few years and evaluated skin elasticity and facial wrinkles.

In general, the women had only mild wrinkling; however, white women had nearly double the wrinkles than black women.

According to Dr. Hugh S. Taylor, The theory is that white women show wrinkles sooner because their skin is more susceptible to damage from a lifetime of sun exposure.

“That’s what we suspect may be going on, though our study does not prove that,” Taylor, of Yale University School of Medicine in New Haven, Connecticut, told Reuters.

If that deliberation is correct, it should give lighter skinned women more incentive to avoid major sun exposure.

This doesn’t mean African American women shouldn’t worry about preventing wrinkles, findings just show that darker skin may not show visible signs of aging as early as a white women’s.

Skin elasticity is measure with a device called a durometer. Taylor believes skin elasticity may be largely dependent on structures underneath the skin, and it’s possible that those structures are more responsive to changes in estrogen levels — whereas wrinkling at the skin’s surface may be more dependent on factors like sun damage.

This research is part of an ongoing trial called KEEPS, which is looking at the effects of hormone therapy, begun soon after menopause, and the risk of heart disease. Taylor and his colleagues are also looking into whether hormone therapy has any effects on skin aging.
 
In 2002, a large U.S. government study found that postmenopausal women given HRT had higher risks of heart attack, stroke, breast cancer and blood clots than women given a placebo. Women in that study were about 63 years old, on average; the KEEPS trial is testing the theory that starting women on hormone therapy soon after menopause, when they are in their 40s and 50s, will have heart benefits.

It is unknown whether hormone therapy has any benefits for younger women, for either their heart or their skin, but it is not recommended that women use hormones in an effort to hinder the signs of aging.

The study is published in the journal Fertility and Sterility.

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On the Net:

• Yale University School of Medicine
• Fertility and Sterility

(Ivanhoe Newswire) — If it were left up to the American Academy of Neurology (AAN), there’d be no more “Ëœtaking it for the team’ or “Ëœshaking it off’ for athletes taking the tough blows.

According to the Centers for Disease Control, three million sports-related concussions occur in the United States every year.  Concussions are now second only to car crashes as a leading cause of traumatic brain injury for young people between the ages of 15 and 24.

The AAN is actively calling for any athlete who is suspected of having a concussion to be removed from play until the athlete is evaluated by a physician with training in the evaluation and management of sports concussions.

“While the majority of concussion are self-limited injuries, catastrophic results can occur and we do not yet know the long-term effects of multiple concussions,” Jeffrey Kutcher, M.D., MPH, chair of the AAN’s Sports Neurology Section, was quoted as saying. “We owe it to athletes to advocate for policy measures that promote high quality, safe care for those participating in contact sports.”

The request is one of five recommendations from a new position statement approved by the AAN’s Board of Directors that targets policymakers with authority over determining the policy procedure for when an athlete suffers from a concussion while participating in a sporting activity.

According to the new AAN position statement, no athlete should be allowed to participate in sports if he or she is still experiencing symptoms from a concussion, and a neurologist or physician with proper training should be consulted prior to clearing the athlete for return to participation.

In addition, the AAN recommends a certified athletic trainer be present at all sporting events, including practices, where athletes are at risk for concussions.

Education efforts should also be maximized to improving the understanding of concussions by all athletes, parents and coaches.

“We need to make sure coaches, trainers, and even parents, are properly educated on this issue, and that the right steps have been taken before an athlete return to the field,” Dr. Kutcher said.

SOURCE: The American Academy of Neurology

Researchers at Mayo Clinic (http://www.mayoclinic.org/) have found a significant difference in cancer progression and death in chronic lymphocytic leukemia (CLL) patients who had sufficient vitamin D (http://www.mayoclinic.com/health/vitamin-d/NS_patient-vitamind) levels in their blood compared to those who didn’t.

VIDEO ALERT: Additional audio and video resources, including excerpts from an interview with Dr. Tait Shanafelt, are available on the Mayo Clinic News Blog (http://newsblog.mayoclinic.org/2010/11/03/mayo-clinic-finds-insufficient-vitamin-d-levels-in-cll-patients-linked-to-cancer-progression-and-death/).

In the Mayo Clinic study, published online in the journal Blood (http://bloodjournal.hematologylibrary.org/), the researchers found that patients with insufficient levels of vitamin D when their leukemia was diagnosed progressed much faster and were about twice as likely to die as were patients with adequate levels of vitamin D.

They also found solid trends: increasing vitamin D levels across patients matched longer survival times and decreasing levels matched shortening intervals between diagnosis and cancer progression. The association also remained after controlling for other prognostic factors associated with leukemia progression.

The finding is significant in a number of ways. For the first time, it potentially offers patients with this typically slower growing form of leukemia a way to slow progression, says the study’s lead author, Tait Shanafelt, M.D., (http://mayoresearch.mayo.edu/staff/shanafelt_td.cfm) a hematologist at Mayo Clinic in Rochester, Minn.

“This finding may be particularly relevant for this kind of leukemia because although we often identify it at an early stage, the standard approach is to wait until symptoms develop before treating patients with chemotherapy,” Dr. Shanafelt says. “This watch and wait approach is difficult for patients because they feel there is nothing they can do to help themselves.”

“It appears vitamin D levels may be a modifiable risk factor for leukemia progression. It is simple for patients to have their vitamin D levels checked by their physicians with a blood test,” he says. “And if they are deficient, vitamin D supplements are widely available and have minimal side effects.”

While the researchers have not yet determined if vitamin D replacement in patients with initially low levels will reverse the more rapid progression associated with insufficiency, they are planning a study to explore that hypothesis.

This research adds to the growing body of evidence that vitamin D deficiency is a risk factor for development and/or progression of a number of cancers, the researchers say. Studies have suggested that low blood vitamin D levels may be associated with increased incidence of colorectal, breast and other solid cancers. Other studies have suggested that low vitamin D levels at diagnosis may be associated with poorer outcomes in colorectal, breast, melanoma and lung cancers, as well as lymphoma.

Replacing vitamin D in some patients has proven to be beneficial, the researchers say. For example, they cite a placebo-controlled clinical trial that found women who increased their vitamin D intake reduced their risk of cancer development.

Vitamin D insufficiency, in general, is widespread, Dr. Shanafelt says. “Between one-fourth and one-half of patients seen in routine clinical practice have vitamin D levels below the optimal range, and it is estimated that up to 1 billion people worldwide have vitamin D insufficiency,” he says.

Vitamin D is obtained from skin exposure to sunlight, from certain foods (fatty fish and eggs) and from supplements.

In this study, the research team, including physicians at the University of Iowa (http://www.uihealthcare.com/), enrolled 390 CLL patients into a prospective, observational study. They tested the blood of these newly diagnosed patients for plasma concentration of 25-hydroxyl-vitamin D and found that 30 percent of these CLL patients were considered to have insufficient vitamin D levels, which is classified as a level less than 25 nanograms per milliliter.

After a median follow-up of three years, CLL patients deficient in vitamin D were 66 percent more likely to progress and require chemotherapy; deficient patients also had a two-fold increased risk of death.

To confirm these findings, they then studied a different group of 153 untreated CLL patients who had been followed for an average of 10 years. The researchers found that about 40 percent of these 153 CLL patients were vitamin D deficient at the time of their diagnosis. Patients with vitamin D deficiency were again significantly more likely to have had their leukemia progress and to have died, Dr. Shanafelt says.

“This tells us that vitamin D insufficiency may be the first potentially modifiable risk factor associated with prognosis in newly diagnosed CLL,” he says.

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On the Net:

• Mayo Clinic
• Blood

(Ivanhoe Newswire) — The average American adult typically has a cold two to four times a year, while children can catch between 10 and 12 people per year, totaling in about 1 billion colds per year in the U.S. All common colds cost the U.S. economy around $40 billion dollars every year. This study shows that colds can be reduced in frequency and severity with more physical activity.

The study was conducted on 1,000 adults up to the age of 85. Their respiratory health was tracked for 12 weeks during the autumn and winter of 2008. All the participants reported back on how frequently they aerobically exercised, and rated their fitness levels using a validated 10-point scoring system. They were also asked about lifestyle, diet, and recent stressful events, since these can all affect immune system response.

In autumn, the number of days with cold symptoms was 8, and in winter 13 days were reported.

Being older, male, and married, seemed to reduce the frequency of colds, but after taking into account other influential factors, the most significant factors were perceived fitness and the amount of exercise done.

The participants who said they were physically active at least five days a week and felt fit reported almost half as many days with cold-like symptoms, compared to those who exercise at most one day a week. The severity of symptoms fell by 41% among those who felt the fittes,t and by 31% among those who were the most active.

Exercise sparks a temporary rise in immune system cells circulating around the body. Although these levels fall back within a few hours, each bout of exercise is likely to increase the awareness of harmful bacteria and viruses, therefore reducing the number and severity of infections like the common cold.

SOURCE: British Journal of Sports Medicine, published online November 1, 2010

In an article published in November 3 edition of Journal of the American Medical Association (JAMA), Chad Boult, MD, MPH, MBA, professor of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health, calls for key improvements to primary care in order to improve the health of the nation’s most costly patients””older adults with multiple chronic conditions. Boult and his co-author, G. Darryl Wieland, PhD, MPH, research director of Geriatrics Services at Palmetto Health Richland Hospital, Columbia, South Carolina, evaluated studies of new primary care models to determine the best way to improve care and outcomes for the more than 10 million older adults living with four or more chronic conditions.

“Today’s primary care physicians are often overwhelmed by the complex needs of patients with multiple chronic health challenges, such as diabetes, high blood pressure, arthritis and more,” said Boult. “Current medical training often does not prepare physicians to provide the comprehensive support that these patients require. Through our research, we identifed four processes that can improve how we care for these patients, and three models that include these critical processes.”

Boult and Wieland reveiwed all peer-reviewed studies of comprehensive primary care models for older adults with multiple conditions published between 1999 and 2010. From this review, they identified four processes that are present in most successful models of primary care for these patients:

    * A comprehensive patient assessment that includes a complete review of all medical, psychosocial, lifestyle and values issues,
    * Creation and implementation of an evidenced-based plan of care that addresses all of the patient’s health-related needs,
    * Communication and coordination with all who provide care for the patient, and
    * Promotion of the patient’s (and their family caregiver’s) engagement in their own health care.

“Most of today’s primary care does not include these four processes, so patients receive fragmented and inefficient care that is further undermined by a lack of family and community support, ” said Wieland, research director of Geriatrics Services at Palmetto Health Richland Hospital. “However, new models of primary care that include these processes have improved health outcomes, and patient and physician satisfaction, and have in some cases lowered the cost of care.”

Boult and Wieland identified three models of care that have the greatest potential to improve effectiveness and efficiency of complex primary health care. All three models include a team-based approach to primary care, and they provide many of the same services to complex older patients, beginning with a comprehensive assessment and an evidence-based care plan. All of these models include proactive monitoring and coaching, coordination of care across all sites of care, support of patient’s transitions from acute to post-acute settings, and access to community-based agencies.

    * GRACE (Geriatric Resources for Assessment and Care of Elders), a team-based intervention developed by researchers from Indiana University and the Regenstrief Institute. In a large clinical trial, GRACE improved the quality of care, decreased emergency department visits, and lowered hospital admission rates and costs in a group at high risk for hospital admission.
    * PACE (Program of All-inclusive Care for the Elderly), provides comprehensive, interdisciplinary team care to low-income frail elders. Based in an adult day health center, PACE professionals provide (or contract for) primary, specialty, emergency, hospital, home, and long-term care. PACE has been found to increase health screenings, reduce hospital admissions, increase nursing home stays, and reduce mortality among PACE participants at high risk of dying.
    * Guided Care, a multi-disciplinary model of comprehensive primary care for people with multiple chronic conditions, was developed by Johns Hopkins researchers. Early results from a multi-site, randomized controlled trial indicate that Guided Care improves the quality of patients’ care, improves physician’s satisfaction with some aspects of chronic care, and tends to reduce the use and cost of expensive health-related services.

Of the three models, only PACE is currently reimbursable through Medicare and state Medicaid programs.

“While most of the programs noted here are not yet widely available, we are hopeful that new initiatives launched by the Patient Protection and Affordable Care Act of 2010 will provide new opportunities for primary care physicians to care for their chronically ill patients more effectively and efficiently,” said Boult. “More research is needed to define the optimal methods for identifying the patients who will benefit most, for providing the essential clinical processes, for disseminating and expanding the reach of these models, and for paying for excellent chronic care.”

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On the Net:

• Johns Hopkins University Bloomberg School of Public Health
• Journal of the American Medical Association

When Stephen Barrager was diagnosed in 2007 with acute multiple myeloma, a form of bone marrow cancer, he endured the same anxiety that troubles all those who receive an upsetting diagnosis. The way he went about dealing with his disease and its treatment, however, was different. Barrager drew upon his engineering and management science background to help him make difficult decisions. Now he is sharing his insights with hospitals and doctors in his native Bay Area and with colleagues at a conference coming to Austin on November 7.

The annual meeting of the Institute for Operations Research and the Management Sciences (INFORMS®) takes place at the Austin Convention Center and the Hilton Austin from Sunday, November 7- Wednesday, October 10. Dr. Barrager speaks on Sunday, November 7 at 11 AM at the Convention Center in Session SB 31 on Level 4 in Room 18B. The program is open only to conference participants and reporters.

Dr. Barrager is available for interview.

When Dr. Stephen Barrager was diagnosed with multiple myeloma in February of 2007, he found himself facing numerous choices that were hard for a patient to process. Which of the recommended medications should he take? Was he a candidate for a stem cell transplant? Were there drug trials?

“I didn’t understand the medicine, I didn’t know the people who were treating me, and the people who were treating me couldn’t explain things in a way that made sense to me,” he recalls. “I was scared, very sick, and totally confused.” Barrager’s wife, his advocate, who accompanied him to every doctor consultation and hospital treatment, was also overwhelmed. She ran interference for him and tried to make certain his care was the best possible, but she agrees there is something missing in the system.

During this troubling time, Barrager referred to a book written by his friend, the late Nobel Laureate Stephen Schneider of Stanford University. Schneider had gone through his own battle with cancer, and lived to write The Patient from Hell, a book about his experiences and his recommendations for improving the cancer care system. In addition to advising patients to have an “advocate”, Schneider’s book recommends that doctors and hospitals use more management science thinking and tools, and do a better job of communicating probabilities.

When Barrager presented these ideas to his doctors, they responded that bringing in management science thinking and tools would present a host of challenges: doctors are trained as scientists, not engineers. Doctors are restricted by insurance regulations and other system constraints. Patients themselves vary in their ability to process this different way of deciding.

So Barrager went back to the drawing board and modified his friend’s recommendations. He came up with his own unique adaptation, which features two concepts: the Cancer Quarterback and the Decision Coach.

The Cancer Quarterback’s role is to help the patient stay healthy within the constraints of the medical system; confer with specialists; help patients learn more about their disease; and communicate with a Decision Coach.

The Decision Coach’s job is to help the Cancer Quarterback by structuring decisions; gathering and processing treatment information; doing analysis of potential treatments; and collaborating with fellow coaches.

In his case, Barrager’s family doctor served as his Cancer Quarterback. Barrager, a trained management scientist, served as his own Decision Coach. He obtained information that let him assess the probable success of each possible treatment.

Almost four years later, the collaboration between Cancer Quarterback and Decision Coach seems to be working: Stephen Barrager’s rare and raging, blood-based cancer is currently under control.

Dr. Barrager is now beginning to advocate that many more cancer patients be provided with a Cancer Quarterback and Decision Coach. To his satisfaction, hospital administrators believe that the model may help patients and save medical costs. He is exploring the concept of Cancer Quarterback and Decision Coach with doctors, specialists, and administrative executives at his Bay Area hospitals: California Pacific Medical Center, Stanford University and UCSF.

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On the Net:

• INFORMS

Simple mobile technology, like basic cell phones, can be used to save the lives of mothers in childbirth, and improve the care of newborns and children, reaching underserved populations in remote areas.

More advanced mobile technology can do even more, such as checking on patients, keeping records, improving diagnosis and treatment in the field, and letting community health workers consult general practitioners and specialists for guidance.

“With mobile technologies for health, called ‘mhealth’ or ‘mobile health,’ we’re extending capabilities to where they don’t exist today,” says David Aylward, who heads mHealth Alliance, a partnership founded by the United Nations Foundation, the Rockefeller Foundation and the Vodafone Foundation.

“At the most basic level, mobile phones can be used to keep track of people, call for emergency assistance, remind them of appointments and share information,” says Julian Schweitzer, PhD, former Chair of The Partnership for Maternal, Newborn & Child Care (PMNCH) and the Chair of the Finance Working Group for the UN Secretary-General’s Global Strategy for Women’s and Children’s Health, launched in September. “But then you can layer on things like check lists, protocols, the steps to ensure a safe birth and action instructions in particular circumstances,” says Dr. Schweitzer.

Used by midwives in rural, urban slums and isolated areas, cell phones can also be attached to diagnostic devices, including those used for remote fetal monitoring or remote wireless ultrasound. This lets a midwife or health worker know in advance that a mother must get to a clinic. They can also be used for recording births and deaths or assuring that both women and children get the care they need when and where they need it.

“In the near future, wireless diagnostics like stethoscopes, blood pressure, temperature and insulin monitors, and ultrasounds will enable remote diagnosis and treatment far from the closest doctor or clinic, ” says Mr. Aylward.

Use spreading rapidly

Five years ago, the idea of using cell phones to improve health care for mothers, infants and children wasn’t feasible.

That has changed rapidly.

Consider these facts:

    * 70 percent of the world’s 5 billion cell phone subscribers are in the developing world.
    * Today almost 90 percent of the world’s population has access to a wireless telephone signal.
    * In India alone, 33 percent of people living in villages have mobile phones.
    * About three quarters of mobile phone users have texting capability and features such as GPS that can pinpoint their location.
    * By 2015, about 60 percent of mobile phones are expected to be web-enabled.

“These networks are being extended almost everywhere. People are paying for the devices and the service, which shows that people value access to information and the ability to communicate, and that includes health information and communication,” says Mr. Aylward.

mHealth Summit and Partnership meeting

Two thousand technology and health experts are expected at the second annual mHeath Summit, Nov. 8-10 in Washington, D.C. The summit is co-sponsored by the mHealth Alliance, the Foundation for the National Institutes of Health and NIH to further explore the potential of mobile technology in the health field, to promote its use, and to seek ways to overcome some of the current obstacles.

Featured conference speakers include William Gates, head of the Gates Foundation, Aneesh Chopra, U.S. Chief Technology Officer, Julio Frenk, M.D., Dean of the Harvard School of Public Health and Chairman of The Partnership for Maternal, Newborn & Child Health, Ted Turner, Chairman and Founder of the United Nations Foundation and Judith Rodin, President of the Rockefeller Foundation.

Mobile technology and mHealth also will play a key role as the partners in The Partnership for Maternal, Newborn & Child Health (PMNCH) meet in New Delhi on Nov. 13-14. In addition to a number of speakers during the plenary sessions, PMNCH and the mHealth Alliance are organizing a detailed mHealth implementation workshop bringing together expert practitioners with industry to discuss specific ways to deploy mHealth systems.

PMNCH was formed to ensure that all countries meet the UN’s Millennium Development Goals (MDGs) for improving the health of women and reducing the toll of infant and child deaths by 2015. Widely used, mobile technology could help less developed countries meet those goals. “I’m not saying that mobile technology is a panacea, but there’s such tremendous possibility, primarily because the cell phones are already there and usage is growing so fast,” says Dr. Schweitzer.

Help for meeting MDGs

The potential for the rapid spread of mobile technology suggests it will help those countries that lag behind, many of them in sub-Saharan Africa, in meeting the MDGs.

Of special concern are MDGs 4 and 5, which call for reduced child and maternal mortality. At the most recent assessment, 49 of the 68 high-burden countries had made little, if any progress toward meeting those goals.

But mHealth has the ability to support those goals by improving information and communication for mothers, providers and administrators.

The recently announced Global Strategy for Women’s and Children’s Health identifies mHealth as a critical innovation that needs to be broadly applied to achieve the MDGs. PMNCH acted as the platform for the development of the Global Strategy, and will continue to advocate for financial and policy commitments to the Global Strategy.

The Government of Norway chairs the Innovation Working Group (IWG) of the Global Strategy. “We cannot reach the MDGs by merely continuing to do more of what we have been doing,” says Tore Godal, M.D., Chairman of the IWG and Special Advisor to the Prime Minister of Norway for Global Health. “The best new idea is to use mobile technology and cell phones.”

Doing what everyone else is doing

As this growth has occurred, more than 100 countries are exploring ways to use mobile phones to improve health.

“The information technology is not revolutionary – its use in health is,” says Dr. Schweitzer. “We are talking about applying in health care the same kinds of sophisticated information systems that most businesses use, extending them with wireless to reach everyone. In low and middle- income countries we have the opportunity to leap frog the developed world and do it right. This is a huge opportunity.”

Some issues being addressed

The recently announced Maternal mHealth Initiative, a partnership between PMNCH and the mHealth Alliance, will develop a global consensus on mobile technology. The new partnership will conduct trials using an integrated information and communications technology system to underpin the full continuum of recommended care for expectant mothers and newborns.

The Earth Institute’s Millennium Villages Project is working with governments and ministries of health along with telecommunications companies like Ericsson, AirTel Bharti, and MTN in 10 countries in Africa, to design, test, and implement standardized and interoperable mHealth systems. “Many countries are looking at mHealth as a strategy for health service delivery,” says Patricia Mechael, PhD, of The Earth Institute.

In 1994, the University of Oslo began the Health Information Systems Programme (HISP). It developed the open source based District Health Information Software (DHIS) implemented in 15 African countries and 23 states in India, Bangladesh and Vietnam.

In the last two years, HISP has started to use basic cell phones to collect data on maternal and child health in an integrated manner where there are no computers or Internet. Because of the collaboration with ministers of health, the HISP program differs from other mobile projects.

“Data goes into the ministries’ health systems so it can be read and analyzed at every level, ” says project director Professor Kristin Braa of the University of Oslo. “The information comes back to the local level where it can be used to identify problems and trends. Otherwise mother and child health will not be improved.”

In one pilot project in Aceh Besar, Indonesia, a group of midwives was provided with mobile phones and their use and experiences documented. Those midwives who were given the phones found them a “basic necessity.” The main benefit was the ease of communication.

Midwives reported an increase in patient load because they could be contacted so easily. They also found they could get advice and information more readily, especially during emergencies, and could refer patients to the hospital when needed. Midwives were able to consult patients more often and provide a regular check of their condition, then enter the information into the patient’s record, which could be updated and accessed via the mobile phone.

Infrastructure was a problem in remote areas where transmission was often poor, and where midwives were in greatest need. Lack of data in the local language also proved a barrier. Most midwives in the study learned how to use the technology readily, and said they planned to keep using the phones when the project ended.

Yet the promise comes with caveats and warnings about too much hype. One reason is the absence of controlled studies. “mHealth can really expand the capability of public health, in particular, but the potential for reaching UN MDGs 4 and 5 is yet to be realized,” cautions Joan Dzenowagis, M.D. of the World Health Organization.

“Anecdotally, we can see the transformative effect,” says Dr. Mechael, who, sponsored by the mHealth Alliance, has recently completed an analysis of 2,400 published mHealth reports. Working with WHO, she found that many countries either have already or are considering introducing mHealth into their health systems. mHealth is so new, however, “the data is just not there yet to prove the case,” says Dr. Mechael.

Many different groups and organizations are carrying out countless pilot projects. That presents a potential barrier to expansion. “Most projects are designed as a single solution for a specific problem,” says Dr. Dzenowagis. “In the field everyone has a different system which means a lack of coordination. This leads to duplication of expense and effort and means information may not be available to those who need it.”

The mHealth Alliance and its Maternal mHealth Initiative with PMNCH are designed to bring coordination and information sharing to the field, focusing on integrated solutions.

“We won’t be talking about mobile health in 2015,” says Dr. Mechael. “By then, we won’t need to pull it out and talk about it and examine it because it will be a fully accepted tool for health care.”

Second Annual mHeath Summit on Nov. 8-10 in Washington, D.C.
http://www.mhealthalliance.org

mHealth stands for mobile-based or mobile-enhanced health solutions, or the idea that global wireless networks and mobile devices (cellphones, smartphones, mobile-enabled diagnostic devices) are powerful vehicles for delivering innovative medical and health services to the farthest reaches of the globe.

The Institute of Medicine (IOM) recently released a study, The Future of Nursing: Leading Change, Advancing Health. The report calls for new and expanded roles for nurses in a redesigned health care system. It recommends improving education for all nurses and allowing nurses to practice to the full extent of their license and ability. It advocates overhauling state scope of practice acts and suggests that advanced practice registered nurses (APRNs) — certified registered nurse anesthetists, certified nurse-midwives, clinical nurse specialists, and certified nurse practitioners ““ should be allowed to practice independently.

Although many of the recommendations of the IOM report are consistent with positions advocated by the American College of Physicians (ACP), other elements are of concern:

    * The College agrees that the nursing and medical professions together have critical roles and responsibilities in providing comprehensive, team-based and patient-centered care that takes full advantage of the training and experiences of each profession. As trained health care professionals, physicians and nurses share a commitment to providing high-quality care.

    * Recommendation #1 of the IOM report seeks to remove scope-of-practice barriers. It includes calls upon state legislatures to reform scope-of-practice regulations to conform to the National Council of State Boards of Nursing advanced practice registered nurse model rules and regulations that would allow APRNs to practice independently. The IOM’s emphasis on independent practice is at odds with the goal of ensuring that patients receive comprehensive and patient-centered care within the context of a health care team.

          o Today, no one clinician should practice independently of other clinicians. Instead, the goal should be to develop collaborative and team-based models that allow every member of the team to contribute to the best possible outcomes to the full level of their training and skills while recognizing differences in their training and skills.

    * Physicians and nurses complete training with different levels of knowledge, skills, and abilities that are complementary but not equivalent:

          o Physicians must complete four years of medical school with two years of clinical rotations during the third and fourth years of medical school (3200 hours of general clinical education) and a minimum of three years of full-time clinical postgraduate residency training (minimum 7800 hours) in their specialty.

          o Licensed Practical /Licensed Vocational Nurses (LPN/LVNs) complete a 12 to 18 month educational program at a vocational/technical school or community college. They work under the supervision of a physician or registered nurse.

          o Registered Nurses (RNs) may complete a two-three year Associate Degree (ASN) program of study at a community college, diploma school of nursing or a four-year college or university; however, a four-year Baccalaureate Degree in Nursing (BSN) is the standard for a registered nurse and Recommendation 4 of the IOM calls for increasing the proportion of nurses with a baccalaureate degree to 80 percent by 2020. Many registered nurses receive additional training and specialize in areas such as critical care, public health, or oncology.

          o Advanced Practice Registered Nurses (APRNs) generally receive a Master’s degree and/or post Master’s Certificate. Increasingly, APRNs go on to obtain degrees as Doctor of Nursing Practice (DNP) or Doctor of Philosophy in Nursing (PhD). There are also post-baccalaureate programs that combine the Master’s and Doctorate programs and take approximately three years to complete on a fulltime schedule.

          o The IOM report acknowledges that “the nursing profession itself must undergo a fundamental transformation if the committee’s vision for health care is to be realized.” It also recognizes that physicians receive more extensive and specialized education and training than nurses. The IOM report concludes, “Nurses should achieve higher levels of education and training through an improved education system that promotes seamless academic progression.”

    * Internists are particularly well suited to provide long-term, comprehensive care in the office and the hospital, managing both common and complex illnesses of adolescents, adults, and the elderly:

          o Internists receive in-depth training in the diagnosis and treatment of conditions affecting all organ systems.

          o Internists have a strong grounding in the scientific basis of clinical medicine and in disease pathophysiology, providing them with the background to effectively integrate current and evolving scientific knowledge with the delivery of clinical care.

          o Internists are specially trained to solve puzzling diagnostic problems and can handle severe, complex chronic illnesses and situations where several different illnesses may strike at the same time.

          o Internists’ training is solely directed to care of adult patients; consequently, internists are especially focused on care of adult and aged patients with multiple complex chronic diseases.

          o Internists are trained in the essentials of primary care internal medicine, which incorporates an understanding of disease prevention, wellness, substance abuse, and mental health.

          o Because of the differences in years and content of training, patients with complex problems, multiple diagnoses, or difficult management challenges will typically be best served by internists and other physician specialists working with a team of health care professionals that may include nurse practitioners, physician assistants (PAs), and other non-physician clinicians.

          o A personal physician, working collaboratively with teams of other qualified health professionals, plays an essential role in delivering high quality, patient-centered, and coordinated care to patients. Advanced practice nursing cannot substitute for nor replace primary care medical practice as provided by general internists, family physicians, pediatricians and other physicians.

    * Whenever possible, the needs and preferences of every patient should be met by the health care professional with the most appropriate skills and training to provide the necessary care:

          o Patients rely on a health care clinician’s professional designation as an indication of the level of training, skills, and knowledge of those providing their care. The use of the prefix “Dr.” or “Doctor” by nurses who have obtained the DNP degree could lead to confusion and misconceptions by patients.

          o Patients have the right to be informed of the credentials and qualifications of health care professionals involved in their care to better enable them to understand the background and orientation of their care givers. Consequently, information should be available to patients to help them distinguish among the different health care professionals involved in their care

    * Workforce policies should recognize that training more nurse practitioners or physician assistants does not eliminate the need or substitute for increasing the numbers of general internists and other physicians trained to provide primary care. A recent study projects a shortage of tens of thousands of primary care physicians for adult patients, even after the contributions of the nursing profession, physician assistants, and other non-physician health professionals are taken into account.

    * In addition to nursing, the contributions of physician assistants, working together with physicians, nurses and other health professionals in a team-oriented practice, such as the patient-centered medical home, should be supported as a proven model for delivering high-quality, cost-effective patient care.

    * Physicians, nurses, APRNs, and physician assistants need to be trained to know when they should refer or hand-off a patient to a clinician with a different level of skill and training. This applies not only to non-physicians, but also to primary care physicians and subspecialists who need to engage the skills of another physician-specialist.

    * The IOM recommends that the FTC and the Antitrust Division of the Department of Justice should review state regulations concerning APRNs to identify those that have anti-competitive effects without contributing to the health and safety of the public. It further recommends that “States with unduly restrictive regulations should be urged to amend them to allow advanced practice registered nurses to provide care to patients in all circumstances in which they are qualified to do so.”

          o State licensing laws and regulations are intended to protect the public by ensuring that all licensed health clinicians and health professionals have the skills, training and experience required to provide a defined level of service to patients.

          o In this era of transformation of health care delivery, review of state licensing laws would be better served by looking at those areas where APRNs are not allowed to perform functions within the patient-centered medical home that evidence suggests their knowledge, skills, and abilities should allow them to perform. Delivery models such as the VA could be looked to for guidance. Data from patient-centered medical homes can provide additional evidence-based guidance over time as to the specific functions best filled by different health care professionals.

          o Review of state licensing laws should not lead to changes that could harm patient care by allowing any group of health care professionals to provide care for which that profession does not have the requisite training, experience and skills. Such laws should, however, allow all health care professionals to practice to the full level of their training, experience and skills working in a collaborative, team-based environment.

ACP believes that the future of health care delivery will require multidisciplinary teams of health care professionals that collaborate to provide patient-centered care. The key to high performance in multidisciplinary teams is an understanding of the distinctive roles, skills, and values of all team members ““ primary care physicians, medical and surgical specialists, nurses (including APRNs, RNs and NPs), physician assistants, and other health professionals ““ working together to delivery high quality, effective, coordinated and team-based care.

Recognizing and building on the common ground between the physicians, nurses, physician assistants, and other health professionals is vital to improving collaboration to meet the complex health care needs of the population.

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On the Net:

• American College of Physicians

Researchers at North Carolina State University have found that the overproduction of a key protein in stem cells causes those stem cells to form cancerous tumors. Their work may lead to new treatments for a variety of cancers.

Dr. Jon Horowitz, associate professor of molecular biomedical sciences, and a team of NC State researchers looked at the protein SP2, which regulates the activity of other genes. They knew that elevated amounts of SP2 had been observed in human prostate-cancer patients, and that these levels only increased as the tumors became more dangerous. They then showed that precisely the same thing occurs in mouse skin tumors.

Horowitz and the team decided to look at SP2 as a possible cause of tumor formation in epithelial cell-derived tumors, which comprise about 80 percent of all human tumors; epithelial cells cover the body’s internal and external surfaces. They found that overproduction of the SP2 protein in epithelial stem cells stopped them from spawning mature descendants. The affected stem cells, unable to produce mature cells, just kept proliferating, resulting in the formation of tumors.

The researchers’ results are published in the Nov. 3 edition of the journal Cancer Research.

“Something happens to normal stem cells that changes the way SP2 is regulated, and it starts being overproduced,” Horowitz says. “SP2 basically hijacks the stem cell, and turns it into its evil twin ““ a cancer cell.”

Now that the link between tumor formation and SP2 has been shown, Horowitz says, scientists can turn their attention to looking at ways to target the overproduction of this protein. “Our hope is that we can find an “Ëœantidote’ to SP2, to restore normal cell proliferation to those cancer stem cells and reverse the process.”

The research was funded by a grant from the National Institutes of Health (NIH). The Department of Molecular Biomedical Sciences is part of NC State’s College of Veterinary Medicine.

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On the Net:

• NCSU
• Cancer Research

Treatment offers patients an alternative to surgery

Adding chemotherapy to radiation therapy for muscle invasive bladder cancer allows 67 percent of people to be free of disease in their bladders two years after treatment. This compares to 54 percent of people who receive radiation alone, according to the largest randomized study of its kind presented at the plenary session, November 1, 2010, at the 52nd Annual Meeting of the American Society for Radiation Oncology (ASTRO).

“The trial shows that this treatment offers improved control of cancer within the bladder with acceptable long-term side effects and is therefore a viable alternative to radical surgery in patients with muscle invasive bladder cancer,” said Nicholas James, M.D., an oncologist at University of Birmingham in Birmingham, England, United Kingdom, who jointly led the study with Robert Huddart, M.D., from the Institute of Cancer Research in the United Kingdom. “This may shift the balance from surgery to chemo-radiotherapy as the primary treatment for many patients with invasive bladder cancer.”

Bladder cancer affects about 70,000 Americans each year. It is four times more common in men than in women and two times more common in Caucasians than African-Americans. Cure rates for advanced bladder cancer are generally poor, with only around 40 percent of those with this form of the disease living more than five years after diagnosis.

In the United States, the most common treatment for advanced bladder cancer is complete removal of the bladder, which compromises patients’ normal urinary function. Radiotherapy has been used as an alternative for some time. Doctors have been making advances in combining radiation therapy and chemotherapy as a way to treat bladder cancer while allowing patients an opportunity to maintain normal bladder function.

This multicenter randomized trial, conducted at 45 institutions in the United Kingdom, examined whether adding chemotherapy to radiation treatment is safe and more effective than giving radiation alone in preventing bladder cancer from returning. The trial also compared two ways of giving radiation therapy.

From August 2001 to April 2008, 458 invasive bladder cancer patients entered the trial. Results of the study show that the combination of chemotherapy and radiation treatment reduced the long-term risk of recurrence of cancer within the bladder, while also preserving bladder function.

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On the Net:

• American Society for Radiation Oncology

(Ivanhoe Newswire) — Tired of the pain, pills and joint swelling? A team of researchers in North Carolina discovered that lubricin, a synovial fluid glycoprotein, may treat or prevent joint disease.

Osteoarthritis is the most common form of arthritis, the degenerative joint disease.  It mostly affects cartilage, the slippery tissue that covers the ends of bones where they meet to form a joint, and allows bones to glide over one another with limited friction and wear.  Osteoarthritis causes cartilage to be broken down through a vicious cycle of mechanical and metabolic factors, and mechanical wear of cartilage is widely believed to contribute to this process.  Eventually, the bones under the cartilage rub together, which can cause a tremendous amount of pain, swelling, and loss of motion at the joint.

Many studies have examined cartilage friction and lubrication with the goal of understanding cartilage wear prevention.  Very few studies have focused on measuring wear directly, though, and until now no other studies have directly assessed the effects of synovial fluid constituents in mediating wear.

“We measured the effect of the synovial fluid protein lubricin on cartilage wear,” Stefan Zauscher, an associate professor of mechanical engineering and material science, as well as biomedical engineering, at Duke University in Durham, N.C., was quoted as saying.

“Our measurements were performed at the surface level using an atomic force microscope with pressures and sliding speeds comparable to those seen in joints.  The measurements show a direct link between lubricin in solution and reduction of cartilage wear,” Zauscher stated.

This indicates that lubricin is important for cartilage preservation physiologically, which may have important implications for treating or preventing joint disease in the future.

SOURCE: Lubricin Reduces Microscale Cartilage Wear, October 2010

(Ivanhoe Newswire) — The first experimental evidence to directly support the idea that genetic differences make some people more susceptible to the addictive effects of alcohol and other drugs was provided in this study.

The study compared the brain’s response to long-term alcohol drinking in two genetic variants of mice. One strain lacked the gene for dopamine D2, a specific brain receptor that responds to dopamine. Dopamine is the brain’s “feel good” chemical. It produces feelings of pleasure and reward. The other strain was genetically normal. In the dopamine-receptor-deficient mice, long-term alcohol drinking resulted in significant biochemical changes in areas of the brain known to be involved in alcoholism and addiction.

“This study shows that the effects of chronic alcohol consumption on brain chemistry are critically influenced by an individual’s pre-existing genetic makeup,” lead author Panayotis (Peter) Thanos, a neuroscientist with Brookhaven Lab and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Laboratory of Neuroimaging was quoted as saying. “Our findings may help explain how someone’s genetic profile can interact with the environment “” in this case, chronic alcohol drinking “” to produce these changes only in some individuals, but not in others with a less vulnerable genetic profile. The work supports the idea that genetic screening could provide individuals with valuable information relevant to understanding risks when deciding whether or not to consume alcohol.”

The scientists were particularly interested in the dopamine system because many studies suggest that deficiency in dopamine D2 receptors may make people less able to experience ordinary pleasures and more vulnerable to alcoholism, drug abuse, and even obesity. The ability to genetically engineer mice lacking the D2 gene, along with carefully controlling and monitoring their alcohol intake, made it possible to test the effect of this genetic influence on the brain’s response to chronic alcohol drinking. This was the first study of its kind.

In the study, scientists studied male mice lacking the dopamine D2 gene and genetically normal male mice. They gave half of each group only water to drink, and the other half a solution of 20 percent ethanol to stimulate heavy drinking. After six months, the scientists compared the levels of a different kind of brain receptor known as cannabinoid type 1 (CB1) in various parts of the brain in all four groups. CB1 receptors are located near dopamine receptors and are also known to play a role in alcohol consumption and addiction. Many findings indicate that the two types of receptors may influence one another.

SOURCE: Alcoholism Clinical Experimental Research, published online October 19, 2010

(Ivanhoe Newswire) — It has been known for many years that drinking alcohol while pregnant can cause serious and irreversible damage to the baby. Now new research shows one more reason why you should only be concerned with your baby’s bottle.

Fetal alcohol syndrome is a developmental problem that is caused before birth when a baby is exposed to alcohol. It has been shown to affect many different aspects of brain development, including brain size and difficulties in memory and information processing. New research by researchers at Wayne State University School of Psychiatry shows that exposure to alcohol also affects visual perception, control attention and demand processing.

They collected data from 217 children that were placed in either the alcohol-exposed group, where mothers reported binge drinking while pregnant, or the control group.

Electroencephalography (EEG) was used to observe the changing voltage of the brain’s electrical activity during the memory and coordination trials. This allowed the researchers to explore the differences in the brain’s electrical activity, called event-related potentials, which change in specific ways depending on what task was presented, between the alcohol-exposed and control groups.

“The study demonstrates that there are alterations in this group of children on their processing of information related to these functions,” Claire Coles, a Professor of the Department of Psychiatry and Behavioral Science and Pediatrics at the Emory University School of Medicine was quoted saying. “Hopefully, such information can be used to develop more effective teaching methods for children affected by prenatal exposure.”

Researchers also say this information can help children diagnosed with FASD and FAS and it may be able to help create new therapies and treatment.

SOURCE: Alcoholism: Clinical & Experimental Research, October 2010

Researchers from the University of North Carolina (UNC) School of Medicine have discovered a gene that they say plays a key role in the metabolic processing of alcohol.

The discovery of the gene CYP2E1, which was located by UNC Genetics Professor Kirk Wilhelmsen and his colleagues in the terminal region of chromosome 10, could help protect against alcoholism. Between 10% and 20% of people possess a gene variant that has been linked to a low tolerance to alcoholic beverages. As a result, they need to consume fewer glasses of beer or wine to feel inebriated.

“We have found a gene that protects against alcoholism, and on top of that, has a very strong effect,” Wilhelmsen said in a statement. “But alcoholism is a very complex disease, and there are lots of complicated reasons why people drink. This may be just one of the reasons.”

“It turns out that a specific version or allele of CYP2E1 makes people more sensitive to alcohol, and we are now exploring whether it is because it generates more of these free radicals,” he added. “This finding”¦ hints at a totally new mechanism of how we perceive alcohol when we drink. The conventional model basically says that alcohol affects how neurotransmitters, the molecules that communicate between neurons, do their job. But our findings suggest it is even more complex than that.”

Williamson is hopeful that the results of the study, which will be published in the January 2011 issue of Alcoholism: Clinical & Experimental Research, will ultimately lead to the creation of drugs that induce CYP2E1 in order to increase a person’s alcohol sensitivity prior to drinking, or help them sober up once they become inebriated.

In related news, a study conducted at the Department of Energy’s (DOE) Brookhaven National Laboratory compared the effects of long-term alcohol consumption in two different types of mice–one of which lacked the brain receptor known as dopamine D2 and the other which possessed it.

According to a DOE press release, the scientists targeted the dopamine system because a deficiency in the so-called “feel good” chemical is believed to make people more vulnerable to alcoholism. Some of the mice without D2 receptors were given water, and others alcohol, and the levels of a related brain receptor–cannabinoid type 1 or CB1–were monitored. The researchers determined that under normal conditions, the absence of D2 led to increased CB1 levels, suggesting a link between the two. However, the effect was negated by chronic alcohol consumption.

“This study shows that the effects of chronic alcohol consumption on brain chemistry are critically influenced by an individual’s pre-existing genetic makeup,” Panayotis Thanos, a neuroscientist with the Brookhaven Lab and lead author of the study, said in a statement.

“Our findings may help explain how someone’s genetic profile can interact with the environment–in this case, chronic alcohol drinking–to produce these changes only in some individuals, but not in others with a less vulnerable genetic profile,” he added. “The work supports the idea that genetic screening could provide individuals with valuable information relevant to understanding risks when deciding whether or not to consume alcohol.”

Like the UNC study, the DOE one is scheduled for publication in Alcoholism: Clinical & Experimental Research. Both are currently available online in the journal’s Early View edition.

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On the Net:

• UNC School of Medicine
• Alcoholism Clinical Experimental Research
• Department of Energy’s (DOE) Brookhaven National Laboratory

In five different studies presented at the American College of Gastroenterology’s (ACG) 75th Annual Scientific meeting in San Antonio, researchers explored the impact of various factors on increasing rates of Clostridium difficile infection (C. difficile), such as the use of proton pump inhibitors (PPIs) and the substantial increase in antibiotic use due to new National Hospital Quality Measures; strategies to combat high rates of C. difficile infections; and cutting”Âedge treatments for this potentially deadly””and quite common””infection.

Five studies were featured during an ACG press briefing on Tuesday, October 18, 2010 entitled: “Attack on C. difficile: A GI Perspective “Â How We Can Combat this Serious Health Issue.”

C. difficile associated diarrhea (CDAD) is a major cause of morbidity and increasing health care costs among hospitalized patients, as C. difficile infections have dramatically increased in recent years, with 500,000 cases in the United States annually and approximately 15,000 deaths each year, according to the U.S. Centers for Disease Control & Prevention.

Proton Pump Inhibitors Linked to Incidence of C. difficile Associated Diarrhea

While antibiotic use is the most documented risk factor for CDAD, attention has been directed towards a plausible””Âbut controversial””Âlink with proton pump inhibitors (PPIs). Researchers today unveiled results of a meta”Âanalysis of 16 observational studies, which explored the association between CDAD and PPIs. The study, “A Meta”Âanalysis of 16 Observational Studies on Proton”ÂPump Inhibitor Use and Risk of Clostridium difficile Associated Diarrhea” investigated the association between PPIs and CDAD from 1980″Â2010 and involved more than 1.2 million hospitalized patients.

The investigators extracted adjusted risk estimates from the studies and used a random effects meta”Âanalysis. The summary risk estimate showed a 65 percent increase in the incidence of CDAD among PPI users, according to Sailajah Janarthanan, M.D., who co”Âauthored the study. Researchers also conducted a stratified analysis by study design and when looking at both prospective and retrospective studies, found that there was still a significant increase in C. difficile among PPI users.

The Introduction of National Hospital Quality Measures Linked to Rising C. difficile Rates

In 2004, the Joint Commission on Accreditation of Health Care Organizations (JCAHO) and the Centers for Medicare and Medicaid Services (CMS) introduced National Hospital Quality Measures (NHQM) to improve pneumonia and surgical infection outcomes. However, these new quality measures have resulted in a substantial increase of antibiotic usage, which researchers hypothesized has led to an increase in C. difficile associated diarrhea and colitis in an inner city hospital in New York. As a result, researchers reviewed charts of all patients with confirmed C. difficile infection admitted to the Bronx Lebanon Hospital Center from January 1, 2003 to December 31, 2008. Antibiotic usage for all inpatients during the same time was also reviewed.

The study, “National Quality Measures and Clostridium difficile Infection in an Inner City Hospital,” found a total of 439 patients with confirmed C. difficile infection from January 1. 2003 to December 31, 2008.

“We observed significant increase in Clostridium difficile infection rate between 2003 and 2006,” said Ariyo Ihimoyan, M.D. The number of cases per 10,000 admissions was 16 in 2003; 20 in 2004; 50 in 2005; 36 in 2006; 40 in 2007; and 58 in 2008. The total number of antibiotic doses uses per 1000 admissions was 3268 in 2003; 3536 in 2004; 4585 in 2005; 5150 in 2006; 5848 in 2007; and 5867 in 2008.

“From these findings, we conclude that the introduction of National Hospital Quality Measures have led to a substantial increase in antibiotic usage,” said Dr. Ihimoyan. “We believe this resulted in an increase in Clostridium difficile infections in our patient population. Antibiotic usage”Ârelated quality measures may have resulted in unintended complications and should be re”Âevaluated.”

How Can We Combat C. difficile?

Another study unveiled during the October 18 press briefing addressed the ways hospitals, gastroenterologists and other health care practitioners could combat C. difficile entitled, “Aggressive Attack on C. difficile Results in Significant Decrease in Hospital Infection Rate: the INTEGRIS Baptist Medical Center Experience.”

Waging “an all out war on C. difficile,” researchers implemented a number of measures over a three”Âmonth period at INTEGRIS Baptist Medical Center, a tertiary care facility in Oklahoma City which admits approximately 26,000 patients per year and experienced an increase in C. difficile cases.

“Aimed at reducing the incidences of C. difficile infections, these measures consisted of a multi”Âfaceted attack on C. difficile, including improved prevention, early detection, review and full implementation of national infection control guidelines, and aggressive treatment measures,” explained Mark H. Mellow, M.D., FACG, Center for Digestive Health, Oklahoma City, OK. “In addition to standard isolation procedures, we also elicited suggestions from physicians and nurses to best ensure compliance, such as placing a trashcan near the door to avoid traversing the room after de”Âgowning; keeping an uncluttered sink area; using appropriate size gloves; and making stethoscopes easily accessible,” said Dr. Mellow.

Dr. Mellow and his team also initiated a campaign to limit proton pump inhibitor use outside of critical care units and encouraged nursing staff to send stool for C. difficile toxin (CDT) testing if C. difficile was suspected, without waiting for physician order.

“In the 12 months prior to our interventions, the incidence of CDT positive hospitalized patients was 11.3 per 100 admissions,” said Dr. Mellow. “After a 3″Âmonth implementation period, the ensuing 12″Âmonth positive CDT incidence fell to 6.9 per 1000 patients, a decrease in C. difficile infection incidence of 40 percent. As a result, a ‘war on C. difficile’ can have a significant positive impact on a hospital’s rate of infection,” said Dr. Mellow.

Cutting Edge Treatments Help Patients with C. difficile

Up to 25 percent of patients will have a recurrence of C. difficile infection, and a proportion will be refractory to antibiotics. Additional therapies for this difficult”Âto”Âtreat subpopulation include antibiotics, probiotics, toxin”Âbinding medications, active vaccination, intravenous immunoglobon, and fecal bacteriotherapy (FB).

“Fecal bacteriotherapy, more commonly known as fecal transplant, has been slowly gaining ground as a rescue for recurrent and refractory cases of C. difficile associated diarrhea,” said C. Brock Miller, M.D., University of North Carolina at Chapel. Dr. Miller and his research team today reported findings from their initial experience using FB via colonoscopy, “Fecal Bacteriotherapy via Colonscopy for Refractory and Recurrent Clostridium difficile Associated Diarrhea,” which showcased two patients.

The first patient, a healthy 34″Âyear old woman who developed CDAD after eight courses of antibiotics over six months, and had ongoing recurrences of CDAD, had an immediate improvement in symptoms and has been infection”Âfree for nine months after fresh stool donated from her healthy 40″Âyear old sister was liquefied and delivered throughout the terminal ileum and entire colon via colonoscopy.

A second patient, a healthy 50″Âyear old female, who also developed recurrent C. difficile toxin positive diarrhea, elected to undergo FB via colonoscopy after testing and donation by her husband. She has been cured of C. difficile associated diarrhea to date, according to Dr. Miller.

“While further clinical studies and long”Âterm follow”Âup of patients are required, fecal bacteriotherapy appears to be a viable, safe, and inexpensive option for cases of recurrent and refractory disease,” said Dr. Miller.

The goal of another study unveiled today was to explore novel and inexpensive antimicrobial agents commonly found in nature in an effort to combat C. difficile in hospitals.

“For more than 2000 years in the Indian subcontinent, indigenous people have been using turmeric in their daily food,” explained Rattan Patel, M.D. “Traditional Indian medicine, Ayurveda, has been using this spice to help decrease the rate of gastrointestinal infection.”

In the study, “Inhibiting Hospital Associated Infection of Toxigenic Clostridium difficile Using Natural Spice ““ Turmeric (Curcumin),” Dr. Patel and his research team found that all strains of of C. difficile were inhibited by turmeric extract (curcumin).

“Turmeric has been shown to be relatively safe in clinical studies, with more than 40 clinical trials already performed in the United States using curcumin as an intervention as per the Clinical Trail database,” said Dr. Patel. “It’s likely that daily use of turmeric in hospital settings, in food products like curry or soup, can potentially decrease the incidence of Clostridium difficile associated diarrhea. But more studies are needed to determine the mechanism of action of turmeric and the physiological effects of turmeric in animal models of pseudomembranous colitis,” said Dr. Patel.

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On the Net:

• American College of Gastroenterology