Denise Napoli

Overcrowding and understaffing of hospitals are two of the major underlying factors driving the spread of methicillin-resistant Staphylococcus aureus in this setting, according to a review.

Furthermore, “the economic benefits of downsizing health care systems are likely to have been offset by the increased burden of adverse events, such as MRSA,” the authors wrote.

Archie Clements, Ph.D., of the division of epidemiology and social medicine at the University of Queensland (Australia), and his colleagues from the fields of mathematics, statistics, infection surveillance, and medicine, cited 140 studies in their review (Lancet Infect. Dis. 2008;8:427-34).

They concluded that the direct mechanisms through which hospital-acquired infections are spread—including a decrease in handwashing, less “cohorting” of patients (meaning patients interact with a large number of health care workers), and closer proximity of infected patients to noninfected patients—are themselves caused by a dearth of health care professionals and a surplus of patients.

For instance, in the case of handwashing—a known, simple, and inexpensive method to reduce the spread of MRSA dramatically—overworked health care staff are less likely to wash when indicated, according to several studies cited by the authors. In one, noncompliance was highest in cases of high “intensity of patient care,” when there were more than 40 opportunities for handwashing per hour of care, compared with when there were fewer indications per hour (Ann. Intern. Med. 1999;130:126-30).

Additionally, the spread of MRSA within a facility exacerbates overcrowding, as patients' stays are extended, which in turn fuels chronic understaffing. “This contributes to a vicious cycle, where the occurrence of MRSA makes it more difficult to implement effective infection control strategies, leading to subsequent breakdowns in infection control and further increases in the incidence of MRSA,” the authors wrote.

The number of patients seeking care, inpatient or otherwise, is not likely to decrease any time soon—an aging population in the developed world means that countries like Australia can anticipate a 70%-130% increase in hospital bed requirements by 2050, according to the review. But there is hope—the authors praised institutions in the Netherlands and Scandinavian countries, for example, for keeping MRSA infection down.

On the level of individual facilities, the researchers cited several studies wherein screening of new admissions for infection, isolation of high-risk patients, and use of more effective hand hygiene products have proved successful.

The authors wrote that they had no conflicts of interest to disclose.

Overcrowding and understaffing of hospitals are two of the major underlying factors driving the spread of methicillin-resistant Staphylococcus aureus in this setting, according to a review.

Furthermore, “the economic benefits of downsizing health care systems are likely to have been offset by the increased burden of adverse events, such as MRSA,” the authors wrote.

Archie Clements, Ph.D., of the division of epidemiology and social medicine at the University of Queensland (Australia), and his colleagues from the fields of mathematics, statistics, infection surveillance, and medicine, cited 140 studies in their review (Lancet Infect. Dis. 2008;8:427-34).

They concluded that the direct mechanisms through which hospital-acquired infections are spread—including a decrease in handwashing, less “cohorting” of patients (meaning patients interact with a large number of health care workers), and closer proximity of infected patients to noninfected patients—are themselves caused by a dearth of health care professionals and a surplus of patients.

For instance, in the case of handwashing—a known, simple, and inexpensive method to reduce the spread of MRSA dramatically—overworked health care staff are less likely to wash when indicated, according to several studies cited by the authors. In one, noncompliance was highest in cases of high “intensity of patient care,” when there were more than 40 opportunities for handwashing per hour of care, compared with when there were fewer indications per hour (Ann. Intern. Med. 1999;130:126-30).

Additionally, the spread of MRSA within a facility exacerbates overcrowding, as patients' stays are extended, which in turn fuels chronic understaffing. “This contributes to a vicious cycle, where the occurrence of MRSA makes it more difficult to implement effective infection control strategies, leading to subsequent breakdowns in infection control and further increases in the incidence of MRSA,” the authors wrote.

The number of patients seeking care, inpatient or otherwise, is not likely to decrease any time soon—an aging population in the developed world means that countries like Australia can anticipate a 70%-130% increase in hospital bed requirements by 2050, according to the review. But there is hope—the authors praised institutions in the Netherlands and Scandinavian countries, for example, for keeping MRSA infection down.

On the level of individual facilities, the researchers cited several studies wherein screening of new admissions for infection, isolation of high-risk patients, and use of more effective hand hygiene products have proved successful.

The authors wrote that they had no conflicts of interest to disclose.

Overcrowding and understaffing of hospitals are two of the major underlying factors driving the spread of methicillin-resistant Staphylococcus aureus in this setting, according to a review.

Furthermore, “the economic benefits of downsizing health care systems are likely to have been offset by the increased burden of adverse events, such as MRSA,” the authors wrote.

Archie Clements, Ph.D., of the division of epidemiology and social medicine at the University of Queensland (Australia), and his colleagues from the fields of mathematics, statistics, infection surveillance, and medicine, cited 140 studies in their review (Lancet Infect. Dis. 2008;8:427-34).

They concluded that the direct mechanisms through which hospital-acquired infections are spread—including a decrease in handwashing, less “cohorting” of patients (meaning patients interact with a large number of health care workers), and closer proximity of infected patients to noninfected patients—are themselves caused by a dearth of health care professionals and a surplus of patients.

For instance, in the case of handwashing—a known, simple, and inexpensive method to reduce the spread of MRSA dramatically—overworked health care staff are less likely to wash when indicated, according to several studies cited by the authors. In one, noncompliance was highest in cases of high “intensity of patient care,” when there were more than 40 opportunities for handwashing per hour of care, compared with when there were fewer indications per hour (Ann. Intern. Med. 1999;130:126-30).

Additionally, the spread of MRSA within a facility exacerbates overcrowding, as patients' stays are extended, which in turn fuels chronic understaffing. “This contributes to a vicious cycle, where the occurrence of MRSA makes it more difficult to implement effective infection control strategies, leading to subsequent breakdowns in infection control and further increases in the incidence of MRSA,” the authors wrote.

The number of patients seeking care, inpatient or otherwise, is not likely to decrease any time soon—an aging population in the developed world means that countries like Australia can anticipate a 70%-130% increase in hospital bed requirements by 2050, according to the review. But there is hope—the authors praised institutions in the Netherlands and Scandinavian countries, for example, for keeping MRSA infection down.

On the level of individual facilities, the researchers cited several studies wherein screening of new admissions for infection, isolation of high-risk patients, and use of more effective hand hygiene products have proved successful.

The authors wrote that they had no conflicts of interest to disclose.

Overcrowding and understaffing of hospitals are two of the major underlying factors driving the spread of methicillin-resistant Staphylococcus aureus in this setting, according to a review.

Furthermore, "the economic benefits of downsizing health care systems are likely to have been offset by the increased burden of adverse events, such as MRSA," the authors wrote.

Archie Clements, Ph.D., of the division of epidemiology and social medicine at the University of Queensland (Australia), and his colleagues from the fields of mathematics, statistics, infection surveillance, and medicine, cited 140 studies in their review (Lancet Infect. Dis. 2008;8:427-34).

They concluded that the direct mechanisms through which hospital-acquired infections are spread—including a decrease in handwashing, less "cohorting" of patients (meaning patients interact with a large number of health care workers), and closer proximity of infected patients to noninfected patients—are themselves caused by a dearth of health care professionals and a surplus of patients.

For instance, in the case of handwashing—a known, simple, and inexpensive method to reduce the spread of MRSA dramatically—overworked health care staff are less likely to wash when indicated, according to several studies cited by the authors.

In one study, noncompliance was highest in cases of high "intensity of patient care," when there were more than 40 opportunities for handwashing per hour of care, compared with when there were fewer indications per hour (Ann. Intern. Med. 1999;130:126-30).

Additionally, the spread of methicillin-resistant S. aureus within a facility exacerbates overcrowding, as patients' stays are extended, which in turn fuels chronic understaffing.

"This contributes to a vicious cycle, where the occurrence of MRSA makes it more difficult to implement effective infection control strategies, leading to subsequent breakdowns in infection control and further increases in the incidence of MRSA," the authors wrote.

The number of patients seeking care, inpatient or otherwise, is not likely to decrease any time soon—an aging population in the developed world means that countries like Australia can anticipate a 70%-130% increase in hospital bed requirements by 2050, according to the review.

There is hope, however. The authors praised institutions in the Netherlands and Scandinavian countries, for example, for keeping MRSA infection down.

On the level of individual facilities, the researchers cited several studies wherein screening of new admissions for infection, isolation of high-risk patients, and use of more effective hand hygiene products have proved successful.

More studies need to be undertaken to determine the "most cost-effective MRSA control strategies for a given situation," they added.

The authors wrote that they had no conflicts of interest to disclose.

Overcrowding and understaffing of hospitals are two of the major underlying factors driving the spread of methicillin-resistant Staphylococcus aureus in this setting, according to a review.

Furthermore, "the economic benefits of downsizing health care systems are likely to have been offset by the increased burden of adverse events, such as MRSA," the authors wrote.

Archie Clements, Ph.D., of the division of epidemiology and social medicine at the University of Queensland (Australia), and his colleagues from the fields of mathematics, statistics, infection surveillance, and medicine, cited 140 studies in their review (Lancet Infect. Dis. 2008;8:427-34).

They concluded that the direct mechanisms through which hospital-acquired infections are spread—including a decrease in handwashing, less "cohorting" of patients (meaning patients interact with a large number of health care workers), and closer proximity of infected patients to noninfected patients—are themselves caused by a dearth of health care professionals and a surplus of patients.

For instance, in the case of handwashing—a known, simple, and inexpensive method to reduce the spread of MRSA dramatically—overworked health care staff are less likely to wash when indicated, according to several studies cited by the authors.

In one study, noncompliance was highest in cases of high "intensity of patient care," when there were more than 40 opportunities for handwashing per hour of care, compared with when there were fewer indications per hour (Ann. Intern. Med. 1999;130:126-30).

Additionally, the spread of methicillin-resistant S. aureus within a facility exacerbates overcrowding, as patients' stays are extended, which in turn fuels chronic understaffing.

"This contributes to a vicious cycle, where the occurrence of MRSA makes it more difficult to implement effective infection control strategies, leading to subsequent breakdowns in infection control and further increases in the incidence of MRSA," the authors wrote.

The number of patients seeking care, inpatient or otherwise, is not likely to decrease any time soon—an aging population in the developed world means that countries like Australia can anticipate a 70%-130% increase in hospital bed requirements by 2050, according to the review.

There is hope, however. The authors praised institutions in the Netherlands and Scandinavian countries, for example, for keeping MRSA infection down.

On the level of individual facilities, the researchers cited several studies wherein screening of new admissions for infection, isolation of high-risk patients, and use of more effective hand hygiene products have proved successful.

More studies need to be undertaken to determine the "most cost-effective MRSA control strategies for a given situation," they added.

The authors wrote that they had no conflicts of interest to disclose.

Overcrowding and understaffing of hospitals are two of the major underlying factors driving the spread of methicillin-resistant Staphylococcus aureus in this setting, according to a review.

Furthermore, "the economic benefits of downsizing health care systems are likely to have been offset by the increased burden of adverse events, such as MRSA," the authors wrote.

Archie Clements, Ph.D., of the division of epidemiology and social medicine at the University of Queensland (Australia), and his colleagues from the fields of mathematics, statistics, infection surveillance, and medicine, cited 140 studies in their review (Lancet Infect. Dis. 2008;8:427-34).

They concluded that the direct mechanisms through which hospital-acquired infections are spread—including a decrease in handwashing, less "cohorting" of patients (meaning patients interact with a large number of health care workers), and closer proximity of infected patients to noninfected patients—are themselves caused by a dearth of health care professionals and a surplus of patients.

For instance, in the case of handwashing—a known, simple, and inexpensive method to reduce the spread of MRSA dramatically—overworked health care staff are less likely to wash when indicated, according to several studies cited by the authors.

In one study, noncompliance was highest in cases of high "intensity of patient care," when there were more than 40 opportunities for handwashing per hour of care, compared with when there were fewer indications per hour (Ann. Intern. Med. 1999;130:126-30).

Additionally, the spread of methicillin-resistant S. aureus within a facility exacerbates overcrowding, as patients' stays are extended, which in turn fuels chronic understaffing.

"This contributes to a vicious cycle, where the occurrence of MRSA makes it more difficult to implement effective infection control strategies, leading to subsequent breakdowns in infection control and further increases in the incidence of MRSA," the authors wrote.

The number of patients seeking care, inpatient or otherwise, is not likely to decrease any time soon—an aging population in the developed world means that countries like Australia can anticipate a 70%-130% increase in hospital bed requirements by 2050, according to the review.

There is hope, however. The authors praised institutions in the Netherlands and Scandinavian countries, for example, for keeping MRSA infection down.

On the level of individual facilities, the researchers cited several studies wherein screening of new admissions for infection, isolation of high-risk patients, and use of more effective hand hygiene products have proved successful.

More studies need to be undertaken to determine the "most cost-effective MRSA control strategies for a given situation," they added.

The authors wrote that they had no conflicts of interest to disclose.

WASHINGTON — The Recovery Audit Contractor program, charged with investigating and remedying improper Medicare payments to providers, must undergo some serious structural changes before it is ready for prime time, said several physicians in testimony before the House Committee on Small Business.

The Recovery Audit Contractor (RAC) program employs private contractors to investigate improper payments by Medicare to health care providers. The program was mandated in the Medicare Modernization Act and tested in New York, California, and Florida beginning in 2005. With the pilot now completed, nationwide adoption is scheduled to begin in 2010.

Dr. Karen Smith, a member of the American Academy of Family Physician's Commission on Practice Enhancement, testified about her own experience dealing with RAC audits. She said that in 2005, two representatives from one contractor, AdvanceMed, showed up at her office unannounced, flashing badges, and requested 72 charts for records from the previous year and a half.

“The care of my patients was disrupted in our open access, rural family practice as patients, pharmaceutical vendors, and other visitors of the practice observed the unannounced review,” according to her submitted testimony.

Five months after the audit, Dr. Smith received notice that 72 claims with 154 services were reviewed by the RAC, of which 91 services were disallowed for payment. The RAC then used an extrapolation formula to determine how much Dr. Smith owed, except it relied on an incorrect “sampling frame size” of 2,935 Medicare patients, nearly 2,000 more than Dr. Smith had in her practice.

“The discrepancy was not acknowledged or corrected in the final calculations,” Dr. Smith said. The alleged Medicare overpayment, using this flawed calculation, totalled $48,245, she said.

After a lengthy, costly, and ultimately not totally successful series of appeals, Dr. Smith was forced to use proceeds from a home equity loan to pay CMS an adjusted sum of $18,158. “The 'guilty until proven innocent' audit we endured used sampling and extrapolation calculations [that] are not properly verified for validity,” said Dr. Smith.

Dr. William A. Dolan, a member of the American Medical Association board of trustees, also testified before the committee, which is chaired by Rep. Charles Gonzalez (D-Texas).

“The best way to reduce common billing and coding mistakes is through targeted education and outreach, rather than onerous audits performed by outside contractors provided with incentives to deny claims,” he wrote in his testimony.

One of the greatest problems is RAC's ability to designate improper payments based on contractors' judgment of “medical necessity…. We do not think that these reviews are appropriate for the RAC program and believe that they exceed the authority imparted to the RAC by Congress. These reviews should be conducted by clinicians with relevant experience and expertise,” testified Dr. Michael Schweitz, a practicing rheumatologist from West Palm Beach, Fla.

Mr. Timothy B. Hill, chief financial officer and director of CMS' office of financial management, testified that once the RAC program is made permanent in 2010, each contractor will be required to have a medical director who oversees medical necessity questions. This was not the case in the demonstration project.

Another request, voiced by Dr. Dolan, was that program contractors be prohibited from reviewing claims from the past 12 months, which may be “still under review by carriers and other fiscal intermediaries.” He also called for a limit on the number of medical records requested from individual physicians. “I know of a urologist in California who was hit with 50 RAC requests,” he said.

“CMS should also raise the minimum claim level from $10 to at least $25,” he added. In a question-and-answer period after the testimony, Dr. Dolan amended his recommendation to $100.

Mr. Hill said that contractors are paid a commission on all of the improper payments they recover. “The incentive to identify underpayments is exactly the same as the incentive to identify overpayments,” he said. However, in 10 years of sampling “the vast majority of the improper payments” are overpayments.”

WASHINGTON — The Recovery Audit Contractor program, charged with investigating and remedying improper Medicare payments to providers, must undergo some serious structural changes before it is ready for prime time, said several physicians in testimony before the House Committee on Small Business.

The Recovery Audit Contractor (RAC) program employs private contractors to investigate improper payments by Medicare to health care providers. The program was mandated in the Medicare Modernization Act and tested in New York, California, and Florida beginning in 2005. With the pilot now completed, nationwide adoption is scheduled to begin in 2010.

Dr. Karen Smith, a member of the American Academy of Family Physician's Commission on Practice Enhancement, testified about her own experience dealing with RAC audits. She said that in 2005, two representatives from one contractor, AdvanceMed, showed up at her office unannounced, flashing badges, and requested 72 charts for records from the previous year and a half.

“The care of my patients was disrupted in our open access, rural family practice as patients, pharmaceutical vendors, and other visitors of the practice observed the unannounced review,” according to her submitted testimony.

Five months after the audit, Dr. Smith received notice that 72 claims with 154 services were reviewed by the RAC, of which 91 services were disallowed for payment. The RAC then used an extrapolation formula to determine how much Dr. Smith owed, except it relied on an incorrect “sampling frame size” of 2,935 Medicare patients, nearly 2,000 more than Dr. Smith had in her practice.

“The discrepancy was not acknowledged or corrected in the final calculations,” Dr. Smith said. The alleged Medicare overpayment, using this flawed calculation, totalled $48,245, she said.

After a lengthy, costly, and ultimately not totally successful series of appeals, Dr. Smith was forced to use proceeds from a home equity loan to pay CMS an adjusted sum of $18,158. “The 'guilty until proven innocent' audit we endured used sampling and extrapolation calculations [that] are not properly verified for validity,” said Dr. Smith.

Dr. William A. Dolan, a member of the American Medical Association board of trustees, also testified before the committee, which is chaired by Rep. Charles Gonzalez (D-Texas).

“The best way to reduce common billing and coding mistakes is through targeted education and outreach, rather than onerous audits performed by outside contractors provided with incentives to deny claims,” he wrote in his testimony.

One of the greatest problems is RAC's ability to designate improper payments based on contractors' judgment of “medical necessity…. We do not think that these reviews are appropriate for the RAC program and believe that they exceed the authority imparted to the RAC by Congress. These reviews should be conducted by clinicians with relevant experience and expertise,” testified Dr. Michael Schweitz, a practicing rheumatologist from West Palm Beach, Fla.

Mr. Timothy B. Hill, chief financial officer and director of CMS' office of financial management, testified that once the RAC program is made permanent in 2010, each contractor will be required to have a medical director who oversees medical necessity questions. This was not the case in the demonstration project.

Another request, voiced by Dr. Dolan, was that program contractors be prohibited from reviewing claims from the past 12 months, which may be “still under review by carriers and other fiscal intermediaries.” He also called for a limit on the number of medical records requested from individual physicians. “I know of a urologist in California who was hit with 50 RAC requests,” he said.

“CMS should also raise the minimum claim level from $10 to at least $25,” he added. In a question-and-answer period after the testimony, Dr. Dolan amended his recommendation to $100.

Mr. Hill said that contractors are paid a commission on all of the improper payments they recover. “The incentive to identify underpayments is exactly the same as the incentive to identify overpayments,” he said. However, in 10 years of sampling “the vast majority of the improper payments” are overpayments.”

WASHINGTON — The Recovery Audit Contractor program, charged with investigating and remedying improper Medicare payments to providers, must undergo some serious structural changes before it is ready for prime time, said several physicians in testimony before the House Committee on Small Business.

The Recovery Audit Contractor (RAC) program employs private contractors to investigate improper payments by Medicare to health care providers. The program was mandated in the Medicare Modernization Act and tested in New York, California, and Florida beginning in 2005. With the pilot now completed, nationwide adoption is scheduled to begin in 2010.

Dr. Karen Smith, a member of the American Academy of Family Physician's Commission on Practice Enhancement, testified about her own experience dealing with RAC audits. She said that in 2005, two representatives from one contractor, AdvanceMed, showed up at her office unannounced, flashing badges, and requested 72 charts for records from the previous year and a half.

“The care of my patients was disrupted in our open access, rural family practice as patients, pharmaceutical vendors, and other visitors of the practice observed the unannounced review,” according to her submitted testimony.

Five months after the audit, Dr. Smith received notice that 72 claims with 154 services were reviewed by the RAC, of which 91 services were disallowed for payment. The RAC then used an extrapolation formula to determine how much Dr. Smith owed, except it relied on an incorrect “sampling frame size” of 2,935 Medicare patients, nearly 2,000 more than Dr. Smith had in her practice.

“The discrepancy was not acknowledged or corrected in the final calculations,” Dr. Smith said. The alleged Medicare overpayment, using this flawed calculation, totalled $48,245, she said.

After a lengthy, costly, and ultimately not totally successful series of appeals, Dr. Smith was forced to use proceeds from a home equity loan to pay CMS an adjusted sum of $18,158. “The 'guilty until proven innocent' audit we endured used sampling and extrapolation calculations [that] are not properly verified for validity,” said Dr. Smith.

Dr. William A. Dolan, a member of the American Medical Association board of trustees, also testified before the committee, which is chaired by Rep. Charles Gonzalez (D-Texas).

“The best way to reduce common billing and coding mistakes is through targeted education and outreach, rather than onerous audits performed by outside contractors provided with incentives to deny claims,” he wrote in his testimony.

One of the greatest problems is RAC's ability to designate improper payments based on contractors' judgment of “medical necessity…. We do not think that these reviews are appropriate for the RAC program and believe that they exceed the authority imparted to the RAC by Congress. These reviews should be conducted by clinicians with relevant experience and expertise,” testified Dr. Michael Schweitz, a practicing rheumatologist from West Palm Beach, Fla.

Mr. Timothy B. Hill, chief financial officer and director of CMS' office of financial management, testified that once the RAC program is made permanent in 2010, each contractor will be required to have a medical director who oversees medical necessity questions. This was not the case in the demonstration project.

Another request, voiced by Dr. Dolan, was that program contractors be prohibited from reviewing claims from the past 12 months, which may be “still under review by carriers and other fiscal intermediaries.” He also called for a limit on the number of medical records requested from individual physicians. “I know of a urologist in California who was hit with 50 RAC requests,” he said.

“CMS should also raise the minimum claim level from $10 to at least $25,” he added. In a question-and-answer period after the testimony, Dr. Dolan amended his recommendation to $100.

Mr. Hill said that contractors are paid a commission on all of the improper payments they recover. “The incentive to identify underpayments is exactly the same as the incentive to identify overpayments,” he said. However, in 10 years of sampling “the vast majority of the improper payments” are overpayments.”

CHICAGO — Chemotherapy-related cognitive impairment was infrequent in a small study of 30 patients who underwent adjuvant chemotherapy for nonmetastatic breast cancer.

“People could be making decisions about whether or not to have chemotherapy based on stories they've heard about 'chemofog' or 'chemobrain,'” said Dr. David G. Darby, “We hope this information will help people make informed decisions.”

Dr. Darby and his colleagues looked at a total of 30 women who had already undergone either lumpectomy or mastectomy and were scheduled to undergo either the chemotherapy regimen known as AC (n = 15) or CEF or CMF regimens (n = 15).

▸ The AC regimen involves doxorubicin 60 mg/m

▸ The CEF regimen involves cyclophosphamide administered orally in doses of 75 mg/m

▸ The CMF regimen involves cyclophosphamide 100 mg/m

The women were compared with 30 age-matched controls.

Women took several tests designed to measure cognition as well as mood a few days before initiating chemotherapy (but after the diagnosis had been given and treatment course was decided); again at the start of each new treatment cycle; and for the last time 28 days after the final treatment cycle had begun in each group. Patients were assessed on the National Institute of Mental Health's Center for Epidemiologic Studies Depression (CES-D) scale, the State-Trait Anxiety Inventory (STAI) scale, and a test of Dr. Darby's own design, which measures detection speed, identification speed, working memory, and learning ability in a 10- to 12-minute battery.

Dr. Darby is the chief medical officer of a company he formed, called CogState, which produces and scores these tests. It is based in Australia and partly funded this study.

“The first finding of interest was that prior to the first cycle of chemo there was impairment in learning of moderate amplitude, and that was also associated with a mild reduction on mood scales or depressive scales,” said Dr. Darby in an interview. No women were clinically depressed (clinically depressed patients were excluded from the study) and none of the women were on antidepressants at baseline or throughout the study. However, he said, “There may have been an impairment there initially, prior to chemo.”

Two other findings also emerged, both good and bad. “There was an improvement of some of the learning aspects of their performance and a mild improvement on scores on anxiety scales, but there was also a mild deterioration in aspects of concentration and psychomotor speed [as the study progressed].” There was also evidence that patients' mood was declining slightly throughout the treatment.

Individual patients showed “quite a lot of variation—in particular, some patients would have impairment on only one occasion and then improve, and others would have impairment on two or more occasions,” he said. Persistent impairment, that occurring on two consecutive occasions, was seen in only three patients, or 10% of the total, Dr. Darby reported at the annual meeting of the American Academy of Neurology.

Impairment in concentration was not severe, “equivalent to the sort of jet-lag that I'm feeling now, having travelled from Australia.” He also likened it to the sort of impairment one would feel after being awake for about 17 hours.

Dr. Darby found no significant differences in the risk for cognitive impairment based on the women's age, menopausal status (pre-, peri-, or post-), or time from surgery.

As for the practical applications of his results, Dr. Darby said, “When women are confronting breast cancer, coming to terms with the many different aspects of it, and trying to take advice and understand what's happening to them, the issues of quality of life are important. They should realize that these sorts of changes seem to be very mild.”

CHICAGO — Chemotherapy-related cognitive impairment was infrequent in a small study of 30 patients who underwent adjuvant chemotherapy for nonmetastatic breast cancer.

“People could be making decisions about whether or not to have chemotherapy based on stories they've heard about 'chemofog' or 'chemobrain,'” said Dr. David G. Darby, “We hope this information will help people make informed decisions.”

Dr. Darby and his colleagues looked at a total of 30 women who had already undergone either lumpectomy or mastectomy and were scheduled to undergo either the chemotherapy regimen known as AC (n = 15) or CEF or CMF regimens (n = 15).

▸ The AC regimen involves doxorubicin 60 mg/m

▸ The CEF regimen involves cyclophosphamide administered orally in doses of 75 mg/m

▸ The CMF regimen involves cyclophosphamide 100 mg/m

The women were compared with 30 age-matched controls.

Women took several tests designed to measure cognition as well as mood a few days before initiating chemotherapy (but after the diagnosis had been given and treatment course was decided); again at the start of each new treatment cycle; and for the last time 28 days after the final treatment cycle had begun in each group. Patients were assessed on the National Institute of Mental Health's Center for Epidemiologic Studies Depression (CES-D) scale, the State-Trait Anxiety Inventory (STAI) scale, and a test of Dr. Darby's own design, which measures detection speed, identification speed, working memory, and learning ability in a 10- to 12-minute battery.

Dr. Darby is the chief medical officer of a company he formed, called CogState, which produces and scores these tests. It is based in Australia and partly funded this study.

“The first finding of interest was that prior to the first cycle of chemo there was impairment in learning of moderate amplitude, and that was also associated with a mild reduction on mood scales or depressive scales,” said Dr. Darby in an interview. No women were clinically depressed (clinically depressed patients were excluded from the study) and none of the women were on antidepressants at baseline or throughout the study. However, he said, “There may have been an impairment there initially, prior to chemo.”

Two other findings also emerged, both good and bad. “There was an improvement of some of the learning aspects of their performance and a mild improvement on scores on anxiety scales, but there was also a mild deterioration in aspects of concentration and psychomotor speed [as the study progressed].” There was also evidence that patients' mood was declining slightly throughout the treatment.

Individual patients showed “quite a lot of variation—in particular, some patients would have impairment on only one occasion and then improve, and others would have impairment on two or more occasions,” he said. Persistent impairment, that occurring on two consecutive occasions, was seen in only three patients, or 10% of the total, Dr. Darby reported at the annual meeting of the American Academy of Neurology.

Impairment in concentration was not severe, “equivalent to the sort of jet-lag that I'm feeling now, having travelled from Australia.” He also likened it to the sort of impairment one would feel after being awake for about 17 hours.

Dr. Darby found no significant differences in the risk for cognitive impairment based on the women's age, menopausal status (pre-, peri-, or post-), or time from surgery.

As for the practical applications of his results, Dr. Darby said, “When women are confronting breast cancer, coming to terms with the many different aspects of it, and trying to take advice and understand what's happening to them, the issues of quality of life are important. They should realize that these sorts of changes seem to be very mild.”

CHICAGO — Chemotherapy-related cognitive impairment was infrequent in a small study of 30 patients who underwent adjuvant chemotherapy for nonmetastatic breast cancer.

“People could be making decisions about whether or not to have chemotherapy based on stories they've heard about 'chemofog' or 'chemobrain,'” said Dr. David G. Darby, “We hope this information will help people make informed decisions.”

Dr. Darby and his colleagues looked at a total of 30 women who had already undergone either lumpectomy or mastectomy and were scheduled to undergo either the chemotherapy regimen known as AC (n = 15) or CEF or CMF regimens (n = 15).

▸ The AC regimen involves doxorubicin 60 mg/m

▸ The CEF regimen involves cyclophosphamide administered orally in doses of 75 mg/m

▸ The CMF regimen involves cyclophosphamide 100 mg/m

The women were compared with 30 age-matched controls.

Women took several tests designed to measure cognition as well as mood a few days before initiating chemotherapy (but after the diagnosis had been given and treatment course was decided); again at the start of each new treatment cycle; and for the last time 28 days after the final treatment cycle had begun in each group. Patients were assessed on the National Institute of Mental Health's Center for Epidemiologic Studies Depression (CES-D) scale, the State-Trait Anxiety Inventory (STAI) scale, and a test of Dr. Darby's own design, which measures detection speed, identification speed, working memory, and learning ability in a 10- to 12-minute battery.

Dr. Darby is the chief medical officer of a company he formed, called CogState, which produces and scores these tests. It is based in Australia and partly funded this study.

“The first finding of interest was that prior to the first cycle of chemo there was impairment in learning of moderate amplitude, and that was also associated with a mild reduction on mood scales or depressive scales,” said Dr. Darby in an interview. No women were clinically depressed (clinically depressed patients were excluded from the study) and none of the women were on antidepressants at baseline or throughout the study. However, he said, “There may have been an impairment there initially, prior to chemo.”

Two other findings also emerged, both good and bad. “There was an improvement of some of the learning aspects of their performance and a mild improvement on scores on anxiety scales, but there was also a mild deterioration in aspects of concentration and psychomotor speed [as the study progressed].” There was also evidence that patients' mood was declining slightly throughout the treatment.

Individual patients showed “quite a lot of variation—in particular, some patients would have impairment on only one occasion and then improve, and others would have impairment on two or more occasions,” he said. Persistent impairment, that occurring on two consecutive occasions, was seen in only three patients, or 10% of the total, Dr. Darby reported at the annual meeting of the American Academy of Neurology.

Impairment in concentration was not severe, “equivalent to the sort of jet-lag that I'm feeling now, having travelled from Australia.” He also likened it to the sort of impairment one would feel after being awake for about 17 hours.

Dr. Darby found no significant differences in the risk for cognitive impairment based on the women's age, menopausal status (pre-, peri-, or post-), or time from surgery.

As for the practical applications of his results, Dr. Darby said, “When women are confronting breast cancer, coming to terms with the many different aspects of it, and trying to take advice and understand what's happening to them, the issues of quality of life are important. They should realize that these sorts of changes seem to be very mild.”

WASHINGTON — The Recovery Audit Contractor program, charged with investigating and remedying improper Medicare payments to providers, must undergo some serious structural changes before it is ready for prime time, several physicians testified before the House Committee on Small Business.

The Recovery Audit Contractor (RAC) program employs private contractors to investigate improper payments by Medicare to providers. The program was mandated in the Medicare Modernization Act and tested in New York, California, and Florida beginning in 2005. With the pilot now completed, nationwide adoption is scheduled to begin in 2010.

Dr. Michael Schweitz, a rheumatologist from West Palm Beach, Fla., testified that “the demonstration has created unfair and expensive administrative burdens for physician practices, which are after all small businesses with limited capacity for dealing with arbitrary, ill-informed, and often very confusing policies of those contractors.” He added that he supports the institution of a moratorium on RAC activities and expansion until the program's flaws are addressed and corrected.

Dr. Karen Smith, a member of the American Academy of Family Physician's Commission on Practice Enhancement, testified about her own experience with RAC audits. She said that in 2005, two representatives from one contractor, AdvanceMed, showed up at her office unannounced and requested 72 charts for records from the previous year and a half. “The care of my patients was disrupted in our open access, rural family practice as patients, pharmaceutical vendors, and other visitors of the practice observed the unannounced review,” according to her submitted testimony.

Five months after the audit, Dr. Smith received notice that 72 claims with 154 services were reviewed by the RAC, of which 91 services were disallowed for payment. The RAC then used an extrapolation formula to determine how much Dr. Smith owed, except it relied on an incorrect “sampling frame size” of 2,935 Medicare patients, nearly 2,000 more than Dr. Smith had in her practice. The alleged Medicare overpayment, using this flawed calculation, totalled $48,245, said Dr. Smith.

After a lengthy, costly, and ultimately not totally successful series of appeals, Dr. Smith was forced to use proceeds from a home equity loan to pay CMS an adjusted sum of $18,158. “The 'guilty until proven innocent' audit we endured used sampling and extrapolation calculations [that] are not properly verified for validity,” said Dr. Smith.

Dr. William A. Dolan, a member of the American Medical Association board of trustees, also testified before the committee, which is chaired by Rep. Charles Gonzalez (D-Texas).

“The best way to reduce common billing and coding mistakes is through targeted education and outreach, rather than onerous audits performed by outside contractors provided with incentives to deny claims,” he wrote in his testimony.

The RAC program has many problems, according to all three physicians. One of the greatest is contractors' ability to designate improper payments based on contractors' judgment of “medical necessity.” Dr. Schweitz, who is also the vice president of the Coalition of State Rheumatology Associations (CSRA), said, “These reviews should be conducted by clinicians with relevant experience and expertise.” Dr. Schweitz testified on behalf of the Alliance of Specialty Medicine, a coalition of medical societies including CSRA that represents more than 200,000 physicians.

Mr. Timothy B. Hill, chief financial officer and director of CMS' office of financial management, testified that once the RAC program is made permanent in 2010, each contractor will be required to have a medical director who oversees medical necessity questions. This was not the case in the demonstration project.

Another request from Dr. Dolan was that contractors be prohibited from reviewing claims from the past 12 months, which may be “still under review by carriers and other fiscal intermediaries.” He also called for a limit on the number of medical records requested from individuals.

“CMS should also raise the minimum claim level from $10 to at least $25,” he added. In a question-and-answer period after the testimony, Dr. Dolan amended his recommendation to $100.

All three physicians also testified that the “look-back” period, which allowed contractors to audit records from as far back as 4 years ago, should be shortened.

Responding to accusations by Dr. Schweitz and others that contractors operate under a “bounty hunter mechanism,” Mr. Hill said that contractors are paid a negotiated commission on all improper payments they recover—both under- and overpayments—upon recoupment of the payment by Medicare. “The incentive to identify underpayments is exactly the same as the incentive to identify overpayments,” he said. However, in 10 years, he testified that “the vast majority of the improper payments” are overpayments.

Mr. Hill added that a January 2008 report from the Office of Management and Budget reported that Medicare made an estimated $10.8 billion worth of improper payments in fiscal year 2007. The RACs corrected more than $1 billion in improper payments during the 3-year demonstration period, he added.

“If a provider disagrees with the RAC's overpayment determination, he or she can appeal the decision.”

WASHINGTON — The Recovery Audit Contractor program, charged with investigating and remedying improper Medicare payments to providers, must undergo some serious structural changes before it is ready for prime time, several physicians testified before the House Committee on Small Business.

The Recovery Audit Contractor (RAC) program employs private contractors to investigate improper payments by Medicare to providers. The program was mandated in the Medicare Modernization Act and tested in New York, California, and Florida beginning in 2005. With the pilot now completed, nationwide adoption is scheduled to begin in 2010.

Dr. Michael Schweitz, a rheumatologist from West Palm Beach, Fla., testified that “the demonstration has created unfair and expensive administrative burdens for physician practices, which are after all small businesses with limited capacity for dealing with arbitrary, ill-informed, and often very confusing policies of those contractors.” He added that he supports the institution of a moratorium on RAC activities and expansion until the program's flaws are addressed and corrected.

Dr. Karen Smith, a member of the American Academy of Family Physician's Commission on Practice Enhancement, testified about her own experience with RAC audits. She said that in 2005, two representatives from one contractor, AdvanceMed, showed up at her office unannounced and requested 72 charts for records from the previous year and a half. “The care of my patients was disrupted in our open access, rural family practice as patients, pharmaceutical vendors, and other visitors of the practice observed the unannounced review,” according to her submitted testimony.

Five months after the audit, Dr. Smith received notice that 72 claims with 154 services were reviewed by the RAC, of which 91 services were disallowed for payment. The RAC then used an extrapolation formula to determine how much Dr. Smith owed, except it relied on an incorrect “sampling frame size” of 2,935 Medicare patients, nearly 2,000 more than Dr. Smith had in her practice. The alleged Medicare overpayment, using this flawed calculation, totalled $48,245, said Dr. Smith.

After a lengthy, costly, and ultimately not totally successful series of appeals, Dr. Smith was forced to use proceeds from a home equity loan to pay CMS an adjusted sum of $18,158. “The 'guilty until proven innocent' audit we endured used sampling and extrapolation calculations [that] are not properly verified for validity,” said Dr. Smith.

Dr. William A. Dolan, a member of the American Medical Association board of trustees, also testified before the committee, which is chaired by Rep. Charles Gonzalez (D-Texas).

“The best way to reduce common billing and coding mistakes is through targeted education and outreach, rather than onerous audits performed by outside contractors provided with incentives to deny claims,” he wrote in his testimony.

The RAC program has many problems, according to all three physicians. One of the greatest is contractors' ability to designate improper payments based on contractors' judgment of “medical necessity.” Dr. Schweitz, who is also the vice president of the Coalition of State Rheumatology Associations (CSRA), said, “These reviews should be conducted by clinicians with relevant experience and expertise.” Dr. Schweitz testified on behalf of the Alliance of Specialty Medicine, a coalition of medical societies including CSRA that represents more than 200,000 physicians.

Mr. Timothy B. Hill, chief financial officer and director of CMS' office of financial management, testified that once the RAC program is made permanent in 2010, each contractor will be required to have a medical director who oversees medical necessity questions. This was not the case in the demonstration project.

Another request from Dr. Dolan was that contractors be prohibited from reviewing claims from the past 12 months, which may be “still under review by carriers and other fiscal intermediaries.” He also called for a limit on the number of medical records requested from individuals.

“CMS should also raise the minimum claim level from $10 to at least $25,” he added. In a question-and-answer period after the testimony, Dr. Dolan amended his recommendation to $100.

All three physicians also testified that the “look-back” period, which allowed contractors to audit records from as far back as 4 years ago, should be shortened.

Responding to accusations by Dr. Schweitz and others that contractors operate under a “bounty hunter mechanism,” Mr. Hill said that contractors are paid a negotiated commission on all improper payments they recover—both under- and overpayments—upon recoupment of the payment by Medicare. “The incentive to identify underpayments is exactly the same as the incentive to identify overpayments,” he said. However, in 10 years, he testified that “the vast majority of the improper payments” are overpayments.

Mr. Hill added that a January 2008 report from the Office of Management and Budget reported that Medicare made an estimated $10.8 billion worth of improper payments in fiscal year 2007. The RACs corrected more than $1 billion in improper payments during the 3-year demonstration period, he added.

“If a provider disagrees with the RAC's overpayment determination, he or she can appeal the decision.”

WASHINGTON — The Recovery Audit Contractor program, charged with investigating and remedying improper Medicare payments to providers, must undergo some serious structural changes before it is ready for prime time, several physicians testified before the House Committee on Small Business.

The Recovery Audit Contractor (RAC) program employs private contractors to investigate improper payments by Medicare to providers. The program was mandated in the Medicare Modernization Act and tested in New York, California, and Florida beginning in 2005. With the pilot now completed, nationwide adoption is scheduled to begin in 2010.

Dr. Michael Schweitz, a rheumatologist from West Palm Beach, Fla., testified that “the demonstration has created unfair and expensive administrative burdens for physician practices, which are after all small businesses with limited capacity for dealing with arbitrary, ill-informed, and often very confusing policies of those contractors.” He added that he supports the institution of a moratorium on RAC activities and expansion until the program's flaws are addressed and corrected.

Dr. Karen Smith, a member of the American Academy of Family Physician's Commission on Practice Enhancement, testified about her own experience with RAC audits. She said that in 2005, two representatives from one contractor, AdvanceMed, showed up at her office unannounced and requested 72 charts for records from the previous year and a half. “The care of my patients was disrupted in our open access, rural family practice as patients, pharmaceutical vendors, and other visitors of the practice observed the unannounced review,” according to her submitted testimony.

Five months after the audit, Dr. Smith received notice that 72 claims with 154 services were reviewed by the RAC, of which 91 services were disallowed for payment. The RAC then used an extrapolation formula to determine how much Dr. Smith owed, except it relied on an incorrect “sampling frame size” of 2,935 Medicare patients, nearly 2,000 more than Dr. Smith had in her practice. The alleged Medicare overpayment, using this flawed calculation, totalled $48,245, said Dr. Smith.

After a lengthy, costly, and ultimately not totally successful series of appeals, Dr. Smith was forced to use proceeds from a home equity loan to pay CMS an adjusted sum of $18,158. “The 'guilty until proven innocent' audit we endured used sampling and extrapolation calculations [that] are not properly verified for validity,” said Dr. Smith.

Dr. William A. Dolan, a member of the American Medical Association board of trustees, also testified before the committee, which is chaired by Rep. Charles Gonzalez (D-Texas).

“The best way to reduce common billing and coding mistakes is through targeted education and outreach, rather than onerous audits performed by outside contractors provided with incentives to deny claims,” he wrote in his testimony.

The RAC program has many problems, according to all three physicians. One of the greatest is contractors' ability to designate improper payments based on contractors' judgment of “medical necessity.” Dr. Schweitz, who is also the vice president of the Coalition of State Rheumatology Associations (CSRA), said, “These reviews should be conducted by clinicians with relevant experience and expertise.” Dr. Schweitz testified on behalf of the Alliance of Specialty Medicine, a coalition of medical societies including CSRA that represents more than 200,000 physicians.

Mr. Timothy B. Hill, chief financial officer and director of CMS' office of financial management, testified that once the RAC program is made permanent in 2010, each contractor will be required to have a medical director who oversees medical necessity questions. This was not the case in the demonstration project.

Another request from Dr. Dolan was that contractors be prohibited from reviewing claims from the past 12 months, which may be “still under review by carriers and other fiscal intermediaries.” He also called for a limit on the number of medical records requested from individuals.

“CMS should also raise the minimum claim level from $10 to at least $25,” he added. In a question-and-answer period after the testimony, Dr. Dolan amended his recommendation to $100.

All three physicians also testified that the “look-back” period, which allowed contractors to audit records from as far back as 4 years ago, should be shortened.

Responding to accusations by Dr. Schweitz and others that contractors operate under a “bounty hunter mechanism,” Mr. Hill said that contractors are paid a negotiated commission on all improper payments they recover—both under- and overpayments—upon recoupment of the payment by Medicare. “The incentive to identify underpayments is exactly the same as the incentive to identify overpayments,” he said. However, in 10 years, he testified that “the vast majority of the improper payments” are overpayments.

Mr. Hill added that a January 2008 report from the Office of Management and Budget reported that Medicare made an estimated $10.8 billion worth of improper payments in fiscal year 2007. The RACs corrected more than $1 billion in improper payments during the 3-year demonstration period, he added.

“If a provider disagrees with the RAC's overpayment determination, he or she can appeal the decision.”

Overcrowding and understaffing of hospitals are two of the major underlying factors driving the spread of methicillin-resistant Staphylococcus aureus in this setting, according to a review.

“The economic benefits of downsizing health care systems are likely to have been offset by the increased burden of adverse events, such as MRSA,” the authors wrote.

Archie Clements, Ph.D., of the division of epidemiology and social medicine at the University of Queensland (Australia), and his colleagues from the fields of mathematics, statistics, infection surveillance, and medicine, cited 140 studies in their review (Lancet Infect. Dis. 2008;8:427-34).

They concluded that the direct mechanisms through which hospital-acquired infections are spread—including a decrease in hand washing, less “cohorting” of patients (meaning patients interact with a large number of health care workers), and closer proximity of infected patients to noninfected patients—are themselves caused by a dearth of health care professionals and a surplus of patients.

For instance, in the case of hand washing—a simple, inexpensive method to reduce the spread of MRSA—overworked health care staff are less likely to wash when indicated, according to several studies cited by the authors. In one, noncompliance was highest in cases of high “intensity of patient care,” when there were more than 40 opportunities for hand washing per hour of care, compared with when there were fewer indications per hour (Ann. Intern. Med. 1999;130:126-30).

Also, “a vicious cycle” can occur in which the spread of MRSA within a facility exacerbates overcrowding, as patients' stays are extended, which in turn fuels chronic understaffing. “This contributes to a vicious cycle, where the occurrence of MRSA makes it more difficult to implement effective infection control strategies,” the authors wrote.

The authors said they had no conflicts of interest to disclose.

Overcrowding and understaffing of hospitals are two of the major underlying factors driving the spread of methicillin-resistant Staphylococcus aureus in this setting, according to a review.

“The economic benefits of downsizing health care systems are likely to have been offset by the increased burden of adverse events, such as MRSA,” the authors wrote.

Archie Clements, Ph.D., of the division of epidemiology and social medicine at the University of Queensland (Australia), and his colleagues from the fields of mathematics, statistics, infection surveillance, and medicine, cited 140 studies in their review (Lancet Infect. Dis. 2008;8:427-34).

They concluded that the direct mechanisms through which hospital-acquired infections are spread—including a decrease in hand washing, less “cohorting” of patients (meaning patients interact with a large number of health care workers), and closer proximity of infected patients to noninfected patients—are themselves caused by a dearth of health care professionals and a surplus of patients.

For instance, in the case of hand washing—a simple, inexpensive method to reduce the spread of MRSA—overworked health care staff are less likely to wash when indicated, according to several studies cited by the authors. In one, noncompliance was highest in cases of high “intensity of patient care,” when there were more than 40 opportunities for hand washing per hour of care, compared with when there were fewer indications per hour (Ann. Intern. Med. 1999;130:126-30).

Also, “a vicious cycle” can occur in which the spread of MRSA within a facility exacerbates overcrowding, as patients' stays are extended, which in turn fuels chronic understaffing. “This contributes to a vicious cycle, where the occurrence of MRSA makes it more difficult to implement effective infection control strategies,” the authors wrote.

The authors said they had no conflicts of interest to disclose.

Overcrowding and understaffing of hospitals are two of the major underlying factors driving the spread of methicillin-resistant Staphylococcus aureus in this setting, according to a review.

“The economic benefits of downsizing health care systems are likely to have been offset by the increased burden of adverse events, such as MRSA,” the authors wrote.

Archie Clements, Ph.D., of the division of epidemiology and social medicine at the University of Queensland (Australia), and his colleagues from the fields of mathematics, statistics, infection surveillance, and medicine, cited 140 studies in their review (Lancet Infect. Dis. 2008;8:427-34).

They concluded that the direct mechanisms through which hospital-acquired infections are spread—including a decrease in hand washing, less “cohorting” of patients (meaning patients interact with a large number of health care workers), and closer proximity of infected patients to noninfected patients—are themselves caused by a dearth of health care professionals and a surplus of patients.

For instance, in the case of hand washing—a simple, inexpensive method to reduce the spread of MRSA—overworked health care staff are less likely to wash when indicated, according to several studies cited by the authors. In one, noncompliance was highest in cases of high “intensity of patient care,” when there were more than 40 opportunities for hand washing per hour of care, compared with when there were fewer indications per hour (Ann. Intern. Med. 1999;130:126-30).

Also, “a vicious cycle” can occur in which the spread of MRSA within a facility exacerbates overcrowding, as patients' stays are extended, which in turn fuels chronic understaffing. “This contributes to a vicious cycle, where the occurrence of MRSA makes it more difficult to implement effective infection control strategies,” the authors wrote.

The authors said they had no conflicts of interest to disclose.

WASHINGTON — In response to physician groups concerned about the high incidence of deep vein thrombosis and pulmonary embolism, Acting Surgeon General Steven K. Galson has issued a Call to Action statement.

In concert with the statement, which was released at the second annual meeting of the Venous Disease Coalitiion, the National Heart, Lung, and Blood Institute has awarded 5 years' worth of funding to eight research groups investigating venous thromboembolism treatments and prevention. Ongoing studies include a multicenter, randomized clinical trial of genotype-guided dosing of warfarin therapy, which is currently the most commonly used treatment for prophylaxis of recurrent venous thromboembolism, according to Dr. Elizabeth Nabel, director of clinical research at the NHLBI.

The major push to address the rising incidence of DVT and PE dates to a 2006 meeting betweeen former Surgeon General Richard H. Carmona and advocates. As a member of the Coalition to Prevent DVT, Dr. Frank Michota, director of academic affairs in the department of hospital medicine at the Cleveland Clinic, spoke on public advocacy at that meeting.

“Hospitalists will play a pivotal role in the success of this Call to Action,” Dr. Michota said. “This is where hospitalists have an opportunity to develop, encourage, and pull through the systems of care that will guarantee all patients at risk for DVT are identified and that those found to be at risk will receive evidence-based methods of prophylaxis.”

Dr. Michota, medical editor-in-chief for Hospitalist News, added that he believes hospitalists are “more focused on this issue than any other specialty, including pulmonologists and cardiologists. Venous thromboembolism is one of the hospitalist's clinical core competencies.”

Hospitalists have been instrumental in the development of “reminder systems, preprinted order sheets, and multidisciplinary protocols so that no patient falls through the cracks in regards to DVT prevention,” he observed.

Further, there are new incentives to ensure that more hospitalized patients receive appropriate prophylaxis.

As of Oct. 1, 2008, any DVT or PE acquired during an inpatient stay in association with total knee and hip replacement procedures will have “payment implications,” according to the Centers for Medicare and Medicaid Services (HOSPITALIST NEWS, August 2008, p. 1).

Just how many patients are affected annually by venous thromboembolism is unclear. Without an autopsy, many fatal cases—perhaps as many as 50%—are misclassified as myocardial infarctions.

According to Dr. Roy S. Silverstein, chair of the committee of government affairs for the American Society of Hematology, the disease affects almost 1 million Americans annually, and “the estimated number of deaths from PE is higher than the combined number of deaths from breast cancer, HIV disease, and motor vehicle crashes.”

Dr. Galson put PE- or DVT-related deaths at 100,000 annually, with 350,000-600,000 Americans contracting DVT or PE each year.

The American Heart Association estimated the incidence of venous thromboembolism to be 250,000 to 2 million cases per year (Circulation 2002;106:1436). Meanwhile, upcoming studies put the annual number of cases somewhere in between those estimates.

The risk for DVT is known to be greatest among hospitalized spinal cord injury patients. Among those who do not receive VTE prophylaxis, the risk of developing a deep vein thrombosis (DVT) is 60%-80%.

Without VTE prophylaxis, the DVT risk is 40%-60% among hip and knee surgery patients, 20%-40% among patients undergoing major general surgery or gynecologic procedures, and 10%-20% for patients with acute illnesses like pneumonia.

“There is now a public acknowledgment that this is a very significant health care issue that deserves attention from multiple facets of the medical community,” Dr. Thomas Wakefield, head of vascular surgery at the University of Michigan, Ann Arbor said in an interview.

“We've known for a long time that (DVT and PE are) significant problems; however, since the conditions don't belong to one group or another and span so many specialties, it has been difficult to mobilize and raise awareness.”

Dr. Wakefield noted that the NHLBI initiative is an excellent start, but additional studies are needed, including studies of newer drugs and pharmacologic therapies with fewer adverse effects and interactions, and less need for monitoring than has warfarin.

Among the other studies worthy of consideration are investigations of short- and long-term outcomes associated with more aggressive interventions for DVT and PE. One such study, which has been funded by the National Institutes of Health and is slated to start soon, will compare pharmacomechanical thrombolysis plus standard anticoagulation to standard anticoagulation alone for the treatment of significant proximal venous thrombosis.

Booklets Focus on DVT Prevention

Preventing Hospital-Acquired Venous Thromboembolism: A Guide for Effective Quality Improvement is a 60-page booklet that includes case studies and is “designed to help hospitals and clinicians implement processes to prevent dangerous blood clots,” according to Dr. Carolyn Clancy, director of the U.S. Department of Health and Human Services' Agency for Healthcare Research and Quality, which published the booklets.

“Your Guide to Preventing and Treating Blood Clots” is a 12-page consumer booklet summarizing the causes and symptoms of blood clots, ways to avoid them, and what to expect from treatment.

Free copies of both booklets are available either by calling 800-358-9295 or by sending an e-mail to

[email protected]

Warfarin Genotype Study Set to Begin

The National Heart, Lung, and Blood Institute is about to launch its first-ever multicenter, double-blind, pharmacogenetic trial—one focused on warfarin therapy.

The COAG (Clarification of Optimal Anticoagulation Through Genetics) trial aims to determine whether targeting patients according to their genotype during the initiation of warfarin therapy would lead to better and safer anticoagulation control, especially in patients with deep vein thrombosis (DVT), according to an NHLBI representative. Results are anticipated in 2011.

Warfarin is the most commonly used blood-thinning treatment, and the 10th most prescribed medication in the United States, with more than 21 million prescriptions per year, according to the NHLBI. Patients with certain genotypes have been shown to metabolize warfarin better than do others, and some researchers believe that there may be an optimal genotype for toleration of the drug. “It is hoped that prospectively using the genetic information in addition to the clinical information will help clinicians determine better and safer initial dosing for specific patients,” an NHLBI spokesperson said.

The COAG trial will be coordinated by the center for clinical epidemiology and biostatistics at the University of Pennsylvania, Philadelphia. By the end of 2008, study coordinators hope to begin enrolling 1,965 patients. Details are still being finalized, but the NHLBI spokesperson said that she expects participants will have to be starting on warfarin therapy with an indication of at least 3 months of treatment. They will likely have to be warfarin naive, and without any major contraindications to anticoagulant treatment.

To request more information on patient enrollment, send an e-mail to

[email protected]

WASHINGTON — In response to physician groups concerned about the high incidence of deep vein thrombosis and pulmonary embolism, Acting Surgeon General Steven K. Galson has issued a Call to Action statement.

In concert with the statement, which was released at the second annual meeting of the Venous Disease Coalitiion, the National Heart, Lung, and Blood Institute has awarded 5 years' worth of funding to eight research groups investigating venous thromboembolism treatments and prevention. Ongoing studies include a multicenter, randomized clinical trial of genotype-guided dosing of warfarin therapy, which is currently the most commonly used treatment for prophylaxis of recurrent venous thromboembolism, according to Dr. Elizabeth Nabel, director of clinical research at the NHLBI.

The major push to address the rising incidence of DVT and PE dates to a 2006 meeting betweeen former Surgeon General Richard H. Carmona and advocates. As a member of the Coalition to Prevent DVT, Dr. Frank Michota, director of academic affairs in the department of hospital medicine at the Cleveland Clinic, spoke on public advocacy at that meeting.

“Hospitalists will play a pivotal role in the success of this Call to Action,” Dr. Michota said. “This is where hospitalists have an opportunity to develop, encourage, and pull through the systems of care that will guarantee all patients at risk for DVT are identified and that those found to be at risk will receive evidence-based methods of prophylaxis.”

Dr. Michota, medical editor-in-chief for Hospitalist News, added that he believes hospitalists are “more focused on this issue than any other specialty, including pulmonologists and cardiologists. Venous thromboembolism is one of the hospitalist's clinical core competencies.”

Hospitalists have been instrumental in the development of “reminder systems, preprinted order sheets, and multidisciplinary protocols so that no patient falls through the cracks in regards to DVT prevention,” he observed.

Further, there are new incentives to ensure that more hospitalized patients receive appropriate prophylaxis.

As of Oct. 1, 2008, any DVT or PE acquired during an inpatient stay in association with total knee and hip replacement procedures will have “payment implications,” according to the Centers for Medicare and Medicaid Services (HOSPITALIST NEWS, August 2008, p. 1).

Just how many patients are affected annually by venous thromboembolism is unclear. Without an autopsy, many fatal cases—perhaps as many as 50%—are misclassified as myocardial infarctions.

According to Dr. Roy S. Silverstein, chair of the committee of government affairs for the American Society of Hematology, the disease affects almost 1 million Americans annually, and “the estimated number of deaths from PE is higher than the combined number of deaths from breast cancer, HIV disease, and motor vehicle crashes.”

Dr. Galson put PE- or DVT-related deaths at 100,000 annually, with 350,000-600,000 Americans contracting DVT or PE each year.

The American Heart Association estimated the incidence of venous thromboembolism to be 250,000 to 2 million cases per year (Circulation 2002;106:1436). Meanwhile, upcoming studies put the annual number of cases somewhere in between those estimates.

The risk for DVT is known to be greatest among hospitalized spinal cord injury patients. Among those who do not receive VTE prophylaxis, the risk of developing a deep vein thrombosis (DVT) is 60%-80%.

Without VTE prophylaxis, the DVT risk is 40%-60% among hip and knee surgery patients, 20%-40% among patients undergoing major general surgery or gynecologic procedures, and 10%-20% for patients with acute illnesses like pneumonia.

“There is now a public acknowledgment that this is a very significant health care issue that deserves attention from multiple facets of the medical community,” Dr. Thomas Wakefield, head of vascular surgery at the University of Michigan, Ann Arbor said in an interview.

“We've known for a long time that (DVT and PE are) significant problems; however, since the conditions don't belong to one group or another and span so many specialties, it has been difficult to mobilize and raise awareness.”

Dr. Wakefield noted that the NHLBI initiative is an excellent start, but additional studies are needed, including studies of newer drugs and pharmacologic therapies with fewer adverse effects and interactions, and less need for monitoring than has warfarin.

Among the other studies worthy of consideration are investigations of short- and long-term outcomes associated with more aggressive interventions for DVT and PE. One such study, which has been funded by the National Institutes of Health and is slated to start soon, will compare pharmacomechanical thrombolysis plus standard anticoagulation to standard anticoagulation alone for the treatment of significant proximal venous thrombosis.

Booklets Focus on DVT Prevention

Preventing Hospital-Acquired Venous Thromboembolism: A Guide for Effective Quality Improvement is a 60-page booklet that includes case studies and is “designed to help hospitals and clinicians implement processes to prevent dangerous blood clots,” according to Dr. Carolyn Clancy, director of the U.S. Department of Health and Human Services' Agency for Healthcare Research and Quality, which published the booklets.

“Your Guide to Preventing and Treating Blood Clots” is a 12-page consumer booklet summarizing the causes and symptoms of blood clots, ways to avoid them, and what to expect from treatment.

Free copies of both booklets are available either by calling 800-358-9295 or by sending an e-mail to

[email protected]

Warfarin Genotype Study Set to Begin

The National Heart, Lung, and Blood Institute is about to launch its first-ever multicenter, double-blind, pharmacogenetic trial—one focused on warfarin therapy.

The COAG (Clarification of Optimal Anticoagulation Through Genetics) trial aims to determine whether targeting patients according to their genotype during the initiation of warfarin therapy would lead to better and safer anticoagulation control, especially in patients with deep vein thrombosis (DVT), according to an NHLBI representative. Results are anticipated in 2011.

Warfarin is the most commonly used blood-thinning treatment, and the 10th most prescribed medication in the United States, with more than 21 million prescriptions per year, according to the NHLBI. Patients with certain genotypes have been shown to metabolize warfarin better than do others, and some researchers believe that there may be an optimal genotype for toleration of the drug. “It is hoped that prospectively using the genetic information in addition to the clinical information will help clinicians determine better and safer initial dosing for specific patients,” an NHLBI spokesperson said.

The COAG trial will be coordinated by the center for clinical epidemiology and biostatistics at the University of Pennsylvania, Philadelphia. By the end of 2008, study coordinators hope to begin enrolling 1,965 patients. Details are still being finalized, but the NHLBI spokesperson said that she expects participants will have to be starting on warfarin therapy with an indication of at least 3 months of treatment. They will likely have to be warfarin naive, and without any major contraindications to anticoagulant treatment.

To request more information on patient enrollment, send an e-mail to

[email protected]

WASHINGTON — In response to physician groups concerned about the high incidence of deep vein thrombosis and pulmonary embolism, Acting Surgeon General Steven K. Galson has issued a Call to Action statement.

In concert with the statement, which was released at the second annual meeting of the Venous Disease Coalitiion, the National Heart, Lung, and Blood Institute has awarded 5 years' worth of funding to eight research groups investigating venous thromboembolism treatments and prevention. Ongoing studies include a multicenter, randomized clinical trial of genotype-guided dosing of warfarin therapy, which is currently the most commonly used treatment for prophylaxis of recurrent venous thromboembolism, according to Dr. Elizabeth Nabel, director of clinical research at the NHLBI.

The major push to address the rising incidence of DVT and PE dates to a 2006 meeting betweeen former Surgeon General Richard H. Carmona and advocates. As a member of the Coalition to Prevent DVT, Dr. Frank Michota, director of academic affairs in the department of hospital medicine at the Cleveland Clinic, spoke on public advocacy at that meeting.

“Hospitalists will play a pivotal role in the success of this Call to Action,” Dr. Michota said. “This is where hospitalists have an opportunity to develop, encourage, and pull through the systems of care that will guarantee all patients at risk for DVT are identified and that those found to be at risk will receive evidence-based methods of prophylaxis.”

Dr. Michota, medical editor-in-chief for Hospitalist News, added that he believes hospitalists are “more focused on this issue than any other specialty, including pulmonologists and cardiologists. Venous thromboembolism is one of the hospitalist's clinical core competencies.”

Hospitalists have been instrumental in the development of “reminder systems, preprinted order sheets, and multidisciplinary protocols so that no patient falls through the cracks in regards to DVT prevention,” he observed.

Further, there are new incentives to ensure that more hospitalized patients receive appropriate prophylaxis.

As of Oct. 1, 2008, any DVT or PE acquired during an inpatient stay in association with total knee and hip replacement procedures will have “payment implications,” according to the Centers for Medicare and Medicaid Services (HOSPITALIST NEWS, August 2008, p. 1).

Just how many patients are affected annually by venous thromboembolism is unclear. Without an autopsy, many fatal cases—perhaps as many as 50%—are misclassified as myocardial infarctions.

According to Dr. Roy S. Silverstein, chair of the committee of government affairs for the American Society of Hematology, the disease affects almost 1 million Americans annually, and “the estimated number of deaths from PE is higher than the combined number of deaths from breast cancer, HIV disease, and motor vehicle crashes.”

Dr. Galson put PE- or DVT-related deaths at 100,000 annually, with 350,000-600,000 Americans contracting DVT or PE each year.

The American Heart Association estimated the incidence of venous thromboembolism to be 250,000 to 2 million cases per year (Circulation 2002;106:1436). Meanwhile, upcoming studies put the annual number of cases somewhere in between those estimates.

The risk for DVT is known to be greatest among hospitalized spinal cord injury patients. Among those who do not receive VTE prophylaxis, the risk of developing a deep vein thrombosis (DVT) is 60%-80%.

Without VTE prophylaxis, the DVT risk is 40%-60% among hip and knee surgery patients, 20%-40% among patients undergoing major general surgery or gynecologic procedures, and 10%-20% for patients with acute illnesses like pneumonia.

“There is now a public acknowledgment that this is a very significant health care issue that deserves attention from multiple facets of the medical community,” Dr. Thomas Wakefield, head of vascular surgery at the University of Michigan, Ann Arbor said in an interview.

“We've known for a long time that (DVT and PE are) significant problems; however, since the conditions don't belong to one group or another and span so many specialties, it has been difficult to mobilize and raise awareness.”

Dr. Wakefield noted that the NHLBI initiative is an excellent start, but additional studies are needed, including studies of newer drugs and pharmacologic therapies with fewer adverse effects and interactions, and less need for monitoring than has warfarin.

Among the other studies worthy of consideration are investigations of short- and long-term outcomes associated with more aggressive interventions for DVT and PE. One such study, which has been funded by the National Institutes of Health and is slated to start soon, will compare pharmacomechanical thrombolysis plus standard anticoagulation to standard anticoagulation alone for the treatment of significant proximal venous thrombosis.

Booklets Focus on DVT Prevention

Preventing Hospital-Acquired Venous Thromboembolism: A Guide for Effective Quality Improvement is a 60-page booklet that includes case studies and is “designed to help hospitals and clinicians implement processes to prevent dangerous blood clots,” according to Dr. Carolyn Clancy, director of the U.S. Department of Health and Human Services' Agency for Healthcare Research and Quality, which published the booklets.

“Your Guide to Preventing and Treating Blood Clots” is a 12-page consumer booklet summarizing the causes and symptoms of blood clots, ways to avoid them, and what to expect from treatment.

Free copies of both booklets are available either by calling 800-358-9295 or by sending an e-mail to

[email protected]

Warfarin Genotype Study Set to Begin

The National Heart, Lung, and Blood Institute is about to launch its first-ever multicenter, double-blind, pharmacogenetic trial—one focused on warfarin therapy.

The COAG (Clarification of Optimal Anticoagulation Through Genetics) trial aims to determine whether targeting patients according to their genotype during the initiation of warfarin therapy would lead to better and safer anticoagulation control, especially in patients with deep vein thrombosis (DVT), according to an NHLBI representative. Results are anticipated in 2011.

Warfarin is the most commonly used blood-thinning treatment, and the 10th most prescribed medication in the United States, with more than 21 million prescriptions per year, according to the NHLBI. Patients with certain genotypes have been shown to metabolize warfarin better than do others, and some researchers believe that there may be an optimal genotype for toleration of the drug. “It is hoped that prospectively using the genetic information in addition to the clinical information will help clinicians determine better and safer initial dosing for specific patients,” an NHLBI spokesperson said.

The COAG trial will be coordinated by the center for clinical epidemiology and biostatistics at the University of Pennsylvania, Philadelphia. By the end of 2008, study coordinators hope to begin enrolling 1,965 patients. Details are still being finalized, but the NHLBI spokesperson said that she expects participants will have to be starting on warfarin therapy with an indication of at least 3 months of treatment. They will likely have to be warfarin naive, and without any major contraindications to anticoagulant treatment.

To request more information on patient enrollment, send an e-mail to

[email protected]

CHICAGO — The infants of mothers taking antiepileptic drugs showed no adverse cognitive effects as a result of breast-feeding, judging from the findings of a small, preliminary study.

“Concerns have been raised, but there are no prior formal studies examining the effect of breast-feeding in women taking antiepileptic drugs,” the study's lead author, Dr. Kimford Meador, the Melvin Greer Professor of Neurology at the University of Florida, Gainesville, where he serves as director of the epilepsy program and of the clinical Alzheimer program, said in an interview. Findings from “our study suggest that it is safe.”

Dr. Meador and his colleagues looked at 187 children of mothers enrolled in the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study. The NEAD study is a multicenter, prospective, parallel-group, observational study that is ongoing at 25 centers in the United States and the United Kingdom. Pregnant mothers with partial or primary generalized epilepsy taking pharmacologic monotherapy (including valproate, carbamazepine, phenytoin, or lamotrigine) were eligible to enroll. In this study, a blinded cognitive assessment of the children was conducted at 2 years old; follow-up assessments will be conducted at years 3, 4.5, and 6.

Compared with their non-breast-fed counterparts, the breast-fed children in this cohort (41%) actually had higher cognition, 98.1 vs. 89.5 on the Bayley Mental Developmental Index. However, Dr. Meador said that when investigators controlled for the mother's IQ, there was no significant difference between groups.

“The NEAD study is not randomized and was not specifically designed to examine the effects of breast-feeding,” he said, listing some of its limitations. Also, “there are only four drugs in the study.” However, “breast-feeding during antiepilepsy drug treatment doesn't appear to have a negative impact on a child's cognitive abilities.”

Speaking at the annual meeting of the American Academy of Neurology, Dr. Meador added that the 3-year follow-up data analysis is just being completed and that the final child in the study will reach age 6—the last follow-up point—in 2010.

Dr. Meador has received research support from GlaxoSmithKline Inc., UCB SA, Eisai Co., Myriad Genetics Inc., NeuroPace Inc., and SAM Technology Inc. His fellow researchers also disclosed financial or other relationships to drug companies.

CHICAGO — The infants of mothers taking antiepileptic drugs showed no adverse cognitive effects as a result of breast-feeding, judging from the findings of a small, preliminary study.

“Concerns have been raised, but there are no prior formal studies examining the effect of breast-feeding in women taking antiepileptic drugs,” the study's lead author, Dr. Kimford Meador, the Melvin Greer Professor of Neurology at the University of Florida, Gainesville, where he serves as director of the epilepsy program and of the clinical Alzheimer program, said in an interview. Findings from “our study suggest that it is safe.”

Dr. Meador and his colleagues looked at 187 children of mothers enrolled in the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study. The NEAD study is a multicenter, prospective, parallel-group, observational study that is ongoing at 25 centers in the United States and the United Kingdom. Pregnant mothers with partial or primary generalized epilepsy taking pharmacologic monotherapy (including valproate, carbamazepine, phenytoin, or lamotrigine) were eligible to enroll. In this study, a blinded cognitive assessment of the children was conducted at 2 years old; follow-up assessments will be conducted at years 3, 4.5, and 6.

Compared with their non-breast-fed counterparts, the breast-fed children in this cohort (41%) actually had higher cognition, 98.1 vs. 89.5 on the Bayley Mental Developmental Index. However, Dr. Meador said that when investigators controlled for the mother's IQ, there was no significant difference between groups.

“The NEAD study is not randomized and was not specifically designed to examine the effects of breast-feeding,” he said, listing some of its limitations. Also, “there are only four drugs in the study.” However, “breast-feeding during antiepilepsy drug treatment doesn't appear to have a negative impact on a child's cognitive abilities.”

Speaking at the annual meeting of the American Academy of Neurology, Dr. Meador added that the 3-year follow-up data analysis is just being completed and that the final child in the study will reach age 6—the last follow-up point—in 2010.

Dr. Meador has received research support from GlaxoSmithKline Inc., UCB SA, Eisai Co., Myriad Genetics Inc., NeuroPace Inc., and SAM Technology Inc. His fellow researchers also disclosed financial or other relationships to drug companies.

CHICAGO — The infants of mothers taking antiepileptic drugs showed no adverse cognitive effects as a result of breast-feeding, judging from the findings of a small, preliminary study.

“Concerns have been raised, but there are no prior formal studies examining the effect of breast-feeding in women taking antiepileptic drugs,” the study's lead author, Dr. Kimford Meador, the Melvin Greer Professor of Neurology at the University of Florida, Gainesville, where he serves as director of the epilepsy program and of the clinical Alzheimer program, said in an interview. Findings from “our study suggest that it is safe.”

Dr. Meador and his colleagues looked at 187 children of mothers enrolled in the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study. The NEAD study is a multicenter, prospective, parallel-group, observational study that is ongoing at 25 centers in the United States and the United Kingdom. Pregnant mothers with partial or primary generalized epilepsy taking pharmacologic monotherapy (including valproate, carbamazepine, phenytoin, or lamotrigine) were eligible to enroll. In this study, a blinded cognitive assessment of the children was conducted at 2 years old; follow-up assessments will be conducted at years 3, 4.5, and 6.

Compared with their non-breast-fed counterparts, the breast-fed children in this cohort (41%) actually had higher cognition, 98.1 vs. 89.5 on the Bayley Mental Developmental Index. However, Dr. Meador said that when investigators controlled for the mother's IQ, there was no significant difference between groups.

“The NEAD study is not randomized and was not specifically designed to examine the effects of breast-feeding,” he said, listing some of its limitations. Also, “there are only four drugs in the study.” However, “breast-feeding during antiepilepsy drug treatment doesn't appear to have a negative impact on a child's cognitive abilities.”

Speaking at the annual meeting of the American Academy of Neurology, Dr. Meador added that the 3-year follow-up data analysis is just being completed and that the final child in the study will reach age 6—the last follow-up point—in 2010.

Dr. Meador has received research support from GlaxoSmithKline Inc., UCB SA, Eisai Co., Myriad Genetics Inc., NeuroPace Inc., and SAM Technology Inc. His fellow researchers also disclosed financial or other relationships to drug companies.

CHICAGO — Chemotherapy-related cognitive impairment was infrequent in a small study of 30 patients who underwent adjuvant chemotherapy for nonmetastatic breast cancer.

“People could be making decisions about whether or not to have chemotherapy based on stories they've heard about 'chemofog' or 'chemobrain,'” according to Dr. David G. Darby. “We hope this information will help people make informed decisions.”

Dr. Darby and his colleagues looked at a total of 30 women who had already undergone either lumpectomy or mastectomy and were scheduled to undergo either the chemotherapy regimen known as AC (n = 15) or CEF or CMF regimens (n = 15).

▸ The AC regimen involves doxorubicin 60 mg/m

▸ The CEF regimen involves cyclophosphamide administered orally in doses of 75 mg/m

▸ The CMF regimen involves cyclophosphamide 100 mg/m

The women were compared with 30 age-matched controls.

Women took several tests designed to measure cognition as well as mood a few days before initiating chemotherapy (but after the diagnosis had been given and treatment course was decided); again at the start of each new treatment cycle; and for the last time 28 days after the final treatment cycle had begun in each group. Patients were assessed on the National Institute of Mental Health's Center for Epidemiologic Studies Depression Scale (CES-D) depression, the state trait anxiety inventory (STAI) scale, and a test of Dr. Darby's own design, which measures detection speed, identification speed, working memory, and learning ability in a 10- to 12-minute battery.

Dr. Darby is the chief medical officer of a company he formed, called CogState, which produces and scores these tests. It is based in Australia and partly funded this study.

“The first finding of interest was that prior to the first cycle of chemo there was impairment in learning of moderate amplitude, and that was also associated with a mild reduction on mood scales or depressive scales,” said Dr. Darby in an interview. No women were clinically depressed (clinically depressed patients were excluded from the study) and none of the women was on antidepressants at baseline or throughout the study. However, “there may have been an impairment there initially, prior to chemo.”

Two other findings also emerged, both good and bad. “There was an improvement of some of the learning aspects of their performance and a mild improvement on scores on anxiety scales, but there was also a mild deterioration in aspects of concentration and psychomotor speed [as the study progressed].” There was also evidence that patients' mood was declining slightly throughout the treatment.

Individual patients showed “quite a lot of variation—in particular, some patients would have impairment on only one occasion and then improve, and others would have impairment on two or more occasions,” he said. Persistent impairment, that occurring on two consecutive occasions, was seen in only three patients, or 10% of the total, Dr. Darby reported at the annual meeting of the American Academy of Neurology.

Impairment in concentration was not severe, “equivalent to the sort of jet-lag that I'm feeling now, having traveled from Australia.” He also likened it to the sort of impairment one would feel after being awake for about 17 hours.

Dr. Darby found no significant differences in the risk for cognitive impairment based on the women's age, menopausal status (pre-, peri-, or post-), or time from surgery.

“When women are confronting breast cancer, coming to terms with the many different aspects of it, and trying to take advice and understand what's happening to them, the issues of quality of life are important. They should realize that these sorts of changes seem to be very mild. They are present in a minority of women, and they can be measured as well, if need be. In general, discussion with the patients about the mildness of these sorts of changes is probably the most appropriate [course for the treating physician],” said Dr. Darby.

CHICAGO — Chemotherapy-related cognitive impairment was infrequent in a small study of 30 patients who underwent adjuvant chemotherapy for nonmetastatic breast cancer.

“People could be making decisions about whether or not to have chemotherapy based on stories they've heard about 'chemofog' or 'chemobrain,'” according to Dr. David G. Darby. “We hope this information will help people make informed decisions.”

Dr. Darby and his colleagues looked at a total of 30 women who had already undergone either lumpectomy or mastectomy and were scheduled to undergo either the chemotherapy regimen known as AC (n = 15) or CEF or CMF regimens (n = 15).

▸ The AC regimen involves doxorubicin 60 mg/m

▸ The CEF regimen involves cyclophosphamide administered orally in doses of 75 mg/m

▸ The CMF regimen involves cyclophosphamide 100 mg/m

The women were compared with 30 age-matched controls.

Women took several tests designed to measure cognition as well as mood a few days before initiating chemotherapy (but after the diagnosis had been given and treatment course was decided); again at the start of each new treatment cycle; and for the last time 28 days after the final treatment cycle had begun in each group. Patients were assessed on the National Institute of Mental Health's Center for Epidemiologic Studies Depression Scale (CES-D) depression, the state trait anxiety inventory (STAI) scale, and a test of Dr. Darby's own design, which measures detection speed, identification speed, working memory, and learning ability in a 10- to 12-minute battery.

Dr. Darby is the chief medical officer of a company he formed, called CogState, which produces and scores these tests. It is based in Australia and partly funded this study.

“The first finding of interest was that prior to the first cycle of chemo there was impairment in learning of moderate amplitude, and that was also associated with a mild reduction on mood scales or depressive scales,” said Dr. Darby in an interview. No women were clinically depressed (clinically depressed patients were excluded from the study) and none of the women was on antidepressants at baseline or throughout the study. However, “there may have been an impairment there initially, prior to chemo.”

Two other findings also emerged, both good and bad. “There was an improvement of some of the learning aspects of their performance and a mild improvement on scores on anxiety scales, but there was also a mild deterioration in aspects of concentration and psychomotor speed [as the study progressed].” There was also evidence that patients' mood was declining slightly throughout the treatment.

Individual patients showed “quite a lot of variation—in particular, some patients would have impairment on only one occasion and then improve, and others would have impairment on two or more occasions,” he said. Persistent impairment, that occurring on two consecutive occasions, was seen in only three patients, or 10% of the total, Dr. Darby reported at the annual meeting of the American Academy of Neurology.

Impairment in concentration was not severe, “equivalent to the sort of jet-lag that I'm feeling now, having traveled from Australia.” He also likened it to the sort of impairment one would feel after being awake for about 17 hours.

Dr. Darby found no significant differences in the risk for cognitive impairment based on the women's age, menopausal status (pre-, peri-, or post-), or time from surgery.

“When women are confronting breast cancer, coming to terms with the many different aspects of it, and trying to take advice and understand what's happening to them, the issues of quality of life are important. They should realize that these sorts of changes seem to be very mild. They are present in a minority of women, and they can be measured as well, if need be. In general, discussion with the patients about the mildness of these sorts of changes is probably the most appropriate [course for the treating physician],” said Dr. Darby.

CHICAGO — Chemotherapy-related cognitive impairment was infrequent in a small study of 30 patients who underwent adjuvant chemotherapy for nonmetastatic breast cancer.

“People could be making decisions about whether or not to have chemotherapy based on stories they've heard about 'chemofog' or 'chemobrain,'” according to Dr. David G. Darby. “We hope this information will help people make informed decisions.”

Dr. Darby and his colleagues looked at a total of 30 women who had already undergone either lumpectomy or mastectomy and were scheduled to undergo either the chemotherapy regimen known as AC (n = 15) or CEF or CMF regimens (n = 15).

▸ The AC regimen involves doxorubicin 60 mg/m

▸ The CEF regimen involves cyclophosphamide administered orally in doses of 75 mg/m

▸ The CMF regimen involves cyclophosphamide 100 mg/m

The women were compared with 30 age-matched controls.

Women took several tests designed to measure cognition as well as mood a few days before initiating chemotherapy (but after the diagnosis had been given and treatment course was decided); again at the start of each new treatment cycle; and for the last time 28 days after the final treatment cycle had begun in each group. Patients were assessed on the National Institute of Mental Health's Center for Epidemiologic Studies Depression Scale (CES-D) depression, the state trait anxiety inventory (STAI) scale, and a test of Dr. Darby's own design, which measures detection speed, identification speed, working memory, and learning ability in a 10- to 12-minute battery.

Dr. Darby is the chief medical officer of a company he formed, called CogState, which produces and scores these tests. It is based in Australia and partly funded this study.

“The first finding of interest was that prior to the first cycle of chemo there was impairment in learning of moderate amplitude, and that was also associated with a mild reduction on mood scales or depressive scales,” said Dr. Darby in an interview. No women were clinically depressed (clinically depressed patients were excluded from the study) and none of the women was on antidepressants at baseline or throughout the study. However, “there may have been an impairment there initially, prior to chemo.”

Two other findings also emerged, both good and bad. “There was an improvement of some of the learning aspects of their performance and a mild improvement on scores on anxiety scales, but there was also a mild deterioration in aspects of concentration and psychomotor speed [as the study progressed].” There was also evidence that patients' mood was declining slightly throughout the treatment.

Individual patients showed “quite a lot of variation—in particular, some patients would have impairment on only one occasion and then improve, and others would have impairment on two or more occasions,” he said. Persistent impairment, that occurring on two consecutive occasions, was seen in only three patients, or 10% of the total, Dr. Darby reported at the annual meeting of the American Academy of Neurology.

Impairment in concentration was not severe, “equivalent to the sort of jet-lag that I'm feeling now, having traveled from Australia.” He also likened it to the sort of impairment one would feel after being awake for about 17 hours.

Dr. Darby found no significant differences in the risk for cognitive impairment based on the women's age, menopausal status (pre-, peri-, or post-), or time from surgery.

“When women are confronting breast cancer, coming to terms with the many different aspects of it, and trying to take advice and understand what's happening to them, the issues of quality of life are important. They should realize that these sorts of changes seem to be very mild. They are present in a minority of women, and they can be measured as well, if need be. In general, discussion with the patients about the mildness of these sorts of changes is probably the most appropriate [course for the treating physician],” said Dr. Darby.

WASHINGTON — An as-yet-unpublished update to a 2006 meta-analysis found that the risk of heart disease in the presence of subclinical hypothyroidism is attenuated somewhat, to about a 30%-35% increased risk from a previously estimated 65%.

However, the increase is still significant and “clinically meaningful,” Dr. Douglas C. Bauer said at a meeting sponsored by the American Thyroid Association, and what to do about it remains an open question. “The issue of primary versus secondary prevention hasn't really been well looked at. There have been no randomized controlled trials looking at replacement with thyroid hormone in individuals to determine the effect on ischemic heart disease, [which] has limited [our] ability to make practice guidelines.”

Even a relatively small increase in risk for heart disease is important for two reasons, said Dr. Bauer, professor of medicine, epidemiology, and biostatistics at the University of California, San Francisco.

First, subclinical hypothyroidism is a common risk factor, affecting up to 10% of the general population, and second, ischemic heart disease is the most common cause of death in the U.S. These two points add up to a potential major public health problem, said Dr. Bauer. He and his colleagues have submitted the revised meta-analysis for publication in the Annals of Internal Medicine.

The original 2006 meta-analysis included 14 studies, 1,362 coronary heart disease outcomes, and 10,540 patients (Am. J. Med. 2006;119:541–51).

In that study, researchers found a 65% increased risk of heart disease in those who had subclinical hypothyroidism compared with those who were euthyroid.

The risk was lessened slightly in some subgroup analyses according to the study design: There was an increased risk of about 40% in the five prospective cohort studies included in the meta-analysis (OR 1.42, CI 0.91–2.21), closer to the newly revised risk estimate; and a 70% increased risk in the case-control and cross-sectional studies alone (OR 1.72, CI 1.25–2.38).

Additional sensitivity and subgroup analyses in that initial meta-analysis—for example, in studies that adjusted for cardiovascular risk factors, or in studies that used different definitions of subclinical hypothyroidism according to thyroid-stimulating hormone (TSH) values—yielded variable risk factors, but none fell below 40%, said Dr. Bauer.

However, almost all of the studies relied on a single measurement of TSH, suggesting they may have underestimated the true relationship between subclinical hypothyroidism and the incidence of ischemic heart disease because it's “possible that some of those who were initially classified as having subclinical hypothyroidism later reverted to normal.”

In general, Dr. Bauer advocates screening for subclinical hypothyroidism for men and women over age 50 who present at well visits with other cardiac risk factors. And although there is no clear agreement on whether subclinical hypothyroidism should be included in guidelines for risk factors for heart disease, Dr. Bauer said he thinks that they should. He added that general physicians and cardiologists are “not at all” fully cognizant of the heart risks associated with subclinical hypothyroidism.

Dr. Bauer said that he had no disclosures to make in relation to this presentation. The meeting was sponsored in part by Abbott Laboratories and the Genzyme Corp.

WASHINGTON — An as-yet-unpublished update to a 2006 meta-analysis found that the risk of heart disease in the presence of subclinical hypothyroidism is attenuated somewhat, to about a 30%-35% increased risk from a previously estimated 65%.

However, the increase is still significant and “clinically meaningful,” Dr. Douglas C. Bauer said at a meeting sponsored by the American Thyroid Association, and what to do about it remains an open question. “The issue of primary versus secondary prevention hasn't really been well looked at. There have been no randomized controlled trials looking at replacement with thyroid hormone in individuals to determine the effect on ischemic heart disease, [which] has limited [our] ability to make practice guidelines.”

Even a relatively small increase in risk for heart disease is important for two reasons, said Dr. Bauer, professor of medicine, epidemiology, and biostatistics at the University of California, San Francisco.

First, subclinical hypothyroidism is a common risk factor, affecting up to 10% of the general population, and second, ischemic heart disease is the most common cause of death in the U.S. These two points add up to a potential major public health problem, said Dr. Bauer. He and his colleagues have submitted the revised meta-analysis for publication in the Annals of Internal Medicine.

The original 2006 meta-analysis included 14 studies, 1,362 coronary heart disease outcomes, and 10,540 patients (Am. J. Med. 2006;119:541–51).

In that study, researchers found a 65% increased risk of heart disease in those who had subclinical hypothyroidism compared with those who were euthyroid.

The risk was lessened slightly in some subgroup analyses according to the study design: There was an increased risk of about 40% in the five prospective cohort studies included in the meta-analysis (OR 1.42, CI 0.91–2.21), closer to the newly revised risk estimate; and a 70% increased risk in the case-control and cross-sectional studies alone (OR 1.72, CI 1.25–2.38).

Additional sensitivity and subgroup analyses in that initial meta-analysis—for example, in studies that adjusted for cardiovascular risk factors, or in studies that used different definitions of subclinical hypothyroidism according to thyroid-stimulating hormone (TSH) values—yielded variable risk factors, but none fell below 40%, said Dr. Bauer.

However, almost all of the studies relied on a single measurement of TSH, suggesting they may have underestimated the true relationship between subclinical hypothyroidism and the incidence of ischemic heart disease because it's “possible that some of those who were initially classified as having subclinical hypothyroidism later reverted to normal.”

In general, Dr. Bauer advocates screening for subclinical hypothyroidism for men and women over age 50 who present at well visits with other cardiac risk factors. And although there is no clear agreement on whether subclinical hypothyroidism should be included in guidelines for risk factors for heart disease, Dr. Bauer said he thinks that they should. He added that general physicians and cardiologists are “not at all” fully cognizant of the heart risks associated with subclinical hypothyroidism.

Dr. Bauer said that he had no disclosures to make in relation to this presentation. The meeting was sponsored in part by Abbott Laboratories and the Genzyme Corp.

WASHINGTON — An as-yet-unpublished update to a 2006 meta-analysis found that the risk of heart disease in the presence of subclinical hypothyroidism is attenuated somewhat, to about a 30%-35% increased risk from a previously estimated 65%.

However, the increase is still significant and “clinically meaningful,” Dr. Douglas C. Bauer said at a meeting sponsored by the American Thyroid Association, and what to do about it remains an open question. “The issue of primary versus secondary prevention hasn't really been well looked at. There have been no randomized controlled trials looking at replacement with thyroid hormone in individuals to determine the effect on ischemic heart disease, [which] has limited [our] ability to make practice guidelines.”

Even a relatively small increase in risk for heart disease is important for two reasons, said Dr. Bauer, professor of medicine, epidemiology, and biostatistics at the University of California, San Francisco.

First, subclinical hypothyroidism is a common risk factor, affecting up to 10% of the general population, and second, ischemic heart disease is the most common cause of death in the U.S. These two points add up to a potential major public health problem, said Dr. Bauer. He and his colleagues have submitted the revised meta-analysis for publication in the Annals of Internal Medicine.

The original 2006 meta-analysis included 14 studies, 1,362 coronary heart disease outcomes, and 10,540 patients (Am. J. Med. 2006;119:541–51).

In that study, researchers found a 65% increased risk of heart disease in those who had subclinical hypothyroidism compared with those who were euthyroid.

The risk was lessened slightly in some subgroup analyses according to the study design: There was an increased risk of about 40% in the five prospective cohort studies included in the meta-analysis (OR 1.42, CI 0.91–2.21), closer to the newly revised risk estimate; and a 70% increased risk in the case-control and cross-sectional studies alone (OR 1.72, CI 1.25–2.38).

Additional sensitivity and subgroup analyses in that initial meta-analysis—for example, in studies that adjusted for cardiovascular risk factors, or in studies that used different definitions of subclinical hypothyroidism according to thyroid-stimulating hormone (TSH) values—yielded variable risk factors, but none fell below 40%, said Dr. Bauer.

However, almost all of the studies relied on a single measurement of TSH, suggesting they may have underestimated the true relationship between subclinical hypothyroidism and the incidence of ischemic heart disease because it's “possible that some of those who were initially classified as having subclinical hypothyroidism later reverted to normal.”

In general, Dr. Bauer advocates screening for subclinical hypothyroidism for men and women over age 50 who present at well visits with other cardiac risk factors. And although there is no clear agreement on whether subclinical hypothyroidism should be included in guidelines for risk factors for heart disease, Dr. Bauer said he thinks that they should. He added that general physicians and cardiologists are “not at all” fully cognizant of the heart risks associated with subclinical hypothyroidism.

Dr. Bauer said that he had no disclosures to make in relation to this presentation. The meeting was sponsored in part by Abbott Laboratories and the Genzyme Corp.