Debra L. Beck

TORONTO — Overweight teens assigned to a 6-month low-carbohydrate diet experienced significant weight loss, decreased body mass index, and improved self-esteem while being managed in an office-based setting, Dr. Robert Siegel reported at the annual meeting of the Pediatric Academic Societies.

“The question we asked is can a low-carbohydrate diet be practically implemented in the office setting,” said Dr. Siegel of Cincinnati Children's Hospital. Dr. Siegel also is the medical director of the Cincinnati Pediatric Research Group (CPRG), a network of 47 practice-based pediatricians in the Cincinnati area committed to translating research into practice.

Interestingly enough, fat intake by self-report did not significantly increase in these subjects. Increased fat intake is a concern with low-carbohydrate diets, he said.

A total of 63 healthy children 12–18 years of age and with a body mass index (BMI) greater than the 95th percentile for age were put on a low-carb diet (LCD) of less than 50 g of carbohydrate daily. Subjects were seen regularly by a dietitian and counseled on good nutrition and physical activity along with specific LCD recommendations.

A total of 38 teens (60%) finished the 6-month study. The mean age of the study group was 15 years; 79% were female. Twenty-two percent were African American, 74% were white, and the ethnicity of the rest was unspecified.

Overall caloric intake and carbohydrate intake both dropped significantly during the 6-month study period. At baseline, average carbohydrate intake was 324 g daily and dropped precipitously to 62 g/day at 6 months.

Fat and protein intake did not, however, differ significantly between baseline and 6 months.

Average body weight dropped from 93.4 kg to 88.3 kg, BMI fell from 34.9 to 32.5, and BMI percentile fell from 98.4 to 97.1.

A total of 32 of 38 teens lost at least some weight during the study period; the greatest loss was 23.9 kg of body weight. Average weight loss was 5.1 kg.

There also was a significant improvement in Rosenberg Self Esteem Scale scores, from 16.6 at baseline to 15.0 at 6 months. At study end, 54% of teens felt that the LCD was easier to follow than previously tried diets, and 38% said they planned to remain on the diet beyond 1 year.

“We tried to in our study mirror what goes on in practices,” said Dr. Siegel. However, not all practices have access to a dietitian, and the study wasn't randomized.

This study was funded by the Dr. Robert C. and Veronica Atkins Foundation.

Overall caloric intake and carbohydrate intake both dropped significantly during the study. DR. SIEGEL

TORONTO — Overweight teens assigned to a 6-month low-carbohydrate diet experienced significant weight loss, decreased body mass index, and improved self-esteem while being managed in an office-based setting, Dr. Robert Siegel reported at the annual meeting of the Pediatric Academic Societies.

“The question we asked is can a low-carbohydrate diet be practically implemented in the office setting,” said Dr. Siegel of Cincinnati Children's Hospital. Dr. Siegel also is the medical director of the Cincinnati Pediatric Research Group (CPRG), a network of 47 practice-based pediatricians in the Cincinnati area committed to translating research into practice.

Interestingly enough, fat intake by self-report did not significantly increase in these subjects. Increased fat intake is a concern with low-carbohydrate diets, he said.

A total of 63 healthy children 12–18 years of age and with a body mass index (BMI) greater than the 95th percentile for age were put on a low-carb diet (LCD) of less than 50 g of carbohydrate daily. Subjects were seen regularly by a dietitian and counseled on good nutrition and physical activity along with specific LCD recommendations.

A total of 38 teens (60%) finished the 6-month study. The mean age of the study group was 15 years; 79% were female. Twenty-two percent were African American, 74% were white, and the ethnicity of the rest was unspecified.

Overall caloric intake and carbohydrate intake both dropped significantly during the 6-month study period. At baseline, average carbohydrate intake was 324 g daily and dropped precipitously to 62 g/day at 6 months.

Fat and protein intake did not, however, differ significantly between baseline and 6 months.

Average body weight dropped from 93.4 kg to 88.3 kg, BMI fell from 34.9 to 32.5, and BMI percentile fell from 98.4 to 97.1.

A total of 32 of 38 teens lost at least some weight during the study period; the greatest loss was 23.9 kg of body weight. Average weight loss was 5.1 kg.

There also was a significant improvement in Rosenberg Self Esteem Scale scores, from 16.6 at baseline to 15.0 at 6 months. At study end, 54% of teens felt that the LCD was easier to follow than previously tried diets, and 38% said they planned to remain on the diet beyond 1 year.

“We tried to in our study mirror what goes on in practices,” said Dr. Siegel. However, not all practices have access to a dietitian, and the study wasn't randomized.

This study was funded by the Dr. Robert C. and Veronica Atkins Foundation.

Overall caloric intake and carbohydrate intake both dropped significantly during the study. DR. SIEGEL

TORONTO — Overweight teens assigned to a 6-month low-carbohydrate diet experienced significant weight loss, decreased body mass index, and improved self-esteem while being managed in an office-based setting, Dr. Robert Siegel reported at the annual meeting of the Pediatric Academic Societies.

“The question we asked is can a low-carbohydrate diet be practically implemented in the office setting,” said Dr. Siegel of Cincinnati Children's Hospital. Dr. Siegel also is the medical director of the Cincinnati Pediatric Research Group (CPRG), a network of 47 practice-based pediatricians in the Cincinnati area committed to translating research into practice.

Interestingly enough, fat intake by self-report did not significantly increase in these subjects. Increased fat intake is a concern with low-carbohydrate diets, he said.

A total of 63 healthy children 12–18 years of age and with a body mass index (BMI) greater than the 95th percentile for age were put on a low-carb diet (LCD) of less than 50 g of carbohydrate daily. Subjects were seen regularly by a dietitian and counseled on good nutrition and physical activity along with specific LCD recommendations.

A total of 38 teens (60%) finished the 6-month study. The mean age of the study group was 15 years; 79% were female. Twenty-two percent were African American, 74% were white, and the ethnicity of the rest was unspecified.

Overall caloric intake and carbohydrate intake both dropped significantly during the 6-month study period. At baseline, average carbohydrate intake was 324 g daily and dropped precipitously to 62 g/day at 6 months.

Fat and protein intake did not, however, differ significantly between baseline and 6 months.

Average body weight dropped from 93.4 kg to 88.3 kg, BMI fell from 34.9 to 32.5, and BMI percentile fell from 98.4 to 97.1.

A total of 32 of 38 teens lost at least some weight during the study period; the greatest loss was 23.9 kg of body weight. Average weight loss was 5.1 kg.

There also was a significant improvement in Rosenberg Self Esteem Scale scores, from 16.6 at baseline to 15.0 at 6 months. At study end, 54% of teens felt that the LCD was easier to follow than previously tried diets, and 38% said they planned to remain on the diet beyond 1 year.

“We tried to in our study mirror what goes on in practices,” said Dr. Siegel. However, not all practices have access to a dietitian, and the study wasn't randomized.

This study was funded by the Dr. Robert C. and Veronica Atkins Foundation.

Overall caloric intake and carbohydrate intake both dropped significantly during the study. DR. SIEGEL

TORONTO — Copayments exceeding $10 or coinsurance of more than 10% are associated with lower rates of breast cancer screening, Dr. Amal Trivedi said at the annual meeting of the Society of General Internal Medicine.

Across all study years, rates of breast cancer screening were 77.5% in plans with full coverage, compared with 69.2% in plans with cost sharing.

Differences in screening rates between full coverage and cost-sharing plans ranged from 8% to 11% during each year.

The negative effect of cost sharing on mammography rates was significantly greater for enrollees residing in less-affluent and less-educated areas and for enrollees with Medicaid eligibility (P less than .001).

“Cost sharing disproportionately affects vulnerable populations, and its prevalence is dramatically increasing in Medicare managed care,” said Dr. Trivedi, of Brown University, Providence, R.I. “Cost sharing should be tailored to the underlying value of the health service,” he said. “Eliminating copayments may increase adherence to appropriate preventive care.”

Asked somewhat facetiously whether he thought perhaps patients should be paid to get regular mammograms, Dr. Trivedi conceded that was unlikely to happen. “But we do need to remove barriers to regular screening,” he said. “Copayments reduce [the] moral hazard to 'overconsume' health care with full insurance, but they may also reduce use of appropriate preventive care.”

Dr. Trivedi's abstract was a Hamolsky Junior Faculty Research Award finalist, a designation given to the top-rated abstracts submitted for presentation at the meeting.

The investigators reviewed mammography coverage for 366,475 women aged 65–69 years enrolled in 174 health plans in 2001–2004. They examined rates of biennial breast cancer screening in plans requiring a copayment of more than $10 or more than 10% coinsurance for mammography, and compared them with screening rates in plans with full coverage for this service.

They also looked at whether the impact of copayments or coinsurance varied by income, education, Medicaid eligibility, or race. Finally, they looked at the change in mammography rates of seven health plans that instituted cost sharing in 2003, compared with a control group of plans with continuous participation in Medicare from 2002 through 2004 that did not institute cost sharing.

The number of Medicare plans with cost sharing for mammography increased from 3 in 2001 (representing 0.5% of women in the study) to 21 in 2004 (11.4% of women). The median copayment was $20 (range $13–$35). Five plans charged 20% coinsurance.

In multivariate analyses, the presence of cost sharing was associated with a 7.2% lower adjusted rate of screening (P less than .001), an effect that was greater in magnitude than any other plan-level covariate in the model.

When they looked only at the seven plans that instituted cost sharing in 2003, adjusted rates dropped 5.5% in 2004 from 2002 levels, compared with a 3.4% increase in utilization in 14 control plans that retained full coverage.

“Relatively small copayments for mammography are associated with significantly lower biennial mammography rates among women who should receive breast cancer screening according to accepted clinical guidelines,” Dr. Trivedi concluded. “For important preventive services such as mammography, exempting the elderly from cost sharing may be warranted.”

TORONTO — Copayments exceeding $10 or coinsurance of more than 10% are associated with lower rates of breast cancer screening, Dr. Amal Trivedi said at the annual meeting of the Society of General Internal Medicine.

Across all study years, rates of breast cancer screening were 77.5% in plans with full coverage, compared with 69.2% in plans with cost sharing.

Differences in screening rates between full coverage and cost-sharing plans ranged from 8% to 11% during each year.

The negative effect of cost sharing on mammography rates was significantly greater for enrollees residing in less-affluent and less-educated areas and for enrollees with Medicaid eligibility (P less than .001).

“Cost sharing disproportionately affects vulnerable populations, and its prevalence is dramatically increasing in Medicare managed care,” said Dr. Trivedi, of Brown University, Providence, R.I. “Cost sharing should be tailored to the underlying value of the health service,” he said. “Eliminating copayments may increase adherence to appropriate preventive care.”

Asked somewhat facetiously whether he thought perhaps patients should be paid to get regular mammograms, Dr. Trivedi conceded that was unlikely to happen. “But we do need to remove barriers to regular screening,” he said. “Copayments reduce [the] moral hazard to 'overconsume' health care with full insurance, but they may also reduce use of appropriate preventive care.”

Dr. Trivedi's abstract was a Hamolsky Junior Faculty Research Award finalist, a designation given to the top-rated abstracts submitted for presentation at the meeting.

The investigators reviewed mammography coverage for 366,475 women aged 65–69 years enrolled in 174 health plans in 2001–2004. They examined rates of biennial breast cancer screening in plans requiring a copayment of more than $10 or more than 10% coinsurance for mammography, and compared them with screening rates in plans with full coverage for this service.

They also looked at whether the impact of copayments or coinsurance varied by income, education, Medicaid eligibility, or race. Finally, they looked at the change in mammography rates of seven health plans that instituted cost sharing in 2003, compared with a control group of plans with continuous participation in Medicare from 2002 through 2004 that did not institute cost sharing.

The number of Medicare plans with cost sharing for mammography increased from 3 in 2001 (representing 0.5% of women in the study) to 21 in 2004 (11.4% of women). The median copayment was $20 (range $13–$35). Five plans charged 20% coinsurance.

In multivariate analyses, the presence of cost sharing was associated with a 7.2% lower adjusted rate of screening (P less than .001), an effect that was greater in magnitude than any other plan-level covariate in the model.

When they looked only at the seven plans that instituted cost sharing in 2003, adjusted rates dropped 5.5% in 2004 from 2002 levels, compared with a 3.4% increase in utilization in 14 control plans that retained full coverage.

“Relatively small copayments for mammography are associated with significantly lower biennial mammography rates among women who should receive breast cancer screening according to accepted clinical guidelines,” Dr. Trivedi concluded. “For important preventive services such as mammography, exempting the elderly from cost sharing may be warranted.”

TORONTO — Copayments exceeding $10 or coinsurance of more than 10% are associated with lower rates of breast cancer screening, Dr. Amal Trivedi said at the annual meeting of the Society of General Internal Medicine.

Across all study years, rates of breast cancer screening were 77.5% in plans with full coverage, compared with 69.2% in plans with cost sharing.

Differences in screening rates between full coverage and cost-sharing plans ranged from 8% to 11% during each year.

The negative effect of cost sharing on mammography rates was significantly greater for enrollees residing in less-affluent and less-educated areas and for enrollees with Medicaid eligibility (P less than .001).

“Cost sharing disproportionately affects vulnerable populations, and its prevalence is dramatically increasing in Medicare managed care,” said Dr. Trivedi, of Brown University, Providence, R.I. “Cost sharing should be tailored to the underlying value of the health service,” he said. “Eliminating copayments may increase adherence to appropriate preventive care.”

Asked somewhat facetiously whether he thought perhaps patients should be paid to get regular mammograms, Dr. Trivedi conceded that was unlikely to happen. “But we do need to remove barriers to regular screening,” he said. “Copayments reduce [the] moral hazard to 'overconsume' health care with full insurance, but they may also reduce use of appropriate preventive care.”

Dr. Trivedi's abstract was a Hamolsky Junior Faculty Research Award finalist, a designation given to the top-rated abstracts submitted for presentation at the meeting.

The investigators reviewed mammography coverage for 366,475 women aged 65–69 years enrolled in 174 health plans in 2001–2004. They examined rates of biennial breast cancer screening in plans requiring a copayment of more than $10 or more than 10% coinsurance for mammography, and compared them with screening rates in plans with full coverage for this service.

They also looked at whether the impact of copayments or coinsurance varied by income, education, Medicaid eligibility, or race. Finally, they looked at the change in mammography rates of seven health plans that instituted cost sharing in 2003, compared with a control group of plans with continuous participation in Medicare from 2002 through 2004 that did not institute cost sharing.

The number of Medicare plans with cost sharing for mammography increased from 3 in 2001 (representing 0.5% of women in the study) to 21 in 2004 (11.4% of women). The median copayment was $20 (range $13–$35). Five plans charged 20% coinsurance.

In multivariate analyses, the presence of cost sharing was associated with a 7.2% lower adjusted rate of screening (P less than .001), an effect that was greater in magnitude than any other plan-level covariate in the model.

When they looked only at the seven plans that instituted cost sharing in 2003, adjusted rates dropped 5.5% in 2004 from 2002 levels, compared with a 3.4% increase in utilization in 14 control plans that retained full coverage.

“Relatively small copayments for mammography are associated with significantly lower biennial mammography rates among women who should receive breast cancer screening according to accepted clinical guidelines,” Dr. Trivedi concluded. “For important preventive services such as mammography, exempting the elderly from cost sharing may be warranted.”

TORONTO — Physician practices treating higher proportions of less-educated patients have consistently lower HEDIS performance scores, according to preliminary research presented at the annual meeting of the Society of General Internal Medicine.

In fact, an increase of one standard deviation in the proportion of non-college graduate patients is associated with a significant Health Employer Data and Information Set (HEDIS) performance score decrease of as much as 2.5%.

“Our concern is that practice sites caring for disproportionate shares of vulnerable patients may be penalized by public performance reporting and pay-for-performance contracts,” reported Dr. Mark Friedberg, of the division of general medicine at Brigham and Women's Hospital and Harvard School of Public Health, both in Boston.

“Without adjusting HEDIS scores for patient sociodemographic characteristics—or adjusting some aspect of the way these scores are used—physicians may feel an incentive to avoid patients from vulnerable populations,” he said.

The measurement of primary care quality for public reporting has become a hot issue in recent years, with physicians who care for minority patients and those with lower incomes worried that they may be at a disadvantage in a system with a one-size-fits-all approach to quality measurement.

Dr. Friedberg noted a recent study (Health Aff. 2007;26:w405-w414 [Epub doi:10.1377/hlthaff.26.3.w405]) that found that 85% of physicians polled agreed with the statement:

“At present, measures of quality are not adequately adjusted for patients' socioeconomic status.”

Fully 82% were concerned that measuring quality may deter physicians from treating high-risk patients.

Dr. Friedberg and his colleagues used the Massachusetts Health Quality Partners (MHQP) statewide reporting program, which supplied data from commercial insurers aggregated at the physician level on eight HEDIS measures: breast cancer, cervical cancer, chlamydia, asthma controller medications, HbA_1c testing, cholesterol testing, eye exams, and nephropathy.

MHQP is a statewide collaborative that includes the five largest health plans in Massachusetts, contracting with 90% of state primary care providers and covering 63% of Massachusetts residents, or about 4 million people.

Data were collected from 241 physician practice sites (including 1,489 physicians) that provided adult primary care to insured patients during 2004.

These data were linked to patient responses from the 2002–2003 Massachusetts Ambulatory Care Experiences Survey to calculate the prevalence of sociodemographic characteristics (age, gender, race, ethnicity, and education) within each practice site's patient panel. Practice site was used as the unit of analysis.

Median site-level HEDIS scores ranged from 94% for HbA_1c screening (interquartile range, 90%–96%) to 43% for chlamydia screening in women aged 21–25 years (interquartile range 34%–52%).

In bivariate analyses, lower site-level proportions of college graduate patients were significantly associated with lower HEDIS scores on all eight measures. These associations remained statistically significant for seven of the eight measures even after multivariate adjustment.

Significant bivariate associations between sites' HEDIS scores and the age, race, and ethnic composition of their patient panels were present for chlamydia screening, but these associations did not remain statistically significant after multivariate adjustment.

“Primary care practice sites with disproportionate shares of patients having lower educational attainment may incur a 'performance measure penalty' on widely used HEDIS quality measures,” Dr. Friedberg concluded.

TORONTO — Physician practices treating higher proportions of less-educated patients have consistently lower HEDIS performance scores, according to preliminary research presented at the annual meeting of the Society of General Internal Medicine.

In fact, an increase of one standard deviation in the proportion of non-college graduate patients is associated with a significant Health Employer Data and Information Set (HEDIS) performance score decrease of as much as 2.5%.

“Our concern is that practice sites caring for disproportionate shares of vulnerable patients may be penalized by public performance reporting and pay-for-performance contracts,” reported Dr. Mark Friedberg, of the division of general medicine at Brigham and Women's Hospital and Harvard School of Public Health, both in Boston.

“Without adjusting HEDIS scores for patient sociodemographic characteristics—or adjusting some aspect of the way these scores are used—physicians may feel an incentive to avoid patients from vulnerable populations,” he said.

The measurement of primary care quality for public reporting has become a hot issue in recent years, with physicians who care for minority patients and those with lower incomes worried that they may be at a disadvantage in a system with a one-size-fits-all approach to quality measurement.

Dr. Friedberg noted a recent study (Health Aff. 2007;26:w405-w414 [Epub doi:10.1377/hlthaff.26.3.w405]) that found that 85% of physicians polled agreed with the statement:

“At present, measures of quality are not adequately adjusted for patients' socioeconomic status.”

Fully 82% were concerned that measuring quality may deter physicians from treating high-risk patients.

Dr. Friedberg and his colleagues used the Massachusetts Health Quality Partners (MHQP) statewide reporting program, which supplied data from commercial insurers aggregated at the physician level on eight HEDIS measures: breast cancer, cervical cancer, chlamydia, asthma controller medications, HbA_1c testing, cholesterol testing, eye exams, and nephropathy.

MHQP is a statewide collaborative that includes the five largest health plans in Massachusetts, contracting with 90% of state primary care providers and covering 63% of Massachusetts residents, or about 4 million people.

Data were collected from 241 physician practice sites (including 1,489 physicians) that provided adult primary care to insured patients during 2004.

These data were linked to patient responses from the 2002–2003 Massachusetts Ambulatory Care Experiences Survey to calculate the prevalence of sociodemographic characteristics (age, gender, race, ethnicity, and education) within each practice site's patient panel. Practice site was used as the unit of analysis.

Median site-level HEDIS scores ranged from 94% for HbA_1c screening (interquartile range, 90%–96%) to 43% for chlamydia screening in women aged 21–25 years (interquartile range 34%–52%).

In bivariate analyses, lower site-level proportions of college graduate patients were significantly associated with lower HEDIS scores on all eight measures. These associations remained statistically significant for seven of the eight measures even after multivariate adjustment.

Significant bivariate associations between sites' HEDIS scores and the age, race, and ethnic composition of their patient panels were present for chlamydia screening, but these associations did not remain statistically significant after multivariate adjustment.

“Primary care practice sites with disproportionate shares of patients having lower educational attainment may incur a 'performance measure penalty' on widely used HEDIS quality measures,” Dr. Friedberg concluded.

TORONTO — Physician practices treating higher proportions of less-educated patients have consistently lower HEDIS performance scores, according to preliminary research presented at the annual meeting of the Society of General Internal Medicine.

In fact, an increase of one standard deviation in the proportion of non-college graduate patients is associated with a significant Health Employer Data and Information Set (HEDIS) performance score decrease of as much as 2.5%.

“Our concern is that practice sites caring for disproportionate shares of vulnerable patients may be penalized by public performance reporting and pay-for-performance contracts,” reported Dr. Mark Friedberg, of the division of general medicine at Brigham and Women's Hospital and Harvard School of Public Health, both in Boston.

“Without adjusting HEDIS scores for patient sociodemographic characteristics—or adjusting some aspect of the way these scores are used—physicians may feel an incentive to avoid patients from vulnerable populations,” he said.

The measurement of primary care quality for public reporting has become a hot issue in recent years, with physicians who care for minority patients and those with lower incomes worried that they may be at a disadvantage in a system with a one-size-fits-all approach to quality measurement.

Dr. Friedberg noted a recent study (Health Aff. 2007;26:w405-w414 [Epub doi:10.1377/hlthaff.26.3.w405]) that found that 85% of physicians polled agreed with the statement:

“At present, measures of quality are not adequately adjusted for patients' socioeconomic status.”

Fully 82% were concerned that measuring quality may deter physicians from treating high-risk patients.

Dr. Friedberg and his colleagues used the Massachusetts Health Quality Partners (MHQP) statewide reporting program, which supplied data from commercial insurers aggregated at the physician level on eight HEDIS measures: breast cancer, cervical cancer, chlamydia, asthma controller medications, HbA_1c testing, cholesterol testing, eye exams, and nephropathy.

MHQP is a statewide collaborative that includes the five largest health plans in Massachusetts, contracting with 90% of state primary care providers and covering 63% of Massachusetts residents, or about 4 million people.

Data were collected from 241 physician practice sites (including 1,489 physicians) that provided adult primary care to insured patients during 2004.

These data were linked to patient responses from the 2002–2003 Massachusetts Ambulatory Care Experiences Survey to calculate the prevalence of sociodemographic characteristics (age, gender, race, ethnicity, and education) within each practice site's patient panel. Practice site was used as the unit of analysis.

Median site-level HEDIS scores ranged from 94% for HbA_1c screening (interquartile range, 90%–96%) to 43% for chlamydia screening in women aged 21–25 years (interquartile range 34%–52%).

In bivariate analyses, lower site-level proportions of college graduate patients were significantly associated with lower HEDIS scores on all eight measures. These associations remained statistically significant for seven of the eight measures even after multivariate adjustment.

Significant bivariate associations between sites' HEDIS scores and the age, race, and ethnic composition of their patient panels were present for chlamydia screening, but these associations did not remain statistically significant after multivariate adjustment.

“Primary care practice sites with disproportionate shares of patients having lower educational attainment may incur a 'performance measure penalty' on widely used HEDIS quality measures,” Dr. Friedberg concluded.

TORONTO — In infant outpatients with bronchiolitis who received corticosteroids in the emergency department, continuation of therapy beyond the initial dose appeared to offer no additional benefit, according to Dr. Suzanne Schuh of The Hospital for Sick Children in Toronto.

“Most babies with bronchiolitis do not need corticosteroids,” she said. “In fact, it's highly controversial, but one would wonder whether any of them need corticosteroids.”

“It's often difficult to tell whether a baby has acute asthma or bronchiolitis. Sometimes you can get a hint from the family history, but often babies with bronchiolitis will be given corticosteroids” before a definitive diagnosis is reached, Dr. Schuh explained at the annual meeting of the Pediatric Academic Societies.

“We asked in infants [who were] ultimately determined to have asthma if a single dose of corticosteroid is just as good as a 5- or 6-day course, and the answer was 'yes,'” she said.

In a randomized, double-blind study, Dr. Schuh and her colleagues looked at infants with bronchiolitis given 1 mg/kg oral dexamethasone in the ED and discharged on four further daily doses (0.15 mg/kg per day) versus those discharged on placebo.

Eligible infants were between 2 and 23 months of age, had bronchiolitis, and had baseline Respiratory Disease Assessment Instrument (RDAI) scores of 6 or greater. Average age was 8 months in the single-dose group (n = 61) and 7 months in the multiple-dose group (n = 64).

The primary outcome was the proportion of randomized outpatients subsequently hospitalized or given bronchodilators or corticosteroids for dyspnea outside of protocol by day 6.

The rate of primary outcome did not differ significantly between groups: 14% in the single-dose arm and 12% in the multiple-dose arm. In the single-dose arm, 19% of patients had unscheduled medical visits by day 6, compared with 18% in the multiple-dose arm, a nonsignificant difference. RDAI scores decreased in both groups from baseline, but did not differ between groups at day 4 or day 6.

TORONTO — In infant outpatients with bronchiolitis who received corticosteroids in the emergency department, continuation of therapy beyond the initial dose appeared to offer no additional benefit, according to Dr. Suzanne Schuh of The Hospital for Sick Children in Toronto.

“Most babies with bronchiolitis do not need corticosteroids,” she said. “In fact, it's highly controversial, but one would wonder whether any of them need corticosteroids.”

“It's often difficult to tell whether a baby has acute asthma or bronchiolitis. Sometimes you can get a hint from the family history, but often babies with bronchiolitis will be given corticosteroids” before a definitive diagnosis is reached, Dr. Schuh explained at the annual meeting of the Pediatric Academic Societies.

“We asked in infants [who were] ultimately determined to have asthma if a single dose of corticosteroid is just as good as a 5- or 6-day course, and the answer was 'yes,'” she said.

In a randomized, double-blind study, Dr. Schuh and her colleagues looked at infants with bronchiolitis given 1 mg/kg oral dexamethasone in the ED and discharged on four further daily doses (0.15 mg/kg per day) versus those discharged on placebo.

Eligible infants were between 2 and 23 months of age, had bronchiolitis, and had baseline Respiratory Disease Assessment Instrument (RDAI) scores of 6 or greater. Average age was 8 months in the single-dose group (n = 61) and 7 months in the multiple-dose group (n = 64).

The primary outcome was the proportion of randomized outpatients subsequently hospitalized or given bronchodilators or corticosteroids for dyspnea outside of protocol by day 6.

The rate of primary outcome did not differ significantly between groups: 14% in the single-dose arm and 12% in the multiple-dose arm. In the single-dose arm, 19% of patients had unscheduled medical visits by day 6, compared with 18% in the multiple-dose arm, a nonsignificant difference. RDAI scores decreased in both groups from baseline, but did not differ between groups at day 4 or day 6.

TORONTO — In infant outpatients with bronchiolitis who received corticosteroids in the emergency department, continuation of therapy beyond the initial dose appeared to offer no additional benefit, according to Dr. Suzanne Schuh of The Hospital for Sick Children in Toronto.

“Most babies with bronchiolitis do not need corticosteroids,” she said. “In fact, it's highly controversial, but one would wonder whether any of them need corticosteroids.”

“It's often difficult to tell whether a baby has acute asthma or bronchiolitis. Sometimes you can get a hint from the family history, but often babies with bronchiolitis will be given corticosteroids” before a definitive diagnosis is reached, Dr. Schuh explained at the annual meeting of the Pediatric Academic Societies.

“We asked in infants [who were] ultimately determined to have asthma if a single dose of corticosteroid is just as good as a 5- or 6-day course, and the answer was 'yes,'” she said.

In a randomized, double-blind study, Dr. Schuh and her colleagues looked at infants with bronchiolitis given 1 mg/kg oral dexamethasone in the ED and discharged on four further daily doses (0.15 mg/kg per day) versus those discharged on placebo.

Eligible infants were between 2 and 23 months of age, had bronchiolitis, and had baseline Respiratory Disease Assessment Instrument (RDAI) scores of 6 or greater. Average age was 8 months in the single-dose group (n = 61) and 7 months in the multiple-dose group (n = 64).

The primary outcome was the proportion of randomized outpatients subsequently hospitalized or given bronchodilators or corticosteroids for dyspnea outside of protocol by day 6.

The rate of primary outcome did not differ significantly between groups: 14% in the single-dose arm and 12% in the multiple-dose arm. In the single-dose arm, 19% of patients had unscheduled medical visits by day 6, compared with 18% in the multiple-dose arm, a nonsignificant difference. RDAI scores decreased in both groups from baseline, but did not differ between groups at day 4 or day 6.

TORONTO — Copayments exceeding $10 or coinsurance of more than 10% is associated with lower rates of breast cancer screening, Dr. Amal Trivedi said at the annual meeting of the Society of General Internal Medicine.

Across all study years, rates of breast cancer screening were 77.5% in plans with full coverage, compared with 69.2% in plans with cost sharing.

Differences in screening rates between full coverage and cost-sharing plans ranged from 8% to 11% during each year.

The negative effect of cost sharing on mammography rates was significantly greater for enrollees residing in less-affluent and less-educated areas and for enrollees with Medicaid eligibility (P less than .001).

“Cost sharing disproportionately affects vulnerable populations, and its prevalence is dramatically increasing in Medicare managed care,” said Dr. Trivedi, of Brown University, Providence, R.I.

“Cost sharing should be tailored to the underlying value of the health service,” he said. “Eliminating copayments may increase adherence to appropriate preventive care.”

Asked somewhat facetiously whether he thought perhaps patients should be paid to get regular mammograms, Dr. Trivedi conceded that was unlikely to happen.

“But we do need to remove barriers to regular screening,” he said. “Copayments reduce [the] moral hazard to 'overconsume' health care with full insurance, but they may also reduce use of appropriate preventive care.”

Dr. Trivedi's abstract was a Hamolsky Junior Faculty Research Award finalist, a designation given to the top-rated abstracts submitted for presentation at the meeting.

The investigators reviewed mammography coverage for 366,475 women aged 65–69 years enrolled in 174 health plans in 2001–2004. They examined rates of biennial breast cancer screening in plans requiring a copayment of more than $10 or more than 10% coinsurance for mammography, and compared them with screening rates in plans with full coverage for this service.

They also looked at whether the impact of copayments or coinsurance varied by income, education, Medicaid eligibility, or race. Finally, they looked at the change in mammography rates of seven health plans that instituted cost sharing in 2003, compared with a control group of plans with continuous participation in Medicare from 2002 through 2004 that did not institute cost sharing.

The number of Medicare plans with cost sharing for mammography increased from 3 in 2001 (representing 0.5% of women in the study) to 21 in 2004 (11.4% of women).

The median copayment was $20 (range $13-$35). Five plans charged 20% coinsurance.

In multivariate analyses, the presence of cost sharing was associated with a 7.2% lower adjusted rate of screening (P less than .001), an effect that was greater in magnitude than any other plan-level covariate in the model.

When they looked only at the seven plans that instituted cost sharing in 2003, adjusted rates dropped 5.5% in 2004 from 2002 levels, compared with a 3.4% increase in utilization in 14 control plans that retained full coverage.

“Relatively small copayments for mammography are associated with significantly lower biennial mammography rates among women who should receive breast cancer screening according to accepted clinical guidelines,” Dr. Trivedi concluded. “For important preventive services such as mammography, exempting the elderly from cost sharing may be warranted.”

In his discussion of the study's limitations, Dr. Trivedi noted that the investigators were unable to analyze differential impacts of specific copayment amounts. They also used zip-code proxies, a fairly blunt instrument to measure socioeconomic status and education.

TORONTO — Copayments exceeding $10 or coinsurance of more than 10% is associated with lower rates of breast cancer screening, Dr. Amal Trivedi said at the annual meeting of the Society of General Internal Medicine.

Across all study years, rates of breast cancer screening were 77.5% in plans with full coverage, compared with 69.2% in plans with cost sharing.

Differences in screening rates between full coverage and cost-sharing plans ranged from 8% to 11% during each year.

The negative effect of cost sharing on mammography rates was significantly greater for enrollees residing in less-affluent and less-educated areas and for enrollees with Medicaid eligibility (P less than .001).

“Cost sharing disproportionately affects vulnerable populations, and its prevalence is dramatically increasing in Medicare managed care,” said Dr. Trivedi, of Brown University, Providence, R.I.

“Cost sharing should be tailored to the underlying value of the health service,” he said. “Eliminating copayments may increase adherence to appropriate preventive care.”

Asked somewhat facetiously whether he thought perhaps patients should be paid to get regular mammograms, Dr. Trivedi conceded that was unlikely to happen.

“But we do need to remove barriers to regular screening,” he said. “Copayments reduce [the] moral hazard to 'overconsume' health care with full insurance, but they may also reduce use of appropriate preventive care.”

Dr. Trivedi's abstract was a Hamolsky Junior Faculty Research Award finalist, a designation given to the top-rated abstracts submitted for presentation at the meeting.

The investigators reviewed mammography coverage for 366,475 women aged 65–69 years enrolled in 174 health plans in 2001–2004. They examined rates of biennial breast cancer screening in plans requiring a copayment of more than $10 or more than 10% coinsurance for mammography, and compared them with screening rates in plans with full coverage for this service.

They also looked at whether the impact of copayments or coinsurance varied by income, education, Medicaid eligibility, or race. Finally, they looked at the change in mammography rates of seven health plans that instituted cost sharing in 2003, compared with a control group of plans with continuous participation in Medicare from 2002 through 2004 that did not institute cost sharing.

The number of Medicare plans with cost sharing for mammography increased from 3 in 2001 (representing 0.5% of women in the study) to 21 in 2004 (11.4% of women).

The median copayment was $20 (range $13-$35). Five plans charged 20% coinsurance.

In multivariate analyses, the presence of cost sharing was associated with a 7.2% lower adjusted rate of screening (P less than .001), an effect that was greater in magnitude than any other plan-level covariate in the model.

When they looked only at the seven plans that instituted cost sharing in 2003, adjusted rates dropped 5.5% in 2004 from 2002 levels, compared with a 3.4% increase in utilization in 14 control plans that retained full coverage.

“Relatively small copayments for mammography are associated with significantly lower biennial mammography rates among women who should receive breast cancer screening according to accepted clinical guidelines,” Dr. Trivedi concluded. “For important preventive services such as mammography, exempting the elderly from cost sharing may be warranted.”

In his discussion of the study's limitations, Dr. Trivedi noted that the investigators were unable to analyze differential impacts of specific copayment amounts. They also used zip-code proxies, a fairly blunt instrument to measure socioeconomic status and education.

TORONTO — Copayments exceeding $10 or coinsurance of more than 10% is associated with lower rates of breast cancer screening, Dr. Amal Trivedi said at the annual meeting of the Society of General Internal Medicine.

Across all study years, rates of breast cancer screening were 77.5% in plans with full coverage, compared with 69.2% in plans with cost sharing.

Differences in screening rates between full coverage and cost-sharing plans ranged from 8% to 11% during each year.

The negative effect of cost sharing on mammography rates was significantly greater for enrollees residing in less-affluent and less-educated areas and for enrollees with Medicaid eligibility (P less than .001).

“Cost sharing disproportionately affects vulnerable populations, and its prevalence is dramatically increasing in Medicare managed care,” said Dr. Trivedi, of Brown University, Providence, R.I.

“Cost sharing should be tailored to the underlying value of the health service,” he said. “Eliminating copayments may increase adherence to appropriate preventive care.”

Asked somewhat facetiously whether he thought perhaps patients should be paid to get regular mammograms, Dr. Trivedi conceded that was unlikely to happen.

“But we do need to remove barriers to regular screening,” he said. “Copayments reduce [the] moral hazard to 'overconsume' health care with full insurance, but they may also reduce use of appropriate preventive care.”

Dr. Trivedi's abstract was a Hamolsky Junior Faculty Research Award finalist, a designation given to the top-rated abstracts submitted for presentation at the meeting.

The investigators reviewed mammography coverage for 366,475 women aged 65–69 years enrolled in 174 health plans in 2001–2004. They examined rates of biennial breast cancer screening in plans requiring a copayment of more than $10 or more than 10% coinsurance for mammography, and compared them with screening rates in plans with full coverage for this service.

They also looked at whether the impact of copayments or coinsurance varied by income, education, Medicaid eligibility, or race. Finally, they looked at the change in mammography rates of seven health plans that instituted cost sharing in 2003, compared with a control group of plans with continuous participation in Medicare from 2002 through 2004 that did not institute cost sharing.

The number of Medicare plans with cost sharing for mammography increased from 3 in 2001 (representing 0.5% of women in the study) to 21 in 2004 (11.4% of women).

The median copayment was $20 (range $13-$35). Five plans charged 20% coinsurance.

In multivariate analyses, the presence of cost sharing was associated with a 7.2% lower adjusted rate of screening (P less than .001), an effect that was greater in magnitude than any other plan-level covariate in the model.

When they looked only at the seven plans that instituted cost sharing in 2003, adjusted rates dropped 5.5% in 2004 from 2002 levels, compared with a 3.4% increase in utilization in 14 control plans that retained full coverage.

“Relatively small copayments for mammography are associated with significantly lower biennial mammography rates among women who should receive breast cancer screening according to accepted clinical guidelines,” Dr. Trivedi concluded. “For important preventive services such as mammography, exempting the elderly from cost sharing may be warranted.”

In his discussion of the study's limitations, Dr. Trivedi noted that the investigators were unable to analyze differential impacts of specific copayment amounts. They also used zip-code proxies, a fairly blunt instrument to measure socioeconomic status and education.

TORONTO — If accepting free pens or lunches from industry represents a potential conflict of interest for physicians, what do you call it when a medical school dean is also the corporate director of a large, for-profit health care company?

"An academic medical leader serving on the board of directors of a health care corporation could entail huge conflicts of interest," Dr. Roy M. Poses said at the annual meeting of the Society of General Internal Medicine.

"Directors of a for-profit corporation have legally enforceable fiduciary responsibilities to its stockholders for the corporation's direction and financial viability, including its profitability," said Dr. Poses, president of the Foundation for Integrity and Responsibility in Medicine, a not-for-profit educational group.

In a cross-sectional study, Dr. Poses and his colleagues scrutinized the biographies of all board members of "pure" health care companies among the Standard & Poor's (S&P) 1500. Their data came from publicly available company proxy statements, annual reports, and Web sites.

In 2005, there were 164 U.S. health care companies in the S&P 1500, and 125 U.S. medical schools. The investigators identified 198 people who served on the companies' boards of directors and had faculty or leadership positions at a medical school. Of the 125 medical schools, 65 (52%) had at least one faculty member and/or academic leader who also served on a health care corporation's board of directors. Four schools had 10 or more such individuals, and 15 schools had 5 or more.

Of the 125 medical schools, 7 reported to university presidents who also were directors of health care corporations, 11 reported to vice presidents for health affairs who were corporate directors, and 5 were lead by deans who also were health care corporate directors. Also, 11 schools had academic medical center CEOs who were corporate directors, and 22 schools had at least one top leader who also was a director of a health care corporation.

"There are a lot of factors at play, including how aware you are of the potential conflict and how much transparency protects you from acting in a conflicted way if you are conflicted," said Dr. Nicole Lurie, codirector for public health at the Center for Domestic and International Health Security, in an interview. The first thing is to open yourself up, look at yourself, and examine the issue. Then you have to think, if these relationships exist, are there things you can do to make them work, because I don't think as a matter of public policy that we're going to succeed in obliterating all these relationships," Dr. Lurie said.

Amid efforts to prevent physicians from accepting gifts, meals, and travel reimbursement from company sales representatives, the study highlights a potentially much bigger problem, noted Dr. Poses.

TORONTO — If accepting free pens or lunches from industry represents a potential conflict of interest for physicians, what do you call it when a medical school dean is also the corporate director of a large, for-profit health care company?

"An academic medical leader serving on the board of directors of a health care corporation could entail huge conflicts of interest," Dr. Roy M. Poses said at the annual meeting of the Society of General Internal Medicine.

"Directors of a for-profit corporation have legally enforceable fiduciary responsibilities to its stockholders for the corporation's direction and financial viability, including its profitability," said Dr. Poses, president of the Foundation for Integrity and Responsibility in Medicine, a not-for-profit educational group.

In a cross-sectional study, Dr. Poses and his colleagues scrutinized the biographies of all board members of "pure" health care companies among the Standard & Poor's (S&P) 1500. Their data came from publicly available company proxy statements, annual reports, and Web sites.

In 2005, there were 164 U.S. health care companies in the S&P 1500, and 125 U.S. medical schools. The investigators identified 198 people who served on the companies' boards of directors and had faculty or leadership positions at a medical school. Of the 125 medical schools, 65 (52%) had at least one faculty member and/or academic leader who also served on a health care corporation's board of directors. Four schools had 10 or more such individuals, and 15 schools had 5 or more.

Of the 125 medical schools, 7 reported to university presidents who also were directors of health care corporations, 11 reported to vice presidents for health affairs who were corporate directors, and 5 were lead by deans who also were health care corporate directors. Also, 11 schools had academic medical center CEOs who were corporate directors, and 22 schools had at least one top leader who also was a director of a health care corporation.

"There are a lot of factors at play, including how aware you are of the potential conflict and how much transparency protects you from acting in a conflicted way if you are conflicted," said Dr. Nicole Lurie, codirector for public health at the Center for Domestic and International Health Security, in an interview. The first thing is to open yourself up, look at yourself, and examine the issue. Then you have to think, if these relationships exist, are there things you can do to make them work, because I don't think as a matter of public policy that we're going to succeed in obliterating all these relationships," Dr. Lurie said.

Amid efforts to prevent physicians from accepting gifts, meals, and travel reimbursement from company sales representatives, the study highlights a potentially much bigger problem, noted Dr. Poses.

TORONTO — If accepting free pens or lunches from industry represents a potential conflict of interest for physicians, what do you call it when a medical school dean is also the corporate director of a large, for-profit health care company?

"An academic medical leader serving on the board of directors of a health care corporation could entail huge conflicts of interest," Dr. Roy M. Poses said at the annual meeting of the Society of General Internal Medicine.

"Directors of a for-profit corporation have legally enforceable fiduciary responsibilities to its stockholders for the corporation's direction and financial viability, including its profitability," said Dr. Poses, president of the Foundation for Integrity and Responsibility in Medicine, a not-for-profit educational group.

In a cross-sectional study, Dr. Poses and his colleagues scrutinized the biographies of all board members of "pure" health care companies among the Standard & Poor's (S&P) 1500. Their data came from publicly available company proxy statements, annual reports, and Web sites.

In 2005, there were 164 U.S. health care companies in the S&P 1500, and 125 U.S. medical schools. The investigators identified 198 people who served on the companies' boards of directors and had faculty or leadership positions at a medical school. Of the 125 medical schools, 65 (52%) had at least one faculty member and/or academic leader who also served on a health care corporation's board of directors. Four schools had 10 or more such individuals, and 15 schools had 5 or more.

Of the 125 medical schools, 7 reported to university presidents who also were directors of health care corporations, 11 reported to vice presidents for health affairs who were corporate directors, and 5 were lead by deans who also were health care corporate directors. Also, 11 schools had academic medical center CEOs who were corporate directors, and 22 schools had at least one top leader who also was a director of a health care corporation.

"There are a lot of factors at play, including how aware you are of the potential conflict and how much transparency protects you from acting in a conflicted way if you are conflicted," said Dr. Nicole Lurie, codirector for public health at the Center for Domestic and International Health Security, in an interview. The first thing is to open yourself up, look at yourself, and examine the issue. Then you have to think, if these relationships exist, are there things you can do to make them work, because I don't think as a matter of public policy that we're going to succeed in obliterating all these relationships," Dr. Lurie said.

Amid efforts to prevent physicians from accepting gifts, meals, and travel reimbursement from company sales representatives, the study highlights a potentially much bigger problem, noted Dr. Poses.

TORONTO — Elderly patients at high risk for acute cardiovascular events benefit as much from LDL cholesterol reduction as do younger patients but are significantly less likely to be prescribed statins, according to study findings presented at the annual meeting of the Society of General Internal Medicine.

“Just as in younger patients, the magnitude of cardiovascular benefit is proportional to the magnitude of LDL reduction,” said Dr. Catherine Rahilly, of the Massachusetts Veterans Epidemiology Research and Information Center at Boston University and the Boston Veterans Affairs (VA) Healthcare System.

“The evidence supports treating older patients with the same high doses of statins we use in younger patients,” she said.

Although it's well known that a graded relationship between magnitude of LDL reduction and magnitude of cardiovascular benefit exists in general in the cardiovascular population, there has been debate as to whether aggressive LDL cholesterol reduction is similarly beneficial in elderly patients.

Dr. Rahilly and her colleagues studied 23,513 veterans from the New England VA Healthcare database who were diagnosed with coronary artery disease, peripheral vascular disease, or diabetes mellitus. Eligible subjects were followed retrospectively for a combined outcome of first acute myocardial infarction or revascularization.

In their study, significantly fewer elderly patients (older than 75.3 years) were prescribed statins, compared with younger patients (70% vs. 78%–82%; P less than .0001).

Dr. Rahilly said that despite this, there were enough subjects in the oldest age quartile who achieved a large LDL reduction to demonstrate that such patients experienced fewer events than did their counterparts, who had achieved only small or medium LDL reductions.

Preoutcome LDL reduction was categorized as no reduction (less than 10 mg/dL), small reduction (10–40 mg/dL), moderate reduction (40–70 mg/dL), and large reduction (more than 70 mg/dL).

For each age quartile, a significant relationship was seen at any final LDL cholesterol level between the amount of LDL change and the magnitude of risk reduction for the combined outcome of first acute myocardial infarction and surgical or percutaneous revascularization.

In patients who achieved large LDL reductions, compared with those with no reduction, the hazard ratios for the primary outcomes were similar across age quartiles after adjustment for age, gender, cholesterol-modifying therapy, hypertension, renal disease, thyroid disease, and cerebrovascular disease.

In the subgroup of 2,038 patients aged 80 or older, the hazard ratio for those who achieved only a small reduction in LDL cholesterol was 0.65, dropping to 0.27 for those with the largest LDL reduction, said Dr. Rahilly, also of Brigham and Women's Hospital, Boston.

Median baseline age in the cohort was 67.1 years, and average follow-up time was 3.86 years. In all, 6,150 patients had a myocardial infarction or underwent revascularization during the study.

In her presentation, Dr. Rahilly conceded that the study might have missed outcome events that occurred outside the VA medical system.

They also did not have data on race, smoking, or socioeconomic status and, thus, were unable to control for those variables.

The findings, however, are similar to those seen in previous meta-analyses and in the recently published Study Assessing Goals in the Elderly (SAGE) study, in which a 67% reduction in risk for all-cause death was seen in subjects treated with a daily 80-mg dose of atorvastatin (Circulation 2007;115:700–7).

TORONTO — Elderly patients at high risk for acute cardiovascular events benefit as much from LDL cholesterol reduction as do younger patients but are significantly less likely to be prescribed statins, according to study findings presented at the annual meeting of the Society of General Internal Medicine.

“Just as in younger patients, the magnitude of cardiovascular benefit is proportional to the magnitude of LDL reduction,” said Dr. Catherine Rahilly, of the Massachusetts Veterans Epidemiology Research and Information Center at Boston University and the Boston Veterans Affairs (VA) Healthcare System.

“The evidence supports treating older patients with the same high doses of statins we use in younger patients,” she said.

Although it's well known that a graded relationship between magnitude of LDL reduction and magnitude of cardiovascular benefit exists in general in the cardiovascular population, there has been debate as to whether aggressive LDL cholesterol reduction is similarly beneficial in elderly patients.

Dr. Rahilly and her colleagues studied 23,513 veterans from the New England VA Healthcare database who were diagnosed with coronary artery disease, peripheral vascular disease, or diabetes mellitus. Eligible subjects were followed retrospectively for a combined outcome of first acute myocardial infarction or revascularization.

In their study, significantly fewer elderly patients (older than 75.3 years) were prescribed statins, compared with younger patients (70% vs. 78%–82%; P less than .0001).

Dr. Rahilly said that despite this, there were enough subjects in the oldest age quartile who achieved a large LDL reduction to demonstrate that such patients experienced fewer events than did their counterparts, who had achieved only small or medium LDL reductions.

Preoutcome LDL reduction was categorized as no reduction (less than 10 mg/dL), small reduction (10–40 mg/dL), moderate reduction (40–70 mg/dL), and large reduction (more than 70 mg/dL).

For each age quartile, a significant relationship was seen at any final LDL cholesterol level between the amount of LDL change and the magnitude of risk reduction for the combined outcome of first acute myocardial infarction and surgical or percutaneous revascularization.

In patients who achieved large LDL reductions, compared with those with no reduction, the hazard ratios for the primary outcomes were similar across age quartiles after adjustment for age, gender, cholesterol-modifying therapy, hypertension, renal disease, thyroid disease, and cerebrovascular disease.

In the subgroup of 2,038 patients aged 80 or older, the hazard ratio for those who achieved only a small reduction in LDL cholesterol was 0.65, dropping to 0.27 for those with the largest LDL reduction, said Dr. Rahilly, also of Brigham and Women's Hospital, Boston.

Median baseline age in the cohort was 67.1 years, and average follow-up time was 3.86 years. In all, 6,150 patients had a myocardial infarction or underwent revascularization during the study.

In her presentation, Dr. Rahilly conceded that the study might have missed outcome events that occurred outside the VA medical system.

They also did not have data on race, smoking, or socioeconomic status and, thus, were unable to control for those variables.

The findings, however, are similar to those seen in previous meta-analyses and in the recently published Study Assessing Goals in the Elderly (SAGE) study, in which a 67% reduction in risk for all-cause death was seen in subjects treated with a daily 80-mg dose of atorvastatin (Circulation 2007;115:700–7).

TORONTO — Elderly patients at high risk for acute cardiovascular events benefit as much from LDL cholesterol reduction as do younger patients but are significantly less likely to be prescribed statins, according to study findings presented at the annual meeting of the Society of General Internal Medicine.

“Just as in younger patients, the magnitude of cardiovascular benefit is proportional to the magnitude of LDL reduction,” said Dr. Catherine Rahilly, of the Massachusetts Veterans Epidemiology Research and Information Center at Boston University and the Boston Veterans Affairs (VA) Healthcare System.

“The evidence supports treating older patients with the same high doses of statins we use in younger patients,” she said.

Although it's well known that a graded relationship between magnitude of LDL reduction and magnitude of cardiovascular benefit exists in general in the cardiovascular population, there has been debate as to whether aggressive LDL cholesterol reduction is similarly beneficial in elderly patients.

Dr. Rahilly and her colleagues studied 23,513 veterans from the New England VA Healthcare database who were diagnosed with coronary artery disease, peripheral vascular disease, or diabetes mellitus. Eligible subjects were followed retrospectively for a combined outcome of first acute myocardial infarction or revascularization.

In their study, significantly fewer elderly patients (older than 75.3 years) were prescribed statins, compared with younger patients (70% vs. 78%–82%; P less than .0001).

Dr. Rahilly said that despite this, there were enough subjects in the oldest age quartile who achieved a large LDL reduction to demonstrate that such patients experienced fewer events than did their counterparts, who had achieved only small or medium LDL reductions.

Preoutcome LDL reduction was categorized as no reduction (less than 10 mg/dL), small reduction (10–40 mg/dL), moderate reduction (40–70 mg/dL), and large reduction (more than 70 mg/dL).

For each age quartile, a significant relationship was seen at any final LDL cholesterol level between the amount of LDL change and the magnitude of risk reduction for the combined outcome of first acute myocardial infarction and surgical or percutaneous revascularization.

In patients who achieved large LDL reductions, compared with those with no reduction, the hazard ratios for the primary outcomes were similar across age quartiles after adjustment for age, gender, cholesterol-modifying therapy, hypertension, renal disease, thyroid disease, and cerebrovascular disease.

In the subgroup of 2,038 patients aged 80 or older, the hazard ratio for those who achieved only a small reduction in LDL cholesterol was 0.65, dropping to 0.27 for those with the largest LDL reduction, said Dr. Rahilly, also of Brigham and Women's Hospital, Boston.

Median baseline age in the cohort was 67.1 years, and average follow-up time was 3.86 years. In all, 6,150 patients had a myocardial infarction or underwent revascularization during the study.

In her presentation, Dr. Rahilly conceded that the study might have missed outcome events that occurred outside the VA medical system.

They also did not have data on race, smoking, or socioeconomic status and, thus, were unable to control for those variables.

The findings, however, are similar to those seen in previous meta-analyses and in the recently published Study Assessing Goals in the Elderly (SAGE) study, in which a 67% reduction in risk for all-cause death was seen in subjects treated with a daily 80-mg dose of atorvastatin (Circulation 2007;115:700–7).

TORONTO — If accepting free pens or lunches from industry represents a potential conflict of interest for physicians, what do you call it when a medical school dean is also the corporate director of a large, for-profit health care company?

“An academic medical leader serving on the board of directors of a health care corporation could entail huge conflicts of interest,” Dr. Roy M. Poses said at the annual meeting of the Society of General Internal Medicine.

“Directors of a for-profit corporation have legally enforceable fiduciary responsibilities to its stockholders for the corporation's direction and financial viability, including its profitability,” said Dr. Poses, president of the Foundation for Integrity and Responsibility in Medicine, a not-for-profit educational group.

In a cross-sectional study, Dr. Poses and his colleagues scrutinized the biographies of all board members of “pure” health care companies among the Standard & Poor's (S&P) 1500. Their data came from publicly available company proxy statements, annual reports, and Web sites.

In 2005, there were 164 U.S. health care companies in the S&P 1500, and 125 U.S. medical schools. The investigators identified 198 people who served on the companies' boards of directors and had faculty or leadership positions at a medical school. Of the 125 medical schools, 65 (52%) had at least one faculty member and/or academic leader who also served on a health care corporation's board of directors. Four schools had 10 or more such individuals, and 15 schools had 5 or more.

Of the 125 medical schools, 7 reported to university presidents who also were directors of health care corporations, 11 reported to vice presidents for health affairs who were corporate directors, and 5 were lead by deans who also were health care corporate directors. Also, 11 schools had academic medical center CEOs who were corporate directors, and 22 schools had at least one top leader who also was a director of a health care corporation.

“There are a lot of factors at play, including how aware you are of the potential conflict and how much transparency protects you from acting in a conflicted way if you are conflicted,” said Dr. Nicole Lurie, codirector for public health at the Center for Domestic and International Health Security, in an interview.

“Many physicians in practice don't perceive a conflict at all. The first thing is to open yourself up, look at yourself, and examine the issue. Then you have to think, if these relationships exist, are there things you can do to make them work, because I don't think as a matter of public policy that we're going to succeed in obliterating all these relationships,” Dr. Lurie said.

Amid efforts to prevent physicians from accepting small gifts, meals, and travel reimbursement from company sales representatives, the new study highlights a potentially much bigger problem.

“The bottom line is that a substantial portion of medical schools are led or influenced by people who are also obligated to have 'unyielding loyalty' to stockholders of for-profit health care corporations,” Dr. Poses said.

The study used readily accessible public data only and did not collect data on board members of smaller U.S. health care corporations, other U.S. corporations with major health care activities, corporations outside the United States, or privately held corporations. “So, our data really only give lower-bound estimates of the number of medical schools influenced or led by people who also have fiduciary duties to health care corporations that may conflict with their academic leadership obligations,” Dr. Poses said.

“At a minimum, all in academia who also serve on boards of directors for health-related for-profit corporations should fully disclose their relationships in any context in which such relationships could possibly be considered influential,” he suggested.

TORONTO — If accepting free pens or lunches from industry represents a potential conflict of interest for physicians, what do you call it when a medical school dean is also the corporate director of a large, for-profit health care company?

“An academic medical leader serving on the board of directors of a health care corporation could entail huge conflicts of interest,” Dr. Roy M. Poses said at the annual meeting of the Society of General Internal Medicine.

“Directors of a for-profit corporation have legally enforceable fiduciary responsibilities to its stockholders for the corporation's direction and financial viability, including its profitability,” said Dr. Poses, president of the Foundation for Integrity and Responsibility in Medicine, a not-for-profit educational group.

In a cross-sectional study, Dr. Poses and his colleagues scrutinized the biographies of all board members of “pure” health care companies among the Standard & Poor's (S&P) 1500. Their data came from publicly available company proxy statements, annual reports, and Web sites.

In 2005, there were 164 U.S. health care companies in the S&P 1500, and 125 U.S. medical schools. The investigators identified 198 people who served on the companies' boards of directors and had faculty or leadership positions at a medical school. Of the 125 medical schools, 65 (52%) had at least one faculty member and/or academic leader who also served on a health care corporation's board of directors. Four schools had 10 or more such individuals, and 15 schools had 5 or more.

Of the 125 medical schools, 7 reported to university presidents who also were directors of health care corporations, 11 reported to vice presidents for health affairs who were corporate directors, and 5 were lead by deans who also were health care corporate directors. Also, 11 schools had academic medical center CEOs who were corporate directors, and 22 schools had at least one top leader who also was a director of a health care corporation.

“There are a lot of factors at play, including how aware you are of the potential conflict and how much transparency protects you from acting in a conflicted way if you are conflicted,” said Dr. Nicole Lurie, codirector for public health at the Center for Domestic and International Health Security, in an interview.

“Many physicians in practice don't perceive a conflict at all. The first thing is to open yourself up, look at yourself, and examine the issue. Then you have to think, if these relationships exist, are there things you can do to make them work, because I don't think as a matter of public policy that we're going to succeed in obliterating all these relationships,” Dr. Lurie said.

Amid efforts to prevent physicians from accepting small gifts, meals, and travel reimbursement from company sales representatives, the new study highlights a potentially much bigger problem.

“The bottom line is that a substantial portion of medical schools are led or influenced by people who are also obligated to have 'unyielding loyalty' to stockholders of for-profit health care corporations,” Dr. Poses said.

The study used readily accessible public data only and did not collect data on board members of smaller U.S. health care corporations, other U.S. corporations with major health care activities, corporations outside the United States, or privately held corporations. “So, our data really only give lower-bound estimates of the number of medical schools influenced or led by people who also have fiduciary duties to health care corporations that may conflict with their academic leadership obligations,” Dr. Poses said.

“At a minimum, all in academia who also serve on boards of directors for health-related for-profit corporations should fully disclose their relationships in any context in which such relationships could possibly be considered influential,” he suggested.

TORONTO — If accepting free pens or lunches from industry represents a potential conflict of interest for physicians, what do you call it when a medical school dean is also the corporate director of a large, for-profit health care company?

“An academic medical leader serving on the board of directors of a health care corporation could entail huge conflicts of interest,” Dr. Roy M. Poses said at the annual meeting of the Society of General Internal Medicine.

“Directors of a for-profit corporation have legally enforceable fiduciary responsibilities to its stockholders for the corporation's direction and financial viability, including its profitability,” said Dr. Poses, president of the Foundation for Integrity and Responsibility in Medicine, a not-for-profit educational group.

In a cross-sectional study, Dr. Poses and his colleagues scrutinized the biographies of all board members of “pure” health care companies among the Standard & Poor's (S&P) 1500. Their data came from publicly available company proxy statements, annual reports, and Web sites.

In 2005, there were 164 U.S. health care companies in the S&P 1500, and 125 U.S. medical schools. The investigators identified 198 people who served on the companies' boards of directors and had faculty or leadership positions at a medical school. Of the 125 medical schools, 65 (52%) had at least one faculty member and/or academic leader who also served on a health care corporation's board of directors. Four schools had 10 or more such individuals, and 15 schools had 5 or more.

Of the 125 medical schools, 7 reported to university presidents who also were directors of health care corporations, 11 reported to vice presidents for health affairs who were corporate directors, and 5 were lead by deans who also were health care corporate directors. Also, 11 schools had academic medical center CEOs who were corporate directors, and 22 schools had at least one top leader who also was a director of a health care corporation.

“There are a lot of factors at play, including how aware you are of the potential conflict and how much transparency protects you from acting in a conflicted way if you are conflicted,” said Dr. Nicole Lurie, codirector for public health at the Center for Domestic and International Health Security, in an interview.

“Many physicians in practice don't perceive a conflict at all. The first thing is to open yourself up, look at yourself, and examine the issue. Then you have to think, if these relationships exist, are there things you can do to make them work, because I don't think as a matter of public policy that we're going to succeed in obliterating all these relationships,” Dr. Lurie said.

Amid efforts to prevent physicians from accepting small gifts, meals, and travel reimbursement from company sales representatives, the new study highlights a potentially much bigger problem.

“The bottom line is that a substantial portion of medical schools are led or influenced by people who are also obligated to have 'unyielding loyalty' to stockholders of for-profit health care corporations,” Dr. Poses said.

The study used readily accessible public data only and did not collect data on board members of smaller U.S. health care corporations, other U.S. corporations with major health care activities, corporations outside the United States, or privately held corporations. “So, our data really only give lower-bound estimates of the number of medical schools influenced or led by people who also have fiduciary duties to health care corporations that may conflict with their academic leadership obligations,” Dr. Poses said.

“At a minimum, all in academia who also serve on boards of directors for health-related for-profit corporations should fully disclose their relationships in any context in which such relationships could possibly be considered influential,” he suggested.

CHICAGO — Antioxidant B vitamins and folic acid failed to slow the progression of cardiovascular disease in women at high risk or with established cardiovascular disease, according to results from the WAFACS trial presented at the annual scientific sessions of the American Heart Association.

“The combination of folic acid, vitamin B₆, and vitamin B₁₂ did not reduce risk of total cardiovascular events or any of the individual secondary end points among 5,442 women at high risk for cardiovascular disease over a very long follow-up of 7.3 years,” reported Dr. Christine M. Albert of the division of preventive medicine at Brigham and Women's Hospital, Boston.

In WAFACS (Women's Antioxidant and Folic Acid Cardiovascular Study), 5,442 female health professionals participating in another randomized trial of antioxidant vitamins (WACS) were randomly assigned to a combination of folic acid (2.5 mg daily), vitamin B₆ (50 mg daily), and vitamin B₁₂ (1 mg daily).

They were considered to be high risk based on either a confirmed history of cardiovascular disease or the presence of at least three cardiovascular disease risk factors, including hypertension, hypercholesterolemia, diabetes, current smoking, a body mass index of higher than 30 kg/m

After a mean follow-up of 7.3 years, 796 women (14.6%) experienced a confirmed cardiovascular event. In the intention-to-treat analysis, the cumulative incidence of the primary end point did not differ between those given active folate treatment and those given folate placebo.

“This absence of benefit was observed in all prespecified subgroups, including the high-risk primary prevention population,” said Dr. Albert.

The researchers tested whether homocysteine lowering by background folic acid fortification in the food supply, which took effect between 1996 and 1998, might have accounted for the null findings, but found that was not so. Homocysteine levels were about 18% lower in the active treatment arm, compared with the placebo arm, but still there was no benefit.

Discussant Dr. Rita F. Redberg considered the question of whether the results of WAFACS can be generalized to men and to the primary prevention setting. If such studies were to be done in those populations, results would be unlikely to differ significantly from those seen in this trial, she said.

“Study after study has failed to find a benefit from dietary supplements, and I think there's just no getting away from an emphasis on a heart-healthy diet and regular physical activity,” said Dr. Redberg, director of women's cardiovascular services at the University of California, San Francisco.

CHICAGO — Antioxidant B vitamins and folic acid failed to slow the progression of cardiovascular disease in women at high risk or with established cardiovascular disease, according to results from the WAFACS trial presented at the annual scientific sessions of the American Heart Association.

“The combination of folic acid, vitamin B₆, and vitamin B₁₂ did not reduce risk of total cardiovascular events or any of the individual secondary end points among 5,442 women at high risk for cardiovascular disease over a very long follow-up of 7.3 years,” reported Dr. Christine M. Albert of the division of preventive medicine at Brigham and Women's Hospital, Boston.

In WAFACS (Women's Antioxidant and Folic Acid Cardiovascular Study), 5,442 female health professionals participating in another randomized trial of antioxidant vitamins (WACS) were randomly assigned to a combination of folic acid (2.5 mg daily), vitamin B₆ (50 mg daily), and vitamin B₁₂ (1 mg daily).

They were considered to be high risk based on either a confirmed history of cardiovascular disease or the presence of at least three cardiovascular disease risk factors, including hypertension, hypercholesterolemia, diabetes, current smoking, a body mass index of higher than 30 kg/m

After a mean follow-up of 7.3 years, 796 women (14.6%) experienced a confirmed cardiovascular event. In the intention-to-treat analysis, the cumulative incidence of the primary end point did not differ between those given active folate treatment and those given folate placebo.

“This absence of benefit was observed in all prespecified subgroups, including the high-risk primary prevention population,” said Dr. Albert.

The researchers tested whether homocysteine lowering by background folic acid fortification in the food supply, which took effect between 1996 and 1998, might have accounted for the null findings, but found that was not so. Homocysteine levels were about 18% lower in the active treatment arm, compared with the placebo arm, but still there was no benefit.

Discussant Dr. Rita F. Redberg considered the question of whether the results of WAFACS can be generalized to men and to the primary prevention setting. If such studies were to be done in those populations, results would be unlikely to differ significantly from those seen in this trial, she said.

“Study after study has failed to find a benefit from dietary supplements, and I think there's just no getting away from an emphasis on a heart-healthy diet and regular physical activity,” said Dr. Redberg, director of women's cardiovascular services at the University of California, San Francisco.

CHICAGO — Antioxidant B vitamins and folic acid failed to slow the progression of cardiovascular disease in women at high risk or with established cardiovascular disease, according to results from the WAFACS trial presented at the annual scientific sessions of the American Heart Association.

“The combination of folic acid, vitamin B₆, and vitamin B₁₂ did not reduce risk of total cardiovascular events or any of the individual secondary end points among 5,442 women at high risk for cardiovascular disease over a very long follow-up of 7.3 years,” reported Dr. Christine M. Albert of the division of preventive medicine at Brigham and Women's Hospital, Boston.

In WAFACS (Women's Antioxidant and Folic Acid Cardiovascular Study), 5,442 female health professionals participating in another randomized trial of antioxidant vitamins (WACS) were randomly assigned to a combination of folic acid (2.5 mg daily), vitamin B₆ (50 mg daily), and vitamin B₁₂ (1 mg daily).

They were considered to be high risk based on either a confirmed history of cardiovascular disease or the presence of at least three cardiovascular disease risk factors, including hypertension, hypercholesterolemia, diabetes, current smoking, a body mass index of higher than 30 kg/m

After a mean follow-up of 7.3 years, 796 women (14.6%) experienced a confirmed cardiovascular event. In the intention-to-treat analysis, the cumulative incidence of the primary end point did not differ between those given active folate treatment and those given folate placebo.

“This absence of benefit was observed in all prespecified subgroups, including the high-risk primary prevention population,” said Dr. Albert.

The researchers tested whether homocysteine lowering by background folic acid fortification in the food supply, which took effect between 1996 and 1998, might have accounted for the null findings, but found that was not so. Homocysteine levels were about 18% lower in the active treatment arm, compared with the placebo arm, but still there was no benefit.

Discussant Dr. Rita F. Redberg considered the question of whether the results of WAFACS can be generalized to men and to the primary prevention setting. If such studies were to be done in those populations, results would be unlikely to differ significantly from those seen in this trial, she said.

“Study after study has failed to find a benefit from dietary supplements, and I think there's just no getting away from an emphasis on a heart-healthy diet and regular physical activity,” said Dr. Redberg, director of women's cardiovascular services at the University of California, San Francisco.

CHICAGO — Antioxidant B vitamins and folic acid failed to slow the progression of cardiovascular disease in women at high risk or with established cardiovascular disease, according to results from the WAFACS trial presented at the annual scientific sessions of the American Heart Association.

“These data, along with those from previously published randomized trials, do not support the use of folic acid and B vitamin supplements as preventive agents against cardiovascular disease among those with established vascular disease or those at high risk,” reported Dr. Christine M. Albert of the division of preventive medicine at Brigham and Women's Hospital, Boston.

“The combination of folic acid, vitamin B₆, and vitamin B₁₂ did not reduce risk of total cardiovascular events or any of the individual secondary end points among 5,442 women at high risk for cardiovascular disease over a very long follow-up of 7.3 years,” she said.

In WAFACS (Women's Antioxidant and Folic Acid Cardiovascular Study), 5,442 female health professionals participating in another randomized trial of antioxidant vitamins (WACS) were randomly assigned to a combination of folic acid (2.5 mg daily), vitamin B₆ (50 mg daily), and vitamin B₁₂ (1 mg daily). These women were considered to be high risk based on either a confirmed history of cardiovascular disease or the presence of at least three cardiovascular disease risk factors, including hypertension, hypercholesterolemia, diabetes, current smoking, body mass index higher than 30 kg/m

After a mean follow-up of 7.3 years, 796 women (14.6%) had a confirmed cardiovascular event. In the intention-to-treat analysis, the cumulative incidence of the primary end point did not differ between those given active folate treatment and those given folate placebo.

“This absence of benefit was observed in all prespecified subgroups including the high-risk primary prevention population,” said Dr. Albert.

The researchers tested whether homocysteine lowering by background folic acid fortification in the food supply, which took effect between 1996 and 1998, might have accounted for the null findings, and found that this was not the case. Homocysteine levels were about 18% lower in the active treatment arm, compared with the placebo arm, but still there was no benefit.

Discussant Dr. Rita F. Redberg considered the question of whether the results of WAFACS can be generalized to men and to the primary prevention setting. If such studies were to be done in those populations, results would be unlikely to differ significantly from those seen in this trial, she said.

“Study after study has failed to find a benefit from dietary supplements, and I think there's just no getting away from an emphasis on a heart-healthy diet and regular physical activity,” concluded Dr. Redberg, director of women's cardiovascular services at the University of California, San Francisco.

CHICAGO — Antioxidant B vitamins and folic acid failed to slow the progression of cardiovascular disease in women at high risk or with established cardiovascular disease, according to results from the WAFACS trial presented at the annual scientific sessions of the American Heart Association.

“These data, along with those from previously published randomized trials, do not support the use of folic acid and B vitamin supplements as preventive agents against cardiovascular disease among those with established vascular disease or those at high risk,” reported Dr. Christine M. Albert of the division of preventive medicine at Brigham and Women's Hospital, Boston.

“The combination of folic acid, vitamin B₆, and vitamin B₁₂ did not reduce risk of total cardiovascular events or any of the individual secondary end points among 5,442 women at high risk for cardiovascular disease over a very long follow-up of 7.3 years,” she said.

In WAFACS (Women's Antioxidant and Folic Acid Cardiovascular Study), 5,442 female health professionals participating in another randomized trial of antioxidant vitamins (WACS) were randomly assigned to a combination of folic acid (2.5 mg daily), vitamin B₆ (50 mg daily), and vitamin B₁₂ (1 mg daily). These women were considered to be high risk based on either a confirmed history of cardiovascular disease or the presence of at least three cardiovascular disease risk factors, including hypertension, hypercholesterolemia, diabetes, current smoking, body mass index higher than 30 kg/m

After a mean follow-up of 7.3 years, 796 women (14.6%) had a confirmed cardiovascular event. In the intention-to-treat analysis, the cumulative incidence of the primary end point did not differ between those given active folate treatment and those given folate placebo.

“This absence of benefit was observed in all prespecified subgroups including the high-risk primary prevention population,” said Dr. Albert.

The researchers tested whether homocysteine lowering by background folic acid fortification in the food supply, which took effect between 1996 and 1998, might have accounted for the null findings, and found that this was not the case. Homocysteine levels were about 18% lower in the active treatment arm, compared with the placebo arm, but still there was no benefit.

Discussant Dr. Rita F. Redberg considered the question of whether the results of WAFACS can be generalized to men and to the primary prevention setting. If such studies were to be done in those populations, results would be unlikely to differ significantly from those seen in this trial, she said.

“Study after study has failed to find a benefit from dietary supplements, and I think there's just no getting away from an emphasis on a heart-healthy diet and regular physical activity,” concluded Dr. Redberg, director of women's cardiovascular services at the University of California, San Francisco.

CHICAGO — Antioxidant B vitamins and folic acid failed to slow the progression of cardiovascular disease in women at high risk or with established cardiovascular disease, according to results from the WAFACS trial presented at the annual scientific sessions of the American Heart Association.

“These data, along with those from previously published randomized trials, do not support the use of folic acid and B vitamin supplements as preventive agents against cardiovascular disease among those with established vascular disease or those at high risk,” reported Dr. Christine M. Albert of the division of preventive medicine at Brigham and Women's Hospital, Boston.

“The combination of folic acid, vitamin B₆, and vitamin B₁₂ did not reduce risk of total cardiovascular events or any of the individual secondary end points among 5,442 women at high risk for cardiovascular disease over a very long follow-up of 7.3 years,” she said.

In WAFACS (Women's Antioxidant and Folic Acid Cardiovascular Study), 5,442 female health professionals participating in another randomized trial of antioxidant vitamins (WACS) were randomly assigned to a combination of folic acid (2.5 mg daily), vitamin B₆ (50 mg daily), and vitamin B₁₂ (1 mg daily). These women were considered to be high risk based on either a confirmed history of cardiovascular disease or the presence of at least three cardiovascular disease risk factors, including hypertension, hypercholesterolemia, diabetes, current smoking, body mass index higher than 30 kg/m

After a mean follow-up of 7.3 years, 796 women (14.6%) had a confirmed cardiovascular event. In the intention-to-treat analysis, the cumulative incidence of the primary end point did not differ between those given active folate treatment and those given folate placebo.

“This absence of benefit was observed in all prespecified subgroups including the high-risk primary prevention population,” said Dr. Albert.

The researchers tested whether homocysteine lowering by background folic acid fortification in the food supply, which took effect between 1996 and 1998, might have accounted for the null findings, and found that this was not the case. Homocysteine levels were about 18% lower in the active treatment arm, compared with the placebo arm, but still there was no benefit.

Discussant Dr. Rita F. Redberg considered the question of whether the results of WAFACS can be generalized to men and to the primary prevention setting. If such studies were to be done in those populations, results would be unlikely to differ significantly from those seen in this trial, she said.

“Study after study has failed to find a benefit from dietary supplements, and I think there's just no getting away from an emphasis on a heart-healthy diet and regular physical activity,” concluded Dr. Redberg, director of women's cardiovascular services at the University of California, San Francisco.