Pay for Performance Not Yet Showing Efficacy

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SEATTLE — When the physicians of Rochester, N.Y., first had a pay-for-performance program imposed on them, they ignored it.

That denial ended when the first performance-based checks were disbursed, and after 3 years, pay-for-performance (P4P) measures have paid off in reduced health plan costs of almost $5 million, said Dr. Howard B. Beckman, the medical director of the Rochester Individual Physician Association (IPA), speaking at the annual research meeting of AcademyHealth.

Dr. Beckman was one of three physicians who presented research on whether pay for performance improves quality of care and efficiency in medicine enough to make worthwhile all the effort being put into it. He was the only one of the three to have a positive conclusion.

The other two investigations of pay for performance, in California and Massachusetts, looked more specifically at individual aspects of clinical care. Those investigators found they could not document an impact from the programs.

But those investigators also pointed out that, as in Rochester, it takes time for physicians to get accustomed to the idea of greater accountability, and to develop the capabilities to record and report for the programs, so their findings might reflect the fact that the programs have not been going long enough.

On the other hand, the findings may show that financial incentives do not work for professionals, something research in other fields has suggested, they noted.

The Rochester physicians went through stages of acceptance of pay for performance, Dr. Beckman said.

After the first performance bonus checks were sent out and denial ended, there was anger. The physicians complained that strict performance measures impinge on their autonomy, and they were even offended by the implication that money could influence their behavior, he said.

Then, after about 2 years, the general resistance abated, and the angry phone calls stopped, Dr. Beckman said. Now when he gets phone calls about the program, it is an individual physician trying to negotiate something.

The Rochester IPA represents all 3,200 physicians in the Rochester area and has insurance contracts that cover about 50% of the community market. Its individual physician profiling program began in 2002.

The program's individual physician payments vary, but overall the program pays out about $15 million a year, and the average internist can earn from $4,000 to $12,000 from the quality reports. The physicians get three reports a year, and payments are made at the end of the year.

Dr. Beckman looked at the provider profile data for patients with diabetes and coronary artery disease. He found that when expected costs were compared with actual costs in the diabetes patients in 2003 and 2004, there was a savings of about $1 million in the first year and $2 million in the second year. Most of that savings, about $1.3 million, came from reduced inpatient hospitalization costs.

The savings for the coronary artery disease patients was about $2 million over the 2 years, for a total savings for just those two groups of patients of about $5 million, Dr. Beckman said. Given what the group had put into the program (about $1.1 million, mostly for computer capability), the return on investment for the program was about four times what was spent.

Dr. Beckman pointed out that many people have expressed concern that pay-for-performance programs could be unfair to physicians with the most difficult, least compliant patients, so he looked at different practices. It appeared that differences were greater between individual doctors than they were between practices and practice locations.

Pay for performance began in California at about the same time as the Rochester program, and it has yet to show any meaningful overall improvement in clinical care, said Cheryl L. Damberg, Ph.D., a researcher for the RAND Corp., who has been analyzing data from the California collaborative managed by the Integrated Healthcare Association, which includes seven HMOs and point-of-service plans contracting with 225 physician groups.

In Massachusetts, doctors with pay-for-performance contracts have improved their quality since programs were introduced into the state, but so have doctors without contracts, said Dr. Steven D. Pearson, the director of the Center for Ethics in Managed Care at Harvard Medical School, Boston.

He looked at data collected from the state's pay-for-performance programs put together by the Massachusetts Health Quality Partnership, a collaboration of five nonprofit health plans covering 4 million people, and physician groups representing about 5,000 primary care physicians.

In 2001, there were four pay-for-performance contracts in the state. That rose to 8 in 2002, and 18 in 2003.

Comparing Health Plan Employer Data and Information Set measures from the groups with those contracts to measures from control groups without contracts, Dr. Pearson found that, for 4 of 30 measures, the contract groups had more improvement for those years than the control groups. For 21 measures, the groups had similar improvement.

 

 

But, for five measures—chlamydia testing, hemoglobin A1c testing in diabetics, LDL cholesterol testing in diabetics, urine testing in diabetics, and well-child visits by adolescents—the control groups had more improvement. And, two of the four measures for which the contract groups outperformed the control groups were dominated by a special contract and a single 38-physician practice, Dr. Pearson said.

Moreover, when he restricted his analysis to just groups termed “high-incentive” groups, there was still no more improvement than in controls. High-incentive groups were defined as ones that could receive performance bonuses of $100,000 or more, or for whom individual primary care physicians could receive bonuses of more than $1,000.

There are two plausible explanations for the findings, Dr. Pearson said. “Either P4P has worked in Massachusetts because it is part of this atmosphere of driving quality improvement or P4P has failed because it is either too weak—not enough money on the table—or it was poorly designed.”

Money indeed may turn out to be the pressing issue as pay for performance becomes more common.

Slowly but surely, many physicians seem to be coming around to pay for performance because they see it as an effort in medicine to make quality a priority, these investigators said.

But Dr. Damberg said California groups have told her they want help recouping their investments. If it doesn't come, she is afraid they will lose patience. “It is really still too early to declare victory or defeat for pay for performance,” Dr. Damberg concluded.

Ignoring pay for performance won't make it go away, said Dr. Howard B. Beckman, medical director of the Rochester IPA. Timothy F. Kirn/Elsevier Global Medical News

Fragmented Care Undermines P4P

Pay-for-performance schemes may be thwarted by patients seeing too many doctors, making it difficult to assign any one patient's care to a particular physician, according to a study presented at the annual research meeting of AcademyHealth.

The average Medicare patient sees seven physicians (two primary care, five specialists) over a 2-year period, Dr. Hoangmai Pham, a senior researcher with the Center for Studying Health System Change, Washington, said at the meeting.

Dr. Pham analyzed data from a number of Medicare sources to come to her conclusion. These sources included claims data and nationwide physician surveys for 2000–2003.

Not only do patients see a number of physicians, but their main physician may not even see them the majority of the time; they also switch their primary provider often.

Only 53% of Medicare beneficiaries' evaluation and management visits, and 35% of their total visits, are with the physician identified as their primary, or usual-source-of-care, physician.

During a 2-year period, 30% of beneficiaries switch their usual-source-of-care physician, and in 59% of the cases where beneficiaries switch, they never even see one of the designated physicians in a year, Dr. Pham said.

According to the physician survey data, a primary care physician's regular, usual-source-of-care patients make up an average of only 39% of his or her total patient population.

What is really needed is an overhaul of the way the medical system is organized to allow single physicians or groups to be responsible for individual patients.

Alternatively, there needs to be more financial incentive in pay for performance to make it worthwhile for physicians to invest in the infrastructure needed to participate, because they are going to be able to show good performance for only a small proportion of their patients, she added.

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SEATTLE — When the physicians of Rochester, N.Y., first had a pay-for-performance program imposed on them, they ignored it.

That denial ended when the first performance-based checks were disbursed, and after 3 years, pay-for-performance (P4P) measures have paid off in reduced health plan costs of almost $5 million, said Dr. Howard B. Beckman, the medical director of the Rochester Individual Physician Association (IPA), speaking at the annual research meeting of AcademyHealth.

Dr. Beckman was one of three physicians who presented research on whether pay for performance improves quality of care and efficiency in medicine enough to make worthwhile all the effort being put into it. He was the only one of the three to have a positive conclusion.

The other two investigations of pay for performance, in California and Massachusetts, looked more specifically at individual aspects of clinical care. Those investigators found they could not document an impact from the programs.

But those investigators also pointed out that, as in Rochester, it takes time for physicians to get accustomed to the idea of greater accountability, and to develop the capabilities to record and report for the programs, so their findings might reflect the fact that the programs have not been going long enough.

On the other hand, the findings may show that financial incentives do not work for professionals, something research in other fields has suggested, they noted.

The Rochester physicians went through stages of acceptance of pay for performance, Dr. Beckman said.

After the first performance bonus checks were sent out and denial ended, there was anger. The physicians complained that strict performance measures impinge on their autonomy, and they were even offended by the implication that money could influence their behavior, he said.

Then, after about 2 years, the general resistance abated, and the angry phone calls stopped, Dr. Beckman said. Now when he gets phone calls about the program, it is an individual physician trying to negotiate something.

The Rochester IPA represents all 3,200 physicians in the Rochester area and has insurance contracts that cover about 50% of the community market. Its individual physician profiling program began in 2002.

The program's individual physician payments vary, but overall the program pays out about $15 million a year, and the average internist can earn from $4,000 to $12,000 from the quality reports. The physicians get three reports a year, and payments are made at the end of the year.

Dr. Beckman looked at the provider profile data for patients with diabetes and coronary artery disease. He found that when expected costs were compared with actual costs in the diabetes patients in 2003 and 2004, there was a savings of about $1 million in the first year and $2 million in the second year. Most of that savings, about $1.3 million, came from reduced inpatient hospitalization costs.

The savings for the coronary artery disease patients was about $2 million over the 2 years, for a total savings for just those two groups of patients of about $5 million, Dr. Beckman said. Given what the group had put into the program (about $1.1 million, mostly for computer capability), the return on investment for the program was about four times what was spent.

Dr. Beckman pointed out that many people have expressed concern that pay-for-performance programs could be unfair to physicians with the most difficult, least compliant patients, so he looked at different practices. It appeared that differences were greater between individual doctors than they were between practices and practice locations.

Pay for performance began in California at about the same time as the Rochester program, and it has yet to show any meaningful overall improvement in clinical care, said Cheryl L. Damberg, Ph.D., a researcher for the RAND Corp., who has been analyzing data from the California collaborative managed by the Integrated Healthcare Association, which includes seven HMOs and point-of-service plans contracting with 225 physician groups.

In Massachusetts, doctors with pay-for-performance contracts have improved their quality since programs were introduced into the state, but so have doctors without contracts, said Dr. Steven D. Pearson, the director of the Center for Ethics in Managed Care at Harvard Medical School, Boston.

He looked at data collected from the state's pay-for-performance programs put together by the Massachusetts Health Quality Partnership, a collaboration of five nonprofit health plans covering 4 million people, and physician groups representing about 5,000 primary care physicians.

In 2001, there were four pay-for-performance contracts in the state. That rose to 8 in 2002, and 18 in 2003.

Comparing Health Plan Employer Data and Information Set measures from the groups with those contracts to measures from control groups without contracts, Dr. Pearson found that, for 4 of 30 measures, the contract groups had more improvement for those years than the control groups. For 21 measures, the groups had similar improvement.

 

 

But, for five measures—chlamydia testing, hemoglobin A1c testing in diabetics, LDL cholesterol testing in diabetics, urine testing in diabetics, and well-child visits by adolescents—the control groups had more improvement. And, two of the four measures for which the contract groups outperformed the control groups were dominated by a special contract and a single 38-physician practice, Dr. Pearson said.

Moreover, when he restricted his analysis to just groups termed “high-incentive” groups, there was still no more improvement than in controls. High-incentive groups were defined as ones that could receive performance bonuses of $100,000 or more, or for whom individual primary care physicians could receive bonuses of more than $1,000.

There are two plausible explanations for the findings, Dr. Pearson said. “Either P4P has worked in Massachusetts because it is part of this atmosphere of driving quality improvement or P4P has failed because it is either too weak—not enough money on the table—or it was poorly designed.”

Money indeed may turn out to be the pressing issue as pay for performance becomes more common.

Slowly but surely, many physicians seem to be coming around to pay for performance because they see it as an effort in medicine to make quality a priority, these investigators said.

But Dr. Damberg said California groups have told her they want help recouping their investments. If it doesn't come, she is afraid they will lose patience. “It is really still too early to declare victory or defeat for pay for performance,” Dr. Damberg concluded.

Ignoring pay for performance won't make it go away, said Dr. Howard B. Beckman, medical director of the Rochester IPA. Timothy F. Kirn/Elsevier Global Medical News

Fragmented Care Undermines P4P

Pay-for-performance schemes may be thwarted by patients seeing too many doctors, making it difficult to assign any one patient's care to a particular physician, according to a study presented at the annual research meeting of AcademyHealth.

The average Medicare patient sees seven physicians (two primary care, five specialists) over a 2-year period, Dr. Hoangmai Pham, a senior researcher with the Center for Studying Health System Change, Washington, said at the meeting.

Dr. Pham analyzed data from a number of Medicare sources to come to her conclusion. These sources included claims data and nationwide physician surveys for 2000–2003.

Not only do patients see a number of physicians, but their main physician may not even see them the majority of the time; they also switch their primary provider often.

Only 53% of Medicare beneficiaries' evaluation and management visits, and 35% of their total visits, are with the physician identified as their primary, or usual-source-of-care, physician.

During a 2-year period, 30% of beneficiaries switch their usual-source-of-care physician, and in 59% of the cases where beneficiaries switch, they never even see one of the designated physicians in a year, Dr. Pham said.

According to the physician survey data, a primary care physician's regular, usual-source-of-care patients make up an average of only 39% of his or her total patient population.

What is really needed is an overhaul of the way the medical system is organized to allow single physicians or groups to be responsible for individual patients.

Alternatively, there needs to be more financial incentive in pay for performance to make it worthwhile for physicians to invest in the infrastructure needed to participate, because they are going to be able to show good performance for only a small proportion of their patients, she added.

SEATTLE — When the physicians of Rochester, N.Y., first had a pay-for-performance program imposed on them, they ignored it.

That denial ended when the first performance-based checks were disbursed, and after 3 years, pay-for-performance (P4P) measures have paid off in reduced health plan costs of almost $5 million, said Dr. Howard B. Beckman, the medical director of the Rochester Individual Physician Association (IPA), speaking at the annual research meeting of AcademyHealth.

Dr. Beckman was one of three physicians who presented research on whether pay for performance improves quality of care and efficiency in medicine enough to make worthwhile all the effort being put into it. He was the only one of the three to have a positive conclusion.

The other two investigations of pay for performance, in California and Massachusetts, looked more specifically at individual aspects of clinical care. Those investigators found they could not document an impact from the programs.

But those investigators also pointed out that, as in Rochester, it takes time for physicians to get accustomed to the idea of greater accountability, and to develop the capabilities to record and report for the programs, so their findings might reflect the fact that the programs have not been going long enough.

On the other hand, the findings may show that financial incentives do not work for professionals, something research in other fields has suggested, they noted.

The Rochester physicians went through stages of acceptance of pay for performance, Dr. Beckman said.

After the first performance bonus checks were sent out and denial ended, there was anger. The physicians complained that strict performance measures impinge on their autonomy, and they were even offended by the implication that money could influence their behavior, he said.

Then, after about 2 years, the general resistance abated, and the angry phone calls stopped, Dr. Beckman said. Now when he gets phone calls about the program, it is an individual physician trying to negotiate something.

The Rochester IPA represents all 3,200 physicians in the Rochester area and has insurance contracts that cover about 50% of the community market. Its individual physician profiling program began in 2002.

The program's individual physician payments vary, but overall the program pays out about $15 million a year, and the average internist can earn from $4,000 to $12,000 from the quality reports. The physicians get three reports a year, and payments are made at the end of the year.

Dr. Beckman looked at the provider profile data for patients with diabetes and coronary artery disease. He found that when expected costs were compared with actual costs in the diabetes patients in 2003 and 2004, there was a savings of about $1 million in the first year and $2 million in the second year. Most of that savings, about $1.3 million, came from reduced inpatient hospitalization costs.

The savings for the coronary artery disease patients was about $2 million over the 2 years, for a total savings for just those two groups of patients of about $5 million, Dr. Beckman said. Given what the group had put into the program (about $1.1 million, mostly for computer capability), the return on investment for the program was about four times what was spent.

Dr. Beckman pointed out that many people have expressed concern that pay-for-performance programs could be unfair to physicians with the most difficult, least compliant patients, so he looked at different practices. It appeared that differences were greater between individual doctors than they were between practices and practice locations.

Pay for performance began in California at about the same time as the Rochester program, and it has yet to show any meaningful overall improvement in clinical care, said Cheryl L. Damberg, Ph.D., a researcher for the RAND Corp., who has been analyzing data from the California collaborative managed by the Integrated Healthcare Association, which includes seven HMOs and point-of-service plans contracting with 225 physician groups.

In Massachusetts, doctors with pay-for-performance contracts have improved their quality since programs were introduced into the state, but so have doctors without contracts, said Dr. Steven D. Pearson, the director of the Center for Ethics in Managed Care at Harvard Medical School, Boston.

He looked at data collected from the state's pay-for-performance programs put together by the Massachusetts Health Quality Partnership, a collaboration of five nonprofit health plans covering 4 million people, and physician groups representing about 5,000 primary care physicians.

In 2001, there were four pay-for-performance contracts in the state. That rose to 8 in 2002, and 18 in 2003.

Comparing Health Plan Employer Data and Information Set measures from the groups with those contracts to measures from control groups without contracts, Dr. Pearson found that, for 4 of 30 measures, the contract groups had more improvement for those years than the control groups. For 21 measures, the groups had similar improvement.

 

 

But, for five measures—chlamydia testing, hemoglobin A1c testing in diabetics, LDL cholesterol testing in diabetics, urine testing in diabetics, and well-child visits by adolescents—the control groups had more improvement. And, two of the four measures for which the contract groups outperformed the control groups were dominated by a special contract and a single 38-physician practice, Dr. Pearson said.

Moreover, when he restricted his analysis to just groups termed “high-incentive” groups, there was still no more improvement than in controls. High-incentive groups were defined as ones that could receive performance bonuses of $100,000 or more, or for whom individual primary care physicians could receive bonuses of more than $1,000.

There are two plausible explanations for the findings, Dr. Pearson said. “Either P4P has worked in Massachusetts because it is part of this atmosphere of driving quality improvement or P4P has failed because it is either too weak—not enough money on the table—or it was poorly designed.”

Money indeed may turn out to be the pressing issue as pay for performance becomes more common.

Slowly but surely, many physicians seem to be coming around to pay for performance because they see it as an effort in medicine to make quality a priority, these investigators said.

But Dr. Damberg said California groups have told her they want help recouping their investments. If it doesn't come, she is afraid they will lose patience. “It is really still too early to declare victory or defeat for pay for performance,” Dr. Damberg concluded.

Ignoring pay for performance won't make it go away, said Dr. Howard B. Beckman, medical director of the Rochester IPA. Timothy F. Kirn/Elsevier Global Medical News

Fragmented Care Undermines P4P

Pay-for-performance schemes may be thwarted by patients seeing too many doctors, making it difficult to assign any one patient's care to a particular physician, according to a study presented at the annual research meeting of AcademyHealth.

The average Medicare patient sees seven physicians (two primary care, five specialists) over a 2-year period, Dr. Hoangmai Pham, a senior researcher with the Center for Studying Health System Change, Washington, said at the meeting.

Dr. Pham analyzed data from a number of Medicare sources to come to her conclusion. These sources included claims data and nationwide physician surveys for 2000–2003.

Not only do patients see a number of physicians, but their main physician may not even see them the majority of the time; they also switch their primary provider often.

Only 53% of Medicare beneficiaries' evaluation and management visits, and 35% of their total visits, are with the physician identified as their primary, or usual-source-of-care, physician.

During a 2-year period, 30% of beneficiaries switch their usual-source-of-care physician, and in 59% of the cases where beneficiaries switch, they never even see one of the designated physicians in a year, Dr. Pham said.

According to the physician survey data, a primary care physician's regular, usual-source-of-care patients make up an average of only 39% of his or her total patient population.

What is really needed is an overhaul of the way the medical system is organized to allow single physicians or groups to be responsible for individual patients.

Alternatively, there needs to be more financial incentive in pay for performance to make it worthwhile for physicians to invest in the infrastructure needed to participate, because they are going to be able to show good performance for only a small proportion of their patients, she added.

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Faced With Part D Gap, Some Go Without Drugs

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SEATTLE — Patients taking cholesterol-lowering drugs who are in pharmacy-capped plans, like the new Medicare Part D drug benefit, often stop taking their drugs when they reach the cap, Geoffrey Joyce, Ph.D., said at the annual research meeting of Academy Health.

Between 6% and 11% of patients in the Medicare Part D program are likely to hit the so-called “doughnut hole” of coverage in any given year, said Dr. Joyce, a senior economist with the RAND Corp., Santa Monica, Calif.

The so-called doughnut hole is the gap in coverage that goes into effect during a coverage year when a patient's drug expenditures reach $2,250, and continues until the expenditures reach $5,100. After expenditures have reached $5,100, catastrophic coverage kicks in and patients pay only 5% of costs. Within the doughnut hole, patients pay 100% of their drug costs.

Dr. Joyce and colleagues looked at two employer health plans with drug benefits that had a cap on coverage of $2,500, in order to get an idea of what is likely to happen with the Medicare plan.

In the years considered (2003 and 2004), 7% of beneficiaries in one plan and 11% in the other plan hit the cap.

The median time of year when patients hit the cap was September. However, one quarter of the patients who hit the cap did so in June, meaning they had no drug coverage for a full 6 months, Dr. Joyce said.

Patients did not appear to switch from brand-name drugs to generic drugs in any appreciable degree when they reached the cap. However, some patients did stop taking certain drugs. The most common medications the patients stopped taking were cholesterol-lowering drugs and antidepressants.

What was most concerning about those who stopped was that only about 40% of those who stopped then restarted those drugs at the beginning of the new year, Dr. Joyce said.

Previous studies of drug benefit caps have shown that they do reduce plan costs significantly. In one study of a Kaiser Permanente plan, a cap resulted in 31% lower drug costs.

That study found, however, that there may be a price to pay for curtailing drug benefits too drastically, Dr. Joyce noted.

Overall, the Kaiser study found that the capped plan did not result in higher medical care costs. But there were more hospitalizations and more emergency department visits in the capped plan, than in a noncapped plan. There was also a 22% higher mortality in patients in the capped plan.

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SEATTLE — Patients taking cholesterol-lowering drugs who are in pharmacy-capped plans, like the new Medicare Part D drug benefit, often stop taking their drugs when they reach the cap, Geoffrey Joyce, Ph.D., said at the annual research meeting of Academy Health.

Between 6% and 11% of patients in the Medicare Part D program are likely to hit the so-called “doughnut hole” of coverage in any given year, said Dr. Joyce, a senior economist with the RAND Corp., Santa Monica, Calif.

The so-called doughnut hole is the gap in coverage that goes into effect during a coverage year when a patient's drug expenditures reach $2,250, and continues until the expenditures reach $5,100. After expenditures have reached $5,100, catastrophic coverage kicks in and patients pay only 5% of costs. Within the doughnut hole, patients pay 100% of their drug costs.

Dr. Joyce and colleagues looked at two employer health plans with drug benefits that had a cap on coverage of $2,500, in order to get an idea of what is likely to happen with the Medicare plan.

In the years considered (2003 and 2004), 7% of beneficiaries in one plan and 11% in the other plan hit the cap.

The median time of year when patients hit the cap was September. However, one quarter of the patients who hit the cap did so in June, meaning they had no drug coverage for a full 6 months, Dr. Joyce said.

Patients did not appear to switch from brand-name drugs to generic drugs in any appreciable degree when they reached the cap. However, some patients did stop taking certain drugs. The most common medications the patients stopped taking were cholesterol-lowering drugs and antidepressants.

What was most concerning about those who stopped was that only about 40% of those who stopped then restarted those drugs at the beginning of the new year, Dr. Joyce said.

Previous studies of drug benefit caps have shown that they do reduce plan costs significantly. In one study of a Kaiser Permanente plan, a cap resulted in 31% lower drug costs.

That study found, however, that there may be a price to pay for curtailing drug benefits too drastically, Dr. Joyce noted.

Overall, the Kaiser study found that the capped plan did not result in higher medical care costs. But there were more hospitalizations and more emergency department visits in the capped plan, than in a noncapped plan. There was also a 22% higher mortality in patients in the capped plan.

SEATTLE — Patients taking cholesterol-lowering drugs who are in pharmacy-capped plans, like the new Medicare Part D drug benefit, often stop taking their drugs when they reach the cap, Geoffrey Joyce, Ph.D., said at the annual research meeting of Academy Health.

Between 6% and 11% of patients in the Medicare Part D program are likely to hit the so-called “doughnut hole” of coverage in any given year, said Dr. Joyce, a senior economist with the RAND Corp., Santa Monica, Calif.

The so-called doughnut hole is the gap in coverage that goes into effect during a coverage year when a patient's drug expenditures reach $2,250, and continues until the expenditures reach $5,100. After expenditures have reached $5,100, catastrophic coverage kicks in and patients pay only 5% of costs. Within the doughnut hole, patients pay 100% of their drug costs.

Dr. Joyce and colleagues looked at two employer health plans with drug benefits that had a cap on coverage of $2,500, in order to get an idea of what is likely to happen with the Medicare plan.

In the years considered (2003 and 2004), 7% of beneficiaries in one plan and 11% in the other plan hit the cap.

The median time of year when patients hit the cap was September. However, one quarter of the patients who hit the cap did so in June, meaning they had no drug coverage for a full 6 months, Dr. Joyce said.

Patients did not appear to switch from brand-name drugs to generic drugs in any appreciable degree when they reached the cap. However, some patients did stop taking certain drugs. The most common medications the patients stopped taking were cholesterol-lowering drugs and antidepressants.

What was most concerning about those who stopped was that only about 40% of those who stopped then restarted those drugs at the beginning of the new year, Dr. Joyce said.

Previous studies of drug benefit caps have shown that they do reduce plan costs significantly. In one study of a Kaiser Permanente plan, a cap resulted in 31% lower drug costs.

That study found, however, that there may be a price to pay for curtailing drug benefits too drastically, Dr. Joyce noted.

Overall, the Kaiser study found that the capped plan did not result in higher medical care costs. But there were more hospitalizations and more emergency department visits in the capped plan, than in a noncapped plan. There was also a 22% higher mortality in patients in the capped plan.

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Enterovirus 71 May Be Transmissible by Respiration

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ASPEN, COLO. — When Colorado had two separate outbreaks of aseptic meningoencephalitis associated with enterovirus 71, the patients were more likely to have the virus detected in throat swabs than in the cerebrospinal fluid, Dr. Mark J. Abzug said at a conference on pediatric infectious disease sponsored by Children's Hospital, Denver.

That may mean this particular virus is easily transmissible via respiratory secretions, and that could explain the recent, prolonged outbreaks of this very serious disease that have been occurring in various locations, primarily in East Asian countries and most notably in Taiwan, said Dr. Abzug, a professor of pediatrics at the University of Colorado, Denver.

In the outbreaks, infection with this virus has been associated with brain stem encephalitis with an acute flaccid paralysis reminiscent of polio and, in the cases where it has proved fatal, pulmonary edema and cardiovascular collapse.

In children less than 5 years of age, who make up the majority of patients with these infections, the disease has been fatal in 20% of cases, Dr. Abzug said.

Colorado has had 17 cases, with 8 in 2003 and 9 in 2005. The individual children ranged in age from 4 months to 9 years, although most were under 5 years of age. One child died and one was left respirator dependent. Three were left with some persistent paralysis.

Only 5 of these 17 patients had virus retrieved from the cerebrospinal fluid, with all of the testing being polymerase chain reaction (PCR) assay. These patients tended to be the younger ones; they generally were tapped early in the course of their illness, and none had pleocytosis. Most of these patients had less severe disease.

Those with pleocytosis tended to be the older patients, and they generally did not have virus retrieved from their cerebrospinal fluid.

On the other hand, all of the 12 patients who had throat swabs tested by PCR were positive for the virus. Some of these patients had stools that tested positive as well. Many of these patients had mucocutaneous rash, and the progression in those who developed acute flaccid paralysis was rapid, Dr. Abzug said.

Imaging of patients has suggested that the virus causes lesions in the spinal anterior horn cells, much like polio virus does. The hypothesis is that the cardiopulmonary manifestations of severe cases comes not from direct destruction of the heart and lungs by the virus, but rather from the brain stem lesions causing sympathetic system hyperactivity.

Care of these patients is largely supportive, Dr. Abzug added. In Taiwan, physicians have treated patients with intravenous immunoglobulin, but the experience has suggested that it does not help, and a small trial conducted in Australia of immunoglobulin also found it was of no benefit. Others have tried interferon-α, corticosteroids, and pleconaril, none of which have shown any benefit.

Supportive care includes fluid restriction and vasodilators for those with cardiac and pulmonary involvement. Inotropes have been shown to be associated with a worse outcome, but milrinone, which is both an inotrope and a vasodilator, may be associated with some improvement in outcome.

Notable enterovirus 71-encephalitis outbreaks are becoming more common, but infection does not appear to be rare, and it is not seen just in foreign locales, Dr. Abzug said. One serosurvey conducted in New York state found that 26% of adults had antibodies to the virus. Prior to the Colorado cases, there was a previous U.S. outbreak in 1994.

There have been three proposed explanations for the recent outbreaks. One is that the virus itself may be becoming more neurovirulent. Another is that it has become more readily transmissible via respiration. The last is that perhaps more people are becoming susceptible to serious sequelae.

Prior to the Colorado evidence, findings from Taiwan have suggested that all three are probably factors, Dr. Abzug said.

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ASPEN, COLO. — When Colorado had two separate outbreaks of aseptic meningoencephalitis associated with enterovirus 71, the patients were more likely to have the virus detected in throat swabs than in the cerebrospinal fluid, Dr. Mark J. Abzug said at a conference on pediatric infectious disease sponsored by Children's Hospital, Denver.

That may mean this particular virus is easily transmissible via respiratory secretions, and that could explain the recent, prolonged outbreaks of this very serious disease that have been occurring in various locations, primarily in East Asian countries and most notably in Taiwan, said Dr. Abzug, a professor of pediatrics at the University of Colorado, Denver.

In the outbreaks, infection with this virus has been associated with brain stem encephalitis with an acute flaccid paralysis reminiscent of polio and, in the cases where it has proved fatal, pulmonary edema and cardiovascular collapse.

In children less than 5 years of age, who make up the majority of patients with these infections, the disease has been fatal in 20% of cases, Dr. Abzug said.

Colorado has had 17 cases, with 8 in 2003 and 9 in 2005. The individual children ranged in age from 4 months to 9 years, although most were under 5 years of age. One child died and one was left respirator dependent. Three were left with some persistent paralysis.

Only 5 of these 17 patients had virus retrieved from the cerebrospinal fluid, with all of the testing being polymerase chain reaction (PCR) assay. These patients tended to be the younger ones; they generally were tapped early in the course of their illness, and none had pleocytosis. Most of these patients had less severe disease.

Those with pleocytosis tended to be the older patients, and they generally did not have virus retrieved from their cerebrospinal fluid.

On the other hand, all of the 12 patients who had throat swabs tested by PCR were positive for the virus. Some of these patients had stools that tested positive as well. Many of these patients had mucocutaneous rash, and the progression in those who developed acute flaccid paralysis was rapid, Dr. Abzug said.

Imaging of patients has suggested that the virus causes lesions in the spinal anterior horn cells, much like polio virus does. The hypothesis is that the cardiopulmonary manifestations of severe cases comes not from direct destruction of the heart and lungs by the virus, but rather from the brain stem lesions causing sympathetic system hyperactivity.

Care of these patients is largely supportive, Dr. Abzug added. In Taiwan, physicians have treated patients with intravenous immunoglobulin, but the experience has suggested that it does not help, and a small trial conducted in Australia of immunoglobulin also found it was of no benefit. Others have tried interferon-α, corticosteroids, and pleconaril, none of which have shown any benefit.

Supportive care includes fluid restriction and vasodilators for those with cardiac and pulmonary involvement. Inotropes have been shown to be associated with a worse outcome, but milrinone, which is both an inotrope and a vasodilator, may be associated with some improvement in outcome.

Notable enterovirus 71-encephalitis outbreaks are becoming more common, but infection does not appear to be rare, and it is not seen just in foreign locales, Dr. Abzug said. One serosurvey conducted in New York state found that 26% of adults had antibodies to the virus. Prior to the Colorado cases, there was a previous U.S. outbreak in 1994.

There have been three proposed explanations for the recent outbreaks. One is that the virus itself may be becoming more neurovirulent. Another is that it has become more readily transmissible via respiration. The last is that perhaps more people are becoming susceptible to serious sequelae.

Prior to the Colorado evidence, findings from Taiwan have suggested that all three are probably factors, Dr. Abzug said.

ASPEN, COLO. — When Colorado had two separate outbreaks of aseptic meningoencephalitis associated with enterovirus 71, the patients were more likely to have the virus detected in throat swabs than in the cerebrospinal fluid, Dr. Mark J. Abzug said at a conference on pediatric infectious disease sponsored by Children's Hospital, Denver.

That may mean this particular virus is easily transmissible via respiratory secretions, and that could explain the recent, prolonged outbreaks of this very serious disease that have been occurring in various locations, primarily in East Asian countries and most notably in Taiwan, said Dr. Abzug, a professor of pediatrics at the University of Colorado, Denver.

In the outbreaks, infection with this virus has been associated with brain stem encephalitis with an acute flaccid paralysis reminiscent of polio and, in the cases where it has proved fatal, pulmonary edema and cardiovascular collapse.

In children less than 5 years of age, who make up the majority of patients with these infections, the disease has been fatal in 20% of cases, Dr. Abzug said.

Colorado has had 17 cases, with 8 in 2003 and 9 in 2005. The individual children ranged in age from 4 months to 9 years, although most were under 5 years of age. One child died and one was left respirator dependent. Three were left with some persistent paralysis.

Only 5 of these 17 patients had virus retrieved from the cerebrospinal fluid, with all of the testing being polymerase chain reaction (PCR) assay. These patients tended to be the younger ones; they generally were tapped early in the course of their illness, and none had pleocytosis. Most of these patients had less severe disease.

Those with pleocytosis tended to be the older patients, and they generally did not have virus retrieved from their cerebrospinal fluid.

On the other hand, all of the 12 patients who had throat swabs tested by PCR were positive for the virus. Some of these patients had stools that tested positive as well. Many of these patients had mucocutaneous rash, and the progression in those who developed acute flaccid paralysis was rapid, Dr. Abzug said.

Imaging of patients has suggested that the virus causes lesions in the spinal anterior horn cells, much like polio virus does. The hypothesis is that the cardiopulmonary manifestations of severe cases comes not from direct destruction of the heart and lungs by the virus, but rather from the brain stem lesions causing sympathetic system hyperactivity.

Care of these patients is largely supportive, Dr. Abzug added. In Taiwan, physicians have treated patients with intravenous immunoglobulin, but the experience has suggested that it does not help, and a small trial conducted in Australia of immunoglobulin also found it was of no benefit. Others have tried interferon-α, corticosteroids, and pleconaril, none of which have shown any benefit.

Supportive care includes fluid restriction and vasodilators for those with cardiac and pulmonary involvement. Inotropes have been shown to be associated with a worse outcome, but milrinone, which is both an inotrope and a vasodilator, may be associated with some improvement in outcome.

Notable enterovirus 71-encephalitis outbreaks are becoming more common, but infection does not appear to be rare, and it is not seen just in foreign locales, Dr. Abzug said. One serosurvey conducted in New York state found that 26% of adults had antibodies to the virus. Prior to the Colorado cases, there was a previous U.S. outbreak in 1994.

There have been three proposed explanations for the recent outbreaks. One is that the virus itself may be becoming more neurovirulent. Another is that it has become more readily transmissible via respiration. The last is that perhaps more people are becoming susceptible to serious sequelae.

Prior to the Colorado evidence, findings from Taiwan have suggested that all three are probably factors, Dr. Abzug said.

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Educate About Repeated Staph Skin Infections

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ASPEN, COLO. — Can patients with repeated Staphylococcus aureus infections be decolonized to prevent recurrences?

The evidence supporting this approach is not very good. But, it is always worth a try, Dr. Sarah K. Parker said at a meeting on pediatric infectious diseases sponsored by the Children's Hospital, Denver.

Community-acquired staphylococcal infections are on the rise, even in normal, healthy children. Now, many of the organisms seen in the community—as well as in the hospital—are methicillin resistant.

Two or three times a week, she sees a child with a small, pustular lesion (often on the buttocks) that the child's primary-care physician has called a bug bite, but which turns out to be a S. aureus infection instead, said Dr. Parker of the pediatric infectious diseases department at the hospital.

That's a very common misdiagnosis of these infections. It is one that has been noted by other infectious disease specialists, and it illustrates not just how common the misdiagnosis has become, but also how common the infections now are, Dr. Parker said.

Some individuals do have recurrences that may be the result of incomplete treatment, but it also appears that some individuals just may be prone to repeated infections.

The Cochrane Collaboration recently reviewed evidence on methods for decolonizing patients with antibiotic treatment, Dr. Parker noted. It concluded that the practice of treating patients prophylactically with antibiotics or mupirocin to reduce nasal carriage of S. aureus is not supported by enough good evidence.

The exception may be for the use of mupirocin, which has been the subject of various studies. In general, that research shows that, if patients are treated twice daily for 5–7 days, 85% of them will be culture negative at about 14 days. However, 25% of those will be recolonized by 30 days, and 50%–70% will be recolonized by 6 months, Dr. Parker said.

Moreover, the nose isn't the entire story, she added. About 60% of individuals with staphylococcus in the nares also are colonized at other sites, and 20% of those colonized in sites other than the nose are not colonized in the nose.

One placebo-controlled study that used mupirocin in 32 normal individuals with recurrent infections for 5 days each month for 12 months reported that infections were reduced by about 50%, but not totally (Arch. Int. Med. 1996;65:109–13).

Also, in that study and others, resistance did develop. “This is a serious concern,” she said.

Therefore, given the questionable efficacy that prophylactic mupirocin treatment is likely to have and the resistance, Dr. Parker said she focuses on education for patients and families that have recurrent infections and resorts to a single, twice-daily course of mupirocin for 5 days only on occasion in those who have already been educated.

Among the measures she educates patients about include the following:

She tells parents to inspect the child carefully and often, since many times the sites of infections are in places covered by clothing.

Nails need to be kept clean and short to prevent scratches.

Bathing with an antimicrobial soap, such as hexachlorophene or chlorhexidine, can be 20%–50% effective at decolonizing extranasal sites in the short term.

Some recommend having patients bathe with bleach in the water, about 1 tablespoon per gallon, which is not much more than is found in a chlorinated swimming pool.

Towels and underwear need to be changed and washed often, Dr. Parker said.

For the physicians who see these infections, surgical treatment is most important.

“Incise these lesions and drain them very early, like as soon as you see a little head, get this thing open,” Dr. Parker said. “Scrub it, clean it, and even use a topical antistaph [treatment] on it.”

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ASPEN, COLO. — Can patients with repeated Staphylococcus aureus infections be decolonized to prevent recurrences?

The evidence supporting this approach is not very good. But, it is always worth a try, Dr. Sarah K. Parker said at a meeting on pediatric infectious diseases sponsored by the Children's Hospital, Denver.

Community-acquired staphylococcal infections are on the rise, even in normal, healthy children. Now, many of the organisms seen in the community—as well as in the hospital—are methicillin resistant.

Two or three times a week, she sees a child with a small, pustular lesion (often on the buttocks) that the child's primary-care physician has called a bug bite, but which turns out to be a S. aureus infection instead, said Dr. Parker of the pediatric infectious diseases department at the hospital.

That's a very common misdiagnosis of these infections. It is one that has been noted by other infectious disease specialists, and it illustrates not just how common the misdiagnosis has become, but also how common the infections now are, Dr. Parker said.

Some individuals do have recurrences that may be the result of incomplete treatment, but it also appears that some individuals just may be prone to repeated infections.

The Cochrane Collaboration recently reviewed evidence on methods for decolonizing patients with antibiotic treatment, Dr. Parker noted. It concluded that the practice of treating patients prophylactically with antibiotics or mupirocin to reduce nasal carriage of S. aureus is not supported by enough good evidence.

The exception may be for the use of mupirocin, which has been the subject of various studies. In general, that research shows that, if patients are treated twice daily for 5–7 days, 85% of them will be culture negative at about 14 days. However, 25% of those will be recolonized by 30 days, and 50%–70% will be recolonized by 6 months, Dr. Parker said.

Moreover, the nose isn't the entire story, she added. About 60% of individuals with staphylococcus in the nares also are colonized at other sites, and 20% of those colonized in sites other than the nose are not colonized in the nose.

One placebo-controlled study that used mupirocin in 32 normal individuals with recurrent infections for 5 days each month for 12 months reported that infections were reduced by about 50%, but not totally (Arch. Int. Med. 1996;65:109–13).

Also, in that study and others, resistance did develop. “This is a serious concern,” she said.

Therefore, given the questionable efficacy that prophylactic mupirocin treatment is likely to have and the resistance, Dr. Parker said she focuses on education for patients and families that have recurrent infections and resorts to a single, twice-daily course of mupirocin for 5 days only on occasion in those who have already been educated.

Among the measures she educates patients about include the following:

She tells parents to inspect the child carefully and often, since many times the sites of infections are in places covered by clothing.

Nails need to be kept clean and short to prevent scratches.

Bathing with an antimicrobial soap, such as hexachlorophene or chlorhexidine, can be 20%–50% effective at decolonizing extranasal sites in the short term.

Some recommend having patients bathe with bleach in the water, about 1 tablespoon per gallon, which is not much more than is found in a chlorinated swimming pool.

Towels and underwear need to be changed and washed often, Dr. Parker said.

For the physicians who see these infections, surgical treatment is most important.

“Incise these lesions and drain them very early, like as soon as you see a little head, get this thing open,” Dr. Parker said. “Scrub it, clean it, and even use a topical antistaph [treatment] on it.”

ASPEN, COLO. — Can patients with repeated Staphylococcus aureus infections be decolonized to prevent recurrences?

The evidence supporting this approach is not very good. But, it is always worth a try, Dr. Sarah K. Parker said at a meeting on pediatric infectious diseases sponsored by the Children's Hospital, Denver.

Community-acquired staphylococcal infections are on the rise, even in normal, healthy children. Now, many of the organisms seen in the community—as well as in the hospital—are methicillin resistant.

Two or three times a week, she sees a child with a small, pustular lesion (often on the buttocks) that the child's primary-care physician has called a bug bite, but which turns out to be a S. aureus infection instead, said Dr. Parker of the pediatric infectious diseases department at the hospital.

That's a very common misdiagnosis of these infections. It is one that has been noted by other infectious disease specialists, and it illustrates not just how common the misdiagnosis has become, but also how common the infections now are, Dr. Parker said.

Some individuals do have recurrences that may be the result of incomplete treatment, but it also appears that some individuals just may be prone to repeated infections.

The Cochrane Collaboration recently reviewed evidence on methods for decolonizing patients with antibiotic treatment, Dr. Parker noted. It concluded that the practice of treating patients prophylactically with antibiotics or mupirocin to reduce nasal carriage of S. aureus is not supported by enough good evidence.

The exception may be for the use of mupirocin, which has been the subject of various studies. In general, that research shows that, if patients are treated twice daily for 5–7 days, 85% of them will be culture negative at about 14 days. However, 25% of those will be recolonized by 30 days, and 50%–70% will be recolonized by 6 months, Dr. Parker said.

Moreover, the nose isn't the entire story, she added. About 60% of individuals with staphylococcus in the nares also are colonized at other sites, and 20% of those colonized in sites other than the nose are not colonized in the nose.

One placebo-controlled study that used mupirocin in 32 normal individuals with recurrent infections for 5 days each month for 12 months reported that infections were reduced by about 50%, but not totally (Arch. Int. Med. 1996;65:109–13).

Also, in that study and others, resistance did develop. “This is a serious concern,” she said.

Therefore, given the questionable efficacy that prophylactic mupirocin treatment is likely to have and the resistance, Dr. Parker said she focuses on education for patients and families that have recurrent infections and resorts to a single, twice-daily course of mupirocin for 5 days only on occasion in those who have already been educated.

Among the measures she educates patients about include the following:

She tells parents to inspect the child carefully and often, since many times the sites of infections are in places covered by clothing.

Nails need to be kept clean and short to prevent scratches.

Bathing with an antimicrobial soap, such as hexachlorophene or chlorhexidine, can be 20%–50% effective at decolonizing extranasal sites in the short term.

Some recommend having patients bathe with bleach in the water, about 1 tablespoon per gallon, which is not much more than is found in a chlorinated swimming pool.

Towels and underwear need to be changed and washed often, Dr. Parker said.

For the physicians who see these infections, surgical treatment is most important.

“Incise these lesions and drain them very early, like as soon as you see a little head, get this thing open,” Dr. Parker said. “Scrub it, clean it, and even use a topical antistaph [treatment] on it.”

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Community-Acquired MRSA Spread Detailed

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ASPEN, COLO. — In Dallas, by the time the infectious disease specialists found out they had a problem with community-acquired methicillin-resistant Staphylococcus aureus, it already comprised one-third of staphylococcal infections, Dr. Sheldon L. Kaplan said at a conference on pediatric infectious diseases sponsored by Children's Hospital, Denver.

In a round-up talk about the present situation with community-acquired methicillin-resistant S. aureus (MRSA), Dr. Kaplan, the chief of infectious diseases service at Texas Children's Hospital, Dallas, described how extremely quickly it has spread—in this country and worldwide.

“I don't think we are really going to control [MRSA] unless we have a vaccine,” Dr. Kaplan said.

At Texas Children's Hospital, the infectious disease specialists didn't pay much attention to community-acquired MRSA until 2000 when they started noticing more cases.

By that time—in February of that year—MRSA already made up about one-third of community-acquired staphylococcal infections seen at the hospital's emergency center. By November, it represented 50%. Currently, it is about 77%, Dr. Kaplan said.

About 15% of the cases annually are in children less than 1 year of age, 15% are children in the second year of life, and about 20% are in patients 10 years or older.

Ninety-six percent of the cases at the hospital are associated with skin and soft tissue infections. Nonetheless, 62% of all community-acquired MRSA cases seen are then hospitalized. That compares with 52% of the community-acquired methicillin-susceptible infections seen.

The average duration of hospitalization is 4 days.

Dr. Kaplan also noted that they are seeing increasing numbers of staphylococcal infections in normal, healthy infants in the first 30 days of life, and almost all of these cases are MRSA.

In the United States, the most common strain is one known as USA300. In 2003, 96% of MRSA isolates at Texas Children's were USA300. “This USA300 [strain], once it comes into a community, appears to take over,” Dr. Kaplan said.

The genetic sequence of USA300 recently has been published, and that sequence has shown that USA300 has incorporated certain genetic elements of S. epidermidis. Those elements, which could confer a better ability to colonize skin, may explain why this USA300 clone has been able to spread through communities so quickly.

Fortunately, the USA300 strain has not been found to produce the toxins associated with toxic shock syndrome, Dr. Kaplan added.

There is little good guidance on best antibiotic treatment of these community-acquired MRSA infections, Dr. Kaplan said.

One study found that long-acting tetracyclines are 90%–100% effective in treating skin and soft tissue infections, although they may not be for more serious infections.

Moreover, virtually all community-acquired MRSA associated with skin and soft tissue infection is susceptible to trimethoprim-sulfamethoxazole.

Therefore, at Texas Children's, the recommendation is to use trimethoprim-sulfamethoxazole as the first-line treatment for these infections.

That said, a survey of practice at the hospital found it was never used first line by any of the doctors, Dr. Kaplan said.

Several other studies have shown that the effective treatment for skin and soft tissue infection is surgical drainage and that the choice of antibiotic therapy makes little difference.

One study in particular showed that when an abscess was 5 cm or less in diameter, antibiotic choice made no difference in outcome, although it is not known whether ineffective or less-effective antibiotic treatment is associated with recurrence, Dr. Kaplan said.

Clindamycin resistance among community-acquired MRSA is not yet a big problem at Texas Children's, because the rate appears to be about 7% presently. However, clindamycin resistance there, and everywhere, is increasing, and in some places in this country may run as high as a rate of 30%.

“You have to know what is going on in your area,” Dr. Kaplan said.

'I don't think we are really going to control [MRSA] unless we have a vaccine.' DR. KAPLAN

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ASPEN, COLO. — In Dallas, by the time the infectious disease specialists found out they had a problem with community-acquired methicillin-resistant Staphylococcus aureus, it already comprised one-third of staphylococcal infections, Dr. Sheldon L. Kaplan said at a conference on pediatric infectious diseases sponsored by Children's Hospital, Denver.

In a round-up talk about the present situation with community-acquired methicillin-resistant S. aureus (MRSA), Dr. Kaplan, the chief of infectious diseases service at Texas Children's Hospital, Dallas, described how extremely quickly it has spread—in this country and worldwide.

“I don't think we are really going to control [MRSA] unless we have a vaccine,” Dr. Kaplan said.

At Texas Children's Hospital, the infectious disease specialists didn't pay much attention to community-acquired MRSA until 2000 when they started noticing more cases.

By that time—in February of that year—MRSA already made up about one-third of community-acquired staphylococcal infections seen at the hospital's emergency center. By November, it represented 50%. Currently, it is about 77%, Dr. Kaplan said.

About 15% of the cases annually are in children less than 1 year of age, 15% are children in the second year of life, and about 20% are in patients 10 years or older.

Ninety-six percent of the cases at the hospital are associated with skin and soft tissue infections. Nonetheless, 62% of all community-acquired MRSA cases seen are then hospitalized. That compares with 52% of the community-acquired methicillin-susceptible infections seen.

The average duration of hospitalization is 4 days.

Dr. Kaplan also noted that they are seeing increasing numbers of staphylococcal infections in normal, healthy infants in the first 30 days of life, and almost all of these cases are MRSA.

In the United States, the most common strain is one known as USA300. In 2003, 96% of MRSA isolates at Texas Children's were USA300. “This USA300 [strain], once it comes into a community, appears to take over,” Dr. Kaplan said.

The genetic sequence of USA300 recently has been published, and that sequence has shown that USA300 has incorporated certain genetic elements of S. epidermidis. Those elements, which could confer a better ability to colonize skin, may explain why this USA300 clone has been able to spread through communities so quickly.

Fortunately, the USA300 strain has not been found to produce the toxins associated with toxic shock syndrome, Dr. Kaplan added.

There is little good guidance on best antibiotic treatment of these community-acquired MRSA infections, Dr. Kaplan said.

One study found that long-acting tetracyclines are 90%–100% effective in treating skin and soft tissue infections, although they may not be for more serious infections.

Moreover, virtually all community-acquired MRSA associated with skin and soft tissue infection is susceptible to trimethoprim-sulfamethoxazole.

Therefore, at Texas Children's, the recommendation is to use trimethoprim-sulfamethoxazole as the first-line treatment for these infections.

That said, a survey of practice at the hospital found it was never used first line by any of the doctors, Dr. Kaplan said.

Several other studies have shown that the effective treatment for skin and soft tissue infection is surgical drainage and that the choice of antibiotic therapy makes little difference.

One study in particular showed that when an abscess was 5 cm or less in diameter, antibiotic choice made no difference in outcome, although it is not known whether ineffective or less-effective antibiotic treatment is associated with recurrence, Dr. Kaplan said.

Clindamycin resistance among community-acquired MRSA is not yet a big problem at Texas Children's, because the rate appears to be about 7% presently. However, clindamycin resistance there, and everywhere, is increasing, and in some places in this country may run as high as a rate of 30%.

“You have to know what is going on in your area,” Dr. Kaplan said.

'I don't think we are really going to control [MRSA] unless we have a vaccine.' DR. KAPLAN

ASPEN, COLO. — In Dallas, by the time the infectious disease specialists found out they had a problem with community-acquired methicillin-resistant Staphylococcus aureus, it already comprised one-third of staphylococcal infections, Dr. Sheldon L. Kaplan said at a conference on pediatric infectious diseases sponsored by Children's Hospital, Denver.

In a round-up talk about the present situation with community-acquired methicillin-resistant S. aureus (MRSA), Dr. Kaplan, the chief of infectious diseases service at Texas Children's Hospital, Dallas, described how extremely quickly it has spread—in this country and worldwide.

“I don't think we are really going to control [MRSA] unless we have a vaccine,” Dr. Kaplan said.

At Texas Children's Hospital, the infectious disease specialists didn't pay much attention to community-acquired MRSA until 2000 when they started noticing more cases.

By that time—in February of that year—MRSA already made up about one-third of community-acquired staphylococcal infections seen at the hospital's emergency center. By November, it represented 50%. Currently, it is about 77%, Dr. Kaplan said.

About 15% of the cases annually are in children less than 1 year of age, 15% are children in the second year of life, and about 20% are in patients 10 years or older.

Ninety-six percent of the cases at the hospital are associated with skin and soft tissue infections. Nonetheless, 62% of all community-acquired MRSA cases seen are then hospitalized. That compares with 52% of the community-acquired methicillin-susceptible infections seen.

The average duration of hospitalization is 4 days.

Dr. Kaplan also noted that they are seeing increasing numbers of staphylococcal infections in normal, healthy infants in the first 30 days of life, and almost all of these cases are MRSA.

In the United States, the most common strain is one known as USA300. In 2003, 96% of MRSA isolates at Texas Children's were USA300. “This USA300 [strain], once it comes into a community, appears to take over,” Dr. Kaplan said.

The genetic sequence of USA300 recently has been published, and that sequence has shown that USA300 has incorporated certain genetic elements of S. epidermidis. Those elements, which could confer a better ability to colonize skin, may explain why this USA300 clone has been able to spread through communities so quickly.

Fortunately, the USA300 strain has not been found to produce the toxins associated with toxic shock syndrome, Dr. Kaplan added.

There is little good guidance on best antibiotic treatment of these community-acquired MRSA infections, Dr. Kaplan said.

One study found that long-acting tetracyclines are 90%–100% effective in treating skin and soft tissue infections, although they may not be for more serious infections.

Moreover, virtually all community-acquired MRSA associated with skin and soft tissue infection is susceptible to trimethoprim-sulfamethoxazole.

Therefore, at Texas Children's, the recommendation is to use trimethoprim-sulfamethoxazole as the first-line treatment for these infections.

That said, a survey of practice at the hospital found it was never used first line by any of the doctors, Dr. Kaplan said.

Several other studies have shown that the effective treatment for skin and soft tissue infection is surgical drainage and that the choice of antibiotic therapy makes little difference.

One study in particular showed that when an abscess was 5 cm or less in diameter, antibiotic choice made no difference in outcome, although it is not known whether ineffective or less-effective antibiotic treatment is associated with recurrence, Dr. Kaplan said.

Clindamycin resistance among community-acquired MRSA is not yet a big problem at Texas Children's, because the rate appears to be about 7% presently. However, clindamycin resistance there, and everywhere, is increasing, and in some places in this country may run as high as a rate of 30%.

“You have to know what is going on in your area,” Dr. Kaplan said.

'I don't think we are really going to control [MRSA] unless we have a vaccine.' DR. KAPLAN

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Rectal Cancer Trial Supports Preoperative Radiation

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SEATTLE — Rectal cancer patients who got radiotherapy before their surgery had a lower local recurrence rate—even in T1 and T2 stage tumors—than did those who did not receive prior radiotherapy, according to preliminary results of a British trial.

“Meticulous surgery producing clear margins in patients with favorable tumors is simply not enough,” Dr. John R.T. Monson said at the annual meeting of the American Society of Colon and Rectal Surgeons.

The prospective Medical Research Council CRO7 trial enrolled 1,350 patients with adenocarcinoma of the rectum, in 80 centers, 69 of which were in the United Kingdom. Patients were enrolled between 1998 and 2005, said Dr. Monson, a professor in the academic surgical unit at the University of Hull and Castle Hill Hospital, Cottingham, England.

A total of 674 patients were randomized to receive radiation treatment before surgery (25 Gy), and the remaining 676 received radiation treatment after surgery (45 Gy) if they had a positive margin in their resection. All of the patients received postoperative chemotherapy, according to accepted protocol, on the basis of their lymph node status. About two-thirds of the patients had a low anterior resection, and one-third had an abdomino-perineal excision.

The investigators found that after a median follow-up of 3.5 years, local recurrence was 5% in the 674 patients who received presurgical radiotherapy, compared with 11% in the 676 subjects who did not. And when the cancers were broken down by T category and analyzed by margin status, the investigators found that for every individual stage, the local recurrence rate was lower with radiation therapy given before surgery. (See chart.)

To date, the local recurrence rate in patients who had a clear circumferential resection margin and received prior radiation is 4%, vs. 14% in the group that didn't receive prior radiotherapy. For those with a positive margin, the rates are 16% and 31%, respectively.

Disease-free survival, a secondary end point in the trial, also was significantly better at 3 years: 80% in the prior-radiotherapy group vs. 75% in the group that didn't receive prior radiation. At 5 years, disease-free survival was 75% vs. 67%, but this difference was not statistically significant—a fact that Dr. Monson attributed to the small number of patients (138) who reached 5 years post surgery.

“These are relatively early data, and we suspect that if the curves continue to move in this direction, they will be significantly different in due course,” Dr. Monson said.

Despite the varied locations, the quality of the trial—the surgery in particular—appeared to be good and is not likely to become an issue, Dr. Monson said.

Positive margins were found in about 10% of both groups. However, the rate of positive margins declined consistently over the course of the trial. This indicates that as the surgeons became more experienced, they improved, which suggests that their competence generally was good, Dr. Monson asserted. “The quality of the surgery in this trial was high,” he said.

The most common surgical complication in the anterior resection group was anastomotic dehiscence, occurring in 8% of the prior-radiation patients and 7% of the patients who didn't receive prior radiotherapy. The most common complication in the abdomino-perineal excision group was a nonhealing perineum, occurring in 36% and 22% of the patients, respectively.

The biological factor that appeared to be of most relevance to local recurrence was extramural vascular invasion. The study found that when patients had extramural vascular invasion, they were four times as likely to have a local recurrence.

“We believe this is likely to be one of the potential explanations for the incidence of local recurrence occurring in those patients with the most favorable tumors,” Dr. Monson said.

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SEATTLE — Rectal cancer patients who got radiotherapy before their surgery had a lower local recurrence rate—even in T1 and T2 stage tumors—than did those who did not receive prior radiotherapy, according to preliminary results of a British trial.

“Meticulous surgery producing clear margins in patients with favorable tumors is simply not enough,” Dr. John R.T. Monson said at the annual meeting of the American Society of Colon and Rectal Surgeons.

The prospective Medical Research Council CRO7 trial enrolled 1,350 patients with adenocarcinoma of the rectum, in 80 centers, 69 of which were in the United Kingdom. Patients were enrolled between 1998 and 2005, said Dr. Monson, a professor in the academic surgical unit at the University of Hull and Castle Hill Hospital, Cottingham, England.

A total of 674 patients were randomized to receive radiation treatment before surgery (25 Gy), and the remaining 676 received radiation treatment after surgery (45 Gy) if they had a positive margin in their resection. All of the patients received postoperative chemotherapy, according to accepted protocol, on the basis of their lymph node status. About two-thirds of the patients had a low anterior resection, and one-third had an abdomino-perineal excision.

The investigators found that after a median follow-up of 3.5 years, local recurrence was 5% in the 674 patients who received presurgical radiotherapy, compared with 11% in the 676 subjects who did not. And when the cancers were broken down by T category and analyzed by margin status, the investigators found that for every individual stage, the local recurrence rate was lower with radiation therapy given before surgery. (See chart.)

To date, the local recurrence rate in patients who had a clear circumferential resection margin and received prior radiation is 4%, vs. 14% in the group that didn't receive prior radiotherapy. For those with a positive margin, the rates are 16% and 31%, respectively.

Disease-free survival, a secondary end point in the trial, also was significantly better at 3 years: 80% in the prior-radiotherapy group vs. 75% in the group that didn't receive prior radiation. At 5 years, disease-free survival was 75% vs. 67%, but this difference was not statistically significant—a fact that Dr. Monson attributed to the small number of patients (138) who reached 5 years post surgery.

“These are relatively early data, and we suspect that if the curves continue to move in this direction, they will be significantly different in due course,” Dr. Monson said.

Despite the varied locations, the quality of the trial—the surgery in particular—appeared to be good and is not likely to become an issue, Dr. Monson said.

Positive margins were found in about 10% of both groups. However, the rate of positive margins declined consistently over the course of the trial. This indicates that as the surgeons became more experienced, they improved, which suggests that their competence generally was good, Dr. Monson asserted. “The quality of the surgery in this trial was high,” he said.

The most common surgical complication in the anterior resection group was anastomotic dehiscence, occurring in 8% of the prior-radiation patients and 7% of the patients who didn't receive prior radiotherapy. The most common complication in the abdomino-perineal excision group was a nonhealing perineum, occurring in 36% and 22% of the patients, respectively.

The biological factor that appeared to be of most relevance to local recurrence was extramural vascular invasion. The study found that when patients had extramural vascular invasion, they were four times as likely to have a local recurrence.

“We believe this is likely to be one of the potential explanations for the incidence of local recurrence occurring in those patients with the most favorable tumors,” Dr. Monson said.

SEATTLE — Rectal cancer patients who got radiotherapy before their surgery had a lower local recurrence rate—even in T1 and T2 stage tumors—than did those who did not receive prior radiotherapy, according to preliminary results of a British trial.

“Meticulous surgery producing clear margins in patients with favorable tumors is simply not enough,” Dr. John R.T. Monson said at the annual meeting of the American Society of Colon and Rectal Surgeons.

The prospective Medical Research Council CRO7 trial enrolled 1,350 patients with adenocarcinoma of the rectum, in 80 centers, 69 of which were in the United Kingdom. Patients were enrolled between 1998 and 2005, said Dr. Monson, a professor in the academic surgical unit at the University of Hull and Castle Hill Hospital, Cottingham, England.

A total of 674 patients were randomized to receive radiation treatment before surgery (25 Gy), and the remaining 676 received radiation treatment after surgery (45 Gy) if they had a positive margin in their resection. All of the patients received postoperative chemotherapy, according to accepted protocol, on the basis of their lymph node status. About two-thirds of the patients had a low anterior resection, and one-third had an abdomino-perineal excision.

The investigators found that after a median follow-up of 3.5 years, local recurrence was 5% in the 674 patients who received presurgical radiotherapy, compared with 11% in the 676 subjects who did not. And when the cancers were broken down by T category and analyzed by margin status, the investigators found that for every individual stage, the local recurrence rate was lower with radiation therapy given before surgery. (See chart.)

To date, the local recurrence rate in patients who had a clear circumferential resection margin and received prior radiation is 4%, vs. 14% in the group that didn't receive prior radiotherapy. For those with a positive margin, the rates are 16% and 31%, respectively.

Disease-free survival, a secondary end point in the trial, also was significantly better at 3 years: 80% in the prior-radiotherapy group vs. 75% in the group that didn't receive prior radiation. At 5 years, disease-free survival was 75% vs. 67%, but this difference was not statistically significant—a fact that Dr. Monson attributed to the small number of patients (138) who reached 5 years post surgery.

“These are relatively early data, and we suspect that if the curves continue to move in this direction, they will be significantly different in due course,” Dr. Monson said.

Despite the varied locations, the quality of the trial—the surgery in particular—appeared to be good and is not likely to become an issue, Dr. Monson said.

Positive margins were found in about 10% of both groups. However, the rate of positive margins declined consistently over the course of the trial. This indicates that as the surgeons became more experienced, they improved, which suggests that their competence generally was good, Dr. Monson asserted. “The quality of the surgery in this trial was high,” he said.

The most common surgical complication in the anterior resection group was anastomotic dehiscence, occurring in 8% of the prior-radiation patients and 7% of the patients who didn't receive prior radiotherapy. The most common complication in the abdomino-perineal excision group was a nonhealing perineum, occurring in 36% and 22% of the patients, respectively.

The biological factor that appeared to be of most relevance to local recurrence was extramural vascular invasion. The study found that when patients had extramural vascular invasion, they were four times as likely to have a local recurrence.

“We believe this is likely to be one of the potential explanations for the incidence of local recurrence occurring in those patients with the most favorable tumors,” Dr. Monson said.

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Nature and Media's Nurture Spawn Girl Violence

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ATLANTA — The media shares the blame for the rising tide of girl violence. But this tide would not be rising if females did not naturally have tendencies to aggression that are in some ways as strong as those of males, James Garbarino, Ph.D., said at a meeting of the National Adolescent Perpetration Network.

Many think that girls lack the same capacity for violence as males. But like many concepts, that is a little simplistic, said Dr. Garbarino, the Maude C. Clarke chair in humanistic psychology at Loyola University, Chicago, and the author of the recent book “See Jane Hit: Why Girls Are Growing More Violent and What We Can Do About It” (Penguin Press, 2006).

All humans are naturally aggressive, and infants and children growing up are taught to control their aggression, Dr. Garbarino said at the meeting, sponsored by the University of Colorado. That concept—advanced mostly by Richard E. Tremblay, Ph.D., of the University of Montreal—is an important one. And it is now generally accepted.

“You don't have to teach a baby to bite; you teach them not to bite,” he said.

Moreover, a violent nature is almost equally true of females as of males, and, in fact, in some contexts, females can show even more aggression than males.

Dr. Garbarino noted one study in which children who were brought into a laboratory played a video game that involved dropping bombs. With some of the subjects, the researchers personalized the environment and introduced the children and let them get to know each other. In the second group of subjects, the investigators purposely had the subjects and the game remain anonymous.

In the personalized scenario, the boys dropped more bombs during the game than the girls did, an average of 31 bombs versus 27 bombs. However, in the anonymous scenario, both groups increased the number of bombs they dropped, but the girls had a greater increase and even tended to drop more bombs than the boys, an average of 41 bombs versus 37 bombs.

In addition, Dr. Tremblay had showed that at 17 months of age, 90% of boys and more than 80% of girls were still acting in demonstrably aggressive ways, he said.

The role that the media has played in creating a rise in girl violence is not in encouraging it, but rather in removing constraints that previously inhibited it, he said. But it is still a powerful effect.

Much research has been done on the effect of media violence on behavior and aggression, he said. It shows a strong correlation, almost as strong a correlation as that between smoking and lung cancer, and an effect that is larger.

Smoking accounts for 10% of the variance in lung cancer. Television violence accounts for 15% of the variance in teenagers' violent behavior, he stated.

In the 1960s, studies seemed to show that females were immune to the effect of television violence. But that was no longer true by the 1980s, he said. What changed? Images portrayed by the media—which do not need to create aggression, only validate it—became more violent. The heroes became as violent as the bad guys, and many of those heroes are female.

Such images send the message that one can be the good guy and be violent; that message resonates with individuals because when they become agitated enough to become violent, they usually think they are justified, he said.

In the past, one could tell a girl that “girls don't hit,” and the culture essentially backed that up. Nowadays, in the movies, strong women do hit.

“The messages are much more positive about violence than they used to be,” he said. For example, at the end of the third movie in the Harry Potter series, it is the very likeable and admirable character, Hermione, who punches the bully, Draco Malfoy. She turns around and she is cheered, and she says: “That felt good.”

“The message is very clear,” Dr. Garbarino said. “Powerful, good, strong girls hit, and they enjoy it.”

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ATLANTA — The media shares the blame for the rising tide of girl violence. But this tide would not be rising if females did not naturally have tendencies to aggression that are in some ways as strong as those of males, James Garbarino, Ph.D., said at a meeting of the National Adolescent Perpetration Network.

Many think that girls lack the same capacity for violence as males. But like many concepts, that is a little simplistic, said Dr. Garbarino, the Maude C. Clarke chair in humanistic psychology at Loyola University, Chicago, and the author of the recent book “See Jane Hit: Why Girls Are Growing More Violent and What We Can Do About It” (Penguin Press, 2006).

All humans are naturally aggressive, and infants and children growing up are taught to control their aggression, Dr. Garbarino said at the meeting, sponsored by the University of Colorado. That concept—advanced mostly by Richard E. Tremblay, Ph.D., of the University of Montreal—is an important one. And it is now generally accepted.

“You don't have to teach a baby to bite; you teach them not to bite,” he said.

Moreover, a violent nature is almost equally true of females as of males, and, in fact, in some contexts, females can show even more aggression than males.

Dr. Garbarino noted one study in which children who were brought into a laboratory played a video game that involved dropping bombs. With some of the subjects, the researchers personalized the environment and introduced the children and let them get to know each other. In the second group of subjects, the investigators purposely had the subjects and the game remain anonymous.

In the personalized scenario, the boys dropped more bombs during the game than the girls did, an average of 31 bombs versus 27 bombs. However, in the anonymous scenario, both groups increased the number of bombs they dropped, but the girls had a greater increase and even tended to drop more bombs than the boys, an average of 41 bombs versus 37 bombs.

In addition, Dr. Tremblay had showed that at 17 months of age, 90% of boys and more than 80% of girls were still acting in demonstrably aggressive ways, he said.

The role that the media has played in creating a rise in girl violence is not in encouraging it, but rather in removing constraints that previously inhibited it, he said. But it is still a powerful effect.

Much research has been done on the effect of media violence on behavior and aggression, he said. It shows a strong correlation, almost as strong a correlation as that between smoking and lung cancer, and an effect that is larger.

Smoking accounts for 10% of the variance in lung cancer. Television violence accounts for 15% of the variance in teenagers' violent behavior, he stated.

In the 1960s, studies seemed to show that females were immune to the effect of television violence. But that was no longer true by the 1980s, he said. What changed? Images portrayed by the media—which do not need to create aggression, only validate it—became more violent. The heroes became as violent as the bad guys, and many of those heroes are female.

Such images send the message that one can be the good guy and be violent; that message resonates with individuals because when they become agitated enough to become violent, they usually think they are justified, he said.

In the past, one could tell a girl that “girls don't hit,” and the culture essentially backed that up. Nowadays, in the movies, strong women do hit.

“The messages are much more positive about violence than they used to be,” he said. For example, at the end of the third movie in the Harry Potter series, it is the very likeable and admirable character, Hermione, who punches the bully, Draco Malfoy. She turns around and she is cheered, and she says: “That felt good.”

“The message is very clear,” Dr. Garbarino said. “Powerful, good, strong girls hit, and they enjoy it.”

ATLANTA — The media shares the blame for the rising tide of girl violence. But this tide would not be rising if females did not naturally have tendencies to aggression that are in some ways as strong as those of males, James Garbarino, Ph.D., said at a meeting of the National Adolescent Perpetration Network.

Many think that girls lack the same capacity for violence as males. But like many concepts, that is a little simplistic, said Dr. Garbarino, the Maude C. Clarke chair in humanistic psychology at Loyola University, Chicago, and the author of the recent book “See Jane Hit: Why Girls Are Growing More Violent and What We Can Do About It” (Penguin Press, 2006).

All humans are naturally aggressive, and infants and children growing up are taught to control their aggression, Dr. Garbarino said at the meeting, sponsored by the University of Colorado. That concept—advanced mostly by Richard E. Tremblay, Ph.D., of the University of Montreal—is an important one. And it is now generally accepted.

“You don't have to teach a baby to bite; you teach them not to bite,” he said.

Moreover, a violent nature is almost equally true of females as of males, and, in fact, in some contexts, females can show even more aggression than males.

Dr. Garbarino noted one study in which children who were brought into a laboratory played a video game that involved dropping bombs. With some of the subjects, the researchers personalized the environment and introduced the children and let them get to know each other. In the second group of subjects, the investigators purposely had the subjects and the game remain anonymous.

In the personalized scenario, the boys dropped more bombs during the game than the girls did, an average of 31 bombs versus 27 bombs. However, in the anonymous scenario, both groups increased the number of bombs they dropped, but the girls had a greater increase and even tended to drop more bombs than the boys, an average of 41 bombs versus 37 bombs.

In addition, Dr. Tremblay had showed that at 17 months of age, 90% of boys and more than 80% of girls were still acting in demonstrably aggressive ways, he said.

The role that the media has played in creating a rise in girl violence is not in encouraging it, but rather in removing constraints that previously inhibited it, he said. But it is still a powerful effect.

Much research has been done on the effect of media violence on behavior and aggression, he said. It shows a strong correlation, almost as strong a correlation as that between smoking and lung cancer, and an effect that is larger.

Smoking accounts for 10% of the variance in lung cancer. Television violence accounts for 15% of the variance in teenagers' violent behavior, he stated.

In the 1960s, studies seemed to show that females were immune to the effect of television violence. But that was no longer true by the 1980s, he said. What changed? Images portrayed by the media—which do not need to create aggression, only validate it—became more violent. The heroes became as violent as the bad guys, and many of those heroes are female.

Such images send the message that one can be the good guy and be violent; that message resonates with individuals because when they become agitated enough to become violent, they usually think they are justified, he said.

In the past, one could tell a girl that “girls don't hit,” and the culture essentially backed that up. Nowadays, in the movies, strong women do hit.

“The messages are much more positive about violence than they used to be,” he said. For example, at the end of the third movie in the Harry Potter series, it is the very likeable and admirable character, Hermione, who punches the bully, Draco Malfoy. She turns around and she is cheered, and she says: “That felt good.”

“The message is very clear,” Dr. Garbarino said. “Powerful, good, strong girls hit, and they enjoy it.”

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Primary Care Physicians Are Urged To Watch for Acute HIV

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ASPEN, COLO. — A rash in a teenager with an apparent viral syndrome should raise the diagnostic possibility of acute retroviral syndrome because of a recently acquired HIV infection, Dr. Elizabeth McFarland said at a conference on pediatric infectious disease sponsored by Children's Hospital, Denver.

HIV infection “is not necessarily a rare disease,” said Dr. McFarland, director of the Children's Hospital (Denver) HIV program.

About 40,000 new cases of HIV infection occur annually in the United States, and half of them may affect teenagers. Moreover, those patients do come for medical attention.

In one urgent-care center in Boston, 1% of adults who presented with any viral symptoms had acute HIV, she noted. In a university hospital in the same city, almost 1% of persons tested for mononucleosis had acute HIV infection.

Similarly, in an emergency department in North Carolina, 0.3% of all people presenting with fever had acute HIV infection.

The most distinctive symptoms seen with acute HIV infections are rash, thrush, and neurologic symptoms, Dr. McFarland said. Around 2 weeks after exposure, 40%–90% of those newly infected with HIV will have symptoms; 96% of them will have fever, 74% will have lymphadenopathy, 70% will have pharyngitis, and 70% will have rash.

As the fourth most common symptom and the only relatively uncommon one in a patient with an apparent viral illness, rash should trigger suspicion of HIV.

The appearance of the skin rash is not notable, but mouth ulcers often are also present or may occur alone.

The thrush and neurologic symptoms are not common, but like the rash, they are unusual for a viral illness. Both are seen in 12% of newly infected patients.

Other symptoms include myalgia or arthralgia (54%), diarrhea (32%), headache (32%), and nausea and vomiting (27%).

“If they have compatible symptoms, it really is reasonable to test” patients for human immunodeficiency virus, Dr. McFarland urged.

Around 2 weeks after exposure, 40%–90% of those newly infected with HIV will have symptoms. DR. MCFARLAND

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ASPEN, COLO. — A rash in a teenager with an apparent viral syndrome should raise the diagnostic possibility of acute retroviral syndrome because of a recently acquired HIV infection, Dr. Elizabeth McFarland said at a conference on pediatric infectious disease sponsored by Children's Hospital, Denver.

HIV infection “is not necessarily a rare disease,” said Dr. McFarland, director of the Children's Hospital (Denver) HIV program.

About 40,000 new cases of HIV infection occur annually in the United States, and half of them may affect teenagers. Moreover, those patients do come for medical attention.

In one urgent-care center in Boston, 1% of adults who presented with any viral symptoms had acute HIV, she noted. In a university hospital in the same city, almost 1% of persons tested for mononucleosis had acute HIV infection.

Similarly, in an emergency department in North Carolina, 0.3% of all people presenting with fever had acute HIV infection.

The most distinctive symptoms seen with acute HIV infections are rash, thrush, and neurologic symptoms, Dr. McFarland said. Around 2 weeks after exposure, 40%–90% of those newly infected with HIV will have symptoms; 96% of them will have fever, 74% will have lymphadenopathy, 70% will have pharyngitis, and 70% will have rash.

As the fourth most common symptom and the only relatively uncommon one in a patient with an apparent viral illness, rash should trigger suspicion of HIV.

The appearance of the skin rash is not notable, but mouth ulcers often are also present or may occur alone.

The thrush and neurologic symptoms are not common, but like the rash, they are unusual for a viral illness. Both are seen in 12% of newly infected patients.

Other symptoms include myalgia or arthralgia (54%), diarrhea (32%), headache (32%), and nausea and vomiting (27%).

“If they have compatible symptoms, it really is reasonable to test” patients for human immunodeficiency virus, Dr. McFarland urged.

Around 2 weeks after exposure, 40%–90% of those newly infected with HIV will have symptoms. DR. MCFARLAND

ASPEN, COLO. — A rash in a teenager with an apparent viral syndrome should raise the diagnostic possibility of acute retroviral syndrome because of a recently acquired HIV infection, Dr. Elizabeth McFarland said at a conference on pediatric infectious disease sponsored by Children's Hospital, Denver.

HIV infection “is not necessarily a rare disease,” said Dr. McFarland, director of the Children's Hospital (Denver) HIV program.

About 40,000 new cases of HIV infection occur annually in the United States, and half of them may affect teenagers. Moreover, those patients do come for medical attention.

In one urgent-care center in Boston, 1% of adults who presented with any viral symptoms had acute HIV, she noted. In a university hospital in the same city, almost 1% of persons tested for mononucleosis had acute HIV infection.

Similarly, in an emergency department in North Carolina, 0.3% of all people presenting with fever had acute HIV infection.

The most distinctive symptoms seen with acute HIV infections are rash, thrush, and neurologic symptoms, Dr. McFarland said. Around 2 weeks after exposure, 40%–90% of those newly infected with HIV will have symptoms; 96% of them will have fever, 74% will have lymphadenopathy, 70% will have pharyngitis, and 70% will have rash.

As the fourth most common symptom and the only relatively uncommon one in a patient with an apparent viral illness, rash should trigger suspicion of HIV.

The appearance of the skin rash is not notable, but mouth ulcers often are also present or may occur alone.

The thrush and neurologic symptoms are not common, but like the rash, they are unusual for a viral illness. Both are seen in 12% of newly infected patients.

Other symptoms include myalgia or arthralgia (54%), diarrhea (32%), headache (32%), and nausea and vomiting (27%).

“If they have compatible symptoms, it really is reasonable to test” patients for human immunodeficiency virus, Dr. McFarland urged.

Around 2 weeks after exposure, 40%–90% of those newly infected with HIV will have symptoms. DR. MCFARLAND

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Medicare D 'Doughnut Hole' Halts Many Drug Regimens

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SEATTLE — Patients taking antidepressants and cholesterol-lowering drugs who are in pharmacy-capped plans, like the new Medicare Part D drug benefit, often stop taking their drugs when they reach the cap, Geoffrey Joyce, Ph.D., said at the annual research meeting of Academy Health.

According to his research, anywhere from 6% to 11% of patients in the Medicare Part D program are likely to hit what is known as the “doughnut hole” of coverage in any given year, said Dr. Joyce, a senior economist with the RAND Corp., Santa Monica, Calif.

The so-called doughnut hole is the gap in coverage that goes into effect during a coverage year when a patient's drug expenditures reach $2,250, and continues until the expenditures reach $5,100. Prior to reaching the doughnut-hole gap, beneficiaries have a $250 annual deductible and pay 25% of their drug costs. After expenditures have reached $5,100, catastrophic coverage kicks in and patients pay only 5% of costs. Within the doughnut hole, patients pay 100% of their drug costs.

Many health economists and others have worried that the Medicare Part D patients most likely to spend their way into the doughnut hole are the sickest patients, and that those patients might become noncompliant with their medication regimens when they surpass their $2,250 limit. Dr. Joyce and colleagues looked at two employer health plans with drug benefits that had a cap on coverage of $2,500, to get an idea of what is likely to happen with the Medicare plan.

In the years considered (2003 and 2004), 7% of beneficiaries in one plan and 11% in the other plan hit the cap.

The median time of year when patients hit the cap was September. However, one-quarter of the patients who hit the cap did so in June, meaning they had no drug coverage for a full 6 months, Dr. Joyce said.

Patients did not appear to switch from brand-name drugs to generic drugs in any appreciable degree when they reached the cap. However, some patients did stop taking certain drugs. The most common medications the patients stopped taking were antidepressants and cholesterol-lowering drugs.

What was most concerning about those who stopped was that only about 40% of those who stopped then restarted those drugs at the beginning of the new year, he said. Previous studies of drug benefit caps have shown that they do reduce plan costs significantly. In one study of a Kaiser Permanente plan, a cap resulted in 31% lower drug costs.

That study found, however, that there may be a price to pay for curtailing drug benefits too drastically, Dr. Joyce noted.

Overall, the Kaiser study found that the capped plan did not result in higher medical care costs. But there were more hospitalizations and more emergency department visits in the capped plan, compared to a noncapped plan. There was also a 22% higher mortality among patients in the capped plan.

Given the higher hospitalization and ED visit rates, the finding that medical care costs were no higher is probably a statistical anomaly, and is not accurate, he said.

In this study, the investigators have begun looking at ancillary costs that might be associated with patients' not filling prescriptions they otherwise would have filled. But that work is not completed yet.

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SEATTLE — Patients taking antidepressants and cholesterol-lowering drugs who are in pharmacy-capped plans, like the new Medicare Part D drug benefit, often stop taking their drugs when they reach the cap, Geoffrey Joyce, Ph.D., said at the annual research meeting of Academy Health.

According to his research, anywhere from 6% to 11% of patients in the Medicare Part D program are likely to hit what is known as the “doughnut hole” of coverage in any given year, said Dr. Joyce, a senior economist with the RAND Corp., Santa Monica, Calif.

The so-called doughnut hole is the gap in coverage that goes into effect during a coverage year when a patient's drug expenditures reach $2,250, and continues until the expenditures reach $5,100. Prior to reaching the doughnut-hole gap, beneficiaries have a $250 annual deductible and pay 25% of their drug costs. After expenditures have reached $5,100, catastrophic coverage kicks in and patients pay only 5% of costs. Within the doughnut hole, patients pay 100% of their drug costs.

Many health economists and others have worried that the Medicare Part D patients most likely to spend their way into the doughnut hole are the sickest patients, and that those patients might become noncompliant with their medication regimens when they surpass their $2,250 limit. Dr. Joyce and colleagues looked at two employer health plans with drug benefits that had a cap on coverage of $2,500, to get an idea of what is likely to happen with the Medicare plan.

In the years considered (2003 and 2004), 7% of beneficiaries in one plan and 11% in the other plan hit the cap.

The median time of year when patients hit the cap was September. However, one-quarter of the patients who hit the cap did so in June, meaning they had no drug coverage for a full 6 months, Dr. Joyce said.

Patients did not appear to switch from brand-name drugs to generic drugs in any appreciable degree when they reached the cap. However, some patients did stop taking certain drugs. The most common medications the patients stopped taking were antidepressants and cholesterol-lowering drugs.

What was most concerning about those who stopped was that only about 40% of those who stopped then restarted those drugs at the beginning of the new year, he said. Previous studies of drug benefit caps have shown that they do reduce plan costs significantly. In one study of a Kaiser Permanente plan, a cap resulted in 31% lower drug costs.

That study found, however, that there may be a price to pay for curtailing drug benefits too drastically, Dr. Joyce noted.

Overall, the Kaiser study found that the capped plan did not result in higher medical care costs. But there were more hospitalizations and more emergency department visits in the capped plan, compared to a noncapped plan. There was also a 22% higher mortality among patients in the capped plan.

Given the higher hospitalization and ED visit rates, the finding that medical care costs were no higher is probably a statistical anomaly, and is not accurate, he said.

In this study, the investigators have begun looking at ancillary costs that might be associated with patients' not filling prescriptions they otherwise would have filled. But that work is not completed yet.

SEATTLE — Patients taking antidepressants and cholesterol-lowering drugs who are in pharmacy-capped plans, like the new Medicare Part D drug benefit, often stop taking their drugs when they reach the cap, Geoffrey Joyce, Ph.D., said at the annual research meeting of Academy Health.

According to his research, anywhere from 6% to 11% of patients in the Medicare Part D program are likely to hit what is known as the “doughnut hole” of coverage in any given year, said Dr. Joyce, a senior economist with the RAND Corp., Santa Monica, Calif.

The so-called doughnut hole is the gap in coverage that goes into effect during a coverage year when a patient's drug expenditures reach $2,250, and continues until the expenditures reach $5,100. Prior to reaching the doughnut-hole gap, beneficiaries have a $250 annual deductible and pay 25% of their drug costs. After expenditures have reached $5,100, catastrophic coverage kicks in and patients pay only 5% of costs. Within the doughnut hole, patients pay 100% of their drug costs.

Many health economists and others have worried that the Medicare Part D patients most likely to spend their way into the doughnut hole are the sickest patients, and that those patients might become noncompliant with their medication regimens when they surpass their $2,250 limit. Dr. Joyce and colleagues looked at two employer health plans with drug benefits that had a cap on coverage of $2,500, to get an idea of what is likely to happen with the Medicare plan.

In the years considered (2003 and 2004), 7% of beneficiaries in one plan and 11% in the other plan hit the cap.

The median time of year when patients hit the cap was September. However, one-quarter of the patients who hit the cap did so in June, meaning they had no drug coverage for a full 6 months, Dr. Joyce said.

Patients did not appear to switch from brand-name drugs to generic drugs in any appreciable degree when they reached the cap. However, some patients did stop taking certain drugs. The most common medications the patients stopped taking were antidepressants and cholesterol-lowering drugs.

What was most concerning about those who stopped was that only about 40% of those who stopped then restarted those drugs at the beginning of the new year, he said. Previous studies of drug benefit caps have shown that they do reduce plan costs significantly. In one study of a Kaiser Permanente plan, a cap resulted in 31% lower drug costs.

That study found, however, that there may be a price to pay for curtailing drug benefits too drastically, Dr. Joyce noted.

Overall, the Kaiser study found that the capped plan did not result in higher medical care costs. But there were more hospitalizations and more emergency department visits in the capped plan, compared to a noncapped plan. There was also a 22% higher mortality among patients in the capped plan.

Given the higher hospitalization and ED visit rates, the finding that medical care costs were no higher is probably a statistical anomaly, and is not accurate, he said.

In this study, the investigators have begun looking at ancillary costs that might be associated with patients' not filling prescriptions they otherwise would have filled. But that work is not completed yet.

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Preoperative Radiation Cut Rectal Ca Recurrence

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SEATTLE — Rectal cancer patients who got radiotherapy before their surgery had a lower local recurrence rate—even in T1 and T2 stage tumors—than those who did not receive prior radiotherapy, according to preliminary results of a British trial.

“Meticulous surgery producing clear margins in patients with favorable tumors is simply not enough,” Dr. John R.T. Monson said at the annual meeting of the American Society of Colon and Rectal Surgeons.

The prospective Medical Research Council CRO7 trial enrolled 1,350 patients with adenocarcinoma of the rectum, in 80 centers, 69 of which were in the United Kingdom. Patients were enrolled between 1998 and 2005, said Dr. Monson, a surgeon at the University of Hull and Castle Hill Hospital, Cottingham, England.

A total of 674 patients were randomized to receive radiation treatment before surgery (25 Gy), and the remaining 676 received radiation treatment after surgery (45 Gy) if they had a positive margin in their resection. All patients received postoperative chemotherapy, according to accepted protocol, on the basis of their lymph node status. About two-thirds of the patients had a low anterior resection, and one-third had an abdomino-perineal excision.

After a median follow-up of 3.5 years, local recurrence was 5% in the 674 patients who received presurgical radiotherapy, compared with 11% in the 676 subjects who did not. And when the cancers were broken down by T category and analyzed by margin status, the investigators found that for every individual stage, the local recurrence rate was lower with radiation therapy given before surgery. (See chart.)

To date, the local recurrence rate in patients who had a clear circumferential resection margin and received prior radiation is 4%, vs. 14% in the group that didn't receive prior radiotherapy. For those with a positive margin, the rates are 16% and 31%, respectively.

Disease-free survival, a secondary end point in the trial, also was significantly better at 3 years: 80% in the prior-radiotherapy group vs. 75% in the group that did not receive prior radiation. At 5 years, disease-free survival was 75% vs. 67%, but this difference was not statistically significant—a fact that Dr. Monson attributed to the small number of patients (138) who reached 5 years post surgery.

Positive margins were found in about 10% of both groups. However, the rate of positive margins declined consistently over the course of the trial. This indicates that as the surgeons became more experienced, they improved, which suggests that their competence generally was good, Dr. Monson asserted. “The quality of the surgery in this trial was high,” he said.

The most common surgical complication in the anterior resection group was anastomotic dehiscence, occurring in 8% of the prior-radiation patients and 7% of the patients who didn't receive prior radiotherapy. The most common complication in the abdomino-perineal excision group was a nonhealing perineum, occurring in 36% and 22% of the patients, respectively. The biological factor that appeared to be of most relevance to local recurrence was extramural vascular invasion. The study found that when patients had extramural vascular invasion, they were four times as likely to have a local recurrence.

“We believe this is likely to be one of the potential explanations for the incidence of local recurrence occurring in those patients with the most favorable tumors,” Dr. Monson said.

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SEATTLE — Rectal cancer patients who got radiotherapy before their surgery had a lower local recurrence rate—even in T1 and T2 stage tumors—than those who did not receive prior radiotherapy, according to preliminary results of a British trial.

“Meticulous surgery producing clear margins in patients with favorable tumors is simply not enough,” Dr. John R.T. Monson said at the annual meeting of the American Society of Colon and Rectal Surgeons.

The prospective Medical Research Council CRO7 trial enrolled 1,350 patients with adenocarcinoma of the rectum, in 80 centers, 69 of which were in the United Kingdom. Patients were enrolled between 1998 and 2005, said Dr. Monson, a surgeon at the University of Hull and Castle Hill Hospital, Cottingham, England.

A total of 674 patients were randomized to receive radiation treatment before surgery (25 Gy), and the remaining 676 received radiation treatment after surgery (45 Gy) if they had a positive margin in their resection. All patients received postoperative chemotherapy, according to accepted protocol, on the basis of their lymph node status. About two-thirds of the patients had a low anterior resection, and one-third had an abdomino-perineal excision.

After a median follow-up of 3.5 years, local recurrence was 5% in the 674 patients who received presurgical radiotherapy, compared with 11% in the 676 subjects who did not. And when the cancers were broken down by T category and analyzed by margin status, the investigators found that for every individual stage, the local recurrence rate was lower with radiation therapy given before surgery. (See chart.)

To date, the local recurrence rate in patients who had a clear circumferential resection margin and received prior radiation is 4%, vs. 14% in the group that didn't receive prior radiotherapy. For those with a positive margin, the rates are 16% and 31%, respectively.

Disease-free survival, a secondary end point in the trial, also was significantly better at 3 years: 80% in the prior-radiotherapy group vs. 75% in the group that did not receive prior radiation. At 5 years, disease-free survival was 75% vs. 67%, but this difference was not statistically significant—a fact that Dr. Monson attributed to the small number of patients (138) who reached 5 years post surgery.

Positive margins were found in about 10% of both groups. However, the rate of positive margins declined consistently over the course of the trial. This indicates that as the surgeons became more experienced, they improved, which suggests that their competence generally was good, Dr. Monson asserted. “The quality of the surgery in this trial was high,” he said.

The most common surgical complication in the anterior resection group was anastomotic dehiscence, occurring in 8% of the prior-radiation patients and 7% of the patients who didn't receive prior radiotherapy. The most common complication in the abdomino-perineal excision group was a nonhealing perineum, occurring in 36% and 22% of the patients, respectively. The biological factor that appeared to be of most relevance to local recurrence was extramural vascular invasion. The study found that when patients had extramural vascular invasion, they were four times as likely to have a local recurrence.

“We believe this is likely to be one of the potential explanations for the incidence of local recurrence occurring in those patients with the most favorable tumors,” Dr. Monson said.

ELSEVIER GLOBAL MEDICAL NEWS

SEATTLE — Rectal cancer patients who got radiotherapy before their surgery had a lower local recurrence rate—even in T1 and T2 stage tumors—than those who did not receive prior radiotherapy, according to preliminary results of a British trial.

“Meticulous surgery producing clear margins in patients with favorable tumors is simply not enough,” Dr. John R.T. Monson said at the annual meeting of the American Society of Colon and Rectal Surgeons.

The prospective Medical Research Council CRO7 trial enrolled 1,350 patients with adenocarcinoma of the rectum, in 80 centers, 69 of which were in the United Kingdom. Patients were enrolled between 1998 and 2005, said Dr. Monson, a surgeon at the University of Hull and Castle Hill Hospital, Cottingham, England.

A total of 674 patients were randomized to receive radiation treatment before surgery (25 Gy), and the remaining 676 received radiation treatment after surgery (45 Gy) if they had a positive margin in their resection. All patients received postoperative chemotherapy, according to accepted protocol, on the basis of their lymph node status. About two-thirds of the patients had a low anterior resection, and one-third had an abdomino-perineal excision.

After a median follow-up of 3.5 years, local recurrence was 5% in the 674 patients who received presurgical radiotherapy, compared with 11% in the 676 subjects who did not. And when the cancers were broken down by T category and analyzed by margin status, the investigators found that for every individual stage, the local recurrence rate was lower with radiation therapy given before surgery. (See chart.)

To date, the local recurrence rate in patients who had a clear circumferential resection margin and received prior radiation is 4%, vs. 14% in the group that didn't receive prior radiotherapy. For those with a positive margin, the rates are 16% and 31%, respectively.

Disease-free survival, a secondary end point in the trial, also was significantly better at 3 years: 80% in the prior-radiotherapy group vs. 75% in the group that did not receive prior radiation. At 5 years, disease-free survival was 75% vs. 67%, but this difference was not statistically significant—a fact that Dr. Monson attributed to the small number of patients (138) who reached 5 years post surgery.

Positive margins were found in about 10% of both groups. However, the rate of positive margins declined consistently over the course of the trial. This indicates that as the surgeons became more experienced, they improved, which suggests that their competence generally was good, Dr. Monson asserted. “The quality of the surgery in this trial was high,” he said.

The most common surgical complication in the anterior resection group was anastomotic dehiscence, occurring in 8% of the prior-radiation patients and 7% of the patients who didn't receive prior radiotherapy. The most common complication in the abdomino-perineal excision group was a nonhealing perineum, occurring in 36% and 22% of the patients, respectively. The biological factor that appeared to be of most relevance to local recurrence was extramural vascular invasion. The study found that when patients had extramural vascular invasion, they were four times as likely to have a local recurrence.

“We believe this is likely to be one of the potential explanations for the incidence of local recurrence occurring in those patients with the most favorable tumors,” Dr. Monson said.

ELSEVIER GLOBAL MEDICAL NEWS

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