Virtual reality exercise games, like the Wii Fit, may help older adults fight cognitive decline, researchers found.
Seniors who played a racing game by pedaling a stationary bike saw a significant boost in overall executive function on cognitive testing compared with stationary bike use alone (P=0.002), in a clinical trial by Cay Anderson-Hanley, PhD, of Union College in Schenectady, N.Y., and colleagues.
“Cybercycling” for three months in the trial reduced risk of clinical progression to mild cognitive impairment by a relative 23%, the group reported in the February issue of the American Journal of Preventive Medicine.

“Our findings give us hope that there can be an impact on improved brain health for older adults by this kind of synergistic mental and physical exercise,” Anderson-Hanley told MedPage Today. “The other thing is it’s a lot of fun.”

Participants in the trial often said they enjoyed exercise when playing the virtual reality game, she noted in an interview, which she suggested could help seniors start up and stick to a regimen.

“If more people in later life were to embrace regular physical exercise, such as this ‘exergaming’ type of exercise, that there would be a significant benefit across the community,” Anderson-Hanley said.

Delaying the onset of dementia by even one year could cut the projected U.S. prevalence from 8 million down to 7 million in 2050, she explained.

While virtual reality exercise games have proliferated for Nintendo’s Wii and other consoles for the gym and home, not all may provide the same benefits, Anderson-Hanley cautioned.

“It’s hard to know yet whether we can generalize our findings to other forms of exergaming that have more intermittent activity, like tennis or golf,” she told MedPage Today.

Her study used cycling because it continuously elevates heart rate.

It included 102 older adults at eight independent-living retirement facilities who were randomized to stationary recumbent bike use an average three times a week for three months with the virtual reality game monitor either turned on or off.

Playing the game while cycling had a large effect on change in cognitive scores on the Color Trails Difference, Stroop C, and Digits Backwards tests (P=0.002 for time by treatment interaction together).

Cybercyclists improved their performance on the Color Trails Difference (P=0.01) and Stroop C (P=0.05) tests over baseline, whereas traditional cyclists showed no change.

The intervention group also maintained their Digits Backwards test performance over the three-month period, whereas the controls’ performance declined (P=0.01).

The average improvement in cognitive performance with cybercycling was one-half a standard deviation over and above traditional exercise, the researchers noted.

During the study, three of the game participants and nine of those doing cycling alone developed mild cognitive impairment diagnosed clinically, for a 23% reduced risk with the intervention.

The groups didn’t differ in frequency, duration, or intensity of exercise, with both expending about 100 calories on average during a session.

The only difference between groups was the virtual reality experience, Anderson-Hanley’s group pointed out.

“Navigating a 3D landscape, anticipating turns, and competing with others requires additional focus, expanded divided attention, and enhanced decision making,” they wrote in the paper. “These are activities that depend in part on executive function, which was significantly affected.”

The group noted the relatively high level of education and low diversity of their study population, making further study necessary to determine generalizability, though the intervention should be widely applicable.

Other limitations included unequal education and age between the groups, though controlled for in the results.

The study was funded by a grant from the Robert Wood Johnson Foundation, through the Health Games Research national program, and by faculty and student grants from Union and Skidmore Colleges.

The researchers reported having no conflicts of interest to disclose.

The FDA has announced that it will detain all dairy products, fruits, and vegetables originating in the vicinity of Japan’s damaged atomic energy complex that was heavily damaged in the March 11 earthquake and tsunami.

Foods exported from the area may contain radioactive particles, after tests in Japan showed that milk, spinach, and other vegetables from in and around Fukushima prefecture had potentially dangerous levels of radiation.

The agency plans to quarantine any such products entering U.S. ports and prevent their distribution, an FDA spokesperson said.

Releases of radioactive particles from reactor buildings at the Fukushima Daiichi nuclear station on Japan’s northeast coast have continued for more than a week.

A series of explosions and deliberate releases have sent clouds of radioactive particles billowing from the plant since early last week.

Japanese authorities initially downplayed the risk of food contamination, but radiation has been detected in agricultural products from the general area of the plant.

In a terse situation update issued Monday, the World Health Organization (WHO) said “low-level contamination of drinking water” had been confirmed as well.

The Wall Street Journal reported Tuesday that elevated radiation levels had been detected in water supplies serving five towns near the plant. It said the Japanese government had characterized the short-term health risk as negligible but also advised residents to avoid giving the water to infants.

On Monday, the government stopped shipments of spinach and other types of leafy produce from four prefectures (roughly corresponding to counties in the U.S.) around the nuclear site.

Sales of fresh dairy products from Fukushima prefecture were also halted.

Milk samples from Fukushima were found to have iodine-131 levels that were 17 times higher than the maximum allowed by law, according to the Wall Street Journal.

U.S. officials have continued to say that significant contamination of foods on this side of the Pacific Ocean was highly unlikely, because radioactive particles emanating from the Japanese facility would be dispersed into the vastness of the atmosphere and ocean.

“At this time, there is no public health threat in the U.S. related to radiation exposure,” according to a statement posted Monday on the FDA’s website and still featured prominently late Tuesday.

“FDA, together with other agencies, is carefully monitoring any possibility for distribution of radiation to the United States. At this time, theoretical models do not indicate that significant amounts of radiation will reach the U.S. coast or affect U.S. fishing waters.”

The agency added that the Environmental Protection Agency was tracking the drift of radiation to the U.S. — already detected but at levels far below those believed to pose a health risk. The FDA also promised that it would take action if its own monitoring showed that accumulation in domestic dairy products or other foods had become significant.

Concern about foods — and other products — imported from Japan had already become international. Many of the country’s Asian trading partners have stepped up screening of Japanese agricultural exports or, like the U.S., stopped imports from Japan altogether.

The WHO said it was working with officials from the U.N.’s Food and Agriculture Organization (FAO) to monitor the situation.

The FAO, in turn, noted that it has had an ongoing joint program with the International Atomic Energy Agency addressing the threats to food supplies from radiological events like the one now occurring in Japan.

Primarily, the agencies develop guidelines and standards. The FAO said it could send teams of specialists to event locations to provide “analytical services,” but did not indicate whether it had done so in Japan.

Stuttering may arise from genetic defects in a basic metabolic process by which cells dispose of waste, researchers found.
The mutations in several genetic regions on chromosome 12 appear to play a role in 5% to 10% of patients who stutter, Dennis Drayna, PhD, of the National Institute on Deafness and Other Communication Disorders in Bethesda, Md., and colleagues reported online in the New England Journal of Medicine.
Although rare, these variants represent the first cause pinpointed for stuttering, which has been known to have a strong genetic component based — until now — on largely observational evidence.
Importantly, these results strengthen the evidence that stuttering is not a behavioral disorder, commented Gerald A. Maguire, MD, of the University of California Irvine.
“This study will allow our greater society to no longer stigmatize stuttering as simply a disorder where one ‘needs to slow down’ or that one ‘needs to relax,’” he said in an e-mail.

However, the biologic pathway implicated by the study raises more questions than it answers, noted Simon E. Fisher, DPhil, of Oxford University in Oxford, England, in an editorial that accompanied the study’s publication.

The researchers had previously found a significant linkage with a locus on chromosome 12q when studying blood relatives in 46 Pakistani families with stuttering.

In follow-up to this familial study, Drayna’s group focused in on the largest family and found one or two copies of a missense mutation in the GNPTAB gene — which encodes the alpha and beta catalytic subunits of GlcNac-phosphotransferase (TNPT) — in all but three family members with stuttering.

Two of the family members carried two copies and one carried one copy of this G3598A mutation but didn’t stutter, suggesting that the mutation increases risk but doesn’t always result in stuttering, Drayna’s group said.

Further screening for mutations in GNPTAB was done in one unrelated individual with stuttering from the 46 original families along with 77 additional unrelated persons with stuttering from Pakistan, 96 unrelated controls without stuttering from Pakistan, and 270 affected, unrelated individuals and 276 unaffected matched controls from the U.S. and England.

The variant showed up in affected individuals in three other Pakistani families for a total penetrance of 10%, one affected American of Asian Indian ancestry, and two affected unrelated Pakistani people. Only one control — an individual from Pakistan — carried the GNPTAB G3598A mutation.

“This mutation thus appears to be most common in populations from the Asian subcontinent,” the investigators wrote.

Three other mutations in GNPTAB were also seen in unrelated individuals with stuttering but not in controls.

Three mutations in the related GNPTG gene — it encodes the gamma rather than alpha and beta subunits of GNPT — appeared in both Asian and European study participants with stuttering but not in controls.

Three more mutations were seen in the NAGPA gene, which encodes another enzyme in the same pathway, again in affected individuals but not controls.

Altogether, these variants accounted for 5% (21 of 393) of stuttering cases in unrelated persons and implicated a class of genes in the same pathway.

“These genes encode enzymes that generate the mannose-6-phosphate signal, which directs a diverse group of hydrolases to the lysosome,” the researchers wrote.

Lysosomes are found in most cell types where they act as the “garbage bag” for waste products broken down by the hydrolase enzymes.

Failure of this pathway is known to result in the rare but fatal disorder mucolipidosis type II and other lysosomal storage disorders that typically affect bone, connective tissue, and neurologic function.

But carriers of the GNPTAB, GNPTG, and NAGPA gene mutations didn’t appear to have such symptoms and were otherwise normal, editorialist Fisher noted.

“Why would dysfunction of a basic process found in many cell types selectively affect the neural circuits involved in speech fluency?” he wrote. “The task of connecting the dots between genes and stuttering is just beginning.”

It is notable that GNPTG has its most localized expression in brain structures associated with emotion and motor function — both implicated in severity of stuttering, the researchers wrote.

Nevertheless, it could be years before this research yields clinical fruit, agreed Robert Marion, MD, a leading geneticist at the Children’s Hospital at Montefiore and Albert Einstein College of Medicine in New York City.

However, it does open up the possibility of screening infants for propensity to stuttering, he said in an interview.

High-risk children could be started on speech therapy before stuttering appears and potentially prevent it, Marion speculated.

Incorporating such a test into the existing newborn screening program would likely be too expensive and fraught with unresolved ethical concerns now, he acknowledged, but he wagered that will change within a few years.

The study was supported by grants from the Intramural Research Program of the National Institute on Deafness and Other Communication Disorders and the National Human Genome Research Institute.

The researchers reported no conflicts of interest.

Fisher and Marion reported no conflicts of interest.

Maguire provided no information on conflicts of interest.

Dermatologists conducting full-body skin exams were better at detecting skin cancers than patients themselves in a study that attempts to shed light on a controversial procedure.

The benefit of a doctor’s exam was particularly evident with early-stage melanomas that have not invaded below the surface of the skin, according to Jonathan Kantor, MD, MSCE, and Deborah E. Kantor, MSN, CRNP, of North Florida Dermatology Associates.

The findings were published in the Aug. 17 Archives of Dermatology.

About 56% of melanomas were discovered by dermatologists who conducted full-body skin examinations (FBSEs) when patients visited with an unrelated complaint (95% CI 47.6% to 65.1%), the authors reported.

Of the melanomas that had not invaded below the surface of the skin, 60% were detected by a dermatologist (95% CI 48.7% to 71.3%).

“These data suggest that minimizing the substantial public health and financial impact of melanoma may be aided by a full-body skin examination,” the investigators wrote.

The use of FBSEs to find early melanomas so that they can be surgically removed is a matter of debate among dermatologists.

While evidence exists to suggest that FBSE is effective for catching skin cancer, a recent report by the US Preventive Service Task Force (USPSTF) concluded that that the evidence was insufficient to conclusively recommend the exam as a routine procedure.

“Our aim was to determine the proportion of patients in a private dermatology practice in whom melanoma was detected but was not the presenting complaint,” Kantor and Kantor wrote.

“If a substantial proportion of melanomas are detected only after a dermatologist’s examination, this may suggest that FBSE, and not simply a problem-focused approach, should at least be considered for selected patients.”

The researchers analyzed 126 melanoma cases diagnosed at the Jacksonville, Fl., practice between July 2005 and October 2008. Of the patients in the study, 51 had invasive melanoma that had spread to deeper layers of the skin and 75 had melanoma that remained on the surface of the skin (in situ tumors).

In addition to finding that dermatologists were more likely to discover melanomas, particularly when the tumor was in situ, they also found that detection by dermatologists was associated with thinner invasive tumors.

The median invasive melanoma depth for the physician-detected tumors was 0.33 millimeters compared to 0.55 millimeters for patient-detected tumors, the study found. Dermatologist-detected tumors were associated with melanomas smaller than 1 millimeter in thickness (OR 5.0, 95% CI 1.0 to 25.3).

“While self-examination plays a critical role in early detection, prior studies have suggested that physicians, and dermatologists in particular, may be better able to detect melanomas with lesser tumor thickness,” the authors wrote.

“Because increasing tumor thickness is closely correlated with decreasing survival, it follows that complete examination plays an important role, particularly in high-risk populations.”

However, the authors pointed out that the study was limited by its small sample size as well as its retrospective nature.

In an accompanying editorial, Daniel G. Federman, MD, of VA Connecticut Health Care, and colleagues noted that other influential organizations, including the American Cancer Society and the American College of Preventive Medicine, support selected screening for skin cancer. They said the USPSTF’s “less enthusiastic” take on screening may stem from its stringent requirements for strong evidence.

“Unfortunately … owing to the difficulties of conducting an adequately powered [randomized controlled trial] to demonstrate the efficacy of skin cancer in lowering mortality, such evidence will probably not be forthcoming soon or perhaps ever,” they wrote.

They cautioned that while the results of the new study are intriguing, its small size and potential for bias limit its power. They also noted that the evidence is contradictory concerning the relative skills of primary care physicians versus dermatologists at detecting melanomas.

But they also quoted the late astronomer Carl Sagan, who said that “Absence of evidence is not evidence of absence,” in their summation of FBSE in screening for skin cancer.

“At this time, we see the metaphorical glass with respect to screening for skin cancer as ‘half full,’” Federman and colleagues wrote. “Findings from suitable reports, such as the article by Kantor and Kantor, contribute information that adds incrementally to our understanding of the issues involved. Perhaps we can sip from the glass (i.e., consider FBSE to be a reasonable approach), assuming that future studies will eventually fill the remaining half with fine wine.”

No funding sources for the study were reported.

The authors of the study and the authors of the editorial reported no financial conflicts of interest.

MONTREAL -– When diabetes is complicated by a diagnosis of schizophrenia, the risk of cardiovascular events increases, but when those events occur, the patient is less likely to undergo revascularization, researchers reported here.

In a retrospective study of more than 126,000 patients with diabetes — including 2,952 with diabetes and schizophrenia — patients who were dually diagnosed were about 20% more likely to have cardiovascular disease, but 49% less likely to undergo revascularization than patients diagnosed with diabetes or schizophrenia alone, Lauren Bresee, MSc, of the University of Alberta School of Public Health, reported at the International Diabetes Federation World Congress of Diabetes.

Patients with diabetes and schizophrenia were about 30% more likely to have congestive heart failure (OR 1.3, 95% CI 1.18 to 146) and also faced higher risk of stroke (OR 1.27, 95% CI 1.14 to 1.42), she said.

Among patients with cardiovascular disease (CVD), defined as ischemic heart disease, congestive heart failure, stroke, or acute coronary syndrome, the numbers suggest a schizophrenia diagnosis drives the revascularization decision.

Bresee said it is important for physicians treating schizophrenia patients to address these issues before they translate to cardiovascular events.

“Modifiable risk factors like dyslipidemia and hypertension can be treated with medication, and smoking cessation can be offered,” she said.

“Yes, the population is less adherent than the general population, and they may be more difficult because of their mental illness, but these people live very long lives, some of them have families and jobs, and so we need to make sure we are doing enough to prevent these illnesses, just as we would in the general diabetes population.”

“Although diabetes is common among schizophrenics, physicians tend to concentrate on their mental illness and not necessarily on their metabolic or cardiovascular problems,” she added.

Schizophrenia is associated with overweight/obesity, dysglycemia/type 2 diabetes, dyslipidemia, metabolic syndrome, and cardiovascular disease, she said.

Bresee and colleagues examined the rate of cardiovascular risk factors, cardiovascular disease, and revascularization procedures in patients from the province of Alberta who had both schizophrenia and diabetes (n=2,952), diabetes alone (n=126,857), and schizophrenia alone (n=25,803), from Jan. 1, 1995 through Dec. 31, 2006.

All subjects were 20 years or older. Diabetes patients were identified from the Canadian National Diabetes Surveillance System, and schizophrenia patients were identified by ICD-9 and ICD-10 codes from physician claims and hospitalization data.

As expected, patients with schizophrenia alone were considerably younger (46.5 years) than those with either diabetes alone (60 years) or those with both conditions (57.6 years).

After multivariable logistic regression analysis, adjusting for age, sex, subsidized healthcare, and urban versus rural dwelling, the study found that patients with both diabetes and schizophrenia had the highest rate of cardiovascular disease (43%), compared with those with either diabetes alone (39.9%) or schizophrenia alone (20%).

Despite the high rate of CVD, the combination of schizophrenia and diabetes was associated with significantly lower rates of hypertension (51.5%) compared with those with diabetes alone (61.2%), or schizophrenia alone (19.4%); and similar rates of dyslipidemia (38.4%) compared to those with diabetes alone (40.7%), but not schizophrenia alone (21%).

Bresee offered several possible explanations for why CV risk factors would be lower, while CV events might be higher in the combination group.

“One possibility is that they’re not being screened and diagnosed with CV risk factors, and they simply enter the system when they have a CV event. Another is that they do receive lab requisitions, but they just don’t go,” she said.

“Or, perhaps they really do have a lower risk for lipids and blood pressure, and it is their obesity, smoking, and low activity that are contributing to their cardiovascular disease.”

Although diabetes is common among people with schizophrenia, the relationship is not well understood, she added.

“There seems to be a multitude of factors, including smoking, obesity, poor diet, socioeconomic status, and ability to purchase healthy foods,” she said. “And medications definitely add to it.”

The current first-line treatments for schizophrenia are the atypical antipsychotic agents, such as clozapine, olanzapine, quetiapine, risperidone, and ziprasidone.

“These agents seem to be more effective at treating schizophrenia compared with the typicals like Haldol or loxapine, but they definitely do cause more weight gain, more glucose abnormalities, and more dyslipidemia,” she said.

Among the limitations of her study was its reliance on retrospective data, which did not include information about medication use in the schizophrenic patients.

“Medications do promote a significant amount of weight gain and may increase the risk of diabetes, but that may be the price one has to pay for better control of schizophrenia,” said Hertzl Gerstein, MD, a professor of medicine at McMaster University in Hamilton, who was not involved in the study.

“Schizophrenia itself could reflect a defect in the brain that could also increase the risk of diabetes and we don’t really understand that,” Gerstein said.

The study was funded by a Canadian Institutes of Health Research (CIHR) Clinical Fellowship.

Bresee declared no conflicts of interest.

Gerstein is a paid lecturer for GSK, sanofi-aventis, Novo Nordisk, Lilly, and Bayer. He is on the Advisory Boards of the above companies, excluding Bayer, Astra-Zeneca, and BMS.

He also declared grants from GSK and sanofi-aventis.

DALLAS, Sept. 26 — Individual variations in the occurrence of non-alcoholic fatty liver disease may be explained by a gene that has an unknown function, researchers here said.

In a genome-wide association scan, two variants on chromosome 22 were significantly associated with ethnic, racial, and individual diversity in hepatic fat content, according to Helen Hobbs, M.D., of the University of Texas Southwestern Medical Center, and colleagues.

One of the variants — most common among Hispanics, who are the most susceptible to fatty liver — was associated with increased hepatic fat content, Dr. Hobbs and colleagues said online in Nature Genetics.

The other was most common among African Americans, who are at lower risk of non-alcoholic fatty liver disease, and was associated with lower fat content in the liver, the researchers said.

Both variants are single nucleotide polymorphisms (SNPs) on the gene PNPLA3, which encodes a protein that belongs to the patatin-like phospholipase family.

The function of the protein is currently not known, Dr. Hobbs and colleagues said, and it remains unclear how it affects the liver.

Researchers at UT Southwestern reported in 2004 that the propensity to develop hepatic steatosis, or fatty liver, differs among ancestry groups. The frequency of the condition among African Americans is 24%, compared with 45% among Hispanics and 33% among European Americans.

The current finding provides a genetic explanation of that diversity, Dr. Hobbs said.

“A single variation in the PNPLA3 gene was strongly associated with hepatic fat content, even after adjusting for other factors, such as obesity, diabetes status, and alcohol intake,” she said. “Sequence variations in this gene explain much of the increased propensity of Hispanics to accumulate excess liver fat.”

The researchers scanned the genomes of 1,032 African Americans, 696 European Americans, and 383 Hispanic participants in the Dallas Heart Study, for whom proton magnetic resonance spectroscopy of the liver was available.

The first variant found, dubbed rs738409, is a cytosine-to-guanine substitution that was strongly associated with hepatic fat levels and with hepatic inflammation, at P=5.9?—10-10 and P=3.7?—10??’4, respectively.

The association was significant after adjustment for body mass index, diabetes status, ethanol use, as well as global and local ancestry, and was apparent in all three ancestry groups, the researchers said.

That said, Dr. Hobbs and colleagues noted the frequency of the variant was highest in Hispanics (at 0.49), followed by European Americans (0.23) and African Americans (0.17).

The variant was also highly associated with elevated liver enzymes in Hispanics, but not in other groups. Serum concentrations of alanine aminotransferase were associated with the variant in Hispanics at P=1.3?—10??’5, as were serum aspartate aminotransferase concentrations, at P=0.002.

Subsequent analysis located another variant, dubbed rs6006460, which is a guanine-to-tyrosine switch that was common in African Americans but rare among the other groups.

Compared with African Americans who have two copies of the wild-type allele, those with at least one copy of the T allele had a median hepatic triglyceride content that was 18% lower. (The triglyceride proportions were 3.3% versus 2.7%, a difference that was significant at P=6.0?—10??’4.)

The findings may eventually help clinicians tell who’s in danger of a fatty liver, said co-author Jonathan Cohen, Ph.D., also of UT Southwestern.

The gene variations “might provide a way to predict who is most at risk for developing fatty liver disease and liver injury in response to environmental stresses such as obesity or infection,” Dr. Cohen said.

The study was supported by the Donald W. Reynolds Foundation, the NIH, and the Department of Energy. Dr. Hobbs and Dr. Cohen did not report any conflicts.

Primary source: Nature Genetics

Source reference:

Romeo S, et al “Genetic variation in PNPLA3 confers susceptibility to nonalcoholic fatty liver disease” Nature Genetics 2008; DOI: 10.1038/ng.257.

States may be falling short on tobacco-cessation programs for Medicaid enrollees, the CDC warned in a report.

Although 92% of states covered some form of tobacco-dependence treatment, only eight states covered all recommended medications along with at least one form of counseling for all enrollees in 2009, Sara B. McMenamin, PhD, of the University of California Berkeley, and colleagues found in collaboration with the CDC.

Still, this represents an improvement over 2007, with increased coverage in 12 states, they reported in the Oct. 22 issue of Morbidity and Mortality Weekly Report.

Penny-conscious states may be pound-foolish, as an editorial note accompanying the MMWR article pointed out.

“Tobacco-dependence treatments are one of the few clinical preventive services shown to reduce costs,” the editors wrote.

Medicaid covers a population with nearly twice the smoking rate of adults in the general population (37% versus 21%). Smoking-related medical costs eat up approximately 11% of Medicaid spending.

The federal government advocated in its Healthy People 2010 goals for Medicaid programs to cover all FDA-approved medications and counseling for tobacco cessation.

To see how the states were doing on that goal, McMenamin’s group surveyed Medicaid programs in all 50 states and the District of Columbia for 2009.

A total of 47 states offered coverage of tobacco-dependence treatments for at least some enrollees, including 38 that covered at least one such treatment for all enrollees without differences between fee-for-service and managed care organization plans.

Widespread coverage included: The nicotine patch, in 34 programs Generic bupropion or brand name Zyban, in 33 programs Nicotine gum, in 32 programs Varenicline (Chantix), in 32 programs Nicotine nasal spray, in 28 programs Nicotine inhalers, in 27 programs Nicotine lozenges, in 25 programs

Coverage for pharmacotherapy combinations was less common with the exception of the nicotine patch plus bupropion, which was covered by 33 programs.

Counseling coverage was more of a problem.

In all, 18 programs covered individual counseling for all Medicaid enrollees, six programs covered individual counseling only for fee-for-service enrollees (with two restricting coverage to pregnant women), one covered managed care enrollees only, and six covered only pregnant women, according to the report.

As for group coverage, eight states covered group counseling for all Medicaid enrollees, three programs covered group counseling for fee-for-service enrollees only (with two restricting coverage to pregnant women), two states covered only managed care enrollees, and five programs covered group counseling for pregnant women only.

Only five states — Indiana, Massachusetts, Minnesota, Montana, and Pennsylvania — covered not only all recommended pharmacotherapies but also individual and group counseling for all Medicaid enrollees, whether fee-for-service or managed care.

Four states — Connecticut, Georgia, Missouri, and Tennessee — covered no tobacco-dependence treatments at all.

Overall, 16 Medicaid programs differed in their tobacco-cessation coverage for fee-for-service versus managed-care enrollees.

“To increase the effectiveness of recommended tobacco-dependence treatments,” McMenamin’s group concluded in the report, “Medicaid programs should inform their enrollees and providers about coverage changes, offer tobacco-dependence treatments without barriers or limitations, measure treatment usage rates, and assess any remaining barriers to coverage.”

There may be some hope for change, the editorial note explained.

As part of the recently-enacted Affordable Care Act, the federal government will bump up assistance to the states by an entire percentage point for expenditures on counseling and FDA-approved treatments for tobacco dependence when they are offered without cost-sharing.

The study may have been limited by lack of documentation to verify coverage policies in a few cases, the editorial note cautioned.

Moreover, some managed care organizations offered Medicaid enrollees coverage for tobacco dependence not required by the contracts with state Medicaid programs, which might have led to under-reporting of coverage among these enrollees in the report, it added.

Most of the researchers reported being employed by the CDC or state departments of health.

Percutaneous coronary intervention (PCI) is now considered “appropriate” in relatively benign three-vessel disease, according to an update of criteria for revascularization of complex coronary artery disease. It had previously been categorized as “uncertain.”

A writing group representing major cardiology and cardiac surgery organizations made the updates of “appropriate use” criteria driven mainly by the SYNTAX trial results.

The update also moves PCI from “inappropriate” to “uncertain” for simple forms of left main disease, according to the document published online in the Journal of the American College of Cardiology.

“The publication of the randomized SYNTAX trial and a few other trials caused the writing committee and technical committee to reevaluate high-risk findings in complex coronary disease,” Gregory J. Dehmer, MD, who represented the Society for Cardiovascular Angiography and Interventions (SCAI) on the writing group, told MedPage Today.

In the SYNTAX trial, PCI was compared with surgery in patients with complex coronary artery disease. “Results indicated that PCI was a viable option in patients with low-burden complex disease,” said Dehmer, a professor of medicine at Texas A&M College of Medicine in Temple, Texas.

It’s important to realize, Dehmer said, that the classification of “uncertain” merely means that more research and patient information is needed to classify the indication definitively. In fact, the document points out that “the writing group, technical panel, AUC Task Force, and clinical community do not believe an uncertain rating justifies denial of reimbursement for revascularization.”

Another important change to reflect emerging data and also be consistent with guidelines is an update to the cutpoint for fractional flow reserve (FFR) from 0.75 to 0.80. This change was evident in the indication for one- or two-vessel coronary artery disease (CAD) with borderline stenosis (50% to 60%) in patients without prior bypass surgery who either have had equivocal test results or no noninvasive testing (indication #22 on a table explaining the criteria) .

The appropriateness use criteria were developed with five core variables considered: The clinical presentation, or the stability of the patient The symptom class (very mild or class 4 symptoms at rest) Extent of ischemia on noninvasive testing and the presence or absence of other prognostic factors, such as congestive heart failure, depressed left ventricular function, or diabetes Extent of medical therapy Extent of anatomic disease

Although there are a multitude of other variables that inform medical decision-making, such as age, gender, and comorbidities, “it would be impractical for us to create a classification for the myriad potential patient scenarios,” Dehmer said. “The document would be too large and not very user-friendly.”

So the classification of “uncertain” allows for clinical judgment on an individual basis. It also identifies areas where more focused research needs to be done, he said.

Most of the ratings in the document are listed by indication (i.e., ST-segment elevation myocardial infarction [STEMI], non-STEMI, one-vessel CAD involving the proximal left anterior descending artery [LAD]) and they are not intended to distinguish between different methods of revascularization.

However, the “writing group identified four indications possibly affected by results of the SYNTAX trial for reexamination. The writing group also split two of the indications to represent levels of disease burden, recognizing, however, that the ability to reproducibly quantify the SYNTAX score in routine clinical practice has challenges,” according to the focused update document.

Coronary artery bypass grafting (CABG) is deemed “appropriate” in all of these indications. PCI is “appropriate” for two-vessel with proximal LAD stenosis and for three-vessel CAD with low CAD burden (i.e., three focal stenoses, low SYNTAX score).

PCI is deemed “uncertain” in three scenarios: Three-vessel CAD with intermediate to high CAD burden (i.e., multiple diffuse lesions, presence of chronic total occlusion, or high SYNTAX score) Isolated left main stenosis Left main stenosis and additional CAD with low CAD burden (i.e., one- to two-vessel additional involvement, low SYNTAX score)

Also updated is the “inappropriate” designation for performing PCI in patients with left main stenosis and additional CAD with intermediate to high CAD burden.

“The key is for surgeons and cardiologists to work together to determine the best course of action for the patient,” Peter K. Smith, MD, chief of cardiothoracic surgery at Duke University in Durham, N.C., told MedPage Today.

Smith, who represented the Society of Thoracic Surgeons in the writing group, said the updated appropriateness criteria are in step with the updated CABG guidelines released in November, of which Smith was a member of the writing group.

Besides stressing the concept of the “heart team,” the guidelines affirmed the results of the SYNTAX trial, that PCI is a viable option in patients with less severe complex disease and CABG is better in all other scenarios.

“The appropriateness use criteria and the updated CABG and PCI guidelines are complementary,” Smith said.

The criteria were jointly developed by the American College of Cardiology Foundation, SCAI, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology, Heart Failure Society of America, and Society of Cardiovascular Computed Tomography. They have been endorsed by the American Society of Echocardiography and Heart Rhythm Society.

Several authors indicated relationships with St. Jude Medical, Eli Lilly, Bristol-Myers Squibb, sanofi-aventis, Medtronic, WellPoint, Boston Scientific, Siemens Medical Solitions, Philips, and GE Healthcare.

Children are four times more likely to be hit by a car on Halloween night than on any other night of the year, according to experts at the U.S. Centers for Disease Control and Prevention.

In addition, the researchers warned that eye trauma from sharp objects and burns from flammable costumes are also common Halloween injuries.

“Children should be out having fun and spending time with family and friends. They should not have to spend Halloween in the ER because of some injury that could have been easily prevented,” Dr. Sandra Schneider, president of the American College of Emergency Physicians, said in an ACEP news release.

The U.S. Census Bureau estimates that 40 million kids aged 5 to 14 will be keeping up the tradition of knocking on doors on Halloween.

When planning for the big night, the ACEP offers the following tips to adults to help them protect kids from frightful injuries:

Local community centers, shopping malls or schools should be encouraged to organize Halloween festivities that allow kids to “trick-or-treat” without walking outside in the dark.
If kids do go out at night, make sure they stick to the sidewalks and obey traffic signals.
Remind children to stay together in a group with at least one adult chaperone.
Be sure children are aware of the potential dangers from strangers, and remind them to stay in familiar areas.
Avoid masks that block children’s vision and costumes that could cause them to trip, such as baggy pants and high heels.
Make sure costume fabrics and accessories are made of flame-resistant materials, such as nylon or polyester.
Keep kids away from candlelit Jack-O-Lanterns.
Inspect all candy before children eat it and dispose of anything not in a sealed wrapper.
Bring a flashlight while trick-or-treating to increase visibility.
Costume accessories, such as wands and swords, should be made from safe, flexible materials and not have any sharp edges.

More information

The American Academy of Pediatrics offers more Halloween safety tips.

WASHINGTON — Makers of the supplement ArimaDex — advertised to boost testosterone and build lean muscle mass — voluntarily recalled the product after traces of an aromatase inhibitor, used in the treatment of breast cancer, was found in an FDA analysis.

Genetic Edge Technologies recalled all lots of the supplement, which is sold in white plastic bottles containing 60 orange soft-gels. The product has the UPC code 718122466511.

Adverse events caused by aromatase inhibitors include decreased rate of bone maturation, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction.

Patients with kidney, liver, adrenal, or prostate problems are at increased risk for adverse events while taking aromatase inhibitors.

No adverse event reports stemming from use of the product have been filed, according to the manufacturer.

The soft-gels were sold through retail stores and over the Internet.