Advanced MRI Locates Unique Blast-Related Brain Damage In Troops

Using a advanced form of MRI, researchers found unique structural abnormalities in the brains of US troops with mild blast-related traumatic brain injuries that have not been seen with other types of scanning technology. In a study published this week
in the New England Journal of Medicine, they emphasize, however, that their findings are tentative, the significance of
the abnormalities is not yet fully understood, and more work needs to be done to establish whether the abnormalities represent
significant brain damage.

The team includes researchers from the Washington University School of Medicine in St. Louis in the US and the Landstuhl
Regional Medical Center in Landstuhl, Germany.

They examined US soldiers who had been wounded in the wars in Iraq and Afghanistan and evacuated to Landstuhl. Many such
evacuees have a disproportionate number of injuries, including brain trauma, from blasts caused by improvised explosive devices
(IEDs).

Estimates suggest as many as 320,000 soldiers have suffered traumatic brain injury in the wars in Iraq and Afghanistan, mostly
classifed as mild traumatic brain injury, or concussion.

But, as senior study author Dr David L Brody, assistant professor of neurology at Washington University School of Medicine,
told the press:

“We call these injuries ‘mild’, but in reality they sometimes can have serious consequences.”

For the study, Brody and colleagues took advanced MRI brain scans of 84 injured soldiers and found unique structural
abnormalities in 18 of 63 diagnosed with traumatic brain injury, but not in 21 who had suffered other types of injury.

The abnormalities they found were in the white matter of the brain: specifically damage to axons, the nerve fibres that enable
brain cells to communicate with each other.

The damaged fibers were found in two places: the orbitofrontal cortex, located at the front of the brain behind the eyes, and the
cerebellum, thats sits at the back, underpart of the brain. The first of these helps regulate emotion and reward-based behavior,
and the second is involved in controlling movement, coordination, and also organization and planning.

The MRI method they used is called DTI, short for “diffusion tensor imaging”, a method that tracks the movement of water in
tissue. Although DTI-detected change in the pattern of water movement is often injury-related, the researchers said it was not
possible to tell from their results how significant the abnormalities may be.

These particular abnormalities have not been found in DTI scans of civilians with mild traumatic brain injury, although the scans
in this study did show abnormalities in parts of the brain known to be affected in civilian trauma.

Lead author Dr Christine L Mac Donald, research instructor in neurology at Washington University, said:

“There is still a lot more work to be done before we fully understand whether these abnormalities truly represent significant
damage to the brain white matter.”

The nub of the problem will be assessing how this type of damage affects a range of functions important to the patient’s quality of
life, such as attention, memory, sleep, balance, coordination, and regulation of emotion. There are also questions about how it
might influence the link between mild traumatic brain injury and post-traumatic stress disorder (PTSD).

There is an urgent need in research to improve the diagnosis of traumatic brain injury and differentiate it from PTSD.

“Our ongoing studies will hopefully start to answer some of these questions,” said Mac Donald.

Mild traumatic brain injury is a controversial topic because it is not possible always to establish if the symptoms are caused by
changes in brain chemistry, structural damage, psychological factors, or a combination of some or all of these.

The results of this study suggest there may be fundamental differences between the brain injuries caused by bomb-blasts and the
types of brain injury normally sustained by civilians, such as in road traffic accidents, sports, falls and blows to the
head.

However, because all the soldiers who took part in this study also had other injuries sustained during the bomb-blast, such as
from hitting their head in a vehicle crash, falls, or being hit by a blunt object, it was not possible to separate out the direct effects
from the blasts.

This is relevant because, as Dr Allan Ropper, a neurologist at Brigham and Women’s Hospital, Boston, points out in an
accompanying editorial, there has been skepticism about whether a bomb that goes off at a distance and causes no visible wound
can penetrate the skull and damage the brain.

Part of the problem is the complexity of the physics and thereby determining what exactly causes injury. First, there is an initial
shock wave, then a supersonic wind, and a reverse underpressure, the scale of these depending on the inverse square of the
distance. Injury occurs at various points in the unfolding timescale of these events, not necessarily at a single point, as Ropper
explains:

“Tissues are damaged when the shock energy is dissipated at the interface between air and liquid that presents a change in
acoustic impedance. The blast wind is the source of separate injury, throwing people against fixed objects and dispersing
projectiles that penetrate the body.”

The researchers said they could detect the white matter abnormalities up to a year after injury, although the DTI scans showed
they changed with time.

Ropper suggests there are two key findings in the research. The first is the clear difference in results between DTI scans as
opposed to conventional MRI: many regions of axonal disruption show up with DTI that MRI can’t spot. The second is when
the researchers did further DTI scans at follow-up 6 and 12 months later, they could see the abnormalities had evolved in a way
that suggests the injuries did in fact occur at the time of the blast and were not the result of head injuries from another
event.

“We now have tentative validation in mild traumatic brain injury of the disruption of cerebral axons by blasts from improvised
explosive devices. Even if this information is exploratory, with further information on the relationship among blasts, axonal
damage, and PTSD anticipated in the future, soldiers injured in this way and their resultant disability deserve the utmost
attention,” writes Ropper.

In the meantime, Brody points out that the diagnosis of mild traumatic brain injury is still based on the history of an injury to the
head that results in loss of consciousness, loss of memory, confusion, or other signs of brain disruption.

“A negative MRI scan, even with these advanced methods, does not rule out mild traumatic brain injury,” he emphasizes, adding
that:

“These MRI-based methods show great promise, but are not yet ready to be used in routine clinical practice.”

However, he and his colleagues are optimistic that the study will increase understanding of brain injury not only in soldiers but
also in civilians, including children.

“Detection of Blast
-Related Traumatic Brain Injury in U.S. Military Personnel.”, Christine L. Mac Donald et al., N Engl J
Med 2011; 364:2091-2100, published online 2 June 2011.

Additional source: Washington University School of Medicine.

: Catharine Paddock, PhD

Australia Should Be Looking At Prevention Approaches Rather Than Treatment When It Comes To Obesity

A CQUniversity Professor of Physical Activity and Population Health says Australia should be looking at prevention approaches rather than treatment when it comes to obesity.

Professor Kerry Mummery acknowledges the burden that obesity is currently placing on individuals and on the health care system, but calls for more support in prevention, rather than treatment programs.

The Inquiry into Obesity in Australia – is investigating the long-term implications of obesity on the health system. aph.au/house/committee/haa/obesity/index.htm

At the Brisbane public hearing yesterday (October 1) Doctor Linda Selvey from Queensland Health told the inquiry that Medicare rebates should be made available for accredited weight control programs.

“By recognising obesity as a chronic condition in its own right, rather than just a risk factor for chronic conditions, then that potentially opens up a number of existing Medicare items for people with chronic diseases,” she said. (Source: ABC)

Professor Mummery said: “Obesity is a tremendous problem in all age groups and both genders. [See Central Queensland statistics below] Medicare rebates for accredited weight control programs are only a small step in the fight against obesity”.

“More resources are required across a range of health, education and recreation groups to strengthen the preventive, rather than the treatment approach to this problem”.

Central Queensland statistics

Overall

23.7% obese
61.9% overweight or obese

Gender

Males = 24.9% obese
Females = 22.4% obese

Age

18-34 = 21.7% obese
35-44 = 22.6% obese
45-54 = 22.9% obese
55+ = 22.9% obese
(Source: 2007 Central Queensland Social Survey, Population Research Laboratory, CQUniversity)

Costs of obesity

Estimated at $3.767 billion in Australia in 2005
(Source: 2006, The economic costs of obesity, Access Economics Pty Limited)

Central Queensland Social Survey

CorMatrix Receives FDA IDE Approval To Begin Prospective, Randomized Evaluation Of New Onset Postoperative Atrial Fibrillation

CorMatrix Cardiovascular, Inc., a medical device company developing and delivering unique extracellular matrix (ECM) biomaterial devices that harness the body’s innate ability to repair damaged cardiovascular tissue, announced that FDA has granted conditional approval for the start of a multi-center, prospective, randomized clinical trial to demonstrate the safety and efficacy of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation. Patients enrolled in the trial will undergo circumferential reconstruction of the normal pericardial anatomy following isolated, first-time, coronary artery bypass grafting (CABG) procedures and will be compared to subjects who do not undergo pericardial closure.

The clinical trial, anticipated to enroll more than 400 patients at up to 15 cardiac surgery sites in the United States, is being initiated by CorMatrix following analysis of data from a retrospective study that demonstrated a statistically significant reduction in the rate of new onset postoperative atrial fibrillation in CABG patients following pericardial closure with the CorMatrix ECM. Data from this retrospective study have been accepted and will soon be published in a peer-reviewed journal.

“We’ve heard anecdotally for some time that the use of CorMatrix ECM technology to reconstruct the native pericardial anatomy seems to reduce the risk for new onset postoperative atrial fibrillation,” said Robert G. Matheny, M.D., Chief Scientific Officer, CorMatrix Cardiovascular. “Following a review of the retrospective data and the growing data on the incidence and significance of postoperative atrial fibrillation, we believe this is an important study to undertake.”

Following cardiac surgery, new onset postoperative atrial fibrillation is the most common arrhythmic complication, with reported incidence between 32% and 64%, and poses a serious concern for patients undergoing cardiac surgery procedures [Creswell 1993; Auer 2005; Echahidi 2008]. A recent retrospective analysis of more than 16,000 patients with no history of atrial fibrillation who underwent CABG surgery found an association between new onset postoperative atrial fibrillation and a 21% relative increase in mortality, with the greatest negative impact seen in the long-term survival of women. [El-Chami 2010].

“Postoperative atrial fibrillation is a significant concern for patient outcomes,” added James L. Cox, MD, Emeritus Evarts A. Graham Professor of Surgery, Washington University School of Medicine, Barnes-Jewish Hospital, St. Louis, MO, President and CEO, World Heart Foundation, and CorMatrix Scientific Advisory Board member. “Despite efforts over the last 30 years to reduce postoperative arrhythmias, we continue to see a high incidence level and increased risk of death for patients. Ongoing study of new approaches is both warranted and encouraging as surgeons strive to further advance our care of patients undergoing bypass surgery.”

CorMatrix ECM for Pericardial Closure received 510(k) clearance from the FDA in 2006 for the reconstruction and repair of the pericardium. CorMatrix ECM supports tissue remodeling by allowing native cells to migrate and attach within the ECM. The body’s natural healing processes result in the ECM material being gradually resorbed and replaced by native tissue. Preclinical data suggests that reformation of the pericardial space provides a solution for surgeons to reconstruct the pericardium and restore the normal anatomic structure. The prospective clinical trial is being initiated under an IDE to investigate the safety and effectiveness of implanting CorMatrix ECM for Pericardial Closure for a new clinical indication to reduce the incidence of new onset postoperative atrial fibrillation.

About Extracellular Matrix Biomaterial

The unique properties of extracellular matrix biomaterials were discovered at Purdue University. The decellularized matrix material serves as a scaffold to allow adjacent tissues to deliver cells and nutrients to the matrix, which then differentiate into tissue-specific cells. The ECM material is gradually replaced, as the patient’s own body reinforces and rebuilds the weakened site. During the repair, the matrix is naturally degraded and resorbed, leaving remodeled functional tissue where scar tissue or injured tissue would normally be expected.

The use of extracellular matrix materials in non-cardiovascular applications has established a significant foothold in soft tissue repair, wound management and orthopedic applications. The safety of extracellular matrices has been well established in a number of different clinical applications. The extracellular matrix has been studied extensively, with more than 500 published papers. Since 1999, an estimated 500,000 patients worldwide have received an extracellular matrix implant.

REFERENCES

Auer J, Weber T, Berent R, Ng CK, Lamm G, Eber B. 2005. Risk factors of postoperative atrial fibrillation after cardiac surgery. J Card Surg 20:425-31.

Creswell LL, Schuessler RB, Rosenbloom M, Cox JL. 1993. Hazards of postoperative atrial arrhythmias. Ann Thorac Surg 56:539-49.

Echahidi N, Pibarot P, O’Hara G, Mathieu P. 2008. Mechanisms, prevention, and treatment of atrial fibrillation after cardiac surgery. J Am Coll Cardiol 51:793-801.

El-Chami MF, Kilgo P, Thourani V, et al. 2010. New-Onset Atrial Fibrillation Predicts Long-Term Mortality After Coronary Artery Bypass Graft. J Am Coll Cardiol 55: 1370 – 6.

Source: CorMatrix Cardiovascular, Inc

CardioTech Receives FDA Approval For Export Of Second Graft Size For CardioPass Clinical Trial

CardioTech International, Inc. (AMEX: CTE), a leading developer and manufacturer of advanced biomaterials for a broad range of medical devices, announced that it has received the necessary U.S. Food and Drug Administration (“FDA”) approval to export its 4mm graft in further support of the ongoing European clinical trial of CardioPass™ , the Company’s proprietary synthetic coronary bypass graft.

Commenting on today’s announcement, Michael Adams, CEO and President, said, “We are pleased with the FDA’s timely review and approval of our request to export the 4mm graft for use in our CardioPass™ European clinical trial. This important milestone provides a second graft size available for use in the trial and expands the potential patient population available for treatment. In concert with our team of clinical and regulatory professionals in Europe, we believe we are now poised to move towards the completion of our clinical trial.”

Approval by the Notified Body for a CE Mark would allow CardioPass™ to be marketed and sold in all European Union countries as well as other countries worldwide that accept this approval for registration within those countries.

CardioPass™ Synthetic Graft for Coronary Artery Bypass

CardioPass™ is designed to be an effective alternative for patients who have undergone repeat procedures or have insufficient native vessels for bypass. Repeat surgeries account for up to 20 percent of all bypass procedures. CardioPass™ is made from ChronoFlex®, the Company’s proprietary biodurable medical-grade polymer and engineered to be pulsatile, biostable, torque-resistant and suturable. Once it is implanted, the graft’s polymer construction allows it to incorporate the patient’s own cells and tissue, so that the inner surface mimics the normal environment for blood contact. ChronoFlex® has also been specially formulated to be flexible, enabling CardioPass™ to pulse like a human vein would as it carries blood to the heart.

About CardioTech International

Through its newly formed AdvanSource Biomaterials Corporation subsidiary, CardioTech develops advanced polymer materials which provide critical characteristics in the design and development of medical devices. The Company’s biomaterials are used in devices that are designed for treating a broad range of anatomical sites and disease states. The Company’s business model leverages its proprietary materials science technology and manufacturing expertise in order to expand its product sales and royalty and license fee income. CardioTech is conducting a clinical trial for regulatory approval in Europe for its CardioPass™ synthetic coronary bypass graft. More information about CardioTech is available at its new website: advbiomaterials

Forward-Looking Statements

CardioTech believes that this press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties. Such statements are based on management’s current expectations and are subject to risks and uncertainties that could cause results to differ materially from the forward-looking statements. For further information on such risks and uncertainties, you are encouraged to review CardioTech’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended March 31, 2008. CardioTech assumes no obligation to update any forward-looking statements as a result of new information or future events or developments, except as required by law.

CardioTech International

Age-Related Memory Loss Tied To Slip In Filtering Information Quickly

Scientists have identified a way in which the brain’s ability to process information diminishes with age, and shown that this break down contributes to the decreased ability to form memories that is associated with normal aging.

The finding, reported in the current online early edition of Proceedings of the National Academy of Sciences, fuels the researchers’ efforts, they say, to explore strategies for enhancing brain function in the healthy aging population, through mental training exercises and pharmaceutical treatments.

The research, conducted by University of California, San Francisco and University of California, Berkeley scientists, builds on the team’s seminal 2005 discovery (“Nature Neuroscience,” October 2005) that the brain’s capacity to ignore irrelevant information diminishes with age.

The capacity to ignore irrelevant information – such as most of the faces in a crowded room when one is looking for a long-lost friend – and to enhance pertinent information – such as the face of a new acquaintance met during the search for the old friend – is key to memory formation. This process is known as top-down modulation.

In the 2005 study, the team recorded brain activity in younger and older adults given a visual memory test in which they were shown sequences of images (sets of two faces and two scenes), told to remember a specific category, and then asked to identify an image from that category nine seconds later. The scientists, using functional magnetic resonance imaging (fMRI), determined that the neurons of the older participants (ages 60 to 72) responded excessively to the images they should have ignored, compared to the younger adults (ages 19 to 33). This attention to the distracting information directly correlated with how well the participants did on the memory test.

In the current study, the team used electroencephalography (EEG), which measures the speed of neural processing, to examine the relationship between this inhibitory deficit hypothesis of normal aging and another leading hypothesis – that the brain’s ability to process information quickly, diminishes. According to this theory, if information is not moving quickly onto the brain’s conveyor belt, of sorts, there will be a backup of data, and this, in turn, will delay later information processing that will disrupt memory formation.

The new study, involving the same visual memory test used in the previous research, revealed that both brain processes – the capacity to ignore irrelevant information and the ability to process information quickly – diminished with age and, in fact, worked in tandem. The participants had trouble suppressing unnecessary information, but only because the speed with which they processed the irrelevant data decreased. Significantly, the slow down in processing time happened only in the very early stages of visual processing – within 200 milliseconds.

“The study showed that the brains of older adults have a deficit in suppressing irrelevant information during visual working memory encoding, but only in the first tenth to two tenths of a second of visual processing,” says the lead author of the study, Adam Gazzaley, MD, PhD, assistant professor of neurology, a member of the UCSF Memory and Aging Center and director of the UCSF Neuroscience Imaging Center.

Moreover, despite the aging brain’s ability to suppress extraneous information in the ensuing milliseconds, the memory deficit persists, implying, he says, that interference by irrelevant information apparently overwhelms a limited working memory capacity, which is the ability to hold information in mind for brief periods of time to guide your actions.

As to what causes the break down in inhibition and processing speed, scientists do not know. They do know that, in the course of aging, there are changes in the structure of neurons, the density of neural tissue and the actions of neurochemicals acting on the cells. They also know that there are changes in the neural connections between neurons in far flung parts of the brain.

In the healthy aging brain, these changes are subtle. In the brains of those with mild cognitive impairment and the more severe form of impairment, such as Alzheimer’s disease, they are substantial.

The team is now trying to relate how these changes might affect changes in inhibition and processing speed.

They also are investigating strategies for remediating these changes, both mental training exercises that would improve the speed and efficiency of information processing and drugs that would inhibit the brain’s attention to extraneous information.

“People’s expectations for their later years have changed,” says Gazzaley. “They want to remain actively engaged – to continue to work, to learn new languages, to move to countries where they can practice their new language.

“The ability to selectively focus our attention, suppress distracting input and hold relevant information in our mind defines our conscious experience and serves as a critical crossroad between attention and memory. The people in our study are functioning well; many are still working, but they want to function at the level they did previously.”

Notes:

The senior author of the study is Mark D’Esposito, MD, professor of neuroscience and psychology and director of the Henry H. Wheeler Jr. Brain Imaging Center, UC Berkeley. Other co-authors of the study are Wesley Clapp, Jon Kelley and Kevin McEvoy of the UCSF departments of neurology and physiology, and Robert T. Knight of UC Berkeley.

The study was funded by the National Institute of Health and the American Federation for Aging Research.

UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.

Related links:

Gazzaley lab
gazzaleylab.ucsf.edu/research.html

D’Esposito lab
bic.berkeley.edu/despolab/

UCSF Memory and Aging Center
memory.ucsf.edu/

UCSF
ucsf.edu

UCB
berkeley.edu/

Source:
Jennifer O’Brien
University of California – San Francisco

Ablatherm-HIFU Launches RPP Service At First Scandinavian Site

EDAP TMS S.A. (Nasdaq:
EDAP) the global leader in High Intensity Focused Ultrasound treatment of
prostate cancer announces the launch of Ablatherm-HIFU services at Aker
Hospital in Oslo, Norway, the first HIFU treatment center in Scandinavia.
Aker represents the largest Urology Department in Norway and is a leading
center in Scandinavia. Aker will use the Ablatherm-HIFU device under EDAP’s
innovative fixed installation Revenue-Per-Procedure (RPP) model. This model
allows the hospital to offer the Ablatherm device without up-front capital
expense by committing to minimum use levels. The Ablatherm-HIFU unit will
be broadly available to patients from all Scandinavian countries.

Ablatherm-HIFU will initially address radiation failure patients
through a unique partnership between the Urology and Radiotherapy
departments within the hospital. The device is also proven highly effective
in treating first indication cases of localized prostate cancer. In both
cases, the Ablatherm- HIFU can offer an effective curative treatment with
outcomes rivaling more traditional therapies but with lower potential side
effects. This unique blend of high efficacy with lower side effects offers
patients an opportunity to preserve their quality of life post therapy
without creating a therapeutic impasse in the event of a cancer recurrence.

Aker University Hospital (Oslo, Norway) was founded in 1895 and is one
of Oslo’s four sector hospitals. Since January 2002 the hospital is
organized as a for profit health center fully owned by Helse Ost RHF. The
hospital is associated with the University of Oslo Medical School, largest,
most prestigious and oldest university in Norway. Aker is also a primary
site for academic medical research in Norway. Oslo Urological University
Clinic (OUU) at Aker University Hospital is the largest urological clinic
in Norway. It serves a local population of 580,000 people and is the
urological regional center in Helse Ost RHF with a population of 1.7
million people. OUU covers all aspects of urological problems and disease,
and is especially focused on laparoscopic and other minimally invasive
techniques.

“We are very interested in the Ablatherm-HIFU device because it can
effectively offer a curative care option to patients suffering from a
cancer recurrence after radiation treatment in addition to effective
treatment for newly diagnosed patients,” said Dr Steinar Karlsen, chairman
and professor at OUU Aker University Hospital. “Ablatherm-HIFU is the most
clinically proven HIFU device for prostate cancer and clearly demonstrated
in the clinical literature to offer significant potential benefits to many
patients. The Ablatherm-HIFU device is also unique in that it offers a
specialized protocol specific to the unique treatment parameters necessary
to effectively treat post-radiation recurrence cases. These patients often
have few choices for curative care. The Ablatherm will be very attractive
to these patients who are increasingly considering their quality of life as
part of their treatment decision.”

“We are excited to launch the first HIFU site in Scandinavia serving
patients suffering from prostate cancer, and to do so at a major center
serving the entire Scandinavian population so even more patients will have
the opportunity to benefit from Ablatherm-HIFU therapy as a consideration
in treating their cancer,” said Hugues de Bantel, CEO of EDAP. “As always,
the center made a thorough review of the clinical data, literature and user
experience associated with HIFU and came to the conclusion that
Ablatherm-HIFU is the most proven and most beneficial choice available
today. The dedicated and thoroughly researched parameters for radiation
failure cases clearly address a growing need for a means to help these
patients, and Ablatherm-HIFU is the only HIFU device that has these
dedicated features offering a safe, effective, well documented and quality
of life preserving treatment choice to patients who currently face very
difficult choices. Our focus continues to be the clear, accurate and
appropriate education of both the medical and patient communities to help
secure the best standards of care for every patient case, and
Ablatherm-HIFU clearly has a significant role in offering a potentially
better option to many patients, both newly diagnosed and those suffering
from the return of cancer after prior radiation treatment.

About EDAP TMS S.A.

EDAP TMS S.A. develops and markets Ablatherm, the most advanced and
clinically proven choice for High Intensity Focused Ultrasound (HIFU)
treatment of localized prostate cancer. HIFU treatment is shown to be a
minimally invasive and effective treatment option with a low occurrence of
side effects. Ablatherm-HIFU is generally recommended for patients with
localized prostate cancer (stages T1-T2) who are not candidates for surgery
or who prefer an alternative option or patients who failed radiotherapy
treatment. The company is also developing this technology for the treatment
of certain other types of tumors. EDAP TMS S.A. also produces and
commercializes medical equipment for treatment of urinary tract stones
using Extra-corporeal Shockwave Lithotripsy (ESWL).

This press release contains, in addition to historical information,
forward-looking statements that involve risks and uncertainties. These
include statements regarding the Company’s growth and expansion plans. Such
statements are based on management’s current expectations and are subject
to a number of uncertainties and risks that could cause actual results to
differ materially from those described in the forward-looking statements.
Factors that may cause such a difference include, but are not limited to,
those described in the Company’s filings with the Securities and Exchange
Commission. Ablatherm-HIFU treatment is in clinical trials but not yet FDA
approved or marketed in the United States.

EDAP TMS S.A.
edap-tms

Computerized Systems Reduce Psychiatric Drug Errors

Coupling an electronic prescription drug ordering system with a computerized method for reporting adverse events can dramatically reduce the number of medication errors in a hospital’s psychiatric unit, suggests new Johns Hopkins research.

“Medication errors are a leading cause of adverse events in hospitals,” says study leader Geetha Jayaram, M.D., M.B.A., an associate professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine. “With the use of electronic ordering, training of personnel and standardized information technology systems, it is possible to eliminate dangerous medication errors.”

The findings, published in the March issue of The Journal of Psychiatric Practice, outline how the 88-bed psychiatric unit at The Johns Hopkins Hospital in Baltimore went from a medication error rate of 27.89 per 1,000 patient days in 2003 to 3.43 per 1,000 patient days in 2007, a highly significant rate reduction.

Jayaram noted that during the study period, there were no medication errors that caused death or serious, permanent harm. Medication errors, which can be lethal, are known to be caused by illegible handwriting, misinterpretation of orders, fatigue on the part of medical personnel, pharmacy dispensing errors and administration mistakes. A pharmacy may misread what a physician has written or give the wrong medication or the wrong drug dose to a patient.

“Having something typed eliminates bad writing – and most errors – immediately,” she says. “It’s a good reason for going electronic.”

The computer program used in the psychiatric department, and hospital-wide at Johns Hopkins, also includes integrated decision support for drug dosage selection, drug allergy alerts, drug interactions, patient identifiers and monitoring – things that can be lost with a manual system that relies on layers of human beings to ensure the correct decisions are made, Jayaram says. The more the number of steps involved in the process, the greater the likelihood of mistakes.

At the same time that the drug ordering system was put in place, Hopkins instituted the use of the Patient Safety Net error reporting system. The hospital-wide Patient Safety Net (PSN) is an online, Web-based reporting tool that is accessible to all caregivers, regardless of discipline. Whenever a mistake is made, big or small, it is to be reported on the PSN. This system allows for follow up, corrective action and the ability to learn from common mistakes. It also categorizes unsafe conditions and near-miss events, and this can aid in future improvements. Near misses are more likely to be readily reported by frontline staff.

Another key to the success of both of these programs, Jayaram says, is the creation of a “culture of safety” throughout the psychiatry department. This is done through annual safety training, reporting of all adverse events as they occur and feedback that focuses not by blaming or shaming, but on how to prevent an error from happening again through education and corrective action.

One advantage in a psychiatric department, she says, is that medication mistakes involving psychotropic drugs are rarely deadly. But psychiatric patients also take other kinds of medication – insulin, blood thinners and others that can be lethal if given in the wrong doses or in the wrong combination. In a psychiatric department, some nonpsychotropic medications are considered high-risk and, as a precaution, two nurses must check them off before they are administered, Jayaram says.

Jayaram says that even with computerized backstops, complacency is the enemy of safe care. Errors can still slip through in ways no one has thought of yet, she says, so the system is constantly evolving.

“You have to be vigilant for new problems that might come up,” she says.

Along with Jayaram, other Hopkins researchers involved in the study include Donald Steinwachs, Ph.D., and Jack Samuels, Ph.D.

Source:
Johns Hopkins Medicine

Computerized Testing System Helps Determine Whether Athletes With Concussions Can Get Back In The Game

How soon can I get back in the game? Despite a severe blow to the head, that is a frequent question by athletes who have suffered a concussion. Returning to play too soon can have catastrophic consequences. Suffering a second blow to the head while recovering from an initial concussion can cause permanent brain damage or death.

Dr. Shaun O’Leary, a neurosurgeon at Rush University Medical Center, is now using ImPACT, a new neurocognitive screening tool to help determine a concussion’s severity as well as if and when it is safe for the athlete to return to contact sports.

With ImPACT, physicians and team athletic trainers collect and store pre-season baseline data on the athletes’ neurocognitive functional state by having them take a 20-minute computerized test that measures brain processing, speed, memory and visual motor skills.

If an athlete experiences a concussion during the season, he or she is re-tested and the post-concussion data are compared to the baseline data. This information helps physicians and athletic trainers determine the player’s post-concussion neurocognitive status and when it is safe for the player to return to active sports.

“Prior to ImPACT, physicians and medical trainers had some rough guidelines, but no good objective devices to figure out when an athlete could return to play,” said O’Leary. “It is especially difficult to determine the impact of a mild concussion. Symptoms could be quite subtle and may go unnoticed by the athlete, team medical staff, or coaches.”

O’Leary plans to partner with local sporting programs and schools to screen athletes at baseline. However, the system also includes historical norms for each age group so it can be used even if the athlete did not perform a baseline test.

“All concussions are serious, but often players wrongfully think it shows strength and courage to play injured,” said O’Leary. “Players may say they are just fine. With ImPACT, we can objectively measure cognitive function to ensure we are allowing enough time for healing and recovery.”

A repeat concussion that occurs before the brain recovers from the first can slow recovery or increase the likelihood of having long-term problems. In rare cases, repeat concussions can result in brain swelling, permanent brain damage, and even death. This more serious condition is called second impact syndrome.

According to the Centers for Disease Control as many as 3.8 million sports and recreation-related concussions occur in the United States each year. A concussion occurs when the brain is violently rocked back and forth inside the skull due to a blow to the head or neck.

A concussion can occur without loss of consciousness. Other signs and symptoms include headache; nausea or vomiting; balance problems; double or blurry vision; sensitivity to light or noise; feeling sluggish, hazy, foggy or groggy; concentration or memory problems; and behavior or personality changes.

Some athletes many not experience or report symptoms until hours or days after an injury. Coaches who have a suspicion that an athlete has a concussion should keep the athlete out of the game or practice until they are evaluated and given permission to return to play by a health care professional with experience in evaluating for concussion.

Dr. Shaun O’Leary is the first credentialed ImPACT consultant in Chicago. Credentialed consultants have appropriate education, training, and experience with the ImPACT program.

rush.edu

Chocolates Eaten More Often When They Are Clearly Visible – Out Of Sight Out Of Mouth

When it comes to candy, it is out of sight, out of the mouth, a Cornell University researcher finds.

The study finds that women eat more than twice as many Hershey Kisses when they are in clear containers on their desks than when they are in opaque containers on their desks — but fewer when they are six feet away.

“Interestingly, however, we found that participants consistently underestimated their intake of the candies on their desks yet overestimated how much they ate when the candies were farther away,” said Brian Wansink, the John S. Dyson Professor of Marketing and of Applied Economics at Cornell.

The study — one of the few experiments to quantify the “temptation factor” — was presented at the Obesity Society meeting of the North American Association for the Study of Obesity in September in Vancouver, Canada. It is published online and will be published in an upcoming February issue of the International Journal of Obesity.

Wansink and his co-authors, James E. Painter and Yeon-Kyung Lee, assistant professor and visiting scholar, respectively, in food science at the University of Illinois-Champaign, gave 40 university female staff and faculty members 30 chocolate Kisses in either clear or opaque candy jars on their desks or six feet away. Each night, the researchers counted how many candies were eaten and refilled the jars.

“Not surprisingly, the participants ate fewer candies when the Kisses were in opaque rather than clear candy jars on their desks and even fewer when the opaque jars were six feet away from their desks,” Wansink said. “The less visible and less convenient the candy, the less people thought about it and were tempted.”

Specifically, participants ate an average of 7.7 Kisses each day when the chocolates were in clear containers on their desks; 4.6 when in opaque containers on the desk; 5.6 when in clear jars six feet away; and 3.1 when in opaque jars six feet away.

What was surprising, however, was that the women consistently thought they ate more when they had to get up to get them. This suggests, Wansink said, that you are likely to eat fewer cookies in the cupboard versus those on the counter for two reasons. They take more effort to get, and you tend to think you ate more than you did.

“You eat more chocolate if it’s visibly nearby, but the silver lining is this might also work for fruits and vegetables — in other words, what makes the close candy dish nutritionally dangerous might just bring the fruit bowl back in vogue,” he concluded.

Wansink, the author of the new book “Marketing Nutrition: Soy, Functional Foods, Biotechnology and Obesity,” is also director of the Cornell Food and Brand Lab, made up of a group of interdisciplinary researchers who have conducted more than 200 studies on the psychology behind what people eat and how often they eat it.

by Susan S. Lang (Cornell Press Office)

Brian Wansink
WansinkCornell.edu
Cornell Food & Brand Lab
Cornell.edu

Caffeine Appears To Be Beneficial In Males But Not Females With Lou Gehrig’s Disease

Amyotrophic lateral sclerosis (ALS) is a fatal disease that damages key neurons in the brain and spinal cord. The disease causes progressive paralysis of voluntary muscles and often death within five years of symptoms. Although ALS (Lou Gehrig’s disease) was discovered over a century ago, neither the cause nor a cure have been found, but several mechanisms seem to play a role in its development, including oxidative stress.

Coffee, Caffeine and ALS

Researchers agree that ALS is a multifactorial disease that involves a complex interplay between a genetic predisposition and environmental factors. One environmental factor is diet. With oxidative stress (which damages the cells) a common concern in ALS pathology, it is worth examining what role antioxidants (which confer benefits to the cells) might play.

Antioxidants (the vitamins and nutrients that protect the cells from damage) are found in commonly consumed beverages and foods. Coffee in particular has received attention as a potent dietary antioxidant. It is worth noting that coffee has significantly more antioxidant capacity than cocoa and green, black or herbal teas. However, coffee contains several components, the largest of which are caffeine and chlorogenic acid, a dietary polyphenol that is beneficial to the immune system.

Previous studies have shown positive effects with coffee, caffeine, or chlorogenic acid supplementation in improving oxidative stress and its associated cell death mechanisms.

A New Study

A new study investigates the role of dietary intervention focused on an antioxidant popular in diets worldwide–coffee. The researchers examined the effect of coffee, caffeine and chlorogenic acid supplementation on markers of oxidative stress, antioxidant enzyme protein content and cell death in male and female mice models of ALS.

The study, entitled Caffeine Reduces Motor Performance and Antioxidant Enzyme Capacity in the Brain of Female G93A Mice, An Animal Model of Amyotrophic Lateral Sclerosis (ALS) was conducted by Rajini Seevaratnam1 supervised by Mazen J. Hamadeh1,2 , and co-authored by Sandeep Raha2 and Mark A. Tarnopolsky2 (1School of Kinesiology and Health Science, York University, Toronto, ON, Canada; 2Department of Pediatrics and Medicine, McMaster University Hamilton, ON, Canada). The researchers will present their findings at the 122nd Annual Meeting of the American Physiological Society (APS; www.the-aps/press), which is part of the Experimental Biology 2009 scientific conference. The meeting will be held April 18-22, 2009 in New Orleans.

Study Design

Fifty-one G93A mice were randomly divided into eight groups: control (6 males, 8 females), coffee (5 males, 7 females), caffeine (5 males, 8 females), chlrogenic acid (5 males, 7 females). The control groups were fed a standard rodent diet and were not given any additional supplements. The intervention groups were provided with coffee, caffeine, and chlorogenic acid extracts, respectively, in amounts found in 5-10 cups of coffee per day, controlled for body weight.

Clinical measures: Food intake, body weight, body condition, ability to move, clinical score, and motor performance were all assessed for the effect of diet and time prior to animal sacrifice.

Molecular measures: Markers of oxidative stress (4-HNE; 3-NY), antioxidant enzyme protein content (MnSOD; CAT; GPx1; GR; GPx1 to GR ratio), and cell death (Bax; Bcl-2) were analyzed using the brains of these mice at age 108 days.

Statistical analysis was conducted for males and females separately.

At the end of the study, the researchers found that:

In males:

Coffee: increased food intake by 21%, decreased markers of oxidative stress by 39-65%, increased markers of antioxidant enzyme protein content by 46-139%, and decreased markers of cell death by 34-36%.

Caffeine: increased food intake by 22%, decreased markers of oxidative stress by 45-81%, increased markers of antioxidant enzyme protein content by 21-99%, and decreased markers of cell death by 17-22%.

Chlorogenic acid: increased food intake by 12%, decreased markers of oxidative stress by 25-35%, increased markers of antioxidant enzyme proteins by 23-44%, and decreased cell death by 41-44%.

In females:

Coffee: increased food intake by 30%, decreased markers of oxidative stress by 64%, but did not increase markers of antioxidant enzymes or decrease markers of cell death.

Caffeine: increased food intake by 28%, decreased motor performance by 20%, decreased markers of oxidative stress by 58%, decreased markers of antioxidant enzyme protein content by 11-48%, and increased cell death by 23-74%.

Chlorogenic acid: increased markers of oxidative stress by 178%, had equivocal effects on markers of antioxidant enzyme protein content, and decreased cell death 33-39%.

Conclusion

According to Ms. Seevaratnam, “If we were to extrapolate these results to human patients with ALS, then coffee appears to be beneficial for men, both reducing oxidative stress and cell death, and increasing antioxidants. But for women, caffeine appears to be harmful. Women with the disorder may want to restrict caffeine consumption, or switch to decaffeinated products which contain the antioxidants, but with little caffeine.”

Physiology is the study of how molecules, cells, tissues and organs function to create health or disease. The American Physiological Society has been an integral part of this discovery process since it was established in 1887.

Source: American Physiological Society (APS)