Medical Residents Treat Stroke Faster, Just As Safely
Diagnosing acute stroke is a high-pressure decision. The speed with which treatment is delivered makes all the difference. Early treatment can stop brain damage, but if treatment is given inappropriately, it can dangerously increase the risk of bleeding in the brain.
Because of this risk, the final decision to administer stroke treatment a clot-busting enzyme known as tissue plasminogen activator (tPA) is usually reserved for neurologists or, in some cases, other attending physicians. But now a study conducted by researchers at Washington University School of Medicine in St. Louis with neurology residents at Barnes-Jewish Hospital has shown that residents with appropriate training can safely make the call, ensuring that effective treatment is delivered faster.
“Door-to-needle” times, measured as the time between a patient’s arrival and the administration of tPA, were reduced by 26%, from an average of 81 minutes to 60 minutes.
“What’s critical here is ability to safely reduce ‘door-to-needle’ time without unnecessarily increasing the risk of a brain hemorrhage,” says Jin-Moo Lee, M.D., Ph.D., director of the cerebrovascular section in Neurology at Washington University and Barnes-Jewish Hospital. “What we’ve shown is that with proper training, feedback and supervision, residents are more than capable of making this complex decision safely.”
The study appears online in Stroke.
Although they have completed medical school and passed the license exams necessary to practice general medicine, residents are working in hospitals to undertake more advanced postgraduate training. A select group of critical life-and-death treatment decisions traditionally have been reserved only for physicians who have already completed their residencies.
Stroke treatment is one such decision. At academic and community medical centers, it is usually held for specialists in neurology, or, in some cases, emergency medicine. But while residents are almost always immediately available in the emergency room, neurologists may not be, and the time spent waiting for such a physician to be summoned can allow harm from the stroke to intensify and spread.
For the study, which began in 2004, neurology residents at Barnes-Jewish Hospital started taking an annual three- to four-hour mini-course on use of tPA. The course taught them how to appropriately choose candidates for tPA and how to administer it. After residents were given the authority to administer tPA, a committee of medical faculty and staff met monthly to review the case of every patient evaluated for stroke treatment, giving residents feedback on their decision-making.
Researchers assessed the results by comparing the outcomes and complications of stroke patients treated by residents from 2004 to 2007 against the same data for stroke patients treated by attendings and fellows from 1998 to 2002. There was no significant increase in negative outcomes, including bleeding in the brain, and door-to-needle times were notably shorter for patients treated by residents.
“It makes sense residents are always in house, and if they can make a direct decision on treatment without waiting for an attending or a fellow to respond to a pager, then the treatment time is going to be shorter,” says lead author Andria Ford, M.D., a Washington University neurologist at Barnes-Jewish Hospital.
Neurology residents at Barnes-Jewish Hospital continue to regularly train in tPA usage and to have the authority to administer tPA. Given an academic medical center where the resources exist to expand resident training and provide regular feedback, Lee thinks the model can be applied “across the board not just to neurologists in training but to emergency department physicians in training, for example.”
Lee characterizes the study as the culmination of two major branches of the work of senior author Abdullah Nassief, M.D., a stroke expert who died suddenly of coronary artery disease on Feb. 3.
“Dr. Nassief was both director of the neurology department’s residency program and of the Clinical Stroke Center and acute rehabilitation program at Barnes-Jewish Hospital, so he was very interested in the residents and in stroke treatment,” he says. “In this last paper, he let the resident physicians teach the attending physicians a lesson: that with the proper training, they can make these complex decisions as well as the attendings.”
Ford AL, Connor LT, Tan DK, Williams JA, Lee J-M, Nassief AM. Resident-based acute stroke protocol is expeditious and safe. Stroke, online publication.
This study was funded by the National Institute of Stroke and Neurological Disorders, the Lillian Strauss Fund for Neuroscience Research of the Barnes-Jewish Hospital Foundation and the James S. McDonnell Foundation.
Washington University School of Medicine’s 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked third in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.
Washington University in St. Louis
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Researchers Uncover ‘Obesity Gene’ Involved In Response To High-Fat Diet
Scientists have determined that a specific gene plays a role in the weight-gain response to a high-fat diet.
The finding in an animal study suggests that blocking this gene could one day be a therapeutic strategy to reduce diet-related obesity and associated disorders, such as diabetes and liver damage, in humans.
The researchers found that a diet rich in fat induced production of this gene, called protein kinase C beta (PKC beta), in the fat cells of mice. These mice rapidly gained weight while eating a high-fat diet for 12 weeks.
On the other hand, mice genetically engineered to lack PKC beta gained relatively little weight and showed minimal health effects after eating the same high-fat diet.
In comparing the effects of the high-fat diet and a regular diet, the scientists found that mice fed the high-fat diet produced more PKC beta in their fat tissue than did mice eating a regular diet.
“So we now know this gene is induced by a high-fat diet in fat cells, and a deficiency of this gene leads to resistance to fat-induced obesity and related insulin resistance and liver damage,” said Kamal Mehta, senior author of the study and a professor of molecular and cellular biochemistry in Ohio State University’s College of Medicine.
“It could be that the high-fat diet is a signal to the body to store more fat. And when that gene is not there, then the fat storage cannot occur.”
Though the complete mechanism remains unknown, the research to date suggests that rather than storing fat, mice lacking the gene burn fat more rapidly than they would if the PKC beta were present, Mehta said.
The research is available online in the journal Hepatology and is scheduled for later print publication.
Mehta and colleagues previously had created the hybrid mouse model by cross-breeding mice deficient in PKC beta with the C57 black mouse, a common animal used in research for studying diabetes and obesity. Despite the propensity for obesity from their original genes, the new mice lost weight while eating up to 30 percent more food than other mice.
In the earlier study, the mice ate a regular diet. In this new study, the researchers fed PKC beta-deficient and normal mice either a diet in which 60 percent of calories were derived from fat the high-fat diet or a standard diet in which 15 percent of calories came from fat. In the typical American diet, about 40 percent of calories are derived from fat.
The normal mice on the high-fat diet showed weight gain within three weeks, a trend that continued throughout the 12-week study. The PKC beta-deficient mice on the same diet gained less weight even while appearing to be extra hungry and eating more calories than the normal mice meaning their lower body weight was not the result of eating less.
Of animals eating the high-fat diet, the fat tissue and livers in the normal mice were larger than those in the PKC beta-deficient mice, as well. The livers of the normal mice were on average about 50 percent larger than the livers in mice lacking the gene. And the white fat tissue the tissue in which PKC beta was expressed as a result of the high-fat diet was almost three times as heavy in the normal mice as in the PKC beta-deficient mice.
The protein-deficient mice were able to clear insulin to regulate blood sugar more rapidly than normal mice after eating the high-fat diet, meaning avoiding obesity also allowed them to avoid development of insulin resistance associated with diabetes, said Mehta, also an investigator in Ohio State’s Davis Heart and Lung Research Institute.
“Obesity leads to liver damage and to diabetes. So if we can take care of obesity associated with a high-fat diet, we can also take care of most of the related disorders,” Mehta said.
A separate component of the current study further showed that mice engineered to be obese also had about 500 percent more of the gene in their fat cells than did normal mice. Mehta and colleagues have assembled a team that includes an endocrinologist, bariatric surgeon and molecular biologist to examine human fat tissue from obese and lean patients to see if levels of PKC beta are elevated in obese humans, as well.
“It is very likely that this gene may be involved in a predisposition to obesity,” he said.
Knowing the gene is responsive in the fat cells is important to figuring out how to suppress its action. Future research will involve deleting the gene from fat cells in mice to see if these new mice have the same lean body type as mice that are completely deficient of PKC beta throughout their entire genome.
“We are generating more mouse models to vary expression of this gene and study the consequences of that on obesity and related disorders,” Mehta said.
So far, mouse models lacking the protein have not shown any damaging side effects related to the suppression of the gene, Mehta said. He speculates that PKC beta could be a so-called “thrifty” gene left over from humans’ days as hunter-gatherers, when the body needed to retain fat for survival.
This work is supported by the National Institutes of Health.
Co-authors on the paper were Wei Huang and Rishipal Bansode of the Department of Molecular and Cellular Biochemistry, and Madhu Mehta of the Department of Internal Medicine, all at Ohio State.
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Update Presented On Disease In Pork Plant Workers
More than a year after developing a unique neurological disorder, the affected pork processing plant workers have improved, but all have some continuing symptoms and many have ongoing mild pain, according to a study released today that will be presented at the American Academy of Neurology’s 61st Annual Meeting in Seattle, April 25 to May 2, 2009.
The workers developed symptoms such as walking difficulties, weakness, numbness and tingling in the arms and legs, pain and fatigue. All had worked in or near the area where compressed air was used to extract pig brains. All plants have discontinued the practice.
For the study, researchers reexamined 24 of the workers affected at plants in Minnesota and Indiana. Of those, 17 were treated with immune therapy such as steroids. Sixteen people improved with treatment; 12 had marked improvement, two had moderate improvement and two had mild improvement. Six of the people who had no treatment also improved after they were no longer exposed to the pig brain mist.
Neurologists have identified the illness as a new disorder that is a sensory predominant polyradiculoneuropathy. The patients all have a unique antibody not seen before. The disease affects the nerves, and can usually be identified by standard tests (nerve conduction studies and EMG), although in four mild cases specialized tests were needed to detect the abnormalities. The disease seems to improve with treatment and removal of exposure to pig brain.
The disorder likely has an autoimmune basis, with workers exposed to the pig brains developing an autoimmune response that caused nerve damage. The researchers hope that further studies on this disease will aid understanding of other autoimmune disorders. “There are other autoimmune disorders where the trigger is not known, so this case with a known trigger could provide us with an opportunity to understand how an antigen can trigger the body’s immune system to produce disease,” said study author P. James B. Dyck, MD, of the Mayo Clinic in Rochester, MN, and a Fellow of the American Academy of Neurology.
Additional details on the patients’ testing and outcomes will be presented at the AAN Annual Meeting.
The study was supported by the National Institute of Neurological Disorders and Stroke.
The American Academy of Neurology, an association of more than 21,000 neurologists and neuroscience professionals, is dedicated to promoting the highest quality patient-centered neurologic care. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as multiple sclerosis, restless legs syndrome, Alzheimer’s disease, narcolepsy, and stroke.
For more information about the American Academy of Neurology, visit http://www.aan.com.
The AAN 61st Annual Meeting, the world’s largest gathering of neurology professionals, takes place April 25 to May 2, 2009, in Seattle. Visit http://www.aan.com/am for more information.
To access 2009 AAN Annual Meeting abstracts available February 25, 2009, visit http://www.aan.com/go/science/abstracts.
Late-breaking abstracts will be featured in press release at the 2009 AAN Annual Meeting in Seattle.
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Screening Cuts Cervical Cancer Rates By Half, UK
In the wake of Jade Goody’s tragic story, the latest Cancer Research UK statistics reveal that there is hope on the horizon for cervical cancer.
The figures show that women are now half as likely to be diagnosed with cervical cancer as they were when the NHS Cervical Screening Programme began in 1988.
The rate of women diagnosed with the disease has halved from 16 per 100,000 in 1988 to 8 per 100,000 according to the latest figures.
In the late 1980s around 4,800 women were diagnosed with cervical cancer each year in Great Britain. Now, after 20 years of screening only around 2,700 women are diagnosed with the disease.
Before the programme started cervical cancer was the sixth most commonly diagnosed cancer in women. But because of screening, twenty years later, it is now ranked 13th.
Sara Hiom, Cancer Research UK’s director of health information, said: “These compelling figures show how effective the programme has been in preventing the disease and saving lives. Screening works by picking up early changes in the cervix before they can develop into cancer.”
The number of deaths from cervical cancer has also seen a huge drop. Twenty years ago more than 2,000 women died in Britain every year from the disease compared to 921 in 2006. This means cervical cancer is no longer one of the top 20 most common causes of cancer death.
But, the latest reports show that the number of women taking up their invitations for screening is falling, particularly among those aged 25-34.
Sara Hiom said: “Even though cervical cancer is no longer in the top 10 of all cancers, it is still the second most common cancer for women under the age of 35. Crucially, women must attend screening as soon as they receive the invitation letter from their GP – it could save their lives. If signs of the disease are picked up early then treatment is easy and effective.”
Notes
For further details about incidence or mortality go here.
For more detailed screening figures, go here.
About cervical cancer
For further information on cervical cancer go to http://www.cancerhelp.org.uk
Cancer Research UK
Court Enjoins Seafood Processing Company, Owners
At the request of the U.S. Food and Drug Administration, the U.S. District Court for the District of Minnesota on Feb. 17, 2009, entered an order of permanent injunction against seafood processor Captain’s Select Seafood Inc., Minneapolis, Minn., and its co-owners Carolyn M. Young and William J. Young.
The defendants are charged with repeatedly violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA’s Hazard Analysis Critical Control Point (HACCP) regulations for seafood processors.
The court held that the evidence presented by the FDA showed a lengthy and undisputed history of violations from 2004 through at least early 2008, during which time Captain’s Select did not have a HACCP plan that complied with the FDA’s regulations. The FDA’s HACCP regulations require that all seafood processors develop and implement adequate plans that identify all food safety hazards likely to occur for each kind of seafood product, and contain preventative measures that the processor can implement to control those hazards. The court held that failure to have a compliant HACCP plan established that the defendants violated the FD&C Act on countless occasions by handling food in a manner that rendered it adulterated.
“While there are no reported illnesses associated with consuming Captain’s Select Seafood products, we cannot allow a company to put the public’s health at risk by not having adequate procedures and plans to produce safe food,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will take action against companies and against their executives who violate the law and endanger public health.”
The order of permanent injunction requires that either the FDA or a federal district court must first approve the defendants’ HACCP plans before any of the defendants can resume operating any food-supply business, or any food-related business involving seafood.
Should consumers have any food safety questions, they can call the FDA’s toll-free Food Safety Hotline at (888) SAFEFOOD, and they can report any problems to the FDA consumer complaint coordinator in their geographic area. Contact numbers may be found on-line at http://www.fda.gov/opacom/backgrounders/complain.html.
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[Via http://www.medicalnewstoday.com]
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Cardiovascular Disease Treatment Guidelines Frequently Not Based On Solid Evidence
A study in the February 25 issue of JAMA reports that evaluation of clinical practice procedure for treating cardiovascular disease finds that present recommendations mainly rely on inferior levels of evidence or expert opinion.
According to background data in the article, practitioners base their decision for suitable heath care for particular patients’ circumstances on clinical practice guidelines which are frequently considered as standard of evidence-based medicine.
Clinical practice guidelines have been released to offer recommendations on how to care for cardiovascular disease patients by the American College of Cardiology (ACC) and the American Heart Association (AHA), for more than two decades. Degree of evidence and class of recommendations are the basis for the grading system presently used by the ACC/AHA guidelines. The combination of an objective description of evidence and the types of studies sustaining the recommendation and expert opinion is used for the classification of level of evidence, and categorized as A (higher level of evidence), B, or C (lower level of evidence).
The level of recommendation is indicated by class of recommendation. It involves an opinion of the guideline writers on the comparative strengths and weaknesses of the study information, as well as an evaluation of the relative consequence of the risks and benefits identified by the evidence. The classes are ranked as I (evidence that a treatment or procedure is effective), II, IIa, IIb and III (evidence that a treatment or procedure is not effective).
It is unknown if the rise in cardiovascular disease studies increases the certainty of guideline recommendations and supporting evidence. The changes in recommendations in ACC/AHA cardiovascular guidelines and the evaluation of the adequacy of the evidence used for present guideline recommendations were studied by Pierluigi Tricoci, M.D., M.H.S., Ph.D., Duke University, Durham, N.C. and team. Information from ACC/AHA practice guidelines issued from 1984 to September 2008 was used in the study. A total of 7,196 recommendations and fifty-three guidelines on twenty-two topics were analyzed.
The total number of recommendations had a 48 percent increase (1,330 to 1,973), from the earliest guideline to the present version, taking into account only the current guidelines with at least one review. In general, there was a shift to class II recommendations, a drop in class II recommendations, while the use of class I remained invariable. In a total of 2,711 recommendations, in the sixteen present guidelines reporting levels of evidence, 11 percent (314) of the recommendations were classified as level of evidence A, and 48 percent (1,246) as level of evidence C.
In the total of 1,305 class I recommendations of guidelines reporting evidence, only 19 percent (245) have a level of evidence A, 36 percent (481) have a level of evidence C. In the different categories of guidelines (disease, intervention, or diagnosis) and the different individual guidelines, the level of evidence considerably varies.
In conclusion, the authors write: “Our finding that a large proportion of recommendations in ACC/AHA guidelines are based on lower levels of evidence or expert opinion highlights deficiencies in the sources of definitive data available for the generation of cardiovascular guidelines. To remedy this problem, the medical research community needs to streamline clinical trials, focus on areas of deficient evidence, and expand funding for clinical research. In addition, the process of developing guidelines needs to be improved with information about the impact that recommendations based on lower levels of evidence has on clinical practice. Finally, clinicians need to exercise caution when considering recommendations not supported by solid evidence.”
JAMA. 2009; 301[8]:831-841
Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Editorial: Re-evaluation of Clinical Practice Guidelines
Terrence M. Shaneyfelt, M.D., M.P.H., and Robert M. Centor, M.D., University of Alabama School of Medicine, Birmingham, in a complementary editorial, note that there is a need for important changes in clinical practice guidelines if they are to be maintained.
“However, it seems unlikely that substantial change will occur because many guideline developers seem set in their ways. If all that can be produced are biased, minimally applicable consensus statements, perhaps guidelines should be avoided completely. Unless there is evidence of appropriate changes in the guideline process, clinicians and policy makers must reject calls for adherence to guidelines. Physicians would be better off making clinical decisions based on valid primary data.”
JAMA. 2009 ;301[8]:868-869.
Written by Stephanie Brunner (B.A.)
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