MADRID — Implanting a cardiac resynchronization therapy (CRT) device at the time of coronary artery bypass grafting in patients with ischemic heart failure improves outcomes over CABG alone, a small, randomized trial showed.

The addition of CRT improved left ventricular systolic function, reduced signs of dyssynchrony, and ultimately reduced mortality through 18 months of follow-up (P<0.05 for all), according to Alexander Romanov, MD, of the Novosibirsk State Research Institute of Circulation Pathology in Russia.

Also, patients who received CRT had significantly greater improvements in NYHA functional class, six-minute walk test, and quality of life (P<0.05 for all), Romanov reported here at EUROPACE, the meeting of the European Heart Rhythm Association.

“Our data demonstrate that we don’t need to wait if patients have indications for surgery and indications for CRT,” he said. “We need to do it concomitantly.”

In a previous study of patients with ischemic heart failure, those who had left ventricular dyssynchrony before CABG tended to have dyssynchrony after surgery, showing that CABG alone was not sufficient to resynchronize the left ventricular contraction pattern in most patients, according to Romanov.

Post-CABG dyssynchrony was associated with poorer long-term outcomes.

To see whether adding epicardial CRT at the time of CABG improved outcomes, Romanov and his colleagues randomized 178 consecutive patients with severe ischemic heart failure (NYHA class III or IV) and left ventricular dyssynchrony to CABG alone or CABG plus CRT at the time of surgery.

All of the patients had indications for both CABG and CRT.

The study was conducted at three centers — one each in Russia, Poland, and Slovenia.

Dyssynchrony was defined as the presence of at least one of the following criteria: a QRS duration greater than 120 milliseconds (ms), an aortic pre-ejection delay greater than 140 ms, an interventricular mechanical delay greater than 40 ms, delayed activation of the posterolateral left ventricular wall, and tissue tracking and tissue synchronization image on tissue Doppler imaging.

The patients in the two groups were well matched at baseline, with a mean age of 62.8, a mean left ventricular ejection fraction of 29%, and a mean QRS duration of 139 ms.

Short-term postoperative outcomes were better in the group that received CRT, illustrated by a shorter average stay in the intensive care unit (2.5 versus 3.9 days) and a better cardiac index on the second day after the operation (P<0.001 for both).

Long-term outcomes through an average follow-up of 18.4 months were better in the patients who received CRT, as well.

In the CABG alone group, left ventricular ejection fraction improved slightly by three months but then returned to baseline levels. In the CABG plus CRT group, ejection fraction increased through about six months and then leveled out.

Thus, at 18 months, ejection fraction was significantly greater in the CABG plus CRT group (42% versus 28%, P=0.0001).

Measures of left ventricular dyssynchrony on tissue Doppler imaging — which was associated with all-cause death and heart failure hospitalization (HR 2.60, 95% CI 1.20 to 5.75) — improved more in the CABG plus CRT group.

Through follow-up, there were 32 deaths overall.

Four of the five that occurred in the early postoperative period were in the CABG alone group. One patient died because of ventricular fibrillation four days after the operation and three patients died because of progression of heart failure.

One patient died of postoperative MI in the CABG plus CRT group.

During the entire follow-up period, the mortality rate was significantly higher in the CABG alone group (26.4% versus 9.9%, P=0.006).

All but three of the observed deaths were cardiac — 16 pump failure deaths, 12 sudden cardiac deaths, and one death resulting from a cardiac procedure.

Three-quarters of the sudden cardiac deaths occurred in the patients who did not receive a CRT device.

Romanov reported receiving speaking honoraria from Medtronic and Biosense Webster.

MRI-detected midwall fibrosis may identify aortic stenosis patients at elevated risk of a bad outcome, researchers found.

Midwall fibrosis predicted a 5.35-fold increase in all-cause mortality after adjustment for other risk factors (P=0.03), Sanjay K. Prasad, MD, of Royal Brompton Hospital in London, and colleagues reported.

Ejection fraction was also prognostic in these patients, but the two appeared to be independent risk factors in the study appearing in the Sept. 13 issue of the Journal of the American College of Cardiology.

“It may prove to be a useful method of risk stratification in patients with advanced aortic valve disease or as a future target for antifibrotic medication,” the group concluded in the paper.

Cardiac MRI has already been used to show that fibrosis associated with cardiomyopathy puts people at increased risk of sudden cardiac death. The imaging technique also has shown that atrial fibrosis is a predictor of poor response to atrial fibrillation ablation.

How midwall fibrosis arises and what impact it has on mechanics and electrophysiology of the heart aren’t clear yet, noted Saman Nazarian, MD, of Johns Hopkins Hospital, in an accompanying editorial.

But finding those answers “may lead to improved management strategies in aortic stenosis and other nonischemic causes of myopathy,” Nazarian wrote.

One possibility is use of antifibrotic medications for such patients, Prasad’s group suggested.

Their study included 143 consecutive patients with moderate or severe aortic stenosis who had an MRI with gadolinium contrast at a single center.

During two years of follow-up, 72 got an aortic valve replacement and 27 died.

The 54 patients (38%) with a midwall fibrosis pattern of late gadolinium enhancement on the scan were 8.59-fold more likely to have died in the unadjusted analysis than other patients (P=0.004), which the researchers noted was “despite similar aortic stenosis severity and coronary artery disease burden.”

By comparison, the typical localized pattern of late gadolinium enhancement seen after a myocardial infarction (MI) was associated with a 6.46-fold elevated unadjusted risk of all-cause mortality (P=0.017).

A greater burden of fibrosis predicted greater mortality risk, with a 5% rise for every 1% increase in the percentage of late gadolinium-enhancing mass (P=0.005).

Midwall fibrosis patients had the highest indexed left ventricular mass (11 g/m2 higher on average versus patients without fibrosis, P=0.005), although severity of aortic stenosis and hypertension prevalence were similar among the groups.

Midwall fibrosis was also linked to lower ejection fraction (P=0.007), despite no difference in coronary artery disease.

Although all three sudden cardiac deaths in the cohort had been seen to have midwall fibrosis, the numbers were too small to draw any conclusions.

Aortic valve replacement appeared to substantially reduce mortality among patients with midwall fibrosis, as in the other groups — bringing the rate down to 54 rather than the 219 per 1,000 patient-years seen in those who didn’t get a new valve.

Notably, more than half of the midwall fibrosis patients who died during follow-up had only moderate aortic stenosis that wouldn’t have met conventional criteria for valve replacement, Prasad’s group noted.

“Myocardial fibrosis may therefore have a role in the risk stratification of patients being considered for surgery,” they wrote in the paper.

The researchers cautioned that a larger, multicenter study is needed to confirm their findings.

The study was supported by the National Institutes of Health Research Cardiovascular Biomedical Research Unit, a collaboration between Royal Brompton Hospital and Imperial College London, as well as by the British Heart Foundation and CORDA.

Prasad reported having received honoraria from Schering.

Nazarian reported being funded by a grant from the National Institutes of Health.

CAMBRIDGE, England, Sept. 11 — An MRI scan of the optic nerve sheath may provide an accurate, noninvasive way to screen for raised intracranial pressure, researchers found.
MRI-measured diameter of the optic nerve sheath could identify or rule out elevated intracranial pressure in at least 90% of traumatic brain injury cases, reported Thomas Geeraerts, M.D., of Addenbrooke’s Hospital here, and colleagues online in Critical Care.
These findings from a small retrospective cohort study suggest that MRI could be clinically useful in determining which patients need invasive intracranial pressure monitoring, the current gold standard, and for screening patients when the invasive devices are unavailable, the researchers said.

However, the question remains whether the technique would be useful outside the acute setting in comparison with fundoscopic examination of the eye for papilloedema, commented Stephen D. Silberstein, M.D., of Thomas Jefferson University in Philadelphia, in an interview.

“If it shows increased pressure even in patients without papilloedema, then it would be extremely important,” he said.

Intracranial hypertension is frequent in stroke, liver failure, meningitis, and other conditions, and the ischemic brain damage it causes raises the risk of mortality and poor neurological outcomes.

“Early detection and treatment of raised intracranial pressure is therefore critical but often challenging,” the researchers said, “because invasive intracranial pressure monitoring is not routinely undertaken in these settings.”

Also, the clinical signs — such as headache, vomiting, and drowsiness — are not specific or easy to interpret, particularly in sedated patients, Dr. Geeraerts’ group said.

MRI is often done in these patients for other reasons, they noted.

For instance, at their institution, brain MRI is done for research purposes during acute traumatic brain injury, typically in patients who are sedated, mechanically ventilated, and on invasive intracranial pressure monitoring.

To see whether this MRI scan could pull double duty, the researchers compared the correlation between MRI measurement of the diameter of the optic nerve sheath and invasive testing for detection of intracranial pressure.

They retrospectively analyzed blinded brain MRIs from a prospective cohort of 38 patients on invasive parenchymal sensor intracranial pressure monitoring after severe traumatic brain injury and from 36 healthy volunteers.

Overall, measurement of the optic nerve sheath with MRI imaging was feasible for 95% of patients with significantly higher average diameter in those with traumatic brain injury than controls (5.72 versus 5.08 mm, P=0.0001).

MRI-measured nerve sheath diameter significantly predicted intracranial pressure measured by more invasive means (P

TORONTO, April 24 — A simplified scoring system using readily available preoperative information predicts acute renal failure and need for replacement therapy after cardiac surgery, researchers here reported.

The predictive index for these heart-surgery patients identified those at high or low risk for renal replacement therapy with hemodialysis or continuous venovenous hemodiafiltration, according to a report in the April 25 issue of the Journal of the American Medical Association.

Among the 6% of patients with high-risk scores, the risk of renal replacement therapy was 25 times greater than that of the 53% of patients with low-risk scores, Duminda N. Wijeysundera, M.D., of the University of Toronto, and colleagues found.

Although high-risk kidney patients constitute less than 2% of patients having open-heart surgery, patients needing postoperative renal replacement therapy use 12% of intensive-care-unit resources, as measured by length of stay, Dr. Wijeysundera said.

Accurate preoperative risk stratification for risk of renal replacement therapy after cardiac surgery would inform clinical decision making and also research design, the investigators said.

To provide accurate and generalizable prognostic information, the predictive index should remain stable when the index is externally validated in different data sets, geographic locales, and time periods, the researchers wrote.

“This simple predictive index may facilitate preoperative risk stratification for [renal risk therapy], and thereby improve clinical decision making, communication of perioperative risk, resource allocation, and research design,” they concluded.

To develop a predictive index, the researchers studied a retrospective cohort of 20,131 cardiac-surgery patients at two hospitals in the province of Ontario. Patients 18 or older underwent cardiac surgery under cardiopulmonary bypass.

The derivation cohort included 10,751 patients at Toronto General Hospital (1999-2004).

Two validation cohorts included 2,566 patients at Toronto General Hospital (2004-2005) and 6,814 patients at the Ottawa Heart Institute (1999-2003). The validation hospitals differed in locale and data-collection methods.

Renal replacement rates in the derivation cohort and the Toronto and Ottawa validation cohorts were 1.3% (N=139), 1.8% (N=45), and 2.2% (152), respectively, the researchers reported.

The multivariable predictors of renal replacement therapy included eight predictors and were scored from zero to eight points. These included an estimated glomerular filtration rate less than or equal to 30 mL/min, which was assigned two points.

Other components, assigned one point each, were estimated glomerular filtration rate 31 to 60 mL/min, diabetes requiring medication, ejection fraction less than or equal to 40%, previous cardiac surgery, procedure other than coronary-artery-bypass grafting, intra-aortic balloon pump, and being a nonelective case.

Among the 53% of patients with low-risk scores (?‰¤1), the renal-replacement risk was 0.4%. By comparison, this risk was 10% among the 6% of patients with high-risk scores (?‰?4), the researchers reported.

The predictive index had areas under the receiver operating characteristic curve in the derivation, Toronto validation, and Ottawa validation cohorts of 0.81, 0.78, and 0.78, respectively.

When these cohorts were stratified on the basis of index scores, likelihood ratios for renal replacement were more concordant than the observed rates.

The predictive index of this simplified scoring system, which used readily available, clinically sensible preoperative information, compared favorably with other perioperative risk indices with regard to discriminating between high- and low-risk patients, the researchers said.

The principal strength of the index is its combination of simplicity and accuracy. The index used only eight components, almost all equally weighted, which should promote its use in clinical care and research settings, the investigators said.

It also differed from recent comparable indices by measuring preoperative renal function using estimated glomerular filtration rates, found in studies to be superior to serum creatinine as a predictor of clinical outcomes, they said.

Low-risk kidney individuals, about 55% of cardiac surgery patients, would require no specific modifications in usual management. Intermediate-risk patients might benefit from limited use of renal-protective interventions, for example, strict control of intraoperative hematocrit and off-pump surgery.

High-risk patients might benefit from more aggressive use of potential renal-protective interventions. In addition, the researchers said, identifying these high-risk patients might assist intensive care units in planning use of post-op renal-therapy resources.

Clinical trials, they said, might improve selection of intermediate-to-high-risk patients by using this index in their inclusion criteria.

The researchers noted several study limitations. The association between glomerular filtration and renal replacement observed in this study, they said, should not be extrapolated to alternative prediction equations, such as the Modification of Diet in Renal Disease formula or cystatin-C-based equations.

In addition, they said, the data were limited to in-hospital outcomes, therefore precluding long-term implications. Given that starting renal replacement therapy is based on clinical judgment, consulting nephrologists might have also modified their threshold for in-hospital renal therapy on the basis of their clinical judgment.

Finally, the investigators said, the index should be validated in other geographic regions to further characterize its generalizability.

The calibration of this index across cohorts improved generalizability when used to estimate likelihood ratios for renal replacement as opposed to predicted event rates, the researchers said.

No financial conflicts were reported.

Primary source: Journal of the American Medical Association

Source reference:

Wijeysundera DM, et al “Derivation and Validation of a Simplified Predictive Index for Renal Replacement Therapy After Cardiac Surgery” JAMA 2007; 297:1801-1809.

WASHINGTON-An invisible silent killer stalks the nation, causing a plague of lung cancer, but most people are only dimly aware of the deadly hazard. People can take precautions without much effort although relatively few do.

That, according to many authorities, is the status in America of radon, a colorless, odorless, radioactive gas that seeps into people’s houses from the soil beneath and causes occupants to die of lung cancer many years later. The annual toll may top out at 21,000 deaths a year, according to the Environmental Protection Agency.

Of course, that pales next to the 150,000 lung cancer deaths caused by smoking. Yet it’s enough to make radon the second leading cause of lung cancer deaths in the country, says Phil Jalbert, acting director of the EPA’s center for radon and air toxics.

Radon is a major risk, he said, even compared with other common causes of death, such as drunk driving (about 18,000 deaths a year), accidental falls in the home (8,000), and fires in the home (3,000).

The scientific consensus is that radon “represents a major environmental health hazard,” says Bill Field, Ph.D., of the University of Iowa’s College of Public Health. That consensus has been strengthened by several recent developments, Dr. Field says:

A pooled analysis of seven different North American residential radon studies, published in the journal Epidemiology in January, showed an 11% to 21% increase in lung cancer risk for those exposed to the gas. The risk grew with increasing radon exposure.

A similar study in Europe, published in the British Medical Journal in January, concluded that radon in European homes accounts for about 9% of deaths from lung cancer.

The World Health Organization launched a radon program, after concluding that the gas causes between 6% and 15% of all cases of lung cancer in the world. “Radon poses an easily reducible health risk to populations all over the world, but has not up to now received widespread attention,” says Mike Repacholi, coordinator of WHO’s Radiation and Environmental Health Unit.

U.S. Surgeon General Richard H. Carmona issued a national health advisory in January, urging citizens to take action against radon.

Radon comes from the radioactive decay of uranium in the soil. It has no immediate health effects, but it in turn gives rise to so-called “daughter products.” Among them are two radioactive isotopes of polonium that can lodge in the lungs and cause cancer.

In the outside air, the concentration of radon is low – about 0.4 picoCuries per liter on average – but when it seeps into houses from soil, it can build up to higher levels.

The EPA argues that householders should have their houses tested for radon and take steps to reduce it if the average concentration is greater than the co-called “action level” of 4 picoCuries per liter of air.

Because uranium is not uniformly distributed, some places have less radon than others. In the U.S., for instance, Iowa has the highest radon concentrations, while states like Florida are relatively low.

But, Jalbert said, even in areas where radon is generally low, it can still build up to the action level in any given house, depending on how it is built and ventilated. “It’s impossible to predict,” he said.

Radon has not always been the bad guy. After its discovery in 1900, it was regarded as having curative powers and was added to everything from toothpaste to hair cream.

The link between lung cancer and radon was first shown in uranium miners, exposed to high levels of the gas during their work. Based on theoretical models, the EPA and many researchers argue that there’s no safe threshold. What kills miners at high levels will also kill average citizens at lower levels.

And indeed, many studies seem to show just that. The European pooled analysis in January, for instance, concluded that the dose-response curve was linear, with no evidence of a threshold of safety.

The contrary view is championed by Bernard Cohen, Ph.D., a physicist at the University of Pittsburgh, who has argued for years that such studies are based on a flawed model — the so-called linear, no-threshold model — and buttressed by weak statistics.

The model essentially says that there’s no safe threshold below which exposure to radon is safe. “We do not know at what level there might not be a cancer effect,” said the EPA’s Jalbert.

With colleagues, Dr. Cohen looked at average radon levels in 1,600 counties in the U.S., containing more than 90% of the nation’s population, and plotted them against lung cancer deaths.

If the model were correct, he argues, counties with the highest average radon levels should have the highest rates of lung cancer — but they don’t. “It’s just the other way around,” he said.

To Dr. Cohen, the EPA’s action level is a waste of time. “To worry about 4 picoCuries is really not justified,” he says.

But if you are worried, says Dr. Field, the hazard can be banished without much effort.

In fact, the EPA’s action level was set not because the agency thinks it’s a safe level but because if the radon is at 4 picoCuries, it is relatively easy and inexpensive to reduce it sharply, says Jalbert.

The standard way of reducing radon levels is called sub-slab depressurization. Dr. Field says.

It works like this. A homeowner hires someone to drill through the basement floor (the “slab”), dig out some of the soil to create a hole, and insert a piece of plastic pipe. Attach a fan to the pipe and run the other end through the wall of the house into the open.

The idea is that the fan will create an area of low pressure in the small hole under the slab; soil gas, including any radon, will seep into that area, rather than the house itself, and be vented harmlessly into the atmosphere.

“It costs anywhere from $700 on up,” Dr. Field says. Testing radon levels costs between $5 and $15 and should be done every few years, even if a radon mitigation system is installed in the house, he said.

The EPA says millions of American homes have been tested and about
575,000 have had mitigation systems installed.

People aren’t worried about radon because there are “no sensory reminders,” Dr. Field says – the gas is colorless, tasteless and odorless. “Because people don’t see it, they don’t think about it,” he says.

“If radon were purple, people would be testing like crazy.”

Primary source: British Medical Journal

Source reference:

Darby S et al. Radon in Homes and Risk of Lung Cancer: Collaborative Analysis of Individual Data from 13 European Case-control Studies. BMJ 2005 January 29, 330 (7485): 223.

Additional source: Epidemiology

Source reference:

Krewski D et al. Residential radon and risk of lung cancer: a combined analysis of 7 North American case-control studies. Epidemiology. 2005 Mar;16(2):137-45.

Additional source: Health Physics

Source reference:

Cohen BL. Lung cancer rate vs. mean radon level in U.S. counties of various characteristics. Health Phys. 1997 Jan;72(1):114-9.

WASHINGTON, Feb. 26 — The $634-billion healthcare slice of President Barack Obama’s budget takes the threat of reduced Medicare payment off the table this year and may provide a baseline for a permanent truce in the annual Medicare reimbursement battle.

A real fix will require Congress to recast the physician payment formula by eliminating the sustainable growth rate (SGR) formula, a calculation factor tied to the gross domestic product.

For more than a decade, the GDP link has threatened to automatically reduce physician payments each year, and each year Congress has stepped in at the last minute with a one-year fix.

This year the automatic cut would have reduced payments by 21%, but Obama’s budget resets the budget baseline to zero.

The net result is that the automatic cut is off the table — for now. And that was enough for the AMA to start celebrating.

“President Obama’s budget proposal takes a huge step forward to ensure that physicians can care for seniors by rejecting planned Medicare physician payment cuts of 40 percent over the next decade,” said AMA president Nancy Nielsen, M.D.

“Looming widespread physician shortages, coupled with aging baby boomers, highlight the urgent need for permanent Medicare physician payment system reform to preserve seniors’ access to healthcare,” she said in a prepared statement.

The president did not outline physician payment specifics in his budget but said, “The administration believes Medicare and the country need to move toward a system in which doctors face better incentives for high-quality care rather than simply more care.”

That “higher quality” will save $12 billion over the next decade, according to the budget document, which also calls for “comprehensive, but fiscally responsible reforms in the payment formula.”

The budget provides $634 billion to create a healthcare reform reserve over a 10-year-period.

Half of that money would come from raising taxes on the wealthiest Americans (with incomes over $250,000); the rest would come from “efficiency improvements,” such as payment reforms and tweaks to Medicare.

Among the details:

Saving $175 billion over 10 years by restructuring Medicare Advantage, the private plans offered to Medicare beneficiaries. Studies have shown that these plans cost the government 14% more than delivering the same services directly to beneficiaries. Under the Obama proposal, the private insurers operating those plans — generally favored by Republicans and opposed by Democrats — would have to enter competitive bids to serve beneficiaries. The winning bidder would have to offer coverage at a price equal to the average of the bids.

$26 billion in savings over 10 years by bundling hospital payments to include certain post-acute care. Under the plan, hospitals will be paid less if patients are re-admitted to the hospital within 30 days.

$330 million to address provider shortages in medically underserved areas. The money will go toward loan repayment programs for physicians, nurses, and dentists who practice in those areas. It would also increase the capacity of nursing schools and enlarge the dental health workforce.

Compared to current cost projections, the Medicare program would save $6 billion dollars from 2010 through 2019 if the president’s proposals are enacted.

The budget also outlines a plan to prevent private drug companies from blocking generic competitors. It calls for creating a “workable regulatory, scientific, and legal pathway” for generic drugs.

The president’s plan also calls for an increase in the Medicaid rebate that manufacturers must offer for brand-name drugs. Overall, proposed Medicaid changes would save $3 billion over the next decade.

The budget also mentions a “substantial increase,” but does not specify an exact amount, for the FDA, in part to help its efforts to make medical products safer.

According to an Office of Management and Budget official, the budget provides a basis for allowing the FDA to approve the re-importation of foreign drugs.

The spending plan would also provide the FDA with $1 billion to “increase and improve inspections, domestic surveillance, laboratory capacity, and domestic response to prevent and control food-borne illness.”

Obama also proposed doubling National Institutes of Health funds for cancer research. The recently enacted economic stimulus bill gave NIH $10 billion for research and upgrades.

The budget would allocate nearly $77 billion to the Department of Health and Human Services in 2010, an increase of $7 billion over fiscal 2008. It also proposes increasing resources to detect, prevent, and treat HIV/AIDs in the U.S.

The budget also includes:

$4 billion for the Indian Health Service
$211 million to HHS for autism research
$73 million to improve access to healthcare in rural areas
Money for states to provide home visits by nurses to first-time, low-income mothers
Support for state, community, and faith-based efforts to reduce teen pregnancy by promoting abstinence while providing “medically-accurate and age-appropriate information” to sexually active young people
Increased funding for domestic violence programs
Expanded treatment capacity for drug courts, including services for young methamphetamine addicts
Resources to address health disparities

The budget does not include a specific plan for expanding health insurance to more people, or other key features of a full healthcare reform plan. Details on such a plan will be worked out between the president and Congress, according to the Office of Management and Budget.

WASHINGTON, May 7 — An injectable, long-lasting form of the atypical antipsychotic drug paliperidone (Invega) markedly slowed the rate of relapse in patients with schizophrenia, a researcher said here.

An industry-sponsored trial was stopped early by its data monitoring committee because of the significant benefit of paliperidone palmitate over placebo, according to David Hough, M.D., of Johnson & Johnson Pharmaceutical Research & Development in Princeton, N.J., manufacturer of the drug.

The study was halted at a pre-planned level of 68 recurrences and 312 patients were included in the analysis at that point, Dr. Hough said at the American Psychiatric Association meeting.

That interim analysis showed that the average time to first recurrence for patients on placebo was 163 days; so few paliperidone patients had relapsed that the corresponding number could not yet be calculated, Dr. Hough reported.

The difference between the two arms was statistically significant at P

BRISTOL, England, March 21 — Even an extra 15 minutes a day of moderate to vigorous running, jumping, or kicking a ball can dramatically cut the risk of childhood obesity, according to researchers here.

In a cross-sectional study of more than 5,000 12-year-olds, a daily quarter-hour of moderate to vigorous exercise was associated with a 50% drop in the risk of obesity for boys, found Andy Ness, Ph.D., of the University of Bristol.

In girls, the decline in risk was lower, at nearly 40%, Dr. Ness and colleagues reported online in the open-access journal PLoS Medicine.

“The association between physical activity and obesity we observed was strong,” Dr. Ness said. “These associations suggest that modest increases in physical activity could lead to important reductions in childhood obesity.”

The study is among the first to use objective measures both of physical activity and lean and fat mass, the researchers said.

The study was part of the long-running prospective Avon Longitudinal Study of Parents and Children, which enrolled more than 14,000 pregnant women in England in 1991 and 1992 and has followed the mothers and children in detail since.

For this analysis, the researchers asked children in the larger study to wear an Actigraph, a device containing an accelerometer, for a week, taking it off only to bathe, to swim, or when cycling (because the instrument is not accurate for cycling).

The device registers vertical motion as counts per minute and has been validated as a measure of energy expenditure, Dr. Ness and colleagues said. For this study, the researchers calculated both total physical activity and moderate to vigorous activity, defined as an Actigraph output of more than 3,600 counts per minute.

The researchers calculated the body-mass index of the children using standard tools and also measured fat and lean mass using dual energy x-ray absorptiometry scanning.

Of the 6,622 children who agreed to wear an Actigraph, 5,595 wore it at least 10 hours a day for at least three days and were included in the analysis. Absorptiometry scanning was available for 5,500 of them.

Analysis found “a strong negative dose-response association between objectively measured physical activity and DXA-derived measures of fat mass and obesity,” the researchers said.

Specifically:

In boys, a difference of 15 minutes of moderate to vigorous activity was associated with between a 55% and 70% reduction in the risk of obesity, depending on which multivariate model was used. Both risk reductions were highly significant at P

VANCOUVER — When parents administer complicated drug regimens to children with chronic diseases, errors are common and sometimes result in injury, a researcher said here.
The process is “highly chaotic and error-prone,” said Kathleen Walsh, MD, of the University of Massachusetts Medical School in Worcester.
What’s more, most mistakes go undetected by parents and physicians, Walsh told a scientific session at the meeting of the Pediatric Academic Societies.

“Many of the errors we found at home were insidious,” Walsh told MedPage Today after her presentation. “Parents thought what they were doing was right, and the doctors thought what the parents were doing was right.”

The findings, from in-home observations of parents and children, suggest that most errors are not simple measuring mistakes but instead are “highly complex and not likely to be solved with a single intervention,” Walsh told attendees.

She and colleagues conducted home visits — including direct observations of treatment, interviews with parents, and review of dosing and labeling — with 78 families whose children had sickle cell disease, seizure disorder, or cancer.

Walsh noted that the parents involved had a median score of 90 on the Short Test of Functional Health Literacy, suggesting “this is a pretty literate group.”

The median number of medications was four for children with sickle cell, five for those with seizures, and 10 for those with cancer. But the numbers ranged as high as 12, 17, and 26, respectively, Walsh said.

The researchers observed delivery of 166 medications to 83 children and found that 24% were associated with an error, Walsh said.

Parents were not aware of 54% of the mistakes they made, and the doctors involved were not aware of 80%, she said.

The most common error varied with type of disease: For sickle cell, missed doses were most frequent, followed by administration errors. For seizures and cancer, incorrect drug labeling was most common followed again by administration errors.

Incorrect drug labeling arises because drugs are titrated up and down, and often the original label “had nothing to do with how the child was currently taking the medication,” Walsh said.

Such an error can lead to problems if the parent who usually handles medication hands the job off to the other for some reason, she said.

Administration errors can result in improper dosing, she said, citing a case in which a parent used the wrong equipment to cut pills, resulting in most of the dose being crushed and unusable.

Walsh said the study possibly missed some errors, including any that resulted in injury serious enough to mean the child was not in the home at the time of the visit.

The findings are not surprising, given that more and more care for such complicated conditions is being given outside a medical setting, said Charles Irwin, MD, of the University of California San Francisco. Irwin was not part of the study but moderated the session at which it was presented.

“Surgical patients are come-and-go, most oncologic treatments now are come-and-go,” he told MedPage Today. “I’m always surprised at how complicated regimens are for both adults and children.”

“We have errors in hospital,” he said, where drugs are given by trained professionals. “It’s not surprising to me” that the same thing could happen in the home, Irwin said.

Walsh did not report any external support for the study and said she had nothing to disclose.

Irwin had no disclosures.

TORONTO, May 25 — The novel antipsychotic Abilify (aripiprazole) is well tolerated and effective in the acute and maintenance setting for schizophrenia as well as in patients with bipolar I disorder, even when they have high levels of agitation.

These were the key findings of three company-sponsored studies presented at the American Psychiatric Association meeting here.

The Schizophrenia Trial of Aripiprazole (STAR) assessed the drug’s overall effectiveness, encompassing aspects of symptom relief, safety, tolerability, patient preference for drug, and quality of life in a naturalistic, real-world setting. STAR results were presented in a poster by Prof. Robert Kerwin of the Institute of Psychiatry at King’s College, London.

The 555 STAR participants were community-treated schizophrenia patients who required a change in medication because of tolerability problems or poor symptom control. They were evenly randomized to open-label treatment with Abilify at 10 mg to 30 mg/day or to standard care, which consisted of treatment with one of three atypical antipsychotic medications: Zyprexa (olanzapine) at 5 mg to 20 mg/day, Seroquel (quetiapine), at 100 mg to 800 mg/day, or Risperdal (risperidone) 2 mg to 8 mg/day, according to clinical discretion.

At every time point during the course of the 26-week trial, according to the investigator, Abilify showed superior effectiveness compared with controls as assessed by the Investigator Assessment Questionnaire (IAQ) Total Score (P